Reprocessing single-use devices--regulatory roles

This is the third in a series of three articles about reprocessing medical devices labeled as "single use" by the manufacturer. The goal of reprocessing single-use devices (SUDs) is to save money and decrease environmental pollution. Reprocessing can be performed on SUDs that have been used on other patients or opened but not used. This article discusses the roles of the involved regulatory agencies and organizations guiding the process. The first article in the series, published in the May 2002 issue of the AORN Journal, discusses the ethical component of reusing SUDs. The second article, published in the June 2002 issue of the Journal, discusses the procedures for reprocessing (e.g., cleaning, inspecting, sterilizing, tracking, testing, validating) and establishing a reuse program.