Additional Battery Testing Recommended By FDA

Manufacturers may want to put more effort into testing batteries destined for use in medical products. According to an FDA official, agency inspectors will be looking at production controls and acceptance activities related to batteries, as well as battery storage, during routine audits of manufacturing facilities. Inspectors will be on the lookout for such quality issues as unexplained battery depletion, battery leakage and unexplained premature failure of implanted devices, said Kimberly Lewandowski-Walker, in the FDA’s Division of Field Investigations. 
Devices & Diagnostics Letter