India’s drug regulators have issued a risk-alert on an imported insulin pump because of the medical devices’ “cyber-security” vulnerabilities.
The Central Drugs Standard Control Organisation has issued the alert over the Medtronic-made insulin pump, days after it was sounded out by the US Food and Drug Administration. The company is one of the world’s largest manufacturers of medical devices.
“The MiniMed and Paradigm series of insulin pumps are designed to communicate using a wireless radio frequency with other devices such as a blood glucose meter, glucose sensor transmitter and CareLink USB devices. Security researchers have identified potential cyber-security vulnerabilities related to those insulin pumps. An unauthorised person with special technical skills and equipment could potentially connect wirelessly to a nearby insulin pump to change settings and control delivery,” says the CDSCO alert issued on July 2.
The Indian regulator, however, made it clear that so far it had not received any complaints from the market.
After last week’s FDA alert, Medtronic announced the immediate recall of all MiniMed 508 and Paradigm series insulin pumps.
While the FDA noted that there are around 4,000 US patients, identified by the company, who were using the affected models, the agency also maintained that there could be an unknown number of patients in other countries.
Insulin pumps are small, computerised devices that mimic the way the human pancreas works by delivering small doses of short-acting insulin continuously.
But to do that it needs to be connected with a glucose monitor to know the patient’s blood sugar level – that’s where its vulnerability lies.