ASA Dues-paying Members only -
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ASA Dues-paying Members only -
Exclusive educational opportunity for ASA dues-paying members details on page 2 ► Take Advantage of This Special Offer for ASA Dues-Paying Members Only CSFAs: Earn more than 10% of your recertification requirements for only $1.50/per credit* For only $15 you will receive: Targeted Information ∎∎ Authored by experienced surgical personnel—from veteran CSTs, CSFAs, MDs and PhDs ∎∎ Original articles—not generically published for the mass health care audience ∎∎ Information that is targeted to You and what you as a surgical assistant need to know to provide the highest quality care to your patients. Topics Related to the Advanced Practitioners ∎∎ These articles are written for the advanced practitioners for advanced practitioners ∎∎ Innovative Instrumentation and technologies ∎∎ Ethical considerations ∎∎ Safety in the OR ∎∎ Trends in surgical patient care Learning Objectives Each article includes five learning objectives that have been developed by surgical assistant practitioners. The objectives highlight the salient points of each article. You can use the objectives to evaluate your level of comprehension while reading. Professional Exams The tests that follow each exam specifically address the information in the article and were designed to evaluate your comprehension and retention of the information presented by the individual author. Instructions for completing the online booklet 10 CEs Table of Contents Hernias of the Abdominal Wall: Inguinal Anatomy in the Male . . . . . . . . . . . . . . 3 Hazards of Vaporized Tissue Plume . . . . . . . . . . 6 Tourniquet safety: Preventing skin injuries . . . . . . . . . . . . . . 10 Understanding anaphylaxis . . . . . . . . . . 16 Electrosurgery . . . . . . . . 20 Blood Clotting Mechanism . . . . . . . . . . 25 Bioethics in Solid Organ Transplantation . . . . . . . 30 Maintaining Patient Confidentiality: HIPAA Compliance . . . . 36 Radiation Risk . . . . . . . . 46 Birmingham Hip Resurfacing . . . . . . . . . . 51 CSFAs should download and read the articles; and answer all exam questions. The interactive answer sheet should be completed and submitted with payment. If you click the appropriate response on the individual exam after each article, your answer will be automatically transferred to the answer key. If preferred, download the answer sheet, fill it out completely. Indicate type of credit card or include a check. To fax: send it to 303-694-9169. To mail: ASA: Attn: CE credits, 6 West Dry Creek Circle, Ste 200, Littleton, CO 80120. CSAs and SA-Cs should follow the policies of the NSAA and ABSA accordingly. *Based on 75 CE credits in a four-year cycle for the CSFA. 2 Association of Surgical Assistants ∎ www.surgicalassistant.org ∎ Table of Contents Hernias of the Abdominal Wall: Inguinal Anatomy in the Male by Bob Caruthers, CST, PhD, FAST Learning objectives: 1. Review groin anatomy. 2. Define the differences between direct and indirect hernias. 3.Understand the significance of inguinal ligament. 4.Explain the importance of the transversalis fascia. 5.List the contents of the inguinal canal. The surgical repair of an inguinal hernia, although one of the most common of surgical procedures, presents a special challenge: Groin anatomy remains one of the more difficult topics to master for both the entry-level student and the first assistant. This article reviews the relevant anatomy of the male groin. Major Fascial and Ligamental Structures The abdominal wall contains muscle groups representing two broad areas: anterolateral and posterior. The posterior muscles, the quadratus lumborum, do not concern us in this discussion. The anterolateral group consists of two muscle groups whose bodies are near the midline and whose fibers are oriented vertically in the standing human: the rectus abdominis and the pyramidalis. The muscle bodies of the other three groups are more lateral, have significantly larger aponeuroses, and have obliquely oriented fibers. These three groups contribute the major portion of the fascial and ligamental structures in the groin area.1,2,3 At the level of the inguinal canal, the layers of the abdominal wall include skin, subcutaneous tissue (Camper’s and Scarpa’s fascia), external oblique fascia, cremasteric muscle fibers, spermatic cord structures, the transversus abdominis aponeurosis, the transversalis fascia, preperitoneal tissues, and peritoneum.1,2,3 External Abdominal Oblique Muscle The external abdominal oblique muscle is the most superficial, thickest, and largest of the anterolateral muscle groups. The muscle body is found laterally, having a strong, flat aponeurosis occurring anteriorly. The external abdominal oblique muscle arises from the lower outside border of the lower eight ribs. Fibers from the bottom two ribs insert 3 in the iliac crest, while fibers from the upper six ribs course downward obliquely and anteriorly to become the external oblique aponeurosis. The aponeurotic fibers from each side interlace with fibers from the opposite side in the linea alba. Fibers of the external abdominal oblique fuse with fibers from the underlying internal abdominal oblique to form the sheath of the rectus abdominis muscle.1,2,3,4 Inguinal Ligament In the groin area, a continuation of the aponeurosis of the external abdominal oblique stretches from the pubic tubercle to the anterior-superior iliac spine. This extension is a rolled-under, inferior margin of the aponeurosis of the external abdominal oblique and is called the inguinal (Poupart’s) ligament. This ligament marks, in the groin, the separation between the abdominal wall and the lower limb. Hernias that occur immediately above this ligament are considered to be in the inguinal area, while hernias existing below the ligament are called femoral hernias. The more medial of the rolled-under fibers of the inguinal ligament flatten into a horizontal shelf. These fibers attach to the os pubis, and this continuation of the inguinal ligament is called the lacunar (Gimbernat’s) ligament. The spermatic cord, which courses through the inguinal canal, rests on the lacunar ligament until it turns to exit through the superficial inguinal ring. Fibers that continue laterally along the anterior border of the superior ramus of the pubis contribute to the pectineal (Cooper’s) ligament.1,2,3 Internal Abdominal Oblique Muscle The internal abdominal oblique muscle—as the middle one of the three flat abdominal muscles—is a thin, muscular sheet arising from the posterior layer of the thoracolumbar fascia, the anterior two-thirds of the iliac crest, the lateral two-thirds of the inguinal ligament, and the iliacus fascia. Posterior fibers ascend vertically to the inferior borders of the lower 3 or 4 ribs, while the other fibers spread fan-like in a forward and medial fashion. The ultimate insertion of these fibers is the linea alba and the pubic bone. In the upper abdomen, the internal abdominal oblique aponuerosis splits at the linea semilunaris, having an anterior and posterior sheath. In the lower quarter of the abdomen, the aponeurosis does not split, but masses to the midline, anterior to the rectus abdominis muscle. The lower Hernias of the Abdominal Wall: Inguinal Anatomy in the Male fibers arch over the spermatic cord and insert in the superior border of the pubis. These fibers join with similar fibers from the transversalis muscle to form the falx inguinalis.1,2,3 Cremaster Muscle and Fascia The cremaster muscle originates from the inferior margin of the internal abdominal oblique muscle and forms part of the coverings of the cord and testis: It underlies the external spermatic fascia and serves as the middle one of the three covering layers of the cord and testis.1,2 Transversus Abdominis Muscle The transversus abdominis muscle is the innermost of the flat muscles of the abdomen, having an extensive and varied origin in the cartilages of the six lower ribs, the thoracolumbar fascia, the iliac crest, and the inguinal ligament. The internal surface of the muscle is lined by the tranversalis fascia.1,2,3 Transversalis Fascia The endoabdominal fascia forms a continuous lining of the abdominal cavity. When this fascia lies deep to the transversus abdominis muscle, it is labeled “transversalis fascia.” When the endoabdominal fascia is intact, no hernia exists; therefore, all hernias in the groin represent a defect in the transversalis fascia. This fascia is attached to the iliac crest and descends upon the iliac fascia, serving as the superior fascia of the pelvic diaphragm. The internal spermatic fascia is the principal outpouching of the transversalis fascia; its mouth is the deep inguinal ring.1,2,3 Inguinal Canal The inguinal canal is approximately 4-cm long and obliquely oriented; it lies 2 cm to 4 cm above and parallel to the inguinal ligament. Entrance to the canal is the deep inguinal ring found above the midpoint of the inguinal ligament. The deep inguinal ring is not truly “ring-like,” but a fingerlike diverticulum of the transversalis fascia. The canal is directed lateral to medial, deep to superficial, and cephalad to caudad, exiting at the superficial inguinal ring occurring above and lateral to the pubic tubercle. Whereas the superficial boundary of the canal is formed by the external oblique aponeurosis, the most cephalad wall is formed by the internal oblique and tranversus muscles, along with aponeurotic fibers from each. The inferior wall is formed by the inguinal and lacunar ligaments; the posterior wall—sometimes called the “floor”—is formed by the transversalis fascia and transversus abdominis muscle. In the male, the contents of the inguinal canal include the vas deferens; deferential artery and vein; testicular artery; lymphatics; autonomic nerves; the ilioinguinal nerve and genital portion of the genitofemoral nerve; and the cremaster artery, which is a branch of the inferior epigastric artery.1,2,3,4 4 Inferior Epigastric Vessels The external iliac arteries supply blood to the legs, and the internal iliac arteries supply the pelvis and perineum. The external iliac artery passes under the inguinal ligament at a point midway between the anterior-superior iliac spine and the symphysis pubis: At that crossing point, it becomes the femoral artery. The external iliac artery follows the medial border of the psoas muscle, giving off several branches. The inferior epigastric artery branches from the external iliac artery just above the inguinal ligament and has its origin at the medial border of the deep inguinal ring. The spermatic cord passes behind and lateral to the epigastric artery and vein. By using three points—the inferior epigastric artery and vein, the symphysis pubis, and the rectus abdominis muscle as it reaches the midline of the abdomen—one can create an imaginary triangle called “Hesselbach’s triangle,” which is used to determine whether a hernia is considered direct or indirect.1,2,3 Inguinal Hernias Several schemes are used to describe hernias: One of the more traditional distinctions made when referring to inguinal hernias is that between direct and indirect hernias. The indirect inguinal hernia is characterized by a herniation of abdominal contents into an unobliterated vaginal process within the coverings of the spermatic cord that begins at the deep inguinal ring. The structures traverse the inguinal canal to emerge at the superficial inguinal ring, and the contents may descend into the scrotum. The direct inguinal hernia, which occurs one-third as frequently as the indirect hernia, develops secondarily to a weakness in the superficial inguinal ring and the abdominal wall lateral to the falx inguinalis. The inferior epigastric artery lies lateral to the mass; that is to say, the mass occurs in Hesselbach’s triangle. The covering layers of this type of hernia are those of the abdominal wall. The techniques of hernia repair are beyond the scope of this review, but the Certified Surgical Technologist will recognize that the various methods of repair tend to make use of different ligaments to reconstruct an intact and sufficiently strong transversalis fascial plane.1,2,3,4 References 1. Woodburne RT, Burkel WE. Essentials of Human Anatomy. 8th ed. New York, NY Oxford University Press, 1988. 2. Wantz GE. Open Repair of Hernias of the Abdominal Wall. Scientific American CD-ROM. Scientific American Inc, 1997. 3. Netter F. A Guide to the Interactive Atlas of Human Anatomy. Summit, NJ: Ciba-Geigy Corporation, 1995. 4. Sabiston DC. Textbook of Surgery: The Biological Basis of Modern Surgical Practice. Philadelphia, Pa: W.B. Saunders Co, 1997. Hernias of the Abdominal Wall: Inguinal Anatomy in the Male CE Exam: Hernias of the Abdominal Wall: Inguinal Anatomy in the Male 1. Those fibers of the external abdominal oblique muscle that arise from the bottom two ribs insert in the , while the fibers arising from the upper six ribs become the external oblique aponeurosis. 6. The layer represents the middle one of the three covering layers of the cord and testis. A superior ramus of the pubis B anterior surface of the xiphoid process C iIiac crest D superior border of the pubis 7. The deep inguinal ring, the entrance to the , is described as . 2. In the abdominal wall, the two anterolateral muscle groups whose fibers are vertically oriented are the . A pyramidalis and transverses abdominis B external and internal abdominal oblique C quadratus lumborum and transversus abdominis D rectus abdominis and pyramidalis 3. In the upper abdomen, the internal abdominal oblique aponeurosis splits at the , with a/an sheath. A linea alba; anteriorsuperior B linea semilunaris; anterior and posterior C costal margin; inferolaretal D margin of the xiphoid process; superolateral 4. The ligament marks the separation between the abdominal wall and the lower limb; hernias occurring below it are called hernias. A pectineal; unobliterated B Gimbernat’s; endoabdominal C lacunar; inguinal D inguinal; femoral A transversalis fascia B external spermatic fascia C cremaster muscle and fascia D internal spermatic fascia A falx inguinalis; sickle‑shaped B inguinal canal; a diverticulum C femoral canal; ring-like D iliopubic tract; an invagination 8. Three points create Hesselbach’s triangle: the symphysis pubis, the inferior epigastric vessels, and the . A falx inguinalis B rectus abdominis at the midline C linea alba D deep inguinal ring 9. The inguinal canal A contains the elements of the spermatic cord. B serves strictly as a passageway for the lymphatics and blood vessels. C excludes the elements of the spermatic cord. D has an inferior wall that is also known as the “floor.” 10. The type of hernia that occurs in Hesselbach’s triangle is a/an hernia. A indirect B unobliterated C direct D diverticular 5. A groin hernia represents a defect in the fascia. A transversalis B thoracolumbar C cremaster D extraperitoneal 5 Hernias of the Abdominal Wall: Inguinal Anatomy in the Male Hazards of Vaporized Tissue Plume by Kevin W Gracie, CST, CSFA Learning objectives: 1. Summarize the health concerns caused by laser plume 2. Define and analyze vaporized tissue plume 3.Identify the chemical and biological byproducts in laser plume 4.Examine the recommended clinical practice guidelines 5.Evaluate the methods for removal of airborne contaminants While the medical use of cautery for the treatment of hemorrhage and lesions has been documented since 3000 BCE, it was not until the early 1800s when newly discovered electricity was used to heat a probe for cauterization. In 1936 the first practical electrosurgical unit (ESU) was designed by WT Bovie and used by the famed neurosurgeon Harvey Cushing. Since the ESU has become recognized as an invaluable tool in medicine and widely accepted, its use has been estimated in 90 percent of the 24,000,000 cases performed each year. For the surgical team, the inhalation of vaporized tissue plume is routine and has been accepted as part of the working environment. Occasional upper respiratory tract and ocular irritation is expected. Additionally, the view of the surgical field may be temporarily obstructed by the plume, causing minor delays.1,7 It was not until laser surgery became popular in the 1980s that concerns grew about the laser plume’s content. Coincidentally, this was about the same time the true hazards of tobacco smoke became evident to the general public. Research studies were conducted in the early 1980s to determine the content of plume, as well as the potential hazard of exposure to the pungent white/gray billow that emanates from both the laser and the ESU as it cuts and cauterizes tissue. Researchers were able to identify chemical byproducts contained in the vaporized tissue plume and noted that particle size in the plume ranged from 0.1 to 0.8 microns. (Standard surgical masks are capable of 5.0 micron particle diameter filtration.)7 Research also demonstrated that exposure to laser plume caused pathological changes in the lungs of rats and that a carbon dioxide laser could vaporize intact DNA from the human papilloma virus (HPV).7 6 An increase in the number of procedures that can be performed endoscopically prompted additional research in the 1990s. This research demonstrated that: ∎∎ plume within the abdominal cavity reduced the oxygen-carrying capacity of the blood due to an increase in methemoglobin. ∎∎ HIV DNA was detected in laser plume in culture on the 14th day. As a result of these findings, the National Institution for Occupational Safety and Health (NIOSH) issued a hazard control statement that calls for evacuation of plume generated by electrosurgical units and lasers.7 Vaporized tissue plume Vaporized tissue plume is the term commonly used to describe the smoke generated when tissue (including bone) is thermally destroyed and vaporized through the use of the ESU or the laser. However, when discussing plume, it is important to include the smoke and aerosol that is formed with the use of power instrumentation, such as saws, drills, and reamers, and devices that produce pulsatile lavage. Even if proper cooling techniques are used, power instrumentation can produce a vaporized tissue plume, and aerosol formation is likely with pulsatile lavage devices. Although, aerosols may not contain the byproducts associated with smoke, they must be considered airborne contaminants and treated accordingly. Whatever the original source, all vaporized tissue plume is similar in content.2 The plume has been shown to contain more than 600 components (Table 1), some of which are known to be toxic, mutagenic, and carcinogenic. Among the known hazards is benzene, which is documented as being a trigger for leukemia.7 Precautions are mandated in OSHA’s booklet, “Health Hazards of Benzene.” For more information about the other hazardous components of plume, refer to www.osha-scl.gov or the hospital’s Material Safety Data Sheets (MSDS). One study comparing cigarette smoke to laser-generated smoke, demonstrated that 1 gram of tissue cut with the carbon dioxide laser was found to have the same harmful potential as smoking three unfiltered cigarettes.7 More recent studies have been directed toward the possibility of active/viable microbial cells within the plume. Transmission by inhalation has been reported, and in one Hazards of Vaporized Tissue Plume Table 1 Chemical and biological byproducts found in vaporized tissue plume 2,4,5,7,8 ∎∎ ∎∎ ∎∎ ∎∎ ∎∎ ∎∎ ∎∎ ∎∎ ∎∎ Acetonitrile Acetylene Acrolein Acrylonitrile Alkyl benzenes Benzene Butadiene Butene Carbon monoxide ∎∎ Carbonized cell fragments ∎∎ Creosols ∎∎ Ethane ∎∎ Ethene ∎∎ Ethylene ∎∎ Formaldehyde ∎∎ Free radicals ∎∎ Gasses ∎∎ Hydrogen cyanide case, a 44-year-old laser surgeon developed laryngeal papillomatosis. Biopsies revealed HPV DNA types consistent with the anogenital condylomas lased from his patients. Another report involved a patient who underwent laparoscopic resection of an intraabdominal tumor. The patient later developed trocar site metastasis, suggesting that active cancer cells in the smoke may have attached to the trocar, which were transferred to the tissue as the trocars were removed. Also under investigation is the potential build up of carbon monoxide within the patient’s abdomen and its potential to reach a toxic level. As studies continue to pinpoint potential vaporized tissue plume hazards, steps must be taken to protect the surgical team members (including auxiliary personnel) and the patient from exposure. Patients undergoing laparoscopic procedures and receiving general anesthesia alternatives are at highest risk. Recommended clinical practice guidelines Recommended clinical practice guidelines, presented in Table 2, are a combination of recommendations from the American Society for Laser Medicine & Surgery, the National Institute for Occupational Safety and Health (NIOSH), the Occupational Safety & Health Administration (OSHA—US Department of Labor), and the Ontario Ministry of Labour (Canadian Centre for Occupational Health and Safety). Please note that these are recommendations, not requirements. Currently, there are no standards specific to vaporized tissue plume; however, compliance with specific standards is applied to certain situations.5 Examples include: ∎∎ Standard Precautions are used in all patient-care situations in which blood, any body Xuid, secretion, or excretion (with the exception of sweat), non-intact skin, and mucous membranes may be encountered. 7 ∎∎ Isobuteine ∎∎ Methane ∎∎ Microbial cellular DNA constituents ∎∎ Organic vapors ∎∎ Particulate matter ∎∎ Phenol ∎∎ Polycyclic aromatic hydrocarbons ∎∎ Propene ∎∎ ∎∎ ∎∎ ∎∎ ∎∎ ∎∎ ∎∎ ∎∎ ∎∎ Propylene Pyridine Pyrrole Styrene Toluene Trace toxic gasses Viral fragments Water vapor Xylene ∎∎ General Duty Clause 5(a)1 OHS Act of 1970 states the duties of the employer and responsibilities of the employee in reference to workplace hazards. ∎∎ OHSA Standard 1910.134(a)(1) Respiratory Protection’s primary objective is to control occupational diseases caused by breathing air contaminated with harmful substances. This is to be accomplished through accepted engineering controls if feasible or through the use of appropriate respirators. (Note: surgical masks used to prevent contamination of the patient are not certified for respiratory protection of medical employees.) ∎∎ OSHA Standard 1910.1030(d)(3)(i) Blood-borne Pathogens states that the employer must supply appropriate personal protective equipment, such as gloves, gowns, masks, and eye protection. This standard would apply if such items become contaminated with viable blood-borne pathogens from vaporized tissue plume. Methods for removal Two main methods are used to remove airborne contaminants from the operating room. 1. Room-air exchange systems, such as laminar Xow, are not sufficient to capture vaporized tissue plume at its point of origin. The surgical team and patient have already been exposed to the contaminants prior to their removal from the operating room. 2. Local exhaust ventilation offers several methods to capture vaporized tissue plume at its point of origin. Ideally, the local exhaust-ventilation system is composed of an inlet nozzle or tip, hose, filter, and suction unit. A.Hand-held wand attached to a suction device. This technology has been available for more than a decade and is effective only when the surgical first assistant is able to hold the device in close proximity to the plume’s point of origin. Hazards of Vaporized Tissue Plume Table 2 Clinical practice guidelines 1,4,5,6 1. Vaporized tissue plume (from any source) should be considered potentially hazardous for two reasons: A.Presence of particulate matter B.Presence of infective agents 2. Vaporized tissue plume should be collected by an appropriate mechanical evacuation system at all times. Ideally, the evacuation system will: A.Have a high flow volume. B.Be vented outdoors. C.Contain an appropriate filter (HEPA, highefficiency particulate air, or ULPA, ultra-low penetration air, used with charcoal) that has the ability to detect overloading and is subject to frequent filter changes. D.Allow placement of the evacuator nozzle/tip as close to the point of origin of the vaporized tissue plume (2-5 cm) as possible. E. Treat disposable components as biohazardous material, as needed. F. Have non-disposable components sterilized prior to reuse, as needed. G.Be maintained according to the manufacturers recommendations. 3. Personal protective equipment is required in all situations that vaporized tissue plume is generated. A.Appropriate clothing—fluid-resistant or fluidproof long-sleeve apron or surgical gown. B.Eye protection—sufficient to protect from splatter. C.Mask—effective filtration or respirator. D.Gloves—latex preferred or suitable substitute. 4. Smoke evacuation should be carried out independently of fluid aspiration B. An adhesive device attached to the patient’s skin or the drapes. This new technology does not require any additional intraoperative handling once positioned and allows for capture, filtration and deodorization of vaporized tissue plume. C.A device that is attached to the outXow port during laparoscopy. This is another new technology that does not require additional intraoperative handling once positioned. It also allows for capture, filtration and deodorization of vaporized tissue plume. The most effective protection against vaporized tissue plume at this time is a high-Xow smoke evacuator that cap- 8 tures smoke at its point of origin. Currently in use are several systems such as the Stackhouse high-Xow evacuator, the Sun Medical SFE-200, and the JLJ Medical Devices International, LLC, Plume-Away. As concern grows over vaporized tissue plume generated during surgery, additional research is necessary, current methods for evacuation must be evaluated, and new evacuation systems must be developed to protect the patient and surgical team from exposure. About the author Kevin Gracie is a self employed CST, CSFA and has provided surgical assistant services to 11 hospitals and clinics in the Minneapolis/St Paul metropolitan area since 1994. Previously, he was a surgical assistant for 15 years at the Institute for Low Back Care. References 1. Longmire A. “Control of Smoke from Laser/ Electric Surgical Procedures.” NIOSH Hazard Controls. www.cdc.gov/niosh/hc11. html Accessed 12-1-00 2. Dikes C. Is it Safe to Allow Smoke in Our Operating Room? Today’s Surgical Nurse—Innovations in Perioperative Nursing. Vol 21, No 2, March/April 1999. 3. Hallmo P, Naess O. “Laryngeal papillomatosis with human papillomavirus DNA contracted by a laser surgeon.” European Archives of Otorhinolaryngology. 1991. 4. Laser Plume in Surgical Procedures. Information Alert Ontario Ministry of Labour/Canadian Centre for Occupational Health and Safety. August 19, 1992. www.ccohs.ca/otherhsin fo/alerts/ alert61.txt Accessed 12-1-00 5. Laser/Electrosurgery Plume. OSHA Technical Links. www.osha-slc.gov/SLTC/laserelectrosurgery plume/index.html Accessed 12-1-00 6. Smoking Guns—Part 1 and Part 2. The American Society for Laser Medicine & Surgery Inc. www.aslms.org/general-smokeguns1.htm and www.aslms.org/general-smokeguns2.htm Accessed 12-1-00 7. Surgical Smoke Plume Infection Control Newsletter. Vol 5, No 2, May 1997. www.uhealth net.on.ca/infection/surgicalsmokeplume. htm Accessed 12-1-00 8. Schultz L, Drogue J. “Unique Devices for EVectively Removing Surgical Plume.” Viewpoint. Surgical Services Management. Vol 6, No 4, April 2000. Additional links A. The OSH Act Public Law 91-596. 91st Congress, S.2193, December 29, 1970. www.osha-slc. gov/OshAct_data/OSHACT. html Accessed 12-1-00 B. OSHA Standards Interpretation and Compliance Letter 4/18/1996—Hazards of Smoke Generated from Surgical Procedures. www.osha-slc.gov/OshDoc/Interp_data/I19960418E. html Accessed 12-1-00 C. OSHA Standards—Respiratory Protection. www.osha-slc.gov/ OshStd_data/1910_0134.html Accessed 12-1-00 D. OSHA Standards—Blood-borne Pathogens. www.osha-sslc.gov/ OshStd_data/1910_1030.html Accessed 12-1-00 Hazards of Vaporized Tissue Plume CE Exam: Hazards of Vaporized Tissue Plume 1. Which is most effective for removing vaporized tissue plume at its origin? 6. Vaporized tissue plume should be considered hazardous for two reasons: A Room-air exchange system B Regular suction A foul odor and eye irritant B eye and respiratory irritant C High-flow smoke evacuator D None of the above C particulate matter and infective agents D skin and respiratory irritant 2. When did plume awareness intensify? 7. Standard precautions are implemented A 3000 BCE B 1980’s C 1936 D 2001 A Only when the patient is known to be infected B Only when exposure to blood is expected C Only when you touch the patient’s intact skin D In all patient care situations in which blood, any body fluid, secretion, or excretion, non-intact skin, and mucous membranes may be encountered 3. The term vaporized tissue plume is used to describe smoke generated by . A electrocautery B laser C power instrumentation (bone saw) D All of the above 4. Which of the following statements concerning vaporized tissue plume is true? A Despite the source, all vaporized tissue plume is similar in content B plume from lased tissue is the most dangerous C plume from the electrosurgical unit is the most dangerous D Vaporized tissue plume poses no threat 5. Why is the patient receiving a general anesthesia alternative at higher risk for exposure to vaporized tissue plume? A They receive 100% oxygen via the ventilator B They are closer to the point of origin of the plume C They are breathing “room-air” D They are at no higher risk than a patient undergoing a general anesthetic 9 8. OSHA Standard 1910.134(a)(1) Respiratory Protection is concerned with A Controlling occupational diseases caused by breathing air contaminated with harmful substances B Protecting yourself from TB C Protecting the patient D Forcing surgical from community acquired personnel to wear infections respirators in all patient care situations 9. Appropriate PPE when exposure to vaporized tissue plume is expected includes: A Appropriate clothing B Face and eye protection C Gloves D All of the above 10. Standard surgical masks are capable of filtering particles. A 2–5 cm B 5 microns C 0.1–0.8 microns D Standard surgical masks do not contain filters Hazards of Vaporized Tissue Plume Tourniquet safety Preventing skin injuries by James A McEwen, PhD, PEng, Kevin Inkpen, MASc Learning objectives: 1. Identify injuries to the patient that occur underneath the tourniquet cuff. 2. Compare the trial results of five adult volunteers. 3.Evaluate the cuff and limb protection configurations. 4.Understand the importance of maximum wrinkle height. 5.Analyze recommended practices for limb protection. For maximum safety, tourniquet cuff pressure and duration should be minimized and skin integrity under the cuff should be maintained.1 Cuff pressure can be minimized by selecting the widest, best fitting cuff for the chosen limb location1,2,3 and by setting the cuff at the patient’s limb occlusion pressure (LOP) plus a safety margin, typically recommended to be 40-80 mmHg for a cuff snugly applied to a normal limb of a normotensive patient.2 Even when cuff fit and pressure are ideal, however, injuries to the skin underneath the cuff, such as indentation, redness and blistering, can still occur.4,5,6 Stockinette or cotton-cast padding is commonly used between the cuff and the skin to help prevent these injuries. Present recommended practices for the operating room state, “Manufacturers’ instructions may suggest that a soft, wrinkle free padding (eg cotton-cast padding, stockinette) be wrapped smoothly around the limb…” Yet related educational material states, “Do not use cotton-cast padding, sheet padding, Webril,™ or any other material that may shed loose fibers; lint from these materials can become embedded in the contact closures and reduce their effectiveness.”7 Some manufacturers make no specific recommendations about underlying padding, leaving the user with no clear guidance on the best limb protection technique. Limb protection sleeves of various types have recently been introduced by other disposable cuff manufacturers; for example, one brand is supplied with a four-layer, loose fitting stockinette sleeve, and the user is instructed to “wrap the area with a stockinette sleeve.” In the literature, there is currently no quantitative comparison of the severity of wrinkling and pinching of the skin under different cuff and 10 limb protection combinations, so it is not clear what type of limb protection minimizes the risk of skin damage, and the question of which technique to use remains unanswered. This question particularly concerns operating room staff who are often responsible for tourniquet application. To answer this question, we have developed a technique of making and analyzing an imprint of the cuff-to-skin interface to quantitatively compare wrinkling and pinching of the skin under various types of padding or limb protection. We have recently described this technique and reported results on pediatric subjects.8 In this article, we present the results from multiple trials on five healthy adult volunteers to demonstrate: ∎∎ a first brand of disposable cuffs applied directly to the bare skin. ∎∎ the same cuffs used with cotton-cast padding. ∎∎ a second brand of disposable cuffs with a built-in layer of ‘gel’ padding applied directly to the bare skin. ∎∎ a third brand of disposable cuffs used with the stockinette sleeve supplied with each cuff. ∎∎ the first brand of cuffs used with tubular elastic material sleeves matched specifically to these cuffs. Our hypothesis is that some types of cuff/ padding combinations will cause substantially less severe wrinkling and pinching of the skin than others. Method The University of British Columbia granted ethical approval for this study. To approximate the deformation of the skin surface in contact with the cuff or padding, we placed a layer of modelling clay sheet (Model Magic, Binney & Smith Canada, Lindsay Ontario Canada, extruded through rollers to a uniform 2.5 mm thickness and covered with a single layer of plastic film) on the limb of the subject. An experienced technician applied the limb protection or padding (if used) and cuff ensuring that the overlap of the cuff was positioned over the modelling clay sheet. The cuff was inflated to 200 mmHg for one minute, deflated, and removed. The modelling clay sheet (now imprinted with the texture of the cuff or padding on the top surface and the skin texture on the underside) was removed, allowed to dry, and bonded skin side down to a flat plastic card using double-sided tape. The top surface (cuff/padding imprint) of the mounted mold was then digitized in a 5 mm proximal-distal (PD) Tourniquet Safety: Preventing Skin Injuries Table 1 Cuff and limb protection configurations Configuration Description Cuff A, Bare Disposable Cuff A (no limb protection supplied). No limb protection used. Cuff A, Two layers cast pad Disposable Cuff A (no limb protection supplied). Two layers of cast padding used. Cuff B (Gel) Disposable Cuff B with built-in ‘gel’ padding. No limb protection used. Cuff C, Four layer stockinette Disposable Cuff C. Four-layer stockinette sleeve (as supplied in the sterile package with the cuff) used. Cuff A, matching Two layer elastic sleeve Disposable Cuff A (no limb protection supplied). Two layer tubular elastic bandage sleeve (matched to specific tourniquet cuff) used. Table 2 Wrinkle and pinch maximum height and sum of heights results (mm) Trial Cuff A, bare Cuff A, two layers cast pad Cuff C, four-layer stockinette Cuff B (gel) Cuff A, matching two-layer elastic sleeve Max Sum Max Sum Max Sum Max Sum Max Sum Subject A, L thigh 3.08 122.80 6.23 194.3 3.20 154.3 1.70 18.0 1.45 4.88 Subject A, R thigh 4.68 151.2 3.08 63.5 3.53 85.0 2.50 37.0 0.00 0.00 Subject A, L arm 2.70 173.1 1.78 8.7 6.23 123.0 0.00 0.0 0.00 0.00 Subject B, R thigh 5.18 138.1 2.43 75.7 2.38 44.6 0.00 0.0 0.00 0.00 Subject B, L arm 2.03 24.4 1.63 32.3 2.95 68.6 1.40 3.6 0.00 0.00 Subject C, R thigh 1.63 82.5 2.48 83.6 4.65 69.7 1.65 12.8 0.00 0.00 Subject C, L arm 2.55 134.9 2.10 69.6 3.65 114.5 1.38 3.6 0.00 0.00 Subject D, R thigh 2.20 58.0 1.48 25.4 4.13 80.8 2.15 9.8 0.00 0.00 Subject D, L arm 2.15 67.75 2.15 64.9 3.00 62.4 1.58 13.1 0.00 0.00 Subject E, R thigh 3.93 117.9 3.13 64.7 3.23 43.6 2.58 16.2 0.00 0.00 Subject E, L arm 3.20 76.7 2.90 53.0 4.50 92.3 1.70 13.7 0.00 0.00 by 0.20 mm circumferential grid on a coordinate measuring machine (Picza Pix-3, Roland Digital Group). The resulting section profiles approximate the circumferential profile of the skin surface at 5 mm PD intervals under the cuff. An area of 95 mm (circumference) by 45 mm (PD, 10 sections spaced at 5 mm intervals) at mid-cuff, including the cuff overlap, was analyzed in all trials. 11 Wrinkles in the skin surface are defined as a change in height of at least 1 mm with a slope of 0.25 (1 mm height change for every 4 mm of distance along the skin surface) or steeper, lying within a 10 mm circumferential length of skin surface. Wrinkles less than 1 mm high are ignored. Pinching of the skin, where the skin is gathered by the cuff from a deep level up to a superficial peak and back down again within 20 mm, is counted as two wrinkles. The maxTourniquet Safety: Preventing Skin Injuries imum wrinkle height and the sum of all wrinkles greater than 1 mm high found on each mold are compared. Five healthy adult volunteers with normal skin and muscle tone (medical research center staff members, age 19-46 years, four male, one female) were recruited. Five different cuff/ padding configurations (see Table 1) were chosen for comparison. Each configuration was tested on one arm and both thighs of one subject, and one arm and one thigh of the remaining four subjects for a total of 55 trials. A repeated measures study design is used with five treatments and 11 subjects, where each different limb is considered to be a separate subject. To compare maximum wrinkle heights, rank sums are compared using Friedman’s statistic, and all possible pairs of configurations are compared using a Student-Newman Keuls’ test.9 Wrinkle height sums are compared using the same methods. Results Maximum wrinkle height represents the single most severe wrinkle or pinch found on a sample regardless of the number or height of the remaining wrinkles. The wrinkle height sums provide comparisons of both the severity and quantity of wrinkles and pinches greater than 1 mm high. All test results are listed in Table 2. The two-layer elastic sleeves matched to the specific tourniquet cuffs used produced significantly lower maximum wrinkle heights and lower wrinkle height sums than each of the other configurations (P < 0.01 for all paired comparisons). On 10 of the 11 limbs tested, the two-layer elastic sleeve had no wrinkles or pinches higher than 1 mm (the minimum detectable height). The four-layer stockinette sleeve eliminated wrinkles and pinches higher than 1 mm on two of the 11 limbs tested and was significantly more effective (P < 0.01) than all configurations except the two-layer elastic sleeve. Two layers of cotton-cast padding gave a slight reduction in maximum wrinkle height compared to applying the same cuff on bare skin and applying the ‘gel’ cuff to bare skin (P < 0.05), but did not significantly reduce the sum wrinkle and pinch heights in either case (P > 0.05). The ‘gel’ cuff applied on bare skin produced slightly higher maximum wrinkle and pinch heights (P = 0.05) with no significant reduction in the sum of wrinkle and pinch heights (P > 0.05) compared to a typical cuff (Cuff A) applied on bare skin. Discussion Rudolph et al surveyed 44 clinics in Europe concerning over 75,000 procedures involving tourniquet use (adult and pediatric).4 Tissue damage was reported in 1.4% of lower limb and 0.4% of upper limb cases (usually reddening with blisters). Many cases involve fluids such as antiseptic flowing under the cuff, but the survey indicates that fluid leak- 12 age, excess pressure, excess duration of cuff or a combination of these factors can cause skin damage. Sixty-five percent of the clinics reported using cotton padding material, 20% other types of padding, and 15% no material under the cuff. Choudhary reported a case of friction burns on an adult patient’s leg due to the tourniquet cuff sliding distally off the padding material during the procedure (no fluids were found under the cuff in this case).6 Present recommended practices for operating room personnel, intended as guidelines adaptable to various practice settings, refer clinicians to cuff manufacturers’ recommendations for limb protection.1 However some manufacturers do not make specific recommendations and refer the clinician to the established protocol at their practice setting. There is little discussion in the literature of pinching of the skin or local high pressure areas and shearing stresses caused by wrinkles in the inflated cuff. Pedowitz qualitatively observed a difference in the limb shape and skin ‘ridges’ (pinched areas) on cross-sectional CT views of a rabbit hindlimb under two different cuffs. He noted similar ridges in MRI images of a human thigh under tourniquet pressure, but did not analyze these differences in detail.10 In a brief note on technique, Harland observes that unprotected skin under a cuff can be damaged due to shearing stresses and that stockinette folded back over the cuff is effective as a padding material and in keeping the cuff in position.5 In the current study, we use a quantitative method to compare the severity of wrinkling and pinching of the skin in adults under the inflated cuff. The two-layer elastic sleeves were significantly more effective in eliminating wrinkles and pinches than all other types of limb protection. In this study, a specific size of two-layer elastic sleeve was selected for each cuff size, so the sleeves stretched to about 1.1 to 1.6 times their relaxed circumference when applied to limbs within the recommended size range of the cuff. This applies compression of between 5 and 15 mm Hg to the limb, ‘artificially’ improving the tone of the skin under the cuff and making the skin resistant to being gathered up into a pinch (particularly at the cuff overlap). Although a standard tensor bandage material could be wrapped around the limb to the same effect, the pressure applied to the limb is highly variable depending on operator technique. Such pressures could easily be above typical venous pressure of 20 mmHg, leading to venous congestion if the sleeve remains on the patient after the cuff is deflated. For example, Biehl measured pressures under Esmarch bandages used as ankle tourniquets and found standard deviations of 35 to 53 mmHg in multi-operator tests.11 The four-layer stockinette sleeves, used in this study (supplied with the cuffs), were loose or only slightly stretched and applied negligible compression when used on a limb within the size range of the corresponding cuff. Tourniquet Safety: Preventing Skin Injuries These sleeves provide a ‘padding’ effect due to their thick buildup of material (rather than the ‘toning’ effect provided by the two-layer elastic sleeves). Wrinkling and pinching of the skin is clearly more severe when applying a typical, disposable cuff directly on the patient’s skin, using a two-layer wrap of typical cotton-cast padding under a typical disposable cuff, and using a ‘gel’ cuff directly on the skin. Cast padding may offer some reduction of the maximum pinch or wrinkle height compared to no limb protection or the gel cuff, but the sum of wrinkle and pinch heights is the same among all three methods. The mold material itself may affect pinching of the skin, and at this stage, no attempt has been made to measure differences in the absolute dimensions of irregularities in the skin surface between actual tourniquet use and the molds. Therefore, this method can be used as a comparison measure only (as used in the current study) and serves the purpose of identifying clear differences between limb protection methods. Due to the wide variety of skin properties found among surgical patients, validation of the mold material’s ‘skin-like’ properties would only apply to a certain percentage of patients and would therefore be of limited value. However, to draw conclusions for clinical practice from the current study, it must be assumed that the relative performance of the various methods is similar on actual skin and over the variety of skin types not fully represented by the healthy volunteers. Although the patient population is not fully represented by testing healthy adult volunteers in a controlled laboratory setting, this approach allows a repeated measures study design (in which each subject receives all of the treatments being compared, in this case different cuff/limb protection combinations) which is the most powerful way of comparing treatments. Such repeated cuff applications may not be practical in a clinical setting or with patients having certain health conditions. The detection of irregularities is sensitive to the height, slope, and maximum distance parameters chosen, and results will change with these parameters. The parameters were adjusted by reviewing each section of a variety of molds and confirming that all irregularities that would be subjectively identified on the mold as a wrinkle or pinch were recorded by the data processing routine. The chosen parameters were then used on all molds and each section was reviewed during processing. For future study, an absolute measure of the cuff/skin interface could be made by taking cross sectional images (MRI) of inflated cuffs on limbs and analyzing the wrinkles and pinches using similar criteria to the current study. Clinical observation of the skin condition (pattern of redness and indentation, reports of irritation or rash) of a series of typical patients after tourniquet cuff removal could also be done to make a more representative but less quantitative comparison of limb protection techniques. 13 Survey Results Prior to researching information for this article, the author conducted a qualitative survey of 10 covered entities. Ten survey questions were asked of the individual or group of individuals responsible for setting up the HIPAA compliance program at their facility (Please refer to Appendix 1). Of the 10 facilities surveyed, a single person was responsible for the program at half of the facilities. There were also teams of two at three facilities, one team of three, and one team of four. Of the 10 facilities surveyed, five facilities put the HIPAA compliance program together from scratch, two facilities hired consultants, and three facilities purchased planning kits. Of the two facilities that hired consultants, both were very satisfied with the consultant’s work. Of the three facilities that purchased planning kits, only one was satisfied with the contents of the kit. The most challenging part of program implementation was reported as time constraints by six of the respondents, one reported that choosing a consultant was the most challenging, one reported problems with the print shop, and two reported no challenges. Eight out of 10 facilities reported compliance problems with the physical layout of the facility and nine out of 10 facilities reported problems with personnel not following the regulations. None of the facilities reported performing regular comprehensive evaluations of the HIPAA program and three are not doing any type of evaluation at all. Of the 10 facilities surveyed, only one reported a relevant patient question about HIPAA. Ninety percent of the facilities reported that they had no HIPAA violations that resulted in citations. Conclusions There has been a lack of clear guidelines and published studies in the clinical literature referring to proper limb protection technique under tourniquet cuffs. Our hypothesis that some types of cuff/padding combinations will cause substantially less severe wrinkling and pinching of the skin than others is supported by the current comparative measurements of skin surface deformation. Based on a total of 55 trials of five different limb protection types on the upper arms and thighs of five adults, stretched sleeves made of two-layer tubular elastic material and matched to specific tourniquet cuffs produced significantly fewer, less severe pinches and wrinkles in the skin surface than all other padTourniquet Safety: Preventing Skin Injuries ding types tested (maximum P < 0.01). When using typical disposable cuffs, wrinkling and pinching were clearly more severe with no padding and with two layers of typical cotton-cast padding compared to both the two-layer tubular elastic and the four-layer loose stockinette sleeves (maximum P < 0.01). Cast padding gave only a slight reduction in maximum wrinkle or pinch height (P < 0.05) and did not reduce the overall amount of wrinkling significantly (P > 0.05) compared to applying the same cuff on bare skin. A new disposable cuff with built-in gel padding applied on the bare skin was worse or not significantly different than the typical disposable cuff applied over either bare skin or cast padding. Acknowledgements The authors would like to thank Kathy Bailey RN, Michael Jameson, Ken Glinz, and the volunteer subjects for their assistance with this study. References 1. AORN (Association of periOperative Registered Nurses). “Recommended practices for use of the pneumatic tourniquet.” In: Standards, Recommended Practices, and Guidelines. Denver: Association of Operating Room Nurses, Inc, 2000: 305-309. 2. McEwen JA, Kelly DL, Jardanowski T, Inkpen K. “Tourniquet safety in lower leg applications: Limb occlusion pressure measurement and a wide contoured cuff allow lower cuff pressure.” Orthopaedic Nursing. 21(5); Sept/ Oct 2002 (in press). 3. Pedowitz RA, Gershuni DH, Botte MJ, Kuiper S, Rydevik BL, Hargens AR. “The use of lower tourniquet inflation pressures in extremity surgery facilitated by curved and wide tourniquets and an integrated cuff inflation system.” Clin Orthop. 287 (Feb. 1993) 237-44. 4. Rudolph H, Gartner J, Studtmann V. “Skin lesions after utilization of a tourniquet.” Unfallchirurgie. 1990; 16(5): 244-51 (Abstract in English & German, article in German). 5. Harland P, Lovell ME. “An alternative method of tourniquet padding.” Annals Royal College of Surgery. England 1994; 76(2):107. 6. Choudhary S, Koshy C, Ahmed J, Evans J. “Friction burns to thigh caused by tourniquet.” British Journal of Plastic Surgery. 1998; 51:142-3. 7. Tourniquet Safety Home Study Guide. Warsaw, IN: Zimmer Inc. Denver: Education Design, Inc; 1997. 8. Tredwell SJ, Wilmink M, Inkpen K, McEwen J. “Pediatric Tourniquets: Analysis of cuff/limb interface, current practice, and guideline for use.” J Ped Orthop. 21(5); Sept/Oct 2001: 671-676. 9. Glantz, SA. Primer of Biostatistics. 4th ed. New York: McGrawHill; 1997. 10.Pedowitz RA, Rydevik BL, Gershuni DH, Hargens AR. “An animal model for the study of neuromuscular injury induced beneath and distal to a pneumatic tourniquet.” Journal of Orthopaedic Research. 1990;8(6):899-908. 11.Biehl WC 3rd, Morgan JM, Wagner FW Jr, Gabriel RA. “The safety of the Esmarch tourniquet.” Foot & Ankle. 1993; 14(5): 278-83. Webril is a registered trademark of of Reemay, Inc. 14 Tourniquet Safety: Preventing Skin Injuries CE Exam: Tourniquet Safety: Preventing Skin Injuries 1. Tourniquets are used: A To establish a dry surgical field B To decrease blood loss 6. Which showed no significant reduction in the sum of wrinkle and pinch heights compared to a cuff applied to bare skin? C In conjunction with limb anesthesia D All of the above A Four-layer stockinette sleeve B Gel padding C Two-layer elastic sleeves D Two-layers of cast padding 2. Limb occlusion pressure is defined as: A The minimum cuff pressure required to maintain a bloodless surgical field. B The maximum cuff pressure required to maintain a bloodless surgical field. C High pressure on the limb D The normal blood under a tourniquet pressure of the radial cuff. artery. 3. A wide cuff, plus which setting minimizes cuff pressure? 7. Wrinkle and pinch heights can be affected by: A Mold material B Patient’s skin properties C both D neither 8. If arterial blood flow is observed past the tourniquet cuff: A Increase tourniquet pressure in 25 mmHg increments until flow stops B Decrease tourniquet pressure in 25 mmHg increments until flow stops 4. Researchers in this study used molding clay to: C Change padding configuration D Amputate the limb A Approximate the skin profile under the cuff B Measure patient’s LOP 9. Prior to tourniquet inflation,which method is used to exsanguinate the limb? C Decrease wrinkling and pinching D All of the above A elevation B elastic bandage C both A and B D exsanguination is not necessary A Patient’s LOP B LOP minus 40-80 mmHg C LOP plus 40-80 mmHg D 40-80 mmHg 5. Which configuration produced the lowest maximum wrinkle heights and lower wrinkle height sums? A No limb protection B Four-layer stockinette sleeve C Gel padding D Two-layer elastic sleeves 15 10. If a limb protection sleeve is unavailable, which should be used? A Two layers of tubular stocking B Two layers of cotton-cast padding C Two layers of tubular elastic bandage D Either A or C Tourniquet Safety: Preventing Skin Injuries Understanding anaphylaxis by Jessica Gentry Learning objectives: 1. Examine the symptoms that characterize the onset of analphylaxis. 2. Identify some of the causes of anaphylaxis. 3.Understand the characteristics of an anaphylaxic reaction to anesthesia. 4.Evaluate the problems of insect stings and allergic reactions. 5.Explore idiopathic anaphylaxis. In 1972, Jackie Kwan was quietly working on her research, munching on some pistachios a coworker had brought back from the Middle East. After she had gorged herself with pistachios, she decided to take a break and proceeded upstairs to collect her paycheck. By the time she had reached the fourth floor, she began to feel very warm and extremely itchy. At that point, the reaction triggered a memory of when she was a child and the same thing had happened after she had eaten pistachio ice cream. Within 10 minutes, hives had covered her body, making her skin flush and swollen. Along with those reactions, she started to vomit and have diarrhea. She could feel her throat swell and start to close shut. Kwan was indeed having an anaphylactic reaction—an acute, life threatening medical emergency. Her symptoms were classic.3,4 Anaphylaxis Anaphylaxis is a very serious manifestation of the allergic response. It is an Immunoglobulin E (IgE) mediated reaction that results when mast cells suddenly release chemical mediators that overwhelm the body. “IgE antibodies attach themselves to mast cells and basophiles [type of white blood cell], priming the body for the allergic reaction… The released mediators cause blood vessels to dilate and leak fluid into the surrounding tissues and cause smooth muscle in the airways to [constrict].”3,4 Since the skin, respiratory, and digestive tracts are rich in mast cells, the organs of these systems are the ones primarily affected in the reaction. The onset of anaphylaxis is usually sudden. Symptoms usually begin to develop within minutes of exposure to some triggering allergic response that may result in 16 death. “The first symptom is usually a sensation of warmth followed by intense itching. The skin flushes, hives may appear, and the face may swell. Breathing becomes difficult, and the patient may feel faint and anxious. The blood pressure may drop precipitously. Convulsions, shock, unconsciousness, even death may follow. Roughly 60% to 80% of anaphylactic deaths are caused by an inability to breath because of swollen airway passages obstructing airflow to the lungs. The second most cause of anaphylactic deaths, about 24% by one estimate is shock, caused by insufficient blood circulating through the body.”3,4 In the 1900s, Charles Richet and Paul Portier initiated research that ultimately clarified the cause of many mysterious deaths. Richet and Portier studied the toxic qualities of the tentacles of the Portuguese man-of-war. They injected dogs with the different toxins to determine fatal levels and to test whether the animals could build an immunity or tolerance to the toxin. To their surprise, some dogs receiving a second injection at very low, presumably harmless, dosage levels suddenly died. Richet and Portier called this result anaphylactic, meaning “contrary to protection.”3 In the same period, other researchers discovered that anaphylaxis could be caused by nontoxic proteins, including animal blood serum. Richet went on to theorize that some special substances in the blood of sensitized animals must react with the toxin to produce anaphylactic disorder. He was on the right track and, in 1913, his work was recognized with a Nobel Prize. Until the post-World War II era, horse serum, the source of an antitoxin used for diphtheria, scarlet fever, tetanus, and tuberculosis, was found to induce the reaction. Scientists have since discovered that the explosive reaction (anaphylaxis) is the culmination of a complicated sequence of events. Today, human serum is the preferred tetanus treatment. In the meantime, penicillin has become one of the most widely administered drugs in the world and one of the most common causes of anaphylaxis. Causes of anaphylactic reactions The following substances are among those reported to have caused anaphylactic reactions: ∎∎ Antibiotics: penicillin, cephalosporin, tetracycline, nitrofurantoin, streptomycin Understanding anaphylaxis ∎∎ Local anesthetics: more than 100 kinds ∎∎ Anti-inflammatory: aspirin, ibuprofen, indomethacin, fenoprofen, naproxen, tolmetin ∎∎ Enzymes: chymopapain, chymotrypsin, streptok inase ∎∎ Psyllium: present in laxatives and added to cereals ∎∎ Hormones and serum: insulin, ACTH, parathyroid hormone, cortisone, horse antibody ∎∎ Diagnostic agents: iodinated contrast media dyes such as bromsulphalein (BSP) ∎∎ Food: most commonly, peanuts, eggs, fish, shellfish, milk, and tree nuts; less common: grains, seeds and fruits. Anaphylactic reaction to anesthesia Occasionally, a patient will have a severe allergic reaction to a muscle relaxant or other drug used during general anesthesia. This presents a concern, because the patient is anesthetized and the reaction is somewhat difficult to spot unless it shows up clearly in the skin with hives, for example. But an alert anesthesia provider will note a change in the patient’s blood pressure or breathing status, indications that the patient is in trouble, and quick action can be taken. Anaphylaxis occurs in one out of 15,000 instances, but only 3% of anaphylactic reactions during surgery result in death. Most deaths occur among adults, and it seems that the risk of anaphylaxis increases somewhat with age. Heightened sensitivity because of repeated exposure to allergens, plus generally weaker health, account for the greater risk as time goes on. The possibility of an allergic reaction is one of the many reasons to be very conservative in using general anesthesia.3 Anaphylactic reactions to insect stings Insect stings are another (among many) major cause of anaphylactic death. About 40 deaths a year are attributed to insect stings, but many others probably go unrecognized.2 Several studies show that some people have no warning that they may be susceptible to a life-threatening reaction to an insect sting until it occurs. A pharmacist from Los Angeles, who was traveling to a convention in the South several years ago, was driving alone in his car when suddenly a yellow jacket made a direct hit on his face. He flinched, but there was no pain and he kept driving. Five to 10 minutes later, he became hot, his faced puffed up and his chest became tight. He considered pulling over, but realized he needed to get to the nearest hospital, which was about five minutes away. The pharmacist recognized that he must have been having a reaction to the yellow jacket, but never knew that he was allergic at all to any kind of insect. He was treated in time and sustained no major repercussions. Unfortunately, delayed reactions to stings can lead to such serious problems, such as kidney dis- 17 ease, vascular disorders, fever and serum sickness, neuritis, and arthritis-like symptoms. People allergic to insect stings can be desensitized, which usually provides good protection.3 Miscellaneous reactions Surprisingly, everyday foods are a relatively common cause of anaphylaxis. Certain foods, such as nuts, eggs, fish, and seeds, are highly allergenic in some people. Anaphylaxis can occur during the transfusion of blood or blood products, as a result of antigens in the donor’s blood, such as egg protein, to which the patient is sensitive. A drug called protamine sulfate, which is derived from fish sperm, is used to counteract overdoses of the blood thinner heparin. This can cause anaphylaxis in people allergic to fish. Men who are infertile or who have had a vasectomy are commonly allergic to protamine.2,3 Seminal fluid evidently can cause anaphylactic reaction in women. A few cases have been reported and the only protection seems to be the use of a condom. Desensitization is now available experimentally for couples that want and are trying to conceive a child. Latex allergy presents a common problem, particularly among health care workers. Idiopathic anaphylaxis Idiopathic anaphylaxis by definition is a form of anaphylaxis where no identifiable stimulus can be found. The incidence in the United States has been estimated recently at close to 33,000 cases.1,3 A typical case of idiopathic anaphylaxis is that of a healthy 35-year-old woman, in New York City, who on a normal afternoon was speaking on the phone with her stepson, who lived about 20 blocks away. He began to realize that she seemed to be ill and fading, and then she hung up abruptly. He quickly called 911 and arrived to find her unconscious with the paramedics working on her. (Her embarrassed husband, who’d been working in the home office, hadn’t heard a thing until the paramedics knocked on the door). The diagnosis at the hospital was anaphylaxis, but no cause was found. In three years, the incident never recurred, but following the advice of her doctor, the woman carries epinephrine and a card in her wallet identifying her problem. In repeated cases, ongoing doses of antihistamines and even ongoing, alternate-day doses of cortisone are used to try to stop the recurrences.3 Because of the life threatening nature of the reaction, a diagnosis and appropriate treatment including emergency protocols, are critical. To aid in the diagnosis and treatment of idiopathic anaphylaxis, an algorithm, classification system and treatment protocol were developed. Recent analyUnderstanding anaphylaxis sis of this protocol have shown to be both effective in placing a majority of patients into remission and decreasing the number of emergency room visits, hospitalizations, intensive care unit admissions, and high health care cost of undiagnosed and untreated cases. Treatment For almost all varieties of anaphylaxis, there are just two treatments: avoidance and emergency measures. The main exception is insect stings, for which venom immunotherapy can be used. Occasionally, an effort is made to desensitize a drug-allergic person so that the drug can be used in treatment. This must be done under constant medical supervision in an appropriate medical facility.3,4 The key in emergency treatment is injection of epinephrine (adrenalin) as soon as possible after reaction begins. This acts to stop the release of chemical mediators of the allergic reaction, and it buys time to get to the hospital or to call medical personnel to the scene. The patient should be in the ER or under the care of trained medical personnel within five to 15 minutes of the onset of the attack, if possible. A tourniquet can be used in the case of an insect sting on the arm or leg. First, the stinger should be removed. The tourniquet should be applied above the site of the sting and loosened every 10 minutes to allow sufficient blood circulation to the extremity. If possible, a cold pack should also be applied. The cold causes the blood vessels to constrict, which slows the venom from getting into the bloodstream.3,4 Epinephrine injections can be repeated every 15 minutes. Antihistamines may be added. Intravenous medications and fluid replacement are often indicated. Oxygen therapy and the insertion of a tube into the trachea to keep it open are frequently necessary. Corticosteroids are used to prevent a second-phase reaction later. Immunotherapy may be attempted for patients who need treatment with a life saving drug to which they are allergic. Desensitization is managed in a medical facility over a short period of time, beginning with extremely diluted solutions of the allergen. The patient will be monitored closely as the dose is gradually increased, so they may be treated immediately if symptoms occur.3,4 Anyone who has had an anaphylactic attack, perhaps anyone in an isolated household, should have emergency epinephrine in injectable form available. This also applies to patients who are on immunotherapy. An EpiPen is a device patients can easily use in an emergency and is available as an EpiPen Jr for children who have attacks. However, some doctors prefer and recommend the Ana-kit, which contains a syringe and needle and two doses of epinephrine. Antihistamines can be kept on hand, but do not help in life-threat- 18 ening situations. It is more important to use epinephrine and to get to an emergency facility quickly. People should also wear a medic alert bracelet or carry a card stating their allergies, that they have had anaphylaxis, and the cause. “Experts disagree about whether certain individuals are predisposed to anaphylaxis. Many feel that people with a history of allergies are more likely to have an anaphylactic episode. Others are unconvinced that this or other factors (such as age, gender, ethnicity, or geographic location) predispose a patient to it. One thing is clear, previous exposure to allergens usually precedes the anaphylactic reaction. Sometimes people will notice that an allergen makes them feel bad in some way, perhaps mild itching or upset stomach. This may indicate that future exposure will produce a more severe reaction.”3,4 Whatever the reason may be for anaphylaxis, it is a condition that must be taken seriously. About the author Jessica Gentry is a second term surgical technology student at San Joaquin Valley College in Fresno, California. References 1. Cook AR. Allergies Sourcebook. Health Reference Series. Vol 19. Detroit: Omnigraphics Inc; 1997. 2. Young SH, Dobozin BS, Miner M. Allergies The Complete Guide to Diagnosis, Treatment, and Daily Management. New York, New York: Plume; 1999. 3. Young H Stuart, MD. Allergies The Complete Guide to Diagnosis, Treatment, and Daily Management. Consumer Reports Books. Yonkers, New York: Consumer Union of United States, Inc; 1991. 4. Segal M. Anaphylaxis: An Allergic Reaction That Can Kill. US Food and Drug Administration. www.fda.gov/bbs/topics/ CONSUMER/ CON00086.html Accessed 10/14/03 Understanding anaphylaxis CE Exam: Understanding anaphylaxis 1. Which is primarily responsible for an anaphylactic reaction? 6. Delayed reactions to insect stings can lead to . A basophiles B mast cells A kidney disease B vascular disorders C IgE antibodies D none of the above C serum sickness D all of the above 2. The leading cause of death by anaphylaxis is: A convulsions B shock C obstructed airflow D insufficient blood circulating through the body 3. Symptoms of anaphylaxis include A itching and hives B vomiting and diarrhea C swelling and difficulty breathing D all of the above 7. Anaphylaxis from undetermined sources is called . A spontaneous anaphylaxis B necrosis C idiopathic anaphylaxis D immuno anaphylaxis 8. After an anaphylactic reaction,the patient should . A wear a med alert bracelet B carry epinephrine D all of the above 4. A common cause of anaphylactic reactions is: C carry a card with allergy and emergency contact information A penicillin B ibuprofen 9. Which is a false statement about anaphylaxis? C peanuts D all are common causes A After a reaction,the patient will be immune to further anaphylactic episodes. B More than one epinephrine injection may be required to stop the reaction. C Corticosteroids are used to prevent a secondphase reaction. D Immunotherapy may help avoid anaphylaxis in the future. 5. Which is most likely to indicate allergic reaction during surgery? A skin rash B temperature change C change in blood pressure or breathing D none of the above 10. Which is the most helpful in an anaphylactic emergency? 19 A antihistamines B cold packs C epinephrine D a tourniquet Understanding anaphylaxis Electrosurgery by Bob Caruthers, CST, PhD, FAST Learning objectives: 1. Understand the basic terminology related to electrosurgery. 2. Compare electrocautery and electrosurgery. 3.Contrast bilpolar and monopolar techniques. 4.Examine the factors affecting coagulation. 5.Review the four classes of lasers. Common language usage in the operating room uses the term electrocautery as an umbrella term for all-electrical instruments and procedures. This is incorrect and will be clarified in this article. A proper understanding will assist with safe, effective, and efficient usage. Basic terminology The following definitions are necessary to a basic understanding of electrosurgery: ∎∎ Blend: a term that indicates that the electrical current is interrupted between 20-50% of the time. ∎∎ Current: the passage of a given amount of electrons through a conductor over a specified period of time (measured in amperes). ∎∎ Electrical power: watts = volts x current. ∎∎ Electricity: the movement of electrons between two poles that are charged, one positive and one negative. ∎∎ Electron: a particle of positive or negative energy that creates heat as it passes through human tissue. ∎∎ Impedance: the resistance to the flow of electrons to a given conductor. ∎∎ Joules: the total energy consumed or given off over a specified period of time. ∎∎ Resistance: difficulty passing a current through a given conductor (measured in ohms). ∎∎ Sparking: the result of an electrical current flowing through a gas. ∎∎ Voltage: the force required to push electrons through a given the substance (eg human tissue). 20 A conceptual distinction A distinction needs to be made between two terms that are typically used interchangeably in the operating room. Electrocautery refers to the use of a direct electrical current to heat metal. The hot metal is then applied to a tissue, which is cauterized. This is a technique that is no longer employed in the operating room. Electrosurgery refers to the manipulation of the electrons through living tissue, using an alternating current that can cause heat build up in the cell and thereby destroy the cell. A generator is the machine that creates an alternating current at a frequency that does not stimulate muscle activity (500,00-3 million cycles per second). An alternating current is one that flows in one direction and then the other. The current flow increases to a maximum in one direction, which produces a positive peak and then flows backward to the alternate maximum or negative peak. This current produces what is called a “sinusoid” wave. This type of current can be manipulated in such a way that it has different effects upon tissue. The wave type has a positive and negative peak. A measurement to from the positive peak to the negative peak is called peak-to-peak voltage. In order to perform electrosurgery, the alternating current must be manipulated. A wave form that is simple, sinusoidal, undamped (unmodulated), is produced by a continuous energy supply. This current is the cutting current used in electrosurgery. The cutting current does not require a peak voltage as high as the coagulating waveform. One advantage of the coagulation current is that the electrons are pushed through in short bursts. A cooling effect between the electrical bursts allows coagulation to take place. Most of the generators today provide a blended current, which is a result of combining the cutting and coagulation currents. The blended waveform interrupts the current at variable intervals. The effect is to have periods of cutting current and periods of coagulating current. Monopolar/bipolar Modern electrosurgery uses monopolar and bipolar techniques. When using the monopolar technique, current travels through an active electrode and is received at another neutral plate (ground plate) after it passes through the body. In this case, the body serves as the conductor. Since the current is disbursed over both plates, it is of relative low intensity. Heat is generated, because the plates Electrosurgery are of dramatically different sizes. The active electrode is small and capable of creating a current of a sufficient density to cause a burn at the point where the electrons enter the body. Even though the ground plate is larger, burns may be produced at the exit point also. Because the potential for unwanted burns is high, the surgeon should use the lowest setting to accomplish any given task. The surgical team must guarantee that the dispersive electrode is making good contact with the patient and is large enough to prohibit a build up in the current density. Generators Generators are required to produce the current. Those used for surgical purposes can produce about 8,000 volts when they are in the coagulation mode; however, normal usage occurs in the 1,000–3,000 volt range. The generators in current usage are relatively safe. They offer what is called an isolated ground circuitry system, which reduces the chances that the current will seek an alternate path to the ground. The most common system used in the operating room employs disposable return electrodes known as “ground pads.” There is a built-in monitor at the generator that will sound an alarm if an imbalance registers between the two pads or points of contact. The operating room team should remember that the returning electrode must be oriented so that each of the two pads is an equal distance from the operating site. Bipolar electrosurgery A bipolar system incorporates an afferent and efferent electrode into an instrument that has two poles. This eliminates the need for a grounding pad. Bipolar current is pure cutting current. The instrument can produce a high power density at each pole of the forceps. This permits a small amount of tissue desiccation, confined to the shape and size of the forceps at the point it is in direct contact with the tissue. This system eliminates the chance of alternate pathways for the current to flow through. This is a clear advantage over the monopolar system. That said, there are some drawbacks and restrictions on the use of the bipolar system. With bipolar use, the impedance load is several times that of monopolar use. This means that there is much less output for any given setting when using the bipolar technique. Bipolar technique, therefore, is generally restricted to situations in which small portions of tissue are being desiccated. In gynecologic surgery, one must be aware that instruments used in laparoscopy and for the purposes of sterilization can differ in both design and the ability to desiccate tissue. The manufacturer’s guidelines should be followed pre- 21 cisely. These guidelines should be known by both the CST in the scrub role and the surgical assistant. Safety Safety principles during electrosurgery should be followed without exception, since the surgeon is often focused elsewhere, the surgical technologist and surgical first assistant should monitor the safe usage of electrosurgical instruments. Surgical technologists should already know basic principles of safety, but select reminders are: ∎∎ All the electrode pencils should be in a safety holster when not in use. ∎∎ A monitored return electrode system should be used. ∎∎ Use the lowest voltage that will create the desired effect. ∎∎ Place the return electrodes as close to the operative site as possible. ∎∎ Inspect the instrument and cord insulation prior to each use. ∎∎ Be aware of the extra length of laparoscopic instruments and make appropriate adjustments. Uses Electrosurgery may be used to vaporize tissue (cut), desiccate tissue (coagulate), and fulgurate tissue (coagulate superficially). When the coagulation waveform is in use, the current sparks to tissue without a cutting effect, because the heat is widely dispersed and the heating effect is intermittent. The water inside of the cells is heated and the cells dehydrate slowly. The term coagulation is generally used to include both desiccation and fulguration. Technically, this is incorrect usage and the two can be compared and contrasted in several different ways: ∎∎ Fulguration always produces necrosis anywhere the sparks land. ∎∎ Desiccation may or may not produce necrosis. ∎∎ Fulguration is more efficient at producing surface-level necrosis. ∎∎ Desiccation is more efficient at producing a deep tissue reaction. ∎∎ Fulguration requires about 20% of the current flow required for desiccation. Factors affecting coagulation Some factors that affect the amount of coagulation verses cutting current include: ∎∎ The faster an electrode is moved over or through tissue, the greater the cutting effect. ∎∎ The broader the electrode, the greater the coagulation defect. ∎∎ If the tissue is touched with the electrode prior to keying the generator, more lateral charring will result. Electrosurgery When a cutting effect is desired, a high electrical current is delivered via a fine electrode. This generates intense intracellular heat and causes the intracellular water to boil and vaporize the cell. Vaporization dissipates some of the heat. This cooling effect prevents thermal spread to adjacent tissues. The reduction and spread is not limited to the lateral direction but includes the depth of penetration and, therefore, may prohibit any deep coagulation effect. In order to increase the vaporizing effect of the cutting waveform, the electrode should be activated prior to touching the tissue to be cut. Four technical points are worth mentioning at this time: ∎∎ Unless the surgeon has extensive experience, skin incisions are best made with a normal surgical scalpel. ∎∎ When working in fatty tissue, one should change to a flat blade and coagulation waveform in order to perform a cutting function. ∎∎ Any time that tissue is grasped with a forceps, either the cutting or coagulation waveform produces desiccation of tissue. ∎∎ When attempting to coagulate surface vessels in a bloody field, irrigation with non-electrolyte solutions improves the efficiency and effectiveness. Argon beam coagulator The argon beam coagulator is a relatively recent method of achieving coagulation. A monopolar electrode is used in conjunction with a beam of argon gas that passes through the cannula at rate of 12 L/min, when used during a laparotomy, and at 4 L/min, when used in conjunction with laparoscopy. Argon gas has certain ionization properties that enhance the distance a spark can travel to complete an electrical circuit. The beam that is produced by the argon is bright with a bluish tint that makes it easy to see and to aim at a bleeding surface. The CST should be familiar with the manufacturers’ guidelines for the specific machines used in their institutions. Lasers Laser stands for Light Amplification by the Stimulated Emission of Radiation. Light is produced when energy is applied to an atom and changes an electron to a higher level of instability. The electron will return to its stable state by releasing a photon of light. This type of light is called incoherent light and has many different wave settings, directions, and phases. When energy is applied to a laser medium, the electrons are changed into an unstable energy level. These electrons spontaneously decay to a lower energy level but one that is higher than its normal international level. This new state is relatively long-lived and stable. Enough energy can be pumped into the laser medium so that the population 22 of atoms is produced which are mostly of this higher energy state. Whenever an electron spontaneously returns to its normal state, a photon is emitted. The photon is of the same wavelength. The photon travels down the long axis of the optical cavity and continues to stimulate at the same wavelength. The photons reach the mirrored ends of the optical cavity and are reversed. They continue to be able to stimulate the further release of photons. Laser radiation is produced as energy is applied to the laser medium. There are four classes of lasers: 1. Low powered or high-powered, embedded lasers 2. (A) Visible lasers (400-700 nm). Under normal circumstances, these do not present a hazard to vision, but if viewed directly for extended periods, the light could cause damage to the eye. (B) Visible lasers that are not intended for viewing and, under normal operating conditions, do not produce an injury to the eye (if viewed directly and for less than 1,000 seconds). 3. (A) Lasers that would not cause injury to the eye if momentarily viewed. (B) Lasers that present a hazard if viewed directly. This includes Intrabeam and specular reflections. 4. These lasers present a hazard from direct, specular, and diffuse reflections. They may also produce skin burns and be a fire hazard. Lasers are commonly identified by their active medium. Excimer gas lasers are either argon or xenon. Excimer lasers include nitrogen, helium-cadmium, argon, krypton, xenon, helium-neon, and hydrogen fluoride. Metal vapor lasers include copper vapor, gold vapor, neodymium-YAG, erbium, holmium-YAG, holmium-YLF, and chromium sapphire as the active medium. Dye lasers use rhodamine, and semiconductor lasers use gallium arsenide. Of course, most of these are not used in the surgical setting. For controlling and focusing the beam, there are two delivery mechanisms available. The first is a micromanipulator. This is a joystick that is used to move a mirror that is placed distal to the focusing lens. This type of manipulator is commonly found on the colposcope and the operative microscope. In the second system, the focusing lens is located in the handpiece. Accidents Because of the potential danger presented by the laser, every hospital has a laser committee and a person appointed as laser safety officer. Everyone should be aware of the guidelines established for the various lasers. Causes of laser accidents are listed below in order of frequency: ∎∎ Incorrect alignment procedure (almost 30%) ∎∎ Incorrect eye wear ∎∎ Voltage too high Electrosurgery ∎∎ ∎∎ ∎∎ ∎∎ Eye protection not used Equipment malfunction Improper service Accidental exposure Indications and frequency As with most new technology, the indications for laser usage continue to expand. At this time, some indications for the use of laser in gynecologic surgery are: ∎∎ Cervical cone ∎∎ Condylomata ∎∎ VIN ∎∎ VAIN ∎∎ Adhesiolysis ∎∎ Endometrial ablation ∎∎ Salpingostomy ∎∎ Myomectomy The relative frequency of laser procedures is as follows: ∎∎ Excision of endometriosis ∎∎ Lysis of adhesions ∎∎ Ovarian cystectomy ∎∎ Uterosacral ligament procedures ∎∎ Presacral neurectomy ∎∎ Salpingo-oophorectomy ∎∎ Ectopic pregnancy ∎∎ Myomectomy ∎∎ Laparoscopic assisted vaginal hysterectomy ∎∎ Retropubic urethropexy ∎∎ Sacral colpopexy CUSA The Cavitron Ultrasonic Surgical Aspirator (CUSA) is a surgical device that affects tissue in three ways: viscous stress, heating, and cavitation. Viscous stress occurs secondary to an interaction between intracellular water and the vibration of bubbles, which are at the micron size. This causes vibration and, if a critical point of shear stress is induced, a breakdown in the cell with attendant hemolysis occurs. The CUSA is an acoustic vibrator. It converts electrical energy into mechanical motion. The handpiece contains an electric coil that is wrapped around a nickel alloy magnetostrictive transducer. This transmits an alternating electrical field to an alternating magnetic field, causing contractions and expansion in the transducer. This fluctuation pulses the hollow, cone-shaped, titanium tip. The standard size has an inner diameter of 2 mm, however, a microtip is also available. Laparoscopic versions are also available today. Both irrigation and aspiration features are built into the handpiece. Cellular debris can be removed from the operative site with ease. The greatest advantage to using the 23 CUSA is that cancerous tissue can be broken down easier than healthy tissue. This makes the CUSA an appropriate device for debulking pelvic tumors. Conclusion Electrosurgery, laser surgery and the Cavitron Ultrasonic Aspirator are just a few of the recently developed resources that enable surgeons to function more efficiently and facilitate the patient’s recovery. More applications for these technologies are undergoing research and, undoubtedly, new benefits will be available in the future. About the author Bob Caruthers, CST, PHD, FAST, served as former AST deputy director and director of professional development. He received his BA from the University of Texas, Austin, in 1972 and his PhD in 1995. He started his medical career as an emergency room orderly and was subsequently employed as a certified operating room technician. He later specialized in neurosurgery and developed a consuming interest in the human brain and its study. He joined the faculty at Austin Community College and later moved to Colorado to work for AST. He was responsible for leading many significant efforts and was executive editor of the first edition of Surgical Technology for the Surgical Technologist: A Positive Care Approach, launched a program of educational CD-ROMs, was instrumental in the success of the AST National Conference and initiated the development of advance practice forums. In January 2000, Bob was diagnosed with glioblastoma multiforme and faced his illness with strength and determination. In 2002, he lost the battle—and is still missed. This article was excerpted from his manuscript that was related to an OB/GYN advanced practice manual. Electrosurgery CE Exam: Electrosurgery 1. refers the use of a direct electrical current to heat metal which is then applied to tissue. A Electrosurgery B Electrocautery C Coagulation D Fulguration 2. What is the passage of a given amount of electrons through a conductor of a specified period of time? A Electricity B Joules C Current D Voltage 3. One consequence of coagulation is a cooling effect produced by: A Vapor spray tip B Reducing current C Interval between electrical bursts D Decreasing generator’s output 4. During monopolar electrosurgery, current travels through and is received at another . A Active electrode, neutral plate B Dispersive electrode, active electrode 6. Electrosurgery may be used to: A Cut B Coagulate C Fulgurate D All of the above 7. When a electrode moves through tissue, the over or the cutting effect: A Faster, greater B Slower, greater C Faster, smaller D Faster, shallower 8. Argon gas has certain properties that enhance the distance a spark can travel. A Physical B Ionization C Biological D Neutral 9. Lasers are commonly identified by: A Color B Active medium C Delivery mechanism D Frequency 10. The Cavitron Ultrasonic Surgical Aspirator affects tissue in: A Viscous stress B Heating C Cavitation D All of the above C Generator, grounding pad D Patient’s body, active electrode 5. Bipolar surgery is generally restricted to situations involving: A Large area of tissues being desiccated B Small area of tissues being desiccated C An inexperienced surgeon D Younger patients 24 Electrosurgery Blood Clotting Mechanism by Teri Junge, CST, CSFA, FAST Learning objectives: 1. Review the four basic steps of hemostasis. 2. Understand the process of vasoconstriction. 3 Examine blood vessel wall anatomy. 4. Identify various blood clotting factors. 5.Define common blood clotting tests. Introduction This article is intended as an introduction to the blood clotting mechanism for the student surgical technologist and as a review for those in practice. Effective control of bleeding occurs through a complex process called hemostasis, which will be explained in four basic steps. The basic steps of the blood clotting process are vasoconstriction, platelet activation, thrombus formation, and dissolution of the clot. Basic laboratory tests used to identify blood clotting problems will also be presented. Blood clotting is initiated in one of two ways. The first, referred to as the intrinsic or internal pathway, occurs when a clot forms inside of a blood vessel due to an internal abnormality or an injury to the blood vessel itself.8 The second, referred to as the extrinsic or external pathway, occurs following an injury, such as a cut, when blood is exposed to the outside environment. No matter how the clotting process is initiated, the clot forms in the same way. This is referred to as the common pathway. Another term used to describe blood clotting is coagulation. Blood cells called platelets, along with numerous factors—proteins, enzymes, vitamin K, and calcium—found in blood plasma, are involved in the clotting process. Blood clotting factors are referred to by Roman numerals and also have names associated with them. Injuries leading to extrinsic blood clotting and the related chain of events will be the focus of this article, as this is the type of injury most commonly seen in the surgical environment. An example is provided in the case study below. Case Study George, an eighteen-month-old male, has fallen while playing on the patio at his home. As he fell, he hit his chin on a terra cotta flower pot and cut himself. His mother rushed to 25 his aid. First, she cleaned the wound with a soft moist cloth; she then applied pressure and ice to help control the bleeding and held George in a sitting position on her lap to calm him. It was determined that George needed stitches in his chin, and he was taken to the urgent care center for further treatment. By the time of his arrival at the urgent care center, the bleeding from his cut had stopped. Anatomy Review To facilitate understanding of the process of vasoconstriction, blood vessel wall anatomy will be reviewed. Please refer to Table 1 for a brief glossary of terms related to blood vessel wall anatomy. Walls of blood vessels, specifically veins and arteries, consist of three main layers called tunics. The outer tunic is called the tunica externa or tunica adventitia and consists of the connective tissue that maintains the cylindrical shape of the blood vessel. The middle tunic is called the tunica media or tunica muscularis and consists of smooth muscle tissue. The inner tunic is called the tunica interna or tunic intima and consists of smooth epithelial tissue that allows the blood to flow freely within the vessel. Additionally, a layer of elastic tissue is present to allow for expansion (vasodilation) and contraction (vasoconstriction) of the vessel. The muscular layer is thicker in arteries than it is in veins, and veins have additional structures called valves, which keep the blood from flowing backward. The exception to the three-layer structure of blood vessel walls are the capillaries that consist of only a single layer of cells. This layer allows the passage of fluids, cells, and molecules to and from the tissue cells.7 Vasoconstriction Vasoconstriction is the term used to describe tightening of the muscle in the blood vessel wall. When an injury occurs, nerves in the tissue surrounding the blood vessel stimulate the muscle of the blood vessel wall to constrict, narrowing the lumen of the vessel, thereby temporarily restricting the flow of blood from the wound. This initial vasoconstriction lasts only about a minute, but then a secondary mechanism takes over that sustains vasoconstriction at the site of the wound. The secondary mechanism involves release of chemicals, such as serotonin and epinephrine, from blood cells called platelets that have started to gather at the site of Blood Clotting Mechanism Table 1 Glossary4,7,8 Artery Large blood vessel that carries blood away from the heart Arteriole Small artery that delivers blood rich in oxygen and nutrients to a capillary Capillary Tiny blood vessel that allows oxygen and nutrients to be delivered to the tissues and carries waste products away Endothelium Smooth flat cells that line the heart, as well as blood and lymphatic vessels Lumen The inside of a tubular structure (eg, the inside of a blood vessel or intestinal tract) Tunic Coat or layer of a structure Tunica Adventitia (Externa) Outer layer of a blood vessel consisting of connective tissue Tunica Intima (Interna) Smooth inner layer of a blood vessel consisting of endothelium Tunica Muscularis (Media) Middle layer of a blood vessel consisting of muscle tissue Vein Large blood vessel that carries blood toward the heart Venule Small vein that carries blood and waste products away from the capillary to a vein the injury. Platelets continue to stimulate the nerves, which causes contraction of the muscle of the vessel for several more minutes.4 First aid measures such as those described in the case study—application of ice and pressure to the wounded area, as well as elevating the wounded area—all assist in the vasoconstriction process. Platelet Activation/Aggregation Following damage, such as an accidental cut or a surgical incision, blood is exposed to collagen from the nearby tissues. At the time of injury, two things happen almost instantly and simultaneously. First, two substances—fibrinogen, found in collagen, and prothrombin, found on the surface of the platelets—are activated. (See Table 2) The platelets, or thrombocytes, begin to adhere to the exposed collagen. This initial step in blood clotting, or coagulation, is called platelet activation or platelet aggregation. As the platelets begin to assemble at the site of the injury, several factors are released from the platelets. One of them, the von Willebrand factor (vWF), binds the platelets to the collagen fibers. Several substances are also released from the platelets, including adenosine diphosphate (ADP), which attracts more platelets until a seal is formed over the opening in the blood vessel wall. The clump of platelets is known as the platelet plug. The platelet plug may be sufficient to seal a small vessel. However, in larger vessels, the platelet plug is temporary and will be replaced by a thrombus.6 The platelet plug does not con- 26 tain red blood cells; therefore, it is sometimes referred to as the white thrombus.1 Thrombus Formation A more stable clot, called a thrombus, must form to make a longer lasting seal on larger injured blood vessels. The thrombus must be able to maintain a seal on the damaged blood vessel wall, especially that of an artery where the blood pressure is higher than in a vein, even after the blood vessel walls are no longer constricted. Fortunately, the clotting process is self-limiting. Substances called antithrombins prevent the clot from continuing to enlarge; otherwise the established clot would block the flow of blood within the vessel.6 Activation of prothrombin in the platelet aggregation phase sets off a series of additional events, starting with activation of factor X, that leads to formation of the thrombus. Activated factor X (Stuart-Prower) leads to activation of factor II (prothrombin). Prothrombin in its active form is referred to as factor IIa (thrombin). Several substances, including thromboplastin (factor III), calcium, and vitamin K, play a role in activation of prothrombin to thrombin.1 Thrombin, in turn, helps to convert fibrinogen (factor I) to fibrin (factor Ia). Fibrin is an insoluble protein that, when it reacts with other substances, polymerizes to form strands that web together to form the basis of the thrombus. The web of fibrin is referred to as fibrin mesh. Factor XIII (fibrinase) is activated to serve as additional stabilization of the fibrin mesh. When viewing the fibrin mesh that has been stabilized with fibrinase under a microscope, it is said Blood Clotting Mechanism Table 2 Blood Clotting Factors 5,6 Roman Numeral Name I Fibrinogen Ia Fibrin (a = activated) II Prothrombin IIa Thrombin III Thromboplastin (also called tissue factor) IV Calcium V Proaccelerin (also called labile factor and accelerator globulin (AcG)) VI Accelerin VII Proconvertin (also called serum prothrombin conversion accelerator (SPCA), cothromboplastin, autoprothrombin I, prothrombokinase and stable factor) VIII Antihemophilic factor A (also called antihemophilic globulin (AHG)) IX Antihemophilic factor B (also called Christmas factor, plasma thromboplastin component (PTC), and autoprothrombin II) X Stuart-Prower factor (also called autoprothrombin C, Prower factor and thrombokinase) XI Antihemophilic factor C (also called plasma thromboplastin antecedent (PTA)) XII Hageman factor (also called glass, contact or activation factor) XIII Fibrinase (also called fibrin stabilizing factor (FSF) and Laki-Lorand factor (LLF). The inactive form is also called protransglutaminase, and the active form as transglutaminase.) 27 to have the appearance of cross stitching on loosely woven fabric.3 Within a few hours of the injury, as part of the inflammatory process that normally occurs following damage to tissue, leukocytes (white blood cells) gather at the site of the injury to help reduce the risk of infection. Local inflammation is identified by the presence of pain (dolor), redness (rubor), heat (calor), swelling (tumor), and loss of function (functio laesa). Systemic inflammation is identified by the presence of fever.7 The thrombus may contain red blood cells; therefore it is sometimes referred to as the red thrombus .1 Dissolution of the Clot Dissolution of the clot, also called fibrinolysis, occurs when a negative feedback system signals that sufficient healing of the blood vessel wall has occurred, and a substance called plasminogen is activated. Plasminogen in its active form is called plasmin. Plasmin signals the clotting mechanism to inactivate the procoagulant (clotting) process and begins the anticoagulant process, with the use of naturally occurring heparin. This is achieved by digesting the fibrin, which is the main component of the thrombus.6 The body then returns to its state of balance, called homeostasis. Identification of Blood Clotting Problems Due to the complexity of the blood clotting mechanism, numerous problems can occur that will impact the clotting ability of the injured patient or the patient scheduled for surgery. Blood clotting disorders will not be discussed in this article; however, knowledge of the status of the patient’s blood clotting mechanism prior to and during surgical intervention is valuable to the surgical team members in planning the care of the patient. Several laboratory tests are available that will help determine if the patient has normal or abnormal clotting ability. If an abnormality is detected, intervention—such as providing blood products, procoagulants, or anticoagulants— may be indicated. Blood Clotting Tests The following is a list of some of the more common blood clotting tests, as well as brief descriptions of each. ∎∎ Bleeding time—Measures the time elapsed from infliction of a small cut until active bleeding has stopped. Normal bleeding time is three to eight minutes. ∎∎ Coagulation factor assay—Measures specific proteins (clotting factors, as well as anticlotting factors) in a volume of blood for normalcy, deficiency or absence. ∎∎ Complete blood count—A group of several tests performed on a volume of blood to detect the number and Blood Clotting Mechanism ∎∎ ∎∎ ∎∎ ∎∎ ∎∎ ∎∎ size of certain cells or cell fragments, including red blood cells, white blood cells (including the various types of white cells), and platelets present in the blood. Fibrinogen test—Measures the levels of fibrinogen (Factor I) in the blood. Miscellaneous—Various tests may be performed as needed to detect vitamin deficiencies, liver malfunction, or leukemia that may affect the blood clotting mechanism. Partial thromboplastin time (PTT)—Measures the amount of time needed (in seconds) that it takes for clotting to occur when reagents are added to plasma in vitro. Normal partial thromboplastin time is 30-45 seconds. Platelet aggregation test—Measures the amount of time needed for platelets to aggregate (adhere to) and seal off the lumen of a vacuum tube that had been coated with collagen and either epinephrine (EPI) or adenosine diphosphate (ADP). As being drawn through the tube, the coating activates the platelets promoting platelet aggregation. The term closure time (CT) is used to refer to the amount of time it takes for a clot to form inside the glass tube and prevent further blood flow. Platelet count—Detects the number of platelets present in the blood. It is typically included in the CBC, but may be ordered independently. The normal platelet count is between 150,000 to 450,000 platelets per ML. Prothrombin time (PT)—Measures the amount of time needed for blood to clot in vitro. Normal prothrombin time is 10–15 seconds.7 Conclusion Many factors influence hemostasis, and the clotting process is a very complex series of chemical interactions that are not all listed in this brief overview. Keep in mind the four basic steps of the blood clotting process (vasoconstriction, platelet activation, thrombus formation, and dissolution of the clot) as you think back to the case study, and try to answer the following questions: 1. Why did George’s mother apply ice and pressure to the wound? George’s mother applied ice and pressure to the wound to assist his body in achieving and maintaining vasoconstriction. 28 2. Why was George kept in a sitting position following his injury? George was kept in a sitting position while his mother was comforting him to elevate the injured area allowing gravity to direct blood away from the wound. 3. Why do you think that the bleeding had stopped by the time George arrived at the urgent care center for stitches? George’s bleeding had stopped by the time he arrived at the urgent care center for stitches, because all the steps involved in his blood clotting mechanism worked correctly. About the author Teri Junge, CST, CSFA, FAST, is surgical technology program director at San Joaquin Valley College in Fresno, California. She is also the editorial reviewer for this journal. Editor’s note: To review the main constituents of the blood, please refer to “Blood Components” by this author in the July, 2003 issue of this journal. For more information about fibrin’s extraordinary elasticity and strength, please visit http://www. wfu.edu/wfunews/2006/2006.08.03.f.html and http://www. madgadget.com/archives/2006/08/fibrin_superher_1.html. References 1. Atkinson L, Fortunato N. Berry & Kohn’s Operating Room Technique, 10th ed. USA: Mosby; 2003. 2 Bhonoah Y. Blood Coagulation. Imperial College of Science, Technology and Medicine: Department of Chemistry. Available at: http://www.chemsoc.org/exemplarchem/entries/2003/imperial_Bhono/bloodcoagulation.html. Accessed June 19, 2006. 3. Carlson C. How Blood Clots. Available at: http://www.med.uiuc. edu/hematology/PtClotInfo.htm. Accessed June 1, 2006. 4. Cohen B. Memmler’s The Human Body in Health and Disease, 10th ed. USA: Lippincott Williams & Wilkins; 2005. 5. Corrigan D. The Blood. Englewood, CO: Association of Surgical Technologists; 1994. 6. King M. Blood Coagulation. Available at: http://web.indstate.edu/ thcme/mwking/blood-coagulation.html. Accessed June 3, 2006. 7. Price P, Frey K, Junge T, eds. Surgical Technology for the Surgical Technologist: A Positive Care Approach, 2nd ed. USA: Thomson Delmar Learning; 2004. 8. Stedman J. Stedman’s Medical Dictionary for the Health Professions and Nursing Illustrated, 5th ed. USA: Lippincott Williams & Wilkins; 2005. 9. Tiscali Encyclopedia. Available at: http://www.tiscali.co.uk. Accessed June 3, 2006. Blood Clotting Mechanism CE Exam: 1. The control system in which feedback concerning changes in the body’s internal environment causes a response that reverses these changes is called A Homeostatic mechanism B Negative feedback C Countercurrent mechanism D Feed-forward 2. Which of the following is NOT a basic step of the clotting process? 6. Plasmin begins the anticoagulant process by… A Using heparin to signal the clotting mechanism B Digesting the fibrin C Activating plasminogen D Accelerating the negative feedback system 7. Which platelet-released substance attracts more platelets until a seal is formed over the opening in a blood vessel? A Adenosine diphosphate B Thrombin A Vasoconstriction B Platelet aggregation C Proconvertin D Fibrinase C Thrombin formation D Fibrinolysis 8. Which of the following is NOT a layer of a blood vessel? 3. As platelets gather at an injury site, which released factor binds the platelets to the collagen fibers? A von Willebrand B Hageman C Stuart-Prower D Laki-Lorand 4. Which of the following does NOT play a role in the activation of prothrombin? A Vitamin K B Calcium C Fibrin D Thromboplastin 5. The platelet plug… A Contains red blood cells B Sufficiently seals large blood vessels C Binds the platelets to the precollagenous fibers D Is also known as a white thrombus 29 A Tunica muscularis B Tunica adventitia C Tunica interna D Tunica serosa 9. polymerizes to form strands, which form the basis of a thrombus. A Proconvertin B Fibrin C Accelerator globulin D Fibrinase 10. During coagulation… A Platelet aggregation begins B Antithrombins prevent an overreaction of the clotting process C Fibrinogen and D Factor X is activated and prothrombin are activated converts fibrinogen to fibrin Blood Clotting Mechanism Bioethics in Solid Organ Transplantation Alternative methodologies being utilized in the prevention of solid organ shortage by Shawn P Huelsman, CST, FAST; Bijan Eghtesad, MD; Charles Modlin, MD Learning objectives: 1. Examine the types of organ donors 2. Analyze the issues related to organ recovery from living donors 3.Understand the concerns of organ recovery from deceased donors 4.Explore the role of education in organ donation 5.Understand the bioethics concepts in organ allocation Introduction Currently in the United States, 95,062 individuals wait for their chance of receiving a lifesaving organ for transplantation.11 Though there were 26,689 transplants performed in 2006, there is still not a sufficient supply of donors and organs to meet the demand of those individuals needing transplantation. Unfortunately six percent of possible recipients die while on the waiting list.11 These staggering figures have opened the bioethical debate of how the United States can compensate for the shortage of solid organs for transplantation. With this in mind, the transplant community is utilizing new methodologies in order to increase the number of organ donors and the amount of solid organs used in transplantation. These methodologies of utilizing marginal donors, living donation, alternative organ allocation systems, xenotransplantation and stem cell research are currently approached in bioethical debate from the local to the national levels. This article will give insight into these methodologies and how they can assist in the increased amount of solid organs for use in transplantation. Organ recovery from marginal donors In today’s organ donation system, organs are recovered from deceased donors (DD) and living donors (LD). In the past, most surgeons would use only those organs that came from healthy, young donors. With the number of waiting candidates surpassing the number of donors 7:1, there has been a need to seek organs from donors who are considered marginal. Marginal donors include those individuals over 55 years of age (extended criteria donors), pediatric donors under 30 5 years of age, non-heart beating donors (or donation after cardiac death, DCD), and donors who have certain disease processes and serologies (ie diabetes and HIV).1 Non-heart beating donors There has been increasing debate in the field of non-heart beating donation. Until recently, few communities would allow recovery of organs from non-heart beating donors. In this type of donation, the patient does not meet all of the criteria to be pronounced “brain dead.” Although, if the patient is removed from life-sustaining medications or ventilation, the patient will ultimately pass on. Donation after cardiac death Donation after cardiac death allows the family to donate their loved one’s organs immediately after the patient’s heart stops beating. The controversy behind this donation is that when the patient enters the operating room, he or she is technically still alive. These patients are removed from their medication and from their ventilator in a controlled method by the intensive care unit staff, as the recovery team waits outside for pronouncement of death. An ethical question surrounding DCD is this: Are physicians being presumptuous in stating that there is no hope for these patients, in order to fight against the problem of organ shortage? Or does this open up another avenue to obtain organs from those individuals for whom, if medications and ventilation are removed, there is no hope of survival? HIV-positive donors Another controversial issue concerns donors who are HIV-positive. With the creation of life-sustaining drugs (ie AZT), HIV patients are able to survive longer than first expected. With their life expectancy increasing, do HIVpositive patients have the right to obtain solid organs for transplantation if they are in need? In order to facilitate this, organs are being recovered from HIV-positive donors and are being transplanted into HIV-positive recipients. This allows the recipient to receive an organ, which they might not otherwise have the opportunity to receive. Does their placement on the Organ Procurement and Transplantation Network (OPTN) list jeopBioethics in Solid Organ Transplantation ardize HIV-negative candidates’ chances of receiving an organ? Organ recovery from living donors (related, unrelated and altruistic) In the shadows of deceased donation, there has been an increase in living donation. Living donation is the process in which a live person is willing to give an organ or a part of an organ to another individual. Though these procedures were created for individuals who were related to one another, there has been a growth of unrelated living donation and donation by altruistic strangers. In 2006, there were 6,194 living donors, compared to 7,383 deceased donors.11 In these cases, an individual who is not related genetically—or is a complete stranger—to the possible recipient, is willing to donate an organ or a part of an organ to someone in need. With the invention of the Internet, it has become easier for altruistic strangers to find a “worthy” candidate for their organs. Websites such as www.MatchingDonors.com and personal websites like www.babymarkjr.com allow prospective living donors to read stories from thousands of individuals that are in need of lifesaving organs. Currently the solid organs that can be given by a living donor include kidney, split liver, lung, split pancreas, and small bowel depending on the situation. The ethical concerns surrounding the use of living donation has sparked the interest of discussion within the US Department of Health and Human Services (HHS), the United Network of Organ Sharing (UNOS), and has most recently been the subject of the President’s Council on Bioethics. The key issue of current discussions has been the question of whether or not performing surgery on a living donor violates the Hippocratic Oath—“To do no harm and to act always in the best interests of every patient in his care.”5 Among the bioethical questions regarding living donation, focus has been placed on donor safety. Currently, neither UNOS nor the HHS has policies regarding a standardized informed consent for living donation.9 This informed consent needs to be created in order to inform possible donors properly of surgical risk, their right to change their minds, and that there may be a possibility of future health problems resulting from the donation, and that those problems may not be covered by insurance.9 In order for living donation to continue being an avenue for preventing organ shortage, the benefits to both donor and recipient must outweigh the surgical and psychological risks. In addition, there is the question of whether living donors should be rewarded for their gift. This reward would come in the form of treatment of future complications resulting from the donor procedure. It would also include 31 allowing the living donor extra points on the OPTN waiting list, in case they are ever in need of an organ. There are also those who feel that living donors should be given financial compensation, but it is still being debated. One effort that has assisted in the living donation of paired exchange (where two or more sets of living donors and candidates are matched with each other to provide compatible donors to each recipient) has been the recent introduction of US House of Representatives Bill 710 and US Senate Bill 487. These proposed bills would create federal legislation that would allow more individuals to become donors, thus creating more opportunities for transplant candidates to receive needed organs.13 Increasing organ recovery from deceased donors Despite efforts to increase the use of extended criteria donors, donation after cardiac death, and living donations, the best source of donors for solid organ transplantation remains deceased donors. Unfortunately the number of deceased donors has increased only 45% since 1988, while the number of living donors has increased 71%.11 How can we increase the number of deceased donors, and therefore reduce the organ shortage? Proposal 1: Greater education According to Cantarovich, society must increase the role of education—both for medical providers and the general public.4 He feels that society must be informed that organ transplantation is a common and successful practice and that the act of donation “offers a unique source of health and provides a chance of life and well-being for everybody.”4 Some of his ideas on education include a youth commitment to organ donation as an obligation to society, the assurance of integrity and respect for the cadaver during and after organ recovery, and an overall improvement in the general public’s unawareness and belief in myths and superstitions regarding organ donation.3 He concludes that education of society could change behaviors toward the use of organs after death, eventually leading to a reduction of the organ shortage.4 Proposal 2: Auction market Dr Jack Kevorkian, the man made famous over the concept of physician-assisted suicide, proposed a second concept of increasing the number of deceased donors. He suggested the implementation of a free, nonprofit and potentially global online auction market.10 His system resembles a modern-day “organ stock market.” When a donor is pronounced “brain dead,” the organs are listed on the auction site. Individuals who want to purBioethics in Solid Organ Transplantation chase the organs make their bid through an “organ broker” at a regional transplant center. Upon confirmation of a bid, the recipient must make payment within 48 hours, or the organs will be given to the next highest bidder. According to Kevorkian’s formula, 33% of the funds would go to the donor’s family, 11% would go to each of the recipient transplant centers (for future bidding and for those patients who are poor or uninsured). Finally a 1%-fee would be applied to cover the administrative costs of running and operating the auction. The idea behind this proposal is that it would give families an incentive to donate their loved one’s organs, and it would provide financial stability to the family. The negative side of this proposal is that some patients may not be able to compete in the bidding process as well as wealthier patients could, regardless of which patient is in greater need of the organ. In addition, how would the money for the donor’s family be distributed? Will it be deposited as part of the donor’s estate, or will it be given to the family member who decides to donate the deceased person’s organs? Similar programs that have been created have included tax breaks, paying for funeral expenses and even paying the family a flat rate for donation. The question for debate is, “Should family members receive financial compensation for donation, since our society views organ donation as an altruistic and unselfish giving of one’s self?” In Kevorkian’s article, “a procured human organ is the most valuable and essential item in any transplantation procedure.”10 It is a fact that without the presence of the human organ the recipient would not be able to receive a transplant, the physicians would not have patients, and the organ procurement organizations (OPO) would not receive any funding. What is wrong with putting a financial number on the recovered human organ? OPOs currently place fees on every organ that is recovered. For instance, many OPOs charge insurance companies and Medicare upwards of $25,000 per kidney recovered. That equals $50,000 received for just the donor’s kidneys, and that doesn’t include other organs that may be recovered, such as heart, lungs, liver, pancreas and small bowel. Regardless, there are still physicians and organizations that feel that payment for organs is “unethical.” Proposal 3: Increased awareness The third proposed way of increasing deceased donation relies on the use of mass media and the Internet to focus attention on the issue. Websites such as www.lifesharers.com as well as personal websites have added the same dynamic as previously stated with living donation. 32 With Lifesharers, individuals volunteer to donate their organs to other Lifesharers members primarily and to nonmembers if there is no suitable member candidate. This allows possible donors to choose who will receive their organs when they die. On the flip side of this method, there has been discussion over presumed consent. Currently in the US, individuals choose if they want to become organ donors by stating this information in the form of a living will, a donor organ card or an indication of consent on one’s driver’s license. Unfortunately, even if a deceased donor has indicated his or her consent to donate, final authorization is still requested from the donor’s family. With presumed consent, it will be presumed that the individual wanted to become an organ donor, unless there is documentation stating that he or she did not. This will eliminate the need to ask the family’s permission and will allow the donor’s organs to be recovered sooner. The downside to the policy of presumed consent is that the altruistic characteristics of organ donation would be abandoned. Organ donation would no longer be “a gift of life”—it would be “an obligation to society.” Changes in organ allocation policy Another area of concern regarding the bioethical concepts to increase the number of organs for transplant is the status of the organ allocation policy. Currently, every individual who is in need of an organ is placed on the OPTN waiting list. This list is based on the individual need of the candidate. It is not influenced by the disease that caused the organ failure, the age of the candidate, nor the socioeconomic status of the candidate. If a deceased donor organ becomes available, the organ is allocated to the person highest on the list based on need, length of time spent on the waiting list and geographical proximity of the candidate to the donor.7 Should an individual with an emergent need but a shorter life expectancy receive an organ before someone with a longer life expectancy? Should individuals who have donated organs in the past be given preference on the list? Should organs be given to individuals who are responsible for their disease processes, for example organ damage caused by smoking or alcohol abuse? Should organs be allocated based on age, geography or racial disparity? Should organs be given to patients who are incarcerated? These are many of the questions being asked in the field of organ allocation. UNOS is currently debating a new system of kidney allocation that would provide kidneys to those individuals who are expected to live the greatest number of years posttransplant.8 One problem with this proposed system is that Bioethics in Solid Organ Transplantation younger candidates will be given preference over those who are elderly. The second problem is that with the emphasis on extended criteria donors, how many more years of survival will a 25-year-old recipient have with a kidney from a donor who is 60 years old? A possible solution is delegating organs from young donors to young recipients and organs from elderly donors to elderly recipients. A third problem involves geography. The Los Angeles Times reported the story of two candidates.15 A patient in New York was on the waiting list for a new liver for more than 10 years. Unfortunately he died on his 53rd birthday before receiving the organ. Another individual waited for four years for a liver and kidney in New York. Frustrated with waiting, he moved to Florida, where he received a new liver and kidney 14 days later. With reports like this, one can see why an individual would move to a place where the waiting list is shorter, but what about people who are not able to relocate? What is the justification for a shortage of organs in one geographical area and a surplus in another? Should these organs be distributed equally among everyone on the waiting list, regardless of geographical distance between donor and recipient? Alternative methodologies Due to the current shortage of organs, there has been a new focus on utilizing alternative methodologies to increase the supply. Some of the methodologies, including xenotransplantation, cloning and the use of stem cell research, challenge some of our society’s traditional concepts and practices and therefore become the subject of media attention and political debate. With xenotransplantation, an organ is removed from a primate or porcine model and is transplanted into a human. Xenotransplantation first entered the bioethical area in 1963, when James D Hardy transplanted the heart of a chimpanzee into the chest of a cardiac-compromised patient.14 This was later followed by Leonard Bailey, MD, who transplanted a baboon heart into an infant with hypoplastic left heart syndrome in 1984. Left untreated, this congenital malformation causes mortality in the first month of life.2 Though both of these grafts failed, research continued in the field of xenotransplantation and prevention of organ rejection. Xenotransplantation lead the way to experimentation with other therapies, including cloning, stem cell research, islet cell research and the development of artificial organs. Unfortunately the bioethical debates concerning these modalities continue to hinder their progress. 33 Some of the ethical issues being debated include the experimental status of these procedures and any potential side effects that may occur, the psychological stress of receiving a cell or organ from an animal and the spread of retroviruses.6 As for artificial organs, they still are used primarily as a temporary measure to preserve life until a human donor organ becomes available. Consider the case of the infant who received the baboon heart. If this therapy had not been used, the chances were very slim of receiving a heart from a donor who was the same age and weight; her only chance of survival was by xenotransplantation. As with human organs, a xenograft has the same potential for rejection. Is it not worth the risk, in order to provide a young infant a chance to live to his or her full potential? Conclusion The 21st century has become the age of discovery in the field of organ transplantation. There are increasing debates on how the US will be able to meet the need for the evergrowing number of candidates in need of lifesaving organs. How can the country face this challenge? It can utilize marginal organs, living donors and new allocation methods. It can also utilize such controversial techniques as xenotransplantation or organs created via stem cell research. It can even give a financial reward to those who donate their organs. Regardless of which technique is used, there is still a need to increase the number of deceased donors by educating the general public about the myths and facts involved in organ donation and transplantation. In addition, the country must also educate the growing number of individuals who are entering the various health professions. If health professionals do not understand this topic, then how will prospective donor families be convinced to donate? About the authors Shawn Huelsman, CST, BSHM, FAST, is an organ preservation specialist at Cleveland Clinic in Cleveland, Ohio. Bijan Eghtesad, MD, is a liver transplant surgeon in the Division of Liver Transplant Surgery at the Transplant Center at Cleveland Clinic. Charles Modlin, MD, is a renal transplant surgeon and department head for the Men’s Minority Health Clinic in the Glickman Urological Institute at Cleveland Clinic. References 1. Abounda GM. The use of marginal-suboptimal donor organs: A practical solution for organ shortage. Annals of Transplantation, 9:2004;62-66. Bioethics in Solid Organ Transplantation 2. Bailey LL, Nehlsen-Cannarella SL, Concepcion W, Jolley WB. Baboon-to-human cardiac xenotransplantation in a neonate. JAMA, 254 (23):1985;3321-3329. 3. Cantarovich F. The role of education in increasing organ donation. Annals of Transplantation, 9:2004a;39-42. 4. Cantarovich F. Organ shortage, Are we doing our best? Annals of Transplantation, 9:2004b;43-45. 5. Cohen E. (2006). Organ transplantation: Defining the ethical and policy issues. The President’s Council on Bioethics. 2006. Available at: http://www.bioethics.gov/background/staff_cohen. html. Accessed January 18, 2007. 6. Cortesini, R. Ethical aspects in xenotransplantation. Transplantation Proceedings, 30:1998;2463-2464. 7. Davis D, Wolitz R. The ethics of organ allocation. The President’s Council on Bioethics. 2006. Available at: http://www.bioethics. gov/background/davispaper.html. Accessed January 18, 2007. 8. Graham J. Transplant change would sideline old for young, healthy. The Plain Dealer. January 9, 2007. 9. Gruters GA. Living donors: Process, outcomes, and ethical questions. The President’s Council on Bioethics. 2006. Available at: http://www.bioethics.gov/background/ginger_ gruters.html. Accessed January 18, 2007. 10.Kevorkian J. Solve the organ shortage: Let the bidding begin! American Journal of Forensic Psychiatry, 22:2001;7-15. 11.Organ Procurement and Transplantation Network (OPTN). 2007. Available at: http://www.optn.org/data. Accessed February 9, 2007. 12.Steinberg D. The allocation of organs donated by altruistic strangers. Annals of Internal Medicine, 145:2006;197-203. 13.United Network for Organ Sharing (UNOS). UNOS statement regarding bills to clarify paired donation within the national organ transplant act. 2007. Available at: http://www.unos.org/news/ newsDetail.asp?id=802. Accessed February 12, 2007. 14.University of Mississippi Medical Center. The James D Hardy Archives. 2007. Available at: http://www.umc.edu/hardy/. Accessed March 2, 2007. 15.Zarembo A. Death by geography. Los Angeles Times. June 11, 2006. Available at: http://www.latimes.com/news/local/la-natransplant11jun11,0,2800948.story?coll=la-home-headlines. Accessed February 14, 2007. 34 Bioethics in Solid Organ Transplantation CE Exam: Bioethics in Solid Organ Transplantation 1. The number of living donors has increased since 1988. 6. A 45% B 56% A Seven B Eight C 71% D 84% C Six D Nine 2. Which of the following is not a subject of current bioethical debate? A Organ donation should require authorization from a family member. B Split pancreas transplants should be performed only if the donor and recipient are related. C Performing surgery on a living donor violates the Hippocratic Oath. D The potential for psychological side effects makes xenotransplantation a risky option. 3. A living donor may donate all of the following except: A Kidney B Lung C Split liver D Cornea 4. US House Bill 710 and US Senate Bill 487 would… A Facilitate more paired B Guarantee life-time exchange living donations insurance coverage for donors C Eliminate the need for family authorization prior to donation D Create a standardized informed consent for living donors percent of transplant candidates die prior to receiving an organ. 7. Organ allocation is influenced by… A Distance between donor and candidate B Age of candidate C Availability of an alternative, such as an artificial organ D Cause of candidate’s organ failure 8. The number of waiting candidates compared to the number of donors is: A 5:1 B 7:1 C 4:1 D 9:1 9. Which of the following are not considered marginal donors? A Children younger than 5 years B HIV-positive adults C Non-heart beating donors D Adults younger than 55 years 10. Cantarovich recommends all of these except: A Dispelling myths and superstitions B Educating the general public C Convincing young people that organ donation is an obligation to society D Improving insurance coverage 5. Xenotransplantation first became the subject of ethical debate in… A 1958 B 1963 C 1972 D 1984 35 Bioethics in Solid Organ Transplantation Maintaining Patient Confidentiality: HIPAA Compliance by Teri Junge, CSFA, BS, FAST Learning objectives: 1. Evaluate your workplace for potential HIPAA trouble spots. 2. Assess your own personal practices as they relate to HIPAA requirements. 3.Examine the potential consequences for noncompliance. 4.Compare and contrast the different methods for notifying patients of the HIPAA policy. 5.Examine the intricacies of business associate agreements. A HIPAA compliance program is necessary in a medical setting to protect the patient’s personal, medical and financial information. It will be necessary to share patient information with other entities, and that must be done legally. This article addresses planning, implementation and evaluation of a HIPAA compliance program. The acronym HIPAA represents the term Health Insurance Portability and Accountability Act, which became federal law in 1996. Implementation and enforcement of HIPAA is the responsibility of the Office for Civil Rights, which is part of the US Department of Health and Human Services.1 A HIPAA compliance program is necessary to ensure delivery of quality health care to the general public and to protect the patient’s personal, medical and financial information. The two main goals of the HIPAA program are portability and accountability.2 The portability portion of HIPAA was set up to broaden the health care options available to an individual by increasing his or her ability to obtain and maintain health coverage, even when changing jobs, or by allowing individuals to purchase health insurance if group coverage is not an option. HIPAA also limits exclusions from health insurance coverage due to preexisting and current conditions.3 The portability portion of HIPAA pertains primarily to health plans, and the focus of this article is on the accountability portion of HIPAA as it pertains to health care providers and health care clearinghouses. Therefore, additional information concerning portability will not be provided. The accountability portion of HIPAA was set up to protect patient privacy in relation to health care. This type 36 of information is called protected health information, and there are three types of health organizations that are required to follow the HIPAA privacy rules. These organizations are called covered entities and include health plans, health care providers, and health care clearing houses.4 Protected Health Information Protected health information (PHI) is defined as any health information that is created or maintained by a covered entity in any form. Forms of information include handwritten or printed documents, electronic documents, and the spoken word. Protected health information consists of anything that is individually identifiable including the patient’s physical or mental status (past, present or future), care that he or she has received, is receiving, or will receive, and the method of payment for that care.2 Protected health information may be released in limited situations. The HIPAA Privacy Rule allows protected health information to be released as permitted by the rule or at the written request of the patient or the patient’s legal representative. Additionally, information must be released to the US Department of Health and Human Services if requested during an investigation of an alleged HIPAA violation or as required by state or federal law.5 Permitted Uses of Protected Health Information Under the HIPAA privacy rule, the two main reasons for release of protected health information without written authorization or notification are to the individual and to business associates who are directly or indirectly involved with treatment, maintenance of treatment records or payment for treatment. Additionally, protected health information may be released in facility directories and to family and friends involved with the patient’s care. Incidental release of information is also allowed, as is release of information for the sake of public interest. Limited information may be released for research purposes.6 Policies and Procedures Each covered entity must appoint an individual as the privacy officer. This person is responsible for creation and maintenance of a HIPAA policy manual that describes all policies and procedures relating to a patient’s protected Maintaining Patient Confidentiality: HIPAA Compliance health information. The policy manual must contain information concerning the covered entity’s business associates and the working agreements that are in place to protect patient information handled by those associates. The manual also includes information notifying the patient about how his or her confidential information is used by the covered entity. This is done via a document called a notice of privacy practices. The patient signs an acknowledgment that he or she has received the notice, and that acknowledgment is kept on file. Should the patient choose to have his or her protected health information released, an authorization form must be available for the patient, or his or her representative, to sign prior to that information being released. The privacy officer is also responsible for updating the policy manual as needed, ensuring that all staff receives HIPAA training and that the training is documented in the employee’s file. Additionally, the privacy officer is to handle all patient questions or complaints concerning the covered entity’s privacy practices.2 Business Associates A business associate is typically not a covered entity, but is an individual or a business that provides services to a covered entity and has access to a patient’s protected health information. Examples of business associates include (but are not limited to) transcription services, billing services, insurance claims processing services, answering service personnel, accountants, consultants (such as quality assurance or utilization review teams), members of a legal team, etc.7 Table 17,8 Component Rationale Name, address and telephone number of covered entity Identifiable information. Name, address and telephone number of business associate Identifiable information. Brief explanation of HIPAA Raise awareness of the business associate. Definition of related terms To eliminate misunderstanding of contractual contents (examples include covered entity, business associate, individual, protected health information, etc.). List of responsibilities of the business associate List the exact terms of the contract including specifics concerning how the privacy rule is to be followed, timelines for completion of work. List of permitted activities of the business associate Description of exactly how the protected health information is to be used. Also contains a provision to extend the agreement to any subcontractors hired by the business associate. Lists reporting requirements and limitations. Procedures to follow should a breach of security occur Covered entity must be notified. List of consequences for noncompliance Includes civil monetary penalties and federal criminal (monetary and incarceration) penalties. Disclosure Covers any possible errors or omissions in the contract and states that HIPAA regulations will prevail. Liability insurance requirement May be optional (according to state law). Signatures and date of signing Validation of the contract. Notarization If desired or required by state law. Business Associate Agreement All business associates of a covered entity who have access to a patient’s protected health information must have a signed business associate agreement in place.7 According to Hinkley, et al, the required contractual provisions include: ∎∎ Ensuring that PHI will not be used or disclosed except in accordance with the business associate contract; ∎∎ Ensuring that appropriate safeguards are in place to protect the confidentiality of PHI; ∎∎ Requiring business associates to report breaches to the covered entity; ∎∎ Requiring agents and subcontractors to comply with the same requirements that apply to business associates; ∎∎ Making PHI available to satisfy patients’ rights; ∎∎ Making PHI available to satisfy HHS’s right to investigate and enforce HIPAA; and ∎∎ Returning or destroying all PHI upon termination of the agreement, if feasible.7 An overview listing the main components of a business associate agreement and the rationale for each entry is provided in Table 1. 37 Maintaining Patient Confidentiality: HIPAA Compliance Notice of Privacy Practices Patient Authorization The notice of privacy practices must be given to the patient and a signed acknowledgment of receipt must be obtained prior to the first interaction unless an emergency situation exists. In the case of treatment necessitated by an emergency, the notice must be provided as soon as is feasible following the emergency and a signed receipt is not necessary. As the notice of privacy practices is updated, the information need only be available to the patient. This may take place by making written brochures available, by posting the information in the reception area, or by posting the updated information on the covered entity’s Web site. As the notice of privacy practices is updated, it is not necessary to obtain an updated, signed acknowledgment of receipt from each patient as long as the necessary updates are available upon request. The document must not use legal or medical terminology, but must be written in terms that most patients can easily understand.9 An overview listing the main components of a notice of privacy practices and the rationale for each entry is provided in Table 2. A covered entity must secure that patient’s permission in writing prior to releasing any protected health information that does not fall under permitted usage or is not covered by a business associate agreement. The patient (or the patient’s legal proxy) must sign and date an authorization form that states exactly what information is to be released, to whom and for what purpose. The date or date range for which the authorization is effective is noted, and the method for revocation of the authorization is also included.9 A log should be kept in each patient’s chart documenting any release of information.11 Table 2 9,10 Component Rationale Name, address, and telephone number of covered entity. Identifiable information. Brief explanation of HIPAA and definitions for any terms that the patient may not understand. Patient education. Disclose how private health information is used, stored, and protected. Raise awareness of the patient. Explain how changes in the notice of privacy practices are handled. General patient information. Patient’s rights and responsibilities are explained. Inform patient of his or her rights and responsibilities. Describe the mechanism by which a patient may make a complaint regarding HIPAA. General patient information. Explain the legal duties of the covered entity. General patient information. List the name and contact information of the privacy officer. Raise level of patient confidence. 38 Operating Procedures When developing the policies and procedures for protecting the patient’s health information, the two main concerns for consideration are privacy and security of information that is to be exchanged between the covered entity and other covered entities, the patient, and business associates, as it applies to written or printed information, electronic information, and spoken information.12 Written or printed information is anything that is on paper, including faxes.13 Some methods of protecting written or printed information include using patient sign-in sheets that contain minimal protected information, placing treatment sheets and staff assignments away from areas where they may be viewed by non-employees, ensuring that patient charts are secure, such as in a locked cabinet or storage room, or by restricting access to the storage location, and placing fax machines where they are not visible to nonemployees.14 Electronic information is anything that is stored in a computer or that is transmitted electronically (excluding faxes). Some methods of protecting electronic information include restricting physical access to computers, including placing computer monitors in locations where they cannot be viewed by non-employees, restricting access to computer files and e-mail accounts, use of firewalls to protect computer files, use of passwords to access computer files and e-mail accounts, and remembering to log off when the computer is not in use. Also, maintenance of computer software and routine backup of computer files is necessary. Laptop computers and personal digital assistant (PDA) devices must be stored in a secure location. Any type of file sharing between covered entities and their business associates, as well as file sharing with patients (for example, access to laboratory results), must be secure.14 Spoken or verbal information is anything that is said about the patient. Some methods of protecting spoken information include conducting telephone and face-to-face conversations with patients or about patients in private areas so that the conversation is not overheard by non-employMaintaining Patient Confidentiality: HIPAA Compliance ees. Employees must also use caution when communicating with the patient by telephone that information is not inadvertently given to someone other than the patient. For example, messages concerning appointments and lab results should not be left on an answering machine without the consent of the patient because someone else could intercept the message or overhear the message being played back.14 Staff Training One of the responsibilities of the privacy officer is to ensure that the staff has been trained according to the HIPAA policy and procedure manual of the covered entity as part of his or her initial orientation and annually thereafter. Documentation of the training must be maintained in the employee’s file. Training should include an overview of the policies and procedures and a review of the patient’s rights. The consequences for violation of the policies and procedures as set forth in the manual are also made known to the employee, who may be legally held personally responsible for any violation that may occur.11 Consequences of Noncompliance Employees of covered entities who do not comply with the HIPAA Privacy Rule by disclosing or improperly using a patient’s protected health information could face civil and federal charges. “Improper use or disclosure of PHI could result in civil monetary penalties of $100 per incident, or as much as $25,000 per person, per year, per standard. Because certain criminal violations qualify as a felony, criminal penalties can range from $50,000 to $250,000 and up to 10 years in prison.”2 All employees of a covered entity should be aware of the severity of the criminal penalties and take compliance with all HIPAA regulations in all aspects of the organization seriously. Evaluation of the HIPAA Compliance Program Most instances of failure to comply with the HIPAA compliance program are inadvertent and, unfortunately, some are purposeful. In order to maintain compliance and reduce the risk of suffering the penalties of noncompliance with the HIPAA regulations, ongoing audits or self-evaluations should occur on a regular basis. Typically, the responsibility for evaluation of the HIPAA compliance program falls to the privacy officer. The evaluations may also be conducted by the risk manager or by an outside consultant. First, the contents of all documents that relate to HIPAA should be compared to the actual regulation to ensure accuracy and thoroughness. Then, actual compliance with the prescribed policies and procedures should be assessed and any corrective action taken. Physical inspections of the facility may also turn up unexpected policy violations. A task as sim- 39 ple as sitting in a reception area while watching the activities and listening to any verbal interactions that involve protected patient information may prove useful in identifying any problem areas. If a violation is suspected, immediate corrective action (that may actually be very easy to implement) must be taken to avoid a possible patient complaint. A potential government-initiated investigation will be time consuming and will take personnel away from his or her normal duties and may result in punitive action.15 Numerous tool kits for self-evaluation of HIPAA compliance programs are available online or for purchase. Conclusion Each facility must maintain a HIPAA policy manual that describes all policies and procedures relating to a patient’s protected health information. Business associate agreements are needed between the covered entity and any organizations that are contracted to provide service to the covered entity that involve protected health information. Additionally, a notice of privacy practices informing the patient of his or her rights concerning protected health information and how his or her protected health information will be used by the covered entity must be developed and provided to each patient. The notice must be provided to the patient and a signed acknowledgment of receipt must be obtained and retained by the covered entity. The patient must authorize in writing any release of protected health information that does not fall under permitted usage or is not covered by a business associate agreement. All staff members must receive and have documentation of HIPAA compliance training upon hire and annually thereafter. The consequences for violation of HIPAA regulations are harsh and may involve fines of up to $250,000 and 10 years in prison for the most severe offenses. About the Author Teri Junge, CSFA, BS, FAST, is the surgical technology program director at San Joaquin Valley College in Fresno, California. She also serves as AST’s editorial review consultant. Ms. Junge recently finished her bachelor’s degree in health services administration. References 1. Frimpong J., Rivers P. (2006). Health insurance portability and accountability act: blessing or curse? Journal of Health Care Finance. New York: Fall 2006. Vol. 33, Iss. 1; pg. 31,9pgs. Retrieved on December 6, 2008, from http://proquest.umi.com/pqdweb?did= 1152143131&Fmt=3&clientId=4684&RQT=309&VName=PQD 2. Ziel, S. (2002). Get on board with HIPAA privacy regulations. Nursing Management. Chicago: Oct 2002. Vol. 33, Iss. 10; pg. 28, 3 pgs. Retrieved on December 7, 2008, from http://proquest.umi. com/pqdweb?did=223140251&Fmt=3&clientId=4684&RQT=309 &VName=PQD Maintaining Patient Confidentiality: HIPAA Compliance 3. Gruber, J., Madrian, B. (1994). Health insurance and job mobility: the effects of public policy on job-lock. Industrial & Labor Relations Review, Vol. 48, 1994. Retrieved on December 6, 2008, from http://www.questia.com/googleScholar.qst;jsessionid=J7yTpm RQnGpGcYlhjm7nlnNPJ5tsY1Q y3fvdKW1bJK0l8Dk63yCv!51528 6004?docId=98939193 4. Davino, M. (2004). Covered entities. Medical Economics. Nov 3, 2004 v81 i21 p25 (1). Retrieved on December 6, 2008, from http://wf2dnvr6.webfeat.org/ 5. United States Department of Health and Human Services. (2008). HIPAA medical privacy—national standards to protect the privacy of personal health information. Retrieved on November 23, 2008, from http://www.hhs.gov/ocr/hipaa 6. Guthrie, J. (2003). Time is running out—the burdens and challenges of HIPAA compliance: a look at preemption analysis, the “minimum necessary” standard, and the notice of privacy practices. Annals of Health Law Pub.: 2003, Volume: 12, Issue: 1, Pages: 143-77, V retrieved on December 7, 2008, from http:// www.ncbi.nlm.nih.gov/pubmed/12705207?ordinalpos=1&itool=En trezSystem2.PEntrez.Pubmed.Pubmed_ResultsPanel.Pubmed_DefaultReportPanel.Pubmed_RVDocSum 7. Hinkley, G., Glitz, R., & Hirsch, W. (2003). Do you know your business associates? Healthcare Financial Management. Westchester: Jan 2003. Vol. 57, Iss. 1; pg. 54, 6 pgs. Retrieved on December 7, 2008, from http://proquest.umi.com/pqdweb?did=276608411&F mt=4&clientId=4684&RQT=309&VName=PQD 8. United States Department of Health and Human Services Department of Human Rights. (2006). Medical privacy—national standards to protect the privacy of personal health information sample business associate contract provisions. Retrieved on December 8, 2008, from http://www.hhs.gov/ocr/hipaa/contractprov. html 9. Sarraille, W., Spencer, A. (2003). Assembling the HIPAA privacy puzzle. Healthcare Financial Management 57 no1 46-52 Ja 2003. Retrieved on December 9, 2008. 10.United States Department of Health and Human Services Office of the Assistant Secretary for Planning and Evaluation. (2008). Section 164.512 notice of privacy practices; rights and procedures. Retrieved on December 9, 2008 from http://aspe.os.dhhs. gov/admnsimp/nprm/pvcnprm3.txt 11. Caplin, R. (2003). HIPAA: Health insurance portability and accountability act of 1996. Dental Assistant. Chicago: Mar/Apr 2003. Vol. 72, Iss. 2; pg. 6, 2 pgs. Retrieved on December 9, 2008, from http://proquest.umi.com/pqdweb?did=324849131&Fmt=4&c lientId=4684&RQT=309&VName=PQD 12. McNealy, T. (2008). HIPAA compliance training. POWERPoint accessible to San Joaquin Valley College faculty. 13. Dodek, D., Dodek, A. (1997). From Hippocrates to facsimile. Protecting patient confidentiality is more difficult and more important than ever before. Canadian Medical Association Journal. Ottawa: Mar 15, 1997. Vol. 156, Iss. 6; pg. 847. Retrieved on December 10, 2008, from http://proquest.umi.com/pqdweb?did=4183 42341&Fmt=3&clientId=4684&RQT=309&VName=PQD 14. Pabrai, U., (2003). Getting started with HIPAA (1st ed). United States: Course Technology PTR. 15. Ross, L., Friedman, M. (2006). HIPAA privacy audit tool. Healthcare Financial Management. Westchester: Feb 2006. Vol. 60, Iss. 2; pg. 133, 4 pgs. Retrieved on December 9, 2008, from http://proquest.umi.com/pqdweb?did=989047281&Fmt=4&clientI d=4684&RQT=309&VName=PQD 40 Survey Results Prior to researching information for this article, the author conducted a qualitative survey of 10 covered entities. Ten survey questions were asked of the individual or group of individuals responsible for setting up the HIPAA compliance program at their facility (Please refer to Appendix 1). Of the 10 facilities surveyed, a single person was responsible for the program at half of the facilities. There were also teams of two at three facilities, one team of three, and one team of four. Of the 10 facilities surveyed, five facilities put the HIPAA compliance program together from scratch, two facilities hired consultants, and three facilities purchased planning kits. Of the two facilities that hired consultants, both were very satisfied with the consultant’s work. Of the three facilities that purchased planning kits, only one was satisfied with the contents of the kit. The most challenging part of program implementation was reported as time constraints by six of the respondents, one reported that choosing a consultant was the most challenging, one reported problems with the print shop, and two reported no challenges. Eight out of 10 facilities reported compliance problems with the physical layout of the facility and nine out of 10 facilities reported problems with personnel not following the regulations. None of the facilities reported performing regular comprehensive evaluations of the HIPAA program and three are not doing any type of evaluation at all. Of the 10 facilities surveyed, only one reported a relevant patient question about HIPAA. Ninety percent of the facilities reported that they had no HIPAA violations that resulted in citations. Maintaining Patient Confidentiality: HIPAA Compliance Appendix 1 — Survey Questions and Responses (continued) Please explain who was responsible for setting up the HIPAA compliance program at your facility. 1. I did it myself. 2. I was the only one responsible for setting up the HIPAA compliance program. 3. Two of us were assigned to the task. 4. The owner and I worked together on the program. 5. Just me. 6. It started out as a committee of four, but I ended up doing all of the work without any input from the other three. 7. I was. 8. Me, by myself. 9. Me and one other person. 10. Three of us worked on the assignment together. Would you please describe the planning and implementation process for the HIPAA compliance program at your facility? 1. I did the research online and set up the program. 2. I hired a consultant. 3. We did quite a bit of research and then decided to purchase a prepackaged program. 4. Neither one of us had much time, so we decided to buy a program from the internet. 5. I did everything. 6. When the committee fell apart, I got permission from the boss to hire a consultant. 7. I started out thinking that I would do everything myself, but it was too much so I bought a kit and worked from there. 8. I researched the options and because of cost constraints I put the program together on my own. 9. We did it all. 10. We divided up the work at the start of the project and then put the finishing touches on together. If a proprietary service (such as a consultant or document center) was used to provide assistance with planning and implementing the program, please describe the amount of the work that was accomplished by the service? 1. N/A. 2. The consultant did about 95% of the work. 3. About half. Even with the purchase of a program, we still did quite a bit of work on the project. 4. The program was good, but we had to tailor it to our facility, so I would say about 75%. 5. Does not apply. 6. The consultant did most of the work, I’d say about 90%. I just had to approve the final documents and train the staff. 7. The kit provided about half of what I actually needed. It was a bare bones kit. I should have done more research before deciding. 8. Did not use. 9. We did not use a service. 10. N/A. 41 Maintaining Patient Confidentiality: HIPAA Compliance Appendix 1 — Survey Questions and Responses (continued) If you relied solely on a proprietary service to provide everything necessary for implementation of the program, what did you like or dislike about their work? 1. N/A. 2. I was very pleased with the consultant’s work - she took care of everything. 3. We were not pleased. The program was basically an outline and we had to fill in all of the information. 4. The program that we bought met our expectations and was satisfactory. 5. Does not apply. 6. Yes, I really liked the consultant. He did absolutely everything! 7. I really disliked the fact that after spending all that money I still had to do a lot of the work myself. 8. Does not apply. 9. We did not use a service. 10. N/A. Please describe what was the most challenging part of planning and implementing the program. 1. Finding the time to do it. 2. Interviewing the three consultants and deciding who would be the best fit. 3. Realizing how much work that the owner and I still had to do after purchasing a prepackaged program. 4. Working with the people at the print shop to make sure that all of the documents were ready by the time we needed them. 5. I wasn’t able to train the staff all at the same time, so I had to repeat the class four times. 6. The consultant pretty much took care of everything. If there were challenges, I was not aware of them. 7. Thinking that I could do everything myself and then caving in a buying a kit. 8. I wish there had been money to hire a consultant because it took me almost a month of working full time (+) to get the HIPAA program together. 9. We didn’t really have any problems. 10. Finding time for the three of us to meet to review and finalize the program. What concerns do you have about maintenance of the program that relate to the physical layout of your facility? 1. The FAX machine had to be moved because it was too visible. 2. We should have planned for a private consultation room. 3. Now that we have redirected traffic to the restroom, we can put the patient’s charts outside of the exam rooms again. 4. I am concerned about security of the patient’s charts because they are not locked up. 5. The walls between the exam rooms are not soundproof. 6. So far, no concerns have arisen. 7. The scale is in a busy hallway. 8. People in the waiting room may be able to overhear telephone conversations. 9. The sign in sheet at the front desk was visible to all and asked for lots of private information, so we simply stopped using it. 10. None yet. 42 Maintaining Patient Confidentiality: HIPAA Compliance Appendix 1 — Survey Questions and Responses (continued) What concerns do you have about maintenance of the program that relate to the personnel at your facility? 1. One employee shared her computer password to another employee. 2. There is no place to hold a private conversation, so we have to really concentrate on keeping our voices low and watching to make sure that nobody hears who shouldn’t. 3. No personnel problems so far (that I know of). 4. The patients are a bigger problem than the personnel because this is a small community and they all know each other. 5. We have a large staff and ensuring that the training is up to date is huge. I try to do all of the training annually, but every time we get a new employee they are off the schedule. Then to get them on track with everyone else, sometimes they take the training twice on one year, so that they are in sync with everyone else. 6. The hardest thing is getting the employees to tell me when we start running low on the printed material so that I can order more before we run out. 7. One employee is constantly leaving charts, lab reports, etc. scattered around the office where they could be seen by other patients and their family members. 8. We had an employee tell her mother that another family member came in for treatment and provided details of the visit. This was reported to HIPAA as a violation and is currently under investigation. This is the only personnel problem that we have had. 9. One employee was using the phone in the reception area to call in prescriptions to the pharmacy. People in the waiting room could hear the conversation. This actually came to our attention because someone in the waiting room reported it to the office manager. 10. We need to set up a formal training program for the employees. So far, we have been doing it from the top of our heads without a checklist. Three of us share the responsibility for training and I think that we each focus on different aspects What types of evaluations are carried out to ensure effectiveness of the program? 1. Requests for information are tracked to be sure that written releases are obtained before the requested information is sent out. 2. All employees are trained and the training is documented in his or her personnel file. 3. We conducted one patient satisfaction survey, but very few patients responded and I don’t think that many of the ones that did actually understood what we were asking. 4. None yet. We just opened about a month ago. 5. I guess the fact that the patients are complaining about having to sign a release to get information released to a family member is a good indicator that we are doing something right! 6. We have a HIPAA binder with all of the regulations and documents in it, but I don’t think that anyone is making sure that we follow the instructions. 7. Are we supposed to be doing evaluations? Like what? 8. We don’t have time to do evaluations. 9. When I have time, I randomly audit patient charts to see if the front office staff is getting them to sign the receipt for the Notice of Privacy Practices. 10. About twice a year I make sure that the Business Associate Agreements are up to date. 43 Maintaining Patient Confidentiality: HIPAA Compliance Appendix 1 — Survey Questions and Responses (continued) What types of questions, if any, do the patients ask about the program? 1. None, most are familiar with the privacy policies from dealing with other facilities. 2. None. 3. I can’t recall anyone asking, but I could check with the receptionist if you need more information. 4. They just sign the receipt without asking. 5. Some people ask why they have to sign the HIPAA document at every facility, but that’s it. 6. None. 7. They don’t ask. 8. We had one patient ask if the privacy policies would prevent her ex-husband from getting information about her health because she was still on his insurance. 9. We stopped using a sign-in sheet at the front desk and the patients quite often ask about that. 10. I can’t remember anyone asking questions about HIPPA. They are more concerned about how long they might have to wait. Please list any citations that your facility has received for HIPAA violations and the describe consequences. 1. None. 2. No citations. 3. One patient threatened to report us for a violation, but once we explained to her that we were allowed to release information to her insurance company in order to receive payment, she understood and did not file a complaint. 4. N/A. 5. None, so far. 6. None. 7. N/A. 8. One complaint has been filed, but it doesn’t look like the facility will be cited. The (former) employee who violated the policy will be held responsible and will most likely pay a significant fine however the investigation is ongoing. 9. N/A. 10. None. 44 Maintaining Patient Confidentiality: HIPAA Compliance CE Exam: Maintaining Patient Confidentiality: HIPAA Compliance 1. The two main goals of the HIPAA program are and . 6. Written or printed information does not include . A Privacy/accessibility B Portability/confidentiality A Medical charts B Faxes C Portability/accountability D Privacy/accountability C Emails D None of the above 2. Which is an example of a health organization that is required to follow HIPAA privacy rules? A Health plans B Health care providers 7. Messages concerning appointments and lab results should only be left on an answering machine if . C Health care clearing houses D All of the above A The patient is not home B The patient has given consent C The information is time sensitive D Information should never be left on an answering machine 3. Information that is created or maintained by a HIPAA-covered entity in any form is . A Medical records B Protected health information C Public domain D Available only to immediate family 8. The most severe consequences for a HIPAA violation include . A A fine of $100 per incident B $25,000 C 10 years in prison D All of the above 4. Prior to interaction with a patient, the must be given to the patient and a signed receipt must be verified. 9. A notice of privacy should A Notice of privacy practices B Liability waiver A Explain the legal duties of the covered entity B Explain patient’s rights and responsibilities C A&B D None of the above C Disclose how information is used, stored and protected D All of the above 5. The notice of privacy practices can be supplied via . A Written brochures B Posted information in the reception area C The entity’s Web site D All of the above 45 . 10. A business associate agreement includes . A A list of consequences for noncompliance B An advance directive C An appointed trustee D All of the above Maintaining Patient Confidentiality: HIPAA Compliance Radiation Risk by Mark Otto Baerlocher, MD Learning objectives: ∎∎ Examine the effects of radiation on the human body. ∎∎ Compare and contrast the difference between necessary procedures and procedures that are perceived to be necessary. ∎∎ Evaluate the rate of radiation-associated cancer risk. ∎∎ Analyze methods of reducing radiation exposure. ∎∎ Explore methods of tracking your personal radiation exposure level. Question: What is the estimated risk of both nonfatal and fatal malignancy associated with a CT of the abdomen at 10 milliSieverts effective dose (mSv) in a 25-year old woman? The use of medical imaging and related exams and procedures includes everything from X-rays, intra-operative fluoroscopy, CT scans, coronary angiography/angioplasty, embolizations, and endoscopic retrograde cholangiopancreatography (ERCP), among others. The use of these exams and procedures has rapidly increased over the last two decades, and has led to enormous improvements in both the diagnosis and the treatment of diseases and pathologies. With this increase comes a concomitant increase in the cumulative exposure to ionizing radiation to patients, and by extension, an increase in estimated associated cancer risk. As patients are largely unaware of the associated risks, it is therefore imperative that health care workers become educated on the topic. The following article briefly discusses the background of radiation risk, the model used to estimate radiation-related cancer risk, and potential education strategies. This article is written with a primary focus on patients. However, the issues apply equally to health care workers, and certainly, to surgical technologists, for their own protection. While patients are undergoing medical imaging and related exams and procedures for their own health, health care workers are being exposed occupationally. A lack of awareness or appreciation could therefore lead to a lack of safety and appropriate protection in an occupation- 46 al setting. And because there is potential for occupational exposure on a daily basis, a lack of appropriate protection could result in very high, systematic exposure rates. It is therefore crucial that all health care workers attain a basic understanding and awareness of the related issues, not only for the sake of patients, but for personal protection as well. Radiation The simplest definition of the term, “radiation,” is the transport of energy through space, which will eventually be absorbed by a material (the Earth, the human body, air particles, etc). Radiation comes in different forms—for example, a person is able to listen to his or her radio due to radiowave radiation, and people can see their surroundings due to light-wave radiation. The type of radiation used for medical imaging purposes is generally “ionizing,” which means that the radiation carries sufficient energy to eject electrons from particles, resulting in the creation of ions.1 Ionizing radiation is used in X-rays, CT scans, fluoroscopy, coronary angiography/ angioplasty, and many other exams and procedures. These positively-charged ions, once created, can then go on to cause damage in human tissue, by creating damage to DNA for example. Due to different protective mechanisms and growth characteristics, some cell types in the human body are more prone to radiation than others; ie they are more “radiosensitive.” In general, it has been found that cell radiosensitivity is directly proportional to the rate of cell division and inversely proportional to the degree of cell differentiation. In short, this means that actively-dividing cells, or those not fully mature, are most at risk from radiation.2 For example, hematopoietic cells, reproductive cells, and cells within the digestive tract are particularly radiosensitive. Effects of Radiation There are two categories of harm that may be caused by radiation: deterministic (nonstochastic), and stochastic. Deterministic effects are those that occur once a given exposure is reached. Infertility and cataracts are two examples of deterministic effects. Skin erythema/redness occurs at a dose of at least five sieverts. The sievert is a unit used to derive a quantity called equivalent dose. This relates the absorbed dose in human tissue to the effective biological Radiation Risk damage of the radiation. Not all radiation has the same biological effect, even for the same amount of absorbed dose. Equivalent dose is often expressed in terms of millionths of a sievert, or micro-sievert. To determine equivalent dose (Sv), you multiply absorbed dose (Gy) by a quality factor (Q) that is unique to the type of incident radiation.1 Stochastic effects are those effects that are probabilistic. In other words, there is no threshold above which the effect always occurs, however, the greater the exposure, the greater the probability of occurrence. The primary stochastic effect is the development of cancer. Estimation of Radiation-Associated (Cancer) Risk Estimation of radiation-associated cancer risks is very difficult due to numerous complexities involved. Many of the estimates are based on extrapolation from atomic bomb data. Arguably, the most expert risk-estimate model estimation comes from the National Academy of Sciences (NAS) Committee on the Biological Effects of Ionizing Radiation (BEIR) VII, which is available to read online at http://www. nap.edu/catalog.php?record_id=11340. The BEIR VII committee uses the linear-no-threshold (LNT) model, which assumes that radiation risk is linear, and non-threshold (ie, there is no minimum radiation exposure which must be surpassed in order to increase the associated risk of developing cancer). As with any model, there are inherent deficiencies and inaccuracies. However, as additional data become available, the risk estimates are re-evaluated and modified. Radiation in Medicine As mentioned above, ionizing radiation is utilized quite extensively in medicine, both in diagnosis (X-rays, CT scans, nuclear medicine scans, fluoroscopy, coronary angiography, ERCP, etc) and in treatment (embolizations, angiogplasty/stenting, ERCP, etc). One of the largest sources of cumulative radiation exposure in medicine is from CT scans, which has increased rapidly over the last two to three decades.3 There have been estimates, for example, that if current CT usage rates continue, up to one and a half to two percent of all cancers in the United States may be caused by CT radiation in the future.3 While patients assume that any test or procedure requested is clinically indicated or necessary, this may not always be the case. There has been evidence, for example, that not all exams ordered may be clinically indicated, and a substantial minority may be ordered for other reasons, such as miscommunication or medico-legal reasons.3 Perhaps one contributing factor is an underestimation of the risks of radiation-associated cancer by many clinicians.4 47 Periodically, there are very high-profile papers published in high-impact medical journals such as the New England Journal of Medicine,3,5 which then lead to articles published in the mainstream media (eg U.S. News & World Report, CBS, The Wall Street Journal, USA Today, CNN, etc). Following such stories, there may be a tendency for misinformation to propagate and misunderstanding to ensue. Decreasing Radiation Exposure There are a number of approaches that are necessary in order to decrease radiation exposure, or more specifically, to ensure that unnecessary radiation is avoided. Education The primary and the crux of any approach must be education, both of health care workers, and of patients. Without at least a general awareness of radiation risk issues, there is little likelihood either group would include radiation risk into decisions regarding their own, or their patients’ care. This author is currently a final-year radiology resident in Toronto, Ontario, Canada. All radiology residents undergo mandatory, extensive radiology and radiation physics training, which includes radiation-risk education. The topic is formally tested on the final medical boards exam (in fact, in the United States, one part of the board exams for the American Board of Radiology is specifically focused on radiology-related physics). As medical imaging and related exams and procedures are so pervasive that they are relevant for most all health care workers, this author suggests that all health care workers be given at least some basic education on radiation-risk awareness. This could be in the form of formal lectures during training, during continuing medical education-style courses and conferences, and in formal publications such as The Surgical Technologist. The best example of an international, large-scale radiation risk awareness initiative is the Image GentlySM campaign by The Alliance for Radiation Safety in Pediatric Imaging, a consortium of professional societies concerned about the amount radiation exposure children receive when undergoing medical imaging procedures (www.pedrad.org). The campaign has achieved much success in increasing awareness among both health care workers and patients, and continues to increase its reach, influence, and its partners. Although this author may hold an obvious bias as a resident in radiology, it is his opinion that the leadership on radiation risk education and awareness should come from within the field where it is most relevant—radiology. This is certainly the case, as the Image GentlySM campaign demonstrates. Radiation Risk Increased Communication Communication, or lack thereof, is one potential cause of unnecessary radiation, such as redundant exams.3 Communication includes exchanges between patients and health care workers, as well as among health care workers themselves. For example, if there is a concern that an exam may be redundant due to miscommunication, contact the relevant person and clarify prior to exposing the patient to potentially unnecessary radiation. Protocol Optimization Depending on the modality and type of exam or procedure, consideration should always be given to decreasing radiation exposure to the patient by optimizing the technique and protocol. This may include the use of shielding and protective garments, and adjustment of specific imaging parameters. The proper use of protective garments for the personal safety of health care workers is crucial. Whereas patients tend to undergo solitary exams sporadically, occupationally-exposed health care workers may have the potential for exposure on a daily or near-daily basis, and therefore, improper protection may lead to very high, systematic, cumulative exposure. Tracking/Logging Exposure, Radiation Passport for the iPhone/iPod Touch There are several excellent electronic and online resources available that have the potential to both educate patients (such as the Image GentlySM campaign and Web site), and now to track radiation exposure and estimate associated risks. One such resource is an application for the iPhone and iPod Touch that this author co-developed with Tidal Pool Software and his brother, Adrian Baerlocher, called Radiation Passport. Radiation Passport is an application that is meant to be useful for both health care workers and patients alike. The application serves two primary functions. It can be used to estimate the associated (nonfatal and fatal) cancer risk from a given medical imaging exposure, related exam or procedure for a patient of a given age and gender; and it can also track or log all of the radiation exposures from medical imaging over a patient’s lifetime, and estimate the associated cancer risks from that radiation. The average effective radiation doses associated with the relevant exams and procedures (modality and body part) were obtained by performing an OVID/Medline search of published medical literature (though if known, users can enter custom radiation doses instead for any given exam or procedure). The risk estimates are based on the LNT model used by the BEIR VII committee (linear, non-threshold, cumulative). The risks are customized to the exam or pro- 48 cedure modality, body part, age, and gender of the patient. The application also includes a series of questions to estimate background (nonmedical) exposure, as well as an extensive background/information section. The application is available on Apple’s iTunes electronic store. Additional information can be found at http://www. tidalpool.ca/radiationpassport/. * While many countries require mandatory radiation logs for those deemed “radiation workers,” most do not require a similar log for patients and other health care workers. This author suggests that it is time that this is considered. Should Patients Be Informed of the Risks? There has been some implied criticism questioning whether or not it is fair to give patients information about the radiation risks, with the worry that they may refuse an exam or procedure based on this information.6 This author argues that not only is it fair, but it is necessary for patients to be provided with full disclosure on potential radiation risks. When any given treatment or procedure is prescribed to a patient, it is implied that the riskbenefit equation tips favorably toward the potential benefit side, meaning that the perceived and potential benefits of the treatment or procedure outweigh the perceived and potential risks. Both sides of the equation should be explained to the patient, as well as all feasible options. The patient should be allowed to make the final treatment decision. In the case of imaging and imaging-related procedures that utilize ionizing radiation, one of the potential risks is developing associated radiation-induced malignancy, and therefore, patients should be made aware of this information. This author co-authored a study that is currently under review, which demonstrates that 92 percent of patients about to undergo an imaging-related exam or procedure are unaware of any radiation risks. The more information patients are empowered with, the better (though it may be to the chagrin of many health care workers who then have to spend additional time discussing the risks). As a patient, if you are about to undergo a cholecystectomy, you would probably want to be informed of the associated major and relevant risks. This is analogous in this author’s opinion, except that the primary risks are of radiation, and potentially contrast reaction, contrast-induced nephropathy (CIN), and extravasation (if relevant). Prepare Yourself with Knowledge There is no question that both the diagnostic and treatment abilities of health care workers has been significantly improved with the greater use of more sophisticated imaging and related exams and procedures. However, it also comes with a price—the increasing risk of radiationRadiation Risk induced cancer. The precise balance between use and misuse, as well as more accurate estimates of radiation risks, will surely come under increasing examination in the coming years. In the meantime, it is the responsibility of those involved with its use to become educated on the topic, both for their own sake, and for the sake of patients. As surgical technologists, you are often the face patients will see coming into and out of their surgery. About the Author Answer to question at the start of the article ∎∎ Approximately risk of nonfatal malignancy to single CT abdomen at 10 mSv for a 25-year old woman: 1 in 1500. ∎∎ Approximately risk of fatal malignancy to single CT abdomen at 10 mSv for a 25-year old woman: 1 in 750. Mark Otto Baerlocher, MD, is a final-year resident in radiology at the University of Toronto, in Toronto, Ontario, Canada. Following his residency, he will attend the University of California, San Diego for a fellowship in interventional radiology. Dr Baerlocher eventually plans on entering the academic field. If you have questions or feedback, please contact him at [email protected]. References 1. Idaho State University. Radiation Information Network’s Radiation Related Terms. 2009. Accessed: 12/8/09. Available at: http:// www.physics.isu.edu/radinf/terms.htm. 2. Rubin P; Casarett G W. Clinical Radiation Pathology. WB Saunders. Philadelphia. 1968. 3. Brenner DJ, Hall EJ. “Computed Tomography—An Increasing Source of Radiation Exposure.” New England Journal of Medicine. 2007; 357:2277-84. 4. Lee CI; Haims AH; Monico EP; Brink JA; Forman HP. “Diagnostic CT scans: assessment of patient, physician, and radiologist awareness of radiation dose and possible risks.” Radiology. 2004;231:393-8. 5. Fazel R; Krumholz HM; Wang Y; Ross JS; Chen J; Ting HH; Shah ND; Nasir K; Einstein AJ; Nallamothu BK. “Exposure to low-dose ionizing radiation from medical imaging procedures.” N Engl J Med. 2009; 361(9):849-57. 6. Mason C. “Tracking radiology’s risks.” CMAJ. 2009; 181(3-4):E5. 49 Radiation Risk CE Exam: Radiation Risk 1. The use of medical imaging . A Has rapidly increased in the last 20 years B Has improved diagnosis and treatment C Increases estimated cancer risks D All of the above 2. Radiation that carries enough energy to eject electrons from particles is described as . A Ionizing B X-Ray C Radiosensitive D All of the above 6. If current rates continue, 1.5-2 percent of future US cancers will be caused by A CT scans B Nuclear medicine scans C Embolizations D Coronary angiography 7. Radiographic procedures can be ordered due to . A Diagnostic reasons B Miscommunications C Medico-legal reasons D All of the above 8. Deterministic effects do not include 3. Radiation effects that are measured by probabilities are considered . A Infertility B Cancer development C Skin erythema D Cataracts A Deterministic B Radiosensitive C Stochastic D Sieverts 9. By optimizing technique and protocol, radiation exposure may be . 4. Many estimates of radiation-associated cancer . risks are based on A Stochastic data B Radiation absorption rate C Atomic bomb data D Size of absorbed dose 5. Cell radiosensitivity is directly proportional to . A The degree of cell differentiation B The rate of cell division C The cell maturity level D None of the above 50 . A Eliminated B Decreased C Accurately measured D Improved . 10. Unnecessary radiation and redundant exams can be eliminated through . A Technological advances B Patient cooperation C Communication D Proper safety attire Radiation Risk Birmingham Hip Resurfacing by Jill Wehling Learning objectives: ∎∎ Review the relevant anatomy for this procedure. ∎∎ Examine the set-up and surgical positioning for this procedure. ∎∎ Compare and contrast the differences between hip resurfacing and hip replacement. ∎∎ Assess the indications for hip resurfacing, including selecting strong candidates. ∎∎ Evaluate the step-by-step process of the Birmingham Hip Resurfacing System. People who are very physically active—whether in a physical work environment or simply playing sports—are often uneasy when told by a physician that they need hip surgery to fix the severe, arthritic groin pain that can become a chronic problem. This article discusses options to return to pre-surgery activity levels without going through a total hip replacement. Rather than replacing entire hip, as in a total hip replacement with traditional metal-on-plastic implants, (high impact activities are restricted because of increased (plastic) wear and loosening of the prosthesis), hip resurfacing simply reshapes the bone by shaving a few millimeters off the femoral head and socket and caps it with a metal component made of cobalt chrome, which allows the patient to get back to his or her active lifestyle in a matter of months. History of Hip Resurfacing Originally developed in the 1970s, many early hip resurfacings resulted in poor outcomes and caused many surgeons to abandon the procedure. These early attempts at the procedure failed largely because the large, metal femoral head rubbed on the then-polyethylene socket, wearing it out. This degenerative wear-and-tear caused the components to loosen, ultimately leading to femoral neck fractures. Surgeons preferred the total hip replacement. In 1997, Derek McMinn, MD, and Ronan Treacy, MD released the original concept of the Birmingham Hip Resurfacing System. Unlike the total hip replacement, in the resurfacing procedure, the femoral head and neck is 51 not resected. McMinn’s and Treacy’s model eliminated the polyethylene component of the resurfacing hardware, and with it, prior concerns about it wearing out. This adaptation allows for a much greater level of activity postoperatively. Because of the larger metal-head size, the risk of dislocation is reduced by a factor of 10. Because the femoral shaft is not broached, future revision, if necessary, is much easier and longer lasting. There are currently three FDA-approved hip-resurfacing systems: the CONSERVE® Plus Total Hip Resurfacing System, Corin Cormet™ Hip Resurfacing System, and the Birmingham Hip™ Resurfacing System, which will be discussed in this article. Ideal Candidate for a Birmingham Hip Resurfacing (BHR) The most common indication for hip resurfacing is osteoarthritis (ie, cartilage loss and bone-on-bone articulation). Other indications include hip dysplasia, avascular necrosis (impaired or disrupted blood supply) and rheumatoid arthritis. Younger, formally active patients with good bone density are the best candidates for this procedure. Surgical Preparation After a patient time out, the patient is anesthetized under general anesthesia on the operating table and the surgeon positions the patient in a lateral position. There are many varieties of positioning equipment, but this article addresses the Maquet positioning equipment. The patient is wellsupported using a pubic padded post and lumbar post along with an axillary roll under the armpit with the upper arm in a “gutter” support. The operative leg is placed in a candy cane stirrup for prepping purposes. A compression stocking is applied to the nonoperative leg, which is slightly bent. The surgical staff is then hooded, gowned and gloved and the patient is draped. A sterile compression stocking is placed on the operative leg. Procedure The surgeon marks his or her incision lines, and 20 cc of local mixture of one percent lidocaine with 1:1,000 epinephrine (30 ml), mixed with 0.25 percent sensorcaine plain (30 ml) for a 50/50 mixture totaling 60 ml. This mixture, used to help maintain hemostasis, is injected at the Birmingham Hip Resurfacing incision site. An initial incision is made and deepened through the fat while an ESU is used to cauterize bleeding vessels. The fibers of gluteus maximus and fascia lata are divided. A self-retaining retractor is placed to open the gluteus maximus incision. The surgeon must be careful not to injure the inferior gluteal nerve, as this can cause weakness and leave a divot in the buttock from muscle atrophy. Dissection between the undersurface of gluteus maximus and the greater trochanteric bursa should be carried out so that the sciatic nerve can easily be palpated. A Charnley retractor is then substituted for the self-retaining retractor. At this point the surgeon injects an additional 20 cc of the local mixture to help maintain hemostasis. The greater trochanteric bursa is divided with the ESU. The next step is to identify the piriformis tendon and divide the connection between the piriformis and the gluteus medius fibers. A dull Hohmann retractor is used to retract the edge of the gluteus medius muscle. A tag suture using 1 polyglactin 910 CT-1, is placed on the piriformis, and it is released. The capsular incision is made over the femoral head to the edge of the acetabulum. A tag suture is also placed on the posterior capsule. The femoral head and posterosuperior edge of the acetabulum is exposed. The superior hip capsule is divided at the edge of the acetabulum and a third tag suture is placed. The hip is now ready to dislocate. Capsular scissors are used in cutting the capsule further around the femoral neck. A sharp Hohmann retractor is used to retract back the minimus medius. A rongeur is used to remove any osteophytes surrounding the femoral head. The surgeon needs to find the true femoral neck in order to be able to size the head and neck for resurfacing. Once the measurement is checked the femoral head is prolapsed under the abductor muscle with a sharp Hohmann. A second sharp Hohmann retractor is placed on the outer edge of the acetabular wall and the Omni-Tract® system is used to secure the Hohmann retractors. A headed pin is placed below the transverse ligament and below the tear-drop and hooked to the Omni-Tract® holder. A full view of the acetabulum is achieved and the surgical technologist is ready for preparation and cup insertion. The acetabular labrum is fully excised, and the ligamentum teres remnant also removed. If an osteophyte is present on the posterior acetabular wall, it is divided with an osteotome and removed with a rongeur. Sometimes there is soft tissue that needs to be removed. Osteophyte in the acetabular floor is excised with an osteotome and rongeur. The surgeon can now begin reaming the acetabulum. Starting with a size 44 or 46 mm reamer, the surgeon reams until he or she is confident that the acetabular floor has been reached—reaming up in 2mm increments until he or she comes close to the final acetabular reaming. At this point, the surgeon will proceed in 1mm increments. It is general- 52 Total hip resurfacing This surgery replaces the diseased and damaged bone in the hip joint with specially-designed and manufactured “ball and socket” all-metal implants. Step 1 After the thigh bone is separated from the hip socket, the damaged area is removed. The hip ball is reshaped to fit the femur and just 10 millimeters of bone is removed from the tip. Step 2 Damaged cartilage and bone are removed from the hip socket (acetabulum). Step 3 A specially-machined, metal shell implant is firmly pressed into the socket of the pelvis in the anatomic position. Step 4 Now the surgeon focuses on the thigh bone implant. The end of the thigh is drilled to accept the stem of the implant and dried. Step 5 Bone cement is placed inside the metal ball component and around the dried bone of the thigh Step 6 The metal ball implant is securely inserted on top of the thigh bone. ly advised to ream one size under the estimated cup size and then verify the measurement by trial. When the surgeon is confident about the fit of the trial acetabular component, the true implant is opened and inserted with an impactor and heavy mallet. The surgeon can often tell by the sound that the acetabular cup is fully seated as it contacts the floor of the acetabulum. The surgeon is aiming for 40 degrees of inclination and 20 degrees of anteversion. When the surgeon is satisfied with cup positioning, the acetabular cables are cut and the impactor cap and the cables are removed. Any protruding osteophyte is removed with a rongeur to prevent impingement. An X-ray-detectable 4x4 is placed in the acetabular cup to protect the cup during the next phase of resurfacing. All retractors are now removed and the headed pin is taken out. Accuracy is extremely critical in the following steps. The femoral head must be fully exposed to carry out the reshaping of the head. In order to obtain the correct varusvalgus alignment of the femoral component, the template distance from the tip of the lesser trochanter to the desired point on the intertrochanteric crest must now be transferred from the X-ray measurement, into the operative field. A ruler and an 18g spinal needle are used to obtain this measurement, and it is marked with the ESU at its point for Birmingham Hip Resurfacing pin insertion. The pin is then drilled into the lesser trochanteric space, and a McMinn guide jig is placed to gain proper varus/valgus alignment. A stylus on the guide jig is used to check perimeters circumferentially on the femoral neck. Once the surgeon is satisfied with the ideal entry point, he or she will then drill a long-guide pin, via a cannulated rod, into the superior femoral head. It is important to check the guide-wire position by using the stylus tip around the femoral neck. The stylus should not touch the femoral neck in any position and should touch the periphery of the femoral head 360 degrees. These are the minimum requirements for guide-wire position. If the surgeon is not happy with the guide-wire position, a guide-wire repositioning instrument can be used. The cannulated rod and stylus are removed, and the surgeon will drill through the lesser trochanter into the canal of the femur to place a drain cannula for suction. A urology drape is then placed around the femoral head to protect the soft tissues from being contaminated by bony reaming during the femoral preparation. The guide wire is now over-drilled with two different-sized drilling instruments then replaced with a guide rod. A continuous flow of irrigation is recommended during the next three stages. A headneck template is used as a protector while reaming the femoral head with the cylindrical reamer. An osteotome is used to remove the peripheral ring of femoral head bone. A rongeur is used to remove any osteophyte left behind on the femoral head-neck junction. The cylindrical reamer is then used by hand to remove any fragments left behind. A marking pen will mark the head and neck joint and summit of the head. A plain cutter is used to carefully resect down to the marked point. This is checked with the head-neck template. The chamfer cutter is used until the instrument is fully seated. There is an internal stop in this instrument. This is the final stage of re-shaping the femoral head. Keyholes are drilled with a Wroblewski drill for cement. The guide rod is removed with a slap hammer and the central hole in the femoral head and neck is enlarged with a taper drill. Any cysts seen are removed with a curette. The femoral head is now prepped by pulse lavage and patted dry with lap sponges and suctioned dry. The surgeon checks the correct size of the femoral head, and the box is opened to surgical staff. Preparation of cement consists of a mixing bowl, spatula, 60 cc catheter tip syringe, cement powder, liquid and stop watch with head impactor with heavy mallet available. The femoral head is draped with three clean lap sponges in alternating directions. At the surgeon’s request, he or she will tell the surgical technologist when to start mixing as he or she has only one minute from the time the liquid contacts the powder to implantation. As a surgical technologist, the mixing has to be done quickly, but thoroughly. Ideally, at about 25 seconds, the surgeon should be able 53 to draw up the liquid in the syringe and start filling the femoral head to one-third full. At the one minute mark, the surgeon places the femoral head with the impactor. Any excess cement is wiped away, and a rongeur is used to remove any small osteophyte at the head—neck junction. A pulse lavage is used to irrigate and clean the femoral head and surrounding tissue. The drain cannula is removed, and a clotting agent is injected into canal. Forceps are used to retrieve the raytec from the acetabular cup, saline is used to fill the acetabular cup and a bone hook is used to lift femoral head component along with traction on the leg to reduce into the acetabulum. The surgeon now double checks the leg length and range of motion for any impingement. Closure For closure, the surgeon chooses to use a 3/32 drill to place an anchor into the greater trochanter. Then a 1-Vicryl® CT-1 is used to close the external rotators and capsule along with the tagged piriformis and posterior capsule. 2-0 Vicryl CT-1 is used to close the subcutaneous layer, followed by staples for skin. The incision area is cleaned with a wet and dry. Skin glue is applied along with two, sterile 4x4s and an island dressing. An anti-embolism stocking is placed on patient’s leg with one pillow between the legs for the first few hours of recovery. An X-ray is taken in recovery when the patient is awake to ensure that dislocation has not occurred in moving from the operating table. Recovery Rehabilitation usually starts on the first day after surgery. Patients are on crutches the next day and weight bearing is allowed as tolerated. Physical therapy will start one or two days after surgery, beginning with simple bed exercises that will strengthen the muscles in the hip and lower extremity. It is the physical therapist’s job to teach the patient proper technique to perform such simple tasks as moving from lying to sitting, sitting to standing and standing to sitting. The patient must learn to perform these movements safely, so that he or she doesn’t dislocate the hip or suffer other injury. Patients will start the use of the pool three days after the operation. The patient should have hip flexion of about 90 degrees four to five weeks postoperatively. Most patients can return to whatever level of physical activity they previously enjoyed approximately one year postoperatively. In the first three months, patients will be able to golf, and at six months, high-impact activities should be possible. However, during the first year, more conservative, low-impact activities, such as walking, swimming and bicycling are recommended for strengthening the femoral neck and muscles around the resurfaced joint. The bone is strengthened as new bone grows. According to Wolff ’s Law, bone in a healthy person will adapt to the loads it is placed Birmingham Hip Resurfacing under. If loading on a particular bone increases, the bone will remodel itself over time to become stronger and resist that sort of loading. Because the femoral neck is maintained in a resurfacing procedure, the weight-bearing forces through the calcar and proximal femur remain normal and calcium deposition is normalized gradually. Conclusion Hip resurfacing is a technically demanding procedure, but it can be successful, and the results can be satisfying for the patient. Hip resurfacing requires good bone quality. Some acetabular deformities cannot be addressed. However, it is an attractive option for a young patient fearing a potentially difficult future revision. About the Author Jill D Wehling, lives in Verona, Wisconsin, and graduated from Mt Hood Community College Surgical Technology Program in Portland, Oregon, in 2003. She currently works at Meriter Hospital in Madison, Wisconsin, where she is the lead orthopedic surgical technologist. References ∎∎ McMinn D, ed. Modern Hip Resurfacing. Birmingham, UK: Springer-Verleg; 2009. ∎∎ Rogerson JS. Birmingham hip resurfacing. Available at: http://orthorogerson.com. Accessed August 9, 2010. ∎∎ Wolff’s law. Encyclopædia Britannica. 2010. Encyclopædia Britannica Online. Available at: http://www. britannica.com/EBchecked/topic/646611/Wolffslaw. Accessed July 19, 2010. CONSERVE is a registered trademark of Wright Medical Technology. Corin Cormet is a trademark of the Corin Group PLC. Birmingham HIP Resurfacing System is a trademark of Smith and Nephew. Omni-Tract is a registered trademark of Omni‑Tract Surgical. Vicryl is a registered trademark of Ethicon, a division of Johnson & Johnson. 54 Birmingham Hip Resurfacing CE Exam: Birmingham Hip Resurfacing 1. A polyethylene component is used in the system. 6. There are currently resurfacing systems. A Total hip replacement B Birmingham Hip Resurfacing A 1 B 2 C Corin Cormet Hip Resurfacing D CONSERVE® Plus Total Hip Resurfacing C 3 D 4 7. A/an is used to remove the peripheral ring of femoral head bone. 2. The acetabular cup should be seated at degrees of inclination and degrees of anteversion. A 40/20 B 20/40 C 44/46 D 46/44 B Sterile 4x4 pad C Urology drape D Drain cannula 4. Indications for hip resurfacing include A Impaired or disrupted blood supply B Rheumatoid arthritis C Bone-on-bone articulation D All of the above B Cannulated rod C Rongeur D Cylindrical reamer A Elderly, inactive patients B Younger, active patients C Elderly, moderately-active D Young, relatively inactive patients patients 9. Rehabilitation can begin . 5. Why is an X-ray-detectable 4x4 placed in the acetabular cup after it is set? A To prevent impingement B To protect the cup during the next process C To take X-ray measurements D All of the above 55 A Osteotome 8. The best candidates for hip resurfacing are . 3. A ___ is placed around the femoral head to protect soft tissues from being contaminated by bony reaming during the femoral preparation. A Continuous flow of irrigation FDA-approved hip after surgery. A One day B Three to five days C One week D 10-15 days 10. “If loading on a particular bone increases, the bone will remodel itself over time to become stronger and resist that sort of loading,” is a principle of . A Science B Medical theory C Wolff’s Law D Birmingham Hip Resurfacing Birmingham Hip Resurfacing Interactive Answer Form Click or use a pen to circle the credit answer ASA Credit Pkg A: 10 Continuing Education Credits (Available to dues-paying ASA members only) ASA Member No.: CSFA Certification No: Name: Address: City: Phone: CSFA State: CSA SA-C ZIP: Email: ASA CREDIT PKG A: 10 CONTINUING EDUCATION CREDITS The fee is $15 for ASA dues-paying members Check enclosed Visa MasterCard AmEx # Expiration Date Signature Hernias of the Abdominal Wall 1. A B C D 5. A B C D 9. A B C D 2. A B C D 6. A B C D 10. A B C D 3. A B C D 7. A B C D 4. A B C D 8. A B C D Circle or click one answer next to each number. Only one correct or best answer can be selected for each question. 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