EU Looks to Tighten Medical Device Safety With Implant Registry

Posted 27 April 2012 | By Alexander Gaffney, RAC 

The European Parliament is actively looking to pass legislation that would make it easier for regulatory authorities to track both medical devices and patients implanted with medical devices, reports Fierce Medical Devices.

"These proposals include the creation of breast implant registers, product traceability and a pre-market authorization system--among other items--to prevent future such episodes involving implantable devices," wrote Fierce.

A Committee within the European Parliament unanimously passed a resolution on 25 April advancing the above proposals, saying "it is essential to […] strengthen surveillance and safety controls and placing on the market requirements."

The Committee's proposal is in response to several high-profile medical device failures, including breast implant products manufactured by now-defunct French manufacturer Poly Implant Prothese and metal-on-metal hip implants manufactured by a number of manufacturers.

The scandals led to a frenzy of investigations and calls for reform in a number of states. Among the most prominent developments:

In France, the Afssaps discovered PIP was selling breast implant products manufactured with industrial-grade silicone, and later arrested the former executive of the company.

In the UK, reports of the failure of PIP implants led to calls for an investigation, top health official Andrew Lansley to announce such an investigation, the medical journal The Lancet to get into a fight with UK regulators and regulators to call for calm while the investigation was under way. Meanwhile, the metal-on-metal hip scandal came to light, leading to new safety concerns, regulators to call for extensive monitoring, the British Medical Journal to warn patients about exposure to toxic metals and UK regulators to warn against using metal-on-metal hip implants in light of significant risks to patients.

Across Europe, a number of top regulators started investigating the PIP implants, called for increased safety controls and postmarketing surveillance for medical devices, called for more coordination between member states, called for more data to be collected about medical devices and called for a more rigorous approvals process for medical devices.

The proposal by the European Parliament is only a starting point in the legislative process, and it remains to be seen whether the measure will advance.

Read more:

Fierce Medical Devices - EU proposes implant register, stringent checks to avoid another PIP scandal

Regulatory Focus - Reuters Analysis: Breast Implant Scandal Shows Shortfalls of Post-marketing Registries

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