Reprocessing single-use medical devices.

Abstract

Health care providers today often can choose between reprocessed single-use devices (SUDs) or SUDs from original equipment manufacturers. The concern about whether reprocessing is safe and should continue was reflected in the US Food and Drug Administration's draft regulations regarding reprocessing and reuse of SUDs; the Government Accounting Office study on SUDs; legislation introduced at both the federal and state levels; and Congressional hearings by the US House of Representatives and the US Senate. This article offers a review of these activities.