This year's congress of the German Society for Sterile Supply (DGSV) was held in new premises, and this was not the only novel aspect of the event - it really seems to have smashed previous records. Both the number of delegates, more than 250, and the industrial exhibits proved to be record breakers; and even the (rainy) weather was right, ensuring the lectures were well attended to the very end.
In her opening speech, Anke Carter, DGSV chairman, exhorted delegates not to be discouraged despite the numerous setbacks faced, e.g. the tight financial situation in the healthcare sector. Making the impossible possible time and again appeared to be one of the special challenges encountered in sterile supply. In this same spirit, Mr. Littau head of the building and technology department from Tübingen University College Hospital outlined the interdisciplinary cooperation between different domains, for example between technology and sterile supplies, which can be achieved only through good quality management. On this occasion, the congress focused in particular on the topic of personnel as well as, once again, on the classification of medical devices.
Right at the outset, delegates were given a preview of the next congress - not the DGSV's, but that of EFHSS. Wim Renders reported on the association's new membership and gave an introduction to the conference venue in Turkey, where sterile supply experts from throughout Europe will be meeting from 5 to 7 May 2004. He also gave an overview of the programme, featuring some unusual topics such as sterilisation with ozone.
The first lecture was given by Dr. J. Attenberger from the Ministry for Labour and Social Affairs of Lower Saxony. He dealt with the requirements being addressed to CSSD personnel from the perspective of the authorities and, on the basis of practical examples, he explained what the authorities especially look out for when conducting inspections. These include personnel qualification and also documentation. Attenberger is currently engaged in a special project entailing medical device operating manuals, which are often most inadequate.
To finish off, he put forward a proposal for personnel qualification, which in his view took account of the existing requirements: each staff member carrying out specialist tasks in an establishment undertaking processing should have completed at least Specialist Course I. But this was a rarity in reality.
The lecture given by B. Göckel, Darmstadt, dealt with staff motivation. He presented various motivational models and pointed out that motivation based on external inducements, such as the prospect of better pay or longer holidays, could be upheld only for a limited time. To ensure motivation in the long term such incentives would have to be replaced by internal motivation of personnel. To retain this, information campaigns, promotion and scheduled continuing education for staff were indispensable.
Rounding off this series of morning lectures, Prof. M. Mielke from the Robert Koch Institute spoke briefly about classification of medical devices. Following requests from the users, some of the regulations had now been described in greater detail (see also modified DGSV flow chart on pages 375-376). Mielke then went on to speak about the problems associated with vCJD, emphasising that in France and Switzerland the sterilisation cycle was permanently set at 18 min hold time and 134 °C. He stated that reports from the United Kingdom suggested that the vCJD cases had appeared to have peaked in the meantime, but he pointed out that "sporadic" cases could be triggered by this disease variant - differential diagnosis was often very difficult.
The ensuing panel discussion revealed very divergent approaches here. Whereas some delegates were already discussing the more minute aspects of medical device classification, such classification had not even been initiated in other establishments. It became clear that specific issues were causing problems time and again. For example, the guideline states that certain instruments did not lend themselves to reprocessing, something that alone for financial reasons was not possible to uphold (e.g. intramedullary reamer).
Processing of Critical Group C medical devices was indeed being conducted in some establishments; but in this context Dr. Attenberger pointed out that to date there was no accreditation centre able to grant certification to a department to process such devices.
To finish off the afternoon's series of lectures, H.-W. Röhlig, a judge from Oberhausen, elaborated on the legal aspects of medical device processing. He stated that in his opinion the guidelines and recommendations of the higher German Federal authorities were to be equated with anticipated expert opinions. Compliance with such recommendations and meticulous documentation of associated tasks protected the user in the event of any official inspections and, in particular, in any liability lawsuits. However, if documentation was incomplete, the burden of proof could be shifted to the user, who in all probability would have difficulty proving the safety of a device on the basis of non-existing data.
The evening event was well attended and in addition to a lavish buffet prizes were awarded as always for the industrial exhibits. The delegates voted the firm McDonald from Walsrode as having the most innovative product (Steamer II/Plus for manual cleaning); the prize for the best presentation was awarded to the company Merz and that for the most original booth (with a cocktail and coffee bar) to the manufacturer Dr. Weigert.
On 4 October the main focus was on personnel. Josef Graf outlined job descriptions for the CSSD and with the help of a tabulated summary he showed that various aspects were regulated in each case by several specifications (e.g. German Medical Devices Act (MPG), Book V of the German Code of Social Law (SGB V), and The German Technical Regulation on Hazardous Substances (TRGS).
Following this, Wolfgang Christ described how these stipulations were put into practice and he outlined the areas for which staff bore responsibility in respect of the various tasks. His talk gave rise to a few discussions, with there being a lack of consensus in particular on the approach to be taken to personnel vaccinations. Even if the latter were advisable and urgently recommended, immunisation of staff against, for example, hepatitis B could not be legally enforced. Good documentation was undoubtedly very useful here in the event of disputes.
On the topic of "planning manpower requirements", Sabine Premer and Roland Frey demonstrated an Excel-based computer program that is able to identify the amount of time needed to perform a single task, so as to thus be able to determine the number of staff needed, and hence also the costs. To begin with, all tasks must of course be registered; Premer stated that this took about 5 working days for one person (for a medium-sized hospital). But this investment paid off especially if changes had to be made in working areas or a department was assigned extra tasks; this also served to bolster one's argument when requesting more staff from the management.
Before the program is finally released it is to be tested out for around six months in a field trial in other establishments.
Towards noon it was once again a matter of "Focus on vCJD". Klaus Roth reported on the current state of research and presented a study in which various processing methods were investigated for effectiveness against prions. While highly alkaline compounds were effective, they were also very damaging to materials. There was another problem as far as ophthalmological instruments were concerned, because these had to be free of any residual alkalinity when used on delicate eye tissues.
A high degree of effectiveness against transmission of vCJD was found only when combining enzymatic cleaning, disinfection and sterilisation. Roth stressed once again that cleaning was of paramount importance especially in the context of prion-mediated problems. After all, a protein-free state also meant absence of prions.
Four workshops were also held on each afternoon of the congress; and since these were repeated on both days, delegates had the opportunity to attend all workshops.
Workshop 1 dealt with dosage of detergents. Following an introduction by Prof. P. Heeg, during which he spoke about the binding nature of stipulations enshrined in the German Medical Devices Act (MPG) and the Guideline of the Robert Koch Institute (RKI), M. Wieder from the firm Dr. Weigert demonstrated a system for process control and data management in a washer-disinfector. Equipped with diverse features, including a flow and temperature control mechanism, it ensures that optimal detergent dosage is always guaranteed.
Workshop 2 focused on parametric release. H. Pahlke from the CIA Working Group in Berlin dealt with the problems associated with classification of medical devices, while actively engaging the delegates in a dialogue. The resulting discussion revealed that once again the operating manuals compiled by the manufacturers were often most inadequate. Herr Giovanettoni from the firm Ulrich explained the operating principles of the Kenus System which is used to code and track instruments.
Workshops 3 and 4 dealt with the role of the computer in the CSSD; on the one hand, in a hospital providing standard services and, on the other hand, in a hospital providing a full range of services. The ensuing discussion revealed that when introducing a computerised system it was not only the trays and instruments that had to be registered; many firmly entrenched working practices had also to be modified in order to derive maximum benefit from the system. For example, supplying each and every ward with "its own" instruments was not really advisable.
The conference was brought to a close on Saturday afternoon with a few short lectures followed by a panel discussion on the topic of personnel qualification. A. Mielke, hygiene specialist and chairman of the German Society of Infection Control Nurses (VHD), reported that in some cases hygiene specialists were promoted to the ranks of CSSD management, stating that this was by all means possible, but under the proviso that the individuals concerned were commensurately qualified, i.e. had completed a specialst courses.
K. Blümel from the Caritas Academy in Cologne, a centre for further training offering, among other things, specialist courses for CSSD as well as courses for OR personnel, spoke about similar requirements for OR personnel. The latter often "participated" in sterilisation especially in smaller hospitals. She therefore advocated that the specialist courses also be made accessible to such staff members because it was not responsible to conduct processing without having the requisite expertise.
On the whole, A. Carter stated, it was naturally desirable that the work carried out in the CSSD should finally be recognised as an independent profession, and not as a task that could simply be discharged by related disciplines.
This congress, just like earlier ones, has certainly brought us closer to reaching this target. So we can only hope that (in the near future) this target will no longer be unachievable and that the CSSD staff through their dedication will once again have made something possible which until recently had appeared to be impossible.
Dr. Gudrun Westermann