Concerns with chlorhexidine preservatives in refillable portable eyewashes

Three major safety equipment suppliers market preservatives based on chlorhexidine gluconate for refillable portable eyewashes. During a quality audit on eyewashes, several water preservation factors were identified that appear to be insufficiently rigorous or unaccounted for, including regulatory compliance (registration with U. S. Environmental Protection Agency under the Federal Insecticide, Fungicide, and Rodenticide Act and registration with U.S. Food and Drug Administration under the Food, Drug, and Cosmetic Act), antimicrobial efficacy (end use concentrations below the minimum inhibitory concentrations for many bacterial pathogens of interest), side reactions with chlorine used as a drinking water disinfectant (chloramination that could result in significant loss of chlorhexidine with concomitant loss of disinfectant properties), dilution effects resulting from topping off after routine testing, safety of chlorhexidine (published studies are not clearly applicable), and even directions for use (widely varying change intervals). Overall, we conclude that chlorhexidine preservatives are best avoided at the present time. Even when used as directed, these products have not been demonstrated to provide adequate health and hygiene protection. Without definitive resolution of the concerns identified, users of these products may risk noncompliance with the OSHA regulation requiring “suitable facilities for quick drenching or flushing of the eyes.”