Dialyzer membrane reuse is the prevailing method of choice for patient dialysis in this country. Reuse necessitates disinfection and storage of membranes between dialysis therapy. Formaldehyde, the most common membrane disinfectant, is cost effective but recognized as carcinogenic, toxic, malodorous and environmentally challenging. Marketed alternatives, glutaraldehyde and peracetic acid ,have not dominated the market because of increased cost. Both of these agents were further compromised when an unbiased study involving 34,000 dialysis patients demonstrated an increased mortality rate using glutaraldehyde or peracetic acid. No increase was demonstrated with formaldehyde. These data suggest that a safe, cost effective disinfectant is not currently available for membrane reuse procedures. Data from our Phase l studies demonstrated that the new dialyzer membrane disinfectant being evaluated was: rapidly biocidal against fungi, viruses, and bacteria, non-toxic, non-carcinogenic, environmentally safe and cost effective. Completion of the Phase II protocols, as outlined in thin proposal, will facilitate the introduction of a much needed disinfectant into the marketplace. This technology will provide a safer employee and patient setting resulting in higher productivity, lower liability and beneficial cost containment for federally subsidized patient dialysis.
