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Single-use medical device reprocessing refers to cleaning, disinfection, testing, sterilization, and remanufacturing of a used medical device to be put in service again. The reuse of single-use medical devices first began in the late 1970s. According to the Centers for Disease Control and Prevention (CDC), around 20 to 30% of the U.S. hospitals reported having reused at least one type of single-use device. The reuse of single-use devices involves ethical, regulatory, legal, medical, and economic issues, which have faced controversy in the last two decades. The reuse of single-use medical devices has increased typically due to the COVID-19 pandemic outbreak.
In general, there are two categories of products that can be reused: active and inert. Active products are required for making new products, while inert products are used for making old products stronger, newer, longer-lasting, and more effective. The useful products that are generated are called inert products. These are products that have a certain amount of value because of their function. They are available in different forms like paper, paperboard, metals, plastic, etc. These products can either be reclaimed from the environment, or produced by industries and used for manufacturing purposes. The mobile devices that need to be recycled for single-use medical device reprocessing include diagnostic devices, sterilization equipment, biopsy instruments, blood glucose analyzers, blood pressure monitors, disposable gloves, medical imaging devices, and many more.
These are the most important and widely used devices. There are so many reasons behind the use of such mobile medical equipment. It is important to note that reused single-use devices will have to comply with the same regulatory requirements when it was originally manufactured. Furthermore, every country has its unique regulatory guidelines regarding single-use medical device reprocessing. For instance, in the U.S., the Food and Drug Administration (FDA) releases guidelines on how single-use medical devices should be reused and how they should be reprocessed. Many companies in the Drug Administration U.S., Italy, and Singapore are focused on introducing novel procedures to reuse single-use medical devices.