Conference Report

In keeping with tradition the members of the German Society for Sterile Supply (DGSV) met once again for their annual conference in early October. Likewise, in keeping with tradition they met this year again in Potsdam. More than 200 delegates had travelled on this occasion to the Seminaris Seehotel - an expression of the widespread interest in the principle topic of this year’s congress: Quality Management (QM).

The members’ general meeting held at the beginning of the conference had some successes to announce, such as for example a further growth in membership, successful cash-keeping over the past year and progress in efforts to have advanced training recognised; it also had some novelties: the DGSV chairman, Toni Zanette, announced his resignation as had already been indicated. But this does not mean that he will be completely withdrawing from the society’s activities; he will be relieved of some tasks and will thus have more time to devote to private interests. Anke Carter has been appointed chairman and Josef Graf vice chairman on a temporary basis. New elections for the board of directors will take place on schedule in 2004.

The conference was opened on 3 October with a speech by Dr. Kaiser, Medical Officer of the Potsdam Public Health Office. She highlighted the already noticeable successes scored in quality management. For example, advertisements for vacant positions in the field of sterile supply now in principle state the specialist qualifications required - something for which not least the DGSV has to be thanked.

Dr. Zastrow, Coordinator for Guidelines and Public Relations of the German Society for Hospital Hygiene (DGKH) reported how only a few years ago proposals to introduce specialist courses for sterile supply personnel were rejected, for example by the German Hospital Association, as being superfluous. In the meantime, both EN ISO 9001 and the RKI guideline on processing call for personnel training; indeed, explicit reference is made to the DGSV training regulations. Well-trained personnel, to cite Zastrow, are a guarantor of superb quality.

Dr. Schmidt from Brandenburg State Medical Council, who is also a member of the Medical Quality Assurance Working Group, conceded that knowledge of sterile supply was poor among doctors. This made it all the more important to strengthen the link between the sterile supply department and the users of the sterile device, in order to foster constructive cooperation.

Even before the actual talks on the agenda for this conference got under way, delegates were invited to next year’s event: Esther Wirth from Switzerland presented the city of Winterthur where next year the congress of the SGSV) will be held jointly with the EFHSS congress. This will be held from 3 - 5 July and will have as its topic "Processes". Next year the SGSV will be celebrating the 20th anniversary of its foundation and is hoping for many delegates from other European countries - provision will be made for simultaneous interpretation in English, German and French.

T. Kull, a Swiss attorney, opened the programme with a talk on quality management entitled "Must or Should"? It soon became clear that quality management is naturally a Must, especially because the environment will insist on it in the event of any procedural deviation or indeed of a claim. Kull pointed out that the RKI Guideline also called for quality management, but the choice of system was left to the individual department. It must be ensured that working procedures are conducted in a consistent manner and yield similar, reproducible results. Thus a QM system could ultimately also contribute to cost reductions. But to a large extent, to cite Kull, quality is "produced in the head" - staff motivation is the chief determinant of success.

M. Mielke from the Robert Koch Institute stressed that quality management in the healthcare sector should not mean "management of an inferior quality". Citing by way of example nosocomial infections, he elaborated on the difficulties that could be encountered here. For example, one could deem instrument processing as being qualitatively adequate if the devices did not give rise to nosocomial infections when used. But only a small fraction of the potential pathogens could be detected at all, and this was even more difficult in the case of viruses. Furthermore, long incubation times (in the case of prions 30 - 40 years) often made it impossible to establish a link. Mielke also stressed that personnel training was the most important determinant of quality assurance. In this respect, the activities of the specialist societies were indispensable.

A. Strunk from the German Society for Quality outlined the practical experiences gleaned from the introduction of a quality management system by a dental association and stated that it was possible to reduce costs even in small organisations when using a QM system. He presented different QM systems such as the ISO system which is recognised in 190 countries throughout the world. This had been developed for the industrial sector and can be used in different branches. He went on to describe the self-audit system of the European Foundation for Quality Management (EFQM) as well as the CTQ System (Cooperation for Transparency and Quality in Hospitals), which likewise is based on self-audit and covers the entire hospital. Strunk stated that to implement a QM system a well-understood nomenclature was indispensable so that employees could understand the targets to be reached and could identify with them. To finish off, he outlined the certification process, ranging from the preliminary tasks to the certification audit and the annual supervisory audit.

The talks were followed by animated discussions, raising in particular legal issues as regards implementation of the RKI Guideline: how can one protect oneself if one’s superior insists on processing a device contrary to the stipulations of the guideline? Various models were discussed, without ultimately finding a valid answer; but it became clear that by invoking the guideline and pointing to the operator’s responsibility and liability involved, superiors have often been made to comply with the requirements.

The afternoon was devoted to different workshops running at the same time. Because the workshops were repeated on the next day, delegates were able to attend a further workshop of their choice.

Under the title "Practice-oriented implementation of an internal audit in the CSSD", a questionnaire for an internal audit was compiled with the delegates of Workshop A; this could then be used to verify the various procedural steps in a CSSD.

Workshop B dealt with batch documentation systems and validable packing processes. The KENUS system from the manufacturer Ulrich was presented; the manufacturer hawo outlined the quality requirements for packaging and for sealing.

Workshop C was organised by the DGSV Quality Task Group and outlined possibilities for quality assurance of automated washer-disinfectors. Of prime focus here was the decision tree for classifying medical devices before processing (see also Recommendations by the Quality Task Group, p. 355).

Workshop D dealt with the use of dataloggers for monitoring washer-disinfectors and autoclaves. Workshop E, organised by the manufacturer Weigert, focused on instrument processing in the light of vCJD. And finally, Workshop F concentrated on the information to be provided by the manufacturer as regards reprocessing of resterilisable devices as per DIN EN ISO 17664 and outlined the benefits offered by such a standard to users and manufacturers; the limitations of this standard were also highlighted.

The second day began with a talk by B. Göckel, Alice Hospital Darmstadt, about the introduction of a QM system for certification of a CSSD. He described the Total Quality Management (TQM) concept in which all staff were involved and stressed that expediency of implementation should not be the pursued goal. Rather, priority should be given to ensuring the participation of each and every individual. Staff should be encouraged to find solutions to problems themselves. Staff training should be well planned and tailored to the level of knowledge and needs of each individual. Ultimately, the system would then be implemented by all staff members and the quality manual compiled by all, rather than by a QM officer. Göckel stressed that the introduction of such a system to begin with also engendered anxiety among staff, e.g. because of having individual procedural steps checked; this anxiety should be curtailed from the outset. If mistakes were made, it was important to establish the reasons for them and find ways of eliminating them rather than apportion blame. He stated that the investment needed to implement the system was not very great in some areas, because often working procedures were indeed being conducted in line with the standards, all that was missing was the appropriate documentation. The costs - a sum in the range of some 40,000 - 50,000 Euros was cited - would be offset not least by savings from not having to engage in reworking following complaints.

C. Hugo reported on a training course for quality manager in the healthcare service organised by the Academy for Medical Training in the Rhineland-Palatinate and the German Society for Quality. The training course comprises 6 modules which can be can be taken separately or in any order. It is possible to take examinations to qualify as a quality officer or quality manager in the healthcare service; the final examination is for quality auditor, which is recognised throughout Europe.

J. Wilke gave the final talk on the legal fundamentals of certification and on how the certification process for a CSSD according to the RKI Guideline unfolds. He began by defining the terms "certification body", "notified body" and "conformity assessment procedure", and elaborated in particular on the definition "placement on the market". Processing for a third party did not constitute placement on the market, if items were processed and returned to the same owner. Wilke also stressed that certificates were also awarded for meeting the specifications while assuring uniform quality, something that says nothing about the absolute quality. To finish off, he gave some practical tips for certification, including on the validity of certificates and on contractual links to the certifier.

Following the workshops the delegates assembled in the early evening for a summary of the events of the 2-day congress by Anke Carter and Josef Graf; delegates were also given an opportunity to make proposals and voice criticism. A change was then already made to next year’s congress programme: although the longer talks, which could go into greater detail, and the workshops had proved popular, many delegates regretted that they could participate in only two of the workshops. By restructuring next year’s programme, delegates will be given the opportunity to attend all workshops successively.

As always the congress was brought to a close with an evening event, which unfortunately was poorly attended this year. But at least this meant that those who did attend had the chance to scrutinise the quality of the buffet in a more leisurely manner. This year’s industrial prizes were awarded to Getinge van Dijk (most innovative product), Merz (best presentation) and, as in the past few years, to Rexam/Bömeda for the most original exhibition booth.

Undoubtedly, quality sometimes means that one gets into a quandary when it has to be delivered in the every day working routine. But here in Potsdam this was definitely not the case, rather the lectures and workshops helped to increase the delegates' motivation - and as we have just learnt, this is one of the most important prerequisites for implementation of a QM system.

Dr. Gudrun Westermann
mhp-Verlag GmbH
Wiesbaden, Germany