Abbott patches pacemaker software to guard against hacks

The implantable cardiac devices from Abbott - which acquired St. Jude Medical in early 2017 - have been under fire since August 2016.

The FDA reviewed the available information regarding the potential for cybersecurity vulnerabilities associated with the RF-enabled implantable cardiac pacemakers, confirming that, if exploited, they would allow for an unauthorized user to access the devices using commercially available equipment. To date, there have been no known reports of patient harm.

Patients with affected devices should schedule an in-person visit to have the firmware update installed, the FDA said.

The FDA alert says the recall involves implantable cardiac pacemakers, including cardiac resynchronization therapy pacemakers under the names Accent, Anthem, Accent MRI, Accent ST, Assurity and Allure. 465,000 implanted pacemakers are now eligible for the new software updates.

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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".

Patients must visit their doctors to get the updates, which should take about three minutes.

Patients' devices will be updated with the new battery alert automatically.

"If we do find them, we could look at it as a reason not trust the devices, or we could look at it like we're going from a mode of silent failures to one where we're starting the process to inform smarter and better designs", Corman said. "As with any firmware update, there is a very low risk of an update malfunction". Based on Abbott's data, there's a 0.161 percent chance the update reloads old firmware due to an incomplete update; a 0.023 percent chance that the update will wipe programmed device settings; a not reported chance of loss of diagnostic data; and a 0.003 percent chance the device becomes bricked. In some cases, the risks may necessitate the performance of the procedure at a facility with a temporary pacemaker generator.

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There haven't been any reports of the vulnerability being exploited in the wild, according to the FDA.

Abbott says it will continue to make updates and product enhancements across its devices as part of the company's "ongoing commitment to provide safe, effective and secure products" for patients.

"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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