The Food and Drug Administration warns the insulin pump users of potential cyber security and hacking risks associated with some devices.
If a patient uses one of the pumps, they may be in danger 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 healthcare providers. and published on Medtronic's website.
"Although we are not aware of patients who may have been harmed by this particular cyber security vulnerability, the patient is at risk of damaging if such a vulnerability left unaddressed is significant," said Suzanne Schwartz, an FDA official specializing in cyber security for medical devices, in a statement.
Acco rding to the FDA, a person "could potentially connect wirelessly to a nearby MiniMed insulin pump and change the pump settings." This could spur expensive health problems. Hypoglycaemia may occur if too much insulin is given. It may also cause insufficient insulin to be delivered and a diabetic patient may suffer from hyperglycaemia and diabetic ketoacidosis.
Insulin pumps provide a convenient way to maintain blood glucose levels as compared to repeated insulin injections. According to the FDA, the MiniMed 508 and MiniMed connect the Paradigm wirelessly with multiple monitoring devices.
The devices cannot be updated, so "Medtronic provides alternative insulin pumps to patients with improved built-in cyber security features," the FDA statement said.
Pamela Reese, Communications Director at Medtronic, said the devices in the FDA Security Notice "were first put on the market in 2012 or earlier" and that most Medtronic customers do not use them. Reese added that the security announcement does not require patients to return the devices.
The FDA is encouraging patients at risk of at least 4,000 people – talking to their doctors about requesting new insulin pumps that do not pose the same risks.
As patients await new devices, Medtronic and FDA are asking users to take specific precautions, including paying attention to blood sugar levels, and having control over insulin pumps and attached devices at all times.
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