UK’s Radio 4 Interview Implies Lack Of Effective Regulation

In the most alarmist and misleading articles we’ve heard for a long time, esteemed news and current events vehicle, the “Today Programme” this morning interviewed Brian Toft, emeritus professor of patient safety at Coventry University in a piece which can be found here.

The interviewer stated that “I imagine these devices go through some sort of screening programme before they’re implanted” following which Brian Toft suggested that all products should somehow be “tested at the point of use”, seemingly believing that all the millions of devices implanted in patients should somehow receive a last minute check from a suitably qualified person. Somehow this person would be better able to assess all the complicated aspects of the device than the rigorously controlled QC function within the company that made it. He then went on to suggest that in Wales such a testing body existed in the form of the “surgical material testing laboratory”, which is able to perform this function, when in fact that facility is definitely not in existence to check every device intended to be used or implanted.

Indeed Brian Toft then suggested that these people currently “go out into hospitals where they think there’s a problem and take product off the shelf for testing”… rather a different thing to testing every product before it gets used.

Somehow the fact that “we haven’t got that in England” places patients in mortal danger despite the fact that he’s clearly mixing up pre-use testing (which would be ridiculous and impossible, not least given the complex and often sterile nature of these devices) with post-event assessment of problematic devices. Again we’d argue that the manufacturer, the entity legally responsible for delivering products compliant with all the medical devices regulations, is far better placed in a correctly regulated world to do this job.

Yet again the media has put two and two together to make what would be a very expensive, impractical, unnecessary and ill-informed “five”.