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medical devices

Medical Device update

Carl Heneghan
Last edited 22nd May 2011

Here is an update to the weeks reporting on the research published on medical devices in the UK by CEBMblog in the BMJ

Lack of clinical data for medical devices is putting patients' lives at risk
The Guardian - Carl Heneghan - ‎May 16, 2011‎
Medical device recalls are rising, yet manufacturers are not willing show clinical data related to the recalls. read more

Doctors call for tougher rules on devices. By Andrew Jack of the Financial TImes. May 16 2011

Europe’s regulatory system for medical devices such as heart valves and diagnostic imaging equipment should be tougher, more centralised and transparent to improve patient safety, leading doctors warn. read more

Paul Flynn MP
In 1993 I had a debate that I could now dust down and repeat in the House of Commons without changing a word.

It would still be relevant. Then it concentrated on the racket in marketing hip prostheses. There were 60 on the market then. One was different to all the others because it was blue. One had been used on thousands of patients and failed them all within four years. Tomorrow the BMJ and Channel 4's Dispatches renew that attack. read more

Early day motion 1819 as a parliamentarty question

That this House thanks Channel Four Dispatches and the British Medical Journal for revealing that defective UK regulations in the use of medical devices are exposing patients to suffering serious injury or worse; is concerned to learn that Suzanne Ludgate of the Medicines and Healthcare Products Regulatory Agency says she was appalled at how many devices are brought to market with a lack of appropriate clinical data; notes that recalls of devices are rising but manufacturers are not willing to publish information on device failures; and calls for a review that will ensure that UK patients have guarantees on the safety and efficacy of devices equivalent to that of patients in the US. read more

Finally see the whole program on channel 4 dispatches here

Medical Device recalls

Carl Heneghan
Last edited 16th May 2011

Today we published in BMJ open an article on Medical-device recalls in the UK and the device-regulation process.

Our conclusion is the number of medical devices subject to recalls or warnings in the UK has risen dramatically. A whopping 1,220% increase.

A substantial number of these devices may have caused serious adverse effects in patients and contributed to healthcare costs. Also significant problems exist in the UK with a lack of access to transparent data and a registry of the highest-risk devices.

The articles worth a read to see the sort of problems we faced in trying to access clnical data on recalled devices. There is also a linked anlysis we wrote in the BMJ

This is what the independent made of the story, "patients lives are put at risk by faulty medical implants."

If you want to know more then look out for tonight's episode of Dispatches on channel 4.

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