MHRA Cautions Against Sudden Switches of Insulin Devices
Posted 27 October 2016 | By
The Medicines and Healthcare products Regulatory Agency (MHRA) on Thursday said it has become aware of patients directly contacted by a manufacturer or other organization inviting them to trial a new insulin delivery system.
“It is crucial people do not suddenly stop using or change their insulin devices without first discussing it with their diabetes specialist,” the regulator says.
The caution comes as MHRA warns that patients who suddenly stop using or change their insulin delivery devices can run the risk of low blood glucose (hypoglycemia), too much blood glucose (hyperglycemia) or not the right insulin dose, risking a potentially life-threatening complication of diabetes caused by a lack of insulin in the body (diabetic ketoacidosis).
John Wilkinson, MHRA’s director of medical devices, said in a statement: “It is vital people use insulin delivery devices which are recommended by their diabetes specialist and we urge everyone not to make changes to their device or delivery system without first seeking guidance from their specialist.”
MHRA is also requesting that healthcare professionals have systems in place to remind their diabetic patients to use devices that have been recommended or prescribed for them, not to stop or change their prescribed insulin management regimen without the advice of a diabetes specialist and to contact the specialist if they are invited by a manufacturer to trial a new device, for example, via social media.
The UK regulator noted examples of insulin delivery systems affected by this alert include disposable patch pumps, reusable ambulatory infusion pumps, handsets and insulin cartridges.
MHRA Device Alert