FDA to patients with St. Jude pacemakers

Stock image

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

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. The device will run on backup mode during the process, but all life-sustaining features will still be available.

It was the second round of updates for the heart implants that Abbott has announced since buying medical device maker St. Jude Medical earlier this year. The organizations looked into the matter after short seller Muddy Waters published a report claiming the devices were easy to hack.

The US Food and Drug Administration (FDA) has approved new firmware from Abbott Laboratories created to fix vulnerabilities in its St Jude cardiac pacemakers which could allow hackers to deplete the device battery.

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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.

The U.S. Food and Drug Administration said then that hospitals should return unused devices and warned patients with an already implanted device to seek immediate medical attention if they get a low-battery alert.

Abbott said it would also update the software embedded in pacemakers to reduce the risk of hacking. However, officials warned that there is always a potential issue with reloading previous version if the update is incomplete, a loss of programmed settings, loss of diagnostic data and a complete loss of device functionality.

No actual remote attacks on these devices are known to have occurred. 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. Pacemakers manufactured beginning August 28, 2017 will have this update pre-loaded in the device and will not need the update. "However, the increased use of wireless technology and software in medical devices can also often offer safer, more efficient, convenient, and timely healthcare delivery".


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