European Medical Devices and their Safety under Questions
The British Medical Journal has recently put a question upon the safety of medical devices, which according to them are not being properly checked before they are approved for widespread use as many reports have revealed that many patients’ implants have failed years earlier than expected.
The Medicines and Healthcare Products Regulatory Agency, which is responsible for monitoring the medical equipments entirely, received 9,000+ reports of adverse incidents including medical devices, of which 1,885 were serious injuries and 202 resulted in death in 2009. In context to which, the BMJ blamed the European regulators and said that they were not fit for purpose because they failed to monitor the safety of devices adequately.
Dr Deborah Cohen, Investigations Editor at the BMJ, said, “Nearly 20 years ago, the BMJ highlighted the dangers of early failure of unproved implants, yet the NHS is currently picking up the bill for faulty devices. Unlike kettles and toasters, which come with warranties, when devices do not last as long as they ought to companies are not necessarily held financially responsible”.
The BMJ has put many claims in the Channel 4 Dispatches documentary, “The Truth about Going under the Knife”, one of which is: BMJ claimed that approx half of ASR metal hip replacements shed metal causing intense pain for patients. Also they marked that that the devices have been always been tested for strength and wear and have always met all EU standards but the problems according to them were only with the inexperienced surgeons, who put them in unsuitable patients.
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