Conference Report

Beautiful weather and a beautiful city - two factors that already create very favourable conditions for a successful congress. At least they put delegates in a good mood. The organisers of this year’s EFHSS congress in Brugge, Belgium, i.e. the Belgian Association of Sterilisation in the Hospital (Vereniging Sterilisatie in het Ziekenhuis, VSZ) and the Dutch Central Sterilization Club (CSC), ensured that everything else was in place - an interesting programme and a well-organised event.

The congress at the same time marked the 15th anniversary of the foundation of the Belgian association. In his opening speech, Wim Renders, chairman of VSZ, listed the successes already scored during this period of time. At first these may not appear very spectacular but there have been some significant achievements in the course of the years. The CSSD has come into the spotlight and has made its presence known to both hospital managements and legislators. Standards and model regulations have created a good theoretical basis for the CSSD’s activities, but how is the situation when it comes to translating these into practice? There are many reasons why this often fails. Financial resources are in short supply everywhere, but what is particularly important, according to Renders, is communication. After all the "state of the art" must also be imparted, e.g. by means of corresponding training and continuing education courses and of exchange between experts from different countries - a priority task for international organisations such as EFHSS.

To begin with, Marianne van Malderen gave an overview of legal developments in Belgium and summarised the requirements enshrined in directive 93/42/EEC. This serves as a guide to quality assurance in the EU single market. Quality assurance measures must be in place before a medical device is first placed on the market. The manufacturer defines the intended purpose and product liability applies accordingly. If the device is put to a different use, the user bears responsibility.

Van Malderen elaborated on a number of misunderstandings that have arisen as regards the implementation of this directive. For instance, even before implementation of the directive the manufacturers bore responsibility for their products in the context of product liability.

A hospital conducting sterilisation for its own needs is not viewed as a manufacturer. Hence there in no need for notifying the notified bodies or for CE marking. But as soon as a CSSD carries out sterilisation for other hospitals, the directives apply fully. Where resterilisation was concerned, van Malderen made it clear that this must be viewed at European level and a corresponding European solution found, whereas at present practices vary from one country to another. A new Belgian directive, currently available in draft form, intends prohibiting reprocessing of all single-use instruments.

Joost van Doornmalen gave a talk entitled "Safety or illusory safety". He outlined the fundamental prerequisites for a quality assurance system, e.g. technical know-how, directives and standards as well as practical experience. At the same time he stated that for steam sterilisation alone there are more than 12 different recommendations which can be interpreted differently. Therefore efficiency and standardisation of processes are indispensable.

Based on a study carried out with small sterilisers, van Doornmalen showed that certain forms of standardisation could confer a misleading sense of safety. It emerged that in the case of 9 sterilisers which all bore the CE mark none was able to meet all requirements. This underlines the importance of regular checks.

Patrick Corstiaans reported on the procedure adopted for internal audits, which are a necessary precondition for accreditation or certification. The audit covers the quality assurance system and must be carried out by an independent auditor. This auditor checks whether the procedures specified in the documentation have been implemented and are being observed. The audit report must contain verifiable statements; it is intended as a basis for discussing corrective measures.

The afternoon session was opened by paying homage to Philip de Vries, who then took over as moderator for the talks. René Vis, chairman of CSC, referred to de Vries’ many years of service and ambassadorial role in different specialist societies, including also in the International Federation IFSS.

Markus Dettenkofer outlined the requirements for processing medical devices and drew attention to a document which the Robert Koch Institute has just compiled on this subject and which can be accessed on the internet at www.rki.de. He then elaborated on the pros and cons of reuse of single-use articles. Pros include e.g. financial and environmental aspects. And devices were often made of high-quality materials whose functionality was not compromised by single use. More importantly, reprocessing is not prohibited in Germany.

The cons are dictated by safety and aesthetic considerations. In some cases liability issues apply, and moreover reprocessing of complex medical devices is laborious and expensive; the financial advantages tend to be overestimated when offset against the high water and power consumption. Savings can be made in particular for non-critical and semi-critical devices, e.g. syringes for enteral feeding. Dettenkofer stated that reprocessing of such devices at University Hospital Freiburg had resulted in savings of more than 25,000 euros as well as in a reduction in waste of more than 1.1 tonnes.

This topic was immediately followed by animated discussions. Anke Carter from the German Society for Sterile Supply (DGSV) stated that it was not at all possible at present to base one’s work practices on these RKI guidelines, because for instance there are no validated cleaning processes.

Frank Waller from the United Kingdom deemed as bizarre the very notion of reprocessing devices, especially complex devices - not least when set against a background of vCJD problems in the United Kingdom. He addressed a provocative question to the audience: how many of them would prefer to have a new and how many a reprocessed catheter if they had to undergo examination with a cardiac catheter. Of course the answer to this can be guessed, thus underlining that when it comes to such critical instruments the patient’s wellbeing cannot be overemphasised.

Thea Daha from the Dutch working group on infection prevention (WIP) subjected the hygiene measures traditionally observed in the OR to critical scrutiny. On the basis of the circuit traversed by items undergoing sterilisation, she explained the links between OR and CSSD and discussed the different issues arising at different points in this circuit, e.g. how to manage transportation trolleys, clothing, use of gloves, orofacial masks and protective footwear as well as routine floor disinfection. Bearing in mind the CSSD, she stressed how important it is to accord top priority to personnel safety on the unclean side. Special clothing, such as aprons, is important here. Head protection can reduce contamination with Staphylococcus aureus on the clean side, bearing in mind that the scalps of 25% of the population are colonised by this bacterium. Hand disinfection serves the same purpose.

Dreha stated that, while evidence-based guidelines are not always available especially for prophylactically employed hygiene measures, a meaningful decision must be taken on the basis of consensus, of scientific publications and not least of common sense where hygiene is concerned.

The talk given by Frank Peys dealt with financing new developments in the healthcare system. He outlined the different price and reimbursement systems on the European market. In the future there must be increasing flexibility in these systems in view of the unfavourable financial situation. Providers of health services will have to take more responsibility; management costs will rise because before introducing a new product, economic evaluation must be carried out. Only in this manner can cost-effective principles be implemented in the long term in the healthcare sector.

The evening was spent exploring Brugge - starting with history with a visit to a former hospital and to the Memling Museum, followed by culinary delicacies in the course of a "walking dinner", during which it was not the diners but rather the foods that wandered around the room, and finishing off with the scenic beauty of the nocturnal city. A sightseeing tour of the canals afforded new views of the ancient walls, and - warmed up with Dutch gin - the weather no longer appeared to be so frosty.

Jan Huys opened - the day after - with an interesting talk on sterile supply in Africa. On the basis of impressive photos, he described the special problems encountered in developing countries where sterilisation frequently fails because of simple things such as water and electricity supply. Often one must strive to achieve an acceptable result while using only the most basic resources. Huys reported on investigations conducted at the Polytechnic Institute in Mombassa, Kenya. Here it was revealed that a test steriliser had not passed the Bowie & Dick test because of inadequate air removal. Hence only a temperature of 40 - 80°C was reached within the load. However, in a number of different measurement series it was possible to optimise the process by using, inter alia, intermittent steam pulses such that that sterilisation was possible.

These investigations served as a basis for another pilot project, a training course for CSSD staff. Here participants were taught not only how sterilisation processes can be rendered safe in small and large sterilisers but corresponding control measures were also implemented. Furthermore, participants were taught how to carry out themselves basic repairs and maintenance tasks - a real contribution to self-sufficiency. The foundations were laid for decisive improvements using only minimal resources, e.g. by teaching cleaning techniques and personal hygiene. It was also possible to considerably improve organisation of different departments, e.g. by means of clear instructions for labelling and storing sterile supplies. Whereas formerly the packets had been placed without a date or label on - often dusty - shelves, it was now possible with simple paper tags and indicator strips to assign them to the operating theatre and affix the sterilisation date.

To summarise, Huys made it clear that European standards cannot be simply extrapolated to developing countries. But experience has shown that with relatively low investments and organisational improvements, in particular by training the staff, major improvements that enhance patient safety can be achieved.

Jay Sommers gave a talk on event-related sterile supply storage, which in the meantime is now also being propagated by the FDA as well as by American Organization of Registered Nurses (AORN) and of the Association for the Advancement of Medical Instrumentation (AAMI). He outlined the preconditions needed for preserving sterility of packed items. For instance, the packaging must not be opened, damp or damaged in any manner; frequent transportation can likewise compromise sterility due to vibrations. Sommers pointed out that microorganisms do not wear watches, so sudden onset of non-sterility should not be assumed on expiry of a certain date. But due to material properties, an expiry date is required for certain products, e.g. for latex or rubber items. To finish off, Sommers warned against a misplaced sense of safety fostered by a printed expiry date; but experience with the event-related system has also revealed that personal pay more attention to factors adversely affecting sterility, which of course can also be manifest before expiry of any given expiry date.

Patrick Cras from Antwerp University gave an overview in his talk of topical scientific insights into CJD. He outlined its history as well as the various forms of the disease and went on to report on the current surveillance results. These indicate that in Belgium the incidence of CJD cases is around 1 patient per million inhabitants per year, corresponding to the general incidence reflected in epidemiological studies. The incidence throughout Europe had declined somewhat during 2000, but this might simply be attributable to less rigorous surveillance efforts. Cras pointed out that clinical diagnosis tends to be made too often, but of the clinically suspected cases only around 50% are confirmed on histology examination.

He also described the risk factors, e.g. exposure to animals and occurrence of familial dementia diseases as well as typical signs on EEC an d magnetic resonance (MRI). But most of these can also be manifest in the case of other diseases of the CNS, e.g. in the case of Herpes simplex encephalitis. Some of the clinical features of the variant form of CJD differ from the other forms of CJD. Malaise and behavioural abnormalities tend to be more pronounced than dementia. To finish off, Cras, emphasised that many issues remain unresolved, not least the issue of how many patients are still incubating vCJD.

René Monié dealt in his talk with sterilisation by external contractors. He described the CSSD as a production site for sterile medical devices and pointed out that the trend towards outsourcing is increasing, not least because of the increasingly more stringent provisions for processing and the increasingly more complex instruments. Monié stressed that communication between the hospital and external contractor is vital here. Only thus could an optimal partnership be forged between the two parties. Subsequent discussion clearly revealed that despite all this outsourcing of all sterilisation services is not to be expected in the long term. Problems can arise for instance due to the transportation times required, which could prolong the time before the instruments could be reused.

In the last talk given at the congress, Jürgen Staffeldt elaborated on cleaning methods in washer-disinfectors. He stressed the importance of the water quality for efficiency and listed different water components that adversely affect the quality, such as silicates, chloride and copper. Using illustrations of evaporation tests, Staffeldt showed the mineral content of water of different quality. The cleaning efficiency of different types of water was verified in investigations using blood-soiled carriers. In view of these findings, Staffeldt recommended using demineralised water for precleaning, as the best results were achieved with this. He continued by outlining the problems encountered in respect of drying; these are attributable to the special chemical properties of the water molecule (surface tension). This surface tension can be reduced and the drying time considerably shortened if special drying aids are used. Staffeldt stated that, contrary to opinions voiced during discussions, these products do not lead to wetness problems during subsequent sterilisation because the residual concentration is too low to cause such an effect. Finally, Staffeldt presented a processing programme for inactivation of prions. Publication of the RKI recommendations on this subject is also expected before the end of the year. An essential component is, inter alia, alkaline cleaning (pH > 10; temperature 50 - 60 °C).

The topics covered were varied, the discussions lively in some cases - with hindsight it was indeed a successful congress from which everyone could profit. As a closing remark, Wim Renders emphasised that further small steps must be taken so as to achieve a uniform and acceptable level of quality for all departments. Only once this goal has been achieved could one speculate on how much is too much when it comes to the requirements and their implementation. The "too much", so much was clear, will certainly be achieved in different countries at different points in time. But the minimum requirements must in principle be the same for all. Compulsory training for all staff members in the CSSD is an important step in this direction. In conclusion, many problems remain unsolved, hence there is ample scope for discussion at future congresses; EFHSS offers the next opportunity for discussion next year in Dublin.

Dr. Gudrun Droop
mhp-Verlag GmbH
Wiesbaden, Germany