Abbott Cybersecurity Advisory 8/29/17

On August 29 2017, Abbott  and the Food and Drug Administration each released a public safety communication regarding the availability of a pacemaker software patch to address a cybersecurity risk. The identified risk could allow unauthorized access to pacemakers that utilizes radio frequency (RF) communications. The Abbott devices covered by this communication are as follows:

  • Accent™/ Anthem™,
  • Accent MRI™,  
  • Assurity™/ Allure™, and
  • Assurity MRI™.

Abbott has not received reports of device compromise or patient injury due to the cybersecurity vulnerabilities in the implanted devices affected by the company’s communication. The firmware update adds an additional layer of protection to address these potential cybersecurity risks.

The firmware update process, which needs to be completed in the physician office, takes approximately 3 minutes to complete, and during this time, the device will operate in back‐up mode (VVI pacing at 67 bpm), and essential, life-sustaining features remain available. As with any firmware update, there is a very low risk of device malfunction resulting from the update (such as failure to pace), estimated by Abbott as approximately 3/100,000. Failure would be of greatest concern for patients who are pacemaker dependent.

As it is critical for patients and physicians to make informed decisions about cardiac implantable electronic devices, HRS recommends that physicians, patients and their care-givers determine the best course of action balancing the benefits of the life-saving devices with the risks related to cybersecurity vulnerabilities and the very low risk associated with firmware updates, based on individuals' medical history, comorbidities, and clinical conditions. Healthcare providers should discuss the risks and benefits of the cybersecurity vulnerabilities and associated firmware update with patients at the next regularly scheduled visit, ideally within six months of this notification.

 
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If you have any questions about this firmware update, please contact your Abbott representative or the Abbott’s customer technical support hotline at 1‐800‐722‐3774 (U.S.).