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Medical device regulations criticised by manufacturers and doctors

Surgeons highlight conflict of interest problems with medical device regulation

Photo of knee surgery: istock

20 February 2012

The British Medical Journal 17.2.12 reports that the regulation of medical devices in the UK has come under fire from surgeons and device manufacturers.  Surgeons say that the regulations can be inadequate and subject to conflict of interest, while manufacturers say that they are unnecessarily cumbersome. It can take up to 18 months to get approval for a study for new medical equipment, clinical trials have to be agreed by national and local ethics committees, NHS research and development departments, an NHS medical devices committee, and the Medicines and Healthcare Products Regulatory Agency. The agency then delegates the decision on whether or not to award a CE mark—the certification that a product meets EU safety, health, and environmental protection requirements—to a so called “notified body.”

Surgeons have also expressed concern about licensing standards of medical devices.  Peter Wilmshurst, a consultant cardiologist with Shrewsbury and Telford Health Authority said: “I don’t understand why, when I implant devices in people’s hearts,” he said, “the standard for licensing is lower than for drugs.”

“There are more than 70 notified bodies with, he claimed, differences in standards and in rigour. “There are suggestions that companies will shop around for the notified body that will give them the easiest ride.”

Conflict of interest

Wilmhurst added: “You get clinicians doing trials on devices that they’ve invented. They may even own shares in the company.” Also, doctors’ poor record on reporting adverse events is exacerbated in the case of devices. “If you’ve put the device in and you report a problem someone may well say that you’re the problem. You put it in badly.”

Jill Paterson, defective products partner at Leigh Day, said:

“We know from first-hand experience that many people suffer from health problems after having medical devices, such as heart defibrillator leads and replacement knees and hips, fitted.  We welcome further public debate on the issue of medical device regulation and hope that the MHRA responds to the serious worries surgeons have expressed on the subject.”.

Medical device failure

Health problems caused by medical devices have been in the news recently, with the BBC recently reporting that nearly 3,000 women fitted with PIP breast implants being referred to the NHS for assessment and the possible removal of the implants. 
Product liability
solicitors at Leigh Day are currently representing hundreds of people who suffered problems following the implantation of metal-on-metal hips, as well as heart defibrillator leads and other replacement prostheses.

If you would like to speak to one of our recognised product liability expert lawyers please contact partner Jill Paterson on 020 7650 1219 for a free initial consultation.

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