Efficacy of Chemical Sterilants/Disinfectants Is There a Light at the End of the Tunnel?

Abstract

Chemical sterilants/disinfectants are used to sterilize or disinfect instruments that cannot tolerate autoclave or gas sterilization. The Environmental Protection Agency (EPA) registers and approves these products for use. Registration is based on approval of data supplied by each manufacturer purporting to prove the efficacy of the product. As described in three previous articles by this author, these claims of efficacy are in question.1-3 Prior to 1982, the conducted limited testing of sterilants, and up to 30% of products failed these verification tests. Since 1982, no tests on manufacturers' claims have been performed by the EPA. Since 1982 and before, independent labs have disputed some of the claims, and the reported inconsistencies in performance have greatly worried infection control personnel. As a result, hearings were conducted by congressional committees, and the conclusions have been reported by the United States General Accounting Office.4 That report states that the EPA does not know whether disinfectants kill the germs claimed on product labels, and the extent to which ineffective disinfectants are marketed (with registration) is unknown.... Evidence exists that some registrants have submitted to the efficacy test data indicating that their disinfectants work, but have withheld other test data indicating that these disinfectants do not work as claimed.