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.
- 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
- 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
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.
Excerpt from the official page. The original is authoritative. Continue reading at UK Drug Safety Update ↗