CLINICAL ENGINEERING CONFERENCE
Tom was a (part time) senior medical officer (devices clinical) at the MHRA for many years. As well as having a clinical commitment at University Hospitals Birmingham, Tom is associate medical director at UHB, Chair of NICE Interventional Procedures Advisory Committee, and a past member of Council at the Royal College of Anaesthetists, where he chaired the Safe Anaesthesia Liaison Group. In 2016 he took on his current role and was named as one of the “100 most influential drivers of the health technology revolution, globally.” Tom began his talk: “The whole world is packed with small companies struggling to get their medical devices to market. According to an MHRA report, it receives between 16,000 and 17,000 adverse incidents every year. However, when this data was broken down, it was revealed that only a few of these incidents were related to broken devices; one third were user-related errors; and one third were ‘don’t knows’ – possibly under-reported.
“Devices are not easy to use and not universally designed to a standard. Human factors and usability will be incorporated in future medical device design, which are supported by the IEC 62366 standard.” This standard calls out the errors caused by inadequate medical device usability. IEC 62366 is a process-based standard that aims to help manufacturers of medical devices to design for high usability, and does not apply to clinical decision-making that
Approximately 99% of surgically related technology that goes through regulatory approval is not used by the NHS. The NHS is
too slow – and too reluctant – to adopt change. Dr Tom Clutton-Brock, ERDF Medical Devices Testing and Evaluation Centre
may be related to the use of the device. Tom continued: “Usability considerations are key at all stages of technology development – and will be increasingly required for regulatory approval.” Nevertheless, he warned: “Approximately 99% of surgically related technology that goes through regulatory approval is not used by the NHS. The NHS is too slow – and too reluctant – to adopt change.”
Medical device safety
Rebecca Flint, devices patient safety manager at MHRA, shared the organisation’s role in the safety of medical devices. Noting the expected benefits of the Medical Devices Regulation (MDR), Rebecca described how it would raise the threshold for clinical evidence, and would result in more medical trials. She observed: “The MDR will also improve device traceability through unique device identification (UDI) and implant cards. Similarly, it will increase the quality of incident reports. Presently, we
receive around 20,000 reports a year, partly because people are more aware of the reporting process. “The MHRA ‘Yellow Card’ system is the only way to guarantee a report goes directly to the MHRA. We then send these to the manufacturers for investigation. However, if this does not happen, we will then take action. Many times, the response will be along the lines of: ‘We were unable to find anything wrong, as the device was thrown away.’ Please remember, when making a report, always keep hold of the device as it helps with the investigation. “Where possible, the MHRA attempts to
identify trends within the adverse incident reports that we receive via manufacturers, clinicians and members of the public. Trigger levels are frequently used by the device specific specialist teams within the agency to signal problems that could potentially be more widespread. “When a trigger is highlighted, this initiates a further examination of the reported
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