WASHINGTON - The Food and Drug Administration is warning insulin pump users about potential cybersecurity and hacking risks involved with some devices.
According to an announcement released Thursday, the MiniMed 508 and the MiniMed Paradigm insulin pumps from Medtronic are vulnerable to possible hacking and are being recalled.
If a patient is using one of the pumps, they could be at risk of "an unauthorized person with special technical skills and equipment" connecting to the device and changing how much insulin is delivered, according to a letter sent to patients and health care providers and posted on Medtronic's website.
"While we are not aware of patients who may have been harmed by this particular cybersecurity vulnerability, the risk of patient harm if such a vulnerability were left unaddressed is significant," Suzanne Schwartz, an FDA official specializing in cybersecurity for medical devices, said in a statement.
According to the FDA, an individual "could potentially connect wirelessly to a nearby MiniMed insulin pump and change the pump's settings." This could spur dire health concerns. Hypoglycemia could occur if too much insulin is delivered. It could also cause too little insulin to be delivered, and a diabetes patient could suffer from hyperglycemia and diabetic ketoacidosis
Insulin pumps offer a convenient way to maintain blood glucose levels compared with repeated insulin injections. According to the FDA, the MiniMed 508 and the MiniMed Paradigm wirelessly connect to multiple monitoring devices.
The devices cannot be updated so "Medtronic is providing alternative insulin pumps to patients with enhanced built-in cybersecurity capabilities," the FDA statement said.
Pamela Reese, a communication director at Medtronic, said the devices listed in the FDA safety notification "were first brought to market in 2012 or earlier," and that most Medtronic costumers are not currently using them. Reese also noted that the safety notice does not require that patients return the devices.
The FDA is encouraging patients who might be at risk - at least 4,000 individuals - to talk to their medical provider about requesting newer insulin pumps that do not pose the same risks.
As patients await new devices, Medtronic and the FDA are asking that users take specific precautions, including paying close attention to blood glucose levels and having control of insulin pumps and connected devices at all times.