Single-use device reprocessing companies. How to choose.
Now that the U.S. Food and Drug Administration (FDA) has come out with its final policy on reusing single-use medical devices (SUDs), many hospitals are reviewing their options concerning reuse. Because FDA's policy imposes a whole new set of burdens on U.S. facilities that reprocess SUDs, a number of those hospitals will undoubtedly decide that they don't want to support an in-house reprocessing program anymore. Some hospitals will turn to third-party reprocessing companies to take on this burden for them. But choosing a reprocessor isn't as simple as looking up a name in the phone book. It's vital that a reprocessor be able to handle the devices that the hospital wants to reprocess (not all companies reprocess all devices). It's also vital that the company have policies and procedures in place that will allow it to provide dependable, high-quality service. And it's vital that the hospital be comfortable with the company or companies that it chooses. This article outlines the issues you need to examine when choosing a third-party reprocessing company. It also includes a checklist that you can use to judge each company under consideration.
D004209:Disposable Equipment / Q000592:standards*; D017743:Equipment Reuse / Q000592:standards*; D017408:Guidelines as Topic; D007221:Industry; D013242:Sterilization / Q000592:standards; D014481:United States; D014486:United States Food and Drug Administration