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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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Upcoming Events

BAUN Summer Educational Event – Essential Urology Skills

Crowne Plaza, Newcastle Stephenson Quarter
6th June 2024

The AfPP Roadshow - Exeter

University of Exeter
22nd June 2024

EBME Expo

Coventry Building Society Arena
26th - 27th June 2024

The AfPP Roadshow - Cardiff

TBA, Cardiff
13th July 2024

AfPP Annual Conference 2024

University of Warwick
2nd - 3rd August 2024

The AfPP Roadshow - London

Cavendish Conference Centre, London
14th September 2024

Access the latest issue of Clinical Services Journal on your mobile device together with an archive of back issues.

Download the FREE Clinical Services Journal app from your device's App store

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