FDA issues recall of 465000 St. Jude pacemakers to patch security holes
Aug 31, 2017, 01:39
On August 23, 2017, the FDA approved a firmware update that is now available and is intended as a recall, specifically a corrective action, to reduce the risk of patient harm due to potential exploitation of cybersecurity vulnerabilities for certain Abbott (formerly St. Jude Medical) pacemakers.
Patients with affected devices should schedule an in-person visit to have the firmware update installed, the FDA said. The update process will take approximately 3 minutes to complete.
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. The firmware update is meant to fix a cybersecurity weakness that allowed hackers to affect the battery life and pacing of 465,000 devices implanted in patients in the U.S.
The software patches are in response to U.S health regulators raising concerns about the safety risks of the device early this year.
The FDA is instructing providers to evaluate the risks and benefits, considering the needs of each patient.
A report from investment firm Muddy Waters Capital and security researcher MedSec found St. Jude's pacemakers and other heart devices are vulnerable to hacking and other cybersecurity threats.
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The patch comes eight months after Abbott released an update meant to fix a vulnerability with the device now providing pacemaker authorization, namely Merlin@home Transmitter.
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.
The FDA confirmed the vulnerabilities months later and issued a warning letter to Abbott in April after the pharmaceutical giant acquired St. Jude Medical.
"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. In some cases, the risks may necessitate the performance of the procedure at a facility with a temporary pacemaker generator.
"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.
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