Endotoxins and medical devices.

The FDA Center for Devices and Radiological Health requires devices in contact with circulating blood or cerebrospinal fluid to be nonpyrogenic. Intraocular lenses also are required to be nonpyrogenic. Requirements for other products are decided on a case-by-case basis by the FDA. Manufacturers planning to use the Limulus Amebocyte Lysate (LAL) test as a pyrogenicity test for devices must validate and test according to the FDA draft LAL guideline or submit data from an alternate method to FDA for review. Traditionally, nonpyrogenic water or saline is used to rinse devices for LAL testing. Data from our initial studies on endotoxin recovery from devices using sodium lauryl sulfate demonstrate higher recovery than with nonpyrogenic water. This method, which provides an alternate rinse solution for recovery of endotoxin from medical devices is undergoing collaborative study.