The Government has today announced its intention to introduce new safety measures for the use of medical devices, through its Medicines and Medical Devices Bill.
Last year we published a bioethics briefing note on medical implants. Medical implants are medical devices that are placed inside the human body, such as hip implants, pacemakers, and glucose monitors.
Complications associated with the use of some implants triggered concerns about the UK’s mechanisms for ensuring the safety of medical devices. For example, vaginal mesh was used to treat urinary incontinence in women, but large numbers of women reported serious side-effects including pain, infection, and mobility problems.
In our briefing note we highlighted the ethical issues raised by the use of medical implants. Key challenges include:
- promoting innovation that addresses patient need,
- ensuring effective post-market surveillance of implants, and
- preparing for data and cybersecurity risks associated with connected implants.
The new Bill confers powers to the Secretary of State to make regulations that must have regard, in broad terms, to “the safety of medical devices, the availability of medical devices, and the attractiveness of the United Kingdom as a place in which to develop or supply medical devices.”
A significant development is that the Bill allows for the introduction of a UK register for all medical devices, their manufacturers or their suppliers. It will permit or require some or all of the information entered to be made publicly available.
We highlighted that registries can play an important role in monitoring the safety of implants. The National Joint Registry already provides early warning for patient safety issues associated with joint replacements and a means of re-contacting patients if issues arise.
The Bill does not specifically consider connected or ‘smart’ implants, which communicate wirelessly with external devices. The emergence of smart implants opens up possibilities for improving patient care through data gathering and use, but these implants are vulnerable to error and attack and raise privacy issues.
In 2019, the UK Department of Health and Social Care published a code of conduct for data-driven health and care technology that highlights the need to make security integral to the design of new technologies. The Code, developed before the UK’s exit from the EU, states that new EU regulations on medical devices will give UK regulators increased oversight of connected medical devices.
As the UK now develops its own medical devices regulations, it will be important that smart medical devices are accompanied by security measures and efforts to ensure data use is in-line with the expectations of patients.