Joint OEGSV/WFHSS Congress
Baden/Vienna, 3 - 5 May 2007
Conference Report

After its foundation, or rather its evolution from the European Forum EFHSS, the World Forum for Hospital Sterile Supply joined forces with the Austrian Society of Sterile Supply (OEGSV) this year in organising the annual congress on medical device decontamination. This was a fitting occasion because, after all, the OEGSV is celebrating the 10th anniversary of its foundation this year.

And it was in that spirit of international collaboration that Tillo Miorini, OEGSV chairman, and Viola Buchrieser, on behalf of the organising team, opened the congress with a simultaneously translated German-English welcoming speech, announcing with justified pride that delegates from more than 50 countries had travelled to Baden, close to Vienna.

Top priority accorded to exchange of information

Wim Renders, president of the WFHSS, congratulated the OEGSV on the 10th anniversary of its foundation, stressing the pivotal role played by the congress in disseminating information and promoting exchange of ideas between experts.

Reflecting this spirit, Yaffa Raz from Israel presented a study that focused on visitors to the WFHSS website. The Questions and Answers section of this page was opened in 1999. In the course of the next years the number of questions posed increased continuously, reaching the figure of 367 in 2005. Concrete analysis of the questions raised had shown that people often had difficultly in understanding normative regulations and standards and there were problems with the implementation of such standards as well as ethical dilemmas because of conflicting requirements. An in-depth analysis of these topics could serve as a basis for designing training programmes to meet the need for information in this multinational forum.

Medical device decontamination worldwide

The next stop in the "Journey around the world of medical device decontamination" was in Malaysia. W. Wan Ngah, chairman of the Malaysian Sterile Supply Association (MSSA), reported on reprocessing in Malaysia. She described the trends seen since the 1950s when boiling was used as the sterilisation method through centralisation of reprocessing activities in the 1970s to the present-day modern sterile supply facilities with corresponding training and continuing professional development programmes. The MSSA had made a significant contribution to that effect. Since its foundation with 38 members in 1996, membership had in the meantime grown to more than 1200. In 2006 the association was able to move into premises of its own, thus making it considerably easier to organise events, e.g. training seminars.

The next lecture meant a return to Europe: Reinhard Berger from the Austrian Agency for Health and Food Safety (AGES) reported on medical device safety in Europe. Devices that met the essential requirements during conformity assessment could be marketed without restriction throughout the entire European Economic Area. Following their placement on the market, they became the focus of market monitoring and medical device vigilance systems. In that context, reports of incidences and almost incidences relating to medical devices were recorded. Berger stated that the majority of such reports were initiated by manufacturers; at present some 1400 reports were submitted each year.

Tillo Miorini delivered a talk on behalf of Dr. Ecker for the Austrian Ministry of Health on hygiene management for medical devices in healthcare establishments. He stated that all EU member states had to transpose EU medical devices directives into national legislation. In 1996 the Austrian Medical Devices Act stipulated that cleaning, disinfection and sterilisation of medical devices in healthcare institutions be conducted with suitable validated processes so that they did not pose any danger to the safety or health of patients, users or third parties. A subsequent amendment to this Medical Devices Act took account of the increasing trend in outsourcing processes, while including all Central Sterile Supply Departments (CSSDs). Detailed regulations were to follow in a directive that was being currently drafted, e.g. risk analysis relating to the medical devices to be reprocessed, based on the algorithms of the German Robert Koch Institute. Some parts of these would have a legal character.

Standards and legal aspects

In the afternoon on opening the "Legal aspects" block of topics, T. Miorini asked the audience whether EN ISO 15883 was to be seen as a milestone. Despite dedicated work over many years the working group WG 8 had not been able, at least as far as Europe was concerned, to formulate uniform test methods to investigate the cleaning performance. This gave rise to a situation whereby was a number of (highly divergent) test methods from the member states had been incorporated into an international standard (or Technical Specification).

Some parts of the standard also described requirements that had to be met at the time of the type and factory tests or during validation (operational and performance qualifications). In Annex 3 to the "Guideline for testing, validation and monitoring automated cleaning and disinfection processes for medical devices", based on the Austrian standard OENORM EN ISO 15883 Part 1, 2 and CEN ISO/TS 15883-5, the OEGSV had defined the contents of a type test report that had to be available before commencing operational testing. What was planned was to compile and publish a list of those washer-disinfector types that met these requirements. Unfortunately, to date very few manufacturers had responded to that call to make the corresponding documentation available.

Despite the fact that work had been completed a long time ago on Part 4 of the standard, which dealt with the requirements addressed to the washer-disinfectors used for flexible endoscopes, it had not been published to date. Based on prEN, the following points should be borne in mind when purchasing an endoscope WD:

• Interposition of a rinse step between the cleaning and disinfection cycle
• Single-channel cleaning (no pressurised-chamber machines)
• Single-channel monitoring?
• Tracking facilities
• Leak test.

Klaus Roth from Tübingen reported on the compilation of a decontamination guide based on ISO 17664. As per ISO 17664 the manufacturer was required to provide a detailed description of a decontamination process for his instruments. Here, it was possible to group together instruments of a similar design and carry out validation in each case for the most difficult instrument. Roth reported on the classification of instruments into 7 groups in accordance with the cleaning requirements. Despite the fact that automated decontamination was recommended for virtually all groups, Roth reported on studies he himself had carried out and that had demonstrated that, depending on the design, more or less intensive precleaning was needed since otherwise residual contamination was a problem, especially in areas that were not amenable to visual inspection.

To finish off, Roth pointed out that it was incumbent on the user to use the process recommended by the manufacturer. Therefore already at the time of purchasing instruments one had to ensure that the specified cleaning process could also be implemented in the given situation.

Hydrogen peroxide plasma sterilisation

Walter Koller spoke about the role played by hydrogen peroxide plasma sterilisation. The first machines placed on the market were not approved by the Austrian authorities since certain criteria had not been met and reliability did not appear to have been assured.

However, recent investigations had attested to adequate sporicidal efficacy of this system, admittedly within narrow limits: for example, one prerequisite was the absence of any form of organic or crystalline substance on surfaces as well as of cotton or other organic carrier or packaging materials. Nor was the procedure suitable for reprocessing long narrow lumens, in particular those of metal-coated instruments. Koller pointed out that the new generation of Sterrad products were fitted with facilities for process control, thus providing for validation - this was one aspect that had been criticised in the first generation of this type of equipment.

He went on to say that since October 2006 this process had been granted approval also in Austria, admittedly with severe restrictions: the process was not to be viewed as an alternative to other low-temperature processes such as ethylene oxide (EO) or formaldehyde (FA) and was recommended only for those medical devices that had not been designed for minimally invasive use. In any case, the special instrument packaging (Tyvek) and associated foil heat sealer recommended by the manufacturer had to be used.

Procurement procedures and how to deal with loaned instruments

The afternoon was devoted to the topic of loaned instruments. Renate Zierler from Graz described the various types of procurement, explaining the features of a clearly defined procurement process in the context of quality management. Increasingly more importance was being ascribed to the actual wording of the tender when purchasing equipment since this had to conform to myriad standards and regulations.

Andrea Percht, Linz, described the procurement process for washer-disinfectors. In a "WD dialogue", organised by the firm MicroMed Mittermayer in 2006 it was concluded that the CSSD management was often not sufficiently conversant with the current requirements and as such failed to take account of important issues. For that reason a working group was set up which compiled Annex 3 dealing with the following:

• Procurement of washer-disinfectors
• Information from the type test that was needed for commissioning/validation
• ÖGSV recommendations as regards WD fittings

This draft was revised and released by the ÖGSV Expert Committee for Testing and could be downloaded from the ÖGSV homepage (www.oegsv.com).

Diana Bijl from Nijmegen University Hospital reported on how loaned instruments were being dealt with in Holland. Using a few photos, she showed the problem areas: unsuitable trays were as commonly encountered as contaminated instruments. The Dutch standard "Loaned instruments" and the position paper published by ASHCSP/IAHCSMM on loaned instruments, dealing with topics such as placement of orders, delivery, inspection of incoming goods, preparation before use for surgical procedures, decontamination after surgery, final inspection and rejects, was useful as was the standard EN ISO 17664 specifying information requirements to be observed by the manufacturers of medical devices. Nijmegen University had compiled a list of requirements for manufacturers and suppliers based on these standards. This list was discussed with all suppliers of loaned instruments. This approach had given rise to very positive experiences, with the result that all university medical centres had already adopted this requirements’ list.

In his afternoon lecture Adrie de Bruijn from the Dutch Institute for Public Health (RIVM) gave an overview of the difficulties encountered when purchasing instruments. Despite the fact that the European Medical Devices Directive mandated that the manufacturer gave clear instructions for reprocessing, this had not been done in the majority of cases. De Bruijn reported on a study carried out by means of a questionnaire to assess the quality of decontamination instructions. He stated that the checklist compiled on the basis of the findings could be consulted before purchasing instruments, thus ensuring prudent decisions were made. A detailed report on this study as well as the checklist were published in Central Service 2006; 14: 30-36.

Protein detection/inspection of cleaning results

The Friday morning’s series of lectures was opened with a talk by Helmut Faber from Graz who presented comparative studies relating to various protein detection tests. These tests had compared the Protect-M, BCA Protein Assay Kit and the Test Kit for protein measurement (Miele), all of which were based on the modified biuret reaction. Furthermore, HemoCheck S, a test for detection of blood, was evaluated. All protein detection tests had their pros and cons. For example, Protect-M had proved to be particularly easy to use; the test kit was very rapid, and thanks the combination of a portable reflectometer it provided for quantitative reading. Faber stated that being able to furnish rapid results was definitely important since in some cases the values were liable to rapid change. The investigations carried out with a standardised soil - as was highlighted in the discussion - did not provide any conclusive information on the reactions when used in conjunction with the proteins encountered in a real-life situation.

Horst Taferner and Jasmin Hribar from Klagenfurt reported on the formulation of a routine policy for checking minimally invasive surgery (MIS) instruments for residual protein. Attention was paid to choosing items for testing to select instruments with intricate, narrow, and in come cases angled design as well as materials that were difficult to clean. The protein detection methods compared were the Pro-tect M, made by VWR (semi-quantitative), BCATM Protein Assay Kit, manufactured by Pierce (semi-quantitative) and the quantitative OPA method manufactured by Miele (semi-quantitative and quantitative photometric measurement). In this study the BCA method scored best since it was simple to use (wipe test) and inexpensive. Furthermore, in duplicate testing by various investigators it showed the highest concordance (>96%). To finish off, Taferner gave the audience a few recommendations for routine operations: protein residues should be measured regularly once a week. Critical MIS instruments should also be subjected to pre-decontamination measures. Thorough cleaning was also recommended on a regular basis.

Tomozo Yamamoto from Japan reported on studies on the effectiveness of cleaning carried out at Japanese hospitals. A working group was to formulate a guideline for quantification of cleanliness. This working group had carried out tests to measure residual protein content following routine cleaning of surgical instruments with clinical soils at four university hospitals and three foundation hospitals. The residual protein content on the surgical instruments from seven hospitals was between 20 and 174 µg bovine serum albumin per instrument. On that basis, stated Yamamoto, it should be possible to formulate acceptance criteria for residual protein on reprocessed instruments.

Prions - current state of research

Walter Schulz-Schaeffer from Göttingen reported on novel insights into prion diseases in relation to decontamination of medical devices. He described the various types of Creutzfeldt-Jakob disease (CJD), citing their distribution and incidence.

In the case of invasive procedures in patients with a high risk of CJD transmission, the following cleaning and disinfection process could be used for steam-sterilisable instruments after use on high-risk tissue:

• 1-2 M NaOH for 24 hours or
• 2.5-5% NaOCl for 24 hours or
• GdnSCN (3 M for 24 hours; 4 M for 1 hour; 6 M for 15 minutes).

Following this, steam sterilisation at 134 °C 3 bar pressure for 1 hour was needed. Instruments that did not lend themselves to steam sterilisation were to be incinerated.

Schulz-Schaeffer once again stressed the importance of cleaning to remove prion proteins. A combination of several decontamination steps using an alkaline cleaning cycle was advisable.

Validation of sterilisation and WD processes

The validation block of topics was opened by Theresia Enko who described how validation of sterilisation processes was conducted in practice. An analysis of the current state was needed before defining the procedure to be adopted. Enko stressed the importance of documentation. A well-functioning error management policy was also important so as to be able to take appropriate remedial measures.

Michael Gehrer, Graz, described implementation of the ÖGSV guideline for validation of WDs. The Austrian method used as a test soil heparinised sheep blood that had been reactivated with protamine sulphate since compared with other test soils, this best reflected the everyday conditions. It was also served to detect less obvious shortcomings and was relatively easy to use. The test soil was applied in situ and results could be evaluated by means of visual inspection without any major investment.

Tillo Miorini reported on the experiences gleaned over a 10-year period by the Institute for Applied Hygiene with testing WDs for medical devices. Using revealing photos he described the drawbacks detected, elaborating in particular on MIS instruments and endoscopes. In the case of MIS instruments, protein detection tests revealed, in some cases, serious shortcomings in cleaning performances, often related to old residual contaminants. In the case of flexible endoscope WDs, cleaning problems were detected as regards the cleaning of channels, chamber and external surface, in particular in the case of "short programmes" without an intermediate rinse step. For that reason as from December 2006 all endosocope WD programmes had to interpose a rinse step between the cleaning and disinfection phase.

Endoscope decontamination

Ulrike Prüfert-Freese spoke about testing and validation of WD processes for flexible endoscopes. She reported on tests carried out with Teflon tubes contaminated with an MNE test soil composed of wheat flour, nigrosin and hen’s egg. The PCDs used to test the disinfection performance, within the framework of the standard method, were Teflon tubes (length: 1.500 mm + 2000 mm; internal diameter: 2 mm und 1 mm) and germ carriers that had been inoculated with a defined microbial suspension (Enterococcus faecium ATCC 6057, 1010). The results demonstrated that following the cleaning phase the test organism had been reduced by between 4 and 7 log levels and that in general the reduction factor obtained for 1 mm tube was one level lower than that achieved for the 2 mm tube. The results for the entire cycle revealed that it was not possible to recover the test organism from any of the germ carriers, thus attesting to the fact that a reduction by > 9 log levels had been achieved. On the basis of those tests, this test method could be interpreted as being a clear-cut method, which was easy to use in situ, for investigating the cleaning and disinfection performance as stipulated y international standards.

Heike Martiny from Berlin outlined the parameters that affect cleaning of flexible endoscopes. Since visual inspection of the cleaning results was not possible for flexible endoscopes, a standardised validated decontamination method was urgently needed. The cleaning outcome itself was dependent on various parameters, including complete wetting/cleaning of all internal and external surfaces, the effectiveness of the detergent, the cleaning temperature and the cleaning time. The cleaning outcome could also be influenced by the water quality.

Visual inspection was used to assess the cleaning results for the external surfaces. More in-depths control methods included the use of a test soil and its successful removal with or without microorganisms and/or removal / measurement of chemical parameters such as proteins.

Martiny cited data from various studies to attest to the crucial role played by the various parameters in assuring good cleaning results, stressing once again that failure to assure the latter jeopardised the success of the other decontamination steps.

In the evening delegates had the opportunity to sample typical new Austrian wine with local specialities in a congenial atmosphere. Nonetheless, a surprisingly large number of people managed to appear early in the congress centre the next morning.

Certification and structured training

The morning of the last conference day was opened by Robyn Williams from Australia who spoke about continuing professional development in Queensland. The training courses in Australia consisted of some 300 hours and by now more than 95% of sterilisation personnel had successfully completed certified courses. But the question was how was this acquired knowledge to be retained and further expanded. The present approach was a structured continuing professional development system based on an American model where participants could voluntarily enrol in different advanced training courses, for which they were given corresponding credits. The idea here was that course attendees should also pass on their expertise and could gain further credits by giving talks to colleagues. The aim was to initiate a long-long, voluntary learning process so that staff were always conversant with the state of the art as far as quality assurance was concerned.

Monika Semler reported on the certification of her department at Vienna General Hospital. Each year around 80,000 StUs were reprocessed in the CSSD. Since June 2006 it had been certified as per ISO 9001:2000 and ISO 13485:2003, as the first CSSD in Austria. Semmler outlined the requirements for staff training, technical equipment, validation and documentation, and went on to describe the approach taken to achieving certification. An important aspect was the concept of "The quality management system as implemented", which ultimately meant continuous further development and improvement of the QS system with the help of all CSSD personnel.

Thomas Kießling and Mr. Breder from the Rheinland Technical Inspectorate reported on their experiences of certification in line with the guideline that was jointly formulated by the Robert Koch Institute (RKI) and the Federal Institute for Drugs and Medical Devices (BfArM).

In virtually all cases the descriptions provided for the decontamination processes were in line with the requirements. For almost all certification audits the required risk classification as per the RKI/BfArM had been carried out and the training concept devised by the German Society of Sterile Supply (DGSV) had been taken into account when defining the level of personnel qualifications needed. Only rarely were serious flaws in hygiene detected.

Shortcomings were found in validation of sterilisation processes (apart from steam sterilisation). There was also a need to improve the availability and evaluation of the manufacturers’ instructions. Another problematic area was the IT systems used. In some cases these were not at all suitable, thus leading to gaps in documentation.

Wood fibres in medical devices

Kaj Henricson from Finland reported on the use of wood fibres in medical devices. Single-use medical devices were composed of a lot of non-recyclable materials and therefore there was a need for devices that could be easily recycled or could be used for heat generation. Wood fibres were eminently suitable to that effect because in general cellulose materials could be recycled. In the course of that study it had come to light that many types of packaging were made of other materials that could easily be replaced by wood fibres. These included, for example, packaging. That study was to be continued and was to soon enter phase II where concrete proposals for new products and solutions could be put forward.

Outsourcing - what must be borne in mind?

And just as in real life, the statutory authorities had the last word here too. Robert Kellner from Healthcare Department of the Lower Austrian State Government spoke about the various aspects of outsourcing to be borne in mind before taking a decision. These related to technical aspects (e.g. shelf life, pretreatment in-house, need for special instruments, etc.), as well as the organisational aspects of such collaboration. Kellner described medical device decontamination as one of a hospital’s core competences which would be relinquished if one were to fully hand over this decontamination service to an external supplier. In such a case, one could not fall back on one’s own resources even in an emergency. Therefore a termination clause should always be agreed so that the contract could be cancelled e.g. in the event of inadequate quality or other disagreements. Kellner compared the role of the statutory authorities with that of a marriage councillor: they could proffer valuable advice, thus contributing to long-term harmonious partnership.

To finish off: prizes, prizes ...

The congress was brought to a close with the award of a number of prizes. Wim Renders awarded this year’s WFHSS Prize, the "Sparkling Egg Award", to Josy Holdener from Switzerland (see p. 184).

The 3M Poster Prize went to Wan from Malaysia as well as to Vlatka Bojic-Turcic from Croatia.

...and fast forward to the future

Showing spectacular photographs the Monza racecourse, Flavia Bossi, chairman of the Italian Sterile Supply Association (AIOS) gave delegates a preview of what to expect next year when the WFHSS Congress was to be jointly organised by AIOS. We hope that many of this year’s as well as new delegates will attend this event so as to maintain this vital exchange of information.

Dr. Gudrun Westermann
mhp-Verlag GmbH
Wiesbaden, Germany