June 28, 2019 — The FDA has recalled sure Medtronic MiniMed insulin pumps as a result of there’s a threat of them being hacked, the company mentioned.
The recall impacts Medtronic’s MiniMed 508 and MiniMed Paradigm sequence insulin pumps. The FDA recommends that sufferers utilizing these fashions change their pump to fashions which might be higher geared up to guard towards these dangers.
“Whereas we aren’t conscious of sufferers who could have been harmed by this specific cybersecurity vulnerability, the danger of affected person hurt if such a vulnerability had been left unaddressed is critical,” Suzanne Schwartz, MD, of the FDA’s Middle for Units and Radiological Well being, mentioned in an announcement.
The cybersecurity dangers discovered within the gadget imply that somebody aside from a affected person, caregiver, or well being care supplier might join wirelessly to a close-by MiniMed insulin pump and alter the pump’s settings, the FDA warns. This might permit an individual to ship an excessive amount of insulin to a affected person, resulting in hypoglycemia, or to cease insulin supply, resulting in hyperglycemia and diabetic ketoacidosis.
Medtronic cannot replace the MiniMed 508 and Paradigm insulin pumps nicely sufficient with any software program or patch to deal with the gadgets’ dangers, the FDA says.
Medtronic has recognized 4,000 sufferers in america who may very well be utilizing the recalled insulin pumps which might be susceptible to this problem. The corporate is working with its distributors to determine different sufferers who is likely to be utilizing these pumps. Medtronic is giving sufferers different insulin pumps which have higher cybersecurity, and the corporate despatched a letter to them explaining the problem.
“The FDA urges producers all over the place to stay vigilant about their medical merchandise — to observe and assess cybersecurity vulnerability threat, and to be proactive about disclosing vulnerabilities and mitigations to deal with them,” Schwartz mentioned.
In March, the FDA warned about cybersecurity dangers in Medtronic’s implantable cardiac gadgets and telemetry methods.