Drug regulator CDSCO warns of cyber security risk to certain Medtronic insulin pumps

Country's apex drug regulator CDSCO Wednesday issued an alert about insulin pumps manufactured by US medical equipment giant Medtronic, saying they have cybersecurity risks as someone other than the patient can wirelessly connect to them, change its settings and control the delivery.

The alert said this could allow a person to overdose the patient with insulin, leading to low blood sugar (hypoglycemia), or to stop insulin delivery, leading to high blood sugar and diabetic ketoacidosis (a buildup of acids in the blood).

"Security researchers have identified potential cybersecurity vulnerabilities related to these insulin pumps.

"Any unauthorised person with special technical skills and equipment could potentially connect wirelessly to a nearby insulin pump and change the pump's settings and control the delivery," the Central Drugs Standard Control Organisation (CDSCO) said in its alert.

The alert comes a week after the US Food and Drug Administration (US FDA) issued a warning to patients and health care providers that certain Medtronic MiniMed insulin pumps are being recalled due to potential cybersecurity risks.

The FDA also recommended that, patients with diabetes using these models, should switch their insulin pump to models that are better equipped to protect against these potential risks even.

It however added that it is not aware of any confirmed reports of patient harm related to these potential cybersecurity risks.

The CDSCO has advised healthcare professionals, distributers and users and staff involved in the management of patients to check and see if the model and the software version of their insulin pump is affected. It has advised them to monitor blood glucose levels closely and immediately cancel any unintended boluses.

It also advised not to share the pump serial number, be attentive to pump notifications, alarms and alerts and connecting the Medtronic insulin pump in use to other Medtronic devices and software only.

The CDSCO stated that it has not received any complaints from the market on the issue.