FDA to patients with St. Jude pacemakers

Dianna Christensen
August 31, 2017

However, the company headquartered in Lake Bluff, Illinois, clarified that there have been no reports of unauthorized access to any patient's implanted device, and cited an advisory issued by the U.S. Department of Homeland Security to claim that compromising the security of these devices would require a highly complex set of circumstances. "This access could be used to modify programming commands to the implanted pacemaker, which could result in patient harm from rapid battery depletion or administration of inappropriate pacing", the FDA warned.

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In approving the firmware, the FDA notes the upgrade means patients won't need new devices replacement.

The firmware update process is described in Abbott's Dear Doctor Letter issued on August 28, 2017.

"These are part of planned updates we mentioned back in January, and further strengthen the security and device management tools for our connected cardiac rhythm management (CRM) devices", Steele Flippin said of this week's pacemaker update.

Making arrangements to have almost a half million patients in the US 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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The Food & Drug Administration released a recommendation for patients to visit their healthcare providers to discuss vulnerability and updates.

No actual remote attacks on these devices are known to have occurred.

The Accent, Anthem, Accent MRI, Accent ST, Assurity, and Allure models are all affected.

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". Abbott described the full update process in a Dear Doctor letter issued August 28, according to a safety update issued by the FDA. "As with any firmware update, there is a very low risk of an update malfunction".

While St. Jude built patches for these flaws, this newest FDA alert provides the framework to fix the vulnerabilities. In some cases, the risks may necessitate the performance of the procedure at a facility with a temporary pacemaker generator.

St. Jude released a first round of security updates in January after working with the FDA and the DHS's ICS-CERT to resolve the issues originally reported by short-seller Muddy Waters Capital and security firm MedSec.

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