Earlier this week, the BBC Radio Four programme “Face the Facts” highlighted the scandalous state of the medical device sector. Their report centred on some women who had experienced extreme adverse reaction to trans-vaginal mesh implants. The programme went on to complain about the lack of the highly controlled and blinded testing regime undergone by drugs.
You can listen to the programme [here].
Part of the problem, they said, was that many medical devices are approved on the basis of “equivalence” to existing devices rather than on specific rigorous testing. Often, medical devices are implanted without ever having been tested in humans.
The BBC exposé is not alone. Back in March 2012, CBS News ran a story about metal hip implants leading to dangerous levels of chromium and cobalt levels in patents’ blood. Again, the principle of “equivalence” – in this case to plastic hip replacements – was cited as to blame.
But is this a red herring? After all, how do you actually carry out a blind trial on something you implant? Isn’t equivalence a pragmatic approach?
You could certainly say so – but perhaps only if there is also a rigorous procedure for gathering and reporting adverse reactions (as there is with drugs in the form of pharmacovigilance).
There have been numerous calls for a register of medical devices so problems can be tracked and dealt with more efficiently and this seems like a very sensible approach. Rigorous device vigilance and safety procedures should mean that the risk:benefit equation for each procedure is better understood.
No one would argue that the modern medical device sector saves countless lives and improves the quality of millions more, but it every silver lining has its cloud – it’s the ratio of the two that counts.
Whitehall Training’s new course deals specifically with the systems and requirements for the reporting of adverse events relating to medical devices. Device Safety and Vigilance covers not only in the current legislative situation but also the principles of adverse event reporting and risk assessment as applied to medical devices. With coverage of risk assessment, AE report types, causality and event types, this course is designed to give a solid grounding in all key aspects of vigilance within this +$300 billion sector.