Potsdam, as announced by the city’s Lord Mayor J. Jakobs in his welcoming speech on opening this year's DGSV (German Society for Sterile Supply) congress, has the highest density of scientists in Germany. During these three days it certainly also had the highest density of experts for sterile supply. Almost 300 delegates had turned up on this occasion - coming not only from Germany.
Prof. Mielke from the Robert Koch Institute (RKI) also gave an introductory talk, in which he pointed to the successes scored in implementing the RKI Recommendation, stating that the flow chart published by the DGSV for classification of medical devices proved to be a practical guide during this implementation process. This Recommendation and its implementation was also eliciting growing interest outside Germany, for example in Switzerland, Austria and Spain.
Dr. Stange from Brandenburg State Public Office outlined the tasks and challenges facing the statutory authorities. She applauded the cooperation with the DGSV, includ. when it came to implementing the RKI Guideline.
Wim Renders from Belgium, chairman of the EFHSS (European Forum for Hospital Sterile Supply), also thanked the congress delegates (see also Editorial). He thanked the DGSV for having supported the EFHSS right from the beginning; for example, the first official EFHSS conference in 2000, also in Potsdam, had been organised in cooperation with the DGSV. The DGSV training regulations, just like the RKI guidelines, served as models for other countries. He concluded his talk by inviting the delegates to participate in the world conference to be held next year in London. This conference will be organised by the British ISSM in cooperation with the EFHSS and the international association IFSS (30 March - 1 April 2005).
In the first specialist lecture, Dr. Attenberger, Hanover, gave an overview of the requirements for processing. He stressed the importance of patient protection and pointed out that, legally, the burden of proof was shifted if there was failure to comply with the RKI Recommendation when processing medical devices. This meant that the department concerned would have to prove that the processes it had used were equally effective. He went on to describe the monitoring procedures used by the statutory authorities, quoting Lower Saxony by way of example. Here, licensed medical practitioners were required to meet the same standards as the hospitals. A high-risk area, to cite Attenberger, was the outpatient surgical centres that frequently used ultra complex instruments and equipment but where staff often had neither the qualifications nor the resources to conduct processing properly. Attenberger reported that there were still widespread disparities throughout Germany in the approach taken to statutory inspections. The aim of having a uniform procedure for the entire country was still a futuristic concept because problems relating to the competent persons and their qualifications had still to be resolved.
Dr. Soltau, head of the German Central State Body for Health Protection with Regard to Drugs and Medical Devices (ZLG) reported on the role played by the ZLG in processing medical devices. She pointed to the recommendatory nature of the guidelines, e.g. of the RKI Guideline; these were accepted as reflecting the current stock of scientific knowledge and the state of the art and anyone engaged in processing had to reach at least this level.
ZLG is the German authority responsible for certification of notified bodies. A list of the applicable requirements can be viewed at www.zlg.de, as well as a list of the accredited laboratories and certified bodies.
Validation must be conducted in line with the recognised rules of technology, bearing in mind the state of the art. The guiding principles are set out in the relevant standards (DIN/EN and prEN/ISO). Validation, to cite Soltau, should also take account of appropriate risk assessment and classification of the respective medical devices. There was, she stated, no documentation available at present for Critical C devices.
To conclude, Soltau summarised various critical points. Often, the manufacturers’ specifications in respect of material compatibility or the effectiveness of certain sterilisation processes were not adequate. Likewise, there were time and again problems with standardisation, e.g. if manual pre-treatment was carried out, or because of deviations in the demineralised water quality or in dosage of disinfectants by different dosing systems.
Therefore cooperation between the authorities and those working in the field was essential, to cite Soltau, in order to arrive at suitable patient-protection provisions which would also be implemented.
Anke Carter, Osnabrück, reported on inspection of CSSDs by the authorities. The statutory basis for this was the German Medical Devices Act Article 3(26). Carter stated that she had had a look at the reports compiled by different authorities and that they had varied greatly in terms of presentation and length. A consistent presentation would, of course, be desirable for users. The DGSV believed that statutory surveillance was advisable in the interest of patient safety, Carter stressed. If properly conducted, it could also help to implement the relevant guidelines.
The Quality Task Force had compiled a checklist for inspections, which was later introduced by N. Ghassemieh. The audit list is intended as a source of help to establishments that process medical devices. It was compiled on the basis of the RKI Recommendation and of the Medical Devices Operator Ordinance (MPBetreibV) and was to be made available to CSSDs and the statutory authorities. This list was organised according to topical areas ranging from staff training to transport and storage of medical devices. The most important aspects were presented in the form of a questionnaire.
K. Roth, Tübingen, reported on processing of ophthalmologic instruments. A typical feature of these ultra intricate and delicate instruments was often lumens and poorly accessible surfaces. The working group had taken on the task of developing an automated, validated method for processing such instruments. The instruments belonging to a typical set for a cataract operation were tested individually for their amenability to cleaning. The instrument trays on which the instruments were placed in the washer-disinfector had been modified in some cases. Fixing them with silicone tape has proved useful, both to protect the instruments and to assure good access to detergents, disinfectants and sterilants. Having taken such measures (modified 3-mach M-Flex-Tray and PICO Power Flush, manufactured by Medisafe) it was possible to achieve good results. However, the need to have each individual instrument validated was revealed.
On this same day, an evening event was held at which the prizes for the industrial exhibition were awarded. The firm Merz won two prizes straight away, for the most original exhibition booth and for the best presentation. The award for the most innovative product went to the firm Brömeda.
Day 2 began with the important topic of continuing professional education. Mr. Sernau for the Brandenburg Training Institute reported on the current state of affairs. There were by now training centres for specialist courses in all German states. The profile of those participating had somewhat changed: whereas earlier some 80% of participants had been nurses, they presently accounted for only 15%. That meant, to cite Sernau, that often basic medical knowledge had to be imparted in many cases first of all.
Outpatient surgery constituted a problem area, according to Sernau. There was an urgent need here for personnel qualification, in particular in view of the fact that, as decreed by the Robert Koch Institute, there should be no disparity between the quality of outpatient and inpatient care; the same hygiene requirements were applicable in both cases.
M. Pfeifer, Waldkraiburg, reported on the critical cleaning parameters encountered in alkaline automated instrument processing. He explained how chemical and mechanical factors affected the cleaning outcome. On the basis of a series of tests he demonstrated that a high pH value in conjunction with a high temperature could potentiate the cleaning action. However, the pH value declined in hard water, so that a value of >10, as recommended by the RKI, was not always reached. Pfeifer stated that the water quality should definitely be checked for processing.
Dr. P. Kober, Neustrelitz, outlined the practical implications that endotoxins had for the CSSD. These lipopolysaccharides originating from the cell wall of Gram-negative bacteria were released primarily on destruction of these microbes and could generate a pyrogenic effect. There were therefore limit values in place for liquids, e.g. for water used for injections. There were no such limit values for surgical instruments. However, it could be assumed that a certain amount of residues remained on sterilised items following automated cleaning and disinfection. Feedwater containers were one source of problems in this respect, since they often harboured biofilms, thus enabling endotoxins to gain access to the saturated steam, to be then deposited on the instruments. Regular emptying and cleaning/disinfection of containers could prevent this problem.
R. Fleischhack, together with a hygiene staff member from Klinikum Neustrelitz spoke about drafting standard operating procedures (SOPs) for non-validable working procedures. In cooperation with hygiene specialists and sterilisation experts from several hospitals, SOPs were compiled for manual working steps, such as for packing or servicing, and tailored in the various departments to the locally prevailing circumstances.
This, he stated, made it possible to document working practices that often could only be verbally explained, possibly with photos - serving also as an important aid when training new staff.
In the last talk K. Hahnen, Neuss, explained the importance of standards for processing medical devices. He gave an overview of activities in the standardisation committees and of the standards relevant to processing. Since standards had to be revised at the latest every five years, they reflected the state of the art. Therefore it was advisable to base one’s working practices on the standards, even if the latter were not legally binding as such. Hahen stressed that standards were no substitute for one’s own independent thought processes.
To round off the talks there was a panel discussion in which the current status of the guideline jointly drafted by the DGSV, DGKH and AKI was discussed. This document focuses on validation of cleaning and disinfection processes. It is intended that this guideline will close the gaps between the standard (prEN 15883) and the user, because the standard contains no information for the practical domain. Prof. Martiny, Mr. Eibel, Mr. Roth, Dr. Michels and Mrs. Jones gave short talks to address the various aspects of the guideline. It is expected that a final draft of this will be adopted already this year.
As had been the case in the past, several workshops were held in the afternoons, running in parallel and repetitively so that all participants had a chance to participate in all of them.
B. Joachim and R. Busch outlined the first certification process for the CSSD of Klinikum Weiden in line with the RKI Guideline. In an animated discussion it was possible to respond to the questions raised by delegates and describe the work involved as well as the pitfalls associated with certification.
S. Premer and R. Frey reported in another workshop on the current state of affairs as regards their system for calculation of staff requirements. The computer-aided system was demonstrated. Unfortunately, unlike last year when first demonstrated, it was not possible to present very many findings from other hospitals showing to what extent the system could be applied to other general settings.
Finally, a third workshop dealt with optimisation of cleaning. Dr. J. Staffeldt, Hamburg, reported on, inter alia, the test phases for verifying detergent efficacy against prions. Dr. W. Michels, Gütersloh, described a cleaning process involving the addition of peroxide which is particularly effective at releasing activated oxygen. Prion-efficacy testing is also being carried out for this process (Oxivario plus), but with a higher dosage.
As always, the congress offered a cornucopia of information as well as, of course, the opportunity to engage in discussions and renew old friendships. It is encouraging that the number of delegates is constantly increasing. As such, congresses are contributing more and more to meeting one of the DGSV's principle aims, i.e. advanced training and continuing professional education. The DGSV members’ general meeting was held as usual before the congress, with election of the board of directors and the advisory board. New members elected to the board of directors were Marion Peißker and Martin Held.
Dr. Gudrun Westermann