Medical devices and adverse incident reporting

medical instruments

Doctors have a duty to report all adverse incidents arising from use of medical devices, as MDU medico-legal adviser Dr Nicola Lennard reports.

Medical devices have an increasing role to play in the clinical care of patients. There are more than 100,000 devices currently on the market and numbers continue to increase.

We classically think of implantable prostheses when describing a medical device, but in fact the definition of a device applies to a vast range of products, from CT scanners and laboratory equipment to complex active implantable devices such as pacemakers. Even wheelchairs and beds are classed as devices.

The regulation of medical devices has been the source of some scrutiny over the past few years. A European system of regulation exists with the affixing of a CE mark to products that have been approved for marketing. In the UK, the Medicines and Healthcare products Regulatory Agency (MHRA) is responsible for regulating devices and investigating 'harmful incidents'. (Please note that there are separate reporting routes in Scotland, Wales and Northern Ireland for device-related adverse incidents.)

The MHRA is aware that there has been massive under-reporting of device-related adverse incidents. When asked why they didn't report a device, clinicians cite a number of reasons, including lack of clarity on what to report and who to report to, and question the value of reporting. Some are also concerned that they may be open to criticism when things have gone wrong.

However, the introduction of new guidance by the GMC has clearly placed responsibility for reporting such incidents on clinicians.

What to report

The GMC advises that all incidents that have resulted in actual harm, or have the potential to put the safety of patients, users, or the public at risk, must be reported. The type of incident that can be reported is not limited to device malfunction but should also include those that arise from poor design or, indeed, human error. Causes such as poor user instructions or training, or inadequate maintenance may not seem immediately important, but when aggregated with similar reports, may indicate that changes are needed.

The reporting of recognised complications with implantable devices may help to identify devices which are not performing as expected. For example, an increased rate of lead fracture in an implantable defibrillator has led to the introduction of a more rigorous, and regularly reviewed, surveillance protocol in patients with such leads in situ.

In all cases, the threshold for reporting should be relatively low. The MHRA requests that adverse incidents are reported via their online reporting tool. Their website includes details about what you can expect once you have reported an incident and provides links to the reporting sites for the devolved nations.

Off-label use

Off-label use occurs when a clinician uses a device for an indication for which it was not intended, or contrary to the instructions for use.

The instructions supplied with many devices contain very specific indications Many aortic stent prostheses, for example, give precise degrees of aortic angulation beyond which the device is not recommended for use. If a clinician uses a device beyond its recommended indication, liability for safety and performance of the device could be transferred from the manufacturer to the user. The same will apply if the user modifies a device in any way.

Clinicians need to bear this in mind when considering off-label use and should ensure, as with off-label prescribing, that patients are appropriately consented and, if necessary, inform their Medical Director.

Dr Nicola Lennard was formerly deputy medical director, Devices Division at the MHRA.

This article originally appeared in the printed version of the April 2014 MDU journal entitled "Medical devices - The responsibilities of clinicians"

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