Study Day Report

The VSZ organized its autumn study day in the beautiful surroundings of the "Castle of Brasschaat". 160 enthusiast participants attended the study day. A record number of 23 companies had accepted the invitation to take part in the industrial exhibition.

In his introduction chairman Wim Renders thanked them and stressed the importance of a close partnership with the pharmaceutical industry. He added that instrument tracing systems - which are in the centre of everybody’s attention nowadays - can contribute to this objective, but in the first place they have to offer a surplus value to the CSSD. They should make the task of the CSSD personnel easier. Moreover, reproducibility should be improved. He expressed the opinion that before a Sterilization Unit decides to invest in traceability it is important to decide up to which level it should be possible to follow the instrument.

Vice-chairman Walter Accoe invited everyone to participate in the European congress which takes place in Cesme (Turkey) from 5 to 7 May.

Ludwig Vandevoorde drew the audience’s attention to the training programmes set up by the VSZ. Basic training courses (10 days) are organized at the Higher Educational Institutes of Roeselare (Katho) and Hasselt (PHL). In September 2004 an advanced training course will once again be given. Moreover, it will also be possible to obtain the degree of Bachelor of Sterilization (within the framework of the European Bologna agreement) at the Katho.

After the introductions Mr Wassenburg presented the first industrial paper. He gave an overview of the problems and bottlenecks in connection with the reprocessing of flexible endoscopes. He provided a detailed comment on the prEN 15883 (-4) which clarifies this process, the relevant checks and the testing methods as validation tools. He drew attention to the importance of adequate reprocessing in a fully automatic washing and disinfecting machine and to the extra advantages as far as process traceability is concerned.

Mr Foubert (Centexbel) informed the audience on the present state of affairs in the lengthy process of the realization of the EN 13795 - surgical drapes, gowns and clean air suits, used as medical devices, for patients, clinical staff and equipment. First he discussed the general framework of this norm, next he provided more details about how European norms come into being.

For the EN 13795 he specified that it consist of 3 parts: EN 13795-1: general requirements, prEN 13795-2: testing methods and prEN 13795-3: minimum requirements. Only part 1 has been published so far. He ended with a clear overview of the requirements contained in the different parts.

Chantal Faber talked about the traceability of instruments in the UCL. She also explained why glutaraldehyde solutions are no longer used in her hospital (fixation of proteins).

After lunch Arjan van Drongelen (Department of Medical Technology of the RIVM) provided information about the report of the RIVM concerning the evaluation of class-I files (M.D.D. 93/42). He came to the conclusion that:

• more than 10% of the products should not have been reported;
• no single filed contained all the required documents;
• there were always problems with the labeling and the instructions for use;
• improvements of the files are possible and desirable.

Furthermore he dealt with EN 17664: sterilization of medical devices - information to be provided by the manufacturers for the processing of resterilizable medical devices.

With justification he stressed the responsibility of the CSSD when requesting the required information. Otherwise nothing will ever change.

Murray Nicholson (Steris) pointed out the different possibilities - disinfection and sterilization - of the vaporized hydrogen peroxide process at low temperatures. Steris will put this product on the European market in the course of 2004.

After the coffee break Brigitte Beckers gave a captivating, interactive presentation about how we could deal with stress.

An enjoyable reception ended this stimulating and interesting day.

Wim Renders
Bruges, 18 January 2004