Evaluation of reprocessing medical devices in 14 German regional hospitals and at 27 medical practitioners‘ offices within the European context

dgkh000220 10.3205/dgkh000220 urn:nbn:de:0183-dgkh0002206 Research Article Evaluation of reprocessing medical devices in 14 German regional hospitals and at 27 medical practitioners‘ offices within the European context – consequences for European harmonization Analyse der Aufbereitung von Medizinprodukten in 14 deutschen Krankenhäusern der Regelversorgung und 27 Arztpraxen unter Berücksichtigung der europäischen Situation – Schlussfolgerungen für eine europäische Harmonisierung Thiede Thiede Birgit B

Regional Council, Rheinstr. 62, 64278 Darmstadt, Germany, Phone: +49 (6151) 12 4105, Fax: +49 (6151) 12 4100Regional Council, Darmstadt, Germany

Birgit.Thiede@rpda.hessen.de author Kramer Kramer Axel A

Institute of Hygiene and Environmental Medicine, University Medicine Greifswald, Germany

author German Medical Science GMS Publishing House

Düsseldorf

610 reprocessing medical devices patient safety legal basis in Europe analysis in medical practitioners' offices analysis in hospitals harmonization Aufbereitung Medizinprodukte Patientensicherheit Gesetzesgrundlage in Europa Analyse in Arztpraxen Analyse in Krankenhäusern Harmonisierung 20131106 engl 2196-5226 8 2 GMS Hygiene and Infection Control GMS Hyg Infect Control 20 Die qualitätsgesicherte Aufbereitung von Medizinprodukten dient der Vorbeugung Health-care-assoziierter Infektionen (HAI) und ist von grundlegender Bedeutung für die Gewährleistung der Patientensicherheit. Nicht nur in Deutschland belegen Studien, dass trotz Durchführung des Aufbereitungsprozesses Restkontaminationen und schwere Infektionen bei Patienten festzustellen waren. Um geeignete Lösungsansätze zu entwickeln, wurde die bestehende Situation in Deutschland und in ausgewählten Staaten Europas analysiert. Als Bestandteil dieser Analyse wurden in 27 Arztpraxen und 14 Krankenhäusern der Regelversorgung mittels Fragebogen, Checkliste und einer Vor-Ort-Besichtigung die realen Bedingungen der Aufbereitung ermittelt. In der Auswertung der Ergebnisse und der strukturierten Recherche der europäischen Situation werden mögliche Alternativen zur Aufbereitung in der eigenen Gesundheitseinrichtung aufgezeigt.Die Analyse in den überprüften Gesundheitseinrichtungen im Süden Hessens (Deutschland) hat ergeben, dass die Voraussetzungen für die Durchführung des Aufbereitungsprozesses nicht den gesetzlichen Bestimmungen entsprechen. Die vorgefundenen Defizite decken sich weitgehend mit anderen Berichten aus Deutschland und Europa. Die Analyse der erhobenen Daten lässt auf verschiedene Ursachen für die Mängel schließen. Die drei Hauptursachen sind die hohen Kosten bei ordnungsgemäßer Durchführung der Aufbereitung, der Stellenwert der Aufbereitungs-Abteilung innerhalb der Gesundheitseinrichtung und Defizite bei der behördlichen Überwachung. Während für die Durchführung des Aufbereitungsprozesses europaweit ähnliche rechtliche Bestimmungen bestehen, sind die Rahmenbedingungen, die Strukturen der Gesundheitssysteme und die behördliche Überwachung unterschiedlich. Sowohl verschiedene Bundesländer in Deutschland als auch die ausgewählten europäischen Staaten diskutieren verstärkt die Problematik der qualitätsgesicherten Durchführung des Aufbereitungsprozesses. Beispielsweise sollte für die Überprüfung von Aufbereitungseinheiten in Krankenhäusern und in Arztpraxen derselbe Überwachungsstandard vorliegen. Drei Alternativen zur Aufbereitung in der eigenen Praxis werden näher betrachtet, der Einsatz von Einmal-Medizinprodukten, das Outsourcen des Aufbereitungsprozesses und die Kooperation von Gesundheitseinrichtungen. Abschließend werden für den Einsatz sicherer Medizinprodukte für chirurgische Eingriffe unter Berücksichtigung ökonomischer und ökologischer Aspekten Möglichkeiten empfohlen, die einen hohen Standard der Patientensicherheit garantieren. Safe reprocessing of medical devices through cleaning, disinfection, and sterilization is essential for the prevention of health care associated infections (HAI) and to guarantee patient safety. Several studies detected residual contamination and even severe infections of patients, despite carrying out reprocessing. To develop appropriate solutions, the existing situation in Germany and selected European countries was analyzed. Additionally, in 27 medical practitioners’ offices and 14 hospitals, the true practice of reprocessing was analyzed using a questionnaire, a checklist, and inspection on site. A structured analysis of potential alternatives to the internal reprocessing was conducted within the German and European context. The results indicate that the conditions for the execution of the reprocessing process in the analyzed health facilities in southern Hesse (Germany) do not satisfy legal requirements. The detected deficiencies were consistent with other reports from Germany and Europe. The analysis gave insight into several reasons for the detected deficiencies. The three main reasons were the high costs for proper implementation, the subjective value assigned to the reprocessing unit in health care facilities, and deficits in monitoring by the health authority. Throughout the European Union, a similar regulatory framework for the performance of the reprocessing process exists, while the environment, structures of the health systems and administrative supervision vary significantly. The German states as well as selected European countries are currently discussing the challenges of increased quality-assured execution of the reprocessing process. For instance, the same supervisory system for hospitals and medical practitioners should be established at an equal standard. Alternatives such as the use of single-use medical devices, outsourcing the decontamination processes, or the cooperation of health facilities may be considered. This paper also discusses economic and ecological aspects. Finally, different options are recommended to ensure the exclusive use of reliable medical devices for surgical procedures that guarantee an adequate standard of patient safety within economic constraints. 1 IntroductionThe reprocessing of medical devices for surgical procedures is a key element of quality assurance in health care facilities. Deficiencies in the implementation of this process involve the risk of health consequences for the patient. A double-blind study conducted in a hospital in England demonstrated that 56% of 23 monitored surgical instruments remained contaminated after reprocessing . The decontamination of flexible endoscopes is always in focus, as the prevention of residual contamination is problematic and requires a validated method , , , , . Moreover, a poorly designed endoscope can impede the decontamination process and may cause infections of patients . Deficiencies were found in the implementation of the process, the spatial and technical requirements, as well as in personnel management and quality assurance , , , .Through the establishment of the European Directive 93/42/EEC, requirements for the reprocessing of medical devices are upheld by the law. To ensure the quality of a sterile medical device, the standardized implementation of the entire reprocessing process using validated methods</PlainText></TextGroup> remains crucial. An important aspect to avoid errors in the reprocessing process is compliance with the cleaning, disinfection, and sterilization guidelines as well as the manufacturer's instructions.</Pgraph><Pgraph>In the present study, the reprocessing process in hospitals with a Central Sterile Supply Department (CSSD) and at medical practitioners’ offices was analyzed. The results are compared with the situation in selected European countries.</Pgraph></TextBlock> <TextBlock linked="yes" name="2 Methods"> <MainHeadline>2 Methods</MainHeadline><Pgraph>The monitoring of hospitals and medical practitioners’ offices was based on the nationally uniform checklist “Hygiene treatment” in Germany <TextLink reference="12"></TextLink>. For the study, 2<TextGroup><PlainText>7 m</PlainText></TextGroup>edical practitioners of different specializations (gynecology, dermatology, surgery, orthopedics) and <TextGroup><PlainText>14 r</PlainText></TextGroup>egional hospitals were reviewed. For statistical analysis, all relevant deficiencies were merged into 4 groups, each with six individual features for the medical practitioners and the hospitals (Table 1 <ImgLink imgNo="1" imgType="table"/>).</Pgraph></TextBlock> <TextBlock linked="yes" name="3 Results"> <MainHeadline>3 Results</MainHeadline><Pgraph>Two of the 27 analyzed medical practitioners’ offices were not considered for the analysis because they only used single-use instruments. The most observable deficiencies at the 25 medical practitioners’ offices were the following:</Pgraph><Pgraph><UnorderedList><ListItem level="1">96% lacked experienced staff </ListItem><ListItem level="1">92% had no system to release the instruments </ListItem><ListItem level="1">60% no separate protective clothing was worn in the unclean sector </ListItem><ListItem level="1">64% deficiencies were found in the packaging of the instruments </ListItem><ListItem level="1">40% no suitable separation of clean and unclean areas was available </ListItem><ListItem level="1">100% of the practitioners’ offices had no validated reprocessing process implemented. </ListItem></UnorderedList></Pgraph><Pgraph>In the 14 hospitals, the following deficiencies were found: </Pgraph><Pgraph><UnorderedList><ListItem level="1">57% basic qualification of staff was not completed </ListItem><ListItem level="1">79% visual inspection was not performed correctly </ListItem><ListItem level="1">50% sterilizers were obsolete or not suitable for performing a validated process</ListItem><ListItem level="1">57% of the washer-disinfectors (WD) were obsolete or not suitable for performing a validated process</ListItem><ListItem level="1">64% of the rooms were in need of renovation </ListItem><ListItem level="1">100% demonstrated a lack of a validated reprocessing process in all sub-steps.</ListItem></UnorderedList></Pgraph><Pgraph>The date of establishment of a medical practice (<TextGroup><PlainText>Figure 1 </PlainText></TextGroup><ImgLink imgNo="1" imgType="figure"/>) or the renovation of a CSSD (Figure 2 <ImgLink imgNo="2" imgType="figure"/>) has a significant impact on the quality of the treatment process. In particular, the spatial situation met the requirements better in newer or renovated facilities.</Pgraph></TextBlock> <TextBlock linked="yes" name="4 Discussion"> <MainHeadline>4 Discussion</MainHeadline><SubHeadline>4.1 Assessment of the reprocessing situation analyzed</SubHeadline><Pgraph>Generally, a risk of contamination remains possible if the reprocessing process is not correctly performed. </Pgraph><Pgraph><Mark1>Personnel requirements:</Mark1> Appropriate education and training is essential for performing the professional reprocessing process. </Pgraph><Pgraph>The official requirements for the staff responsible for reprocessing, described in the German Medical Devices Operator Ordinance (MPBetreibV), the Joint Recommendation of the Commission for Hospital Hygiene and Infection Prevention at the Robert Koch Institute (KRINKO), and the German Federal Institute for Drugs and Medical Devices (BfArM) from 2001 use the term “necessary expertise” <TextLink reference="13"></TextLink>, which is quite unspecific. With revision of the KRINKO-BfArM recommendation <TextLink reference="14"></TextLink>, an additional appendix describes the necessary content for educational curriculum items, and it should preferably be included in addition to vocational training, which as yet is not available for work positions in the CSSD. For the medical practices, the Federal State of Hesse has established an optional course on decontamination education for the training of medical assistants. </Pgraph><Pgraph>A report in the Netherlands explained that although trained staff for the decontamination process is required by law, the personnel qualification in hospitals is very different, because there are no concrete, definitive training standards <TextLink reference="15"></TextLink>.</Pgraph><Pgraph>Inadequate hygiene conditions for the staff can lead to the transmission of pathogens between the immediate area of the health facility and the processing unit. Color coding the clothes for the different areas is already required in operating rooms <TextLink reference="16"></TextLink> and has proven successful in some reprocessing units in southern Hesse. This would ensure that standard area and protective clothing is always worn only at the intended location.</Pgraph><Pgraph>In medical practices, standard area clothing is often worn without additional protective clothing for cleaning potentially contaminated surgical instruments. Generally, staff cleans their clothing themselves at home. Unprofessionally laundered clothing, for example in conventional domestic washing machines, can lead to microbial accumulation in the washing machine or insufficient inactivation of certain pathogens on the laundered clothes <TextLink reference="17"></TextLink>. Pathogen transmission to immuno-compromised patients or to family members of employees has not been established, but cannot, however, be excluded <TextLink reference="18"></TextLink>.</Pgraph><Pgraph><Mark1>Space requirements:</Mark1> The rooms of the CSSD in hospitals are often cramped, where high-quality and standardized work is hardly possible. Without the separation of the aseptic and unclean rooms, it must be assumed that the risk of cross-contamination is given.</Pgraph><Pgraph>In Germany, medical practitioners’ offices generally occupy rented space. One problem is the building’s common washbasin overflow. This direct access to the contaminated siphon poses a high risk to technical hygiene <TextLink reference="19"></TextLink>. Architectural design in hospitals and medical centers usually corresponds to relevant RKI guidelines.</Pgraph><Pgraph><Mark1>Quality assurance:</Mark1> The proper execution of a qualified quality management system is a vital aspect of standardizing decontamination procedures. The appropriate documentation also provides the operator with the necessary legal certainty. Process validation is indubitably required, also in terms of physicians and dentists <TextLink reference="14"></TextLink>.</Pgraph><Pgraph>The presence of a quality management system according to the German social code <TextLink reference="20"></TextLink> leads to fewer deficiencies in medical practice, based on the deficiency-group analysis of space requirements and quality assurance (<TextGroup><PlainText>Figure 3 </PlainText></TextGroup><ImgLink imgNo="3" imgType="figure"/>). In contrast, the effects of a quality management were only slight on decontamination process and personnel requirements. Apparently, the introduction of a quality management system for medical practices does not include the specific requirements for decontamination.</Pgraph><Pgraph>In addition, a considerable need for advice is required in hospitals to carry out the validation of all reprocessing steps. A widespread belief is that the validation of the sterilization process in accordance with EN ISO 17665 <TextLink reference="21"></TextLink>, <TextLink reference="22"></TextLink> and the wash and disinfection process according to EN ISO 15883 <TextLink reference="23"></TextLink> are sufficient. A standardized process flow can be ensured only on the basis of a quality management system with the correct classification of medical devices, detailed standard operating procedures, and packing lists (illustrated, if possible), as well as professional risk assessment. Employees must be involved in the organization of the working process.</Pgraph><Pgraph>Despite the validation of the “most difficult load”, each charge has different requirements and thus is subject to other conditions. The use of indicators for daily charge control is essential and is used according to the results of monitoring in 44% of the 25 medical practitioners’ offices and in 95% of the 14 hospitals. However, studies show that both biological and chemical indicators do not always reliably reflect the quality of the technical process. Therefore, a combination of different types of indicators is recommended <TextLink reference="24"></TextLink>, <TextLink reference="25"></TextLink>. For checking the cleaning performance of a washer-disinfector in Europe, different biological media are used for the indicator.</Pgraph><Pgraph><Mark1>External reprocessing:</Mark1> Although outsourcing of reprocessing is becoming more important, it is still controversial. For private practices or small hospitals, two outsourcing options exist: </Pgraph><Pgraph><OrderedList><ListItem level="1" levelPosition="1" numString="1.">reprocessing in an independent regional or even global CSSD company which supplies several other health care institutions, or </ListItem><ListItem level="1" levelPosition="2" numString="2.">in the CSSD of a large hospital with its own CSSD. </ListItem></OrderedList></Pgraph><Pgraph>The theories of transaction cost economics, founded by Ronald Coase <TextLink reference="26"></TextLink>, explain this by the ever-growing network of the world economy. Today, companies are less dependent to integrate interactions and transactions in companies that do not belong to the actual “core competence” <TextLink reference="27"></TextLink>, <TextLink reference="28"></TextLink>.</Pgraph><Pgraph>The prerequisites for the provision of an external reprocessing service are the validation of all sub-processes, a quality management system, and a well-qualified staff. Many hospitals in southern Hesse, Germany, met the requirements only after official monitoring and adaptation to the legal demands. The same situation was found in CSSDs within a Germany-wide hospital network <TextLink reference="29"></TextLink>. </Pgraph><Pgraph>In 1999, official monitoring of sterilization units in hospi<TextGroup><PlainText>ta</PlainText></TextGroup>ls in the United Kingdom found that they do not always comply with the standards required. This led to the decision to build increasingly central sterilization units in the country <TextLink reference="30"></TextLink>. Similarly, in the Netherlands in recent years, large central sterilization companies have been established. In Germany, however, there are few comparable institutions that offer only the reprocessing service. These central systems have advantages and disadvantages. A survey in the UK in 2008 with a very low number of responses showed problems such as a lack of instruments, wrong labeling of sets, and delayed delivery. In conclusion, it is recommended that these deficiencies, if identified by the customer, should be reported to the authority <TextLink reference="31"></TextLink>.</Pgraph><Pgraph><Mark1>Single-use medical devices:</Mark1> On the German market, the supply of disposable instruments is continuously growing. Most are plastic products; metal products are offered only sporadically. The variety of instruments is limited. To date, the emergency and rescue services and primary care predominantly use disposable instruments. </Pgraph><Pgraph>Some doctors, mostly general practitioners and dermatologists, use disposables in their daily routine. The two most common arguments against the use of single-use instruments are:</Pgraph><Pgraph><UnorderedList><ListItem level="1">Environmental concerns due to the increased amount of waste <TextLink reference="32"></TextLink> </ListItem><ListItem level="1">Subjective perception of lower quality due to the significantly lower weight.</ListItem></UnorderedList></Pgraph><Pgraph>The medical practitioners monitored who already only use disposable instruments do so based on the financial benefit, the safety of sterility, and at least the same quality of interventions. These statements were also described in a study by Puttaiah <TextLink reference="33"></TextLink>. Another study on the use of forceps for endoscopy concludes that for reasons of quality, single-use medical devices should be preferred <TextLink reference="34"></TextLink>.</Pgraph><Pgraph>In the UK, disposable instruments have been increasingly used in recent years, due to the risk of vCJD infection in certain high-risk surgery <TextLink reference="35"></TextLink>. Disposable metallic instruments for tonsillectomies and adenotomies are expensive; therefore, a study was conducted with disposable plastic instruments that were manufactured for that purpose. The quality of the interventions was equivalent with both kind of devices, but a familiarization phase of the doctors was necessary <TextLink reference="36"></TextLink>. </Pgraph><Pgraph>According to a market analysis by two independent institutes, in the future, the quality and innovations in the plastics industry are likely to improve; thus, it will be possible to offer single-use devices as alternatives to reusable medical devices that are particularly difficult to clean <TextLink reference="37"></TextLink>. On the other hand, a cost-benefit analysis shows that decontamination of selected single-use medical devices, for example, ablation catheters, without increased patient risk can amount to savings of up to <TextGroup><PlainText>€ 2</PlainText></TextGroup>3 million per year in Germany <TextLink reference="38"></TextLink>.</Pgraph><Pgraph>It is necessary to review the impact on the environment due to the increased use of disposable instruments in the scope of a Life Cycle Assessment (LCA). Both processes, the new production and the reprocessing of surgical instruments, require a high level of energy and resource use. In 1999, disposable liners were compared with reusable liner fabrics in surgical interventions in hospitals. As a result, disposable fabrics were rated as more ecologically sound <TextLink reference="39"></TextLink>. In 2000, the Austrian Institute for Applied Ecology conducted an LCA for the use of liners. The study summary explains that an LCA on its own does not show the appropriate method for each user; rather, the local conditions must also be taken into account for each product <TextLink reference="40"></TextLink>. In a comprehensive evaluation of liners by the University of Dresden in 2005, it was found that the production of both materials was conducted using new procedures and increasingly improved ecological conditions <TextLink reference="41"></TextLink>.</Pgraph><Pgraph>In Italy it was found that the very high demands placed on in the reprocessing single-use instruments can hardly be met by small- and mid-scale health care institutions <TextLink reference="42"></TextLink>. The health authority in UK warns of reprocessing single-use medical devices due to the occurrence of events with negative consequences for the patient <TextLink reference="43"></TextLink>. The last proposal for the Medical Device Directive <TextLink reference="44"></TextLink> foresees the reprocessing of single-use medical devices. This would allow the process in principle, but it must be subject to strict conditions and would define the re-use of disposable instruments as a return to the market. With these changes, a unified European legal basis will be implemented. It should be noted that the surgeon must easily recognize whether he uses a real single-use device or a reprocessed single-use device. </Pgraph><Pgraph><Mark1>Cooperation of health facilities:</Mark1> Historically, primary health care in Western Europe is based on medical treatment. Finland founded the first community health centers in 1972, with other services such as check-ups included <TextLink reference="45"></TextLink>. Other countries later adopted this model of general health care provision. Surgical procedures were carried out for many years exclusively as outpatient treatment. Within a few years, the inpatient treatment rose in Europe and the US, primarily due to legal and financial arrangements <TextLink reference="46"></TextLink>. </Pgraph><Pgraph>From a health policy perspective, performing outpatient surgery places a smaller burden on the health care system. Both patient waiting time and economic costs can be reduced <TextLink reference="47"></TextLink>. Especially for underdeveloped regions, where only a very low density of physicians exists, alternative models should be considered.</Pgraph><Pgraph>In 2005, it was found that a structured, organized cooperation of physicians in Germany is largely absent <TextLink reference="48"></TextLink>. Today, in southern Hesse, Germany, a different kind of medical practitioner cooperation is on the rise, including collaborations in highly specialized areas, close professional cooperation, and joint use of surgical and reprocessing facilities. The joint reprocessing unit provides logistic and financial advantages. It is important to consider the difficulties faced by small CSSDs in complying with all legal requirements. Training of staff, the current state of technology, and quality assurance are easier to implement in practices with a higher capacity of surgical procedures (Figure 4 <ImgLink imgNo="4" imgType="figure"/>).</Pgraph><SubHeadline>4.2 Prospects for the reprocessing of surgical medical devices</SubHeadline><Pgraph>Reprocessing of medical devices is a complex technical process that needs to adapt to the development of innovative medical devices and the constant changes of the microorganisms <TextLink reference="49"></TextLink>. These challenges are met in different ways within Europe.</Pgraph><Pgraph><UnorderedList><ListItem level="1">Due to the frequent occurrence of transmissible spongiform encephalopathy (TSE) in the UK, in UK is prohibited from reusing instruments of patients with an increased risk of variant Ceutzfeld Jacob Disease (vCJD). Therefore, more disposable instruments are used <TextLink reference="50"></TextLink>, <TextLink reference="51"></TextLink>. A meticulous cleaning and disinfection process is required in the alkaline range to minimize the risk of transmission of vCJD <TextLink reference="52"></TextLink>. </ListItem><ListItem level="1">According to some experts, the statutory SAL value of 10<Superscript>–6</Superscript> pathogens can be reduced due to the scientifically calculated probabilities of contamination <TextLink reference="53"></TextLink>, <TextLink reference="54"></TextLink>.</ListItem><ListItem level="1">The use of robotic surgical systems has increased rapidly in the last few years <TextLink reference="55"></TextLink>. Because the instruments are complex, reprocessing is problematic for these medical devices <TextLink reference="56"></TextLink>. </ListItem></UnorderedList></Pgraph><Pgraph>The analysis of a total of 39 health care facilities and the review of relevant European literature can identify three major causes of shortcomings in the reprocessing process:</Pgraph><Pgraph><UnorderedList><ListItem level="1">High costs for proper implementation of the reprocessing process </ListItem><ListItem level="1">Little importance placed on the reprocessing unit in health care facilities </ListItem><ListItem level="1">Potential deficits of official monitoring.</ListItem></UnorderedList></Pgraph><Pgraph><Mark1>Costs:</Mark1> The standardized implementation of the entire treatment process in appropriate areas with modern equipment and trained personnel is costly. Failure to comply with the rules provides a potential for cost reduction. For small health facilities with only a few surgical interventions per week, it is expensive to implement a functioning reprocessing regime (Figure 5 <ImgLink imgNo="5" imgType="figure"/>). Nevertheless, the conditions for reprocessing are required according to the KRINKO-BfArM recommendation <TextLink reference="14"></TextLink>, even in small facilities. Therefore, it is foreseeable that in the mid- to long-term, washer-disinfectors will replace manual cleaning and disinfection in the performance of reprocessing. It is expected that in the future, medical practitioners’ offices with few surgical interventions will resort to an alternative instead of their own decontamination unit, for instance, the use of disposable instruments, an external reprocessing service, or cooperation with other medical practitioners.</Pgraph><Pgraph>Düwel <TextLink reference="57"></TextLink> used the example of University Medicine Greifswald to show that the introduction of a quality management system improved the quality and reduced the costs of the hospital. In addition, it is indisputable that the prevention of HAI affects the length of hospital stay and positively influences the recovery of patients. The incidence of HAI results in significantly higher treatment costs <TextLink reference="58"></TextLink>, <TextLink reference="59"></TextLink>, <TextLink reference="60"></TextLink>, <TextLink reference="61"></TextLink>, <TextLink reference="62"></TextLink>. A direct causal relationship to the proper implementation of the decontamination process has not yet been demonstrated, although the increased infection risk posed by non-sterile instruments is internationally incontrovertible <TextLink reference="21"></TextLink>, <TextLink reference="35"></TextLink>, <TextLink reference="63"></TextLink>, <TextLink reference="64"></TextLink>, <TextLink reference="65"></TextLink>. </Pgraph><Pgraph>It should be emphasized that cost savings in the implementation of the reprocessing process must not lead to deterioration of performance, and thus to an increased risk for the patient. Funding must take into account the essential requirements of the entire health system.</Pgraph><Pgraph><Mark1>Importance of the reprocessing unit:</Mark1> The target of any health facility is to heal the patient. The central figure is the doctor. In Germany, the reprocessing unit was at the bottom of the hierarchy in the past <TextLink reference="66"></TextLink>, <TextLink reference="67"></TextLink>. The involvement of well-trained employees is important for the integration of the reprocessing unit in the existing structures of the institution. However, the salaries of such employees often correspond to those of untrained personnel. The German Society for Sterile Supply (DGSV) demands a specific job profile for this activity <TextLink reference="68"></TextLink>.</Pgraph><Pgraph>For physicians’ staff, additional specialized training is offered optionally as part of medical-assistant training in Hesse. The goal is to achieve a high level of training coverage <TextLink reference="69"></TextLink>. An equivalent system will probably also be established in other German states. At present, even within the university medical schools, the course modules on hygiene and in particular the decontamination process are only available in small numbers.</Pgraph><Pgraph>The organization of a functioning CSSD is a management task. Close cooperation with various departments/staff, such as purchasing, the end users (operators), the nursing service, hygiene and technical departments is essential <TextLink reference="70"></TextLink>. In case of technical disputes, all stakeholders, including the head of CSSD, need to be able to take equal positions. Based on the Hesse-ASCA Guide <TextLink reference="71"></TextLink> for the development of a systematic occupational safety organization, a guideline for the organization of the CSSD was created (Table 2 <ImgLink imgNo="2" imgType="table"/>).</Pgraph><Pgraph><Mark1>Official monitoring:</Mark1> There is no standard European procedure for monitoring the reprocessing units in health care facilities <TextLink reference="72"></TextLink>. The conditions and structures are all different. However, there is consensus about the fact that official monitoring plays a central role. The presence of a regulatory authority ensures that standards are maintained in the health facilities. Due not only to the mentioned reasons (costs and importance) few health care facilities meet the necessary legal requirements without governmental intervention.</Pgraph><Pgraph>In the UK and in the Netherlands, a central commission is responsible for the coordination of monitoring and cooperation with other health inspectors. The Italian policy for the reprocessing process distinguishes between large and small hospitals, whereas the German KRINKO-BfArM recommendation <TextLink reference="13"></TextLink> separates hospitals and medical practices. In the past, Finland predominantly monitored hospitals, and due to a change in requirements, has increasingly monitored medical practices since the 1990s <TextLink reference="73"></TextLink>. In the Netherlands, it was decided to include the outpatient area in monitoring activities to ensure equivalent protection of patients. The consequences of official monitoring in this area are that not only will practitioners and health centers cooperate in running their reprocessing units at a good quality level, but also that medical practitioners rely increasingly on disposable instruments <TextLink reference="15"></TextLink>. This paradigm shift to increasingly monitor the medical practices is desired in Germany <TextLink reference="74"></TextLink>. However, it did not achieve coverage in the existing structures of the state authorities due to the lack of trained staff. Germany has a uniform federal checklist for implementing the MPBetreibV (German Medical Devices Operator Ordinance) <TextLink reference="75"></TextLink> as well as a binding recommendation for the authorities <TextLink reference="12"></TextLink>. On this basis, in some federal states, such as Mecklenburg-West Pomerania, North Rhine-Westphalia and Hesse, “special monitoring” for the decontamination process has been performed <TextLink reference="11"></TextLink>, <TextLink reference="76"></TextLink>, <TextLink reference="77"></TextLink>. For a uniform implementation of the Directive for Operators of Medical Devices in all federal states, further specifications of the monitoring activities as well as a clear delineation of responsibilities between state and health authorities are required. In the new German Medical Devices Administrative Regulation, inspection and personnel requirements are described, which are currently discussed in the Working Group Medical Devices.</Pgraph><Pgraph>To enable Europe-wide implementation of the Medical Device Directive (MDD), it would be useful for a common body, such as the European Central Management Committee on Medical Devices (CMC) – first convened in December 2010 – to establish uniform frameworks for monitoring authorities.</Pgraph><Pgraph><Mark1>Harmonization of approaches:</Mark1> Basically, the reprocessing process of medical devices must be executed in accordance with the legal provisions and the respective manufacturers’ manuals. Due to the constant development of minimally invasive and complex medical devices, the manufacturer’s instrument-specific decontamination instructions are increasingly important. </Pgraph><Pgraph>The present study shows that the structured administrative monitoring of the processing units is an important pillar of patient safety. The monitoring practices differ across Europe, as national health systems and legal bases are inhomogeneous. However, this fact does not allow any conclusion to be drawn regarding the quality of the reprocessing process of medical devices.</Pgraph><Pgraph>During on-site visits, some CSSD managers noted inadequate manufacturer’s instructions. In addition, in the context of a COEN (Compliance and Enforcement Group) meeting, some countries reported deficiencies in the instruction manuals’ description of the reprocessing processes. In Europe, each manufacturer is obliged under Directive 93/42/EEC and EN ISO 17664 to specify a validated treatment process if the medical product is intended for re-use after reprocessing.</Pgraph><Pgraph>Representatives from some countries (Ireland, UK, Portugal, France, Netherlands, Switzerland and Germany) are planning a COEN project. The aim of this IFU (Instruction for Use of Reusable MDs) working group is to improve descriptions of the decontamination process in the instruction manual. Thus, deficits would be reduced, and the treatment process would be raised to a better standard throughout the EU. The group has developed standardized checklists, and is planning a joint evaluation of the monitoring of all participating countries. With a solid legal basis, a standard is set that is to be respected in all participating countries.</Pgraph><Pgraph>Despite the different structures of the individual countries, a harmonized approach is possible due to the common checklist and the subsequent evaluation. The minimum standard demanded by each of the participating countries is crucial, and should thus provide safety for all countries and ultimately all patients.</Pgraph></TextBlock> <TextBlock linked="yes" name="5 Conclusion"> <MainHeadline>5 Conclusion</MainHeadline><Pgraph>The development of new surgical techniques and medical devices, as well as the changes of pathogens, require ongoing adjustment of the reprocessing process. Consistent standardization, extensive quality assurance measures, and good personnel training are necessary across Europe. Likewise, ecological and economic evaluation is important in the planning phase of a new reprocessing unit. Noncompliance with legal requirements poses a risk to patient safety and should not be tolerated. The three main causes of poor performance of the reprocessing process are: cost savings by reducing quality, low importance of the reprocessing unit in health care facilities, and the insufficient frequency of monitoring by the authorities. </Pgraph><Pgraph>Important approaches to improving and harmonizing the decontamination of surgical medical devices are as follows:</Pgraph><Pgraph><UnorderedList><ListItem level="1">Consideration of alternatives using environmental and economic assessment of the in-house reprocessing, including the type and frequency of surgical interventions in a health care facility</ListItem><ListItem level="1">Establishment of accepted and standardized training programs with adequate remuneration for performing reprocessing</ListItem><ListItem level="1">Development and adaptation of medical devices, cleaning, disinfection and sterilization appliances and of the reprocessing instructions to the needs of health care facilities in Europe</ListItem><ListItem level="1">Europe-wide standardized framework for the authorities for monitoring activities </ListItem><ListItem level="1">Europe-wide standardized framework for the implementation of the decontamination process, personnel requirements, quality assurance measures, and the spatial and technical requirement.</ListItem></UnorderedList></Pgraph></TextBlock> <TextBlock linked="yes" name="Notes"> <MainHeadline>Notes</MainHeadline><SubHeadline>Competing interests</SubHeadline><Pgraph>The authors declare that they have no competing interests.</Pgraph></TextBlock> <References linked="yes"> <Reference refNo="1"> <RefAuthor>Department of Health</RefAuthor> <RefTitle></RefTitle> <RefYear>2009</RefYear> <RefBookTitle>Infectious Diseases & Blood Policy. Department of Health Funded Research on Decontamination of Surgical Instruments. Progress Review 2008</RefBookTitle> <RefPage>org</RefPage> <RefTotal>Department of Health. Infectious Diseases & Blood Policy. Department of Health Funded Research on Decontamination of Surgical Instruments: Progress Review 2008. Department of Health; 2009. Available from: http://www.google.de/url?sa=t&rct=j&q=&esrc=s&frm=1&source=web&cd=1&ved=0CDEQFjAA&url=http%3A%2F%2Fwww.afpp.org.uk%2Ffilegrab%2Fdh-research-on-decontamination.pdf%3Fref%3D1393&ei=SJhVUqKoGIaatQaD-oAQ&usg=AFQjCNF2DaXNTZ-5BK_ScZaAU0n-r3u9rA</RefTotal> <RefLink>http://www.google.de/url?sa=t&rct=j&q=&esrc=s&frm=1&source=web&cd=1&ved=0CDEQFjAA&url=http%3A%2F%2Fwww.afpp.org.uk%2Ffilegrab%2Fdh-research-on-decontamination.pdf%3Fref%3D1393&ei=SJhVUqKoGIaatQaD-oAQ&usg=AFQjCNF2DaXNTZ-5BK_ScZaAU0n-r3u9rA</RefLink> </Reference> <Reference refNo="2"> <RefAuthor>Bryce EA</RefAuthor> <RefAuthor>Walker M</RefAuthor> <RefAuthor>Bevan C</RefAuthor> <RefAuthor>Smith JA</RefAuthor> <RefTitle>Contamination of bronchoscopes with Mycobacterium tuberculosis</RefTitle> <RefYear>1993</RefYear> <RefJournal>Can J Infect Control</RefJournal> <RefPage>35-6</RefPage> <RefTotal>Bryce EA, Walker M, Bevan C, Smith JA. Contamination of bronchoscopes with Mycobacterium tuberculosis. Can J Infect Control. 1993;8(2):35-6.</RefTotal> </Reference> <Reference refNo="3"> <RefAuthor>Roosendaal R</RefAuthor> <RefAuthor>Kuipers EJ</RefAuthor> <RefAuthor>van den Brule AJ</RefAuthor> <RefAuthor>Peña AS</RefAuthor> <RefAuthor>Uyterlinde AM</RefAuthor> <RefAuthor>Walboomers JM</RefAuthor> <RefAuthor>Meuwissen SG</RefAuthor> <RefAuthor>de Graaff J</RefAuthor> <RefTitle>Importance of the fiberoptic endoscope cleaning procedure for detection of Helicobacter pylori in gastric biopsy specimens by PCR</RefTitle> <RefYear>1994</RefYear> <RefJournal>J Clin Microbiol</RefJournal> <RefPage>1123-6</RefPage> <RefTotal>Roosendaal R, Kuipers EJ, van den Brule AJ, Peña AS, Uyterlinde AM, Walboomers JM, Meuwissen SG, de Graaff J. Importance of the fiberoptic endoscope cleaning procedure for detection of Helicobacter pylori in gastric biopsy specimens by PCR. J Clin Microbiol. 1994 Apr;32(4):1123-6.</RefTotal> </Reference> <Reference refNo="4"> <RefAuthor>Bradley CR</RefAuthor> <RefAuthor>Babb JR</RefAuthor> <RefTitle>Endoscope decontamination: automated vs. manual</RefTitle> <RefYear>1995</RefYear> <RefJournal>J Hosp Infect</RefJournal> <RefPage>537-42</RefPage> <RefTotal>Bradley CR, Babb JR. Endoscope decontamination: automated vs. manual. J Hosp Infect. 1995 Jun;30 Suppl:537-42. DOI: 10.1016/0195-6701(95)90060-8</RefTotal> <RefLink>http://dx.doi.org/10.1016/0195-6701(95)90060-8</RefLink> </Reference> <Reference refNo="5"> <RefAuthor>Leiß O</RefAuthor> <RefAuthor>Bader L</RefAuthor> <RefAuthor>Mielke M</RefAuthor> <RefAuthor>Exner M</RefAuthor> <RefTitle>Fünf Jahre Empfehlungen der Kommission für Krankenhaushygiene zur Aufbereitung flexibler Endoskope. Blick zurück und Blick nach vorn</RefTitle> <RefYear>2008</RefYear> <RefJournal>Bundesgesundheitsbl Gesundheitsforsch Gesundheitsschutz</RefJournal> <RefPage>211-20</RefPage> <RefTotal>Leiß O, Bader L, Mielke M, Exner M. Fünf Jahre Empfehlungen der Kommission für Krankenhaushygiene zur Aufbereitung flexibler Endoskope. Blick zurück und Blick nach vorn. Bundesgesundheitsbl Gesundheitsforsch Gesundheitsschutz. 2008;51(2):211-20. DOI: 10.1007/s00103-008-0451-7</RefTotal> <RefLink>http://dx.doi.org/10.1007/s00103-008-0451-7</RefLink> </Reference> <Reference refNo="6"> <RefAuthor>Azizi J</RefAuthor> <RefAuthor>Anderson SG</RefAuthor> <RefAuthor>Murphy S</RefAuthor> <RefAuthor>Pryce S</RefAuthor> <RefTitle>Uphill grime: process improvement in surgical instrument cleaning</RefTitle> <RefYear>2012</RefYear> <RefJournal>AORN J</RefJournal> <RefPage>152-62</RefPage> <RefTotal>Azizi J, Anderson SG, Murphy S, Pryce S. Uphill grime: process improvement in surgical instrument cleaning. AORN J. 2012 Aug;96(2):152-62. DOI: 10.1016/j.aorn.2012.03.018</RefTotal> <RefLink>http://dx.doi.org/10.1016/j.aorn.2012.03.018</RefLink> </Reference> <Reference refNo="7"> <RefAuthor>Srinivasan A</RefAuthor> <RefAuthor>Wolfenden LL</RefAuthor> <RefAuthor>Song X</RefAuthor> <RefAuthor>Mackie K</RefAuthor> <RefAuthor>Hartsell TL</RefAuthor> <RefAuthor>Jones HD</RefAuthor> <RefAuthor>Diette GB</RefAuthor> <RefAuthor>Orens JB</RefAuthor> <RefAuthor>Yung RC</RefAuthor> <RefAuthor>Ross TL</RefAuthor> <RefAuthor>Merz W</RefAuthor> <RefAuthor>Scheel PJ</RefAuthor> <RefAuthor>Haponik EF</RefAuthor> <RefAuthor>Perl TM</RefAuthor> <RefTitle>An outbreak of Pseudomonas aeruginosa infections associated with flexible bronchoscopes</RefTitle> <RefYear>2003</RefYear> <RefJournal>N Engl J Med</RefJournal> <RefPage>221-7</RefPage> <RefTotal>Srinivasan A, Wolfenden LL, Song X, Mackie K, Hartsell TL, Jones HD, Diette GB, Orens JB, Yung RC, Ross TL, Merz W, Scheel PJ, Haponik EF, Perl TM. An outbreak of Pseudomonas aeruginosa infections associated with flexible bronchoscopes. N Engl J Med. 2003 Jan;348(3):221-7. DOI: 10.1056/NEJMoa021808</RefTotal> <RefLink>http://dx.doi.org/10.1056/NEJMoa021808</RefLink> </Reference> <Reference refNo="8"> <RefAuthor>Heudorf U</RefAuthor> <RefAuthor>Hofmann H</RefAuthor> <RefAuthor>Kutzke G</RefAuthor> <RefAuthor>Otto U</RefAuthor> <RefTitle>Hygiene beim ambulanten Operieren. Ergebnisse der infektionshygienischen Überwachung von Einrichtungen für ambulantes Operieren in Frankfurt am Main durch das Gesundheitsamt</RefTitle> <RefYear>2003</RefYear> <RefJournal>Bundesgesundheitsbl Gesundheitsforsch Gesundheitsschutz</RefJournal> <RefPage>756-64</RefPage> <RefTotal>Heudorf U, Hofmann H, Kutzke G, Otto U. Hygiene beim ambulanten Operieren. Ergebnisse der infektionshygienischen Überwachung von Einrichtungen für ambulantes Operieren in Frankfurt am Main durch das Gesundheitsamt. Bundesgesundheitsbl Gesundheitsforsch Gesundheitsschutz. 2003;46(9):756-64. DOI: 10.1007/s00103-003-0674-6</RefTotal> <RefLink>http://dx.doi.org/10.1007/s00103-003-0674-6</RefLink> </Reference> <Reference refNo="9"> <RefAuthor>Attenberger J</RefAuthor> <RefTitle>Rechtliche Grundlagen der Aufbereitung und Tätigkeit der Behörden. Forum Medizinprodukte-Aufbereitung</RefTitle> <RefYear>2005</RefYear> <RefJournal>Z Forum</RefJournal> <RefPage>4-9</RefPage> <RefTotal>Attenberger J. Rechtliche Grundlagen der Aufbereitung und Tätigkeit der Behörden. Forum Medizinprodukte-Aufbereitung. Z Forum. 2005:4-9. </RefTotal> </Reference> <Reference refNo="10"> <RefAuthor>Thiede B</RefAuthor> <RefTitle>Gute Standards für den Instrumenten-Aufbereitungsprozess vermeiden Infektionen im niedergelassenen Bereich und in Kliniken</RefTitle> <RefYear>2010</RefYear> <RefBookTitle>Jahresbericht 2010 der hessischen Arbeitsschutzverwaltung</RefBookTitle> <RefPage>69-76</RefPage> <RefTotal>Thiede B. Gute Standards für den Instrumenten-Aufbereitungsprozess vermeiden Infektionen im niedergelassenen Bereich und in Kliniken. In: Hessisches Sozialministerium, editor. Jahresbericht 2010 der hessischen Arbeitsschutzverwaltung. 2010. p. 69-76. Available from: http://www.sozialnetz.de/global/show_document.asp?id=aaaaaaaaaaagkfd [accessed May 2013]</RefTotal> <RefLink>http://www.sozialnetz.de/global/show_document.asp?id=aaaaaaaaaaagkfd</RefLink> </Reference> <Reference refNo="11"> <RefAuthor>Barion J</RefAuthor> <RefTitle>Inspektion der Aufbereitung</RefTitle> <RefYear>2011</RefYear> <RefJournal>Medizinprod J</RefJournal> <RefPage>110-3</RefPage> <RefTotal>Barion J. Inspektion der Aufbereitung. Medizinprod J. 2011;18(2):110-3.</RefTotal> </Reference> <Reference refNo="12"> <RefAuthor>AGMP (Working Group Medical Devices)</RefAuthor> <RefTitle></RefTitle> <RefYear>2008</RefYear> <RefBookTitle>Empfehlung für die Überwachung der Aufbereitung von Medizinprodukten</RefBookTitle> <RefPage></RefPage> <RefTotal>AGMP (Working Group Medical Devices). Empfehlung für die Überwachung der Aufbereitung von Medizinprodukten. 2008. Available from: http://www.dimdi.de/static/de/mpg/recht/pg-rki-bfarm-empfehlung.pdf [accessed Dec 2012]</RefTotal> <RefLink>http://www.dimdi.de/static/de/mpg/recht/pg-rki-bfarm-empfehlung.pdf</RefLink> </Reference> <Reference refNo="50"> <RefAuthor>ACDP TSE Risk Management Subgroup</RefAuthor> <RefTitle></RefTitle> <RefYear>2011</RefYear> <RefBookTitle>Transmissible Spongiform Encephalopathy Agents: Safe Working and the Prevention of Infection: Part 4. Infection control of CJD, vCJD and other human prion diseases in healthcare and community settings</RefBookTitle> <RefPage></RefPage> <RefTotal>ACDP TSE Risk Management Subgroup. Transmissible Spongiform Encephalopathy Agents: Safe Working and the Prevention of Infection: Part 4. Infection control of CJD, vCJD and other human prion diseases in healthcare and community settings. London: Department of Health; 2003. Revised and updated: January 2011. Available from: http://webarchive.nationalarchives.gov.uk/20130107105354/http://www.dh.gov.uk/prod_consum_dh/groups/dh_digitalassets/@dh/@ab/documents/digitalasset/dh_129681.pdf</RefTotal> <RefLink>http://webarchive.nationalarchives.gov.uk/20130107105354/http://www.dh.gov.uk/prod_consum_dh/groups/dh_digitalassets/@dh/@ab/documents/digitalasset/dh_129681.pdf</RefLink> </Reference> <Reference refNo="13"> <RefAuthor>KRINKO</RefAuthor> <RefAuthor> BfArM</RefAuthor> <RefTitle>Anforderungen an die Hygiene bei der Aufbereitung von Medizinprodukten Empfehlung der Kommission für Krankenhaushygiene und Infektionsprävention beim Robert Koch-Institut (RKI) und des Bundesinstitutes für Arzneimittel und Medizinprodukte (BfArM) zu den “Anforderungen an die Hygiene bei der Aufbereitung von Medizinprodukten”</RefTitle> <RefYear>2001</RefYear> <RefJournal>Bundesgesundheitsbl</RefJournal> <RefPage>1115-26</RefPage> <RefTotal>KRINKO; BfArM. Anforderungen an die Hygiene bei der Aufbereitung von Medizinprodukten Empfehlung der Kommission für Krankenhaushygiene und Infektionsprävention beim Robert Koch-Institut (RKI) und des Bundesinstitutes für Arzneimittel und Medizinprodukte (BfArM) zu den “Anforderungen an die Hygiene bei der Aufbereitung von Medizinprodukten”. Bundesgesundheitsbl. 2001;44(11):1115-26. DOI: 10.1007/s00103-001-0279-x</RefTotal> <RefLink>http://dx.doi.org/10.1007/s00103-001-0279-x</RefLink> </Reference> <Reference refNo="14"> <RefAuthor>KRINKO</RefAuthor> <RefAuthor> BfArM</RefAuthor> <RefTitle>Anforderungen an die Hygiene bei der Aufbereitung von Medizinprodukten. Empfehlung der Kommission für Krankenhaushygiene und Infektionsprävention (KRINKO) beim Robert Koch-Institut (RKI) und des Bundesinstitutes für Arzneimittel und Medizinprodukte (BfArM)</RefTitle> <RefYear>2012</RefYear> <RefJournal>Bundesgesundheitsbl</RefJournal> <RefPage>1244-310</RefPage> <RefTotal>KRINKO; BfArM. Anforderungen an die Hygiene bei der Aufbereitung von Medizinprodukten. Empfehlung der Kommission für Krankenhaushygiene und Infektionsprävention (KRINKO) beim Robert Koch-Institut (RKI) und des Bundesinstitutes für Arzneimittel und Medizinprodukte (BfArM). Bundesgesundheitsbl. 2012;55(10):1244-310. DOI: 10.1007/s00103-012-1548-6</RefTotal> <RefLink>http://dx.doi.org/10.1007/s00103-012-1548-6</RefLink> </Reference> <Reference refNo="15"> <RefAuthor>de Bruijn ACP</RefAuthor> <RefAuthor>van Drongelen AW</RefAuthor> <RefTitle></RefTitle> <RefYear>2010</RefYear> <RefBookTitle>Nederlandse wetgeving voor de sterilisatie van medische hulpmiddelen. Moderniseren of opheffen?</RefBookTitle> <RefPage></RefPage> <RefTotal>de Bruijn ACP, van Drongelen AW. Nederlandse wetgeving voor de sterilisatie van medische hulpmiddelen. Moderniseren of opheffen? Bilthoven: Rijksinstituut voor Volksgezondheid en Milieu; 2010. (RIVM Briefrapprt; 360020003). Available from: http://sterilisatievereniging.nl/publicaties/doc_download/55-nederlandse-wetgeving-voor-de-sterilisatie-van-medische-hulpmiddelen [accessed March 2012]</RefTotal> <RefLink>http://sterilisatievereniging.nl/publicaties/doc_download/55-nederlandse-wetgeving-voor-de-sterilisatie-van-medische-hulpmiddelen</RefLink> </Reference> <Reference refNo="16"> <RefAuthor>Robert Koch-Institut</RefAuthor> <RefTitle>Zur Richtlinie für Krankenhaushygiene und Infektionsprävention: Anforderungen der Krankenhaushygiene und des Arbeitsschutzes an die Hygienebekleidung und persönliche Schutzausrüstung</RefTitle> <RefYear>2007</RefYear> <RefJournal>Epid Bull</RefJournal> <RefPage>3-4</RefPage> <RefTotal>Robert Koch-Institut. Zur Richtlinie für Krankenhaushygiene und Infektionsprävention: Anforderungen der Krankenhaushygiene und des Arbeitsschutzes an die Hygienebekleidung und persönliche Schutzausrüstung. Epid Bull. 2007;(1):3-4. Available from: http://www.rki.de/DE/Content/Infekt/Krankenhaushygiene/Kommission/Downloads/Arbeitsschutz_pdf.pdf?__blob=publicationFile</RefTotal> <RefLink>http://www.rki.de/DE/Content/Infekt/Krankenhaushygiene/Kommission/Downloads/Arbeitsschutz_pdf.pdf?__blob=publicationFile</RefLink> </Reference> <Reference refNo="17"> <RefAuthor>Hübner NO</RefAuthor> <RefAuthor>Haak J</RefAuthor> <RefAuthor>Ryll S</RefAuthor> <RefAuthor>Kramer A</RefAuthor> <RefTitle>Können persönliche Stoff-OP-Hauben ohne erhöhtes Kontaminationsrisiko in der Haushaltswaschmaschine gewaschen werden? Ergebnisse einer orientierenden Pilotstudie</RefTitle> <RefYear>2011</RefYear> <RefJournal>Hyg Med</RefJournal> <RefPage>198-200</RefPage> <RefTotal>Hübner NO, Haak J, Ryll S, Kramer A. Können persönliche Stoff-OP-Hauben ohne erhöhtes Kontaminationsrisiko in der Haushaltswaschmaschine gewaschen werden? Ergebnisse einer orientierenden Pilotstudie. Hyg Med. 2011;36(5):198-200. </RefTotal> </Reference> <Reference refNo="18"> <RefAuthor>Bockmühl D</RefAuthor> <RefTitle>Hygieneaspekte bei Haushaltswaschverfahren</RefTitle> <RefYear>2011</RefYear> <RefJournal>Hyg Med</RefJournal> <RefPage>280-6</RefPage> <RefTotal>Bockmühl D. Hygieneaspekte bei Haushaltswaschverfahren. Hyg Med. 2011;36(7/8):280-6.</RefTotal> </Reference> <Reference refNo="19"> <RefAuthor>Sissoko B</RefAuthor> <RefAuthor>Sütterlin R</RefAuthor> <RefAuthor>Blaschke M</RefAuthor> <RefAuthor>Schluttig A</RefAuthor> <RefAuthor>Stefaniak S</RefAuthor> <RefAuthor>Daeschlein G</RefAuthor> <RefAuthor>Kramer A</RefAuthor> <RefTitle>Emission von Bakterien aus Geruchsverschlüssen</RefTitle> <RefYear>2005</RefYear> <RefJournal>Hyg Med</RefJournal> <RefPage>100-4</RefPage> <RefTotal>Sissoko B, Sütterlin R, Blaschke M, Schluttig A, Stefaniak S, Daeschlein G, Kramer A. Emission von Bakterien aus Geruchsverschlüssen. Hyg Med. 2005;30(4):100-4.</RefTotal> </Reference> <Reference refNo="20"> <RefAuthor>Anonym</RefAuthor> <RefTitle></RefTitle> <RefYear></RefYear> <RefBookTitle>Sozialgesetzbuch (SGB) Fünftes Buch (V). § 135a SGB V – Verpflichtung zur Qualitätssicherung. 1988, Bgbl 1988;I:2477; zuletzt geändert Bgbl 2013:2423</RefBookTitle> <RefPage></RefPage> <RefTotal>Sozialgesetzbuch (SGB) Fünftes Buch (V). § 135a SGB V – Verpflichtung zur Qualitätssicherung. 1988, Bgbl 1988;I:2477; zuletzt geändert Bgbl 2013:2423.</RefTotal> </Reference> <Reference refNo="21"> <RefAuthor>Anonym</RefAuthor> <RefTitle></RefTitle> <RefYear>2006</RefYear> <RefBookTitle>EN ISO 17665-1. Sterilization of health care products – Moist heat – Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices</RefBookTitle> <RefPage></RefPage> <RefTotal>EN ISO 17665-1. Sterilization of health care products – Moist heat – Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices. 2006.</RefTotal> </Reference> <Reference refNo="22"> <RefAuthor>Anonym</RefAuthor> <RefTitle></RefTitle> <RefYear>2009</RefYear> <RefBookTitle>EN ISO 17665-2. Sterilization of health care products – Moist heat – Part 2: Guidance on the application of ANSI/AAMI/ISO17665-1</RefBookTitle> <RefPage></RefPage> <RefTotal>EN ISO 17665-2. Sterilization of health care products – Moist heat – Part 2: Guidance on the application of ANSI/AAMI/ISO17665-1. 2009.</RefTotal> </Reference> <Reference refNo="23"> <RefAuthor>Anonym</RefAuthor> <RefTitle></RefTitle> <RefYear>2009</RefYear> <RefBookTitle>EN ISO 15883-1. Washer-disinfectors – Part 1: General requirements, terms and definitions and tests</RefBookTitle> <RefPage></RefPage> <RefTotal>EN ISO 15883-1. Washer-disinfectors – Part 1: General requirements, terms and definitions and tests. 2009.</RefTotal> </Reference> <Reference refNo="24"> <RefAuthor>Schneider PM</RefAuthor> <RefAuthor>Reich RR</RefAuthor> <RefAuthor>Kirckof SS</RefAuthor> <RefAuthor>Foltz WG</RefAuthor> <RefTitle>Performance of various steam sterilization indicators under optimum and sub-optimum exposure conditions</RefTitle> <RefYear>2005</RefYear> <RefJournal>Am J Infect Control</RefJournal> <RefPage>S55-67</RefPage> <RefTotal>Schneider PM, Reich RR, Kirckof SS, Foltz WG. Performance of various steam sterilization indicators under optimum and sub-optimum exposure conditions. Am J Infect Control. 2005 Jun;33(5 Suppl 2):S55-67. DOI: 10.1016/j.ajic.2005.05.001</RefTotal> <RefLink>http://dx.doi.org/10.1016/j.ajic.2005.05.001</RefLink> </Reference> <Reference refNo="25"> <RefAuthor>Kremmel M</RefAuthor> <RefAuthor>Laudner W</RefAuthor> <RefTitle>Testing the performance of process challenge devices (PCDs) used to check air removal from hollow instruments and effectiveness of sterilisation in steam sterilisation processes</RefTitle> <RefYear>2011</RefYear> <RefJournal>Zentralsteril</RefJournal> <RefPage>100-4</RefPage> <RefTotal>Kremmel M, Laudner W. Testing the performance of process challenge devices (PCDs) used to check air removal from hollow instruments and effectiveness of sterilisation in steam sterilisation processes. Zentralsteril. 2011;19(2):100-4.</RefTotal> </Reference> <Reference refNo="26"> <RefAuthor>Coase RH</RefAuthor> <RefTitle>The nature of the firm</RefTitle> <RefYear>1937</RefYear> <RefJournal>Economica</RefJournal> <RefPage>386-405</RefPage> <RefTotal>Coase RH. The nature of the firm. Economica. 1937;16(4):386-405. DOI: 10.1111/j.1468-0335.1937.tb00002.x</RefTotal> <RefLink>http://dx.doi.org/10.1111/j.1468-0335.1937.tb00002.x</RefLink> </Reference> <Reference refNo="27"> <RefAuthor>Csecsinovitis J</RefAuthor> <RefTitle>Weniger Kosten, mehr Funktionalität</RefTitle> <RefYear>2005</RefYear> <RefBookTitle>Real Time Enterprise in der Praxis</RefBookTitle> <RefPage>345-53</RefPage> <RefTotal>Csecsinovitis J. Weniger Kosten, mehr Funktionalität. In: Kuhlin B, Thielemann H, editors. Real Time Enterprise in der Praxis. Berlin: Springer; 2005. p. 345-53.</RefTotal> </Reference> <Reference refNo="28"> <RefAuthor>de Geyter N</RefAuthor> <RefTitle></RefTitle> <RefYear>2009</RefYear> <RefBookTitle>Outsourcing van de centrale sterilisatieafdeling van ziekenhuizen. Masterproef. Universiteit Gent, Faculteit economie en bedrijfskunde</RefBookTitle> <RefPage></RefPage> <RefTotal>de Geyter N. Outsourcing van de centrale sterilisatieafdeling van ziekenhuizen. Masterproef. Universiteit Gent, Faculteit economie en bedrijfskunde. 2009. Available from: http://lib.ugent.be/fulltxt/RUG01/001/392/200/RUG01-001392200_2010_0001_AC.pdf</RefTotal> <RefLink>http://lib.ugent.be/fulltxt/RUG01/001/392/200/RUG01-001392200_2010_0001_AC.pdf</RefLink> </Reference> <Reference refNo="29"> <RefAuthor>Kramer A</RefAuthor> <RefAuthor>Dörflinger I</RefAuthor> <RefAuthor>Thiede B</RefAuthor> <RefTitle>Quality management of reprocessing of medical devices and results of an analysis in reprocessing of medical devices among 156 German Central Sterilization Service Centers (CSSCs) supplying hospitals of a German-wide hospital network with 250 to >1,000 beds in 14 regional general hospitals and in 18 dermatological doctor’s offices</RefTitle> <RefYear>2012</RefYear> <RefBookTitle>Congress Book Annual WFHSS and JSMI Conference 2012, 13th World Sterilization Congress; 2012 Nov 21-24; Osaka, Japan</RefBookTitle> <RefPage>52-7</RefPage> <RefTotal>Kramer A, Dörflinger I, Thiede B. Quality management of reprocessing of medical devices and results of an analysis in reprocessing of medical devices among 156 German Central Sterilization Service Centers (CSSCs) supplying hospitals of a German-wide hospital network with 250 to >1,000 beds in 14 regional general hospitals and in 18 dermatological doctor’s offices. In: Congress Book Annual WFHSS and JSMI Conference 2012, 13th World Sterilization Congress; 2012 Nov 21-24; Osaka, Japan. p. 52-7.</RefTotal> </Reference> <Reference refNo="30"> <RefAuthor>Gilmour D</RefAuthor> <RefTitle>Patient safety – communication and teamwork are the key</RefTitle> <RefYear>2010</RefYear> <RefJournal>Medical Device Decontamination</RefJournal> <RefPage>8-11</RefPage> <RefTotal>Gilmour D. Patient safety – communication and teamwork are the key. Medical Device Decontamination. 2010;14(4):8-11. Available from: http://www.idsc-uk.co.uk/documents/IDSc_Journal_May-July2010.pdf</RefTotal> <RefLink>http://www.idsc-uk.co.uk/documents/IDSc_Journal_May-July2010.pdf</RefLink> </Reference> <Reference refNo="31"> <RefAuthor>Gilmour D</RefAuthor> <RefAuthor>Cooper R</RefAuthor> <RefTitle>Feedback from members on decontamination services</RefTitle> <RefYear>2008</RefYear> <RefJournal>J Perioper Pract</RefJournal> <RefPage>279-80</RefPage> <RefTotal>Gilmour D, Cooper R. Feedback from members on decontamination services. J Perioper Pract. 2008 Jul;18(7):279-80.</RefTotal> </Reference> <Reference refNo="32"> <RefAuthor>Kramer A</RefAuthor> <RefAuthor>Riemenschneider F</RefAuthor> <RefAuthor>Permien T</RefAuthor> <RefAuthor>Assadian O</RefAuthor> <RefAuthor>Methling W</RefAuthor> <RefTitle>Ethik der Nachhaltigkeit in der Infektionsprävention durch antimikrobielle Wirkstoffe bzw. Verfahren</RefTitle> <RefYear>2008</RefYear> <RefBookTitle>Wallhäußers Praxis der Sterilisation, Desinfektion, Antiseptik und Konservierung. Qualitätssicherung der Hygiene in Industrie, Pharmazie und Medizin</RefBookTitle> <RefPage>577-84</RefPage> <RefTotal>Kramer A, Riemenschneider F, Permien T, Assadian O, Methling W. Ethik der Nachhaltigkeit in der Infektionsprävention durch antimikrobielle Wirkstoffe bzw. Verfahren. In: Kramer A, Assadian O, editors. Wallhäußers Praxis der Sterilisation, Desinfektion, Antiseptik und Konservierung. Qualitätssicherung der Hygiene in Industrie, Pharmazie und Medizin. Stuttgart: Thieme; 2008. p. 577-84.</RefTotal> </Reference> <Reference refNo="33"> <RefAuthor>Puttaiah R</RefAuthor> <RefAuthor>Cederberg R</RefAuthor> <RefAuthor>Youngblood D</RefAuthor> <RefTitle>A pragmatic approach towards single-use-disposable devices in dentistry</RefTitle> <RefYear>2006</RefYear> <RefJournal>Bull Group Int Rech Sci Stomatol Odontol</RefJournal> <RefPage>18-26</RefPage> <RefTotal>Puttaiah R, Cederberg R, Youngblood D. A pragmatic approach towards single-use-disposable devices in dentistry. Bull Group Int Rech Sci Stomatol Odontol. 2006 Mar;47(1):18-26. </RefTotal> </Reference> <Reference refNo="34"> <RefAuthor>Jörgensen E</RefAuthor> <RefAuthor>Busch C</RefAuthor> <RefAuthor>Ujlaky R</RefAuthor> <RefTitle>Wiederverwendbare versus Einweg-Biopsiezangen in der Endoskopie: ein ökonomischer Vergleich</RefTitle> <RefYear>2008</RefYear> <RefJournal>Z Gastroenterol</RefJournal> <RefPage>1185-7</RefPage> <RefTotal>Jörgensen E, Busch C, Ujlaky R. Wiederverwendbare versus Einweg-Biopsiezangen in der Endoskopie: ein ökonomischer Vergleich [Reusable versus disposable biopsy forceps: an economic comparison]. Z Gastroenterol. 2008 Oct;46(10):1185-7. DOI: 10.1055/s-2008-1027542</RefTotal> <RefLink>http://dx.doi.org/10.1055/s-2008-1027542</RefLink> </Reference> <Reference refNo="35"> <RefAuthor>Anonym</RefAuthor> <RefTitle></RefTitle> <RefYear>2006</RefYear> <RefBookTitle>NICE (National Institute for Health and Care Excellence) Guidance. Creutzfeldt-Jakob disease: reducing the risk of transmission by surgical instruments</RefBookTitle> <RefPage></RefPage> <RefTotal>NICE (National Institute for Health and Care Excellence) Guidance. Creutzfeldt-Jakob disease: reducing the risk of transmission by surgical instruments. 2006. (Information about NICE interventional procedure guidance; 196). Available from: http://guidance.nice.org.uk/IPG196/PublicInfo/doc/English [accessed Sept 2011]</RefTotal> <RefLink>http://guidance.nice.org.uk/IPG196/PublicInfo/doc/English</RefLink> </Reference> <Reference refNo="36"> <RefAuthor>Mauz PS</RefAuthor> <RefAuthor>Tropitzsch A</RefAuthor> <RefAuthor>Funk D</RefAuthor> <RefAuthor>Dworschak M</RefAuthor> <RefAuthor>Plinkert PK</RefAuthor> <RefTitle>Kunststoff-Einmalinstrumente aus Hochleistungspolymer bei Tonsillektomien und Adenotomien</RefTitle> <RefYear>2003</RefYear> <RefJournal>HNO</RefJournal> <RefPage>405-13</RefPage> <RefTotal>Mauz PS, Tropitzsch A, Funk D, Dworschak M, Plinkert PK. Kunststoff-Einmalinstrumente aus Hochleistungspolymer bei Tonsillektomien und Adenotomien [The use of disposable instruments of a high performance polymer for tonsillectomy and adenoidectomy]. HNO. 2003 May;51(5):405-13. DOI: 10.1007/s00106-003-0867-1</RefTotal> <RefLink>http://dx.doi.org/10.1007/s00106-003-0867-1</RefLink> </Reference> <Reference refNo="37"> <RefAuthor>Sening W</RefAuthor> <RefAuthor>Leewe J</RefAuthor> <RefTitle>Einmalinstrumente auf dem Vormarsch</RefTitle> <RefYear>2008</RefYear> <RefJournal>Med Plast (Plastverarbeiter Sonderheft)</RefJournal> <RefPage>12-4</RefPage> <RefTotal>Sening W, Leewe J. Einmalinstrumente auf dem Vormarsch. Med Plast (Plastverarbeiter Sonderheft). 2008;6(1):12-4. Available from: http://www.plastverarbeiter.de/texte/anzeigen/10877/EINMALINSTRUMENTE-AUF-DEM-VORMARSCH</RefTotal> <RefLink>http://www.plastverarbeiter.de/texte/anzeigen/10877/EINMALINSTRUMENTE-AUF-DEM-VORMARSCH</RefLink> </Reference> <Reference refNo="38"> <RefAuthor>von Eiff W</RefAuthor> <RefTitle>Wiederaufbereitung von ausgewählten Einwegprodukten senkt Kosten / Gesundheitsökonom von Eiff legt EU-Kommission Kosten-Nutzen-Berechnung vor. Pressemittteilung</RefTitle> <RefYear>2011</RefYear> <RefJournal>Presseportal mdi for Health Economics</RefJournal> <RefPage></RefPage> <RefTotal>von Eiff W. Wiederaufbereitung von ausgewählten Einwegprodukten senkt Kosten / Gesundheitsökonom von Eiff legt EU-Kommission Kosten-Nutzen-Berechnung vor. Pressemittteilung. Presseportal mdi for Health Economics. 2011. Available from: http://www.presseportal.de/meldung/2007682 [accessed Nov 2012]</RefTotal> <RefLink>http://www.presseportal.de/meldung/2007682</RefLink> </Reference> <Reference refNo="39"> <RefAuthor>Dettenkofer M</RefAuthor> <RefAuthor>Griesshammer R</RefAuthor> <RefAuthor>Scherrer M</RefAuthor> <RefAuthor>Daschner F</RefAuthor> <RefTitle>Einweg- versus Mehrweg-Patientenabdeckung im Operationssaal Ökobilanz: Vergleich von Zellstoff-Polyethylen- und Baumwoll-Mischabdeckung</RefTitle> <RefYear>1999</RefYear> <RefJournal>Chirurg</RefJournal> <RefPage>485-91</RefPage> <RefTotal>Dettenkofer M, Griesshammer R, Scherrer M, Daschner F. Einweg- versus Mehrweg-Patientenabdeckung im Operationssaal Ökobilanz: Vergleich von Zellstoff-Polyethylen- und Baumwoll-Mischabdeckung [Life-cycle assessment of single-use versus reusable surgical drapes (cellulose/polyethylene-mixed cotton system)]. Chirurg. 1999 Apr;70(4):485-91</RefTotal> </Reference> <Reference refNo="40"> <RefAuthor>Gupfinger H</RefAuthor> <RefAuthor>Pladerer C</RefAuthor> <RefTitle></RefTitle> <RefYear>2000</RefYear> <RefBookTitle>Mehrweg-Medicalprodukte im Krankenhaus. Marktrecherche, Erfahrungsberichte, Vorschläge zur Umsetzung von Abfallvermeidungsmaßnahmen. Endbericht.</RefBookTitle> <RefPage></RefPage> <RefTotal>Gupfinger H, Pladerer C. Mehrweg-Medicalprodukte im Krankenhaus. Marktrecherche, Erfahrungsberichte, Vorschläge zur Umsetzung von Abfallvermeidungsmaßnahmen. Endbericht. Wien: Österreichisches Ökologie-Institut im Auftrag des Wiener Krankenanstaltenverbundes; 2000. Available from: http://www.ecology.at/files/pr183_1.pdf [accessed Dec 2012]</RefTotal> <RefLink>http://www.ecology.at/files/pr183_1.pdf</RefLink> </Reference> <Reference refNo="41"> <RefAuthor>Cherif C</RefAuthor> <RefAuthor>Günther E</RefAuthor> <RefAuthor>Jatzwauck L</RefAuthor> <RefAuthor>Mecheels S</RefAuthor> <RefTitle></RefTitle> <RefYear>2009</RefYear> <RefBookTitle>Evaluierung von OP-Textilien. Ergebnisse einer Untersuchung nach hygienischen, ökonomischen und ökologischen Gesichtspunkten. Zusammenfassende Darstellung der Forschungsergebnisse des BMBF-Verbundvorhabens (FKZ 0330443A bis 0330446A)</RefBookTitle> <RefPage>122-8</RefPage> <RefTotal>Cherif C, Günther E, Jatzwauck L, Mecheels S, editors. Evaluierung von OP-Textilien. Ergebnisse einer Untersuchung nach hygienischen, ökonomischen und ökologischen Gesichtspunkten. Zusammenfassende Darstellung der Forschungsergebnisse des BMBF-Verbundvorhabens (FKZ 0330443A bis 0330446A). Dresden: Technische Universität Dresden; 2009. p. 122-8. Available from: http://www.tu-dresden.de/die_tu_dresden/fakultaeten/fakultaet_wirtschaftswissenschaften/bwl/bu/forschung/projekte/laufende/dateien/Ergebnisbroschuere%20OPTEX.pdf</RefTotal> <RefLink>http://www.tu-dresden.de/die_tu_dresden/fakultaeten/fakultaet_wirtschaftswissenschaften/bwl/bu/forschung/projekte/laufende/dateien/Ergebnisbroschuere%20OPTEX.pdf</RefLink> </Reference> <Reference refNo="42"> <RefAuthor>Tessarolo F</RefAuthor> <RefAuthor>Caola I</RefAuthor> <RefAuthor>Nollo G</RefAuthor> <RefTitle>Critical Issues in Reprocessing Single-Use Medical Devices for Interventional Cardiology</RefTitle> <RefYear>2011</RefYear> <RefBookTitle>Biomedical Engineering, Trends, Research and Technologies</RefBookTitle> <RefPage></RefPage> <RefTotal>Tessarolo F, Caola I, Nollo G. Critical Issues in Reprocessing Single-Use Medical Devices for Interventional Cardiology. In: Komorowska MA, Olsztynska-Janus S, editors. Biomedical Engineering, Trends, Research and Technologies. 2011. DOI: 10.5772/13582 [accessed Dec 2012]</RefTotal> <RefLink>http://dx.doi.org/10.5772/13582</RefLink> </Reference> <Reference refNo="43"> <RefAuthor>Medicines and Healthcare Products Regulatory Agency (MHRA)</RefAuthor> <RefTitle></RefTitle> <RefYear>2011</RefYear> <RefBookTitle>Single-use Medical Devices: Implications and Consequenses of Reuse Device. Device Bulletin. DB2006(04) v2.0</RefBookTitle> <RefPage></RefPage> <RefTotal>Medicines and Healthcare Products Regulatory Agency (MHRA). Single-use Medical Devices: Implications and Consequenses of Reuse Device. Device Bulletin. DB2006(04) v2.0. 2011. Available from: http://www.mhra.gov.uk/home/groups/dts-iac/documents/publication/con2025021.pdf [accessed Dec 2012]</RefTotal> <RefLink>http://www.mhra.gov.uk/home/groups/dts-iac/documents/publication/con2025021.pdf</RefLink> </Reference> <Reference refNo="44"> <RefAuthor>European Commission</RefAuthor> <RefTitle></RefTitle> <RefYear>2012</RefYear> <RefBookTitle>Proposal for a regulation of the European parliament and of the council on medical devices, and amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009</RefBookTitle> <RefPage></RefPage> <RefTotal>European Commission. Proposal for a regulation of the European parliament and of the council on medical devices, and amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009. 2012. Available from: http://ec.europa.eu/health/medical-devices/files/revision_docs/proposal_2012_542_en.pdf [accessed Oct 2013]</RefTotal> <RefLink>http://ec.europa.eu/health/medical-devices/files/revision_docs/proposal_2012_542_en.pdf</RefLink> </Reference> <Reference refNo="45"> <RefAuthor>Vuorenkoski L</RefAuthor> <RefTitle></RefTitle> <RefYear>2008</RefYear> <RefBookTitle>Finland: Health system review</RefBookTitle> <RefPage></RefPage> <RefTotal>Vuorenkoski L. Finland: Health system review. WHO; 2008. (Health Systems in Transition; 10(4)). Available from: http://www.euro.who.int/__data/assets/pdf_file/0007/80692/E91937.pdf [accessed Sept 2011]</RefTotal> <RefLink>http://www.euro.who.int/__data/assets/pdf_file/0007/80692/E91937.pdf</RefLink> </Reference> <Reference refNo="46"> <RefAuthor>Brökelmann J</RefAuthor> <RefTitle>Entwicklung und Bedeutung ambulanter Eingriffe im internationalen Vergleich</RefTitle> <RefYear>2007</RefYear> <RefBookTitle>Ambulantes Operieren</RefBookTitle> <RefPage>1-7</RefPage> <RefTotal>Brökelmann J. Entwicklung und Bedeutung ambulanter Eingriffe im internationalen Vergleich. In: Busse J, Standl T, editors. Ambulantes Operieren. Heidelberg: Springer; 2007. p. 1-7. DOI: 10.1007/978-3-540-68893-8_1</RefTotal> <RefLink>http://dx.doi.org/10.1007/978-3-540-68893-8_1</RefLink> </Reference> <Reference refNo="47"> <RefAuthor>Serra M</RefAuthor> <RefAuthor>Arévalo A</RefAuthor> <RefAuthor>Ortega C</RefAuthor> <RefAuthor>Ripoll A</RefAuthor> <RefAuthor>Giménez N</RefAuthor> <RefTitle>Minor surgery activity in primary care</RefTitle> <RefYear>2010</RefYear> <RefJournal>J Royal Soc Med</RefJournal> <RefPage>469-70</RefPage> <RefTotal>Serra M, Arévalo A, Ortega C, Ripoll A, Giménez N. Minor surgery activity in primary care. J Royal Soc Med. 2010;1(4):469-70. DOI: 10.1258/jrsm.2010.10k046</RefTotal> <RefLink>http://dx.doi.org/10.1258/jrsm.2010.10k046</RefLink> </Reference> <Reference refNo="48"> <RefAuthor>Busse R</RefAuthor> <RefAuthor>Riesberg A</RefAuthor> <RefTitle></RefTitle> <RefYear>2004</RefYear> <RefBookTitle>Health care systems in transition: Germany</RefBookTitle> <RefPage></RefPage> <RefTotal>Busse R, Riesberg A. Health care systems in transition: Germany. Copenhagen: WHO Regional Office for Europe on behalf of the European Observatory on Health Systems and Policies; 2004. (Health Care Systems in Transition; 6(9)). Available from: http://www.euro.who.int/__data/assets/pdf_file/0018/80703/E85472.pdf</RefTotal> <RefLink>http://www.euro.who.int/__data/assets/pdf_file/0018/80703/E85472.pdf</RefLink> </Reference> <Reference refNo="49"> <RefAuthor>Hell M</RefAuthor> <RefAuthor>Pauser G</RefAuthor> <RefTitle>Disinfection for infection prevention over the course of time</RefTitle> <RefYear>2007</RefYear> <RefJournal>GMS Krankenhaushyg Interdiszip</RefJournal> <RefArticleNo>Doc16</RefArticleNo> <RefTotal>Hell M, Pauser G. Disinfection for infection prevention over the course of time. GMS Krankenhaushyg Interdiszip. 2007;2(1):Doc16. Available from: http://www.egms.de/en/journals/dgkh/2007-2/dgkh000049.shtml</RefTotal> <RefLink>http://www.egms.de/en/journals/dgkh/2007-2/dgkh000049.shtml</RefLink> </Reference> <Reference refNo="75"> <RefAuthor>Working Group Medical Devices (AGMP)</RefAuthor> <RefTitle></RefTitle> <RefYear>2006</RefYear> <RefBookTitle>Anlage 2 zur Verfahrensanweisung Überwachung der Medizinprodukte Betreiberverordnung</RefBookTitle> <RefPage></RefPage> <RefTotal>Working Group Medical Devices (AGMP). Anlage 2 zur Verfahrensanweisung Überwachung der Medizinprodukte Betreiberverordnung. Arbeitsgruppe Medizinprodukte; 2006.</RefTotal> </Reference> <Reference refNo="51"> <RefAuthor>Troop P</RefAuthor> <RefTitle></RefTitle> <RefYear>2001</RefYear> <RefBookTitle>Single-use instruments for tonsil and adenoid surgery</RefBookTitle> <RefPage></RefPage> <RefTotal>Troop P. Single-use instruments for tonsil and adenoid surgery. Department of Health, UK; 2001. Available from: http://webarchive.nationalarchives.gov.uk/20130107105354/http://www.dh.gov.uk/prod_consum_dh/groups/dh_digitalassets/@dh/@en/documents/digitalasset/dh_4014167.pdf [accessed Dec 2012])</RefTotal> <RefLink>http://webarchive.nationalarchives.gov.uk/20130107105354/http://www.dh.gov.uk/prod_consum_dh/groups/dh_digitalassets/@dh/@en/documents/digitalasset/dh_4014167.pdf</RefLink> </Reference> <Reference refNo="52"> <RefAuthor>Murdoch H</RefAuthor> <RefAuthor>Taylor D</RefAuthor> <RefAuthor>Dickinson J</RefAuthor> <RefAuthor>Walker JT</RefAuthor> <RefAuthor>Perrett D</RefAuthor> <RefAuthor>Raven ND</RefAuthor> <RefAuthor>Sutton JM</RefAuthor> <RefTitle>Surface decontamination of surgical instruments: an ongoing dilemma</RefTitle> <RefYear>2006</RefYear> <RefJournal>J Hosp Inf</RefJournal> <RefPage>432-8</RefPage> <RefTotal>Murdoch H, Taylor D, Dickinson J, Walker JT, Perrett D, Raven ND, Sutton JM. Surface decontamination of surgical instruments: an ongoing dilemma. J Hosp Inf. 2006 Aug; 63(4):432-8. </RefTotal> </Reference> <Reference refNo="53"> <RefAuthor>Koczorek M</RefAuthor> <RefTitle>Aufbereitung von Medizinprodukten – Expertengruppe „smdr“ will Qualität erhöhen und Missstände aufdecken</RefTitle> <RefYear>2008</RefYear> <RefJournal>Anästhesiol Intensivmed Notfallmed Schmerzther</RefJournal> <RefPage>562-4</RefPage> <RefTotal>Koczorek M. Aufbereitung von Medizinprodukten – Expertengruppe „smdr“ will Qualität erhöhen und Missstände aufdecken. Anästhesiol Intensivmed Notfallmed Schmerzther. 2008;43(7/8):562-4. DOI: 10.1055/s-0028-1083101</RefTotal> <RefLink>http://dx.doi.org/10.1055/s-0028-1083101</RefLink> </Reference> <Reference refNo="54"> <RefAuthor>von Woedtke T</RefAuthor> <RefAuthor>Kramer A</RefAuthor> <RefTitle>Grenzen der Sterilisationssicherheit</RefTitle> <RefYear>2008</RefYear> <RefBookTitle>Wallhäußers Praxis der Sterilisation, Desinfektion, Antiseptik und Konservierung. Qualitätssicherung der Hygiene in Industrie, Pharmazie und Medizin</RefBookTitle> <RefPage>110-6</RefPage> <RefTotal>von Woedtke T, Kramer A. Grenzen der Sterilisationssicherheit. In: Kramer A, Assadian O, editors. Wallhäußers Praxis der Sterilisation, Desinfektion, Antiseptik und Konservierung. Qualitätssicherung der Hygiene in Industrie, Pharmazie und Medizin. Stuttgart: Thieme; 2008. p. 110-6.</RefTotal> </Reference> <Reference refNo="55"> <RefAuthor>Barbash GI</RefAuthor> <RefAuthor>Glied SA</RefAuthor> <RefTitle>New technology and health care costs – the case of robot-assisted surgery</RefTitle> <RefYear>2010</RefYear> <RefJournal>N Engl J Med</RefJournal> <RefPage>701-4</RefPage> <RefTotal>Barbash GI, Glied SA. New technology and health care costs – the case of robot-assisted surgery. N Engl J Med. 2010 Aug;363(8):701-4. DOI: 10.1056/NEJMp1006602</RefTotal> <RefLink>http://dx.doi.org/10.1056/NEJMp1006602</RefLink> </Reference> <Reference refNo="56"> <RefAuthor>Wehrl M</RefAuthor> <RefAuthor>Michels W</RefAuthor> <RefTitle>Methode zur Prüfung der Reinigung von Robotik-Instrumenten der minimal invasiven Chirurgie</RefTitle> <RefYear>2013</RefYear> <RefJournal>Zentralsteril</RefJournal> <RefPage>195-200</RefPage> <RefTotal>Wehrl M, Michels W. Methode zur Prüfung der Reinigung von Robotik-Instrumenten der minimal invasiven Chirurgie. Zentralsteril. 2013;3:195-200.</RefTotal> </Reference> <Reference refNo="57"> <RefAuthor>Düwel B</RefAuthor> <RefTitle>Kostenreduktion durch Qualitätsmanagement in der Hygiene am Beispiel des Universitätsklinikums Greifswald. Dissertation. Medizinische Fakultät Universität Greifswald</RefTitle> <RefYear>URN:</RefYear> <RefJournal>2003</RefJournal> <RefPage>9-200312-8</RefPage> <RefTotal>Düwel B. Kostenreduktion durch Qualitätsmanagement in der Hygiene am Beispiel des Universitätsklinikums Greifswald. Dissertation. Medizinische Fakultät Universität Greifswald. 2003. URN: urn:nbn:de:gbv:9-200312-8</RefTotal> <RefLink>http://nbn-resolving.org/urn:nbn:de:gbv:9-200312-8</RefLink> </Reference> <Reference refNo="58"> <RefAuthor>Assadian O</RefAuthor> <RefAuthor>Daeschlein G</RefAuthor> <RefAuthor>Kramer A</RefAuthor> <RefTitle>Die Bedeutung der infizierten Problemwunde für den Hygieniker und Mikrobiologen sowie ökonnomische Aspekte der chronischen Wunde</RefTitle> <RefYear>2006</RefYear> <RefJournal>GMS Krankenaushygiene Interdiszipl</RefJournal> <RefArticleNo>Doc30</RefArticleNo> <RefTotal>Assadian O, Daeschlein G, Kramer A. Die Bedeutung der infizierten Problemwunde für den Hygieniker und Mikrobiologen sowie ökonnomische Aspekte der chronischen Wunde [The importance of infected problem wounds for the hygienist and microbiologist and economic aspects of chronic wounds]. GMS Krankenaushygiene Interdiszipl. 2006;1(1):Doc30. Available from: http://www.egms.de/en/journals/dgkh/2006-1/dgkh000030.shtml</RefTotal> <RefLink>http://www.egms.de/en/journals/dgkh/2006-1/dgkh000030.shtml</RefLink> </Reference> <Reference refNo="59"> <RefAuthor>Hübner C</RefAuthor> <RefAuthor>Hübner NO</RefAuthor> <RefAuthor>Wilke F</RefAuthor> <RefAuthor>Fleßa S</RefAuthor> <RefTitle>Nosokomiale Infektionen aus wirtschaftlicher Sicht</RefTitle> <RefYear>2012</RefYear> <RefBookTitle>Krankenhaus- und Praxishygiene. Hygienemanagement und Infektionsprävention in medizinischen und sozialen Einrichtungen</RefBookTitle> <RefPage>539-42</RefPage> <RefTotal>Hübner C, Hübner NO, Wilke F, Fleßa S. Nosokomiale Infektionen aus wirtschaftlicher Sicht. In: Kramer A, Assadian O, Exner M, Hübner NO, Simon A, editors. Krankenhaus- und Praxishygiene. Hygienemanagement und Infektionsprävention in medizinischen und sozialen Einrichtungen. München: Urban Fischer; 2012. p. 539-42.</RefTotal> </Reference> <Reference refNo="60"> <RefAuthor>Hübner C</RefAuthor> <RefAuthor>Hübner NO</RefAuthor> <RefAuthor>Muhr M</RefAuthor> <RefAuthor>Claus F</RefAuthor> <RefAuthor>Leesch H</RefAuthor> <RefAuthor>Kramer A</RefAuthor> <RefAuthor>Fleßa S</RefAuthor> <RefTitle>Kostenanalyse der stationär behandelten Clostridium difficile-assoziierten Diarrhö (CDAD)</RefTitle> <RefYear>2013</RefYear> <RefJournal>Gesundh ökon Qual manag</RefJournal> <RefPage>80-5</RefPage> <RefTotal>Hübner C, Hübner NO, Muhr M, Claus F, Leesch H, Kramer A, Fleßa S. Kostenanalyse der stationär behandelten Clostridium difficile-assoziierten Diarrhö (CDAD) [Cost Analysis of Hospitalized Clostridium Difficile-Associated Diarrhea (CDAD)]. Gesundh ökon Qual manag. 2013;18(2):80-5. DOI: 10.1055/s-0032-1330635</RefTotal> <RefLink>http://dx.doi.org/10.1055/s-0032-1330635</RefLink> </Reference> <Reference refNo="61"> <RefAuthor>Tübbicke A</RefAuthor> <RefAuthor>Hübner C</RefAuthor> <RefAuthor>Hübner NO</RefAuthor> <RefAuthor>Wegner C</RefAuthor> <RefAuthor>Kramer A</RefAuthor> <RefAuthor>Fleßa S</RefAuthor> <RefTitle>Cost comparison of MRSA screening and management – a decision tree analysis</RefTitle> <RefYear>2012</RefYear> <RefJournal>BMC Health Serv Res</RefJournal> <RefPage>438</RefPage> <RefTotal>Tübbicke A, Hübner C, Hübner NO, Wegner C , Kramer A, Fleßa S. Cost comparison of MRSA screening and management – a decision tree analysis. BMC Health Serv Res. 2012;12:438. DOI: 10.1186/1472-6963-12-438</RefTotal> <RefLink>http://dx.doi.org/10.1186/1472-6963-12-438</RefLink> </Reference> <Reference refNo="62"> <RefAuthor>Leisten R</RefAuthor> <RefAuthor>Becker A</RefAuthor> <RefAuthor>Prischepov N</RefAuthor> <RefTitle>Krankenhaus- und Praxishygiene aus wirtschaftlicher Sicht</RefTitle> <RefYear>2012</RefYear> <RefBookTitle>Krankenhaus- und Praxishygiene. Hygienemanagement und Infektionsprävention in medizinischen und sozialen Einrichtungen</RefBookTitle> <RefPage>533-9</RefPage> <RefTotal>Leisten R, Becker A, Prischepov N. Krankenhaus- und Praxishygiene aus wirtschaftlicher Sicht. In: Kramer A, Assadian O, Exner M, Hübner NO, Simon A, editors. Krankenhaus- und Praxishygiene. Hygienemanagement und Infektionsprävention in medizinischen und sozialen Einrichtungen. München: Urban Fischer; 2012. p. 533-9.</RefTotal> </Reference> <Reference refNo="63"> <RefAuthor>Rutala WA</RefAuthor> <RefTitle>Disinfection and sterilization of patient-care items</RefTitle> <RefYear>1996</RefYear> <RefJournal>Infect Control Hosp Epidemiol</RefJournal> <RefPage>377-84</RefPage> <RefTotal>Rutala WA. Disinfection and sterilization of patient-care items. Infect Control Hosp Epidemiol. 1996 Jun;17(6):377-84. DOI: 10.1086/647324</RefTotal> <RefLink>http://dx.doi.org/10.1086/647324</RefLink> </Reference> <Reference refNo="64"> <RefAuthor>von Eiff C</RefAuthor> <RefAuthor>Kohnen W</RefAuthor> <RefAuthor>Becker K</RefAuthor> <RefAuthor>Jansen B</RefAuthor> <RefTitle>Modern strategies in the prevention of implant-associated infections</RefTitle> <RefYear>2005</RefYear> <RefJournal>Int J Artif Organs</RefJournal> <RefPage>1146-56</RefPage> <RefTotal>von Eiff C, Kohnen W, Becker K, Jansen B. Modern strategies in the prevention of implant-associated infections. Int J Artif Organs. 2005 Nov;28(11):1146-56.</RefTotal> </Reference> <Reference refNo="65"> <RefAuthor>DGSV Quality Task Group</RefAuthor> <RefTitle>Commentary by the Quality Task Group of the German Society of Sterile Supply (DGSV) on the topic of the “Hygiene Scandal”</RefTitle> <RefYear>2011</RefYear> <RefJournal>Zentralsteril</RefJournal> <RefPage>144</RefPage> <RefTotal>DGSV Quality Task Group.Commentary by the Quality Task Group of the German Society of Sterile Supply (DGSV) on the topic of the “Hygiene Scandal”. Zentralsteril. 2011;19(2):144.</RefTotal> </Reference> <Reference refNo="66"> <RefAuthor>König K</RefAuthor> <RefAuthor>Rudolph P</RefAuthor> <RefAuthor>Berscheid R</RefAuthor> <RefAuthor>Kramer A</RefAuthor> <RefTitle>Sterilgutversorgung (ZSV)</RefTitle> <RefYear>2012</RefYear> <RefBookTitle>Krankenhaus- und Praxishygiene. Hygienemanagement und Infektionsprävention in medizinischen und sozialen Einrichtungen</RefBookTitle> <RefPage>432-8</RefPage> <RefTotal>König K, Rudolph P, Berscheid R, Kramer A. Sterilgutversorgung (ZSV). In: Kramer A, Assadian O, Exner M, Hübner NO, Simon A, editors. Krankenhaus- und Praxishygiene. Hygienemanagement und Infektionsprävention in medizinischen und sozialen Einrichtungen. München: Urban Fischer; 2012. p. 432-8.</RefTotal> </Reference> <Reference refNo="67"> <RefAuthor>Galekop T</RefAuthor> <RefTitle>Sterilization. Past and future</RefTitle> <RefYear>2011</RefYear> <RefJournal>World Forum for Hospital Sterile Supply (WFHSS)</RefJournal> <RefPage></RefPage> <RefTotal>Galekop T. Sterilization. Past and future. World Forum for Hospital Sterile Supply (WFHSS). 2011. Available from: http://www.wfhss.com/html/educ/articles/educarticle_0002.htm [accessed Sept 2011]</RefTotal> <RefLink>http://www.wfhss.com/html/educ/articles/educarticle_0002.htm</RefLink> </Reference> <Reference refNo="68"> <RefAuthor>Peißker M</RefAuthor> <RefAuthor> Deutsche Gesellschaft für Sterilgutversorgung</RefAuthor> <RefTitle>Entwicklung eines Berufsbildes für Mitarbeiter in der Medizinprodukteaufbereitung. Brief an das Wirtschaftsministerium</RefTitle> <RefYear></RefYear> <RefTotal>Peißker M; Deutsche Gesellschaft für Sterilgutversorgung. Entwicklung eines Berufsbildes für Mitarbeiter in der Medizinprodukteaufbereitung. Brief an das Wirtschaftsministerium. Available from: http://www.dgsv-ev.de/conpresso/_data/Brief_an_Wirtschaftsministerium.pdf [accessed Sept 2012]</RefTotal> <RefLink>http://www.dgsv-ev.de/conpresso/_data/Brief_an_Wirtschaftsministerium.pdf</RefLink> </Reference> <Reference refNo="69"> <RefAuthor>Voegeli-Wagner L</RefAuthor> <RefAuthor>Peichl O</RefAuthor> <RefAuthor>Blum KH</RefAuthor> <RefAuthor>Happel S</RefAuthor> <RefAuthor>Barthel R</RefAuthor> <RefTitle>Aufbereitung von Medizinprodukten - Erwerb der Sachkenntnis in der Berufsausbildung für Medizinische Fachangestellte</RefTitle> <RefYear>2011</RefYear> <RefJournal>Hess Ärztebl</RefJournal> <RefPage>747-8</RefPage> <RefTotal>Voegeli-Wagner L, Peichl O, Blum KH, Happel S, Barthel R. Aufbereitung von Medizinprodukten - Erwerb der Sachkenntnis in der Berufsausbildung für Medizinische Fachangestellte. Hess Ärztebl. 2011;72(12):747-8. Available from: http://www.laekh.de/upload/Hess._Aerzteblatt/2011/2011_12/2011_12_07.pdf</RefTotal> <RefLink>http://www.laekh.de/upload/Hess._Aerzteblatt/2011/2011_12/2011_12_07.pdf</RefLink> </Reference> <Reference refNo="70"> <RefAuthor>DGSV Quality Task Group</RefAuthor> <RefTitle>Empfehlung des Fachausschusses Qualität (AK Qualität). Zusammenarbeit mit dem OP und anderen Abteilungen</RefTitle> <RefYear>2012</RefYear> <RefJournal>Zentralsteril</RefJournal> <RefPage>131-3</RefPage> <RefTotal>DGSV Quality Task Group. Empfehlung des Fachausschusses Qualität (AK Qualität). Zusammenarbeit mit dem OP und anderen Abteilungen [Recommendation by the Quality Task Group of the German Society of Sterile Supply (DGSV)]. Zentralsteril. 2012 Feb;20(2):131-3.</RefTotal> </Reference> <Reference refNo="71"> <RefAuthor>Hessian Ministry of Social Affairs</RefAuthor> <RefTitle></RefTitle> <RefYear>2013</RefYear> <RefBookTitle>Leitfaden Arbeitsschutzorganisation</RefBookTitle> <RefPage></RefPage> <RefTotal>Hessian Ministry of Social Affairs, editor. Leitfaden Arbeitsschutzorganisation. 4th edition. Wiesbaden: Hessisches Sozialministerium; 2013. Available from: http://www.sozialnetz.de/global/show_document.asp?id=aaaaaaaaaaahezm</RefTotal> <RefLink>http://www.sozialnetz.de/global/show_document.asp?id=aaaaaaaaaaahezm</RefLink> </Reference> <Reference refNo="72"> <RefAuthor>Federal Ministry of Health</RefAuthor> <RefTitle></RefTitle> <RefYear>2008</RefYear> <RefBookTitle>Erfahrungsbericht zur Aufbereitung von Medizinprodukten in Deutschland</RefBookTitle> <RefPage></RefPage> <RefTotal>Federal Ministry of Health. Erfahrungsbericht zur Aufbereitung von Medizinprodukten in Deutschland. Bonn/Berlin: Bundesministerium für Gesundheit; 2008. Available from: http://www.bmg.bund.de/fileadmin/dateien/Downloads/M/Medizinprodukte/Medizin_Produkte_Erfahrungsbericht_zur_Aufbereitung_von_Medizinprodukten_in_Deutschland.pdf [accessed Dec 2012]</RefTotal> <RefLink>http://www.bmg.bund.de/fileadmin/dateien/Downloads/M/Medizinprodukte/Medizin_Produkte_Erfahrungsbericht_zur_Aufbereitung_von_Medizinprodukten_in_Deutschland.pdf</RefLink> </Reference> <Reference refNo="73"> <RefAuthor>Nyström B</RefAuthor> <RefTitle>Forty years of control of healthcare-associates infections in Scandinavia</RefTitle> <RefYear>2007</RefYear> <RefJournal>GMS Krankenhaushygiene Interdiszip</RefJournal> <RefArticleNo>Doc09</RefArticleNo> <RefTotal>Nyström B. Forty years of control of healthcare-associates infections in Scandinavia. GMS Krankenhaushygiene Interdiszip. 2007;2(1):Doc09. Available from: http://www.egms.de/en/journals/dgkh/2007-2/dgkh000042.shtml</RefTotal> <RefLink>http://www.egms.de/en/journals/dgkh/2007-2/dgkh000042.shtml</RefLink> </Reference> <Reference refNo="74"> <RefAuthor>Kramer A</RefAuthor> <RefAuthor>Exner M</RefAuthor> <RefAuthor>Simon A</RefAuthor> <RefAuthor>Assadian O</RefAuthor> <RefAuthor>Kramer B</RefAuthor> <RefAuthor>Dornquast T</RefAuthor> <RefTitle>Organisation der Krankenhaushygiene</RefTitle> <RefYear>2012</RefYear> <RefBookTitle>Krankenhaus- und Praxishygiene. Hygienemanagement und Infektionsprävention in medizinischen und sozialen Einrichtungen</RefBookTitle> <RefPage>549-51</RefPage> <RefTotal>Kramer A, Exner M, Simon A, Assadian O, Kramer B, Dornquast T. Organisation der Krankenhaushygiene. In: Kramer A, Assadian O, Exner M, Hübner NO, Simon A, editors. Krankenhaus- und Praxishygiene. Hygienemanagement und Infektionsprävention in medizinischen und sozialen Einrichtungen. München: Urban Fischer; 2012. p. 549-51.</RefTotal> </Reference> <Reference refNo="76"> <RefAuthor>Fuchs H</RefAuthor> <RefTitle>Behördliche Überwachung in Einrichtungen für ambulantes Operieren</RefTitle> <RefYear>2010</RefYear> <RefJournal>Ärztebl Mecklenb Vorpom</RefJournal> <RefPage>331-3</RefPage> <RefTotal>Fuchs H. Behördliche Überwachung in Einrichtungen für ambulantes Operieren. Ärztebl Mecklenb Vorpom. 2010;19:331-3. Available from: http://www.aekmv.de/upload/file/aerzte/Aerzteblatt/2010/heft_09_2010.pdf</RefTotal> <RefLink>http://www.aekmv.de/upload/file/aerzte/Aerzteblatt/2010/heft_09_2010.pdf</RefLink> </Reference> <Reference refNo="77"> <RefAuthor>Thiede B</RefAuthor> <RefAuthor>Wirtz A</RefAuthor> <RefAuthor>Voegeli-Wagner L</RefAuthor> <RefAuthor>Arvand M</RefAuthor> <RefTitle>Schwerpunktaktion zur Verbesserung des Hygienemanagements in Einrichtungen für ambulantes Operieren in Hessen</RefTitle> <RefYear>2011</RefYear> <RefJournal>Hess Ärztebl</RefJournal> <RefPage>745-6</RefPage> <RefTotal>Thiede B, Wirtz A, Voegeli-Wagner L, Arvand M. Schwerpunktaktion zur Verbesserung des Hygienemanagements in Einrichtungen für ambulantes Operieren in Hessen. Hess Ärztebl. 2011;72(12):745-6. Available from: http://www.laekh.de/upload/Hess._Aerzteblatt/2011/2011_12/2011_12_06.pdf</RefTotal> <RefLink>http://www.laekh.de/upload/Hess._Aerzteblatt/2011/2011_12/2011_12_06.pdf</RefLink> </Reference> </References> <Media> <Tables> <Table format="png"> <MediaNo>1</MediaNo> <MediaID>1</MediaID> <Caption><Pgraph><Mark1>Table 1: Analyzed issues</Mark1></Pgraph></Caption> </Table> <Table format="png"> <MediaNo>2</MediaNo> <MediaID>2</MediaID> <Caption><Pgraph><Mark1>Table 2: Organization guideline for CSSD</Mark1></Pgraph></Caption> </Table> <NoOfTables>2</NoOfTables> </Tables> <Figures> <Figure format="png" height="303" width="760"> <MediaNo>1</MediaNo> <MediaID>1</MediaID> <Caption><Pgraph><Mark1>Figure1: Deficiencies (mean of 6 features per deficiency group) at medical practitioners’ offices depending on the date of establishment</Mark1></Pgraph></Caption> </Figure> <Figure format="png" height="307" width="752"> <MediaNo>2</MediaNo> <MediaID>2</MediaID> <Caption><Pgraph><Mark1>Figure 2: Deficiencies (mean of 6 features per deficiency group) in the CSSD, depending on the date of establishment</Mark1></Pgraph></Caption> </Figure> <Figure format="png" height="297" width="760"> <MediaNo>3</MediaNo> <MediaID>3</MediaID> <Caption><Pgraph><Mark1>Figure 3: Deficiencies (mean of 6 features per deficiency group) of medical practices, depending on implementation of a quality management system (QMS)</Mark1></Pgraph></Caption> </Figure> <Figure format="png" height="291" width="760"> <MediaNo>4</MediaNo> <MediaID>4</MediaID> <Caption><Pgraph><Mark1>Figure 4: Deficiencies (mean of 6 features per deficiency group) of medical practices, depending on the frequency of the decontamination process</Mark1></Pgraph></Caption> </Figure> <Figure format="png" height="734" width="753"> <MediaNo>5</MediaNo> <MediaID>5</MediaID> <Caption><Pgraph><Mark1>Figure 5: Cost estimation depending on the number of items for medical devices without special requirements for the reprocessing process</Mark1></Pgraph></Caption> </Figure> <NoOfPictures>5</NoOfPictures> </Figures> <InlineFigures> <NoOfPictures>0</NoOfPictures> </InlineFigures> <Attachments> <NoOfAttachments>0</NoOfAttachments> </Attachments> </Media> </OrigData> </GmsArticle>