AK- BWA Automated Decontamination
Transcription
AK- BWA Automated Decontamination
Automated Decontamination 7th 7th revised revised edition edition AKBWA AKBWA Working Group for Bedframe and Cart Decontamination Systems Automated Decontamination of Bedframes Bedside tables Transport carts Distribution containers Sterilization containers Surgical tables and furnishings Surgical clogs 7th Edition 2006 © All rights reserved for the AK-BWA1). Reproduction in whole or in part prohibited. 1) Working Group for Bedframe and Cart Decontamination Systems Members of the AK-BWA MANUFACTURERS OF CLEANING AND DISINFECTION AGENTS Dr. Jürgen Staffeldt (Chairman) Chemische Fabrik Dr. Weigert GmbH & Co. KG Mühlenhagen 85 20539 Hamburg Telephone +49 (040) 78 96 01 65 Telefax +49 (040) 78 96 01 23 E-mail [email protected] Inke Magens Chemische Fabrik Dr. Weigert GmbH & Co. KG Telephone +49 (040) 78 96 01 76 Telefax +49 (040) 78 96 01 24 E-mail [email protected] Rudolf Glasmacher Ecolab GmbH & Co. OHG Reisholzer Werftstraße 38–42 40589 Düsseldorf Telephone +49 (0211) 9 89 36 68 Telefax +49 (0211) 9 89 36 24 E-mail [email protected] MACHINERY AND SYSTEM MANUFACTURERS Georg Josef Moller formerly: Belimed GmbH Edisonstraße 7a 84453 Mühldorf Telephone +49 (08631) 98 96-0 Telefax +49 (08631) 98 96-300 Uwe Rößler MMM Münchener Medizin Mechanik GmbH Hauptstraße 2 92549 Stadlern Telephone +49 (09674) 80–342 Telefax +49 (09674) 80–2342 E-mail [email protected] Michael Dieterle Dirschl Maschinen- und Apparatebau GmbH Fürholzer Weg 21 85375 Neufahrn/Munich Telephone +49 (08165) 95 87 60 Telefax +49 (08165) 95 87 61 E-mail [email protected] Michael Streb MEIKO Maschinenbau GmbH & Co. KG Englerstraße 3 77652 Offenburg Telephone +49 (0781) 2 03 11 13 Telefax +49 (0781) 2 03 13 43 E-mail [email protected] HYGIENISTS OPERATORS Guest contributors: Köhler+Cie GmbH 69181 Leimen Prof. Dr. Peter Heeg Department of Medical Microbiology and Hospital Hygiene Elfriede-Aulhorn-Straße 6 72076 Tübingen Telephone +49 (07071) 2 98 20 26 Telefax +49 (07071) 29 54 05 E-mail [email protected] Peter Krieger Klinikum Großhadern Dep. Sterilisations- and Kühltechnik Marchionistraße 15 81377 Munich Telephone +49 (089) 70 95 41 73 Telefax +49 (089) 70 95 88 33 E-mail [email protected] Prof. Dr. Ulrich Junghannß Hochschule Anhalt (FH) Fachbereich 7 – LFG Mikrobiologie Bernburger Straße 55 06366 Köthen Telephone +49 (03496) 67 25 34 Telefax +49 (03496) 21 20 81 E-mail [email protected] Matthias Panther Klinikum Stuttgart – Katharinenhospital Kriegsbergstraße 60 70174 Stuttgart Telephone +49 (0711) 2 78 25 00 Telefax +49 (0711) 2 78 25 09 E-mail [email protected] BEDFRAME MANUFACTURERS Jürgen Fiß Joh. Stiegelmeyer GmbH & Co. KG Ackerstraße 42 32051 Herford Telephone +49 (05221) 18 52 31 Telefax +49 (05221) 18 52 72 E-mail [email protected] MANUFACTURERS OF TRANSPORT CARTS Winfried Winkler Novidex Transportsysteme GmbH Schwinningstraße 20 52076 Aachen Telephone +49 (02408) 93 05 44 Telefax +49 (02408) 93 05 33 E-mail [email protected] Zarges Leichtbau GmbH 82362 Weilheim Aesculap AG & Co. KG 78532 Tuttlingen Maquet GmbH & Co. KG 76437 Rastatt Table of Contents Foreword to the 7th edition . . . . . . . . . . . . . . . . . . . . . . . . . .8 Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .9 3.13. 3.14. 3.15. 3.16. Safety technology Control panel and installation of equipment Accompanying documents Information about operating utilities Scope of application . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .9 PART 1 Terminology . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10 2.1. 2.2. PART 2 Legal obligations and regulations in regards to cleaning . . . . . . . . . . . . . . . . . . . . . . . . .13 The European Medical Device Directive MDD 93/42/EEC and the ordinance regarding the setup, operation, and use of medical devices (German Medical Devices Operator Ordinance – MPBetreibV) Industrial safety PART 3 Requirements for decontamination systems (BDS) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .15 3.1. The decontamination process in a circulation system Process step I: Optional cold water pre-rinse Process step II: Decontamination Process step III: Rinsing and drying 3.2. Equipment inside the chamber 3.3. Loading cart 3.4. Spray jet systems 3.5. Design and dimensions 3.6. Usable space dimensions 3.7. Chamber requirements 3.8. Front panel 3.9. Lock and entrance opening 3.10. Machine room 3.11. Automatic control 3.12. Display and monitoring 4.1. 4.2. 4.3. 4.4. PART 4 Requirements for the items to be treated (TI) and maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . .21 Construction and design Item dimensions Materials and components Bedframes Bedside tables, Transport carts Sterilization containers and distribution containers Surgical tables and furnishings Surgical clogs Maintenance Inspection work Maintenance work PART 5 Requirements for process chemicals (PCH) . . . . . . .25 5.1. Decontamination agent 5.2. Rinsing agent 5.3. Material strength 5.4. Composition 5.5. Determining the concentration 5.6. Temperature 5.7. Changing the decontamination solution 5.8. Electric motors 5.9. Documentation 5.10. Dosage 6.1. PART 6 Structural requirements . . . . . . . . . . . . . . . . . . . . . .27 Performance limitations 6.2. Requirements for operating materials and systems Water Steam Condensate Compressed air Electricity supply Waste water Exhaust air processing technology Chamber air supply Heat dissipation 6.3. Structural dimensions 6.4. Pit 6.5. Installations in the machine room 6.6. PCH dosing system Appendix A: Connection and consumption values Appendix B: Operating utilities for decontamination systems PART 7 Operation and management of the BDS . . . . . . . . . .34 7.1. Initial start-up 7.2. Handover 7.3. Operating staff 7.4. Log book 7.5. Operating manual 7.6. Operating instruction 7.7. Parameter settings 7.8. Checks and controls 7.9. Microbiological efficiacy testing 7.10. Maintenance measures PART 8 Tests and reports – Requirements . . . . . . . . . . . . . .36 8.1. Procedure test 8.1.1 Test bacteria and intermediate cultures 8.1.2. Carriers 8.1.3. Applying the test soil onto the carrier 8.1.4. Test parameters and set-up for bedframes and bedside tables for transport carts for distribution containers for reusable sterilization containers for surgical tables and furnishings for surgical clogs 8.1.5. Evaluation 8.1.6. Testing the decontamination solution 8.2. Operational qualification 8.3. Periodic testing 8.4. Special testing 9.1. 9.2. 9.3. 9.4. 9.5. 9.6. PART 9 Ecological requirements . . . . . . . . . . . . . . . . . . . . . .44 Water Energy Process chemicals Waste water Exhaust air Heat dissipation Appendix . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .46 DIN Regulations Normative References Guidelines/Regulations Closing remarks . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .47 Foreword to the 7th edition The AK-BWA was founded at the conclusion of the Hygiene Conference in Marburg in 1988. Fifteen years have passed since those first discussions about bed disinfection took place, in which bedframe manufacturers, manufacturers of bedframe and cart decontamination systems, and of detergents and disinfectants, as well as operators and hospital hygienists took part. The fact that in order to aid the operator, bedframes and the materials related to their manufacture and care need to be coordinated invites discussion of the problems posed by automated bedframe cleaning and disinfection. A specialized working group, the AK-BWA, has taken up the challenge. Of prime importance at the conference were cleaning methods that are led to a gentle processing of the items to be cleaned and then the question of preventative measures against infection. During this time, not only were additional alternatives for automated cleaning established, but it was precisely in the area of cleaning that quite a number of recommendations, as well as national and international standards, were put into effect. Determining which decontamination method to use depends on what the possible dangers of infection are, that is, on the Prof. Dr. Peter Heeg, Tübingen 8 results of risk analyses, on the company specialization, on the structural design and the technical facilities available including transport options, as well as on staff and economic issues. Experience with decontamination systems, which use a circulation system, demonstrate that decontamination systems, originally meant for bed preparation, could also be used for other items, such as transport carts, distribution containers, sterilization boxes, surgical tables and furnishings, as well as surgical clogs. Furthermore, only automated cleaning offers the option of validation and, therefore, the monitoring and documentation required by the German Medical Devices Operator Ordinance in effect since June 29, 1998. This booklet is meant to provide comprehensive information on this topic to the reader and to give him practical assistance. Thanks to years of continuous revision and updating, this booklet has become a valuable reference for all those interested in this field. Prof. Dr. Ulrich Junghannß, Köthen Introduction Experience with decontamination systems has shown that they can be used very successfully to clean items hygienically. This includes bedframes, bedside tables, transport carts, distribution containers, reusable sterilization containers, surgical tables and furnishings, as well as surgical clogs. 쐍 Requirements for process chemicals (PCH) 쐍 Installation requirements 쐍 Operation and management 쐍 Tests and reports 쐍 Ecology The goal of the AK-BWA is to make a resource guide available for the planning, application, operation, and assessment of decontamination systems. In doing so, great effort has been made to take into account the specific requirements of each individual item to be treated. In the scope of current best practice in the field of modern decontamination, the reader will learn about what to be aware of when implementing a decontamination process in a circulation system. This brochure informs the reader about: 쐍 Terms 쐍 Legal obligations and regulations, as well as aspects of industrial safety 쐍 Requirements for decontamination systems (BDS)2) 쐍 Requirements for the items to be treated (TI) In the 7th edition of this booklet, the AK-BWA has included the topic of decontaminating surgical tables and furnishings, as well as reusable sterilization containers. Each chapter has also been revised and updated. 2) BDS = Bedframe and cart decontamination system Scope of application This booklet handles the automated decontamination of various items, chiefly from the area of medicine: Bedframes with bedside tables, transport carts, distribution containers, reusable sterilization containers, surgical tables and furnishings, as well as surgical clogs. Recommendations do not include disinfection according to §§ 17 and 18 of the German Infection Protection Act. 9 Part 1 Terminology In this chapter, terms are defined in relation to decontamination, chiefly as used in the area of medicine. The working group has found it very useful to develop clear and unambiguous definitions of the terms in question. This chapter has been placed at the beginning in order to provide a quick overview of a complex topic. The terms are arranged alphabetically. Please do not become confused when at first glance some of the terms seem “over formulated” while others seem to be “taken for granted”. Once you have become more familiar with the material, you will recognize the justification for some of the more detailed definitions. DIN 58 955 applies to decontamination systems. The AK-BWA definitions have been incorporated in it. Circulation system A circulation system is a decontamination process in which the spray water containing the PCH is recirculated. This can also be a combined fresh water circulation system, in which, for example, only the decontamination solution is recirculated. Cycle time The cycle time is the operation time plus the time necessary for loading and unloading the decontamination chamber. Decontamination Decontamination, as used in this booklet, is the cleaning and disinfection of those areas on items in a TI with which the patient, the personnel or the items being transported would normally come into contact. Decontamination agent Decontamination agents are combined disinfectants and detergents. Decontamination process A decontamination process is a combination of thermo chemical process steps and methods, which ensure that the TI is decontaminated and dried. 10 Decontamination time The decontamination time is the length of time during which the TI is sprayed Abbreviations: AK-BWA Working Group for Bedframe and Cart Decontamination Systems TI Item(s) to be treated PCH Process chemicals BDS Decontamination systems for bedframes, bedside tables, transport carts, distribution containers, reusable sterilization containers, surgical tables and furnishings, surgical clogs, and other items to be treated. with water containing the decontamination agent. Disinfectants and detergents See decontamination agent. Disinfection Disinfection is the reduction of infectious microorganisms on and in contaminated objects to the point where it can be assumed that no more infection is present. The required reduction factor is normally indicated as a ⬎ 5 log10 reduction. Distribution container A distribution container is a rigid reusable vessel for storing and transporting items of all types. It needs to be cleaned regularly. For the purposes of this booklet, a distribution container is an item to be treated (TI). Drying Drying the TI refers to the drying of the visible surfaces of the TI inside and outside of the decontamination chamber until a tolerable level of residual moisture is achieved. ture (see tolerated residual moisture) to dissipate, so that it can then be used again. Fresh water system In a fresh water system, all the spray water is drained into the sewage system after every cycle. Machine room The machine room is the room which contains components and/or mechanisms required to operate the BDS. Part 1 Operating utilities Operating utilities are resources used to maintain and run the decontamination system, for example, steam, electricity, compressed air, water. Drying the TI is dependent on several contribution factors, for example, the final drying temperature, specific heat capacity, design and geometric shape, materials, support by mechanical devices and process chemicals. Items to be treated (TI) The items to be treated are the items to be decontaminated. The acronym TI may refer to individual items or to items in a collective sense. TI may include any of the following items which can be treated in an automatic BDS: bedframes with accessories, bedside tables, transport carts, distribution containers, reusable sterilization containers, surgical tables and furnishings, surgical clogs and similar items. Drying time The drying time is the length of time necessary to pre-dry the TI in the decontamination chamber. Lifting unit A lifting unit is a device integrated into the BDS to put a TI at a certain incline in order to allow liquid to better drain away. Entrance dimensions The inner entrance dimensions are the effective dimensions of the entrance door to the decontamination chamber. The dimensions are given in mm and in the order of height x width. Loading cart A loading cart is a mobile load-bearing structure, on which different types of TI can be transported through the automated decontamination system. The type of cart used depends on the type of TI. Process chemical (PCH) Process chemical is the collective term for decontamination agents, detergents, disinfectants, rinsing agents, anti-corrosive agents, and lubrication agents, all of which can be mixed in water. Final drying time Final drying time is the length of time that the TI must remain in ambient air after being removed from the BDS in order for any residual heat and mois- Machine parts Machine parts is the collective term used for BDS components and/or mechanisms which are located outside the decontamination chamber. Rinsing agent Rinsing agents are products containing wetting agents that are added to rinse water in small amounts. They ensure a uniform and thorough wetting of the TI, Operation time The operation time is the sum of the time needed for decontamination, rinsing, and drying, not including the time necessary for loading and unloading the system. Piggyback system A piggyback system is the decontamination of bedframes and bedside tables in the same decontamination cycle. The bedside tables are placed in the storage spaces of the bedframes. The BDS must be set up for this accordingly. 11 Part X1 aid drying, and prevent drip and stain build up. The rinsing agent can also contain anti-corrosive agents and/or preservatives. Rinsing time The rinsing time is the length of time necessary to spray the TI with warm water containing the rinsing agent. Spray water For the purposes of this booklet, spray water is water that usually contains PCH and is sprayed under pressure through nozzles onto the TI. Sterilization container (container) A sterilization container is a closable germ-proof container for sterilizing, transporting, storing, and the sterile supply of surgical instruments for re-use. Sterilization containers can be used for the dry disposal of used instruments. Wet disposal in a sterilization container is only feasible if the surface of the sterilization container is resistant to the 12 disinfectant used in wet disposal and the container is also constructed to allow wet disposal. Storage tank The storage tank is the part of the BDS that keeps the process chemical solutions ready to use. Surgical tables and furnishings For the purposes of this booklet, surgical tables and furnishings are surgical table tops and transporters of surgical table systems, surgical table accessories, and additional surgical furnishings, which can be treated in a BDS. Tilting Tilting is the lifting and inclination of the TI. Items can be tilted either lengthwise or crosswise or in a combination of both directions. Tolerable residual moisture Tolerable residual moisture is regarded as individual drops of water (not pools), which are still present on unfavorable areas of the TI approximately five min- utes after removal from the BDS. The ambient temperature of the TI must be 23 (+/–2) °C and the relative humidity 50 (+/–10) %. Transport cart For the purposes of this booklet, transport carts are used to transport supplies and waste materials, for example, laundry, dishes, rubbish. Usable space Usable space is the space within the decontamination chamber that holds the TI. Usable space dimensions Usable space dimensions represent the maximum area which the TI can occupy and still be guaranteed complete decontamination. Usable space dimensions are given in mm and in the order of height x width x depth (length). Warm-up time The warm-up time is the length of time required to put the BDS into a state where it can be operated. Legal obligations and regulations with regard to cleaning When selecting the possible cleaning methods for bedframes, bedside tables, transport carts, distribution containers, sterilization containers, surgical tables and furnishings, as well as surgical clogs, etc., the following are to be adhered to: the universally valid technical guidelines for hazardous substances, the regulations for the prevention of industrial accidents specified by the employer’s liability insurance associations, as well as the European Medical Device Directive (MDD) along with its regulations specifically referring to those items to be treated that are medical devices. 2.1. The European Medical Device Directive MDD 93/42/EEC and the ordinance regarding the setup, operation, and use of medical devices (German Medical Devices Operator Ordinance – MPBetreibV) Class 1 medical devices include, for example, hospital beds, surgical table tops, surgical furnishings. The German Medical Devices Operator Ordinance of August 29, 2002 requires that: 쐍 The user of a medical device must be convinced that it is functioning correctly and is in proper condition before he uses it. 쐍 The operator may only commission persons, companies, and organizations with the maintenance of the BDS, who have the expertise, meet the requirements, and have the necessary resources to perform the maintenance. 쐍 Cleaning and disinfection using suitable, validated, and standardized methods are to be performed in such a way that the success of these methods is guaranteed and documented, and that the security and health of patients, operators or third parties are not endangered. Part 42 쐍 After maintenance has been performed, the most important features regarding the security and proper functioning of the BDS must be checked and documented. For beds, these requirements can actually only be fulfilled at a centralized bed-preparation facility. The necessary visual check with the following functional testing is best integrated into the process before the bed is reassembled again. A “naked” bed is the easiest to inspect. The inspector can take a thorough look at each bed before it is prepared for use. For the necessary maintenance and/or repair work, a direct affiliation with the bed preparation facility has proven most effective. The same applies for the cleaning of surgical table tops and surgical furnishings. The demand for validated methods cannot be sufficiently fulfilled by manual wipe-cleaning or wipe-disinfection. However, these demands are fulfilled with the use of an automatic decontamination process. 13 Part 2 2.2. Industrial safety Recommendations for industrial safety are provided by the European directives upon hazardous substances and preparations and technical guidelines for hazardous substances (e.g. German TRGS), as well as the regulations for the prevention of industrial accidents developed by professional trade associations (Berufsgenossenschaften). When working in decentralized or centralized cleaning or the manual or automated cleaning of bedframes and other TIs, the German TRGS 531 “Danger to the skin when working in a moist environment (moist work)” is to be observed in particular. These technical guidelines for hazardous substances are made 14 public by the German Federal Ministry of Social Affairs in the official publication which is called in german “Bundesarbeitsblatt”. The German TRGS 531 regulates duties in which employees spend a substantial number of working hours working with their hands in a moist environment or must spend a corresponding amount of time wearing moisture-proof protective gloves. For example, the German TRGS 531 specifies the following in detail: 쐍 Technical and organizational protective measures have precedence over personal protective equipment and all technical and organizational options are to be used to avoid moist work. 쐍 The employer must reduce moist work as much as possible using technical measures, for example, automation. 쐍 The employer must create a set of operating instructions in which the dangers to the skin related to moist work as well as the necessary protective measures and rules of behavior are defined. Requirements for decontamination systems (BDS) The function of the BDS is to uniformly spray detergents and disinfectants onto the surfaces to be decontaminated and to prepare the TI for re-use according to the guidelines defined for hygiene (see part 8 Microbiological efficacy testing). With these objectives in mind, this booklet describes a proven decontamination process using a circulation system along with the basic technical details of the system. Part 3 3.1. The decontamination process in a circulation system Process step I: Optional cold water pre-rinse When removing bloody residue, for example, from surgical clogs or from sterilization containers, a cold water pre-rinse can improve the cleaning results. Process step II: Decontamination Warm water containing decontamination agents (decontamination solution) kept in a storage tank is sprayed directly onto the TI. The detergent and disinfectant solution collects in a reservoir positioned underneath the TI. They are pumped back into the storage tank. This is how the decontamination solution is recirculated. The recirculation of this solution makes it possible to spray a large volume flow onto the TI. The decontamination time depends on the process parameters chosen. Process step III: Rinsing and drying After the TI has been successfully treated with the decontamination solution, the rest of the decontamination agent still clinging to the TI is rinsed off by being sprayed with a hot rinse aid solution (max. 85 °C). Complete decontamination program Functions Program sequence time definitions Times Open door 1 Load Close door Outside of the machine: Process steps Decontamination Rinsing Drying Open door 2 Unload (Close door Final drying Cycle time Loading/unloading time Operation time Decontamination time Rinsing time Drying time Final drying time Time lapse Figure 1: Example of a program sequence: The decontamination process in a circulation system with drying process using specific heat, and additional sources, if necessary 15 Part 3 Temperature T (°C) Temperature Detergent and disinfectant solution Temperature Rinsing solution Temperature sequence on the TI 100 90 80 70 60 50 40 30 20 10 Time lapse t 0 Load Decontamination time Rinsing time Drying time Unload Process steps Outside the machine Final drying time Figure 2: Example of temperature sequence for a bedframe during a decontamination procedure in a circulation system with drying After rinsing has been completed, the chamber is ventilated and the steam and moist air is evacuated. The heat stored in the TI evaporates the film of moisture clinging to the TI (drying using the specific heat of the TI). This process is aided by the rinsing agent and the tilting of the TI. TI that does not possess sufficient specific heat to dry itself due to its construction may need additional aid in drying. Attention must be given to the following special details in order to reliably run a decontamination process using a circulation system, to achieve the degree of drying defined in this booklet, and to protect the TI: 16 쐍 A consistent concentration of decontamination agent must be ensured during the time required for the decontamination process. This is to be guaranteed by adding additional decontamination agent in conjunction with the partial renewal of the decontamination solution using fresh water or rinsing solution. 쐍 The decontamination solution must be sprayed on the surfaces being treated uniformly. The supply of decontamination agent during operation must be guaranteed. 쐍 The temperature of all spray-water systems used may only be set to a point that a maximum temperature of 70 °C on the TI is not exceeded. 쐍 The warming up of the TI must be done in such a way that drying using the specific heat of the TI is possible. The tolerable residual moisture must lie within the values set in Part 1. 쐍 The decontamination process must satisfy the efficacy tests according to the requirements described in Part 8. 쐍 The level of dryness of the TI can be increased by using warm or hot air. 3.2. Equipment inside the chamber When loading the chamber, care must be taken to place the TI in a predetermined position so that decontamination can be carried out according to the requirements of the decontamination process. Changing the predetermined position can lead to parts of the TI not being sprayed evenly which can compromise the efficacy of decontamination. ing cart designed especially for the respective TI. With respect to the design, dimensions, and materials, the requirements described in Part 4 for TIs also apply to loading carts. This normally includes the use of stainless steel, process chemical-proof fixed and swivel castors as well as guide rollers, that will withstand the process chemicals. warmed to the point of being able to dry using their own specific heat, the spray jet system, spray pressure, and the flow rate of the pumps must be adjusted to suit the nominal capacity and size of the heat exchanger, the storage tank, and the dosing equipment. A safe and reproducible decontamination process is only guaranteed if the system is set up with great care. Part X 3 3.5. Design and dimensions In addition, the unit must be equipped with a device for tilting the TI into an optimal incline. This enables the sprayed-on decontamination agent and rinsing solutions to drain away more easily. The lifting unit must be automatically integrated into the program sequence. It should have a guide rail and clamping mechanism for the TI. The guide rails and the lifting unit must be adapted to the needs of the TI. 3.3. Loading cart Loading carts are used to transport TI (for example, surgical clogs, distribution containers). The loaded cart is pushed into the chamber for the decontamination of the TI (similar to the procedure for bedframes). The TI must be fastened into a suitable position on the loading cart to ensure that the TI is properly and uniformly sprayed with the application solution of the process chemicals. This normally requires a specific load- 3.4. Spray jet systems The spray jet system used is decisive for the success of the decontamination process. It must be ensured that the decontamination solution is sprayed uniformly and completely onto the surfaces to be decontaminated. This is influenced by the following: 쐍 Spray pressure 쐍 Flow rate of the decontamination solution 쐍 Number of spray jets 쐍 Spray angle and the angle of inclination of the jets 쐍 Spray jet characteristics 쐍 Impact pressure and angle of the spray water jet onto the TI 쐍 Distance of the spray jets from the TI 쐍 Position of the TI It is therefore very important to coordinate the individual details exactly. In order to achieve an optimal decontamination process in which the TI are A BDS is designed for two-door operation. This results in a separation of the loading and unloading sides as defined in hygienic requirements. Normally, the BDS is designed for ground level loading on wheels. If it is not possible to guarantee the required installation depth for ground level loading on wheels, a different solution must be found (for example, by installing loading and unloading ramps adapted to the ground clearance of the TI). It is important that sufficient freedom of movement is provided both in front of and behind the unit to allow smooth operation. The dimensions of the TI determine the size of the entrance opening and the working space in the BDS. The following reference values guarantee the effective utilization of space in the chamber which is required for perfect decontamination. 17 Part 3 Chamber height with floor pan Usable space depth A = 2300 B = 2600 Required entrance dimensions 3.6. Usable space dimensions Transverse cross-section The usable space dimensions must be adapted to the TI. Entrance opening Height = 2000 Chamber cross-section – lateral Upper edge of entrance (e.g. upper edge of floor) A = without piggyback system B = with piggyback system Usable space Width = 1100 Entrance opening Width = 1200 Area for arranging the spray jet system (manufacturer specific) Chamber lock/door B: For beds with lifting pole and bedside tables using the piggyback system Height . . . . . . . . . . . . . . . . . . . .2000 mm Width . . . . . . . . . . . . . . . . . . .1100 mm Depth . . . . . . . . . . . . . . . . . . . .2600 mm Usable space width Chamber width Chamber layout Usable space depth C: For surgical tables Height . . . . . . . . . . . . . . .min. 1450 mm Width . . . . . . . . . . . . . . .min. 800 mm Depth . . . . . . . . . . . . . . . . . . . .1900 mm Figure 3: Usable space and inside entrance opening dimensions for bedframes Transverse cross-section Chamber height with floor pan Entrance opening Height > 1450 Chamber cross-section – lateral Upper edge of entrance (e.g. upper edge of floor) Usable space depth Depth > 1600 Usable space Width > 800 Required entrance dimensions Entrance opening Width > 900 Area for arranging the spray jet system (manufacturer specific) Chamber lock/door Usable space width Chamber width Chamber layout Usable space depth 18 Examples A: For beds with lifting pole Height . . . . . . . . . . . . . . . . . . . .2000 mm Width . . . . . . . . . . . . . . . . . . .1100 mm Depth . . . . . . . . . . . . . . . . . . . .2300 mm Figure 4: Usable space and inside entrance dimensions for transport carts, distribution containers, sterilization containers, surgical tables and furnishings, as well as surgical clogs Depending on the structural conditions, the external dimensions of certain unit components must be adapted to the required conditions for installation and loading, see Part 6. 3.7. Chamber requirements The chamber, including the doors, must be water proof. All joints, seals, etc., must be checked for chemical resistance to the decontamination and rinsing agent used. In addition, the materials and components used must also be able to withstand the temperatures and mechanical stresses involved. The chamber and doors should be made of stainless steel, preferably material 1.4301 AISI 304 or better. Alternative materials may also be used if they have the same properties and resistance. It is absolutely essential that the floor area of the chamber be made in the shape of a (water) splash-proof basin. The interior of the chamber must be adequately illuminated. The outer walls of the chamber must fulfill the requirements of DIN 4140 (German industrial standard for heat insulation). 3.8. Front panel Ideally the units should be constructed as two-door models with a loading and an unloading side. The front and, if necessary, the rear sides should be covered with paneling. The paneling should ideally be made out of stainless steel with the usual surface treatment (polish, graining) for such equipment. The entrance to the machine room should be large enough for maintenance purposes. 3.9. Lock and entrance opening Entrance aids are to be provided for safe and easy loading of the TI. Doors which open and close automatically should be provided. Sliding doors, folding doors, and similar constructions may be used. Sliding doors should be poweroperated and open from the side. If an automatic door operating system is used, the German “Guidelines for power-operated windows, doors and gates” (ZH 1/494) must be adhered to. Each door should be fitted with an observation window for checking function and safety. recommended for this. The storage tank should be fitted with a sampling valve. The storage tank overflow should be placed so that floating contaminants are drawn off. Access to the machine room should be laid out in agreement with the person responsible for hygiene and in accordance with structural conditions. Part X3 3.10. Machine room The minimum dimensions of the machine room are based on the space needed for the machines, storage tanks, pumps, heat exchangers, pipelines, valves, etc., which are required for the process. In order to guarantee smooth maintenance, the basic installation dimensions may not be narrowed (see Part 6). In particular, the space above the machines should be kept accessible for maintenance work (third-party channels and pipes may not be laid there). Special care should be taken that all the components required, for example, storage tanks, heat exchangers, pumps, dosing devices, as well as measuring, control, and regulation equipment (I&C equipment) are arranged in a clear and easy-to-maintain order, as many components require daily checks and maintenance to ensure smooth operation. For example, it should be possible to change the detergent and disinfectant solution quickly and easily as required. An automatically controlled program is If the machine room is accessible from an operating room, the climatic requirements specified in DIN 1946-4 must be taken into account. 3.11. Automatic control The entire program sequence, including door closing and opening movements, should take place automatically. From the front of the loading side, it should be possible to select the required programs (if there is more than one choice) and have the individual program steps displayed as they take place. The installation of programmable logic controllers (PLC) is recommended. 3.12. Display and monitoring Decontamination systems should be equipped with the necessary control and display instruments. The following information should be displayed: 쐍 The currently selected program when multiple programs are available 19 Part 3 쐍 The current process step during operation 쐍 The temperature of the decontamination solution and the rinse water 쐍 When the program ends 쐍 Messages when the PCH containers (canisters, tanks) are empty 쐍 Control and measurement of the decontamination solution It must be possible to read all the displays from a distance of 1 meter. 3.13. Safety technology The units must be equipped with the safety devices required by the German employer’s liability association responsible for industrial safety and insurance (Berufsgenossenschaft) and the German Association for Electrical, Electronic and Information Technologies (VDE). This includes monitoring the door closing and opening movements, an emergency system for unlocking the door from inside the chamber, a chamber door-locking system preventing opening during operation so that no contami- 20 nants can escape into unprotected normal working areas, etc. 3.14. Control panel and installation of equipment The electrical equipment of the BDS must comply with the German standard DIN VDE 0100. All the electrical equipment and connections in the machine room must be installed in compliance with the level of protection specified in the German standard DIN VDE 0470-1 IP 33. Push buttons, warning lights, and control panels are to be installed on the working area side according to protection class IP 30. The power for this equipment is to be supplied by a control transformer built into each device. PELV (protective extra low voltage) (24 V) current must be provided for control and safety circuits. 3.15. Accompanying documents At least two sets of documents must accompany the BDS during the acceptance process. a) Operating instructions with a description of the process b) Abbreviated operating instructions with – if necessary – loading information C) All necessary circuit diagrams, pipeline diagrams and process diagrams d) Spare parts lists as well as maintenance instructions 3.16. Information about operating utilities The supply, return and drain pipes, operating utilities, and other structural necessities required by the machines are described in Part 6 “Structural requirements”. Appendix A in Part 6 contains a form to help you determine consumption values. In addition, you will find helpful information about operating utilities in Appendix B in Part 6. Requirements for the items to be treated (TI) and maintenance For the treatment of bedframes, bedside tables, transport carts, distribution containers, reusable sterilization containers, surgical tables and furnishings, as well as surgical clogs in decontamination systems, there are some basic requirements. 4.1. Construction and design The most important requirement is that any items to be treated are constructed in a suitable way for decontamination, in particular at those areas where the patient, the personnel or the items being transported would normally come into contact. The TI must be qualitatively designed for automated decontamination and the manufacturer must attest its suitability for decontamination. Components such as, for example, castors, hydraulics, pneumatics, cranks, drive mechanisms must be constructed in such a manner that they can withstand the effects of the decontamination and rinsing solutions without damaging. The TI should be constructed in such a way that it has no gaps or parts susceptible to corrosion. Hollow areas and cavities, where liquid can collect, are to Part 4 be avoided or constructed in such a way that the liquid can drain off. This is especially important for achieving thorough drying using the specific heat of the TI. Tolerable residual moisture is regarded as being individual drops of water (not pools ), which are still clinging to unfavorable areas on the TI approximately five minutes being removed from the BDS. 4.2. Item dimensions TI dimensions must not exceed the following maximum dimensions: Figure 5a: Bedframes Height incl. lifting pole . . . . . . .1980 mm Width . . . . . . . . . . . . . . . . . . . . .1080 mm Length . . . . . . . . . . . . . . . . . . . . .2300 mm When cleaning a bedframe and bedside table together (piggyback system), the following maximum dimensions must not be exceeded: Height incl. lifting pole . . . . . . .1980 mm Width . . . . . . . . . . . . . . . . . . . . .1080 mm Length . . . . . . . . . . . . . . . . . . . . .2600 mm For cleaning bedside tables and other types of TI separately, the loading and transport carts used must also not exceed these dimensions. 21 Part 4 22 Figure 5b: Transport carts Height . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1980 mm Width . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1080 mm Length . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2300 mm Figure 5d: Surgical table tops with transporter Height . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1450 mm Width . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .800 mm Length . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1900 mm Figure 5c: Loading carts for sterilization containers Height . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1980 mm Width . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1080 mm Length . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2300 mm Figure 5e: Loading carts for surgical clogs Height . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1980 mm Width . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1080 mm Length . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2300 mm Hydraulic and pneumatic components, cranks, pneumatic springs, and electric motors can all be used to power adjusting devices. All drive mechanisms must be designed to withstand the decontamination process. Electric motors must have an additional certificate of suitability for use in the BDS issued by a recognized testing office. All materials and drive mechanisms used in the item to be treated and decontaminated must be resistant to the following influences: 쐍 Temperatures of up to 70°C 쐍 pH-values varying between 5–8 (9)1 쐍 PCH solutions and water (for water Figure 5f: Loading carts for distribution containers Height . . . . . . . . . . . . . . . . . . .1980 mm Width . . . . . . . . . . . . . . . . . . .1080 mm Length . . . . . . . . . . . . . . . . . . .2300 mm quality requirements, see Part 6) 쐍 Spray pressure of 5–8 bar 쐍 Under certain circumstances, surgical tables require lower spray pressures, for example, 1.5 bar 4.3. Materials and components The materials used must be corrosion resistant or have a corrosion-resistant coating and should be able to store heat. Suitable materials include: 쐍 Steel and aluminum with protective coating 쐍 Stainless steel 쐍 Plastic coating (paint finish). The plastic coating should be tight and at least 90 µm thick. Polyester coating has proven effective. 쐍 Non-metallic materials, for example, polyamide, Formica-covered HPL sheeting, and polypropylene. Bedframes Residual moisture is not to be tolerated on the flat horizontal surfaces of the bedframes so that the bed can be prepared for use immediately after a secondary drying time of approximately five minutes. Bedside tables, Transport carts Due to their construction, bedside tables and transport carts have a lower heat storage capacity than other types of TI and therefore, under certain circumstances, do not have enough specific heat to dry their horizontal surfaces to a tolerable level of residual moisture. For this reason, this type of item should be constructed in such a way that the process chemical solutions can drain off when the TI is tilted. Part X4 Sterilization containers and distribution containers In order to be able to decontaminate sterilization containers and distribution containers in a BDS, the following requirements must be met: 쐍 Sterilization containers and distribution containers must be constructed in such a way that there are no surfaces that the spray water cannot reach and that there are no hollow areas where spray water can collect and not be able to drain off. Unavoidable hollow areas or undercuts due to construction constraints must be provided with adequately-sized drainage outlets. 쐍 A loading cart adapted to the shape of the respective sterilization container or distribution container must be available. The sterilization containers or distribution containers must be secured to this cart in such a way that the spray water can reach all the interior and exterior surfaces and, especially, that it can drain off completely from all the concave areas of the TI. In addition, securing the TI ensures that the pressure of the spray water does not move the containers out of their 1 After consulting with the manufacturer of the TI 23 Part 4 set position. The size of the loading cart must be adapted to make use the best possible use of the available interior area of the BDS. Surgical tables and furnishings The manufacturer of the PCH, in coordination with the manufacturer of the TI, must ensure and certify the material compatibility of surgical table tops suitable for decontamination with the PCH. The moisture indicators on the surgical table tops must be monitored according to the manufacturer’s instructions. During automated decontamination, lubricants may be discharged from surgical table tops and surgical table transporters. The re-lubrication cycles recommended by the manufacturers must be ensured. Surgical clogs Surgical clogs are made completely out of polyurethane because this material functions well and can be reliably disinfected. However, this material can only be used in chemo-thermal disinfection processes with a maximum temperature of 60 °C. Clogs that contain other materials are not suitable for automated decontamination. 24 Loading carts for surgical clogs must be constructed in such a way that the PCH can be applied to the entire interior and exterior of each clog. 4.4. Maintenance In order to guarantee and extend the life of the TI, maintenance should be performed at regular intervals according to the instructions provided by the manufacturer. The following maintenance work should be performed at least every 6 months: Medical devices must be checked at regular intervals according to the regulations specified in the German Medical Devices Operator Ordinance (MPBetreibV). Other types of TI must be inspected according to the German Equipment Safety Act (GPSG). A: Inspection work 쐍 All functions and, if necessary, the readjustment of Bowden cables and adjustment devices must be inspected. 쐍 The surface of all plastic coating must be inspected and, if necessary, repaired. 쐍 All accessories, for example, lifting poles and side panels must be inspected. 쐍 The leakage current and insulation resistance on electrical beds must be measured. 쐍 The moisture indicators on surgical table tops must be visually inspected. B: Maintenance work Maintenance should be performed on the following parts according to the manufacturer’s instructions: 쐍 Pivots 쐍 Guidance parts 쐍 Frame ends and pipe sleeves at head and foot of bed 쐍 Brake rods 쐍 Adjustment devices 쐍 Journal pins and bearing bolts 쐍 Caster-locking mechanisms 쐍 Spindles and spindle guides 쐍 Telescopic tubes 쐍 Locks and bolts During automated decontamination, lubricants may be discharged. The relubrication cycles recommended by the manufacturers must be ensured. Refer to the maintenance instructions for information about the various types of grease and oil. A suitable control system should be set up to make it possible to check whether maintenance has been carried out, for example, using a colored number plate or bar code. A card or computer system is recommended for documenting any inspection, service, and repair work performed. A prerequisite for this is that the bedframes are numbered. CAUTION! Consult the manufacturer for special information about cleaning old bedframes, carts, surgical tables, and accessories. Requirements for process chemicals (PCH) The specific properties of the process chemicals (PCH) used in decontamination systems (BDS) must be adapted to the purpose for which it is to be used. In order to avoid damaging either the TI listed in this booklet or the BDS, only PCH which have been especially developed for use in a BDS and whose suitability has been proven may be used. Liquid PCH, which can be automatically dosed, is used. Dosing the PCH directly from the container it was delivered in (canister or barrel) is recommended. The PCH must be sprayed on uniformly so that it completely covers the entire surface of the TI to be decontaminated according to the hygienic guidelines described in Part 8, Testing for efficacy. PCH for medical devices such as bedframes, surgical tables or sterilization containers must show the CE symbol according to the European Medical Device Directive. Part 5 The requirements for PCH are described in detail in the following: 5.1. Decontamination agent The specified concentration of the decontamination agents should not exceed or fall below the pH ranges indicated in Table 1. A tolerance test using the specified water quality and the PCH used in the decontamination system is recommended for sterilization containers, transport carts, and distribution containers made out of aluminum. If acidic or neutral PCH is used, the chloride level in the solutions should not exceed 100 mg/l and should be checked regularly. time ratio applied in the BDS. Evidence of efficacy against Hepatitis B viruses should not be determined in a procedural report but rather should be determined by performing suspension tests. In this context, the test method for “active against enveloped viruses” disinfectants with BVDV (Bovine Viral Diarrhea Virus) and vaccinia viruses according to the RKI recommendation “Test and declaration of the efficacy of disinfectants against viruses” (Bundesgesundheitsblatt 47, 2004, p. 62–66) is to be used. This test includes efficacy against Hepatitis B viruses/HIV. Note that it is the temperatures of the TI during cleaning and not those in the decontamination solution storage tank that are taken into consideration during the test. 5.2. Rinsing agent Decontamination agents for sterilization containers must be effective against Hepatitis B viruses at the temperature- The rinsing agents to be used should achieve a uniform and thorough wetting Table 1 pH range of the solution 1 Surgical tables, Bedframes, Bedside tables and accessories Stainless steel Aluminium Plastic Stainless steel Aluminium 5–8(9)1 2–12 5–8(9)1 5–12 2–12 5–8(9)1 After consulting with the manufacturer of the TI Transport carts Sterilization containers and distribution containers Surgical clogs 5–12 25 Part 5 of the various TI materials. Through this, drying should be aided and the build up of drips and stains avoided. 5.3. Material strength During the life time of the TI indicated by the manufacturer, the PCH used should not cause any corrosion of the TI materials and components described in Part 4. 5.4. Composition The PCH should not degrade the lubricants that ensure the movable parts of the TI function properly (see also Part 4). The PCH must conform to the technical requirements of the BDS described in Part 3. For example, they should not produce interference with foam or cause deposits. 26 5.5. Determining the concentration A method for determining the concentration (±10 % of the nominal value for the decontamination agent) must be indicated. A uniformly efficacy of the decontamination solution must be ensured throughout the entire operating period. 5.6. Temperature The PCH must be usable in the temperature ranges recommended by the manufacturers of the system and the TI, as well as in the specified decontamination process. 5.7. Changing the decontamination solution The decontamination solution must be regenerated or changed when necessary. In any case, in order to ensure complete decontamination storage tanks and filters, as well as jets, must be cleaned regularly if not daily, depending on the type of items being cleaned. 5.8. Electric motors The manufacturer's instructions must be followed when decontaminating bedframes with electric motors. 5.9. Documentation A safety data sheet must be provided for every PCH. 5.10. Dosage The dosage of the PCH can be done either decentrally or from a central point (see Part 6). Structural requirements The prerequisite for a properly functioning system is competent planning and structural preparation, as well as the proper coordination of the supply and disposal systems for the operating facilities. Part 6 6.1. Performance limitations The acquisition of a BDS and the settlement of the warranties, i.e., the delivery and the installation should be done according to the “Supplemental contract conditions for VOB and VOL for trade sterilization and disinfection systems” (EVB STER/DES, last edition). The connection of the BDS to the building utilities (intake air/exhaust air/hot steam/ cold water/compressed air/power supply) is the responsibility of the respective construction trades. Shut-off devices are third-party services. Either the client or the operator must provide the manufacturer with the necessary documents for creating the designs for construction preparation. NOTE For third-party installations above the chamber: The space above the system, especially above the chamber, must not be restricted by third-party installations such as ventilation ducts, pipelines, cable runs, or similar, since the electric motors, drive mechanisms, valves, and other components located in this area must remain accessible for maintenance work. 6.2. Requirements for operating utilities and systems The manufacturer must notify the client or operator in good time about which operating utilities in which qualities and in which quantities must be provided and which third-party measures are necessary for assembling, connecting, and operating the BDS. The operator must meet the manufacturer’s requirements for the quality and quantity of the operating utilities, in- cluding supply and disposal systems. Otherwise, the following can be expected: unsatisfactory function and insufficient efficacy of the decontamination, long cycle times, damage to the TI, and damage to the system. Water pH value . . . . . . . . . . . . . . . . . .5–8 (9)1 Total hardness . . . . . .up to 0.5 mmol/l (up to 3° d – German hardness) Evaporation residue . . . . . .⬍ 500 mg/l Chloride . . . . . . . . . . . . . . . . .⬍ 80 mg/l Silicate as SiO2 . . . . . . . . . . .⬍ 15 mg/l Iron . . . . . . . . . . . . . . . . . . .⬍ 0.05 mg/l Manganese . . . . . . . . . . . .⬍ 0.05 mg/l Copper . . . . . . . . . . . . . . . .⬍ 0.05 mg/l Fully demineralized water may only be used after consultation with the manufacturers of the PCH, TI, and BDS. Due to reasons of material strength, fully demineralized water is recommended for sterilization containers, transport carts, and distribution containers made from anodized aluminum. The cold feed water is heated in the BDS. Warm water can be used. Cold water pipes should be insulated against condensation, where necessary. The water connections should be made in accordance with the regulations specified by the DVGW (the German Technical and Scientific Association for 1 After consulting with the manufacturer of the TI 27 Part 6 Gas and Water). Attention should be paid to the compatibility of the piping materials. The manufacturer must notify the operator of the following: 쐍 Minimum overpressure or flow pressure at the connection point to the system 쐍 Connection dimensions 쐍 Design performance (peak) 쐍 Consumption per hour (maximum consumption) Steam Steam conduits are to be drained on site immediately before the BDS. Horizontal pipelines should be installed with the fall of not less than 1:50 in the direction of the steam flow. The steam conduits must be insulated against heat loss according to the German Heat Conservation Provision. The manufacturer must notify the operator of the following: 쐍 Minimum overpressure at the connection point to the system 쐍 Connection dimension 쐍 Design performance (peak) 쐍 Consumption per hour (maximum consumption) 28 The manufacturer of the decontamination system must be notified if any special materials have been used in the pipework of the building. Condensate When operating a BDS with steam, condensation builds up. The operator must be notified about the expected amount of condensate and the dimensions of the pipeline. Compressed air Compressed air (industrial quality) is used for pneumatic operation and control processes. Compressed air with a minimum overpressure of 6 bar must be available at the connection point. The manufacturer must notify the operator of the following: 쐍 Minimum overpressure 쐍 Connection dimension 쐍 Design performance (peak) 쐍 Consumption per hour (maximum consumption) Electricity supply The connection requirements as specified in the German standard DIN VDE 0100 must be observed. A mains connection must be provided on site as follows. Nominal voltage . . . . . . . . . . .3 x 400 V Nominal frequency . . . . . . . . . . . .50 Hz The manufacturer must be notified of any discrepancies from these values. The manufacturer must notify the operator of the following: 쐍 Connection values (power consumption) 쐍 Fuse protection 쐍 Consumption per hour (maximum consumption) Waste water The German standard DIN 1986 (Drainage systems on private ground) and local waste water regulations are to be observed. The manufacturer must notify the operator about the dimensions of the connection and the amount of waste water. Exhaust air processing technology The ventilation of the chamber using an internal fan must be done via a separate pipe leading to the outside. The exhausted chamber air is saturated with water vapor. Therefore, it is imperative that the pipes are constructed so as to be absolutely waterproof. The manufacturer must notify the operator of the following: 쐍 Flow volume (m3/h at Pa) 쐍 Exhaust air temperature 쐍 Connection dimension In pipes with high pressure loss, the operator must have an additional fan including drainage device installed at the end of the pipe. Chamber air supply A sufficient supply of fresh air must be provided for airing the chamber (drying) either from the working space on the clean side or via the machine room. If the BDS is located within the surgical department, the machine room is considered a Class I surgical side room according to DIN 1946, Part 4. The incoming air is to be channeled accordingly through filters, in as much as its degree of purity does not meet the guidelines for OP rooms set in DIN 1946, Part 4. Front view Observation window 6.3. Structural dimensions The minimum dimensions for the loading path must be supplied by the manufacturer. The load-bearing capacity of the foundations as well as the traffic load capacity at the installation site must be designed to take the weight of the system as indicated by the manufacturer. Height of installation Display and operation Items being treated (TI) Upper edge of the flooring Width of installation Reservoir for recirculated liquid (Take drainage facilities and floor depression into account) Floor depression (Follow manufacturer’s specifications!) Layout TI Machine room Depth of installation Width of usable space Depth of usable space Unloading side Maximum values for installation dimensions: Height . . . . . . . . . . . . . . . . . . . . 3000 mm Width . . . . . . . . . . . . . . . . . . . . . 3000 mm Depth . . . . . . . . . . . . . . . . . . . . 3600 mm Loading side The manufacturer must supply the following information: 쐍 Heat load on the front of the unit 쐍 Heat load in the machine room 쐍 Heat load on the TI at the “unloading side” Height of usable space Upper machine room for supply and waste disposal pipes and for accessing the components Heat dissipation The heat produced by the BDS must be dissipated. Additional thermal loads produced by auxiliary equipment and third-party pipelines must be taken into account. The heat must be dissipated from the machine room and fresh air supplied in such a way that the temperature in the machine room does not exceed 40 °C at a height of 2 m. Heat can be dissipated from the machine room via supply and exhaust air or via exhaust air vents in the machine room and air intakes in the front paneling on the clean side. Part 6 Cross section of the BDS Basic installation dimensions for BDS Installation heights (mm) Installation widths (mm) Installation depths “Lengths” (mm) A – BDS – for bedframes WITHOUT piggyback system 3000 3000 3400 B – BDS – for bedframes WITH piggyback system 3000 3000 3600 C – BDS – for transport carts, distribution containers, surgical clogs, sterilization containers, surgical tables 2700 3000 2750 Figure 6: Basic installation dimensions for a BDS 6.4. Pit The operator must provide a waterproof pit for the installation of the BDS. The edges of the pit must be lined with noncorroding reinforcements constructed according to the manufacturer's specifications. The operator must provide a drainage facility with a siphon for the pit. Maximum installation depth below ground level . . . . . . . . . .250 mm below the upper edge of the flooring 29 Part 6 6.5. Installations in the machine room 6.6. PCH dosing system The operator must install lighting and SCHUKO sockets in the machine room which correspond to a protection class of at least IP 34 according to DIN 40050. The lighting must be laid out in such a way that the machine room is well lit. The dosing of the PCH can be done either decentrally or from a central point. For decentralized dosing, the PCH container is usually located in the BDS machine room. The machine room entrance must be large enough for deliveries of the PCH in vats (take vat diameter into account). Water and compressed air connections (including hose connections) for maintenance and cleaning work must be provided in the machine room. vats) (Fig. 7). Normally, dosing centers are located in a separate room. This room should be easily accessible for the delivery of large containers. The decision of which dosing method to use must be taken into account during the initial planning phases since this has an influence on the structural requirements. For this reason, the PCH manufacturer must be involved in the early planning stages. Centralized dosing systems offer the advantage of being able to supply different BDS and washer disinfectors with PCH from large containers (for example, Tunnel washer for surgical instruments Washer-disinfector for surgical instruments When storing the PCH, the corresponding legal conditions according to the Federal Water Act must be adhered to. BDS I BDS II Centralized dosing system Detergents 30 Figure 7: Example of a dosing center Neutralizing agent Rinsing agent Decontamination agent Part 6 Centralized sterilization Hygiene center for sterilization “Clean side” “Clean side” Unloading side Unloading side Dosing system/PCH BDS Washer-disinfectors Machine room Tunnel washer Loading side Loading side “Dirty side” “Dirty side” Figure 8: An example of the layout of a hygiene center and a centralized sterilization area with centralized PCH dosing system 31 Part 6 Appendix A: Connection and consumption values Form for determining the connection and consumption values for the supply and disposal services for a decontamination system. Project: . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Manufacture: . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Model/type: . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32 Code letters Name Nominal diameter Pressure Temperature Connection ST External steam from building utilities DN bar CO Condensate DN bar CW Cold water, softened, max. 0.5mmol/l (3°d) DN bar m3/h m3/h CA Compressed air, oil-free DN bar Nm3/h Nm3/h DR Discharge water DN GU Gully (floor drain) DN EA Exhaust air from chamber DN TL Thermal load/ exhaust air TL1 TL2 TL3 TL4 IA Intake air Intake from the unloading side EL Electricity supply 3/ N / PE AC 400 V 50 Hz Pa Machine room Unit front, loading side Unit front, unloading side Items to be treated kg/h °C kg/h kg/h °C l/min °C m3/h kW kW kW kW kW Fuse protection Consumption A kWh Appendix B: Operating utilities for decontamination systems Part 6 SUPPLY (guideline values) DISPOSAL (guideline values) ST External steam Dimensions DN 25–40 Pressure 0.5–10 bar 2.5 bar recommended Design performance 250–300 kg/h CO Condensate (recirculated) Dimensions Pressure + temperature Design performance DN 20–25 each depending on FD 250–300 kg/h CW Cold water, softened, max. 0.5 mmol/l (3°d) Dimensions DN 20–25 Pressure 3–5 bar 3 bar recommended Design performance 30–40 l/min DR Discharge water Temperature Design performance up to 80° C 35–50 l/min GU Gully (floor drain) DN 65–80 CA Compressed air Dimensions DN 15–20 Pressure 6–10 bar Design performance 10–15 Nm3/h 8 bar recommended IA Intake air in machine room the air from the room on the unloading side used for machine room ventilation and for airing the chamber (EA) EL Electricity supply (DIN/VDE 0100 is to be observed) Power supply/ frequency 3 x 400 V 50 Hz Backup fuse 35 A Connection value approx. 10–12 kW TL Exhaust air thermal load approx. 2–4 kW TL1machine room temperature ⬍ 40° C TL2 unit front/loading side thermal load approx. 0,5 kW TL3 unit front/unloading side thermal load approx. 0,5 kW TL4 addition thermal load for TI approx. 4–5 kW EA Exhaust air from chamber (interior) Flow volume 1000–1600 m3/h Fan pressure approx. 50–200 Pa Exhaust air temperature up to 80° C humidity 100 % short-term Make sure that the exhaust air pipeline and its drainage facilities are large enough. IMPORTANT NOTE: The precise values needed for preparing the installation must be obtained from the manufacturer of the BDS. The data depends on individual requirements. Appendix A in Part 6 can be used as an aid. 33 Part 7 Operation and management of the BDS In order to guarantee the safe and reproducible operation of the BDS, the maintenance measures specified by the manufacturer must be performed regularly (servicing, as well as inspection and maintenance work, as defined by DIN 31 051). sponsible for operating the system in using and servicing the system. The operator is responsible for making sure his staff is sufficiently trained in operating the system (operator manual). the system competently. This instruction is normally prepared by the operator based on information provided by the manufacturer. 7.7. Parameter settings 7.4. Log book 7.1. Initial start-up Initial start-up must be performed by the manufacturer or by a technically competent person assigned by the manufacturer. During start-up, the functions and correct settings for all regulation, control, and safety equipment must be checked. In addition, the fuse protection for the electrical circuitry and the measures for shock-hazard protection must be checked. 7.2. Handover The manufacturer must provide the operator of the system with the accompanying documentation and maintenance instructions as well as the procedure test report for the various applications (see Part 8). It is recommended that a log book be kept in which running reports are entered daily (for example, number and type of cycles, faults, concentrations and pH values of the cleaning und disinfectant solution, tests performed, etc.) 7.5. Operating manual The operating manual is an integral part of the system and must be kept in the room where the system is installed so that each member of the operating staff can refer to them at any time. It is recommended that a short version of the operating manual be kept in the direct vicinity of the operating panel in a clearly visible area. 34 During the handover of the system, the manufacturer must train the staff re- 7.8. Checks and controls The measures specified in the operator manual and in the operating instructions must be carried out, for example: 쐍 Checking the concentration, tempera- 7.6. Operating instruction 7.3. Operating staff When operating the BDS, the decontamination process parameter settings determined by procedure testing and specified in the operating instructions must be adhered to. These are, for example, temperature, reaction time, PCH concentration, and drying time. Any adaptation of the parameters due to local conditions, such as temperature, reaction time, PCH concentration, and drying time, must be confirmed by procedure testing. The BDS operating instruction contains all the important information an operator needs to know in a form that is easy to understand so that he can operate ture, and if necessary, the pH-value of the detergent and disinfectant solution. 쐍 Replacing the detergent and disinfection solution by emptying the storage tank (see Part 5 also). 쐍 Regularly cleaning the filters and containers. 쐍 Checking the nozzles for free throughput and correct spraying position. 7.9. Microbiological efficacy testing These tests must be carried out according to Part 8. Testing with other types of TI is to be specified in the operating instruction by the operator. 7.10. Maintenance measures Maintenance measures are to be carried out according to the manufacturer’s instructions. 1. It is recommended that a maintenance contract be signed with the manufacturer. 2. The servicing and maintenance work specified in Part 4 must be carried out on the TI. 3. Process chemicals must be used according to the manufacturer's instructions. The recommended consumption must be checked (see Part 5). Safety regulations are to be observed, in particular, parameters determined by procedure testing and which influence the decontamination process may not be altered. Part 7 When replacing components which could change the process parameters of the decontamination process, a special test must be performed as specified in Part 8. Only experts and staff who have been properly trained may carry out servicing and inspection work. When performing servicing work, the manufacturer's instructions must be observed when replacing parts. 35 Part X8 Tests and reports Requirements In processes for cleaning and disinfecting bedframes and bedside tables (with and without a piggyback system), transport carts, distribution containers, reusable sterilization containers, surgical tables and furnishings, as well as surgical clogs, the process must guarantee a 5-log10 reduction of the level of microorganisms detectable on any area with which patients, personnel or items being transported may come into contact. The minimum recommended reduction of microorganisms of 5 to the power of 10 applies only to the decontamination process described. It is not a statement regarding the number of microorganisms generally tolerated. The model, type number, and manufacturer of the TI tested are to be listed in the test report, in as much as it is feasible. NOTE For sterilization containers, it is assumed that they will be sterilized with steam as a final processing step. 36 8.1. Evaluation of the antimicrobial efficacy (Procedure test) This deals with a test method for assessing chemo-thermal decontamination processes for the TI mentioned above. The number of TI and biological indicators to be used for the test as well as the number of successive cycles are indicated according to the respective TI in 8.1.4. Procedure testing consists of a test of the carriers and of the decontamination solution. 8.1.1. Test bacteria and intermediate cultures The test bacteria used: Enterococcus faecium ATCC 6057. The intermediate E. faecium culture must be plated onto tryptic soy agar (TSA) three times at 48 h intervals. The incubation temperature is 36°C ± 1°C. To obtain the test suspensions, each plate is flooded with 10 ml tryptic soy broth (TSB). The suspensions are washed by centrifugation, resuspended in a 0.8 % NaCI solution, and then renewed centrifugation. A sample of test bacteria corresponding to the original volume is then absorbed into a test suspension of blood (sterile, heparinized sheep blood with protamine1) or of a sterile solution containing BSA and mucine (RAM2). The test suspension to be used for each TI is indicated in 8.1.4. The number of bacteria in the test soil must total at least 1 x 108 CFU/ml (CFU = colony forming units). 8.1.2. Carriers Thin plates made from stainless steel (X5 CrNi 18-10 according to the German standard DIN EN 10088-1) with a surface graining of 80 and a size of 10 mm x 130 mm are used as carrier material. The area to be contaminated is 10 mm x 100 mm. When applying the test soil to the plate, make sure that it does not come in contact with the sides of the plate. In order to ensure uniform distribution on the 1 Heparinized sheep blood Manufacturer: for example, Froscheck Labordiagnostik-Tierblutspezialisten GmbH, Arndtstr. 51–55, 45473 Mülheim, Germany or ACILA AG, Opelstr. 14, 64546 Mörfelden-Walldorf, Germany. 2 RAM test suspension 0.6 g BSA (Serva 11930) and 1.0 g mucine (Sigma No. 2378) dissolved in a 100 ml NaCl-peptone solution. The RAM test suspension therefore contains 1% mucine and 0.6 % bovine serum albumin. The sedimented test bacteria are suspended in this solution. surface, the carrier must be thoroughly degreased (alcohol is not sufficient! Recommended are grease solvents, laboratory detergents or cleaning in an industrial washer at approx. 60°C). Multiple reuse is only possible if the carrier is perfectly cleaned. After decontamination, the carriers must be stored in a dry condition. 8.1.3. Applying the test soil onto the carrier A sample of 0.1 ml of the test soil is uniformly applied to each contamination area and dried for 24 h at 22°C ±1°C and with a humidity of 50 % ±10 % (humidity and temperature must be indicated in the test report). The testing must be performed within the first 24 hours after the drying phase. Three transport controls are to be carried out at the same time as the test itself. The number of bacteria per contaminated biological indicator must be high enough that a 5-log10 reduction can be demonstrated (at least 1 x 107 CFU/test sample) even after taking the detectable level into account. 8.1.4. Test parameters and set-up Part 8 햴 햻 햸 햷 햵 햶 8.1.4.1. Test parameters and set-up for bedframes and bedside tables Number of biological indicators per cycle 10 biological indicators per bedframe or 14 biological indicators per bedframe with side rails (with and without piggyback system), 9 biological indicators per child's bedframe, 5 biological indicators per bed-side table Number of cycles to be tested 10 sequential cycles Test suspension Enterococcus faecium ATCC 6057 suspended in blood (sterile, heparinized sheep blood with reactivated protamine sulphate) according to 8.1.1. Preparing the biological indicators On the contamination area of each stainless steel plate, 0.1 ml of test soil is to be applied and let dry according to 8.1.2. and 8.1.3. In addition, three biological indicators are to be prepared for the transport control. Test arrangement The biological indicators are to be arranged according to the illustrations 9a, 9b, 9c, and 9d: Visible biological indicator Biological indicator not in the line of sight 햲 햳 햺 햹 Figure 9a: Positioning the biological indicators on a bedframe 햲 Head end panel, outer surface 햳 Head end panel, inner surface 햴 Head end rail 햵 Foot end panel, outer surface 햶 Foot end panel, inner surface 햷 Foot end rail 햸 Left sidebar 햹 Right sidebar 햺 Middle of lying area 햻 Lifting pole (if present/not removed) 햿 헀 햽 햾 Figure 9b: Positioning the biological indicators on a bedframe with side rails In addition to the biological indicators shown in Fig. 9a, there are four additional biological indicators to be put into position: Side rail… 햽 at head, right panel on outer surface 햾 at head end, right panel on inner surface 햿 at foot end, left panel on outer surface 헀 at foot end, left panel on inner surface 37 Part 8 햶 햳 햲 햴 햵 The biological indicators must be fastened in special clamps so that they cannot move and so that no distortion of the results can be expected. The contaminated areas of the biological indicators must face outwards. Soiling of the decontamination solution After each test cycle, 5 ml of the test soil are to be added to the decontamination solution in the storage tank. Figure 9c: Positioning the biological indicators on a bed-side table 햲 Surface top 햳 Bottom shelf space, middle of inner surface 햴 Drawer, inner surface 햵 Drawer handle 햶 Folding table 햲 햴햳 햺 햹 햸 햶 햷햵 햺 햳 햵 햲 햻 햴 햶 햸 햹 햷 Figure 10a: Positioning the biological indicators on a transport cart 8.1.4.2. Test parameters and set-up for transport carts Number of biological indicators per cycle 10 biological indicators per transport cart Number of cycles to be tested 10 sequential cycles per type of transport cart 햲 Top plate, inner surface 햳 Side wall, left inner surface 햴 Side wall, right inner surface 햵 Back wall, middle inner surface 햶 Base plate, left inner surface 햷 Base plate, right inner surface 햸 Door, left handle area 햹 Door, right handle area 햺 Side wall, left outer surface 햻 Side wall, right outer surface 햳햺 햵 햲햴 햻 햹 Test suspension Enterococcus faecium ATCC 6057 suspended in a RAM solution according to 8.1.1. Figure 9d: Positioning the biological indicators on a child's bedframe 햲 Head end bars, outer surface 햳 Head end bars, inner surface 햴 Head end, upper rail 햵 Foot end bars, outer surface 햶 Foot end bars, inner surface 햷 Foot end, upper rail 햸 Left side rail, top 햹 Right side rail, top 햺 Middle of lying area 38 Visible biological indicator Biological indicator not in line of sight Preparing the biological indicators On the contamination area of each stainless steel plate, 0.1 ml of test soil is to be applied and let dry according to 8.1.2. and 8.1.3. In addition, three biological indicators are to be prepared for the transport control. Test arrangement The biological indicators are to be arranged according to the illustrations 10a and 10b: 햶 햸 햷 Figure 10b: Positioning the biological indicators on a transport cart for dishes 햲 – 햻 as in Fig. 10a Visible biological indicator Biological indicator not in line of sight The biological indicators must be fastened in special clamps so that they cannot move and so that no distortion of the results can be expected. The contaminated areas of the biological indicators must face outwards. 햲햷 Soiling of the decontamination solution After each test cycle, 5 ml of the test soil are to be added to the decontamination solution in the storage tank. Test arrangement The biological indicators are to be arranged according to the illustrations 11a and 11b. 햶햻 햳 햸 햴 햹 햵햺 Figure 11a: Positioning the biological indicators on the distribution container 8.1.4.3. Test parameters and set-up for distribution containers: 햲 Left inner side 햳 Front inner side outer side 햴 Floor side, 햹 Floor side, inner surface Number of TI and biological indicators per cycle 5 distribution containers each with 10 biological indicators per cycle on a fully loaded cart. 햷 Left outer side 햸 Front outer surface 햵 Right 햺 Right inner side outer side 햶 Rear inner side 햻 Rear outer side Visible biological indicator Biological indicator not in line of sight 햲 햴 햳 Number of cycles to be tested 2 sequential cycles per type of distribution container Test suspension Enterococcus faecium ATCC 6057 suspended in a RAM solution according to 8.1.1. Preparing the biological indicators On the contamination area of each stainless steel plate, 0.1 ml of test soil is to be applied and let dry according to 8.1.2. and 8.1.3. In addition, three biological indicators are to be prepared for the transport control. 햶 햵 Figure 11b: Positioning the distribution containers with the biological indicators on the loading cart 햲 Container, top left 햳 Container, top right 햴 Container in the middle area 햵 Container, bottom right 햶 Container, bottom left Part 8 At least 4 distribution containers are to be tested in the positions at the top and at the bottom (front and rear) as well as one in the middle. When the procedure is done, make sure that not only the biological indicator on the left outer side but also the biological indicators on the right outer side are collected. The biological indicators must be fastened in special clamps so that they cannot move and so that no distortion of the results can be expected. The contaminated areas of the biological indicators must face outwards. Soiling of the decontamination solution Before the first test cycle, 5 ml of test soil is to be added to the decontamination solution in the storage tank. In addition after each test cycle, 5 ml of the test soil is added to the decontamination solution. 8.1.4.4. Test parameters and set-up for reusable sterilization containers: Number of TI and biological indicators per cycle 5 sterilization containers incl. lid each with 8 biological indicators on a fully loaded cart 39 Part 8 Number of cycles to be tested 2 sequential cycles per type of container 8.1.4.5. Test parameters and set-up for surgical tables and furnishings: 햸 Test suspension Enterococcus faecium ATCC 6057 suspended in blood (sterile, heparinized sheep blood with reactivated protamine sulphate) according to 8.1.1. Preparing the biological indicators On the contamination area of each stainless steel plate, 0.1 ml of test soil is to be applied and let dry according to 8.1.2. and 8.1.3. In addition, three biological indicators are to be prepared for the transport control. Test arrangement The distribution and positioning of the biological indicators is to be done according to the illustrations 12a and 12b (model). Number of biological indicators per cycle 10 biological indicators per surgical table and transporter. 햹 햷 햵햳 햶 햲 햴 Figure 12a: Positioning the biological indicators on the sterilization containers 햲 Bottom panel, right inner surface 햳 Bottom panel, left outer surface 햴 Side panel (short), right inner surface 햵 Side panel (short), left inner surface 햶 Side panel (long), right inner surface 햷 Side panel (long), left inner surface 햸 Lid, right inner surface 햹 Lid, left outer surface Visible biological indicator Biological indicator not in line of sight 햵 햲 햳 The biological indicators must be fastened in special clamps so that they cannot move and so that no distortion of the results can be expected. The contaminated areas of the biological indicators must face outwards. Soiling of the decontamination solution After each test cycle, 5 ml of the test soil are to be added to the decontamination solution in the storage tank. 40 Number of cycles to be tested 10 sequential cycles Test suspension Enterococcus faecium ATCC 6057 suspended in blood (sterile, heparinized sheep blood with reactivated protamine sulphate) or into a RAM solution according to 8.1.1. Preparing the biological indicators On the contamination area of each stainless steel plate, 0.1 ml of test soil is to be applied and let dry according to 8.1.2. and 8.1.3. In addition, three biological indicators are to be prepared for the transport control. Test arrangement The biological indicators are to be arranged according to illustration 13. 햶 햴 Figure 12b: Positioning the sterilization containers with the biological indicators on a loading cart 햲 Container, top left 햳 Container, top right 햴 Container, bottom right 햵 Container, top right rear 햶 Container, bottom right rear The biological indicators must be fastened in special clamps so that they cannot move and so that no distortion of the results can be expected. The contaminated areas of the biological indicators must face outwards. 8.1.4.6. Test parameters and set-up for surgical clogs: 햲 햵 햳 햶 Part 8 햴햷 Number of TI and biological indicators per cycle 9 surgical clogs each with 2 biological indicators on a fully loaded cart. 햸 햳 햲 햻햹 햺 Fig. 13: Positioning the biological indicators on the surgical table and transporter 햲 Head end plate, top 햳 Middle plate, on the side edge 햴 Underframe 햵 Plate, underside 햶 Foot end plate, underside 햷 Underframe 햸 Bar in the middle area 햹 Middle piece, underneath 햺 Underframe 햻 Middle piece, underneath Visible biological indicator Biological indicator not in line of sight Soiling of the decontamination solution After each test cycle, 5 ml of the test soil are to be added to the decontamination solution in the storage tank. Number of cycles to be tested 10 sequential cycles Test suspension Enterococcus faecium ATCC 6057 suspended in blood (sterile, heparinized sheep blood with reactivated protamine sulphate) according to 8.1.1. Preparing the biological indicators On the contamination area of each stainless steel plate, 0.1 ml of test soil is to be applied and let dry according to 8.1.2. and 8.1.3. In addition, three biological indicators are to be prepared for the transport control. Test arrangement The biological indicators are to be arranged according to the illustrations 14a and 14b. The biological indicators must be fastened in such a way that they cannot move and that no distortion of the results can be expected. The contaminated areas of the biological indicators must face outwards. Soiling of the decontamination solution After each test cycle, 5 ml of the test soil are to be added to the decontamination solution in the storage tank. Figure 14a: Positioning the biological indicators on a surgical clog 햲 Sole, inner surface 햳 Sole, outer surface Visible biological indicator Biological indicator not in line of sight 햳 햲 햵 햶 햴 햷 햸 햹 햺 Figure 14b: Positioning the surgical clogs with the biological indicators on a loading cart 햲 Top left 햳 Top middle 햴 Top right 햵 Middle left 햶 Middle 햷 Middle right 햸 Bottom left 햹 Bottom middle 햺 Bottom right 41 Part 8 8.1.5. Evaluation After the biological indicators are run through the BDS program, they must be removed under aseptic conditions (for example, one sterilized pair of tweezers per test sample), submitted to a visual check for residue from the test soil, and each transferred into 10 ml of phosphate-buffer solution (PBS), if necessary, containing inactivation agents. Composition of the phosphate-buffer solution (PBS) The shaking is done in test tube racks on shaking devices at a frequency of approx. 500 min–1 for at least 20 min. The bacterial count in the shaken liquid is then determined. The method used must be indicated. The transport controls, which were not treated in the decontamination system, are transferred into 10 ml of PBS and evaluated at the same time and in the same manner. Solution A: 16 g NaCl; 0.4 g KCI; 0.4 g KH2PO4 dissolved in 1600 ml distilled water. The following methods for assessing the bacterial count are allowed: 쐍 Series dilution and surface culture 쐍 Spiral plater Solution B: 0.2 g CaCl2 dissolved in 200 ml distilled water. A suitable culture medium (for example, Kanamycin-Aesculin-Azide-Agar) is to be used. Solution C: 0.2 g MgSO4 dissolved in 200 ml distilled water. The method for determining the bacterial count as well as the nutrient broths and culture media used are to be indicated in the report. Solutions A to C are to be sterilized separately and, after being fully cooled under sterile conditions, mixed together, if necessary, with the addition of inactivation agents, see above. 42 The test bacteria are recovered by shaking the treated biological indicators in test tubes. The determination of suitable inactivation agents is to be indicated in the report. The inoculated culture media are to be incubated at 36 ± 1°C for 48 hours. The reduction of microorganisms is determined by taking the difference between the number of test bacteria on the CFU detected on the treated biological indicators and the mean value of the three untreated biological indicators (transport controls). The reduction factor must be at least 5 log10 steps. 8.1.6. Testing the decontamination solution In order to perform a microbiological review of the decontamination solution, samples of 100 ml are taken from the storage tank. This is done once before the start of the test, and then after each test cycle has been treated but before the test soil is added. At the end of the test (that is, after the last test cycle), 1000 ml are taken from the storage tank. After being removed, the samples are immediately mixed into the same volume of a 2-fold concentration of TSB with suitable inactivation agents and then immediately cooled down. The cultures are incubated at 36 ±1°C for 72 h. Cloudy cultures are streaked onto suitable culture media. This is to be indicated in the report. The test bacteria must not be detectable in the volumes tested (100 and 1000 ml, respectively). Information about any accompanying flora should be noted in the report. 8.2. Operational qualification After the system has been installed, the operator must ensure operational qualification (OQ). This is used to demonstrate that, when operated properly, the BDS provides the required decontamination performance according to current testing procedures. These tests are carried out after the technical acceptance and a trial run. The same test method is used as for the procedure test. Normally, two test runs (test cycles), each with one TI resp. with one loading cart with distribution containers, surgical clogs, and sterilization containers are sufficient. If bedframes using the piggyback system are tested, an additional test of bedframes not using the piggyback system is not required. If the system is to be used to clean special bedframes (intensive care or children's beds), transport carts, surgical tables and transporters or sterilization containers, these types must be included in the testing series. The biological indicators are to be prepared and positioned on the TI to be tested as described in 8.1.1– 8.1.4. 8.3. Periodic testing Periodic testing is to be performed at least every 6 months in order to demon- strate that the BDS fulfills hygienic requirements when operated properly. The same test method is used as for OQ. The testing is to be performed on the last cycle of the day. At least two cycles with each type of TI are to be run. If it is determined that one type of TI is more difficult to decontaminate than others, then this TI is to be used. The biological indicators are to be prepared and positioned on the TI to be tested as described in 8.1.1– 8.1.4. In the order to perform a microbiological test of the decontamination solution, 1000 ml is taken from the storage tank at the end of operation time. The sample is treated as described in 8.1.6. The number of colonies may not exceed 100 CFU/ml. Test bacteria must not be detectable. 8.4. Special testing Special testing must be performed whenever repairs affecting the procedure, program changes or alterations to the TI are made. The testing is done according to the guidelines for periodic testing. If necessary, a microbiological test of the decontamination solution is to be performed as described in 8.3. (subsection 5). REMARKS FOR 8.1. TO 8.4. Part 8 The statement about the procedure test in the report applies only to the test conditions in regards to temperature, type, and concentration of the decontamination agent, contact times, specific system parameters, as well as the type of TI used in each case. In addition, statements about the initial tests after installation and the periodical testing refer only to local on-site conditions. BDSs with fresh water systems are subject to the same testing methods except for specific tests for circulation systems, for example, decontamination solution tests. The RAM test suspension can also be used for periodic and special testing of bedframes. For periodic testing, a regular technical review of the jets and filters can be made together with a microbiological test of the decontamination solution in the storage tank, instead of a semi-annual microbiological test with biological indicators. Technical checks should be made 1–3 times per week depending on how heavily the BDS is used. 43 Part 9 Ecological requirements A BDS must guarantee completely accurate decontamination results over the course of the entire operating period while using the least amount of power, water, and PCH possible. From an ecological point of view, the following requirements must be fulfilled: 9.1. Water With regard to water consumption, a circulation system is preferred. In order to achieve the lowest possible consumption, it is necessary to return the warm water containing the rinsing agent back into the system. Experience has shown that with a volume of 250 to 350 l of decontamination solution in the storage tank and depending on the TI and the degree of contamination, it is necessary to add between 10 and 20 l of water (approx. 4–7 %) per cycle. 9.2. Energy 44 A certain expenditure of energy is necessary to guarantee perfect operation of the system. In order to keep energy expenditures as low as possible, all state-of-the-art technology and any feasible alternatives are to be exhausted (for more information, see Part 6). 9.3. Process chemicals The goal, when assessing the procedure test, is to achieve totally accurate hygienic results with the lowest possible concentration of decontamination agent. Note that decontamination times shorter than 120 seconds require higher concentrations of decontamination agent. The manufacturers of BDS and PCH provide dosing devices to ensure an exact dosage. Overdosing means unnecessary environmental pollution, while underdosing means inadequate decontamination or rinsing results. Process chemicals must be developed using raw materials which cause the lowest possible amount of ecological damage. The PCH application solutions should preferably be pH neutral. When treating transport carts, which are normally more heavily contaminated, alkaline or acidic PCHs may be necessary. The most important PCH components are: Surfactants decrease the surface tension of the decontamination solution or of the rinse water. This promotes the cleaning effect and ensures a uniform wetting of the TI, thereby encouraging independent drying. The biological degradability of surfactants is stipulated in Regulation (EC) No. 648/2004 of the European Parliament and of the Council on detergents. The disinfectants in the decontamination agents must not pose a health hazard to the bed center staff when the chamber ventilation is functioning properly and the usual drying times inside the BDS are maintained. The disinfectants in the decontamination agents must be formulated in such a way that, when used properly and diluted normally in waste water, the concentration as well as the antimicrobial properties of the diluted decontamination agent cause no acute danger to sewage sludge organisms and can be degraded or eliminated by them. Other components such as softening agents (chelating agents), dispersing agents, anti-corrosive agents as well as other cleaning agents are subject to the same provisions with regard to degradation or elimination as those for disinfectants. If the process chemicals contain or can form absorbable organic halogen compounds by mixing with other types of waste water or if they contain certain heavy metals, then the limits set down in the regulations for indirect dischargers issued by the governments of the indi- vidual federal states must be observed or an application for a discharge permit must be made. Process chemicals for transport carts may also contain alkalis or acids. Keeping the pH of the waste water in the range of 6 to 10 as specified in the waste water regulations can be done by diluting it with domestic waste water or, if necessary, by using neutralizing agents. The containers used to deliver the PCH should be, if at all possible, made of environmentally friendly plastics (for example, PE or PP). In order to dispose of these containers properly, they need to be emptied completely. In general, the number of empty plastic containers to be disposed of can be reduced by increasing the use of large reusable containers. This allows the PCH to be delivered in refillable containers instead of canisters. 9.4. Waste water eration of the sewage treatment plant, and waste-water monitoring. In order to motivate indirect dischargers to reduce the amount of pollutants they release, many cities and communities have introduced what are called “discharge coefficients”. These values are based on analytical data and used to evaluate how much waste water individual indirect dischargers actually release into the sewage system. This data is used to calculate a fee based on the amount of pollution produced (“pay as you pollute” principle). Independent of the question of fees, indirect dischargers are also subject to the obligatory discharge limits specified in the indirect discharger regulations passed by the individual federal states. These limits must not be exceeded. Due to the high degree of dilution, the biocidal agents and PCH solution components contained in the waste water have no influence on the biological treatment stage at sewage treatment plants. The operators of BDSs are normally also indirect waste water dischargers. The indirect discharge of waste water into the sewage system is regulated by state and local authorities. This means that local regulations may vary from place to place. The decontamination agents used in a BDS must be dosed using suitable dosing devices at the concentration determined in the procedure test. Indirect dischargers pay an effluent charge, which covers the cost of the sewage tax, the sewage system, the op- Exhaust air is ecologically safe. Normally, chamber air saturated with water vapor is ventilated safely outdoors. 9.6. Heat dissipation Part 9 Due to chemo-thermal chemical or thermal decontamination processes, heat dissipates from the front areas of the BDS, the TI, and the machine room. BDS manufacturers are urged to reduce the heat dissipation to the lowest level possible in as much as this is justified by technical and economic considerations. Steam conduits provided by the operator are to be insulated to reduce heat loss according to the German Heat Conservation Provision. 9.5. Exhaust air 45 Appendix DIN REGULATIONS DIN 58 955 – Decontamination equipment for medical use Part 1 – Terminology Part 2 – Requirements Part 3 – Efficiency testing Part 4 – Biological Indicators – Requirements Part 6 – Operation Part 7 – Structural Requirements and Requirements services supply When acquiring a BDS, the basis of agreement between the client and supplier are the provisions in the “supplementary contractual conditions for VOB (Verdingungsordnung für Bauleistungen = Standard Conditions of Building Contract Terms) and VOL (Verdingungsordnung für Leistungen = Standard Conditions of Contract Terms for Works and Services) for trade sterilization and disinfection systems” – EVB STER/DES 07.00. DIN 1946-4: 1999-03 Ventilation and air-conditioning Part 4: Ventilation and air-conditioning systems in hospitals (VDI ventilation rules) DIN 1988: 1988-12 Drinking water supply systems (TRW) Drainage systems on private ground DIN 1986: 1988-06 Technical conditions for construction DIN 50014: 1985-07 Climates and their technical application – standard atmospheres DIN VDE 0100: 1973-05 Erection of power installations with nominal voltages up to 1000 V DIN EN 50110-1: 1997-10 Operation of electrical installations; German version EN 50110-1: 1996 (VDE 0105 Part 1) DIN EN 50178 VDE 060: 1998-04 Electronic equipment for use in power installations; German version EN 50178: 1997 NORMATIVE REFERENCES 46 DIN EN 13190: 2002-03 Dial thermometer DIN EN 60529 VDE 0470-1: 1991 Degrees of protection provided by enclosures (IP code) DIN 18202: 1997-04 Dimensional tolerances in building construction – Buildings DIN EN 10088-1: 1995-08 Stainless steels Part 1: List of stainless steels DIN EN 60073 VDE 0199: 1997-09 Basic and safety principles for manmachine interface, marking and identification - Coding principles for indicators and actuators EN 60204-1 VDE 0113 Teil 1: 1998-11 Safety of machinery - Electrical equipment of machines Part 1: General requirements, DIN 10510: 2001-04 Food hygiene – Commercial dishwashing with multi-tank conveyor dishwashers – Hygiene requirements, procedure testing DIN 4140: 1996-11 Insulation work on industrial installations and building equipment – Execution of thermal and cold insulation DIN EN 61010 VDE 0411 Safety requirements for electrical equipment for measurement, control and laboratory use Part 1: General requirements (German version EN 61010-1:2001), Part 2-045: Particular requirements for washer disinfectors used in medical, pharmaceutical, veterinary and laboratory fields (German version EN 61010-2-045: 2000) GUIDELINES/REGULATIONS a. European Medical Device Directive (MDD) b. German Medical Devices Operator Ordinance (MPBetreibV) h. Recommendation made by the Robert Koch Institute: Testing and declaration of the efficacy of disinfectants against viruses i. German “Guidelines for poweroperated windows, doors and gates” ZH 1/494 c. VDE regulations d. DVGW Guidelines (German Technical and Scientific Association for Gas and Water) e. Safety regulations f. Workplaces Ordinance (ArbStättv) incl. Workplace Regulations g. Guidelines on hospital hygiene and infectious disease prevention developed by the Robert Koch Institute j. When connecting decontamination systems to the power supply system, the “Technical Connection Requirements” (TCR) published by the respective power supply company (PSC) are to be observed. According to these requirements, the client normally hands over the mains connection for the decontamination system to a licensed electrician associated with the responsible PSC. k. Regulation (EC) No. 648/2004 of the European Parliament and of the Council on detergents l. German Chemical Act (Chemikaliengesetz) and German Chemical Regulation (Gefahrstoffverordnung) as well as European Directives upon dangerous substances and preparations (e.g. 67/548/EEC, 1999/45/EC, 2001/58/EC) m. German technical guideline for hazardous substances 531 (German TRGS 531): Danger to the skin when working in a moist environment (moist work) n. German technical guideline for hazardous substances 525 (German TRGS 525, May 1998): Dealing with hazardous substances in facilities for human medical care Closing remarks This booklet describes how the various aspects of the automated decontamination of different types of TI are interrelated. The goal of all measures must be to achieve reliable decontamination while at the same time taking the following points into account: 쐍 Legal requirements 쐍 Economic viability and cost effectiveness 쐍 Gentle treatment of the TI 쐍 Safety of the operating staff 쐍 Minimal ecological damage During operation, be sure to observe all the recommendations described in this booklet, in particular those relating to measures such as testing, checking operating materials, and maintenance. 47 the Working G e an on AK-BWA dC ati for Bedfram Systems of ber p· rou · Me m Submitted by: art Decontam in