MedCity News February 20, 2024
FDA’s regulation of single-use device reprocessing effectively made the U.S. the leader in EP sustainability efforts early on. However, very little has been done to build on this early leadership.
In 2000, when FDA led the U.S. to become the first country in the world to regulate the use of reprocessed single-use devices, the agency responded to concerns from manufacturers and physicians that un-regulated re-use of single-use devices could compromise patient safety. Regulation meant that unsafe reprocessing in hospital sterile processing departments ceased—and that third-party reprocessing companies got a regulatory path for reprocessing so that hospitals could gain financial benefit from device re-use without compromising patient safety.
The regulation of reprocessing also—unintentionally—helped U.S. healthcare become more prepared to address climate...
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