Abbott Releases Planned Security and Performance Updates for Implanted Cardiac Devices

Abbott is releasing the latest in its planned series of cybersecurity and battery performance alert updates: a firmware upgrade to further strengthen the security and enhance the performance of certain high-voltage implantable cardiac devices. This series of updates began with Abbott’s pacemakers, programmers and remote monitoring systems in 2017.
 
Firmware is a kind of software that is embedded in certain medical devices. Devices that use this type of software may require updates from time to time, as technology and security for connected devices and systems continue to advance.
 
The firmware upgrade released today incorporates an enhanced device-based battery performance alert, which will allow patients and physicians to better manage battery performance in certain implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds). It also includes a cybersecurity update, which will provide an additional layer of protection against unauthorized device access.
 
Each of these are planned updates, and part of Abbott’s ongoing commitment to improve patient care and make our products more secure. There have been no reports of unauthorized access to any patient’s implanted device and no new vulnerabilities have been identified. 
 
“Technology and its security are always evolving, and this firmware upgrade is part of our commitment to ensuring our products include the latest advancements and protections for patients,” said Robert Ford, executive vice president, Medical Devices at Abbott.
 
Abbott is communicating with regulatory authorities worldwide to implement the new upgrade to implantable ICDs and CRT-Ds, which will be made available over the next several weeks.
 
These updates are part of a series of planned firmware releases that Abbott announced last year for pacemakers and are now available for ICDs and CRT-Ds.
 
The cybersecurity update provides an additional layer of security against unauthorized access to these devices, to prevent anyone other than a person’s physician from changing device settings.
 
The battery performance alert update will allow the device to monitor for abnormal battery behavior and automatically vibrate to alert the patient if abnormal battery behavior is detected. The capability to detect this was previously only available on the Merlin.net remote monitoring system or during in-clinic office visits via the Merlin programmer.
 
The cybersecurity update applies to the following ICD and CRT-D device families: Fortify, Fortify Assura, Quadra Assura, Quadra Assura MP, Unify, Unify Assura, Unify Quadra, Promote Quadra, and Ellipse. The battery performance alert update applies to the following high voltage devices manufactured between January 2010 and May 2015: Fortify, Fortify Assura, Quadra Assura, Quadra Assura MP, Unify, Unify Assura, and Unify Quadra.