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Annual DGSV Conference 2006
The DGSV 10 Years On - Medical Device Decontamination Today and Tomorrow
Conference Report

1 October 2006 to 3 October 2006
Potsdam, Germany


Conference Report
by Dr. Gudrun Westermann

Conference Report

Conference Report

The German Society of Sterile Supply (DGSV) Congress 2006, which was attended by some 360 delegates once again in Potsdam, marked a very special occasion. This became clear already at the members' general meeting on the eve of the congress when homage was paid to the Society's founding members, an impressive number of whom are still active today, in order to commemorate in due fashion the DGSV's 10th anniversary of its foundation. With just under 700 members, the DGSV has grown in a truly impressive manner since its foundation in 1996. But even more impressive are its accomplishments during this 10-year period, in particular in the domain of education and training. It is thanks to the DGSV's endeavours that today there is a structured training programme, which in the meantime serves as a model for comparative programmes in other countries.

The congress provided many opportunities for reminiscing about the DGSV's early days and for calling to mind just how many changes had taken place since 1996 in various areas, such as in the domain of quality management.

Reflecting this spirit, the congress was opened on 2 October with a whole series of welcoming speeches. Prof. Mielke from the Robert Koch Institute stated that at the age of ten years the society had reached immunological maturity and that puberty could now be expected. He outlined the issues that had preoccupied us during the past decade, e.g. cleaning also in the light of the risks posed by prions, a topic with which we would have to grapple for the coming decades. Accordingly, efforts were directed at devising better prion-inactivating decontamination processes that would lend themselves to everyday use, also for heat-sensitive instruments as well as at the certification and standardisation of supervisory activities.

Prof. Heeg from Tübingen, likewise a founding member of the DGSV, gave a review of the Society's first years, concluding that the first phases of storm and stress in this fast-developing society had already been overcome, however, it is only natural that a certain amount of turbulence can still be expected in the future. Now that certified training centres had already been established on a broad scale, a meaningful task would now be to draft and stipulate suitable rules and intervals for supervision and recertification employing external audits.

In his capacity of chairman, Wim Renders spoke on behalf of the World Forum for Hospital Sterile Supply (WFHSS), congratulating the DGSV on the occasion of its 10th jubilee (see also page 341).

Decontamination and training - the early stages

In the first lecture of the day, Klaus Wiese, Dortmund, spoke about medical device decontamination - yesterday, today and tomorrow. In an interesting historic retrospective he drew the delegates' attention back to the incipient stages of sterilisation, with the first boilers for alkaline soda solutions and the antiquated types of sterilisation drums. At that time the sterilisation pioneers still had to put up with being reproached with conducting "cleanliness to excessive limits". Wiese also highlighted how sterilisation departments were structured, whether as a central sterilisation department, conducting only sterilisation, or as a CSSD where the entire spectrum of decontamination was conducted. In the present day, the organisational structures and, in particular, the communication structures within the department and with other departments were becoming increasingly more important.

To round off these reflections, Anke Carter, Chairman of the DGSV, and Toni Zanette, Tübingen, reported on the initial stages of specialist training courses in Germany, which had already predated the foundation of the DGSV, first with the Brandenburg Training Institute (Brandenburgisches Bildungswerk) in Potsdam and at Tübingen WIT (Department for Transfer of Knowledge). Already within the first years of its foundation, the DGSV laid the foundation for establishing itself as an autonomous specialist association, rather than, for instance, as a section of the German Society of Hospital Hygiene (DGKH) because, to cite Zanette, the aim was to draft an independent job description for the "Technical Sterilisation Assistant".

Within one year of its foundation, the DGSV had already 150 members and the number of those completing the specialist training courses at all levels continued to rise, too, with several hundred certificates being still handed out each year to successful candidates.

Supervision of medical practitioners' offices and hospitals by the statutory authorities

The rest of the morning was devoted to the topic of supervision by the statutory authorities.

B. Vogler from the Trade Supervisory Office in Oldenburg reported on experiences as a competent supervisory authority, stating that the supervisor's qualifications were decisive for effective supervision. Vogler listed the principle four points to be borne in mind for monitoring of effective decontamination: level of staff education and training, premises, organisational structure as well as the processes and equipment. The problems frequently encountered were, for example, a lack of separation of the clean from the unclean area or inadequate restrictions on admittance. In particular in medical practitioners' offices the Robert Koch Institute (RKI) recommendation was often not observed, nor were processes validated. But the most flagrant examples were shortcomings in the training of staff entrusted with decontamination. Vogler illustrated his experiences with impressive, in some cases shocking, photographic material, making it clear that there was still much to be done here.

Dr. Bauer, Cologne, reported on the findings of inspections conducted in 107 medical practitioners' offices in North-Rhine Westphalia. Here, too, considerable drawbacks were noted, for example only in 3% of cases was there a really effective infection control policy in force. In the majority of cases, if at all available, the infection control policies were not tailored to the needs of the respective practice. Many practices continued to use very old washer-disinfectors which did not conform to EN 15883.

M. Kremmel, Augsburg, reported on the monitoring of hospitals in Bavaria. To begin with, he spoke about the organisational structures and competences of the different authorities responsible for supervision, and went on to describe how cooperation in this area could be improved through interaction between various working groups. Kremmel also reported on a number of problem areas, for example incomplete validation of processes, which meant that certain load configurations were not validated, something of which the user was often not aware.

But he also emphasised that frequently vital improvements could be made without any major investment. Personnel qualification was of paramount importance here; in the case of good process sequences executed by well-qualified staff decontamination of critical medical devices did not present any problem either; but if this could not guaranteed, it would be better to consider using single-use instruments.

Guideline drafted by DGKH, DGSV and AKI soon to be completed

To round off the morning lectures, representatives of the working group entrusted with the drafting of the DGKH, DGSV and AKI Guideline on EN 15883 reported on current changes in Part 1 as well as on updates in Part 2 and 3 of the Guideline. In the afternoon the members of the working group conducted a comprehensive colloquium in which the participants discussed various aspects of the Guideline and were able to put forward suggestions. The final result of these discussions will be reproduced in the updated and revised version of the Guideline, which is to be published already before the end of this year as a Supplement to Central Service.

Other workshops held during the afternoon dealt with certification of the QM system in various CSSDs. V. Sielhoff from Bad Oeynhausen as well as F. Hornig and I. Mislimi from Schwäbisch Hall reported on procedures in their respective establishments. Personnel qualification as well as the involvement of staff in decision-making and modification processes were portrayed as being very important. In such a case, proposals were made by staff members themselves since they felt a sense of individual responsibility for continually improving quality.

In its workshop, the Quality Task Force focused on decontamination instructions. The solutions put forward here are soon to be published in the article Recommendations by the Quality Task Force which is regularly featured in Central Service.

To gala evening event was also designed to an extent to reflect the spirit of the jubilee. With a series of photos, Ilse Voigt called to mind the founding event and also the "pioneers" of specialist training in Germany. In addition to food and drink as well as an exchange of views, the award of the industrial prizes are a traditional fixture on the agenda. The prize for the most innovative product went this year to the firm Vanguard. The firm Alvi was awarded the prize for best presentation, while the firm Dr. Weigert had the most original stand according to the opinion of the congress delegates. An honorary prize was awarded to the first DGSV chairman, Toni Zanette, who during his tenure of office had, himself, awarded many of these prizes and who, in workshops, up to the present day continues to promote sterile supply issues also at international level.

Evaluation of sterilisation processes

In the first talk of the second day of the congress, C. Witte, Ethicon, described how sterilisation processes were evaluated in the hospital setting. Using a spatial model, he showed how the various sterilisation processes were assigned depending on their suitability for heat-sensitive instruments and for instruments with special decontamination requirements (e.g. hollow instruments) as well as on the basis of the danger they posed.

Only when efficacy, material compatibility and danger potential were clarified could one in addition evaluate the economic feasibility of the processes. In that respect, Witte reported on experiences with H2O2 plasma sterilisation which could lead to considerable savings for various instruments that, in principle, could also be subjected to steam sterilisation. This was because plasma sterilisation meant that the service life of such medical devices was clearly prolonged, e.g. in the case of optics, electrode cables or flow measuring probes. The dry nature of the system reduced corrosion problems; there was also less thermal damage to optics.

Processing by external contractors

C. Meijer, Duisburg, portrayed decontamination from the perspective of the external contractor. In many areas it was no longer possible to distinguish between hospital-based and contractor decontamination since the boundaries were being blurred by the myriad models currently available (in-house decontamination by external contractor; complete spatial and organisational separation; privatisation and reorganisation of internal departments). From an organisational point of view, centralisation of decontamination made economic sense. If this was entrusted to an external contractor, there was initially a considerable need for regulation since structures and information organisational patterns that had accrued over the years could no longer be used. But this meant a greater willingness to introduce and implement changes as well as a markedly greater understanding of, and demand for, quality. Meijer stated that in the future centralisation and increasing involvement of external contractors or reorganisation of internal departments would give rise to increasing competition. This, in turn, held out good prospects for economically successful and quality-oriented units regardless of their organisational form as well as for well-qualified specialists who also had management and motivation skills.

Packaging as a sterile barrier

Dr. S. Manhart, Feuchtwangen, outlined the requirements set out in the new packaging standard 11607. He defined the term "sterile barrier system" used there, specifying the requirements applicable to various parts of a packing system. Within the framework of the QM system material requirements had also to be defined for the packaging material, e.g. demonstrable microbial barrier or compatibility with the intended sterilisation process. Regular checks by means of validated processes furnished proof of conformity with the standard. What was also important was a regular check of finished packaging materials since they were subjected to transportation - or ageing-mediated stress. For validation of the packing process, installation qualification had to be carried out while making an inventory of existing equipment and defining critical processes, in addition to functional qualification including manufacture of packaging at the lower and upper range limits as well as performance qualification during which the process variables and finally the outcome were checked. This increased investment ultimately meant a reduction in consequential costs; Manhart pointed that, however, what was of paramount importance was that the patient e.g. derived benefit from a reduction of the risk of contracting a nosocomial infection.

The post-certification period is also the pre-recertification period

Cornelia Hugo, QM Officer at Tübingen University Hospital, reported on life after certification. While achieving certification brought much satisfaction initially, one should not sit on one's laurels. Hugo stated that continued efforts were needed to ensure precise documentation and process description as well as continued monitoring to ensure targets were reached. Errors had to be documented and evaluated since not all errors were of an equally critical nature, for example as far as the use of a tray in the surgical department was concerned. Daily routines had to be continually reviewed in internal audits. By enlisting the involvement of staff, their awareness of problems and individual sense of responsibility were increased - something that of course called for commensurate training. Quality management, to cite Hugo, was ultimately a philosophy that had to be put into practice and in this respect the post-certification era was at the same time the pre-recertification era.

Decontamination and the law

Finally, Dr. Schneider, attorney from Pforzheim, spoke about a number of court rulings relating to decontamination. For example, decontamination of critical medical devices could be prohibited if such a decontamination process could not be assured in line with the RKI recommendation. In such cases, it might also be necessary to entrust this task temporarily to an external contractor; after all, one had to assume that such a case posed a general risk that would justify bringing to a temporary standstill all hospital activities, which would be tantamount to closing down the CSSD.

Another court ruling dealt with decontamination of single-use medical devices, something that is not forbidden in Germany. Based on the legal texts of the Federal Government, to cite Schneider, the intended purpose specified by the manufacturer clearly did not refer to the number of decontamination cycles. But single-use products had to be checked for amenability to decontamination. Ultimately, patient safety had to take precedence over cost.

And that brought to an end a congress that once again was able to cast light on the manifold aspects of modern-day medical device decontamination, and which also served as a forum to pay homage in a fitting manner to the DGSV's early days and 10th jubilee. A date or venue has not yet been decided for DGSV Congress 2007; but you should definitely keep the first week in October free for this. Before that, there will be an opportunity to exchange views with international colleagues in early May 2007 at the WFHSS congress in Baden, close to Vienna, Austria.

Dr. Gudrun Westermann
mhp-Verlag GmbH
Wiesbaden, Germany