Doctor Issues Urgent ‘Report Now’ Warning to Those with Condition Affecting Millions
Dr. Alison Cave, a product regulator at the Medicines and Healthcare Products Regulatory Agency, has emphasised the critical importance of prioritising patient safety above all else. She has issued a warning to millions of individuals due to increasing concerns that too few people are reporting issues with a crucial medical device, potentially jeopardising patient safety. In the UK, more than 5.6 million people live with diabetes, with many relying on insulin pumps or continuous glucose monitors (CGMs) to effectively manage their condition.
While these devices are generally reliable and can significantly improve patients’ quality of life, experts at the Medicines and Healthcare Products Regulatory Agency (MHRA) have pointed out that problems can still occur. They stress that not all issues experienced by device users are being reported, and that adverse incidents related to these devices can lead to incorrect insulin dosages, resulting in abnormal blood sugar levels and potentially serious health consequences.
The MHRA operates a “Yellow Card” reporting scheme, allowing individuals experiencing problems with their medical devices to inform experts about any issues they have encountered. However, despite the prevalence of diabetes and the widespread use of insulin pumps and CGMs, the MHRA received fewer than 300 Yellow Card reports related to these devices as of January 2023, a number significantly lower than expected. As a result, the MHRA is urging anyone with safety concerns to report them promptly.
Dr. Alison Cave, MHRA Chief Safety Officer, stated, “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. Every report is valuable and can provide important insights that may inform future regulatory measures to protect patients. If you suspect an issue with any of your diabetes devices, please use the guidance provided to complete a Yellow Card report online or via the free Yellow Card app.”
Douglas Twenefour, Head of Care at Diabetes UK, highlighted the importance of reporting issues with diabetes technology, emphasising that timely reporting can help improve the quality of these devices. He encouraged individuals with concerns to report them promptly, as this information can lead to enhancements in device performance and ultimately benefit users’ health and well-being. Additionally, he advised seeking advice from healthcare professionals if immediate safety concerns arise.
Professor Partha Kar, NHS England Type 1 Diabetes & Technology lead, expressed support for the MHRA’s efforts to ensure the safety of diabetes technologies, acknowledging the life-changing impact these devices can have for individuals with diabetes. He emphasised the critical need for the operational effectiveness of these devices to guarantee users’ safety and peace of mind.
Individuals are encouraged to consult healthcare professionals promptly if they suspect any health issues related to their diabetes devices. Concerns that should be reported include accuracy issues with insulin delivery, accuracy problems with continuous glucose monitors, skin reactions to sensor adhesives, technology malfunctions, physical failures, and other device-related complications.
In light of the MHRA’s warning and the importance of patient safety, it is crucial for individuals using diabetes devices to be vigilant and report any concerns promptly. By prioritising safety and reporting issues promptly, users can contribute to ongoing efforts to enhance the quality and safety of diabetes technology, ultimately benefiting individuals living with diabetes.