Medicines Healthcare Products Regulatory Agency
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It explains how to report safety concerns to the MHRA using the Yellow Card scheme and describes the information we need to support our device investigations.
Advice for healthcare professionals:
- insulin pumps and continuous glucose monitoring (CGM) devices are complex devices with the potential to result in serious harm in the event of error. To aid the MHRA in early identification of safety concerns associated with these devices, users of the equipment need to know how to report safety issues to the MHRA
- we have published guidance to explain to users of all medical devices manufactured for diabetes management how to report safety concerns to the MHRA using the Yellow Card scheme
- this guidance is expected to improve the quality of information the MHRA receives and should the need arise, support a thorough investigation of the relevant equipment
- highlight the guidance to patients using insulin pumps, insulin pens and CGM devices
- remind patients that if they suspect a problem with their device, they should be advised to use an alternative method to manage their diabetes
- we are also providing a poster with a direct link to the guidance (QR code) which can be printed to display in your clinic waiting room
- healthcare professionals should also speak to their local Medical Device Safety Officer (MDSO) on how you can support the reporting of adverse incidents with these medical devices
- report problems and adverse incidents associated with medical devices used in the management of diabetes on a Yellow Card
Advice for healthcare professionals to provide to patients:
- seek medical advice without delay if you have concerns that your health has been impacted by a potential safety issue relating to your device
- use an alternative device if you suspect your current device is not performing adequately in managing your diabetes. Ensure you have an alternative device available at all times
- it is important to read the guidance being given to you on how to report concerns with the equipment used to manage your diabetes
- it is important that you report safety concerns with your devices to the Yellow Card scheme. Yellow Card reports help the MHRA to identify safety issues and to consider actions to improve the safety and performance of devices used by people living with diabetes
- if you believe there is a safety problem with your equipment, submit a report via the Yellow Card scheme and use the guidance document to help you create a report
Background
The MHRA has identified an opportunity to improve the number and quality of reports we receive from members of the public using insulin pumps and CGM equipment for management of their diabetes.
A lack of detail in reports received from device users has made it difficult to thoroughly investigate potential safety issues. Discussion with external stakeholders also highlighted significant under-reporting amongst users of these devices. Contributing factors to under-reporting were a lack of awareness that Yellow Card reporting can be used for medical device-related safety issues, and lack of clarity on why the issue would need to be reported twice (once to the manufacturer to request replacement units and again to the MHRA for signal detection activities).
To address the issues affecting incident reporting with these devices, we have published guidance aimed specifically at device users and their families, care givers and representatives on why reporting concerns to us is important, what information they should include, and step-by-step instructions on how to create a report.
The MHRA requests that healthcare professionals bring this guidance to the attention of patients using insulin pumps and CGM devices.
Report concerns with medical devices on a Yellow Card
If a patient tells you of problems with their equipment, please advise them to submit a report to the MHRA via the Yellow Card scheme and share the guidance document to help them.
If the patient is unable to submit a report, healthcare professionals should report incidents involving medical devices:
- in England and Wales to the Yellow Card scheme or via the Yellow Card app
- in Scotland to Incident Reporting & Investigation Centre (IRIC) and their local incident recording system
- in Northern Ireland to the Northern Ireland Adverse Incident Centre and their local incident recording system.
For queries or more information, please contact info@mhra.gov.uk
Article citation: MHRA Safety Update volume 18, issue 3: October 2024: 2