The Food and Drug Administration should regulate medical devices―not hospitals

摘要

Issues concerning the reuse of medical devices labeled for single-use only are indeed controversial. To further complicate matters, the Food and Drug Administration (FDA) regulations are not only applicable to third-party reprocessors but also to those hospitals that have been reprocessing (cleaning, disinfecting, and sterilizing) them in-house. The agency has now expressed serious concerns about how many hospitals have been sterilizing open but unused (OBU) single-use devices (SUDs). The question to be answered is whether there is sufficient justification for the FDA to impose their regulations on those hospitals that have the capability of reprocessing used or OBU SUDs in-house.