The new technical information report presents survey findings from cardiac clinicians on battery longevity reporting, replacement indicators, and device behavior during prolonged service periods.
The Association for the Advancement of Medical Instrumentation (AAMI) announced the publication of a new guidance document on battery longevity management for implantable cardiac pacemakers and related devices.
Given the limits of existing industry standards for cardiovascular implantable electronic device safety, there is significant variation among devices and in how manufacturers convey longevity information to clinicians, according to a release from AAMI.
The new Technical Information Report (TIR) to help address this discrepancy. AAMI TIR107:2026; Cardiovascular implantable electronic devices—Battery longevity management and reporting and prolonged service period behavior collects survey data from clinicians who specialize in cardiac health and work with devices such as pacemakers and implantable cardiac resynchronization devices that use non-rechargeable batteries. Survey respondents included members of the Heart Rhythm Society, the AAMI Cardiac Rhythm Management Devices Committee, and individual cardiologists and electrophysiologists. Of the clinicians surveyed:
- 71% supported adding an additional power source depletion indicator to warn of the onset of recommended replacement time (RRT).
- 84% of those recommending an additional indicator requested a “dynamic quantitative indicator that provides an estimate of time until RRT.”
- 75% of clinicians surveyed expressed concern over the current lack of International Standards Organization (ISO) requirements governing device behavior during the prolonged service period phase.
- Of those concerned about a lack of ISO requirements, 39% of them felt that no settings on a device should be allowed to automatically change.
AAMI’s Cardiac Rhythm Management Devices Committee developed TIR107. At the time of publication, the committee was composed of volunteer experts from regulatory agencies, health care delivery organizations, and medical device manufacturers. The committee was co-chaired by Shiloh Sison, senior associate research fellow at Abbott Laboratories, and Charles Love, MD, director of the Johns Hopkins Cardiac Rhythm Device Service.
Sison described TIR107 as an important source of “clinician input into battery longevity management and reporting, and prolonged service period behavior.” This input is a critical resource for firms that produce medical devices and is “needed by manufacturers to inform future device designs.”
The document is limited in scope to pacemakers, implantable devices that treat tachyarrhythmia, and implantable cardiac resynchronization devices that use non-rechargeable batteries. AAMI TIR107 does not apply to implantable cardiac monitors, intracardiac or leadless pacemakers, and extravascular defibrillators.
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