Reprocessing of Single Use Medical Devices (SUDs)
The reprocessing of single-use devices (SUDs) has taken the health care world by storm in recent years. It’s really a pretty basic concept. Many medical devices are labeled “single use,” which, under FDA criteria, means that they are to be discarded after one use. It was pretty clear that many devices were good for one or more additional uses after being properly reprocessed, but one would have to obtain specific FDA approval to so do. A couple of entrepreneurial folks decided to apply to FDA for such approvals, then market their reprocessing services to the health-care industry. A fine idea, which has met with great success.
Sally Lee, in her former value analyst role, was instrumental (pun intended) in bringing reprocessing to UC Davis Medical Center. We started with so-called Category III (non-invasive) devices, such as Alternative Leg Pressure (ALP) sleeves and blood pressure cuffs. Our initial reprocessing vendor, Hygia (who reprocesses only Cat III devices) set up collection stations in appropriate areas, from which the Hygia representative periodically collects the used devices for shipment to the reprocessing facility. So far, we have diverted these devices from the waste stream, which saves us a small amount of money. But the reprocessing advantage is yet to come.
The reprocessing companies offer the reprocessed devices for sale back to the health system at a fraction of the cost of the original equipment, a significant savings for us. One can see that many manufacturers of SUDs aren’t particularly happy with this arrangement, and attempt to structure contracts in a manner that minimizes the advantage of purchasing SUDs.
The big step in reprocessing came in January 2012, when Stryker Sustainability (formerly Ascent) came on board to reprocess invasive SUDs from the operating rooms and the electrophysiology lab. This opened up significant opportunities in both waste diversion and purchasing of reprocessed devices. Stryker’s process is similar to that of Hygia’s, in which the representative sets up the collection process, gathers the filled containers and ships them back to their reprocessing plant. All we have to do is inservice staff so they know which items go to the reprocess container instead of the medical waste container. This process has turned out to be a great success, due to the efforts of Sally Lee, Operating Room Staff Educator Carrie Westlake and the Stryker representatives.
The Infection Prevention Committee approves only specific reprocessed devices for purchase. The revised (not yet published as of December, 2012) Hospital P&P 2110 will state: “Single use devices are not re-used unless: The device has been reviewed/approved by the Infection Prevention Committee and after sterilization by a third party vendor.” Approximately two dozen devices were cleared by the committee at their October 17, 2012 meeting, and are listed on Attachment 1 to P&P 2110. Staff members only: view Hospital P&P 2110.
Even with these limitations, the cost savings to the health system have been significant. For FY 11-12, we saw about $200,000 in savings; as the Stryker invasive SUD program will be in place for all of FY 12-13, I expect reprocessing-related savings to approach $600,000. Consider that Kaiser reports an $11 million systemwide savings via reprocessing, and you can be confident that reprocessing is here to stay.