FDA Approves Firmware Fix for St Jude Pacemakers

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

The FDA said that, while there are no known reports of patients being harmed by cybersecurity vulnerabilities, there's still an increased risk that those vulnerabilities could be exploited by an unauthorized user accessing a patient's device.

To view the full article, register now. About 280,000 devices are eligible for the update outside the U.S., Candace Steele Flippin, a spokesperson for Abbott said.

Medical device maker Abbott on Monday announced it is voluntarily recalling some 465,000 pacemakers to install a firmware update to patch cybersecurity vulnerabilities in the devices.

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.

There are now no known reports of patient harm for the 465,000 implanted devices in question, according to the FDA. The FDA and Abbott do not recommend the removal and replacement of affected pacemakers and suggest that the risks of cybersecurity be discussed between patients and their providers.

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

The update is for pacemakers with radio frequency (RF) telemetry capabilities, meaning that they are wirelessly connected by radio waves for recording and transmitting the readings of the devices. During this time, the device will operate in backup mode. and essential, life-sustaining features will remain available.

Doctors will now get a warning should batteries run to dangerously low levels thanks to the new software updates.

Pacemakers that were manufactured beginning August 28, 2017, will come pre-loaded with the new firmware and will not require updating, according to a statement. 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.

But as a precaution, Abbott says that pacing dependent patients should be given the update in a facility where temporary pacing and a pacemaker generator are on hand.

While the Muddy Waters/MedSec report highlighted important cybersecurity issues concerning the St. Jude medical devices, the controversial manner in which the research was released - by an investment company - and its financial arrangement with "ethical hacker" MedSec, which found the vulnerabilities, drew criticism from the healthcare industry.

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