I would like to know the differences between the regulations on sterilization of medical devices in some european countries (between France, UK, Germany, Italy, Spain for example). I would like to know the different approaches to subjects like:

• the non-reusable medical devices
• the regulation of sterilization techniques
• the prion risk
• the sterilization organisation in hospital (the responsibilities, the procedures)
• the regulation of outsourcing

Where can I find websites on the subject? or someone who could enlighten me?
Thank you so much for your assistance

Francois de Lesquen
Paris, France

Bonjour Francois,

Although Belgium is not included in the list of countries I'll provide you with an overview of what is or is not happening here. As a result of the lack of regulation it is not always clear as to what is or isn't allowed. This is for example the case with the reuse of medical devices meant for one time use.

• Reuse is allowed in principle but exclusively if this happens within and for your own hospital. A study group at the Ministry of Health is looking into the matter nowadays. Probably a prohibition of reuse will be imposed because the hospitals are not in a position to provide a quality guarantee. Processing by a third party could perhaps be allowed as an alternative (this is still forbidden at present).
• Regulation: In 1993 a brochure was issued by the Health Council: "Recommendations concerning sterilization". Briefly a number of sterilization issues are discussed. The application of these recommendations has never been imposed with the result that they remained dead letter in most hospitals. These recommendations will be revised shortly. The European norms are followed as far as the purchasing of appliances, e.g. autoclaves and consumption items such as laminate bags is concerned. European norms, which are important for the practical functioning of the CSSD, e.g. validation, quality systems, are very often not applied. However, a change for the better is becoming noticeable.
• Prion risk: In 2001 the same Health Council published the "Recommendations to prevent the transfer of spongiloform encefalopathies (Creutzfeldt Jacob disease) in health care institutes". In this procedure patients are screened and categorized on the basis of risk into high, moderate and other patients. For the category of other patients the materials used undergo normal treatment. In the case of moderate risk the materials are treated in function of the risk connected with the medical procedure. For high risk patients the materials are destroyed after confirmation of the diagnosis. However, in Wallonia- - French speaking - the French guidelines are used.
  The text of the Health Council in French and Dutch can be found on website:
  www.health.fgov.be/CSH_HGR/Francais/Brochures/Creutzfeldt_Jakob.htm
• The sterilization organisation in the hospital: The Royal decree of 1991 is applicable. It points out that: "The hospital pharmacist has to qualitatively guarantee the daily activities around the CSSD by:
  1. providing advice about the choice of the apparatuses and of the sterilization method.
  2. the validation of the sterilization procedures.
  3. the supervision of the different steps prior to the sterilization, cleaning, disinfection and packaging of the materials which have to be sterilized."
  Actually the pharmacist whose name has to be explicitly mentioned, is responsible for the central sterilization department. Moreove there is a circular of the Department of Health (1991). It stipulates the following: "Within the hospital central sterilization is the preferred option" and furthermore "During the sterilization process one nurse has to be permanently present". The latter guideline cannot always be followed. In practice the pharmacist is responsible for the CSSD; the day-to-day activities are organised by a nurse. The other members of staff do not have to meet specific degree requirements.
• Regulation of outsourcing: Outsourcing hasn't yet been regulated. The question arises whether this is possible within the current Belgian legal framework (see the paragraph on reuse). There is no clearcut answer to this question from the Ministry of Health. This problem will be discussed shortly at the ministry.

A bientot a Winterthur?
Wim Renders

Dear,

Poland is going to be member of the European Community. The European regulations will be Polish regulations (we are working on it very hard to be in time).

• Reuse of single use medical devices is forbidden now and probably will be in the nearest future. The reason is HBV. The case rate in Poland is probably almost the highest in Europe.
• Prion risk: it isn't a problem for us, but in this case we have some recommendations (like in other European countries).
• The organization of CSSD in Polish hospitals:
  • Manager (mostly biologists - microbiologists, pharmacists and in smaller hospitals: nurses). The manager is responsible for the sterile medical devices (purchase and preparation of sterile m.d.).
  • nurse supervisor (only in a big hospital and in a big CSSD) is responsible for the staff.
  • Direktor of the hospital is statutory resonsible for the sterility in the hospital.
  • CSSD staff have to pass a specific exam.
• Regulation of outsourcing: it hasn't been regulated yet. This problem is coming to our country and is in a starting point.

Teresa Salinska