MP calls for medical device regulation reforms

Labour MP Owen Smith called for radical reform of the rules regulating the licensing and marketing of certain medical devices in a debate in the House of Commons.

This comes after scandals involving surgical mesh, defective pacemakers, faulty artificial hips and harmful breast implants.

Mr Smith, who is also chair of the All Party Parliamentary Group on Surgical Mesh Implants said: “More and more patients are undergoing surgery involving innovative, implantable devices, the vast majority of which can transform and save lives. However, a number of recent problems involving medical devices have called into serious question the way in which they have historically been tested, approved and marketed to patients and doctors.

“Medical devices cannot, of course, be tested against placebo in randomised control trials, as is the case with medicines, but current checks on the safety and efficacy of these devices are far too weak, with many simply having to prove on paper that their effect and design is equivalent to earlier and similar devices. This has led, for example in the case of surgical mesh, to such follow-on devices being made of completely different, inappropriate and even toxic materials, compared to the original licensed device.”

An Implant Files investigation last November revealed that in the UK alone, the Medicines and Healthcare Products Regulatory Agency (MHRA) received 62,000 “adverse incident” reports linked to medical devices between 2015 and 2018. A third of the incidents had serious repercussions for patients and 1,004 resulted in death.

The investigation showed examples of failure in the devices market including replacement hips and vaginal mesh products sold to hospitals without any clinical trials, patients relying on faulty pacemakers when manufacturers were aware of problems, and regulators approving spinal disc replacements that later disintegrated and migrated in patients.

These scandals have led to calls for tightening of the regulations right across the World and the EU has responded by introducing a new Directive for Medical Devices which is due to come in to effect next year.

During the debate, the parliamentary under secretary of state for the Department of Health Jackie Doyle-Price said the Government "fully intend" to carry the EU regulation forward post-Brexit. 

The MP for Pontypridd added: “The weaknesses in the current testing regime has led to changes at the European level, but even prior to their introduction the new rules have been subject to significant criticism as being insufficiently robust and too favourable to the companies involved. Here in the UK, we face the prospect of not even being protected by the new regulations after Brexit and this poses real questions as to how our regulators are going to respond.

“The MHRA must now set out robust regulations, starting with tougher device licensing and the introduction of a national registry to monitor all devices through a publicly available national database.”