Single use medical device reprocessing
Single-use medical device reprocessing is the disinfection, cleaning, remanufacturing, testing, packaging and labeling, and sterilization among other steps, of a used,, 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 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", 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. In addition, AMDR advocates for reprocessing for benefits including reduced costs, waste, greenhouse gas 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 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 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.
Commonly reprocessed SUDs
Commonly reprocessed medical devices include lower-risk, U.S. FDA Class I non-invasive devices such as sequential compression sleeves, tourniquet cuffs, pulse oximeter sensors, infusor bags, EKC and ECG leads and cables, and fall alarms to medium-risk, FDA Class II minimally invasive surgical devices including cautery electrodes, laparoscopic graspers, scissors, forceps, scalpels, orthopedic blades, bits, burs, external fixation clamps, bolts and components, and electrophysiological cardiac catheters. To date, the FDA has not approved for reprocessing any Class III, or higher risk, SUDs.Safety and efficacy of reprocessed SUDs
The Food and Drug Administration and the independent U.S. Government Accountability Office have concluded that there is no evidence of harm to patients from FDA-regulated reprocessed SUDs. A 2008 GAO report found that of the over 320,000 adverse events filed with FDA between 2000 and 2006, only 65 adverse events "actually involved or were suspected to involve a reprocessed SUD and that the reprocessed SUD was one of several possible causal factors in the adverse event. In reviewing these 65 reports, FDA found that the types of adverse events reported to be associated with the use of reprocessed SUDs were the same types of events that were reported for new devices". The 2008 GAO report concluded: "After reviewing the available evidence – including FDA's process for identifying and investigating device-related adverse events reported to involve reprocessed SUDs, peer-reviewed studies published since 2000, and the results of our and FDA's consultations with hospital representatives – we found no reason to question FDA's analysis indicating that no causative link has been established between reported injuries or deaths and reprocessed SUDs".In a separate letter from FDA to Congressman Tom Davis and Harry Waxman dated January 23, 2006, FDA indicated that a total of 65,325 reports have been filed between 2003 and 2006 for the malfunction or injury associated with the first use of devices labeled for "single use". The same search produced 176 cases of apparent malfunction or injury associated with reprocessed devices. Upon analysis of the latter reports, FDA determined that these adverse events were not related to the reprocessing of the "single use" device.
Although some studies have shown that certain single use devices are not conducive to the initial cleaning required to achieve sterility via validated methods, these studies tend to be funded by the OEM which has a vested interest in sullying the reputation of reprocessed devices. The chain of custody for the reprocessed devices studied usually runs through the OEM, raising questions about the validity of the studies.
Notably, one 2015 study found that, due in part to the rigorous function testing conducted by professional reprocessing companies, reprocessed devices have lower failure rates than original, non-reprocessed or "virgin" devices.
Benefits of reprocessing
Economic
FDA-regulated reprocessed devices cost between 25% and 40% of an original device. Currently, reprocessors estimate that a typical 200-bed hospital, if taking advantage of a reprocessor's full product line, can save between $600,000 and $1 million a year and divert between 5,000 and 15,000 pounds of waste from landfills. According to a study by The Commonwealth Fund with funding from the Robert Wood Johnson Foundation and Health Care Without Harm in November 2012, they estimated that from hospitals implementing a reprocessing program, cost savings over five years was about $57 per procedure, and that if hospitals nationwide adopted an SUD reprocessing intervention, cost savings would be $540 million annually, or $2.7 billion over five years. AMDR data shows that, in 2021, hospitals and surgical centers that reprocessed with AMDR member reprocessors saved more than $462 million on device costs and more than $6 million on waste disposal costs.Greenhouse gas emissions
Research has shown that the use of reprocessed devices can significantly reduce greenhouse gas emissions. For example, a 2021 life cycle assessment of reprocessed electrophysiology catheters found that reprocessing reduced ozone depleting emissions by nearly 90%, and climate change specific emissions by over 50% compared with using an original device. Additionally, research has examined the development of green economic models within the reprocessing industry, such as servitization.As the healthcare sector accounts for nearly five percent of global GHG emissions, regulatory agencies including the UK's National Health Service and the US Agency for Healthcare Research and Quality and policy-makers have advocated for reprocessing as part of broader strategies to meet emissions reductions targets.