Patient safety
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. Patient safety is a fundamental right; a right that guarantees patients ‘a state of freedom from accidental and preventable injuries in medical care.’3
Regulations4 to improve patient
safety and encourage innovation are due to come into force in 2025, following the UK’s exit from the EU. However, while strengthening the regulation of medical devices is an important step towards protecting patients, a tighter regulatory framework could have unwelcome results.
There is a risk that if manufacturers face
tougher legislation when they introduce new devices to the marketplace, it could hinder the innovation of new products or reduce the availability of legacy devices. Undoubtedly, this legislation will increase costs to the manufacturers, which is likely to lead to an increase in the price of implants for the NHS. If this happens, the new regulations could have some unintended consequences, as they could restrict patients from benefitting from new and emerging technologies – the opposite of what is intended.
If the new regulations can hit the right balance between safeguarding patients, while at the same time backing medical innovation, then there will be a positive impact on patient outcomes. Medical registries will have a pivotal role to play in this balancing act.
However, if the new regulations can hit the right balance between safeguarding patients, while at the same time backing medical innovation, then there will be a positive impact on patient outcomes. Medical registries will have a pivotal role to play in this balancing act. Registries hold the key to essential information about the performance of devices and their impact on patient outcomes, which can help mitigate against the risk of the new regulations stifling innovation and reducing the availability of successful legacy devices. We already have arguably the best Joint
Registry in the world (the NJR or National Joint Registry) and, in the UK, we are well on the way to developing a registry for all implants. The ORP, Outcome Registries Programme, goes live this year.
The potential risks of a tighter regulatory framework So, while the drive to ‘improve the rigour and regulation of novel devices’ is welcome, it must
May 2024 I
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