Surgeons call for compulsory registers of all new medical devicesBMJ 2018; 363 doi: https://doi.org/10.1136/bmj.k5010 (Published 26 November 2018) Cite this as: BMJ 2018;363:k5010
- Rebecca Coombes, head of news and views
- The BMJ
The government must act urgently to reform the lax regulation system governing medical devices, including a compulsory registry of all new implants, says the Royal College of Surgeons.
The call comes after a global investigation by journalists from 36 countries, including The BMJ, BBC Panorama, and the Guardian, into the medical device industry, which unearthed thousands of documents to reveal rising numbers of malfunctions and injuries.
The government said that it would work with the UK regulator to see what changes were required.
The investigation also provides new evidence of devices being implanted in humans after tests only in pigs or after small scale studies of just tens of patients. The lack of transparency and available data means that the scale of problems remains hidden from doctors and patients. Unlike with drugs, many devices are introduced rapidly onto the market without clinical trial data or centrally held evidence.
The president of the Royal College of Surgeons, …