Which organization regulates the reprocessing of single-use medical devices?

• A. Food and Drug Administration (FDA)
• B. Centers for Disease Control and Prevention (CDC)
• C. National Institutes of Health (NIH)
• D. Environmental Protection Agency (EPA)

Answer: (A)

The reprocessing of single-use medical devices falls under regulatory oversight to ensure patient safety when a device is cleaned, sterilized, and reused. The agency responsible is the Food and Drug Administration. The FDA oversees medical devices, including the processes used to reprocess them, and requires reprocessors to meet the same quality and safety standards as original manufacturers. This includes registration and listing of facilities, adherence to quality system regulations, and validated methods for cleaning, sterilization, inspection, and testing of reprocessed devices before they’re used again. The CDC, NIH, and EPA handle infection prevention guidelines, research, and environmental issues, respectively, but they do not regulate the reprocessing of medical devices.