Medical registries and MDR: striking a delicate balance

Mr Keith Tucker, FRCS, Chairman of the Orthopaedic Data Evaluation Panel (ODEP) and the Beyond Compliance Advisory Group, discusses how registries can reduce the risk of fewer treatment options under the new medical device regulations. He explores the delicate balance needed to navigate the new regulatory landscape, while ensuring patient safety is prioritised.

"It's like a ticking time bomb inside me. When you go to the doctor, you don't say 'who makes your medicine?' — you just assume it's going to be safe."  These were the words of Rowena Mackintosh, a recipient of PIP breast implants1 which were found to be made of cheap industrial silicone rather than the medical grade gel that should have been used. 

No one who has read the powerful testimonies of the women affected by pelvic mesh implants, the hormone pregnancy tests, or the parents of babies harmed by exposure to sodium valproate in the IMMDS report First Do No Harm2 can fail to be moved and appalled by their painful accounts of long-term health effects.

In my own specialty of orthopaedics, anxiety about long-term health effects would have been the thought running through the minds of the numerous people who have received certain types of Total Hip Replacement (THR) that performed badly. Of course, the vast majority of THRs do very well and transform the lives of patients for the better.

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