Abbott Labs rolls out patch for St. Jude-made pacemakers

Chelsea West
August 31, 2017

"FDA reminds patients, patient caregivers and healthcare providers any medical device connected to a communications network may have cybersecurity vulnerabilities that could be exploited by unauthorized users", officials said.

To view the full article, register now. Abbott Laboratories plans to incorporate the software updates to any new devices prior to them going on sell.

The vulnerability affects devices made by Abbott's (formerly St. Jude Medical's) that are radio frequency-enabled.

Abbott has released a software security update to protect its cardiac pacemakers from hacking.

Contact your Abbott representative, or Abbott's customer technical support hotline at 1‐800‐722‐3774 if you have any questions about the firmware update.

Making arrangements to have almost a half million patients in the USA visit their healthcare provider for the firmware update "will be a logistical nightmare", he says, despite Abbott and the FDA recommending that patients wait until their next regular appointment with physicians to do the update.

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And although there have been no reports of actual harm to patients due to hackers exploiting the vulnerabilities in the devices, "that number can go from zero to a lot of patients quickly" if hackers decide to launch attacks, Corman warns. St. Jude's Accent, Anthem, Accent MRI, Accent ST, Assurity and Allure pacemakers and cardiac resynchronization therapy (CRT) pacemakers are affected.

Abbott and the FDA are advising doctors and patients to discuss these risks and the cybersecurity dangers the patch addresses at their next scheduled visit.

According to the FDA, "the update process will take approximately 3 minutes to complete".

In Tuesday's announcement, William Maisel, acting director of the Office of Device Evaluation and chief scientist in the FDA's Center for Devices and Radiological Health highlighted broader industry concerns about evolving networked medical devices that require manufacturers to "to be vigilant in the face of change threats".

The FDA cited Abbott with a warning letter in April over deficiencies in how the St. Jude plant in Sylmar, Calif., has handled the battery-depletion issue and the cybersecurity issue. During this time, the device will operate in backup mode. and essential, life-sustaining features will remain available. The firmware update will be available beginning August 29, 2017. If deemed appropriate, install the firmware update following the instructions on the programmer. In some cases, the risks may necessitate the performance of the procedure at a facility with a temporary pacemaker generator.

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