WRITTEN QUESTION P-3964/98

by Raphaël Chanterie (PPE) to the Commission

(21 December 1998)

Subject: Legal uncertainty over the use or re-use of disposable equipment

In Belgium the Minister for Health, Mr Colla, stated in reply to a parliamentary question that the entry into force of Directive 93/42/EEC(1) concerning medical devices would not change the current situation in any way, since the equipment concerned should be used in accordance with the manufacturer's instructions. If, according to such instructions, medical equipment might be used only once and it was decided to re-use it after sterilisation, the person taking the decision would be responsible for any consequences. This position was also adopted in the recommendations regarding sterilisation techniques made by the Belgian Minister for Public Health in November 1993.

In this context, I should like to forge a link with the approach adopted by Belgium's National Institute for Health and Invalidity Insurance (INAMI) on disposable equipment. Where the manufacturer states in his instructions for use that the equipment is to be used once only, the health insurance fund bases its (flat-rate) payment on the assumption that the equipment (e.g. disposable catheters) may be used more than once after sterilisation. In other words, the reimbursement is calculated on the basis of the number of times the equipment is resterilised.

The opinions of the Minister for Public Health and the Minister for Social Affairs thus differ.

Where equipment intended for use only once is resterilised, should the hospital or hospital pharmacist be regarded as the manufacturer within the meaning of Directive 93/42 and so subject to the CE marking requirement?

Article 3 of the directive states that medical devices must meet the essential requirements set out in Annex I which apply to them, taking account of the intended purpose of the devices concerned. Some people infer from the wording of Article 3 that disposable equipment may be used once only. Others (including the German Health Minister) feel that the word "use" should be understood within the meaning of the medical definition of the medical device concerned. Thus a catheter may be inserted only at the place for which it was designed.

Can it be deduced from the directive that the resterilisation of disposable equipment is prohibited? If so, on what provisions is this prohibition based?

Answer given by Mr Bangemann on behalf of the Commission

(8 February 1999)

The manufacturer of a medical device determines the intended use. Where a medical device is intended to be reused the manufacturer must supply information on the appropriate processes to allow reuse, including cleaning, packaging, and where appropriate, the method of resterilisation of the device, and any restriction on the number of reuses. Where the manufacturer defines the use of a device as "disposable" or "single use" then this must be stated as part of the information supplied by the manufacturer in particular on the label.

The designation "single use" is made by a manufacturer after evaluation of the device during the design phase. Resterilisation might not be appropriate since the process itself, when performed by the user, might compromise the safety of the device or might not ensure sterility due to characteristics inherent to the design of the device.

Reuse of single use medical devices by users such as hospitals may occur in certain circumstances. It has to be stressed, however, that safety issues are only addressed in Council Directive 93/42/EC concerning medical devices when such a user assumes the role of a "manufacturer" within the meaning of the Directive, thus being bound by the obligations of the Directive. This is only the case when a person assumes responsibility for design, manufacturing and labelling of the device, thus ensuring that the device meets the essential requirements and does not compromise the health and safety of patients when placed on the market or put into service for the first time for its intended purpose.

The Directive does therefore not cover the situations where use of the device is made contrary to indications of manufacturers. The Directive however does not affect the right of Member States to subject such activities to appropriate protection requirements. The practice of resterilizing single use medical devices may therefore be addressed by guidance from professional bodies as well as controls under local or Member State legislation. Resterilisation performed without controls could result in a dangerous "misuse" of devices, could present safety and health uncertainties about resterilisation, and health risks for patients, users and third parties, and could raise liability issues.

(1) OJ L 169, 12.7.1993, p. 1.