In a recent BMJ article, Dr Tom Clutton-Brock, clinical director of the ERDF-funded Medical Devices Testing and Evaluation Centre (MD-TEC), commented on new European regulations and the effect they may have on the design of medical devices.
Dr Clutton-Brock told a Clinical Human Factors Group (CHFG) meeting in London that new EU medical devices regulation that will come in force in May 2020 form “an excellent basis for much safer design but it remains to be seen how these new rules are interpreted and enforced.”
A key change in the new regulation is the additional requirement to demonstrate the ‘usability’ of a device, as well as provide clinical data for performance and safety claims.
“We need to get away from the idea of ‘user error’ where fault is laid at the door of the practitioner,” Dr Clutton-Brock added.
“Manufacturers can no longer hide behind complex instructions for use and then blame users for not reading them. Of course we need instructions, but medical devices should be inherently easy to use.”
Other speakers at the CHFG meeting warned that dangerous usability errors can often be built into device designs, such as unclear labelling about which button to press or whether to pull, push or twist.
Doctors have also been advised to inform their trusts when medical devices are difficult to use or have confusing instructions.
MD-TEC, based here at the Institute of Translational Medicine, provides expertise and support to clinicians, academics and industry to develop their medical devices from initial idea through the approvals and commercialisation process into the NHS.
The BMJ article is available to read at https://www.bmj.com/content/365/bmj.l4446.full