Medical devices suspected of role in patient deaths

Eleven incidents where medical devices are suspected of having played a role in the deaths of patients in just three years are under investigation in Ireland, it has emerged.

However, the Health Products Regulatory Authority (HPRA) could not say when the 11 open investigations into the deaths between 2015 and 2017 would finish.

Some deaths are linked to incubators, hip implants, or coronary pacemakers, but others involve the role played by plasters and bandages, wheelchairs, contact lenses, blood pressure monitors, and even pregnancy test kits.

During the three-year period, investigations into 19 other deaths where a medical device was initially suspected were launched, but ended with no responsibility being laid at the door of equipment.

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So far this year, more than 600 incident reports involving medical devices have been logged with the HPRA. In 2015, 773 reports. Last year, the number grew to nearly 1,000.

Malfunction

Incident reports are logged if they deal with the “malfunction or deterioration” of equipment, or “any inadequacy in the labelling or the instructions for use” that could directly or indirectly lead to death, or harm.

Product recalls to date have included surgical, respiratory and urology devices, among many others

Following receipt of a report, the HPRA orders a manufacturer’s investigation and “determines if the manufacturer has communicated the outcome of the investigation to the user in Ireland”.

Last year, 438 “corrective actions” were made by manufacturers for equipment supplied to the Irish market – nearly a third of which covered safety notices sent out to doctors.

Some 41 per cent of the corrective action led to product removals, 14 per cent related to software upgrades and 15 per cent related to field modifications, a HPRA spokeswoman said.

Products are removed from the market for several reasons, including design errors, manufacturing errors, inadequate pre-market testing by the manufacturer and quality system failures.

Product recalls to date have included surgical, respiratory and urology devices, among many others.

The HPRA defines a medical device as a “health product or piece of equipment that a person uses for a medical purpose”.

Devices can diagnose, monitor or treat illness or disease and assist people with physical impairments.