Medical devices under scrutiny

Health - Jonathan Wood | 17 May 11. 'When Suzanne Ludgate of the Medicines and Healthcare products Regulatory Agency (MHRA), the government regulator of medical devices in the UK, says she was "appalled at how many devices are brought to market with a lack of appropriate clinical data," you know there must be a problem.' So Dr Carl Heneghan, director of the Centre for Evidence-Based Medicine at the University of Oxford, begins a blog post on The Guardian site. The term 'medical device' covers a huge range of products that have a medical use and are not medicines. The MHRA notes that this includes anything from walking sticks and hip replacements to glucose monitors, blood pressure machines and pregnancy testing kits. Every day in the UK, millions of people safely use medical devices. But it is the regulation of these devices that Carl and colleagues at Oxford are concerned with. They have just completed an analysis of product recalls in the UK as part of a joint investigation by the BMJ medical journal and Channel 4's documentary series Dispatches into medical device regulation.