David Hanson – 2015 Parliamentary Question to the Department of Health

The below Parliamentary question was asked by David Hanson on 2015-10-09.

To ask the Secretary of State for Health, what assessment (a) his Department and (b) the Medicines and Healthcare Products Regulatory Agency have made of (i) the rate of reported faults in heart pacemakers and (ii) research from UK and non-UK sources on heart pacemakers since 2010.

George Freeman

Clinicians are encouraged and manufacturers are mandated to report deaths and other incidents to the Medicines and Healthcare products Regulatory Agency (MHRA) if they suspect a device fault.

The numbers of United Kingdom deaths reported annually since 2010 to the MHRA involving patients implanted with approved pacemakers, are as follows:

According to registry data from 2014, over 35,000 pacemakers are implanted annually in the UK. Therefore the number of reported patient deaths listed above which could have potentially related to pacemaker failure represents no more than 0.01% of this population.

Analysis of MHRA investigation conclusions revealed that none of the above deaths resulted from a faulty pacemaker.

As the UK regulatory authority, the MHRA is responsible for monitoring the safety of medical devices once they have been approved for market. Although the majority of pacemakers are well functioning, the MHRA actively monitor the performance of implants using a variety of methods.

One key element involves the investigation of device-related adverse incidents, where manufacturers’ mandatory reports are supplemented by voluntary reports from clinicians and members of the public using the yellow card system.

The MHRA challenges manufacturers if it is believed that the proposed post-investigation action is inadequate to protect public health.

Every new incident, including those involving pacemakers, is assessed and assigned to an appropriate type of investigation according to its severity and the likelihood of obtaining further information on the cause of the event. All reports, even those unsuitable for further investigation, are fully recorded and subject to periodic trend analysis by the MHRA to look for signals suggesting any possible device-related problems.

In addition to scrutinizing manufacturers’ device data provided in incident investigations, and their published product performance reports, the MHRA also monitors relevant published research and articles on potential safety concerns as part of its surveillance of the medical device market. If evidence emerges that affects the safety of UK pacemaker patients, the Agency issues advice to the health service and takes any necessary regulatory action.

Furthermore the Agency actively engages with the clinicians and professional bodies to gauge their opinion on early indications for failure and problems encountered with device usage.