"A new look at an old topic"
Workshop Report

The workshop took place in the beautiful historical surroundings of 'Het Pand' in Ghent. There were 300 participants. Wim Renders, the chairman of the VSZ, not only expressed his thanks to Santa Claus, who had provided a small present, but also the Hospital Hygiene Department of the University Hospital Ghent and more in particular prof. Gerda Verschraeghe for the invitation to jointly organize the workshop.

Wim Renders said that the invitation came as somewhat of a surprise as at first sight it may seem that Central Sterilisation and Hospital Hygiene have very little in common. But closer scrutiny reveals that there is a lot of common ground between the two disciplines. For this reason he had gladly accepted the invitation. He continued:

"The most important link between both disciplines is undoubtedly the concern for the microbial welfare of the patient. But each discipline has its own specificity. I believe that this should be respected because each discipline requires its own expertise. At the same time I am of the opinion that a better synergy can be established in both areas.

Another common element, but a rather negative one, is the continued underestimation of the importance of the preventative role played by both departments. Both the local authorities and the central health administration could do much more despite the fact that in the area of hospital hygiene a substantial effort is undertaken to contain hospital infections and bacterial resistance. The authorities have realised the seriousness of the infection problem and have undertaken to substantially reduce the number of hospital deaths, estimated at 3000 per year in Belgium, due to infection.

Nevertheless, the different supervisors all too often stress the cost of sterilisation and hospital hygiene on the micro-economic level of the hospital. They do not take into account the benefits in terms of:

• for hospital hygiene: fewer infectious and other complications;
• for sterilisation: less replacement of instruments as a result of better care, less loss, shorter waiting times for the surgical team etc.

Too little value is attached to the preventative role played by both departments and the important macro-economic savings which are made. In the case of Central Sterilisation this is apparent in the fact that no framework of norms has been worked out, neither for the infrastructure nor for the recognition of the professional expertise of the staff. Is this lack of "interest" perhaps also due to the fact that the academic circles in Belgium, in contrast to other countries, have paid very little attention to sterilisation?

Is this the reason why it is so difficult to be valued and consequently to be taken seriously? This remains an unanswered question. Maybe this workshop can set the process of change in motion. Undoubtedly the interesting papers, which will be presented today, will contribute to a new and long overdue appreciation. At least I hope so."

Wim introduced the first speaker, Adrie de Bruijn, senior researcher in the department of Medical Aids of the RIVM. Adrie spoke about the controls on the washing process in the washing and disinfecting machines.
"A number of principles can be applied to evaluate the results of the cleaning procedures of reprocessed medical devices. The method most commonly used is visual check after cleaning. A simple swab method may assist in objectifying of the cleanliness. By combining a protein staining agent and a swab method residues of proteinous nature can easily be discovered at low cost. Solid instruments with easily accessible surfaces are clear candidates for this method. Also hollow instruments with an inner diameter of at least 2 mm can be swabbed.
A basic swab procedure is described in the (draft) ISO standard for washer disinfectors using common low-cost, domestic purpose cotton swabs and ninhydrine solution as the staining agent. However, the procedure described has some disadvantages. The test is rather time consuming and unexpected colouring reactions occur that interfere with the reading of the colour reaction on the swab. In order to overcome these problems the critical parameters were identified, such as the type of material used in the swab, the consistency of the material of the swab, the amount of liquid on the swab, incubation temperature and incubation time. The improved protocol renders the method both sensitive (2.5µg of bovine serum albumin on a glass plate) and reproducible. (Zentral Sterilisation, 4/2001)"

The next speaker was René Vis, an expert in sterile medical devices of the VU Medical Centre in Amsterdam. He dealt with the difficult problem of the quality control during the cleaning and the disinfecting of flexible scopes.

"In order to supply every patient with a safe instrument a controlled and reproducible cleaning and disinfecting process has to be set up. To achieve this a number of conditions have to be met: qualified personnel, standard working procedures; validated processes and machines, controlled maintenance protocols for the washing and disinfecting of machines and a good traceability of the instruments.

The present state of affairs, however, is that a lot is still done by hand. For more reproducibility it is necessary to mechanically process the flexible endoscopes. Supervision of the procedures and the functioning of the machines is also necessary. It all has to be part and parcel of a quality system.

The supplier of the endoscope has the obligation under the MDD, essential requirements 13.6h, to provide the cleaning and disinfecting procedure. Moreover, prEN 17664 is in the pipeline. It tells the supplier which information has to be given in the procedure. In prEN 15883 part 1 the requirements for a disinfecting machine are described and in part 4 the specific requirements for a scope disinfecting machine are set out. In the Netherlands we also apply guideline 21b of the study committee Infection Prevention (http://www.wip.nl).

In the Netherlands this has led to the recommendation of the Inspectorate of the Medical Care Department to appoint "expert scopes" in each hospital. As a direct consequence the expert on sterile medical devices is now also responsible for the quality of the scope disinfectioning in the Vumc.

The conclusion is that the cleaning and disinfecting is a specialised procedure, which has to carried out by specifically trained personnel. A quality system has to be in place and a supervisor has to be appointed to ensure the necessary quality. Processing flexible endoscopes by hand is not reliable and should be replaced by the use of validated cleaning and disinfecting machines."

Prof. Dr. Heinz-Peter Werner, HygCen, Bisschofshofen, discussed the importance of type-test of washer-disinfectors.
"Often no exact definitions are given for type tests or for the different objectives of the acceptance tests conducted for washer-disinfectors. Conductance of a qualified type test is a prerequisite specified by the Medical Devices Act (MDA) prior to putting a washer-disinfector into operation. This test serves as a basis for risk analysis. The washer-disinfector manufacturer is responsible for its characteristic data. But the objectives of the acceptance test are completely different. During this test cleaning and disinfecting are defined in accordance with the specific conditions prevailing at the operator’s premises. Only quantitative test methods are required for both tests, with top priority being accorded to the standardisation and practical relevance of the challenges used. Hence, methods that ultimately yield only Yes/No results, and this often only on the basis of visual inspection, are not suitable for such tests. Challenges must reflect the real-life conditions, so that on this basis optimal cleaning results can be achieved. (Hyg Med 2002; 27 [11]: 459-466)"

Peter Hooper, a consultant from the UK, was the last speaker in the morning session. He gave a talk on 'Inspection of SSD-the English Experience'.
"Since late 1999 the NHS in the UK has been responding to the perceived increase in the risk of re-usable medical devices and the association with vCJD. Whilst a number of documents and initiatives have been introduced the main impetus in raising standards has been via inspections of all SSDs. These started with a small sample of healthcare facilities of all types and sizes. The report for this series of inspections was not published until sometime and it was undertaken by events.
A specific inspection of sites performing neurosurgery and posterior ophthalmic work was undertaken but because of the sensitive nature of this report a new and complete inspection was undertaken in England. If the outcome at any hospital was in doubt a further inspection followed by a detailed action plan was put to the hospital Executive. The severity and importance of these surveys effectively created a raising of standards via publication of survey results.
Hospitals placed business cases for centralised funding and new equipment, instrumentation and building layouts are being introduced. The prioritisation of these funds were checked via a final set of quality control inspections to check that action plans had been put into practice.
All SSDs have become familiar with this pattern of inspection, funding and re-inspection and are aware that there is a continuing need to demonstrate to themselves and their patients that re-usable medical devices are being re-processed in the proper manner."

This paper brought a very stimulating morning session to a close. In the afternoon the focus was on Hospital Hygiene.

The participants appreciated the fact that the borders of their own discipline were crossed. They found this very enriching as it was possible in this way to find out about the state of affairs in another discipline. This will undoubtedly lead to a better understanding and more insight. This experiment should definitely be repeated by for example bringing together surgical nurses, surgeons, endoscopists etc.

Wim Renders, Ludwig Van de Voorde
Bruges, 19 February 2003