Research Project
6211515
Disposable hemodialyzers are medical devices that are supplied in a sterile state and intended by the manufacturer for one-time use. However, hemodialyzer reuse is a common, cost-cutting practice that occurs in more than 80% of the dialysis centers in the United States. Aside from economic benefits, reused hemodialyzers can also improve patient tolerance of the dialysis session compared to sessions performed with a new hemodialyzer. Unfortunately, with every use of a reprocessed hemodialyzer, there is a chance that the disinfectant used to control microbial growth could be introduced directly into the vascular system of the patient. The disinfectants most commonly used for reprocessing hemodialyzers include formaldehyde, glutaraldehyde and peracetic acid-hydrogen peroxide. These chemicals are unpleasant to work around and can be hazardous to both the healthcare worker and the patient in the event of exposure. Biomedical Development Corporation has developed a unique, non- toxic disinfectant that is biocidal against a broad spectrum of organisms. Preliminary studies demonstrate that this disinfectant is effective, non- toxic, non-irritating, non-sensitizing, pleasant to work around, and inexpensive to produce. This study will determine the feasibility of using the disinfectant for reprocessing hemodialyzers, thereby reducing the morbidity and mortality associated with exposure to currently used reprocessing disinfectants. PROPOSED COMMERCIAL APPLICATIONS: Over 300,000 patients in the U.S. undergo dialysis treatment each year at a cost of approximately 15.64 billion dollars. For economic reasons, hemodialyzers used for treatments are reprocessed for reuse using formaldehyde, glutaraldehyde or peracetic acid-hydrogen peroxide. This unique, non-toxic disinfectant provides a safe alternative to current hemodialyzer disinfectant products that are dangerous to patients and healthcare workers, unpleasant to work around, and environmentally unsound.
