February 24, 2018

Abbott Updates Pacemaker, Defibrillator Software to Protect Against Hacking

31 August 2017, 01:39 | Frank Carlson

Implantable Cardiac Pacemakers by Abbott (formerly St. Jude Medical): Safety Communication - Firmware Update to Address Cybersecurity Vulnerabilities

An FDA First Cyber Recall for Implantable Device

On Tuesday, the FDA issued a recall for a number of implantable pacemakers manufactured by Abbott Laboratories, formerly St. Jude Medical.

"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.

BACKGROUND: Many medical devices - including St. Jude Medical's implantable cardiac pacemakers - contain configurable embedded computer systems that can be vulnerable to cybersecurity intrusions and exploits. But the FDA has confirmed that Muddy Waters did not notify the agency until after the firm publicly released its findings (see Report on Cardiac Device Cyber Vulnerabilities Fuels Debate).

The firmware update will take just three minutes in-person with the patient's provider.

Abbott pacemakers manufactured beginning August 28, 2017, will have this update pre-loaded in the device and will not need the update, the FDA says.

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However, the FDA warned of a potential - but very small - update failure which could result in: reloading of the previous firmware version; loss of programmed settings; loss of diagnostic data; or complete loss of device functionality.

The St. Jude Medical pacemaker flaws that an investor relied on to short the company's stock has a new patch to address the issue.

"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.

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". In some cases, the risks may necessitate the performance of the procedure at a facility with a temporary pacemaker generator. The device will run on backup mode during the process, but all life-sustaining features will still be available. Abbott says compromising the security of the implantable products would require a complex set of circumstances, but it will update the software nonetheless the reduce the risk of a malicious attack.

"All industries need to be constantly vigilant against unauthorized access", said Robert Ford, Abbot's executive vice president of medical devices.

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