Australia’s TGA Cites Medical Device Batteries as a Growing Concern

Regulatory News

Australia’s Therapeutic Goods Administration (TGA) is calling attention to medical device battery issues, particularly for implantable devices, and saying manufacturers and health facilities should adopt procedures to reduce risk.

A battery-related problem was listed as a potential contributing factor in more than 50 adverse event reports over the past 10 years involving deaths or serious injuries, the Australian regulator said, noting a range of safety alerts over the past three years for cardiac defibrillators, implantable pulse generators, ventricular assist devices and pacemakers.

AIMDS

Of the 345 battery-related reports from January 2013 to October 2015, TGA said in a safety bulletin that active implantable medical devices (AIMDs) are “dominating the battery failure reports.”

The batteries on AIMDs are generally non-rechargeable and replacement would require surgery, TGA notes, though investigations “usually reveal battery depletion is due to excess current drain (low circuit impedances, high output settings and the like) and not generally battery failure.”

Other Failures

In addition to battery problems with AIMDs, there have been reports on the batteries of other devices such as infusion pumps, insulin pumps, patient monitors and vision systems.

The most common kinds of battery failures are for rechargeable batteries that fail to charge, fail to hold a charge or are not inserted correctly.

The US Food and Drug Administration previously conducted a survey on device battery issues and found many of these problems, especially those related to large-volume infusion pumps, may be attributed to staff practices and poor maintenance practices, and not the actual devices.

Recommendations

TGA said users should follow the battery replacement and maintenance recommendations set out by the original equipment manufacturer so that both the device and battery performance will be as expected and certified by the manufacturer.

Health facilities and companies should also establish suitable protocols and procedures to optimize battery management and reduce risks, TGA said, noting other considerations:

• Ensure staff are familiar with and follow the manufacturer's instructions
• Use the best quality battery cells available
• Develop a planned battery replacement schedule
• Retire old batteries
• Make sure charging regimes suit each battery type
• Conduct routine battery testing timetables
• Incorporate recycling options.

TGA