AST Guideline - Environmental Practices in the Operating Room

11 Guideline VI The use of reprocessed SUDs is recommended to surgery departments to reduce the volume of RMW. Refer to the AST Standards of Practice on Single-Use Devices for additional details. 1. More than 60% of medical devices on the U.S. Food and Drug Administration’s list of SUDs known to be reprocessed or considered for reprocessing are used in the surgical treatment of patients. This presents a considerable benefit to ORs and ambulatory surgery centers (ASC) for reducing costs associated with the disposal of RMW and purchasing of new SUDs. 40 The savings is largely realized through the buying back of reprocessed devices often at 40-60% less than the original device. 24, 30 A. The 2002 Medical Device User Fee and Modernization Act (MDUFMA) defines a reprocessed SUD as any “original device that has previously been used on a patient and has been subjected to additional processing and manufacturing for the purpose of an additional single use on a patient.” 16, 41 Examples of SUDs that can be reprocessed and resold include blood pressure cuffs, laparoscopic surgical trocars, pulse oximeter probes, and sequential compression devices. 14 B. Twenty-five percent of the more than 6,000 U.S. HDOs and 2,700 ASCs report using at least one type of reprocessed SUD. 39 C. However, there have been barriers to implementing the use of reprocessed SUDs that revolve around patient safety issues including possible malfunction of reprocessed SUDs; risk of infectious diseases associated with reprocessing procedures; physicians expressing concerns as related to the use of reprocessed devices when the patient has not given consent for use of the device(s) when being treated. 17 (1) The federal government has addressed these concerns through various routes, but most importantly the passage of the 2002 MDUFMA requires all reprocessed SUDs to be labeled that includes the name of the reprocessing business. (2) Additionally, the U.S. Food and Drug Administration requires third party reprocessors to meet the same standards as the original equipment manufacturer (OEM). 39 Third-party reprocessors are required to clean, inspect, functionally test, package and sterilize SUDs as such that the device meets the same safe quality and performance functions when the device was first used. 24 (3) It is important to emphasize that OEMs frequently only test a few of the devices they manufacture, while third-party reprocessors test and inspect every device. 24 (4) In January 2008, the U.S. Government Accountability Office (GAO) released the report Reprocessed Single-Use Medical Devices: FDA Oversight Has Increased, and Available Information Does Not Indicate That Use Presents an Elevated Risk . A key section reported that reprocessed SUDS do not present an increased health risk to patients when compared with new, unused devices. 42 There were 434 adverse events reported to the