Doctor's urgent warning over device affecting millions - 'it's potentially serious'
Millions of UK residents have received a warning amid concerns about the underreporting of issues with a much used medical devices
by Elaine Blackburne · ChronicleLiveMillions of UK residents have received a warning amid concerns about the underreporting of issues with medical devices. Within the UK, over 5.6m individuals live with diabetes, many depending on insulin pumps or continuous glucose monitors (CGM) for their well-being.
Authorities from the Medicines and Healthcare products Regulatory Agency advise that even though these devices generally function dependably and can greatly enhance life quality for those affected, they are not without faults. The experts believe that problems encountered by users often go unreported.
Their statement highlighted: "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."
To facilitate issue reporting, there exists a "Yellow Card" scheme which people can use to inform specialists about malfunctions.
Nevertheless, as per MHRA records from January 2023, fewer than 300 Yellow Card reports have been submitted by healthcare providers and the public concerning these devices a figure much less than anticipated. The MHRA is now pressing the importance of contacting them with any safety concerns that arise.
Dr Alison Cave, MHRA Chief Safety Officer, emphasised the importance of reporting any safety concerns with diabetes management devices, stating: "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 don't result in harm but potentially could have serious consequences."
She further added that each report contributes to safeguarding patient health: "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."
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Cave also provided guidance for those experiencing issues: "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, highlighted the significance of diabetes technology and the need for a reliable reporting system, saying: "Diabetes technology can be a life-changing tool, helping people living with the condition improve their quality of life."
He acknowledged potential problems with such technology: "Unfortunately, we know that sometimes this technology doesn't 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 person's safety, advice from an appropriate healthcare professional should be sought first."
Professor Partha Kar, NHS England Type 1 Diabetes and Technology lead, commented: "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."
The MHRA also encourages individuals to consult a healthcare professional without delay if they have concerns that their health may have been affected 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).
- Skin reaction to the sensor adhesive.
- 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