August 29, 2017 – Cybersecurity Pacemaker Firmware Release Update
Today, Abbott notified physicians of updates to its implantable pacemakers as part of its ongoing commitment to continuously improve patient care.
The update is a planned update to pacemaker firmware (a kind of software) to add additional security protections designed to reduce the risk of unauthorized access to patients’ pacemakers.
“Connected devices are having a significant positive impact for patients and their health,” said Robert Ford, executive vice president, Medical Devices, Abbott. “To further protect our patients, Abbott has developed new firmware with additional security measures that can be installed on our pacemakers.”
There have been no reports of unauthorized access to any patient’s implanted device, and according to an advisory issued by the U.S. Department of Homeland Security, compromising the security of these devices would require a highly complex set of circumstances.
Abbott is communicating with regulatory authorities worldwide to implement the new updates to the implantable devices. Abbott 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,” continued Ford. “This isn’t a static process, which is why we’re working with others in the healthcare sector to ensure we’re proactively addressing common topics to further advance the security of devices and systems.”
About the New Pacemaker Firmware Update
The new pacemaker firmware update is part of Abbott’s planned enhancements that began with updates announced in January 2017 to the Merlin@home™ v8.2.2 software. The new updates provide an additional layer of security against unauthorized access to these devices.
The update contains a software release that includes data encryption, operating system patches, and the ability to disable network connectively features, in addition to the firmware update.
The pacemaker devices to which this update applies include the RF telemetry versions of the following devices in the U.S.: Accent SR RF™, Accent MRI™, Assurity™, Assurity MRI™, Accent DR RF™, Anthem RF™, Allure RF™, Allure Quadra RF™, and Quadra Allure MP RF™.
Every pacemaker manufactured beginning Aug. 28, 2017, will have this update pre-loaded in the device and those devices will not need to be updated. Based on Abbott’s consultation with the U.S. Food and Drug Administration (FDA), this update is being treated as a field action; however, the devices continue to function as intended and replacement of implanted pacemaker devices is not recommended.
For more information about the pacemaker firmware update, please contact our dedicated hotline at 1-800-722-3774 (U.S.) or visit our website at www.sjm.com/cyberupdate.
Abbott is communicating with the FDA, the U.S. Department of Homeland Security, and global regulators, and works with leading independent security experts, to strengthen protections against unauthorized access to its devices.
At Abbott, we’re committed to helping people live their best possible life through the power of health. For more than 125 years, we’ve brought new products and technologies to the world – in nutrition, diagnostics, medical devices, and branded generic pharmaceuticals – that create more possibilities for more people at all stages of life. Today, 94,000 of us are working to help people live not just longer, but better, in the more than 150 countries we serve.
To learn more about Abbott’s commitment to protecting our devices, products and systems, please read our commitment to cybersecurity on the Abbott website.
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