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Sterile Supply Faces New Challenges
Prion diseases dominate the agenda at DGSV Congress
Conference Report

DGSV...

3 October 2001 to 5 October 2001
Tübingen, Germany

Conference Report
by Dr. Gudrun Droop


Conference Report

Conference Report

This year's congress of the German Society for Sterile Supply (DGSV) was largely marked by animated discussions. But the members' general meeting at the beginning of the congress progressed peacefully and in an orderly fashion. The DGSV's accomplishments, outlined by its chairman Toni Zanette, are reason enough to feel proud. For example, since the end of last year the DGSV has been officially recognised as a specialist society. The society's guidelines on training have now been incorporated into the guidelines of the Robert Koch Institute (RKI). Represented by Prof. P. Heeg, Tübingen and T. Zanette, the DGSV is now also part of the CJD Task Force of the RKI.

Cooperation with other specialist societies is going well; this year too members of the German Society for Hospital Hygiene (DGKH) held a workshop during the DGSV congress. DGSV representatives will also participate in the EFHSS congress in Bruges at the beginning of November.

The respective chairpersons gave committee reports. Frau S. Krüger pointed out that the Recommendations by the Quality Task Group could now be accessed on the DGSV homepage that has just been set up. Reporting on the Public Relations Committee, T. Zanette gave more details and demonstrated the homepage. Clearly structured information on the DGSV can be obtained on the internet at www.dgsv-ev.de. The committees with their chairpersons were introduced, as were the members of the board of directors of the Education Committee and the Quality Committee. The persons to contact can be reached directly by e-mail.

The Questions & Answers page gives the opportunity to post a question directly on the website. A list of the accredited training centres gives an overview of where to find suitable training courses.

The "Building and Technology Task Group" is new. Roland Frey has already listed on the homepage the essential structural and functional requirements for a CSSD - ranging from legal requirements through hygienic safety, space allocation, size calculation and installation to a basic sketch. Efforts are still underway to find likeminded persons who together with the DGSV would like to set up a task group to standardise the structural prerequisites for the CSSD.

Prof. Heeg, in the capacity of editor in chief of Central Service, reported on developments regarding this journal. Especially pleasing is the fact that international contacts have continued to be further reinforced. This can also be seen in the current situation as regards manuscripts. The prolific activities of our Japanese colleagues are particularly noteworthy. Therefore an appeal was addressed to German colleagues, exhorting them to continue to commit their research findings to paper, produce manuscripts and submit these for publication. Likewise, the mailbox still has unutilised capacity, which readers can avail of in order to obtain an expert and citable answer to, in some cases, controversial questions; ultimately this could strengthen one's position when it comes to dealing with management.

As from next year Central Service will also be available on CD-ROM to DGSV members. The board of directors has decided that members are to receive this medium as part of their membership. The Annual Edition for 2000 will be published together with the first issue of 2001 in February of next year.

U. Blättermann has resigned from the board of directors and was honoured for his many years' of service. He has been replaced by J. Graf as a temporary board member. New members of the advisory board are R. Frey and U. Blättermann.

V. Hingst, president of the Public Health Office of the state of Baden-Württemberg, stressed in his welcoming speech at the opening of the conference the issue of self-responsibility of users and service providers in the healthcare sector, which will tend to increase in the future. Conversely, control activities of the State will be reduced to a minimum. This makes standardisation of procedures all the more important in the public health service.

On Thursday the subjects on the agenda were quality assurance from the legal, organisational and technical viewpoint. T. M. Kull, a Swiss attorney, focused on the term "risk", showing just how difficult it is to estimate this. Furthermore, a risk calculated by an insurer does not always match the actual risk, and even less so the plight of the individuals concerned as poignantly borne out by recent events. There remains a residual risk and this cannot ultimately be estimated. In this context Kull pointed out that even if the user works in accordance with the pertinent regulations, this does not exonerate him from the duty to engage in risk analysis.

On a topical note, Kull reported on a ruling by the European Court of Justice on quality assurance and product liability. This ruling can have major implications for state hospitals because it shows that these are not exempted from product liability. In specific terms, it was decided that as regards the putting into circulation of a product it was not important whether the latter was manufactured in the hospital itself or at another location associated with it; thus the product need not have left the hospital. Moreover, it is unimportant whether the product must be paid for by the patient or whether the service rendered was a free medical service (a summary of this ruling is given in the Supplement on the DGSV congress, Central Service 2001; 9 (Suppl. 1): 7-8).

R. Jaeckel from the Employees' Health Insurance Funds outlined the repercussions expected from the Diagnosis Related Groups (DRGs) that ar e soon to be introduced, likening the ensuing effects to a culture revolution for the hospitals. He emphasised that investments in documentation will grow considerably. This is warranted in the context of a good quality management, which ultimately also implies good costs' management.

H.-P. Zenner elaborated on CJD problems from the perspective of an ENT surgeon. He outlined how instrument risks are classified in accordance with the tissue with which the respective instrument had come into contact. The risk of transmission following parenteral contact is up to a million times greater than following oral ingestion. One major handicap is that it is virtually impossible to identify risk patients. In addition, Zenner stated, it is possible that during the very long incubation time the altered proteins may be expressed much earlier in the immune system than in the CNS; but the patient continues to be symptomless in the meantime. Further problems are caused by non-specific binding of proteins to metals and by fixation, for example with formaldehyde. If single-use instruments are used, e.g. for tonsillectomy, the high price is not in proportion to the amounts reimbursed - here political decisions are also needed.

If instruments used for CJD patients are treated as recommended with 1M NaOH the surface coating and aluminium components are almost completely destroyed. K. Müller and B. Holz reported on the value preservation of such instruments and demonstrated how an entire tray can be reproduced by reworking the surfaces and replacing parts. But this procedure has its limitations for instance because of dismantling problems. Hence, it is not worthwhile to rework all instruments and there always remains a certain volume of re-investment.

The next discussion went as far as ethical issues. For example, are elaborate measures justified despite the fact that Koch's postulates are not entirely fulfilled as regards infection with prions and, in the opinion of some people, the link between this agent and CJD/vCJD has not been conclusively proven? But it soon emerged that the majority were in favour of observing the recommended measures just as, for ethical reasons, one would not dispense with sterilisation despite a low risk of infection from contaminated instruments which do not probably exceed a SAL of 10-6. There is definitely a need in this controversial area for close cooperation between industry and the CSSD /processors, as well as between surgical departments and the CSSD.

The afternoon of the first day of the conference was devoted to workshops. Under the auspices of the DGKH, Heike Martiny, H.-P. Werner and T. Zweimüller dealt with quantification of microbial reduction and inactivation during the processing steps. The problems associated with prions have resulted in closer attention being paid to microbial reduction during cleaning/disinfection. Martiny reported that through the Robert Koch Institute the "Hygiene requirements for processing medical devices" had been published and could be currently accessed on the RKI homepage at www.rki.de. Standardisation is playing an increasingly important role, and this holds true especially for validation. Martiny briefly outlined the different steps of validation and stressed that in the interest of standardisation manual preparatory tasks were not to be counted here.

H.-P. Werner pointed out that cleanliness does not mean absolute absence of visible contamination; cleanliness denotes rather the probability of absence of contamination. He stated that especially in light of the problems associated with prions a medical device had to be clean, and this ultimately means free of a protein load.

T. Zweimüller elaborated on the importance of steam supply and made it clear that there is still considerable need for improvement as far as the steam quality was concerned. He described, among other things, the problems relating to non-condensable gases which can vary in accordance with the temperature.

In workshops held in parallel, L. Giovanettoni, St. Gallen, presented an IT solution for the CSSD, which using a data matrix code takes charge of the management and documentation of the entire instruments of a hospital (manufacturer: Kenus). The 3M ETS system was demonstrated by G. Jungwirth. A workshop organised by the company BAG dealt with control and fault simulation in steam sterilisation.

The first day drew to a close with a talk by W.-D. Wegner on the subject of sterilisation in light of CJD problems. He stated that the CJD programme had to be included in validation. The use of this programme has far-reaching consequences for the entire workflow. For example, prolonging the load time detracted from the sterilisation capacity. Additional costs are also incurred whether as a result of upgrading older devices or due to inspection and maintenance.

The subject of prions ran like a red thread through the issues covered on the second day of the conference. P. Heeg, Tübingen, opened this part of the programme with his talk on prions as the causative agents of disease, elaborating on how they were discovered and summarising the principle properties of these proteins "with the two faces".

M. Mielke, Berlin, addressed this issue from the RKI perspective. From November it will be possible to consult the RKI recommendations on risk classification on the RKI homepage at www.rki.de.

Mielke also elaborated on some of the principle insights into the subject of prions. For example, the level of exposure differs among countries; it is especially high in the United kingdom. A genetic disposition may have been a contributory factor in the outbreak of the disease. Instruments used on patients suspected of infection with CJD must be preserved and discarded if the diagnosis is confirmed. This is of course a problem in the case of very expensive instruments, e.g. flexible endoscopes. Mielke pointed out that a pool of endoscopes of diverse manufacture has been put together specially for use in cases where disease is suspected; this can be contacted via the Reference Centre in Göouml;ttingen.

To finish off, Mielke spoke about the effectiveness of certain processing procedures. He stated that steam sterilisation was not totally ineffective against prions; one could achieve greater safety by combining all procedures, i.e. cleaning, chemical processing and steam sterilisation. He presented the Risk Assessment Model practised in the United Kingdom which takes account of the microbial reduction achieved with each of these steps and he drew attention to investigations that indicate that is not possible to reduce infectiousness to zero. The greatest possible reduction could be achieved by using suitable chemicals and increased temperatures, alkaline cleaning followed by steam sterilisation (18 min, 134 °C).

The morning finished with a repeat of some of the previous day's workshops. N. Ghassemieh, Berlin, gave a talk entitled "Processing medical devices in the context of new RKI regulations as well as of the 2nd Amendment to the Medical Devices Act", reporting on the processing circuit and quality management measures at the premises of an industrial processor.

The afternoon began with lectures on automated processing. C. Dogs, Hamburg, outlined the chemical aspects of instrument processing and elaborated on processing in respect of CJD, referring for example to various details of the CJD programme.

S. Krüger, Grünendeich, reported on uncertainties and disruptions as regards cleaning and disinfection. She emphasised that based on the Medical Devices Operator Ordinance - in addition to sterilisation - disinfection and cleaning must also be performed with appropriate validated procedures whose success can be reproduced. For example, uncertainty prevails where terms such as "residue free" are concerned - precise definitions are needed here to determine detection limits and residual quantities that do not adversely affect subsequent disinfection. The Central Service Supply Department now faces the task of evaluating, in the context of quality management and risk assessment, the performance of existing instruments and procedures. Only in this manner can the requirements prescribed by standards and directives be implemented in the long term.

T. Zanette, Tübingen, described suitable measures, especially of an organisational nature, when dealing with suspected cases of CJD. In addition to specially labelled waste containers, documentary measures are of paramount importance. If instruments are to be destroyed on confirmation of CJD - and this is not least a major cost factor - one should have the diagnosis definitely confirmed on an appropriate accompanying sheet. Staff training is also of paramount importance in this respect to ensure that staff members respond to this properly and ultimately guarantee their own safety.

J. Graf reported at the end of the conference on the organisation of a CSSD - this was the only subject of the day not touching upon CJD. He stated that the head of the department should call to mind his responsibilities, and should not be renowned only for offering staff support at the packing table. The administrative functions are becoming increasingly more numerous. Special attention must be paid to quality assurance, ideally underpinned by a quality manual; however, the latter should not be a rigid treatise cast in stone but rather a "living" document that must be updated at regular intervals in line with prevailing trends. Involvement of staff members is by all means desirable here; being allowed to correct the "boss", to cite Graf, can unleash additional bursts of motivation.

This year's congress finished with an experiment; for the first time ever the evening event with a framework programme was placed at the end of the congress, and thus at the beginning of the weekend. But one can rely of the DGSV members; the room was practically full when, as every year, the industrial prizes were awarded. The prize for the best presentation was awarded this year to the company ebro Elektronik, Ingolstadt; Dr. Weigert had the most original stand. And finally, the prize for most innovative product went to the IT system Kenus.

Conclusion: the themes covered this year were more topical than ever before. Indeed, some of the issues discussed are not yet available anywhere for consultation. The lectures and especially the lively discussions showed just how widespread is the influence of sterile supply; in light of the problems relating to prions this influence is spreading continually to new areas. Finally, perhaps as never before, sterile supply personnel are facing ethical issues.

It must be hoped that the sterile supply personnel will prove not only to be up to the task of meeting these requirements but that they will continue to expand their knowledge of them, so that in leaps and bounds still more can be done in future for the recognition of this profession and of this important service.

Dr. Gudrun Droop
mhp-Verlag GmbH
Wiesbaden, Germany