Establishing high-level evidence for the safety and efficacy of medical devices and systems

I have recently been made aware of an excellent publication jointly by the Royal Academy of Engineering and the Academy of Medical Sciences entitled Establishing high-level evidence for the safety and efficacy of medical devices and systems, so this post is to reach out to those like me who were previously unaware.

It is a major step forward in applying engineering methodology to evaluating the effectiveness of medical devices & systems and, even more important, ensuring their ongoing safety.  Those of us who have participated in a substantial randomised control trial such as the Whole System Demonstrator (see earlier post today) will take great interest at what follows the quote: “For pharmaceutical innovation, the randomised controlled trial is the acknowledged gold standard for creating a body of high-quality evidence. But designing clinical trials to establish the evidence for medical devices has proven more problematic.”

(Included in the paper is the observation  that the ultimate health improvement device when you leave an aeroplane that is in the air – the parachute – has never been proven by an RCT.)

Finally just to return to an earlier comment, the report makes the point that because medical devices can be changed far more often than the composition of a drug, the importance of appropriate safety monitoring is absolutely critical, an issue that is becoming increasingly relevant as penetration of telehealth (in particular) and telecare increases.  Whilst  we might choose to ignore the different nature of medical devices when assessing a trial, we cannot ignore the different nature of medical devices when designing and putting in place appropriate safety systems.

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