Reprocessing Single-Use Devices, FDA Oversight Has Increased, and Available Information Does Not Indicate That Use Presents Elevated Health Risk
“…After reviewing the available evidence—including FDA’s process for identifying and investigating device-related adverse events reported to involve reprocessed SUDs, peer-reviewed studies published since 2000, and the results of our and FDA’s consultations with hospital representatives—we found no reason to question FDA’s analysis indicating that no causative link has been established between reported injuries or deaths and reprocessed SUDs. That is, the available information regarding safety, while not providing a rigorous safety comparison between reprocessed SUDs and other devices, does not indicate that reprocessed SUDs currently in use pose an increased safety threat.”