GovWire

Over 5.6 million people in the UK live with diabetes, many of whom rely on these devices to manage their condition, and their use can significantly improve the quality of life for patients.

However, adverse incidents relating to these devices can occur, and while most of these incidents do not result in harm to the patient, they can potentially lead to the incorrect amount of insulin which can lead to abnormal blood sugar levels, with potentially serious health consequences.

The MHRA utilises the Yellow Card reporting scheme for signal detection and trending activities to identify safety concerns that may require action. As of January 2023, the MHRA has received fewer than 300Yellow Card reports from healthcare professionals and members of the public relating to these devices, which is significantly fewer than we would expect given their widespread use. The MHRA is therefore reminding users how to report adverse incidents and potential safety issues to us.

To aid this vital reporting, the MHRA has today, Tuesday 08 October, introduced new step-by-step guidance, giving individuals living with diabetes detailed information on how to report any safety concerns with their device and what information they need to include. This guidance provides examples of the types of issues which should be flagged and images to help guide users in their reporting.

Dr Alison Cave, MHRA Chief Safety Officer, said:

Patient safety is our top priority, which is why we urge anyone using devices to manage their diabetes to report to us without delay any safety concerns they may have. We know adverse incidents can occur with the use of these devices. The vast majority of these incidents dont result in harm but potentially could have serious consequences.

Every report is valuable to us as it will provide valuable insight and potentially inform future regulatory measures designed to protect patients. We are ready to take whatever action is needed.

If you are concerned that there is an issue with any of your diabetes devices, please use the guidance to complete a Yellow Card report online using the Yellow Card website or via the free Yellow Card app.

Douglas Twenefour, Head of Care at Diabetes UK, said:

Diabetes technology can be a life-changing tool, helping people living with the condition improve their quality of life.

Unfortunately, we know that sometimes this technology doesnt work as intended, so it is important that users of diabetes tech have a clear and accessible way to report any issues with continuous glucose monitors, insulin pumps and pens.

Diabetes UK welcomes any guidance that gives reassurance for people using diabetes tech to highlight potential problems quickly and easily. We would encourage anyone with a concern about diabetes tech to report it, as this vital information can help improve the quality of devices.

However, if there is any immediate concern about technology that could affect a persons safety, advice from an appropriate healthcare professional should be sought first.

Professor Partha Kar, NHS England Type 1 Diabetes & Technology lead, said:

We welcome this work and its important role in ensuring safety while we oversee the widespread adoption of diabetes technologies using continuous glucose monitors and insulin pumps.

These devices can be life-changing for people living with diabetes, giving them the confidence to go about their days knowing they are safe and able to enjoy themselves, so their operationally effectiveness is of paramount importance.

This initiative will help to ensure standards stay at the highest level as the market continues to expand with new developers.

The MHRA also urges people to speak to a healthcare professional without delay if they have concerns that their health may have been impacted by a potential safety issue relating to their device.

Examples of the types of issue with continuous glucose monitors and insulin pumps that should be reported include:

• Concerns with accuracy of delivery from the insulin pump (for example, suspected underdose or overdose, unexpected bolus doses, non-delivery of insulin)
• Concerns with accuracy of results from a continuous glucose monitor (CGM). As part of your report, please tell us what the readings were on both the CGM and the approved blood glucose meter (see page 6) including the time elapsed between the 2 readings

• Skin reaction to the sensor adhesive. If a patch test was carried out, please let us know.

• Technology concerns, such as:

  • Connectivity issues between the various parts of the diabetes management system

  • Concerns with the touchscreen, display or buttons

• Physical failures, including leaks and cracks

ENDS

Notes to editors

1. The Medicines and Healthcare products Regulatory Agency (MHRA) is responsible for regulating all medicines and medical devices in the UK by ensuring they work and are acceptably safe. All our work is underpinned by robust and fact-based judgements to ensure that the benefits justify any risks.
2. The MHRA is an executive agency of the Department of Health and Social Care.
3. More information can be found on theDevice Safety Information page.
4. For media enquiries, please contact thenewscent
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