Monday, 19 May 2014
Better controls and traceability of medical devices should ensure patients’ safety
On 2 April the European parliament agreed on stricter monitoring and certification procedures to ensure full compliance and traceability of medical devices such as breast or hip implants.
In separate legislation, MEPs reinforced patient safety requirements for medical diagnostic devices used, for example, to perform pregnancy tests, diabetes self-tests, and HIV and DNA tests. Parliament called for an ethics committee to be set up and introduced provisions in order to improve the quality of information provided to patients.
The proposed legislation seeks to improve transparency of information for patients and medical staff and to strengthen traceability rules, without creating additional burdens for innovative small manufacturers.
In the wake of the recent breast and hip implants scandals, patients wearing implants would also receive an "implant card" and be registered, so that they can be alerted if any incidents are reported with a similar product.
Bodies in charge of assessing medical devices often work with subcontractors. In future, MEPs say, they should have a permanent team of in-house experts who meet up-to-date qualification requirements.
The European Parliament voted on its first reading of the draft legislation, in order to consolidate the work done so far and hand it over to the next Parliament. This ensures that the MEPs newly elected in May can build on work done during the current term.