Device failure protocols published in wake of Daily Mail 'scandal'
Earlier this year, the UK's Daily Mail newspaper ran a story on adverse incidents in medical devices, describing what it termed a 'secret scandal', and simultaneously bringing unwelcome attention to the medical device sector.
The Medicines and Healthcare products Regulatory Agency has now issued an up-to-date set of guidelines for manufacturers to use when reporting adverse incidents arising from medical devices.
The guidelines focus on the major product groups, namely:
Biological and mechanical surgical heart valves
Inferior vena cava filter (IVC)
In vitro diagnostic (IVD) blood glucose meters
One figure in particular which was quoted by the Daily Mail was the 13,600 reports of failed devices reported to the MHRA, which were linked to 309 deaths and 5,000 serious injuries.
According to the article, experts from the MHRA "believe reporting of such incidents to be less than 20 per cent of the real figure —and possibly as low as 10 per cent".
While the MHRA does not disclose names of device manufacturers when devices are deemed faulty