First Do No Harm – The report of the Independent Medicines and Medical Devices Safety Review, Baroness Cumberlege published 8th July 2020
Baroness Cumberlege’s report included a letter to the Secretary of State that concluded:
“We have found that the healthcare system – in which I include the NHS, private providers, the regulators and professional bodies, pharmaceutical and device manufacturers, and policymakers – is disjointed, siloed, unresponsive and defensive. It does not adequately recognise that patients are its raison d’etre. It has failed to listen to their concerns and when, belatedly, it has decided to act it has too often moved glacially. Indeed, over these two years we have found ourselves in the position of recommending, encouraging and urging the system to take action that should have been taken long ago.
The system is not good enough at spotting trends in practice and outcomes that give rise to safety concerns. Listening to patients is pivotal to that. This is why one of our principal recommendations is the appointment of an independent Patient Safety Commissioner, a person of standing who sits outside the healthcare system, accountable to Parliament through the Health and Social Care Select Committee. The Commissioner would be the patients’ port of call, listener and advocate, who holds the system to account, monitors trends, encourages and requires the system to act. This person would be the golden thread, tying the disjointed system together in the interests of those who matter most.”
The UK has an enviable system of data collection and regulation authorities however the next critical part of providing a full picture of how well medical devices are performing is the solid evidence provided through the physical analysis of removed medical devices.
The NHS Implant Analysis Service is launching to provide the independent analysis and reporting of used medical devices to rapidly provide trends and outcomes to allow the system to act. It has been launched to assist in preventing repeats of medical device disasters such as those listed in the List of Group Litigation Orders published on the UK Gov website 23 September 2022, a list which includes:
- Hip implants
- PIP breast Implants
- Large diameter heads and metal on metal hips
- Metal on metal hips
- Orthopaedic Polyethylene
- Trilucent breast implants