Failure of the STER-O-LIZER MD 200 to pass the EPA sporicidal test

The U.S. Environmental Protection Agency (EPA) officially licenses and authorizes use of commercial gas and liquid sterilants. Products registered by the EPA include ethylene oxide gas, formalin-alcohol vapor, glutaraldehyde liquid, and chlorine dioxide liquid. One product that is exempted from EPA registration is the STER-O-LIZER MD 200, in which the active component is electropotentiated saline solution. The manufacturer of the STER-O-LIZER claims that the device sterilizes surgical instruments in 2 minutes. Sterilization claims for the product are based on a test selected by the manufacturer. The EPA, however, is not concerned about the use of the STER-O-LIZER because it is non-toxic to humans. This study tested the validity of the manufacturer's claim by using EPA standards.