Strasbourg, 12/06/2003 (Agence Europe) - By adopting the own initiative report of Greek Socialist Minerva Melpomeni Malliori on medical mechanisms, the European Parliament has concluded that certain mechanisms should be reclassified. It stressed that it was necessary to distinguish between medical accompaniments that exercise a pharmaceutical action and others that do not. It is calling on the Commission to decide whether plasticized PVC devices conforms to the essential requirements defined in the 1993 directive. Parliament is emphasising that posterior monitoring for commercialising and gathering information linked to this area has to be improved and this monitoring will have to reflect the risks present in the device. The follow-up system for high risk devices should be put into place. It also highlighted the need to provide medical devices with a coherent labelling adapted to the instruction note that explains any connected to any user after affects. Parliament is calling on Member States to take necessary measures for ensuring that these devices are used once and re-use is prevented, given that reusing constitutes a major risk for patients and personnel in hospitals.
Currently, surgical instruments that are used only once and non-sterilised reusable interments (with and increased risk) are subject to different classification. Only the firs should be subject to a standards inspection by a certified organisation. This procedure should also be applied to non-sterilised instruments. Medical experts are also recommending a new classification of breast implants, stents and orthopaedic implants in order to apply stricter inspections of them. Devices that are in direct contact with the central nervous system should be reclassified in class III: high risk.