Intended for healthcare professionals


Medical devices: new EU regulations won’t guarantee safe design, doctors warn

BMJ 2019; 365 doi: (Published 27 June 2019) Cite this as: BMJ 2019;365:l4446
  1. Jane Feinmann
  1. London, UK

Doctors have been urged to inform their trusts when medical devices are difficult to use or have confusing instructions, amid concerns that new European regulations will fail to guarantee safe design of the devices that doctors are asked to use.

Tom Clutton-Brock, clinical director of the Medical Devices Testing and Evaluation Centre, told a Clinical Human Factors Group (CHFG) meeting in London on 12 June that new EU medical devices regulation that will come in force in May 2020 forms “an excellent basis for much safer design but it remains to be seen how these new rules are interpreted and enforced.”

Under the new regulation, manufacturers will be required to provide in-depth clinical data underpinning safety and performance claims, along with “usability,” Duncan McPherson, clinical director devices of the Medicines and Healthcare Products Regulatory Agency (MHRA), told the meeting.

“I managed to ensure that the word ‘usability’ was included,” he said. “In the future, that will be important as it will mean we can tell manufacturers of medical devices that usability is the third most important component of patient safety.”

Clutton-Brock said this addition was significant. “It means we need to get away from the idea of ‘user error’ where fault is laid at the door of the practitioner,” he said. “We as clinicians must demand that both the regulators and the notified bodies ensure that checks on use and usability are incorporated from the earliest possible point in manufacturing increasingly complex medical devices, diagnostics, and digital health.”

“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,” he said.

“If there are problems, doctors should report them to their trusts—who should make them known centrally. There could be hundreds of problems with a single device but they won’t be known about unless doctors are ready to report them,” he told The BMJ.

Yet the potential for dangerous usability error is too often built in to the design, according to Richard Featherstone, director of human factors, research, and design at the medical devices manufacturing company, Emergo by UL. A common problem was unclear labelling that failed to identify “which button to press or whether to pull, push, or twist—or how to connect two components when one port can connect to two or three different ports,” Featherstone told the meeting.

Chris Frerk, consultant anaesthetist at Northampton General Hospital, warned that doctors are often left in the dark about usability problems, even when they are known to manufacturers and design experts. “We can’t expect medical device manufacturers to tell us about flaws in their devices voluntarily. But nor can we, as end users, be experts about the unintended consequences of design problems,” he told the meeting.

His hospital had commissioned a three month independent usability assessment of four different infusion devices that enabled his department to put the one with the lowest risk of error into medical practice. “But we had to do that ourselves and the information we discovered wasn’t publicly available,” he said.

Jo Simmons, programme manager and an ergonomist at CHFG, told The BMJ that a key cause for concern is that recruitment to the new MHRA devices clinical team which is currently being assembled to oversee the new regulations appeared to overlook the need for ergonomics expertise. “Currently the MHRA is advertising six jobs, but all are for specialist doctors rather than clinicians with human factors expertise. We would like to see this new team reflect the importance of human factors to the efficacy of the new regulations,” she said

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