Increase in medical device concerns reported to Health Products Regulatory Authority

During that timeframe, 30 incidents involved a patient death where the medical device may have been initially suspected to be a contributory cause of the incident.

Where investigations have concluded, and based on information available to date, no deaths were confirmed to be related to a device malfunction, according to the HPRA.

In 2015 the Authority, which conducts market surveillance on medical devices in Ireland, received 773 incident reports. Last year, this rose to 993 reports, data released to the <strong><em>Medical </em></strong><strong><em>Independent</em></strong> (<strong><em>MI</em></strong>) reveals.

Incident reports received by the HPRA are classified as either associated with serious patient harm, or have the potential for serious patient harm.

An incident is defined in the <em>Guidelines on a Medical Devices Vigilance System</em> as “any malfunction or deterioration in the characteristics and/or performance of a device, as well as any inadequacy in the labelling or the instructions for use which, directly or indirectly, might lead to or might have led to the death of a patient, or user or of other persons or to a serious deterioration in their state of health”.

During 2017, the HPRA received 1,210 notifications relating to medical device field safety corrective actions (FSCA), also classified as either associated with serious patient harm or having the potential for serious patient harm.

A FSCA is “an action taken by the manufacturer to reduce a risk of death or serious deterioration in the state of health and may include the return of the device to the supplier, device modification, device retrofit, advice regarding the use of the device and/or follow-up of patients, users or others”.