Conference Report

Already at the very outset of this year’s EFHSS Congress in Winterthur it became clear that the "European" frontiers stretch further than generally thought. The delegates had come from a total of 25 countries, including Australia and Zimbabwe, as announced by Peter Weber in his opening speech.

Another reason for celebration was the 20th jubilee of the Swiss Society for Sterile Supply (SGSV), which had taken charge of organising the congress. A short welcome by the mayor of the city of Winterthur was followed by the opening speech in three languages - German by Peter Weber, French by Frédy Cavin and English by Wim Renders. And after this the simultaneous interpreters were left to contend with the Babylonian jumble of languages, something they excelled at throughout the entire congress.

Subsumed under the title, "Process Control - Control as a Process", Ruth Blumer dealt with quality management in industry in the first lecture. After a brief historical portrayal of quality assurance systems, which were first developed in the 1960s by the military, she elaborated on the ISO 9000 system, describing current developments as regards integrated management systems which are supposed to cover health and safety, environmental compatibility, process-oriented quality management and also social aspects. Blumer stressed that quality management was all about meeting the customers’ expectations. Flexibility and transparency were the chief determinants of this process. To final off, she reported on a study comparing companies that had implemented quality management systems with those that had no such systems. Here it was revealed that despite the requisite investments during the set-up phase, no losses were incurred; after 5 years companies with an up and running quality management system were fairing better than their counterparts who did not have these systems. In this respect, to cite Blumer, such an investment pays off even if one has to take a deep breath to get through the initial set-up phase.

Frédy Cavin reported on his experiences with certification of a hospital CSSD in his capacity of medical device manufacturer. The CSSD of the Centre Hospitalier Universitaire Vaudois (CHUV) cares for both in-house and external clients. Various problems, such as incomplete trays and moist materials attested to the need for quality assurance; at the same time in 1998 the Swiss Medical Devices Regulation came into force, stipulating that conformity of the various processing cycles had to be verified and a quality assurance system implemented.

Cavin outlined how the actual situation had been recorded using standardised forms. The various problem areas were then dealt with in accordance with their urgency. Internal and external audits provided for continual verification and ongoing improvements. A survey conducted among customers had demonstrated in the meantime that between 1999 and 2002 complaints had significantly declined.

After the break, the following three lectures focused on cleaning as the basis for sterilisation and with control of the cleaning processes. David Hurrell presented EN 15883 (washer-disinfectors) and outlined the resultant requirements for medical device operators. For example, in addition to thermal disinfection the preceding cleaning step had to be subjected to definitive verification during the equipment type test and also at the time of process validation. Hurrell stressed that no standard could be implemented without trained personnel.

Sigrid Krüger reported on the various test soils employed in different countries; these are listed in the annex to the standard. These differ greatly from each other in respect of their composition, and hence also as regards, for example, their drying time and response to different temperatures and detergents, as revealed by a study conducted in cooperation with the Free University of Berlin. Reproducibility of the method was paramount when it came to verifying the effectiveness of cleaning.

Benedicte Gourieux described process validation for washer-disinfectors. As the first processing step, cleaning constituted the most important prerequisite for sterilisation. Therefore it was important to check all individual steps such as cleaning, disinfection, rinsing, drying using specific methods. EN ISO 15883-1 could be used to that effect. Of course, the quality of the water and the ambient air as well as the chemical substances employed had to be monitored.

Annette Beaugas’ lecture dealt with the quality and control of the ambient air for sterilisation. French legislation recommends Class 8 Clean Room for certain rooms in sterilisation departments 8 (EN ISO 14644-1). These observe certain limit values for particulate matter, monitoring of room temperature and pressure as well as the number of episodes of air recycling.

In the afternoon Peter Heeg’s lecture dealt with sterilisation control using biological indicators. He described the properties of biological indicators and compared them with those employed for parametric release. Even if parametric release had certain advantages - for example reproducibility and a high level of standardisation of the entire process - biological indicators were not indispensable since some sterilisation processes did not permit parametric release. This was the case in particular for low-temperature processes.

Further lectures were devoted to the packaging. The reliability of sterile supplies also depends to a great extent on the correct choice of packaging, as demonstrated by Christian Wolf. For a long time the packaging used in instrument processing had not been given the attention it deserved, he stated. But in the meantime it was well known that sterility could be preserved only by choosing the correct packaging. Research conducted over the past few years had demonstrated that there were major differences in the levels of safety conferred by the packaging. What was important, he stated, was the barrier function provided by the packaging, the type of closure and also the extent to which the packing processes were amenable to validation. Hence there was a greater need for automation, because this was the only means of assuring reproducible processes and of largely ruling out human error. Christine Denis’s lecture dealt with these fundamental aspects of packing. She pointed out that many activities were a matter of habit, without there being any scientific basis for the respective approach, and this was also the case where packing was concerned. Scientific studies should replace empirical practices as far as possible in future. In addition she expressed her regret that EN 868 did not provide for a check of the final packaging and called for revision of this.

In a small workshop in the early evening a Japanese delegation presented its findings on verification of cleaning by means of ATP detection. (see also Central Service 4/2002).

In the evening the congress venue, the Casino Theatre, came fully into its own. This building which normally tends to be devoted to cabaret rather than to the major art of sterilisation, apparently has at its disposal a fleet of personnel equally capably of undergoing metamorphosis. Accordingly, some waiters and waitresses developed an astonishing double or independent lifestyle in the course of the dinner. The importance of sterilisation had penetrated even as far as Swiss Television and so a frenzied reporter gave the congress delegates the chance to air their views, live and at length. To the amazement of some specialists (both male and female) the questions posed after carrying out cleaning also addressed the bathing habits of the delegates, and the question raised regarding the value of the ladies’ clothes was certainly more important than the details of validation.

And so buoyant from this exchange, the delegates were enthusiastic in applauding the prizewinners: the prize for best presentation went to the manufacturer hawo, and the prize for most innovative product to the enterprise Marcel Blanc & Cie SA.

Seriousness was restored once again the next morning. Brian Kirk asked whether measurements with temperature and pressure loggers could replace the Bowie-Dick test. He outlined the physical fundamentals, showing the relationships between pressure and temperature in saturated steam, and concluded that one could indeed infer the presence of air from the temperature reached - this latter would be lower, with an unchanging pressure value.

However, the volume of air that could be detected with this method was at least 0.8 l - hence the sensitivity would be too low and so the Bowie-Dick test continues to be indispensable.

Dominique Goullet reported on how QM systems for hospital sterilisation had been implemented in France. Despite the fact that sterilisation had been practised since the 19th century, the first directives were drafted only in the 1980s. In 1993 a Guide to Good Sterilisation was published in France. Peculiarly, that guide had been published by the Ministry of Finance. In 1997 - unfortunately, only following a few scandals in the French health care system - a circular was finally published by the ministry, stating that a QM system had to be implemented in the CSSD. That same year an investigation into sterilisation departments revealed shortcomings that even led to closure of some departments. In the meantime, further measures had been taken, he stated. These included the assignment of the CSSD to a class below the pharmacists, the maintenance of a QM system in accordance with strict specifications, government approval for sterilisation departments as well as the appointment of a QM manager.

Markus Zobrist described implementation of medical devices legislation in Switzerland. European law has been transposed into national legislation there since 1996. Apart from the Medical Devices Regulation, there is also a separate regulation governing prevention of Creutzfeldt-Jakob disease (November 2002). The key requirement enshrined in these regulations were, he stated, the QM cycle with the plan - do - check - act phases. Zobrist pointed out that reuse of single-use devices was not prohibited in Switzerland - however, an extensive conformity procedure had to be adhered to.

Finally, Thomas Kull spoke about process control from the legal viewpoint. The manufacturer’s product liability meant that it could come to a withdrawal of licence or closure of business in the event of a claim for damage. Kull pointed out that the burden of proof was shifted in the case of medical devices, i.e. the manufacturer had to afterwards furnish proof of the impeccable condition or sterility of his product - something that of course was not possible in the case of a device that had been put to use. In such a case, proof had to be furnished indirectly, he stated. But this was possible only if a perfect quality control system was in place, so that batch release took place only on the basis of clearly documented measuring results.

This was followed by an animated discussion of the reuse of single-use devices. Kull went on to state that even some reusable devices did not really lend themselves to processing. Therefore it was important to observe the manufacturer’s instructions.

Bringing the conference to a close, Hulya Erbil from Turkey lured the delegates into the future - to the next EFHSS congress. This is to be held on 5 - 7 May 2004 close to Izmir. Judging by the photographs of the congress hotel, some delegates complained that they would face difficulties once again having an application for a business trip to such a location accepted - in any case the leisure component of even specialist discussions could easily be overestimated in such an extensive pool setting. But in any case, the Winterthur delegates will surely be travelling in large numbers to Turkey - to be joined hopefully by many others, because once again this congress demonstrated there can be no substitute for the personal contacts made in such a forum.

Dr. Gudrun Westermann
mhp-Verlag GmbH
Wiesbaden, Germany