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    <author>
        <name>mhp_medien</name>
    </author>
    <title>Blog/Atom feed</title>
    <id>https://shop.mhp-verlag.de/en/recommendations/?sRss=1</id>
    <updated>2026-04-21T13:03:11+02:00</updated>
    
        <entry>
            <title type="text">Recommendation of the Quality Task Group (125): Comparison of sterile barrier...</title>
            <id>https://shop.mhp-verlag.de/en/recommendations/recommendation-of-the-quality-task-group-125-comparison-of-sterile-barrier-systems</id>
            <link href="https://shop.mhp-verlag.de/en/recommendations/recommendation-of-the-quality-task-group-125-comparison-of-sterile-barrier-systems"/>
            <summary type="html">
                <![CDATA[
                
                                            The introduction of a new sterile barrier system (SBS) constitutes a significant change to the instrumentation circuit. The Quality Task Group has compiled a recommendation to support this process.
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            <content type="html">
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                 Recommendation of the Quality Task Group (125):  Comparison of sterile barrier systems 
     Authors: T. Appel, S. Bungardt, D. Diedrich, A. Forster, K. Gehrmann, A. Hartwig, A. Jones, J. Metzing, A. van Waveren; e-mail:  qualitaet@dgsv-ev.de     
 Introduction 
 The introduction of a new STERILE BARRIER SYSTEM (SBS) constitutes a significant change to the instrumentation circuit. This change may impact the process and outcome quality, logistics, storage and, ultimately, the entire cost structure of the reprocessing process.  Therefore, all important aspects and potential effects should be considered and investigated beforehand. This Recommendation is designed to support that undertaking.    
 Business administration assessment 
 In principle it is important to ensure that as few different varieties of SBS as possible are used. REDUCING THE VARIETIES has many benefits: 
 
 Routine work practices save time and reduce mistakes 
 Validation of the packaging process pursuant to DIN EN ISO 11607-2 is less labour intensive (each type of packaging requires separate validation) 
 Less intensive training needed 
 Standardization of transport and storage 
 Less administrative effort (e.g. article numbers, orders, product data sheets) 
 
 Before contemplating changing the SBS, the COST FACTORS of the existing and the new systems should be compared: 
 
 Investment costs (e.g. containers or transport baskets for soft packaging) 
 Costs for consumables (e.g. non-wovens (fleece), paper film packaging, labels, adhesive tapes, filters, absorbent non-wovens, edge and tip protectors, protective packaging, etc.) 
 Maintenance and repair costs (e.g. for containers/transport baskets) 
 Reprocessing costs (e.g. for containers/transport baskets) 
 Time investment for the actual packaging process, handling (e.g. orders, transport, etc.) and/or for the reprocessing process required 
 Disposal costs 
 
 Transportation of contaminated supplies 
 Waste 
 
 Costs for adapting the storage/transport system to the requirements of the new packaging materia 
 
 &amp;nbsp; 
 ++   For further information please download the full recommendation here  ++   
 &amp;nbsp; 
     
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            </content>

                            <updated>2022-02-17T06:45:00+01:00</updated>
                    </entry>

    
    
        <entry>
            <title type="text">Recommendation of the Quality Task Group (123): Quality assurance in the RUME...</title>
            <id>https://shop.mhp-verlag.de/en/recommendations/recommendation-of-the-quality-task-group-123-quality-assurance-in-the-rumed-through-well-targeted-process-monitoring</id>
            <link href="https://shop.mhp-verlag.de/en/recommendations/recommendation-of-the-quality-task-group-123-quality-assurance-in-the-rumed-through-well-targeted-process-monitoring"/>
            <summary type="html">
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                                            In an efficient quality management system processes must be monitored. The process monitoring measures must be planned and the outcomes documented. In that way discrepancies can be recognized at an early stage and remedial action taken.
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                 Recommendation of the Quality Task Group (123):   Quality assurance in the RUMED through well-targeted 
     Authors: T. Appel, D. Diedrich, M. Fažon, A. Hartwig, A. Jones, T. Gerasch, K. Mann, J. Metzing, A. Papadopoulos, C. Schmid, A. van Waveren, U. Zimmermann; e-mail:  qualitaet@dgsv-ev.de     
 
    ++You can also download the recommendation as pdf  here  ++     
 
 &amp;nbsp; 
 The focus of the first part of “Quality assurance in the RUMED” is on the structured and well-targeted development and maintenance of PERSONNEL QUALIFICATIONS. In the second part we would like to draw attention to the myriad OTHER FACTORS that in some cases can imperceptibly influence the process quality and jeopardise the outcome quality. In an efficient quality management system processes must be monitored. The PROCESS MONITORING measures must be planned and the outcomes documented. In that way discrepancies can be recognized at an early stage and remedial action taken (as per the PDCA cycle [1]).  The following quality assurance measures must be planned, implemented and monitored: 
 1. Maintenance plan 
 Maintenance includes servicing, inspection, repair and improvement and must be specified as such in a maintenance plan (Figure 1). 
 One way to IMPLEMENT THE MAINTENANCE PLAN is to enter into contractual agreements with external service providers (inspection contract, servicing contract, maintenance contract, etc.).  The following targets should be achieved: 
 
 Avoidance of disruptions and system breakdowns 
 Minimization of operating and maintenance costs 
 Value retention 
 Improvement of operating safety 
 Optimization of operating processes 
 Cost planning reliability. 
 
 2. Validation 
 Validation involves verification and evidence-based documentation of the process effectiveness. In addition, a process must always function as specified and in compliance with the normative requirements (reproducibility), e.g. as per DIN 58341 [3]. Any discrepancies must be quickly analysed, remedied and this must be documented. Repairs impacting the WD control system may warrant REQUALIFICATION for a particular reason. This is the case e.g. when switching to other process chemicals or in the event of deviation of process parameters requiring system repairs that result in a change to the process. 
 Meticulous preparations should be made by the RUMED and its teams for conduct of process validation. Plans should be made for the WORST CASE SCENARIO of having to decontaminate medical devices that are difficult to reprocess, while paying attention to the actual contamination load and the time lapses until the devices are reprocessed. 
 3. Routine tests 
 Each process step (e.g. cleaning and disinfection process, sealing seam process, etc.) is subject to routine tests to monitor each day, before equipment is placed in operation, whether the process is functioning as specified. Furthermore, other ROUTINE TESTS are carried out at specified intervals to verify compliance with defined quality targets. One such example is verification of the cleaning results in accordance with DIN EN ISO 15883-1 [4]; the applicable intervals are specified at the time of validation.  Routine tests are a core element of quality assurance since they help to quickly identify any discrepancy in the process quality, paving the way for timely and well-targeted improvement measures. For example, equipment with faulty process sequences can be quickly shut down and remedial action taken. This helps to avoid more extensive DAMAGE and minimize downtimes and costs.  The operator is responsible for deciding how often routine tests are carried out (daily, weekly, periodically).&amp;nbsp; For equipment-based processes, the nature of the tests and their intervals will depend on the equipment features (WD manufacturer’s instructions, e.g. flow checks, conductivity test, temperature sensors, etc.) as well as on the process itself.   These tests ensure that 
 
 The validated process continues to function fault-free and faults are detected early on 
 The operating performance of equipment (WD, sterilizer, etc.) is demonstrated to be within specified limited values, 
 The media supply (demineralized water, process chemicals, etc.) complies with the specifications. 
 
  In the case of manual process steps (e.g. packing instructions, device assembly, packaging, loading patterns, etc.), SPOT CHECKS can help to ensure that these manual steps, too, are always carried out to assure the specified quality (in accordance with the in-house standard operating procedures [SOPs]).  All routine tests are set out in a plan and are an integral part of the quality management system. Documentation of the conduct and results of these tests serves as proof of compliance with all legal requirements, demonstrating that the processes continue to function as specified. 
     
 4. Complaints management 
 Complaints are not only an indicator of customer satisfaction but are also a key indicator of process quality. DAILY EVALUATION is recommended for timely identification and elimination of any discrepancies. This helps to avoid similar problems or escalation of customer dissatisfaction. Admittedly, the cause of an error does not always lie with the RUMED. The RUMED has many interfaces which should also be considered in error analysis. 
 Therefore, when carrying out fault analysis the cause, nature, incidence and responsible parties should always be identified and documented on the basis of the agreements in place with the various interfaces. Constructive collaboration between the RUMED and its clients helps to take well-targeted and timely MEASURES to avoid repeating such errors.  The effectiveness of the measures taken must be checked and the process adapted accordingly if necessary. The input of staff should be sought and members given regular training in all partial processes. Staff must always be BRIEFED again following any process adjustment.   Grading of complaints in terms of severity (e.g. minor, moderate, major, near incident, patient damage) gives insights into the nature of the errors. Personnel should be given regular FEEDBACK on individual mistakes as a learning exercise. A digital complaints’ management system contributes to transparent communication between the RUMED and user. 
 &amp;nbsp;5. Feedback management 
 It is recommended to get feedback from the team and evaluate this to gain a better understanding of one’s own processes and potential problems: 
 
 Team meetings 
 Staff meetings 
 Shift management meetings 
 Suggestion boxes 
 Ideas management. 
 
 &amp;nbsp; 
   References  
 
 PDCA cycle: Plan – Do – Check – Act 
 Guideline compiled by the German Society of Hospital Hygiene (DGKH), German Society of Sterile Supply (DGSV) and Working Group Instrument Preparation (AKI) for validation and routine monitoring of automated cleaning and thermal disinfection processes for medical devices, status 2017, page 63, Information 9 
 DIN 58341:2020-07 Requirements for validation of cleaning and disinfection processes 
 DIN EN ISO 15883-1:2014-10 Washer-disinfectors – Part 1: General requirements, definitions and test methods 
 
 &amp;nbsp; 
 
   Download this recommendation here.    
 
 &amp;nbsp; 
     
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            </content>

                            <updated>2021-09-22T07:00:00+02:00</updated>
                    </entry>

    
    
        <entry>
            <title type="text">Requirements for Construction or Reconstruction of a Reprocessing Unit for Me...</title>
            <id>https://shop.mhp-verlag.de/en/recommendations/requirements-for-construction-or-reconstruction-of-a-reprocessing-unit-for-medical-devices-rumed-part-10-compressed-air-for-reprocessing-medical-devices</id>
            <link href="https://shop.mhp-verlag.de/en/recommendations/requirements-for-construction-or-reconstruction-of-a-reprocessing-unit-for-medical-devices-rumed-part-10-compressed-air-for-reprocessing-medical-devices"/>
            <summary type="html">
                <![CDATA[
                
                                            Part 10 of the publication Requirements for Construction or Reconstruction of a Reprocessing Unit for Medical Devices (RUMED) focuses on compressed air for medical use, generally known simply as medical compressed air. 
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            <content type="html">
                <![CDATA[
                   Part 10: Compressed air for reprocessing medical devices   
    Authors: A. Jones (Coordinator), U. Beilenhoff, A. Carter, U. Haffke, M.-TH. Linner, S. Lutzenberger, M. Scherrer, M. Schick-Leisten, R. Stens, A. Wentzler, K. Wiese, Email: hbt@dgsv-ev.de    
       Introduction  
 Part 10 of  the  publication Requirements for Construction or Reconstruction of a Reprocessing Unit for Medical Devices (RUMED) focuses on compressed air for medical use, generally known simply as medical compressed air. 
 It describes issues related to the use of medical compressed air in a RUMED, including for endoscope reprocessing, drying medical devices after disinfection and testing medical devices. 
 The focus here is on medical compressed air produced in healthcare establishments, also known as on-site production. 
 The regulations listed here (e.g. standards, recommendations, guidelines and other legal, normative technical regulations), must always be applied in their currently valid version. 
   Download this recommendation here.    
 &amp;nbsp; 
     
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            </content>

                            <updated>2019-12-17T07:00:00+01:00</updated>
                    </entry>

    
    
        <entry>
            <title type="text">Requirements for Construction or Reconstruction of a Reprocessing Unit for Me...</title>
            <id>https://shop.mhp-verlag.de/en/recommendations/requirements-for-construction-or-reconstruction-of-a-reprocessing-unit-for-medical-devices-rumed-part-11-heating-ventilation-and-air-conditioning-hvac-system-in-a-rumed</id>
            <link href="https://shop.mhp-verlag.de/en/recommendations/requirements-for-construction-or-reconstruction-of-a-reprocessing-unit-for-medical-devices-rumed-part-11-heating-ventilation-and-air-conditioning-hvac-system-in-a-rumed"/>
            <summary type="html">
                <![CDATA[
                
                                            Part 11 of the publication series “Requirements for Construction or Reconstruction of a Reprocessing Unit for Medical Devices (RUMED)” focuses on the heating, ventilation and air conditioning (HVAC) system in a RUMED.
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            </summary>
            <content type="html">
                <![CDATA[
                   Part 11: Heating, ventilation and air conditioning (HVAC) system in a RUMED   
  Authors: A. Jones (Coordinator), A. Carter, U. Haffke, G. Lehnert, M.-TH. Linner, S. Lutzenberger, M. Schick-Leisten, H. Schunk, R. Stens, A. Wentzler, K. Wiese; Email: hbt@dgsv-ev.de  
 Part 11 of the publication series “Requirements for Construction or Reconstruction of a Reprocessing Unit for Medical Devices (RUMED)” focuses on the heating, ventilation and air conditioning (HVAC) system in a RUMED. 
   Download this recommendation here.   
     
                ]]>
            </content>

                            <updated>2019-12-17T07:00:00+01:00</updated>
                    </entry>

    
    
        <entry>
            <title type="text">Information to be provided by the medical device manufacturer for the process...</title>
            <id>https://shop.mhp-verlag.de/en/recommendations/information-to-be-provided-by-the-medical-device-manufacturer-for-the-processing-of-medical-devices-checklist-updated</id>
            <link href="https://shop.mhp-verlag.de/en/recommendations/information-to-be-provided-by-the-medical-device-manufacturer-for-the-processing-of-medical-devices-checklist-updated"/>
            <summary type="html">
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                                            The second part of the recommendation “Information to be provided by the medical device manufacturer” pointed out that the accuracy of the manufacturer’s instructions should be verified already at the time of procurement of medical devices.
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                 The second part of the recommendation “Information to be provided by the medical device manufacturer” pointed out that the accuracy of the manufacturer’s instructions should be verified already at the time of procurement of medical devices. It has been pointed out that, ideally, all relevant parties should play a role in the procurement process. Only in that way the needs of users can be taken into account just like those of the purchasing department and compatibility of the medical devices with the available processing methods can be confirmed. A checklist was provided with Recommendation 108 to support the assessment of all influencing factors in the processing of the newly procured medical device. In the meantime, there have been some comments and suggestions for improvement of this checklist from the readers, which have prompted us to publish an update of the checklist. Please use this revised version of the checklist in the future. It is coordinated with representatives of the AKI, among others, and will certainly provide useful support to the procurement process. You can also download the checklist from the DGSV e.V. website. 
 [...] 
   Download this recommendation here.    
                ]]>
            </content>

                            <updated>2019-09-09T08:10:00+02:00</updated>
                    </entry>

    
    
        <entry>
            <title type="text">Corrosion: an underestimated risk</title>
            <id>https://shop.mhp-verlag.de/en/recommendations/corrosion-an-underestimated-risk</id>
            <link href="https://shop.mhp-verlag.de/en/recommendations/corrosion-an-underestimated-risk"/>
            <summary type="html">
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                                            The healthcare system is always in the spotlight and any suspected hygiene scandal is picked up by the media. “Rusty instruments” makes for a catchy headline but the issues involved are complex.
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                  Introduction  The healthcare system is always in the spotlight and any suspected hygiene scandal is picked up by the media. “Rusty instruments” makes for a catchy headline but the issues involved are complex. As in many other areas of medicine, medical device (MD) development is experiencing rapid progress. Instrument reprocessing, in particular, requires a high degree of flexibility, expertise and willingness to engage in continuing education and training. Only if these are assured can staff and department heads keep abreast of the constantly fast-paced advancements and resultant regulations. With regard to patient safety, topics such as  MD SURFACE CHANGES AND THEIR REPERCUSSIONS (QM)  are among those for which the Reprocessing Unit for Medical Devices (RUMED) is responsible. While there has been widespread knowledge of such issues for several years now and, besides, they are a key aspect of the curriculum of the German Society of Sterile Supply (DGSV), a high number of corroded MDs can still be found is some RUMEDs. The term “corrosion” is derived from the Latin word corrodere: to gnaw away, erode, break down. These surface changes present a risk to patients, users and third parties. In the medical setting steel, aluminium and synthetic materials are of special interest; this present Recommendation now focuses on medical devices (MDs) made of steel. 
  What are the risks posed by corrosion?  1. Hygiene repercussions In principle, medical device reprocessing is associated with risks that can be controlled. Pursuant to DIN EN ISO 17664 instrument manufacturers are required to ascertain by means of validation which reprocessing methods are able to demonstrate that their MDs can be cleaned, disinfected and/or sterilized in compliance with the requirements/threshold values set out in the standards regulating the respective processes. The use of validated processes by a RUMED will assure a SUCCESSFUL REPROCESSING OUTCOME. However, reproducibility of the results can only be assured if all surfaces are intact. Examination of corrosion under a microscope reveals just how difficult it is to assure controlled reprocessing of such an uneven surface, dotted with craters. Furthermore, in the case of pitting corrosion, hidden below the visible pit is an entire cavity where residual soils and microorganisms can persist. 
 [...] 
   Download this recommendation here.   
                ]]>
            </content>

                            <updated>2019-09-09T08:00:00+02:00</updated>
                    </entry>

    
    
        <entry>
            <title type="text">Information to be provided by the medical device manufacturer for the process...</title>
            <id>https://shop.mhp-verlag.de/en/recommendations/information-to-be-provided-by-the-medical-device-manufacturer-for-the-processing-of-medical-devices-part-2</id>
            <link href="https://shop.mhp-verlag.de/en/recommendations/information-to-be-provided-by-the-medical-device-manufacturer-for-the-processing-of-medical-devices-part-2"/>
            <summary type="html">
                <![CDATA[
                
                                            The information provided by the manufacturer serves as THE BASIS FOR PROCESSING each and every medical device (MD) and makes stringent demands on the organizational skills of a Reprocessing Unit for Medical Devices (RUMED) [1] with regard to the practicability and implementati...
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            </summary>
            <content type="html">
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                  Introduction  The information provided by the manufacturer serves as THE BASIS FOR PROCESSING each and every medical device (MD) and makes stringent demands on the organizational skills of a Reprocessing Unit for Medical Devices (RUMED) [1] with regard to the practicability and implementation of such processing measures. The revision of EN ISO 17664:2017 is an opportune moment to examine the changes made to the standard as well as their implications for everyday practice. This present publication also updates Recommendation 46 of the Quality Task Group. Compared with EN ISO 17664:2004-07 [2] changes were made which are listed on page 2 of the standard (see Item “Amendments”): 
 
 The title of the standard has been expanded to include the entire medical device processing process and all medical devices (previously limited to the sterilization process and resterilizable medical devices) 
 The scope of the standard as reflected by the change of title includes the entire processing process (cleaning, disinfection and/or sterilization) and is no longer limited to reusable medical devices subject to terminal sterilization; the standard applies to invasive or other medical devices coming into direct or indirect contact with patients. 
 
 Compared with previously, the medical device manufacturer must provide information PURSUANT TO EN ISO 17664 for considerably more medical devices. These include, in addition to the “resterilizable medical devices“ listed hitherto, all MDs [3] coming into direct or indirect contact with the patient, e.g. stethoscopes, flexible endoscopes, lamp holders, breathing equipment, tourniquets. Further instructions can also be found on this on page 2 and 3 (EN ISO 17664): 
 
 Definitions adapted to existing standards and following terms newly introduced: “medical device”, “reusable medical device”, “single-use medical device”, “processing”, “service life”, “packaging system”, “protective packaging”, “sterile barrier system” “, “sterility assurance level“, “terminal process” and “verification” 
 The requirements for validation of processes specified in the information to be provided by the medical device manufacturer (see Section 4) and requirements for risk analysis (Section 5) have resulted in a fundamental revision of the previous Sections 5 (Validation) and 6 (Risk analysis); the formation of medical device groups is now regulated by a standard 
 
 [...] 
    Download this recommendation here.   
                ]]>
            </content>

                            <updated>2019-09-03T09:40:00+02:00</updated>
                    </entry>

    
    
        <entry>
            <title type="text">Information to be provided by the medical device manufacturer for the process...</title>
            <id>https://shop.mhp-verlag.de/en/recommendations/information-to-be-provided-by-the-medical-device-manufacturer-for-the-processing-of-medical-devices</id>
            <link href="https://shop.mhp-verlag.de/en/recommendations/information-to-be-provided-by-the-medical-device-manufacturer-for-the-processing-of-medical-devices"/>
            <summary type="html">
                <![CDATA[
                
                                            The information provided by the manufacturer serves as THE BASIS FOR PROCESSING each and every medical device (MD) and makes stringent demands on the organizational skills of a Reprocessing Unit for Medical Devices (RUMED) [1] with regard to the practicability and implementati...
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            </summary>
            <content type="html">
                <![CDATA[
                  Introduction  The information provided by the manufacturer serves as THE BASIS FOR PROCESSING each and every medical device (MD) and makes stringent demands on the organizational skills of a Reprocessing Unit for Medical Devices (RUMED) [1] with regard to the practicability and implementation of such processing measures. The revision of EN ISO 17664:2017 is an opportune moment to examine the changes made to the standard as well as their implications for everyday practice. This present publication also updates Recommendation 46 of the Quality Task Group. Compared with EN ISO 17664:2004-07 [2] changes were made which are listed on page 2 of the standard (see Item “Amendments”): 
 
 The title of the standard has been expanded to include the entire medical device processing process and all medical devices (previously limited to the sterilization process and resterilizable medical devices) 
 The scope of the standard as reflected by the change of title includes the entire processing process (cleaning, disinfection and/or sterilization) and is no longer limited to reusable medical devices subject to terminal sterilization; the standard applies to invasive or other medical devices coming into direct or indirect contact with patients. 
 
 Compared with previously, the medical device manufacturer must provide information PURSUANT TO EN ISO 17664 for considerably more medical devices. These include, in addition to the “resterilizable medical devices“ listed hitherto, all MDs [3] coming into direct or indirect contact with the patient, e.g. stethoscopes, flexible endoscopes, lamp holders, breathing equipment, tourniquets. Further instructions can also be found on this on page 2 and 3 (EN ISO 17664): 
 
 Definitions adapted to existing standards and following terms newly introduced: “medical device”, “reusable medical device”, “single-use medical device”, “processing”, “service life”, “packaging system”, “protective packaging”, “sterile barrier system” “, “sterility assurance level“, “terminal process” and “verification” 
 The requirements for validation of processes specified in the information to be provided by the medical device manufacturer (see Section 4) and requirements for risk analysis (Section 5) have resulted in a fundamental revision of the previous Sections 5 (Validation) and 6 (Risk analysis); the formation of medical device groups is now regulated by a standard 
 
 [...] 
    Download this recommendation here.   
                ]]>
            </content>

                            <updated>2019-09-03T09:30:00+02:00</updated>
                    </entry>

    
    
        <entry>
            <title type="text">No reprocessing of kidney bowls or wash bowls in bedpan washer-disinfectors</title>
            <id>https://shop.mhp-verlag.de/en/recommendations/no-reprocessing-of-kidney-bowls-or-wash-bowls-in-bedpan-washer-disinfectors</id>
            <link href="https://shop.mhp-verlag.de/en/recommendations/no-reprocessing-of-kidney-bowls-or-wash-bowls-in-bedpan-washer-disinfectors"/>
            <summary type="html">
                <![CDATA[
                
                                            The washer-disinfectors regulated by standard EN ISO 15883-3 [1] are also known colloquially as BEDPAN WASHER-DISINFECTORS. The terms automatic bedpan washers or faecal washers are also occasionally used. 
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            <content type="html">
                <![CDATA[
                  Introduction  The washer-disinfectors regulated by standard EN ISO 15883-3 [1] are also known colloquially as BEDPAN WASHER-DISINFECTORS. The terms automatic bedpan washers or faecal washers are also occasionally used. These washer-disinfectors (WDs) are primarily designed and intended for disposal of faeces together with reprocessing of the associated containers such as urine bottles, bedpans and toilet commode buckets. However, it can be noted time and again in everyday practice that other items are also reprocessed in these washer-disinfectors. Contrary to the manual reprocessing method formerly used for wash bowls, the standard practice now in many healthcare institutions and homes for the elderly is to reprocess in such washer-disinfectors also kidney bowls, including those used for oral hygiene, as well as the wash bowls used for basic personal hygiene or partial medicinal baths. The technical features of these washer-disinfectors are virtually unable to demonstrate the required proof of validated processes, and certainly do not assure the safety expected of modern WDs in a Reprocessing Unit for Medical Devices (RUMED). THE A0 VALUE REQUIRED FOR SAFE DISINFECTION exceeds the capacity and technical facilities of the majority of the (older) washer-disinfectors currently in operation. In an age of multi-drug resistant organisms there is a particularly high risk of their transmission when disposing of faeces. 
  Historical background   The development of these washer machines dates back to the 1930s [2]. Connected to the cold-water pipeline (drinking water), the most they could do was to rinse off the utensils, while their main purpose was to improve the removal of faeces. Hence, manual pre-and, possibly, post-cleaning could not be avoided. It was not until the 1960s that washer machines also facilitating chemical disinfection after cleaning were developed. These were operated by staff by activating the cleaning pushbutton but by no means was such a washer-disinfector equipped with the programme sequences as we know them today. 
 [...] 
   Download this recommendation here.   
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            </content>

                            <updated>2019-09-03T09:20:00+02:00</updated>
                    </entry>

    
    
        <entry>
            <title type="text">Risk assessment and release of new medical devices before investment and new ...</title>
            <id>https://shop.mhp-verlag.de/en/recommendations/risk-assessment-and-release-of-new-medical-devices-before-investment-and-new-procurement</id>
            <link href="https://shop.mhp-verlag.de/en/recommendations/risk-assessment-and-release-of-new-medical-devices-before-investment-and-new-procurement"/>
            <summary type="html">
                <![CDATA[
                
                                            Reprocessing Units for Medical Devices (RUMEDs) face continual challenges related to the risk assessment and subsequent purchase and release of new medical devices (MDs).
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            <content type="html">
                <![CDATA[
                  Introduction  
 Reprocessing Units for Medical Devices (RUMEDs) face continual challenges related to the risk assessment and subsequent purchase and release of new medical devices (MDs). As part of the decision-making process, in addition to the manufacturer’s instructions, the reprocessing demands arising from assignment of the respective medical device(s) to a risk category as per the KRINKO/BfArM Recommendation* must also be taken into account. Compliance between these two sets of demands is not always assured and it is not unusual for the manufacturer’s instructions to stipulate processes not available or feasible in the respective RUMED. This means that the medical device(s) cannot be reprocessed using the available reprocessing process. If problems arise in relation to reprocessing of the MDs, it should be established prior to purchase whether alternative MDs can be procured from another manufacturer. The MD PROCUREMENT DECISION-MAKING PROCESS should be set out in the quality management (QM) system. Business management aspects will not be discussed in this present Recommendation. 
 Structured approach 1. Risk assessment and classification of MDs in accordance with the provisions of the KRINKO/BfArM Recommendation Factors such as medical device compatibility with the available reprocessing process, or the effectiveness of the latter, cannot necessarily be guaranteed. Accordingly, in addition to the functional requirements the MD manufacturer’s reprocessing instructions must also be evaluated (in accordance with DIN EN ISO 17664). Pursuant to the provisions of the KRINKO/BfArM Recommendation (Item 1.2.1.), RISK ASSESSMENT AND CLASSIFICATION of the MDs as “Non-critical”, “Semi-critical“ or “Critical” is effected in line with the nature of their previous and subsequent use. The aim here is to ascertain the burden and nature of the pathogens anticipated in the area used as well as their resistance to the intended process. 
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            </content>

                            <updated>2019-09-03T09:10:00+02:00</updated>
                    </entry>

    
    
        <entry>
            <title type="text">Requirements for construction or reconstruction of a Reprocessing Unit for Me...</title>
            <id>https://shop.mhp-verlag.de/en/recommendations/requirements-for-construction-or-reconstruction-of-a-reprocessing-unit-for-medical-devices-rumed</id>
            <link href="https://shop.mhp-verlag.de/en/recommendations/requirements-for-construction-or-reconstruction-of-a-reprocessing-unit-for-medical-devices-rumed"/>
            <summary type="html">
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                                            Part 7 of the publication on “Requirements for construction or reconstruction of a reprocessing unit for flexible endoscopes” describes a model approach to determination of the rooms needed, their allocation and the resultant routing systems.
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                  Introduction  Part 7 of the publication on “Requirements for construction or reconstruction of a reprocessing unit for flexible endoscopes” describes a model approach to determination of the rooms needed, their allocation and the resultant routing systems. The spatial requirements in medical healthcare institutions shall be described. No reference is made to the requirements for fire protection, building physics, statics or installation of the various utilities (e.g. gas/water installation, electricity installations, etc.). The recommendations for equipping and furnishing rooms shall be addressed in Part 8. The process employed to reprocess flexible endoscopes is the same regardless of the reprocessing site. The various constructional designs possible are illustrated in drawings A, B and C. - “Drawing A Endoscope reprocessing as a multi-room solution within an endoscopy department” - “Drawing B Endoscope reprocessing in a RUMED” - “Drawing C Endoscope reprocessing as a one-room solution“ If after evaluation of all spatial/structural conditions, a multi-room solution is not deemed feasible, the minimum requirements for equipping and furnishing a reprocessing room as a “one-room solution” in healthcare institutions are presented as another option. “One-room solutions” pose a continuous recontamination risk. If opting for a oneroom solution, strict structural/technical measures must be taken and provision made for organizational/temporal separation of the various working steps. It is explicitly pointed out here that these presentations are intended as examples and that, accordingly, planning must be tailored to the respective structural situations. 
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            </content>

                            <updated>2019-09-03T09:00:00+02:00</updated>
                    </entry>

    
    
        <entry>
            <title type="text">Washer-disinfector performance requalification</title>
            <id>https://shop.mhp-verlag.de/en/recommendations/washer-disinfector-performance-requalification</id>
            <link href="https://shop.mhp-verlag.de/en/recommendations/washer-disinfector-performance-requalification"/>
            <summary type="html">
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                                            The Quality Task Group has deemed it necessary to revise these recommendations to bring them into line with the amended version of the “Guideline compiled by DGKH, DGSV and AKI for the validation and routine monitoring of automated cleaning and thermal disinfection processes f...
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                 This ➜ RECOMMENDATION replaces the two now obsolete Recommendations 54 “Performance Requalification for No Particular Reason” and 55 “Performance Requalification on Changing the Process Chemicals”. The Quality Task Group has deemed it necessary to revise these recommendations to bring them into line with the amended version of the “Guideline compiled by DGKH, DGSV and AKI for the validation and routine monitoring of automated cleaning and thermal disinfection processes for medical devices”, 5th Edition 2017 (termed the Validation Guideline below). In the introduction to Recommendation 54 it was suggested that the requalification interval should be based on the number of hours a washer-disinfector (WD) was in operation. That viewpoint has not prevailed since, just like any other periodic inspections (e.g. road traffic or passenger elevators), ➜ DIFFERENT INTENSITIES OF USE do not automatically lead to amendment of the test interval. Section 5.4 “Performance Requalification (Repeat Performance Qualification)” of the Validation Guideline makes reference to the normative requirements. Section 6.1.5 of standard DIN EN ISO 15883 describes “normal practice” as conduct of repeat performance qualification on a yearly basis. If the recommended test interval is not observed, written risk assessment must be carried out following identification and evaluation of the existing risk. The stipulation in the now obsolete recommendations that maintenance be carried out within 4 to 6 weeks before performance qualification (PQ) has been rescinded. Annex 9 of the Validation Guideline makes clear reference to that in the section on the “Relationship between Maintenance and Repeated PQ”, with the statement “The abovementioned points and references justify the abolition of the 4-week deadline”. That is explained by the advent of modern maintenance concepts that take account of the most diverse aspects of testing and do not necessarily conform to a rigid calendar. 
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            </content>

                            <updated>2019-09-03T08:30:00+02:00</updated>
                    </entry>

    
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