Australia’s Therapeutic Goods Administration is stressing the need for protocols and procedures to help minimize the risks of using medical devices that run on batteries.
The TGA has received more than 50 adverse event reports over the past 10 years involving deaths or serious injuries in which a battery-related problem was listed as a potential contributing factor, the agency says.
Active implantable medical devices dominated the list, with 345 battery-related reports from January 2013 to October 2015.
The batteries in AIMDs are generally nonrechargeable, and replacement would require surgery. Investigations usually reveal battery depletion is due to excess current drain, such as low circuit impedances and high output settings, and generally not battery failure, the TGA says.
Other battery failure reports involved infusion and insulin pumps, patient monitors and vision systems. The most common type of battery failures are for rechargeable batteries that fail to charge, fail to hold a charge or are not inserted correctly.
The TGA says protocols should consider factors, such as using the best quality battery cells available, ensuring charging regimes suit each battery type and setting up routine battery testing timetables.
Read the safety update here: www.fdanews.com/01-22-16-TGA.pdf. — Jonathon Shacat