Medical devices rules: Patients’ safety must be reinforced

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The inadequacy of the EU's legislation on medical devices was highlighted by several recent serious safety problems. In order to regain citizens’ trust, the European Union must reinforce its legislative framework, write several associations.

This opinion article is co-signed by the European Insurance Social Platform (ESIP), the Medicines in Europe Forum (MiEF), the Association internationale de la Mutualité (AIM).

On 26 September 2012, the European Commission proposed a recast of the legislative framework on medical devices, mainly focusing on a reinforcement of the post marketing follow-up.

Many stakeholders welcomed this initiative but wanted to go further and called for a stronger control before medical devices’ commercialisation. Already in June 2012, members of the European Parliament (MEPs) from all political groups called for “lessons [to] be learned from the fraudulent marketing of PIP implants such that (…) requirements for placing products on the market are strengthened at national and at European level”.

And in fact, many agree to say that the EU legislative framework for medical devices, even after the transposition of the last piece of the EU legislation on medical devices (Directive 2007/47/EC) into national legislation, still “suffers from a terrible lack of transparency (…) and is unsuitable to the necessary surveillance of new medical devices”. Franz Terwey, President of the European Social Insurance Platform (ESIP), points out that the current legislation “exposes patients to unjustified risks and harm."

The inadequacy of the legislation was revealed by several recent serious safety problems involving faulty medical devices and leading to serious public health consequences. If the breast implant PIP scandal has called the attention of the media and the public on medical devices’ security, many other incidents have not been covered by the media such as faulty stent grafts or elbow implants.

One of the most famous cases of a serious safety problem involving faulty medical devices was the PIP scandal, involving breast implants and which resulted in almost 15,000 women being explanted only in France between 2001 and December 2012 due to a fraud but also to a defective shell.

Economic consequences for member states and healthcare systems can be very important, due to costs for replacement of defective medical devices and expenses related to renewed surgical interventions.

Moreover, safety problems involving European medical devices threaten the reputation of European medical devices industry and undermine Europe’s competitiveness. All the stakeholders agree on one point: in order to reverse this tendency and regain citizens’ trust, the European Union must reinforce its legislative framework.

This context has put forward this challenge: trying to conciliate patients’ safety, timely access to medical devices, sustainability of the system and innovation for the industry of the sector.

In order to live up to this challenge, protecting patients should be at the centre of the debate.

In the coming vote of the health committee on 18 September, MEPs will adopt a position on these two important issues: how to strengthen high-risk medical devices’ approval procedure, and how to strengthen the rights of patients harmed.