This month we have received three medical safety alerts that healthcare professionals should be aware of.
Accu-Chek Insight insulin pump
Roche have issued a warning about the Accu-Chek Insight insulin pump. The use of low-quality batteries in the pump, or users incorrectly confirming the battery type in the pump settings, can lead to an unexpected shutdown or power depletion of the pump. Undetected, this could cause patients to experience hyperglycaemia as a result of under-delivery of insulin. Roche have released an urgent field safety notice to healthcare professionals, including a recommendation of the high quality batteries to be used in the Accu-Chek pump. Roche are also asking that healthcare professionals talk to patients about confirming the correct type of battery when batteries are changed. If patients have any concerns they can call the Accu-Chek Insight Pump Care Line on 0800 731 2291.
Medicina Ltd automatically retracting safety syringes
Medicina Ltd have issued a medical device alert for automatically retracting safety syringes, including insulin syringes. These devices are being recalled due to 2 problems: there is a risk of needle stick injury as the devices may not automatically retract, and the shelf life stated on the devices is incorrect, compromising the sterility of the syringes. All batches of automatically retracting blue safety syringes, including insulin syringes, with product codes prefixed with RN, for example RNXX/XX and RNXX/XX INS, are being recalled.
EMA review into SGLT2 inhibitors
The European Medicines Agency (EMA) have launched a review into the safety of SGLT2 inhibitors. The investigation comes after more than 100 cases of DKA in people treated with canaglifozin, dapagliflozin and empagliflozin. The EMA noted that although DKA is usually accompanied by high blood glucose levels, in a number of these cases blood glucose levels were only moderately increased. These uncharacteristic blood glucose levels could delay diagnosis and therefore treatment of DKA. The review will look at all available data on the risk of DKA with SGLT2 inhibitors and will consider if any changes are needed to how they are used in the EU. Healthcare professionals will be written to regarding the risk of DKA and how to manage it.