It’s good to know we have such influence.
We’ve been stating for weeks that among all the simple measures that would have given authorities a chance of catching Monsieur Mas and his pals at Poly Implant Protheses, the simple measure of allowing unannounced spot checks would have done the job.
In this article, published today by Reuters, the French competent authority, AFSSAPS, has concluded that; “surprise on-site visits to manufacturers, better communication between national health and regulatory agencies and a simpler method for surgeons to alert authorities to their concerns about medical devices” were needed.
Of course it looks as though the PIP situation is very much a one-off and that to introduce regulations to catch one bad apple would be of limited effect in an industry which fundamentally behaves itself pretty well. But if we’re looking for a single piece of legislation which would sharpen up everybody’s game AND catch the PIPs then how bad an idea is it?
Source: Reuters Health