Single-use medical device reprocessing is the disinfection, cleaning, remanufacturing, testing, packaging and labeling, and sterilization among other steps, of a used, (or, in some cases, a device opened from its original packaging but unused), medical device to be put in service again. All reprocessed medical devices originally labeled for single use in the United States are subject to U.S. Food and Drug Administration (FDA) manufacturing requirements and must meet strict cleaning, functionality, and sterility specifications prior to use.
Although first regulated in the U.S., the reprocessing of medical devices, particularly those that are labeled "Single Use Device" (SUDs), is now a global practice conducted with regulatory oversight in 19 countries. In 2017, the EU adopted a manufacturing regulatory paradigm, like the US, whereby SUD reuse is now held to the same standards as original equipment. In Europe, SUD reprocessing is often referred to as SUD remanufacturing. Some countries in Asia, Africa, and North America are actively engaged in reprocessing as well.
Currently, approximately 2% of all SUDs on the U.S. market are eligible for reprocessing by a qualified commercial vendor. Reprocessing industry estimates indicate the revenue saved by hospitals that use reprocessed devices to be $468 million in 2021, in addition to diverting over 20 million pounds of medical waste from landfills. Over 10,500 hospitals and surgical centers use reprocessed devices in the U.S., Canada, Israel, Germany, the United Kingdom, Jamaica and Japan, according to the Association of Medical Device Reprocessors (AMDR). In addition, AMDR advocates for reprocessing for benefits including reduced costs, waste, greenhouse gas (GHG) emissions and greater supply chain resilience.
History of reprocessing
The practice of reusing medical devices labeled for only one use began in hospitals in the late 1970s. After a thorough review by the U.S. FDA in 1999 and 2000, the agency released a guidance document for reprocessed SUDs that began regulating the sale of these reprocessed devices on the market, under the condition that third-party reprocessors would be treated as the manufacturer and would meet the same criteria as the original equipment manufacturers (OEMs) of the medical device. Following the implementation of FDA regulation, the U.S. Congress codified these standards and other requirements in the Medical Device User Fee Act of 2002. Since then, the practice of reprocessing has proliferated around the world, with countries devising their own, similar, regulatory frameworks.
As researchers, regulators, and other healthcare stakeholders have started to pay increasing attention to the environmental footprint of the health sector,the number of countries that regulate reprocessing and the body of research and media supporting the practice have grown.
The Single Use Label
When a manufacturer designs and develops a product, it determines the materials used and how the device is labeled. In the U.S., to market a device as "reusable", a manufacturer must provide increased data requirements and invest the resources necessary to demonstrate to FDA that the product can be safely reprocessed at the hospital level. Unlike reusable devices, single-use devices are not sold with instructions on how they can be properly cleaned and sterilized nor have they been validated or tested for exposure to cleaning or sterilization processes, including chemical exposure and heat.
However, the single use label does not mean that a device cannot be safely reprocessed, and over 300 kinds of SUDs have been approved for reprocessing by the FDA and other regulatory agencies around the world.
Hospital skepticism of the single-use label was noted in a 2000 U.S. Government Accountability Office (GAO) Report. According to the report, healthcare personnel “distrust the single-use label for some devices” because, among other things, the regulator “cannot require manufacturers to support the designation of a device as single-use,” and “they perceive that manufacturers have an economic incentive to market devices as single-use that could just as well be sold as reusable.”
Relatedly, Yale University research has shown that although healthcare providers and staff are interested in reprocessing, some OEMs have pursued strategies to discourage or outright prevent the practice. Health systems reported contractual stipulations by OEMs prohibiting the use of reprocessed devices as well as planned obsolescence in both the software and hardware (such as software chips or chemical coating that renders a device inoperable upon reprocessing).