On the occasion of its 11th annual congress, the
German Society of Sterile Supply (DGSV) settled for a new venue: this year's conference was held in the "geographic centre" of Germany, in Fulda, so as to ensure that the journey would not be too long for anyone. The congress also began in the afternoon and finished in the afternoon too, so that arrival and departure was possible at the same time on each day.
This year there was not just one topic on the agenda, but rather a diverse range of topics. Accordingly, the talks were equally varied. The first talk was given by Sigrid Krüger and Martin Held on the subject of "The influence exerted by measurements in the cleaning and disinfection process and their practical relevance". They described loggers as used for various process parameters (temperature, pressure, pH value, conductance). The advantage of loggers, which undergo the cleaning and disinfection process together with the medical devices (MDs) and are able to continually record important variables, resides in the fact that the process need not be interrupted to withdraw the sample. The values obtained are not merely spot checks, such as is the case for the measurements carried out on samples of the cleaning solution using hand-held measuring instruments. As such, these loggers are important tools for control and troubleshooting purposes, providing for process optimisation and, thus, for qualification of the equipment in use.
Some detergents are better than others
Verona Schmidt described "Development trends for enhancement of process safety". She stressed that the cleaning performance played a pivotal role in decontamination. This belief had been reinforced by new challenges such as the discovery of prions, which could not be eliminated by conventional disinfection measures, as well as increasingly more intricate, primarily heat-sensitive medical devices. Hence the positive attributes of alkaline detergents had been eliciting increasingly more interest. Mrs Schmidt presented studies conducted to find out whether and under what circumstances alkaline detergents exhibited antimicrobial efficacy. To that effect the microbicidal properties of six alkaline detergents and two aldehyde-based disinfectants were compared. The results demonstrated that the aldehyde-based disinfectants were endowed with the best microbicidal efficacy. Of the alkaline detergents, only one detergent showed comparable microbicidal efficacy, which excelled thanks to, among other things, its surfactant content. It was possible to demonstrate that under the use conditions prevailing in a chemothermal disinfection process this detergent was also endowed with virucidal efficacy as well as with a prion-destabilising effect. These additional characteristics held out completely novel prospects for designing decontamination processes in the future. Application examples included the use of such a product in modern standard cleaning processes, while conferring the additional benefits of a disinfectant and prion-destabilising action. Mrs Schmidt stressed that these properties were not present in all alkaline detergents; the composition of the individual product was decisive.
New standard for steam sterilisation
Dieter Achterberg outlined the implications of DIN EN ISO 17665 (sterilisation with moist heat) on decontamination practices. He stated that, as from August 2009, DIN EN ISO 17665-1 of November 2006 would serve as the new reference standard, since DIN EN 554 would have to be withdrawn by that date in accordance with the regulations. The new standard was essentially more comprehensive than DIN EN 554 used hitherto. It dealt with all moist-heat processes, whereas DIN EN 554 was confined to processes based on the direct effect of saturated steam on the sterile supplies. Furthermore, DIN EN ISO 17665-1 dealt in detail with the process development and description of processes, something that was particularly important for manufacturers.
The standard also contained new sections on process challenge devices as well as on quality management.
Mr Achterberg pointed out that the efforts to achieve an international compromise had given rise to a very "open standard", that made no reference at all, for example, to numerical requirements for specifications. Hence in practical terms where validation of processes and routine operation were concerned this standard needed to be interpreted and supplemented if it was going to be of any use as a guide to everyday activities. Achterberg finished off by expressing the hope that an appropriate document (e.g. in the form of a recommendation or technical report) would be drafted.
Cooperation sought: workshops' results
The workshops held in the afternoon and repeated on the second day of the congress dealt on this occasion with the topics of "Managing repairs in a modern CSSD", "Decontamination and value preservation of MIS instruments" as well as "Validation of processes in a washer-disinfector (WD)".
For the first time, a session was devoted at the end of the congress to summarising the workshops, while presenting the various results.
In Workshop 1 Stephan Knoefel from the company Schnorrenberg spoke about management of repairs. In that respect, driver systems and optics as well as increasingly more complex systems used in the MIS and HF area presented a special challenge. Cooperation with specialist workshops, distributors or manufacturers was therefore often needed. In general this meant that the instruments left the hospital and were not available to the users for a certain period of time. Hence it was important to organise a system that guaranteed the fastest turnaround time possible. The quality management system used here called for clear structures and sequences as well as documentation processes which, in the meantime, were largely computerised. Together with the participants describing problem area as well as positive and negative experiences, Knoefel stressed that an appropriate repairs' management system could also serve as a component for cost control. As such, timely maintenance helped to detect damage on time, thus avoiding expensive long-term effects that could mean that the instrument would have to be replaced.
Workshop 2 focused on value preservation of instruments. Here too close cooperation was needed between reprocessors and manufacturers. Decisive factors related for example to the arrangement of instruments in the loading rack and appropriate adaptor systems. Incompatible cleaning processes, unsuitable reprocessing media or inadequate care could lead to premature wear of highly valuable instruments. Repairs carried out by unqualified persons often resulted in consequential damage to other system components.
Mr Haas stated that the most important aim was to ensure that hygiene requirements were assured for the instrument. Hygienic criteria had to take precedence over economic considerations. The workshop participants were unanimous that instruments sent for repair had to be decontaminated before dispatch. Care should be taken when dealing with non-authorised repair centres since they did not have at their disposal the instruments' original dimensions and spare parts.
In Workshop 3 the team of authors who compiled the WD Guideline were available to answer questions on conductance of validation of WD processes. Robert Eibl reported on additional topics covered since publication of the Guideline in November 2006, such as how to deal with hollow devices and anaesthesia accessories.
He also presented a list of the frequently asked questions (FAQs), which could be answered during the workshop. He gave an overview of the issues that often caused uncertainty among users:
- The normal process sequence had to be observed during validation
- The processes had to be reproducible and documented by independent measurements
- Maintenance comprised inspection, repairs and upkeep; this had to also take account, for example, of the loading trolleys whose connections were often not checked. Malfunctioning connections could lead to loss of pressure.
- Calibration of instruments was not to be equated with adjustment where settings were actually carried out on the instrument. Eibl stated that what was important here was that the person carrying out the task had the level of expertise required.
The CSSD as a business enterprise
The second day of the congress began with the economic aspects of the "CSSD Services Enterprise". H.-J. Kleindienst, Munich, reported on the CSSD as a business enterprise and on quality management in an age of increasing cost pressures. The current trends in the healthcare sectors called for a high degree of strategic planning to strike a balance between quality requirements and economic considerations. Mr Kleindienst reported on the organisational form used at Munich Municipal Hospital (StKM) and described frequent weak links in the organisation. The aim was to assure the legal, economic and organisational outline conditions needed for a tray-related calculation system, down to the individual medical device and specific to the investment involved. An important milestone was thus the provision of concrete structures oriented towards the sterile supplies' circuit, up to the time of delivery to the clients (surgical and other specialist departments, etc.) To that effect, workflow patterns had to be expertly planned, structured, implemented, reviewed and updated. This called for, first of all, thorough knowledge of the actual state: what trays were available, how were they labelled, was this labelling system uniform, how much "dead capital" did the inventory contain etc.? Savings of up to 30% could be made by optimising the loading patterns. Mr Kleindienst described the implementation of organisational measures aimed at optimising the CSSD at Munich Municipal Hospital, and finished off by stressing that quality assurance also ultimately meant a reduction in costs. Here staff represented an important factor; in view of the fact that many people with different backgrounds were involved, it was important that the existing level of knowledge was constantly reviewed and updated.
Barbara Everbeck from Bielefeld described the formulation of a marketing concept for the CSSD. At the Bielefeld Protestant Hospital (EvKB) medical devices belonging to the "Group C" classification were reprocessed at the Johannesstift site. It was thus decided to introduce a quality management system based on DIN EN ISO 13485 for the entire CSSD, and following certification to provide medical device reprocessing services as a professional partner to independent medical practitioners, outpatient surgery departments, medical care centres and smaller hospitals. Frau Everbeck described concepts devised for client acquisition as well as the pros and cons for the external client. For example, it was generally necessary to keep a greater stock of instruments to deal with exchange times. But the service provider hospital had to also make investments, e.g. in hiring and training extra staff. However, Everbeck stated that the provision of comprehensive medical device decontamination services overall produced satisfactory results for the external clients, who through using the service entered into another form of cooperation with the hospital.
Peter Schauerte, from Meschede, described the drafting of a service contract. Many hospitals had to decide whether internal reprocessing of their medical devices paid off in light of the technical, human resources' and quality-assurance requirements to be met or whether it would be better to outsource medical device reprocessing to other hospitals or specialist firms. If an establishment were to decide in favour of "In-house decontamination also for third parties", the operators of such an establishment would then have to face the issue of what the contract would have to cover. Apart from business management issues, top priority would have to be ascribed to the reprocessing quality, regulated by the legal guidelines and standards governing medical device decontamination. Based on these specifications an outline contract could be drafted. What was important here was to draft a contract tailored to individual needs. While the existing legal regulations must not be transgressed, both parties to the contract could avail of customised and hence structure-related quality assurance. The contract should cover the following points: title, parties to the contract, subject of the contract, scope of services, contractual terms, operational prerequisites, quality management system, expert consultation, liability law and liability queries, pricing and invoicing, date at which the contract would come into force (for example, did this also entail any trial period?) and period of validity as well as pertinent documentation. As such, transparency of the entire decontamination process was absolutely indispensable. Schauerte stated that all issues had to be set out in detail to avoid liability problems, e.g. during transportation, often caused by staff who did not have the required expertise, or relating to storage. Such a contract compelled both parties to observe, in the interest of the wellbeing of the patients entrusted to their care, the provisions of the laws and regulations, and ultimately the targets set by themselves.
Sterilisation of heat-sensitive medical devices
A completely different topic was dealt with by R. Salzbrunn in his talk: sterilisation with ethylene oxide (EO). Increasingly more importance was being given to low-temperature sterilisation processes due to the never-ending stream of new requirements in the field of medicine. Approx. 80% of all heat-sensitive medical devices first placed on the market worldwide were sterilised with EO processes. The most important characteristic of EO was its pronounced permeation facility. Having given an overview of the initial attempts to use EO sterilisation, something that no one should seek to emulate, Mr Salzbrunn went on to describe validation and parametric release of EO processes that also entailed desorption of medical devices as per ISO 10993/7.
Frank Hintermaier reported on inspections by the statutory authorities from the perspective of a service provider. In the context of inspections by the statutory authorities no distinction was made in principle between a (external) provider of medical device reprocessing services and a CSSD performing this task in-house for its own needs - after all, what was being inspected here was the actual outcome of decontamination practices. In the meantime the main focus of inspections was on the details of reprocessing. Unfortunately, structural problems relating to medical device decontamination were often ignored, as Herr Hintermaier could demonstrate on the basis of a few current photos. This trend, too, was due to a scarcity of resources. To finish off, Hintermaier advised that a relaxed attitude be adopted to dealings with the authorities. This inspection often served as an important catalyst for change.
The festivities of the evening event were sampled by some people far beyond midnight, hence the wisdom of repeating this congress format was immediately clear: the next day's programme only lasted till midday.
Apart from summarising the results of the workshops, on the last morning of the congress there was also a talk by Thomas Kießling who spoke about certification of decontamination as per DIN EN ISO 13485 in conjunction with the RKI/BfArM* recommendation. Certification pursuant to DIN EN ISO 13485 in conjunction with the RKI/BfArM recommendation may only be carried out by specially accredited bodies. Mr Kießling reported on the evaluation of some 50 audits of the first accredited certification firms, highlighting the strengths and weaknesses of the QM systems. Kießling stated that in principle decontamination processes in hospitals or reprocessing firms, which had a certified quality management system based on DIN EN ISO 13485 in conjunction with the RKI/BfArM recommendation, were of a high level. But there was room for improvement in particular as regards validation of certain processes (especially for low-temperature sterilisation with H2O2), evaluation of manufacturers' instructions and risk management. It was important not only to carry out classification as per the RKI/BfArM recommendation but also to document this. Working procedures that were taken for granted had also to be set out in writing.
The most vital component of a well-functioning system was in particular, to cite Kießling, its management: the system had to have the support of the department management in order to be properly implemented. This would become clear during monitoring or repeat audits carried out at annual or 3 to 5 yearly intervals.
And that brought to a close a successful congress by virtue of whose varied agenda each delegate learned something important for their everyday working life. In that spirit there was much praise expressed in the closing session for the organisational setup and choice of venue - so having the courage to embark on a new pathway has already paid off. The next DGSV annual conference will probably take place between 2 and 4 October 2008 in Potsdam.
Dr. Gudrun Westermann
* RKI: Robert Koch Institute
BfArM: German Federal Institute for Drugs and Medical Devices