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FDA Issues Cybersecurity Alert on Medtronic Insulin Pumps

A technical malfunction could make it vulnerable to trigger the pump to administer the patient with inadequate insulin.
The U.S. Food and Drug Administration issued a warning on Tuesday regarding the vulnerability of some insulin pump devices made by Medtronic. The flaw makes the devices vulnerable to cyberattacks while presenting a possibility for hackers to interfere with insulin delivery by gaining access to the device.

The FDA, a U.S. government organization, has issued an advisory regarding the MiniMed 600 Series Insulin Pump System from Medtronic, which includes the MiniMed 630G and MiniMed 670G devices.

The Department of Health and Human Services safeguards the public's health by ensuring the efficacy, security, and safety of pharmaceuticals for use in humans and animals, medical devices, and vaccinations. The agency is in charge of regulating tobacco products as well as the safety and security of our country's food supply, cosmetics, nutritional supplements, and devices that emit electronic radiation.

The FDA pointed out that many parts, including the insulin pump, constant glucose monitoring (CGM) transmitter, blood glucose meter, and CareLink USB device, connect wirelessly. A technical malfunction could make it possible for someone to break in and trigger the pump to administer the patient with either too much or too little insulin.

The insulin pumps are offered by Medtronic's diabetes division, which generated $2.41 billion in sales in 2021, or 8% of the business's overall revenue.

In the aftermath of the security incident, Medtronic cautioned users about the dangers and offered suggestions, such as advising them to permanently disable the 'Remote Bolus' function on the pump, refrain from disclosing the serial number of the device to unauthorized individuals, and avoid connecting or linking devices in public.

The business warned that patients should never accept remote connection requests and other remote activities unless patients or support persons initiated them and should always detach the USB device from their laptop while it is not being used to download pump data.

Although medical equipment is frequently connected to the internet, hospital networks, and other devices, the FDA warned that these same characteristics may pose cybersecurity threats.

According to the FDA advisory, "Medical devices, like other computer systems, might be subject to security breaches, possibly affecting the device's safety and effectiveness."

The MiniMed 508 and Paradigm insulin pumps have security flaws that Medtronic is unable to fully fix with software updates or patches. The FDA said that it was working with Medtronic to identify, discuss, and anticipate the negative consequences of this risk.


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