Skin Marker Pens - evaluation report CEP08009

Evaluation report
Skin marker pens
CEP 08009
April 2008
Contents
2
Executive summary .................................................................................. 3
Introduction............................................................................................... 5
Product description................................................................................... 6
Methods.................................................................................................... 7
Technical performance........................................................................... 13
Operational considerations..................................................................... 16
Economic considerations ....................................................................... 18
Purchasing ............................................................................................. 19
Acknowledgements ................................................................................ 20
References ............................................................................................. 21
Appendix 1: Supplier contact details ...................................................... 23
Appendix 2: Evaluation protocol............................................................. 25
Appendix 3: Risk of cross-infection ........................................................ 27
Appendix 4: Pharmacy prepared inks .................................................... 28
Author and report information................................................................. 29
CEP 08009: 2008
Executive summary
3
The product
Skin marker pens are used to apply ink directly to the skin of a patient. They usually
resemble a felt-tipped pen and the ink flows from the internal reservoir as the tip is brushed
on the skin surface. Most are CE marked and supplied in sterile packaging with a ruler.
Field of use
Marking the patient’s skin is important in a range of clinical settings and for different reasons
but the principal functions can be to:
• ensure surgery is performed on the correct site
• mark an important internal anatomical feature identified during diagnostic imaging
• target non-invasive treatments
• plan the surgical approach
• ensure natural realignment of skin flaps during wound closure.
Methods
An important reason for using a surgical marker is to ensure correct site surgery. National
Patient Safety Agency (NPSA) guidelines, produced in association with several other
healthcare bodies, recommends that an indelible pen should be used and that the mark
should remain visible after normal perioperative skin preparation at the surgical site and the
application of theatre drapes [1, 2].
Review of the literature and stakeholder consultation has been used to develop an evaluation
protocol suitable for evaluating whether normal pre-operative skin preparations remove skin
marks made by a range of pens sold for this purpose. Observers scored ink mark visibility of
each pen and the sharpness of the line edge (a) shortly after the line was drawn on human
skin, (b) after cleaning with several commonly used surgical preparation fluids and finally,
(c) after the skin was covered with an iodophor-coated incise drape.
Eleven products were supplied for testing. Results of this evaluation study are combined with
relevant features of each pen to produce a summary table of technical performance.
Technical performance
Before surgical preparation the visibility of all pens were scored as either “acceptable” or
“excellent” and we found that overlaying antimicrobial iodophor surgical incise drapes makes
a minimal change to line visibility and sharpness.
No pens provided acceptable visibility after perioperative cleaning with 2 fluids. Povidone
iodine solution causes minimal changes to the visibility of marks made by five pens (Aspen
Richard Allen fine and regular tipped pens, Aspen Writesite pen, Codman Surgical bold
tipped pen and the UN64 skin marker pen). Chlorhexidine gluconate (alcohol) severely
reduces the line visibility of all pens, except for the Viomedex pens.
CEP 08009: 2008
Executive summary
4
Operational considerations
Sterility of pens being used for marking the surgical site is an important factor as pens tested
after clinical use have been identified as vectors for micro-harmful organisms. Multi-patient
usage is not advocated and the use of sterile pens is recommended for marking close to the
incision site and these are usually marked “single use”. In practice care is needed to avoid
contaminating an operative site after using the pen on a potentially infected area on the
same patient.
All pens in this report contain violet/black ink which may be less visible on darker skin tones.
The line width obtained from the pens listed may not be sufficiently precise for use by plastic
surgeons who generally require very fine lines for skin realignment to achieve a good
cosmetic result.
Some patients seek to avoid obvious skin markings persisting for days after surgery. This
could be achieved by selecting one of the five pens listed that are minimally faded by
povidone, followed by postoperative cleaning of the area around the suture line with
chlorhexidine gluconate.
Economic considerations
The increased cost of using single use skin marker pens for all pre-operative marking should
be balanced against the risk and costs associated with post-operative infections and wrong
site surgery, which can include: increased patient stay; operating time; additional diagnostic
imaging and medico-legal claims.
CEP verdict
Some pens remain more visible than others after pre-operative skin cleaning but the results
are dependant on the skin cleaning fluids used. The marks of five of the products tested
remained clearly visible after the application of povidone preparations but were difficult to see
after chlorhexidine gluconate based preparations were used for skin cleaning. By contrast,
we found the Viomedex pens, using an aqueous solvent, remained visible after skin cleaning
with chlorhexidine gluconate but fading occurred with povidone.
This study did not evaluate the performance of the sample pens with notably dark skin tones
and none of the products tested were specifically designed for this clinical situation.
Key factors to consider when selecting a pen suitable for use close to the operative site are:
• risk of infection (ie pen is sterile, especially when used after pre-operative cleaning)
• absence of fading after cleaning with the specific skin preparation fluids used locally
• tip shape, as this should be appropriate for surgeon’s purpose.
CEP 08009: 2008
Introduction
5
Marking the patient’s skin is important in a range of clinical settings and for different reasons
but the principle functions can be to:
• ensure surgery is performed on the correct site eg by identifying the correct limb
• mark an important internal anatomical feature identified during diagnostic imaging
• target non-invasive treatments, eg radiotherapy beam target in cancer treatment
• plan the surgical approach eg by marking incision lines
• ensure natural realignment of skin flaps during wound closure to achieve a good
cosmetic result.
When responding to the problem of incorrect anatomical site surgery the National Patient
Safety Agency (NPSA) emphasised the importance of surgical marking. NPSA guidelines
produced in association with several other healthcare bodies recommends that an indelible
pen should be used and that the mark should remain visible after normal perioperative skin
preparation at the surgical site and the application of theatre drapes [1, 2].
A primary objective of this evaluation report has therefore been to produce independent
evidence demonstrating those skin marker pens capable of withstanding the normal skin
preparation process at the surgical site and remain clearly visible to the surgeon.
CEP 08009: 2008
Product description
6
Skin marker pens are used to apply ink directly to the skin of a patient. All samples supplied
for this evaluation study resembled a typical felt-tipped pen and were between 9.6 – 10.9mm
in diameter, ranged from 135 – 172mm in length. Most were CE marked and supplied in
sterile packaging (Figure 1).
As the tip is applied topically, when brushed on the skin surface, it draws ink from a reservoir
in the pen body. Tip shapes vary (as shown in Figure 2) and may be described by
manufacturers as fine (A), regular (B), bold (C) or versatile (D ie producing fine lines when
held vertically and broader lines when the pen is held at an angle). One pen assessed in this
evaluation contained two tips, one on each end, allowing the user to select a fine or bold tip.
Many pens have centimetre and millimetre scale markings printed on the side of the pen
(Figure 3) to facilitate measurement when marking the skin. Some products may also include
a separate plastic ruler (Figure 4) in the packaging for the same purpose.
Figure 1 Example of pen in sterile packaging
Figure 3: Ruler markings on side of a pen
CEP 08009: 2008
Figure 2 Comparison of tip sizes
Figure 4 Separate plastic ruler supplied
Methods
7
Literature review and consultation
To enable the development of an evaluation protocol for the objective assessment of skin
marker pens this section establishes (a) the normal perioperative processes that pen marks
on the patient’s skin need to withstand and (b) reviews the methodologies described in
published evaluation studies.
Skin preparation before surgery
It is reported that there is wide variation in practice, even amongst surgeons in the same
hospital and, despite scientific evidence supporting change, traditional practices still
dominate [3]. This diversity of protocols was confirmed in a recent postal audit [4] and
consultation with perioperative staff in a tertiary referral hospital. Generally the key stages
comprise:
• marking the patient prior to surgery, after they have cleansed with soap (anti-bacterial
is recommended [4]) and before sedation
• painting the surgical site with a skin preparation applied using a swab or sponge
• air drying
• application of an iodophor-coated surgical incise drape (in a minority of cases [3]).
Factors affecting the choice of skin preparation
A range of different skin preparations are available for use preoperatively and they all have
different properties.
Isopropyl alcohol is anti-bacterial but of limited use against fungi. Alcohol may be used alone
by some surgeons but more commonly it is a component of a number of proprietary skin
cleaning products, as it enhances the activity of other antiseptic solutions [4]. Surgeons using
alcohol-based skin preparations must ensure there is no pooling of flammable vapour, as fire
is a risk during electrosurgery [5].
Iodine-based skin paints are popular as it is easy to verify the area covered by the antiseptic
solution. Iodine is known to kill bacteria, fungi, viruses and spores but skin sensitisation is a
problem for 15% of patients [4]. Povidone-iodine, a mixture of iodine and polyvinyl-pyrrolidine
available in aqueous or alcohol based solutions, was developed to reduce the problems of
skin sensitivity.
Chlorhexidine is a broad spectrum antibacterial agent, similar to the iodophors, with a
prolonged action and there is a lower risk of patient sensitivity [6], although anaphylactic
reactions in patients undergoing surgery has been reported [7]. It is a primary component in
many proprietary skin preparations, either as an aqueous or alcohol based solution, and has
become equally popular for pre-operative skin cleansing.
There is conflicting evidence about the most effective agent. Iodine based preparations are
more effective against fungal spores but chlorhexidine may retain its effectiveness for longer
[8]. In practice both appear equally popular. The ratio of surgeons who used iodine compared
to chlorhexidine was found to be 54%:46% in a survey conducted in the early 1990’s [3]. In a
CEP 08009: 2008
Methods
8
more recent survey the usage was 46%:60% [4], as some 6% of surgeons reported using
both iodine and chlorhexidine products [4].
Friction is considered important for removing micro-organisms from the skin as it can reduce
surface tension and so plays a vital role in improving the efficacy of germicidal solutions [4].
Use of a swab or sponge to apply the skin preparation fluid is therefore popular practice and
was used by all surgeons in the 2005 survey [4].
Using plastic adhesive drapes (incise drapes) to protect the surgical wound from organisms
that may be present on the surrounding skin during surgery is advocated as a way of
preventing surgical site infection. A recent systematic review [9] concluded that clear
adhesive drapes resulted in a higher proportion of infections whilst iodine-impregnated
drapes had no effect on surgical site infection rate. For practical reasons, such as holding
dressing towels in awkward areas (eg the hip and knee), the use of iodine-impregnated
drapes may continue for certain surgical procedures [3]. Our evaluation methodology has
therefore incorporated an assessment of pen marker visibility after the application of
iodophor-coated incise drapes because the coloured plastic film may obscure pen markings.
Review of published evaluation methodologies
Five studies reporting evaluation of skin marker pens were identified in the literature [10 -14,]
and their methodologies are summarised in Table 1 on page 9. These protocols have been
used to form the basis of the test protocol developed for this evaluation study.
A single subject was used in four of these studies [10-13] and the fifth referred to “patients”
and was poorly described [14]. Details of the pre-operative skin preparation fluids used and
their application were provided for three studies[12, 13, 14] and two documented that marker
visibility differed depending on the cleaning agent used [12, 14]. To improve on these earlier
protocols this evaluation study used eleven subjects, so the effect of skin variables (eg
oilyness, skin tone or hairiness) could be included, and we specifically investigated the
influence of a range of skin preparation fluids on marker fading.
The number of observers grading pen visibility were usually one in the earlier studies
[10, 12, 13], two were used in one study [11] and four observers were used another [14]. We
adopted the best of these protocols and ensured that all observers were ‘blind’ to the identity
of the pen when they scored visibility of the marking, a separate score was obtained at each
stage in the skin preparation process [11]. For this evaluation protocol we further improved
the rigour and independence of observer scoring by (a) using multiple observers to score the
same pen marks, (b) displaying the pen marks individually (ie one pen marking at a time and
under controlled viewing conditions) to prevent the visibility of adjacent lines to influence the
observer’s score and (c) displaying pen marks in random order.
CEP 08009: 2008
Methods
9
Table 1 Summary of published research comparing visibility of skin marker pens
Reference
Method
Notes
Lafferty K, Glass
RG. 1986 [10]
• Eight marking pens collected from junior hospital staff
• A patient for varicose vein surgery
• Patient bathed in the evening and morning before surgery
• Operator draws a line and code number in random order, 4
each on both legs
• Spirit based antiseptic solution
• Visual grading by the operator
• Eleven commonly available marking pens
• A patient for vein bypass surgery
• Operator marked leg to indicate course of long saphenous
vein through ultrasound coupling gel
• Visibility ranked 1(best) to 11 (worst) by single observer,
blinded to pen identity
• Visibility scoring repeated after gel removed and again after
skin cleaning with a spirit based antiseptic solution
• Study repeated by a second observer using the same subject
• All scores added for each pen and used to rank them as best,
mediocre & unsatisfactory
• Six pens commonly used for skin markings in plastic surgery
• Volunteer forearms
• Operator draws a line and code number with each pen on
both arms
• Operator cleaned each arm with single application of
antiseptic paint for 60 seconds. Alcohol based povidoneiodine on left arm and chlorhexidine gluconate on right arm
• Operator assessed all markings for visual durability from 0
(disappeared) to 5 (no fading)
Study included pens sold for
use on dry wipe boards and
other general applications
2 Single subject
Magee TR et al.
1990 [11]
Tatla T, et al. 2001.
[12]
Tatla T, Lafferty K.
2002 [13]
Ayhan et al, 2005
[14]
CEP 08009: 2008
• Eight pens used for skin markings
• A patient due for surgery
• Operator draws a line and code number using each pen, 4
each on both legs
• Two applications of antiseptic paint, firstly alcohol based
povidone-iodine then chlorhexidine gluconate (0.5% in 70%
methylated spirits) and an application time of 2 minutes each
• Operator assessed makings for visual clarity and durability
• 6 types of skin markers inc. a skin marking ink (Appendix 4)
• Number of patients not provided
• Operator draws a line and code number with each pen on
both arms
• Operator cleaned each arm with six separate 10 second rubs
of antiseptic paint. Povidone-iodine on one arm and Betadine
(chlorhexidine gluconate) on the other arm
• Four observers independently assessed all markings after
each rub but detailed scores not provided
2 Observer was not ‘blind’
to the identity of the pens or
the location of the markings
Study included pens sold for
use on dry wipe boards and
other general applications
2 Single subject
3 Observer was ‘blind’ to
the identity of the pens or
the location of the markings
3 Two observers
Study included pens sold for
use on dry wipe boards and
other general applications
2 Single subject
2 Observer was not ‘blind’
to the identity of the pens or
the location of the markings
3 Able to compare effect of
different antiseptic paints on
pen marking durability
Study included pens sold for
use on dry wipe boards and
other general applications
2 Single subject
2 Observer was not ‘blind’
to the identity of the pens or
the location of the markings
2 Single observer
Study included red, blue and
black pens, some sold for
general use, two pens sold
for surgical use, two inks
applied with toothpick
2 Method poorly described
3 Four observers
3 Able to compare effect of
different antiseptic paints on
pen marking durability
Methods
10
Evaluation methodology
This evaluation study was designed to compare the performance of skin marker pens, in
terms of ink visibility and line sharpness, when used on human skin which is subsequently
exposed to the typical pre-operative surgical preparation process. As human volunteer
subjects were required for this evaluation study we sought and obtained local ethical
committee approval (REC reference number 06/WSE02/105).
Eleven pens were supplied for evaluation, one sample having two different pen tips on
opposite ends. Information from the suppliers revealed that some pens were sourced from
the same manufacturer, so only ten pen tips required testing.
Pilot Study
The primary objective of the pilot study was to determine which of six commonly used
surgical preparation fluids (see Table 2) were most effective at removing or fading skin marks
made by all the pens supplied for evaluation.
Table 2 Surgical preparation fluids selected for pilot study
Cleaning solution
Proprietary name
Saline (0.9% sodium chloride, sterile)
Surgical Spirit
Povidone-iodine (aqueous solution)
Betadine® Medlock Antiseptic solution, povidoneiodine 10%
Povidone-iodine (in alcohol)
Betadine® Medlock Alcoholic solution, povidoneiodine 10%
Chlorhexidine gluconate (aqueous solution)
Chlorhexidine gluconate (in alcohol)
Unisept® Medlock Solution 0.05%
Hydrex® Adams Health Solution chlorhexidine
gluconate 0.5% in IMS 70% pink
Four normal volunteers were used for the pilot study. Ten pen markings were drawn in the
same random sequence on both inner forearms of each volunteer. Each arm was swabbed
for 60 seconds with one of the cleaning fluids selected from the above list. The fluids were
selected in pairs and used on opposing arms, eg saline on the left arm and surgical spirit on
the right arm. Each arm was photographed before and after cleaning and two observers
separately visually assessed the degree of fading and sharpness of the edge of the pen line.
Preliminary results revealed the aqueous and alcohol based povidone-iodine solutions were
almost identical in their removal of the skin markings. Chlorhexidine gluconate in alcohol was
more effective than the equivalent aqueous solution. Saline had very little pen removal effect
and surgical spirit was only found to be an effective cleaner with prolonged application. We
confirmed an earlier study which reported different results for chlorhexidine gluconate and
povidone-iodine [13]. Consequently both aqueous povidone-iodine solution and chlorhexidine
gluconate in alcohol were selected for the main study as these represented the worst case
scenario and the response of all the pen marks may not be identical.
CEP 08009: 2008
Methods
11
Main Study
Eleven healthy normal volunteer subjects between the ages of 25 and 54 were recruited. The
main evaluation study followed a standardised procedure which was finalised during the pilot
study and is described more fully in Appendix 2.
During all subject testing the pen order was randomised and recorded. After washing with
soap and drying the skin both inner forearms were marked on with a single line from the ten
pen tips, approximately 55mm long and with a spacing of approximately 15mm. The pen
marks were allowed 3 minutes to dry before a digital photograph of each forearm was taken
under controlled conditions (see Figure 5 (a)).
Each forearm was then cleaned using either aqueous povidone-iodine or chlorhexidine
gluconate in alcohol by application with a folded gauze and standardised number of strokes.
The solutions were allowed to dry and a second photograph taken (see Figure 5 (b) and (c)).
An antimicrobial iodophor surgical incise drape was then placed on the test site and a third
photograph was taken (not shown).
Three observers independently scored each pen mark for ink visibility and sharpness of the
edge of the pen line using the scoring criteria summarised in Table 3. The photographs of
individual pen marks were displayed in a random order on a viewing screen under controlled
conditions. The observers were required to score markings as acceptable or excellent only if
the line was very clearly seen along the whole length, to reflect the potential serious
consequences of incorrect mark identification.
A more detailed description of the evaluation methodology can be found in Appendix 2.
Table 3 Observer scoring system for pen marks.
Visibility
Sharpness of the line edge
Excellent
E
Sharp
S
Acceptable
A
Blurred
B
Re-mark of line is necessary
R
Unacceptable
U
Invisible
I
CEP 08009: 2008
Methods
a) after drying in air
12
b) povidone iodine
c) chorhexadine gluconate
Figure 5 Photographs of ten lines drawn with different marker pens on the inner
forearms of a single subject. From left to right the images show the pens markings (a)
right arm after the lines have dried in air (b) after the application of aqueous povidone-iodine
on the left arm and (c) after chlorhexidine gluconate in alcohol was applied to the right arm.
Summary of evaluation test results
•
Before surgical preparation the visibility of all pens were scored as either “acceptable”
or “excellent”. Two pens were more frequently scored as “sharp” lines than the others
•
No pens provided acceptable visibility after perioperative cleaning with both fluids
•
Povidone iodine solution causes minimal changes to the visibility of five pens
•
Chlorhexidine gluconate (alcohol) severely reduces the line visibility, except for two
pens
•
Overlaying antimicrobial iodophor surgical incise drapes makes a minimal change to
line visibility and sharpness.
Product specific results are listed in the Technical performance section. Visibility and
sharpness scores are given a star rating, delete “such that
indicates the best
performance”. For more information see page 13.
CEP 08009: 2008
Technical performance
13
How to use the technical performance tables
Location of
further
information
Notation used
Features
Tip description
Tip description as quoted by the manufacturer
Page 6
Ink solvent
Ink solvent from papers (#Appendix 3 [17]) or provided by manufacturer
Pages 16, 27
Sterile packaging
- Pen (and rule if included) is supplied sterile in sealed packaging
Page 6
Single Use Label
- Pen is marked for single use
Pen rule
Separate rule
Adhesive labels
CE Marked
Pages 6, 27
xcm – A measuring scale, x cm in length, is marked on the pen body
Page 6
ycm – A separate rule, y cm in length, is packaged with the pen
Page 6
- Adhesive labels are packaged with the pen
- The pen is CE marked
Page 6
Percentage where mark visibility was scored as Excellent or Acceptable:
Visibility
Before skin prep
0 – 20%
21 – 40%
41 – 60%
61 – 80%
81 – 100%
1 most marks were invisible or needed remarking
Pages 11,
12, 25 & 26
After PI (aqueous)
Ratings as above, after povidone iodine (aqueous) preparation
Pages 11,
12, 25 & 26
After CH (alcohol)
Ratings as above, after chlorhexidine gluconate (alcohol) preparation
Pages 11,
12, 25 & 26
Percentage of pen markings where the line edge was scored as Sharp:
Sharpness
Before skin prep
0 – 20%
21 – 40%
41 – 60%
61 – 80%
81 – 100%
2 most line edges were blurred or unacceptable
Pages 11,
12, 25 & 26
After PI (aqueous)
Ratings as above, after povidone iodine (aqueous) preparation
Pages 11,
12, 25 & 26
After CH (alcohol)
Ratings as above, after chlorhexidine gluconate (alcohol) preparation
Pages 11,
12, 25 & 26
CEP 08009: 2008
Technical performance
14
Aspen
Richard Allen
Aspen
Richard Allen
Aspen
Writesite
Codman
Microsurgical
Codman
Surgical
Tip description
Fine
Regular
Regular
Fine
Bold
Fine
Bold
Ink solvent
Isopropyl (0-12%)
Isopropyl (0-12%)
Isopropyl (0-12%)
?
?
Aqueous
Aqueous
Pen rule
5cm
5cm
5cm
Separate rule
15cm
15cm
15cm
15cm
11cm
11cm
Novatech Dermotrace*
Features
Sterile packaging
Single Use Label
Adhesive labels
Sharpness
Visibility
CE Marked
Before skin prep
After PI (aqueous)
After CH (alcohol)
1
1
1
1
1
1
1
Before skin prep
2
After PI (aqueous)
2
After CH (alcohol)
CEP 08009: 2008
2
2
Technical performance
15
UN64
Skin marker pen
Viomedex
VX100
Viomedex
VX110
Viomedex
VX200
Viomedex
VX210
Tip description
Versatile
Bold
Bold
Fine
Fine
Ink solvent
?
Aqueous #
Aqueous #
Aqueous #
Aqueous #
Pen rule
4cm
7cm
7cm
7cm
7cm
Separate rule
15cm
Features
Sterile packaging
Single Use Label
12cm
12cm
Adhesive labels
Sharpness
Visibility
CE Marked
Before skin prep
After PI (aqueous)
1
After CH (alcohol)
Before skin prep
After PI (aqueous)
After CH (alcohol)
CEP 08009: 2008
2
2
2
1
Operational considerations
16
Clinical impact
Sterility
Many pens tested in this report were supplied sterile and are marked “for single use” with the
sterility shelf life and the use by date also marked on the packaging.
Cross-contamination and sterility of the skin markers pens is an important factor to consider,
especially for procedures such as joint replacement and the insertion of prosthetic grafts,
where infection at the operative site can be catastrophic [15]. Pens have been identified as
vectors of harmful organisms [16] and some studies report that is common practice for
marker pens to be used indiscriminately on patients, regardless of their known infection
status [15].
A brief overview of published studies assessing the viability of micro-organisms on pen tips
(Appendix 4) indicates that some pens contain ink and/or solvents that appear to have antibacterial and anti-fungal properties. Details of the ink solvent are included in the market
survey tables, as this may indicate their potential for resisting contamination to the pen tip.
One of the products cited in a paper [17] refers to pens listed in this report and other data are
provided by the manufacturer.
Line width
Plastic surgeons require skin markers to have a very fine tip [18] so that ink lines drawn
across the incision line can be accurately matched when the skin is realigned. Some
surgeons report the line produced with currently available pens is not sufficiently precise for
operations where delicate marking is required, such as cleft lip repair or scar revision [19].
Shaping the fibre tip using a blade is advocated to convert it into a thinner applicator which is
more effective and more convenient to use than the other alternatives (see below) [19].
When marking the identity of the limb or organ to avoid wrong site surgery the type of tip is
less important, as long as the ink mark remains clearly visible.
Skin tone and condition
All pens in this study use violet/black ink, which may be less visible on darker skin tones. For
dark-skinned people, light coloured ink materials (white, green, yellow, red) are more visible
[20] but light coloured skin marker pens are not yet commercially available in the UK.
Pharmacy prepared ink materials in a range of colours (see Appendix 4) have been reported
as visually effective on darker skin and non-reactive with other chemicals used on the skin,
eg aqueous povidone-iodine, but it has been shown these are easily removed with alcohol
[20].
Cosmetic considerations
There is a very rare risk of inadvertent tattooing from gentian violet ink in the marking pen
being incorporated into skin tissue during the incision. If patients are anxious about the
visibility of skin marks post-operatively the market table enables choice of a pen which
remains visible after pre-operative cleaning with povidone and can be mostly removed by
chlorhexidine gluconate.
CEP 08009: 2008
Operational considerations
17
Alternative technologies
General purpose pens
Published papers report the use of general purpose felt tipped pens, permanent markers and
whiteboard markers [15, 21, 22] by surgeons for pre-operative marking of the skin (Appendix
3). Their use can not be recommended as none of these products are sold for this purpose.
Liquid inks prepared in the pharmacy
A range of colourings are commonly used in the pharmaceutical industry and several of
these have been reported as being useful for skin marking (see Appendix 4).
Henna
Henna powder, mixed into a paste, is advocated for situations where long term, but not
permanent, marking is required, eg for repetitive non-invasive therapeutic procedures [23].
This can be particularly useful for radiotherapy where skin marks are required to enable
repeated location of laser positioning beams and they need to remain clearly visible for 6-8
weeks. If normal skin marker pens are used the patient must refrain from washing or frequent
reapplication of the pen mark at the target is common which causes positional inaccuracies.
Henna marks can remain visible for 12-48 days, even allowing the patient to wash and
shower freely, so reducing remarking and thereby increasing the accuracy of external
radiotherapy [23].
Tattoo
For situations where accurate and robust long term marking is required (e.g. skin marking for
long term radiotherapy localisation or to provide medical alerts, eg diabetic disease) medical
tattoos may be used. Permanent marks are created by introducing pigment into the deeper
layers of the skin through ruptures in the skin surface made by a fine needle, but there can
be a risk of infection.
User experience
Skin condition
Skin condition was observed to influence the durability of pen markings in this study. Ageinduced looseness of the skin was marked in one subject and the skin surface appeared to
fold around the pen tip during marking, causing the line to be blurred for all pen tips.
Although surface oils and creams were removed by washing with soap before pen marking
the initial visibility still varied between subjects, especially for aqueous based inks.
Patient comfort and allergic sensitivity
During this evaluation study no subjects reported allergic reaction to any of the pens studied
or the cleaning agents used during the study. Four subjects spontaneously commented on
their discomfort while the operator was drawing with two products: Microsurgical, which has a
fine tip, and UN64, which is described as having a versatile tip.
CEP 08009: 2008
Economic considerations
18
To achieve best value when purchasing skin marker pens the benefits of using a particular
product needs to be balanced against wider economic considerations.
A product will provide an overall economic benefit if the risk of wrong site surgery is
decreased by the pen markings being visible after patient washing and perioperative skin
preparation.
Costs to consider include:
Cost of increased length of stay
Failure to use a skin marker pen which remains visible after perioperative cleaning could, in
the extreme, result in wrong site surgery. This may be fatal and/or require extended
hospitalisation for a second operation to achieve the intended therapeutic result.
For some operations pen mark fading may require pre-operative imaging or diagnostic
investigation to be repeated to ensure the tissue to be excised is correctly localised. This
would increase direct patient care costs as well as extend the hospitalisation period.
Medico-legal costs
Medico legal claims by the patient or their relatives could be substantial if inappropriate pens
were used for skin marking and these resulted in wrong site surgery.
Operating time cost
If an inappropriate choice of pen causes fading during bathing or pre-operative skin cleaning
so the mark becomes invisible then additional theatre time will be needed to thoroughly
check the patient’s records and remark the skin.
Purchase cost
Prices quoted by suppliers/manufacturers as their list price are usually negotiable depending
on volume and frequency of orders.
Disposal cost
Many products listed in this report are marked as intended for single use. To avoid the risk of
cross-contamination all pens require incineration and this cost is normally based on weight,
each pen weighing between 6 to 9 grams.
CEP 08009: 2008
Purchasing
19
Determining the clinical requirements
The major factors to consider when choosing to use a skin marker pen are summarised in
the decision tree below.
Patient
requiring a
skin mark
Consider a custom
pharmacy preparation
dark
Patient’s
skin tone
1 day
permanent
Duration
of marking
Consider
tattoo
> 2 weeks
light
Consider
henna
Skin marking area
is operative site
NO
YES
Cleaning inc.
Chlorohexadine
Gluconate
YES
NO
NO
Cleaning inc.
Povoiodine
Cleaning inc.
Povoiodine
YES
Consider changing
skin cleaning
protocol
YES
Consult
Comparative
Market Survey
Table
Figure 6 Decision tree indicating whether use of a skin marker pen is appropriate
Key factors to consider when using the market survey tables to choose a pen suitable for use
close to the operative site are:
• risk of infection (ie pen is sterile, especially when used after pre-operative cleaning)
• absence of fading after cleaning with the specific skin preparation fluids used locally
• tip shape, as this should be appropriate for surgeon’s purpose.
CEP 08009: 2008
Acknowledgements
We would like to thank all the manufacturers and suppliers for providing samples for
evaluation free of charge. We also thank the stakeholders who helped us to prepare this
Buyers’ guide, in particular:
Richard Dale, Medical Director, Commercial Directorate, Department of Health
Peggy Edwards, Patient Safety Manager (Wales), National Patient Safety Agency
Rob Heggie, Principal Clinical Engineer, University Hospital of Wales
Sue Jenkins, Senior Technician, Pharmacy, University Hospital of Wales
Susan Pirie, Professional Officer, Association for Perioperative Practice, Harrogate
Jacqueline Scroggs, Clinical Lead, West Midlands Healthcare Purchasing Consortium
CEP 08009: 2008
20
References
21
1. National Patient Safety Agency. Patient safety alert 06: Correct site surgery, 2005
http://www.npsa.nhs.uk/site/media/documents/883_CSS%20PSA%20FINAL.pdf
2. Association for Perioperative Practice. Standards and Recommendations for Safe
Perioperative Practice, 2007. http://www.afpp.org.uk/publications.cfm?start=51
3. Graham GP, et al. Preparation of skin for surgery. J R Coll Surg Edin 1991; 36:
August
4. McGrath DR, McCrory D. An audit if pre-operative skin preparative methods. Ann R
Coll Surg Engl 2005; 87: 366-368
5. Briscoe CE, et al. Inflammable antiseptics and theatre fires. Br J Surg 1976; 63: 9813
6. Mackenzie I. Perioperative skin preparation and surgical outcome. J Hosp Infect
1988; 11: 27-32
7. Garvey LH, et al. Anaphylactic reactions in anaesthetised patients – four cases of
chlorhexidine allergy. Acta Anaesthsiol Scand 2001; 45: 1290-4
8. Kaul AF, Jewett JF. Agents and techniques for disinfection of the skin. Surg Gynaecol
Obstet 1981; 152: 677-85
9. Webster J, Alghaamdi AA. Use of plastic adhesive drapes during surgery for
preventing surgical site infection. Cochrane database of Systematic Reviews 2007,
Issue 4, Art. No.: CD006353. DOI: 10.1002/14651858.CD006353.pub2
10. Lafferty K, Glass RG. Making your mark in surgery Br J Surg 1986; 73: 609
11. Magee TR, et al. Vein marking through ultrasound coupling gel. Br J Vasc Surg 1990;
4: 491-2
12. Tatla T, et al. Preoperative surgical skin marking in plastic surgery. Br J Plast Surg
2001; 54: 556-7
13. Tatla T, Lafferty K. Making your mark again in surgery. Ann R Coll Surg Engl 2002;
84: 129-130
14. Ayhan M, et al. Skin marking in plastic surgery. Plast Reconstr Surg 2005;115:450-1
15. Kane TPC, et al. Can the tips of marker pens act as a source of cross-infection? Ann
R Coll SAurg Engl 2003; 85: 73
CEP 08009: 2008
References
22
16. French G, et al. Contamination of doctors’ and nurses’ pens with nosocomial
pathogens. Lancet 1998; 351:213
17. Wilson J, Tate D. Can pre-operative skin marking transfer methicillin-resistant
Staphylococcus aureus between patients? J Bone Joint Surg 2006; 88: 541-2
18. Sarifakioglu N, et al. Skin marking in plastic surgery: a helpful suggestion. Plast
Reconstr Surg 2003; 111: 946-7
19. Tuncer S, et al. Increasing the accuracy of sterile marker pens. Plast Reconstr Surg.
2004; 114:1979-80
20. Sarifakioglu N, et al. Skin marking in plastic surgery: colour alternatives for marking.
Plast Reconstr Surg 2003; 112: 1500-1
21. Cronen G, et al. Sterility of Surgical Site Marking. J. Bone Joint Surg. Am. 2005; 87:
2193-2195
22. Tadpathi S, et al. Using marker pens on patients: a potential source of cross infection
with MRSA. Ann R Coll Surg Engl. 2007; 89: 661-4
23. Wurstbauer K, et al. Skin marking in external radiotherapy by temporary tattooing
with henna: improvement of accuracy and increased patient comfort. Int J Radiat
Oncol Biol Phys 2001; 50: 179-81
24. Thomas RJ, et al. The transmission of MRSA via orthopaedic marking pens – fact or
fiction. Ann R Coll Surg Engl 2004; 86: 51-2
25. Ballal MS, et al. The risk of cross-infection when marking surgical patients prior to
surgery - review of two types of marking pens. Ann R Coll Surg Engl. 2007; 89: 226-8
26. O’Boyle C. Wooden Skewrs are cheap, effective , versatile, and safe instruments for
the preoperative marking of skin incision lines. Plast Reconstr Surg 2000; 106: 232-3
27. Granick M, Heckler FR. Caution in the use of marking solutions. Plast Reconstr Surg
1990; 85: 154
28. Safranek TJ et al. Mycobacterium chelonae wound infections after plastic surgery
employing contaminated gentian violet skin-marking solution. N Engl J Med 1987;
317:197-201
CEP 08009: 2008
Appendix 1: Supplier contact details
Supplier
Advanced Medical Systems Ltd
PO Box 4
Banbury
OX17 1TQ
Oxfordshire
Product
Order code
Aspen Writesite
Aspen Richard Allan
Tel: 01295 738244
Fax: 01295 730792
Email: [email protected]
www.advmedical.com
Johnson & Johnson Medical Ltd
The Braccans
London Road
Bracknell
Berkshire
RG12 2AT
Codman Microsurgical
Codman Surgical
Tel: 01344 864000
Fax: 01344 864001
www.jnjgateway.com
Leonhard Lang UK Ltd
Unit 6 Frogmarsh Mill
South Woodchester
Gloucestershire
GL5 5ES
Tel: 01453 874130
Fax: 01453 874131
Email : [email protected]
www.leonhardlang.co.uk
CEP 08009: 2008
Aspen Richard Allan
Fine
SM00372
Regular
SM0572
23
Appendix 1: Supplier contact details
Supplier
Meddis Ltd (Subsidiary of Pro-Care Ltd)
Blackwood Hall Business Park
North Duffield
Selby
North Yorkshire
YO8 5DD
Product
Novatech Dermotrace
Tel: 01757 288694
Fax: 01757 288689
Email: [email protected]
www.pro-care-group.co.uk
Universal Hospital Supplies
George House Unit 6
Delta Park Industrial Estate
Millmarsh Lane
Enfield
London
EN3 7QY
UN64
Tel: 0845 082 0182
Fax: 0845 0820180
Email: [email protected]
www.uhs.co.uk
Vio Healthcare Ltd
Unit 13
Swan Barn Business Centre
Old Swan Lane
Hailsham
East Sussex
BN27 2BY
Tel: 01323 446130
Fax: 01323 847417
Email: [email protected]
www.viomedex.com
CEP 08009: 2008
Viomedex VX100
Viomedex VX110
Viomedex VX200
Viomedex VX210
Order code
18996
24
Appendix 2: Evaluation protocol
25
This study assessed the performance of commercially available skin marker pens through
testing on human subjects. We sought and obtained local ethical committee approval (REC
reference number 06/WSE02/105) for the pilot study and main study. Informed consent was
obtained from all volunteers in accordance with the protocol submitted to and agreed the
ethical committee.
The pilot study used the same protocol as the main study (see below) and was used to
determine:
•
The minimum drying time for the applied pen inks
•
A standard photography set-up in terms of camera, subject and lighting positions and
camera and lighting settings
•
Standard application technique for liquid skin preparation (application device and
number of wipes)
•
The minimum drying time for the liquid skin preparation
•
Standard observer viewing conditions for assessing the photographs, in terms of
lighting, screen background colour and brightness and observer position
•
Sample images to illustrate the scoring system for use in observer training so the
variability in observer scores could be minimised
•
Cleaning techniques for the most effective removal of skin marks and skin
preparations after the experimental study was complete
•
Any potential to reduce the complexity of the main study, eg establishing that two skin
preparations have similar effects on the pen markings, this allowing removal of one of
them from the main study.
During the main experiment participants were required to attend for up to 60 minutes, but
usually the session was approximately 35 minutes. The evaluation protocol was as follows:
1. Each participant changed into a cotton top and trousers (surgical ‘blues’) and a plastic
apron to prevent any damage to their own clothing, eg from iodine splashes, etc.
2. Each participant had both forearms washed with liquid soap (Leverline Liquid Soap
(Soft), Johnson Diversey Ltd) to remove creams and standardise the skin surface
3. Each pen tip (code A -J) was used to make a mark approximately 40mm long
(perpendicular to the long axis of the arm) on both inner forearms of each subject
(with a spacing between lines of 15mm). The pen order was randomised and
recorded for each subject, with both left and right arms being the same order
4. The pen marks were allowed 3 minutes to dry before a digital photograph of each
forearm, was taken under controlled conditions using studio lighting and a fixed
camera position relative to the arm and pen markings (see Figure 5a on 12)
5. Each forearm was then cleaned using either aqueous povidone-iodine (left arm) or
chlorhexidine gluconate in alcohol (right arm). The antiseptic cleaning solution was
applied with a folded gauze held in Rampley’s forceps using standardised number of
strokes. The solutions were allowed to dry and a second photograph taken (see
Figures 5b and 5c, respectively)
CEP 08009: 2008
Appendix 2: Evaluation protocol
26
6. A self adhesive antimicrobial iodophor surgical incise drape (Ioban™ 2 Antimicrobial
3M containing iodophor acrylate 0.12%) was then applied to both test sites on each
arm and each test site was photographed for the third time (not shown)
7. Each photograph was given a unique identifying code which recorded the subject
number, skin status and pen randomisation allocation code
8. All photographic images were separated into segments containing only a single pen
mark (see Figure 8). During observer scoring sessions the photograph of each line
were displayed individually in a random order on a viewing screen under controlled
conditions
9. Three observers ‘blind’ to the identity of the pen, skin status or subject independently
scored each pen mark for ink visibility and line sharpness using the scoring criteria
summarised in Table 3. The photograph number and observer identifying initials were
recorded on an assessment sheet along with the scores
10. The scores from all observers were counted for each pen mark at every stage of the
marking and cleaning process. The counted scores were then converted to star
ratings as described in Technical Performance (page 13).
Figure 7 Standardised (a) illumination and (b) photographic arrangement for all images
Figure 8 Povidone solution was applied with a folded gauze held in Rampley’s forceps
CEP 08009: 2008
Appendix 3: Risk of cross infection
27
Review of the viability of micro-organisms on marking tips
The bacterial content of ‘used’ pens collected from surgical wards has been studied by
several researchers. No microbial activity was found on sixteen ‘used’ pens collected from
orthopaedic wards [14]. Organisms were isolated from eight pens in another hospital but no
evidence of methicillin resistant Staphylococcus aureus (MRSA) was found [24]. In a study of
26 marker pens (Penflex, Pentel, Guilbert, Niceday and Edding) no growth was found on
culture plates after 24 hours incubation but two pens cultured positive to Micrococci species
(skin commensals) after 72 hours [22]. Clearly pens can harbour bacteria commonly present
on human skin but some authors have suggested that some pens demonstrate antibacterial
activity which they attribute to alcohol in the ink solvent used by many manufacturers.
Transmission of MRSA has been studied in the laboratory using two different new pens
(Viomedex and Penflex) which were contaminated with a higher rate of MRSA inoculation
than normally found in a clinical setting by drawing the pen tip across a contaminated culture
plate. Each pen was then used to draw a line on a blood agar plate at 0, 5,15 and 60
minutes, 24 and 48 hours and 1,2 and 3 weeks after inoculation. The MRSA did not survive
for more than 15 minutes on the Penflex marker pen whereas Viomedex pens grew MRSA
for over 1 week after contamination. The different response was credited to their solvents
because the Penflex uses isopropyl alcohol and ethyl alcohol whilst the Viomedex uses
water and no antiseptic is added to inhibit bacterial growth [17]. [Manufacturer comment:
Viomedex states that their pens are for single use only and contain non-toxic ink.]
Antifungal properties of ink colourings
Gentian violet (hexamethyl pararosaniline chloride) is a water soluble dye derived from coal
tar. As a weak solution in water it is painted on skin, gums, serious heat burns, etc. to treat
fungal infections and is also used in histological procedures, as it stains gram positive
bacteria blue-violet. Gentian violet’s worst side effect is staining skin and cloth, so for this
reason it is commonly a key component in the ink of skin marker pens.
Summary
Currently the evidence is not sufficient to advise reuse of skin marking pens unless the
practice is explicitly endorsed by the supplier. Care should also be taken to avoid cross-site
contamination in the same patient, eg from an ulcerating wound to the surgical site.
CEP 08009: 2008
Appendix 4: Pharmacy prepared inks
28
Pharmacy prepared inks reported as useful for skin marking
Reference
Preparation
Applicator
O’Boyle, 2000
[26]
Bonney’s blue
Non-sterile Plastico wooden
skewers, using a broken end
Sarifakioglu et
al, 2003 [18]
Red ink - Basic fuschin (1.34g), 4g phenol (antiseptic),
5.6ml acetone, 7.56g resorcinol (antiseptic), 11ml alcohol,
100ml distilled water
Sterile or non-sterile plastic
stick or needle
Sarifakioglu et
al, 2003 [20]
A range of different coloured inks can be prepared with
1.34g of the selected colouring (see list below) mixed with
4g phenol (antiseptic), 5.6ml acetone, 7.56g resorcinol
(antiseptic), 11ml alcohol, 100ml distilled water
Red ink – Carmoisine (Colour index number: 14720/ E122)
Red ink – Carmine (75470/ E1210)
Black ink – Black PN (28440/ E151)
Orange ink – Canthaxanthine (40850/ E161)
Claret red ink – Amaranth (16185/ E123)
Green ink – Green S (44090/ E142)
Blue ink – Indigo carmine (73015/ E132)
Yellow ink – Tartrazine (19140/ E102)
Yellow ink – Curcumine (75300/ E100)
Sterile or non-sterile plastic
stick or needle
Ayhan et al,
2005 [14]
Red ink - Basic fuschin (1.3g) 5.6ml acetone, 11ml alcohol,
100ml water
Toothpick
Care should be taken to ensure aseptic conditions are maintained during ink preparation and
storage. Skin marking solution has been identified as a source of wound infections in 5
patients after plastic surgical procedures, where the organism had contaminated the water
used to make up the gentian violet marking solution, [27] and eight infections following
cosmetic face lifts and augmentation mammoplastics [28].
Clinical use of these and other alternative technologies (see page 17) close to the operative
site is not advised unless a full risk assessment has been conducted (including: indelibility
after local pre-operative procedures; assessment of sterility; risk of cross-infection; risk of an
allergic reaction).
CEP 08009: 2008
Author and report information
Skin marker pens
Paul O’Connell, Jonathan Lane, Dr Sue
Peirce, Dr Diane C Crawford
Clinical Engineering Device Assessment
and Reporting (CEDAR)
Cardiff Medicentre
Cardiff
CF14 4UJ
Tel: 029 2068 2120
Fax: 029 2075 0239
Email:
[email protected].
uk
For more information on CEDAR and our
earlier reports visit
www.cedar.wales.nhs.uk
About CEP
The Centre for Evidence-based
Purchasing (CEP) is part of the Policy and
Innovation Directorate of the NHS
Purchasing and Supply Agency. We
underpin purchasing decisions by
providing objective evidence to support the
uptake of useful, safe and innovative
products and related procedures in health
and social care.
We are here to help you make informed
purchasing decisions by gathering
evidence globally to support the use of
innovative technologies, assess value and
cost effectiveness of products, and
develop nationally agreed protocols.
CEP 08009: 2008
29
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