EU parliament agrees new rules on medical devices

Stricter monitoring and certification for medical devices such as breast or hip implants were agreed by European Parliament yesterday.

The parliament was told recent “scandals” involving breast and hip implants were only part of the problem, with many devices labelled “single use only” such as certain catheters or forceps, being sterilised and reused.

MEPs also heard groups in charge of assessing and certifying medical devices often rely on subcontractors. In future, MEPs said, such groups should have a permanent team of in-house experts who meet up-to-date qualification requirements. In addition MEPs also want a new group of qualified groups to assess “high risk”devices used inside the human body.

The new regulations would also improve access to clinical data for both patients and health professionals, so that informed choices can be made about which product to use. The parliament will now negotiate legislation with member states, and MEPs said tighter controls could be in place as early as next year.

Breast implants
Irish MEP Nessa Childers, who lobbied for the changes, said recent controversies such as the PIP breast implants "which affected thousands of women in Ireland and across the EU in 2012", were reminders of the need for regulations covering manufacturing quality.

She said hip implants, pacemakers and breast implants, were all in use on a day-to-day basis and problems could jeopardise patients’ lives.

The parliament heard the aim of the new legislation was not to “create additional burdens for innovative small manufacturers”, but improve transparency of information for patients and medical staff. It would also strengthen traceability rules.

“To date, doctors have been telling us that hundreds of hip replacements are defective and have to be taken out again, with huge expenses for the health systems and suffering for patients. We need a better system,” said rapporteur Dagmar Roth-Behrendt.

'Implant card'
MEPs also want patients to receive an "implant card" and to be registered, so that they can be alerted if incidents are reported with a similar product.

MEPs say that persons or institutions who wish to reprocess a single-use device must be held liable and ensure the traceability of the reprocessed device. A list of devices unsuitable for reprocessing should be set up via delegated acts.

In separate legislation, MEPs reinforced patient safety 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 for the informed consent of patients and genetic counselling.

“Yes indeed, there are problems in the world of medical devices and this also applies to diagnostic devices. There has been a HIV test on the market for years that has been giving false negative results, with all the consequence arising from that in cases of blood transfusions or various other kinds of contact,” said Danish centre-right MEP Peter Liese, who is steering the legislation through parliament.