Putting the patient back at the heart of UK medical device regulation

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Baroness Julia Cumberlege, chairing the Independent Medicines and Medical Devices Safety Review originally commissioned by former UK Health Secretary Jeremy Hunt, has in the report "First Do No Harm" shone a spotlight on the harm caused to certain women and their children by three medical interventions, Primodos, sodium valproate and pelvic mesh, and the failure of the healthcare system to address relevant concerns. Among other recommendations, the report calls for:

1. The appointment of an independent Patient Safety Commissioner.

2. The establishment of a Redress Agency for those harmed by medicines and medical devices.

3. The UK regulator of medicines and medical devices, the MHRA, to put patients at the heart of its activity, and to overhaul adverse event reporting and medical device regulation.

4. A central database of key details including the patient, the implanted device, and the surgeon.

5. The expansion of the register of the General Medical Council to include a list of financial and non-pecuniary interests for all doctors, as well as doctors’ clinical interests and specialisms.

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