November 27, 2018
Transparency needed to ensure safety of medical devices
28th November 2018, London – A new media investigation has found unsafe medical devices being used on patients in the UK highlighting both the urgent need for transparency around medical device development, as well as greater awareness of the potentially dire consequences when transparency is lacking.
The investigation found that due to a lax system of opaque regulation, companies that produce medical devices are able to “shop around” at safety organisations across Europe until their product is finally approved. Forcing companies to register clinical trials for medical devices and post all results – whether positive or negative – will enable the medical community to make fully informed decisions about the benefits and harms of particular devices for their patients.
Recent research published in the British Medical Journal, and echoed in a UK Parliamentary report, has found a similar problem in clinical trials for pharmaceutical medicines. For example, one major British research institution had posted results for only one of its 17 applicable trials.
Rachel Cooper, Director of Transparency International Health Initiative, said:
“This new investigation adds to the growing body of evidence that there is simply an unacceptable lack of transparency in the development of both medical devices and medicines. Transparency is necessary to ensure that patients are receiving appropriate care and the benefits and risks have been properly researched. The public must be able to trust that the medical products they rely on are going to improve their health rather than undermine it.”
“When it comes to health it is not simply transparency for transparency’s sake. Lives are on the line and without proper scrutiny over the products we trust to keep us and our children healthy there is an immediate and obvious risk to the lives of millions of people.”
“It’s deeply worrying that the regulation for medical device research is even worse than what is already a poor situation with pharmaceuticals. Those that fail to properly report the findings of medical research must be sanctioned and forced to open up over an issue that has serious implications for funders, clinicians and ultimately patients.”
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