Supporting Device Reprocessing to Reduce Waste in Health Care
The U.S. healthcare system produces 5 million tons of waste annually, or approximately 29 pounds per hospital bed daily. Roughly 80 percent of the healthcare industry’s carbon footprint comes from the production, transportation, use, and disposal of single-use devices (SUDs), which are pervasive in the hospital. Notably, 95% of the environmental impact of single-use medical products results from the production of those products.
While the Food and Drug Administration (FDA) oversees new devices being brought to market, it is up to the manufacturer to determine whether a device will be marketed as single-use or multiple-use. Manufacturers have a financial incentive to market devices for “single-use” or “disposable” as marketing a device as reusable requires expensive cleaning validations.
In order to decrease healthcare waste and environmental impact, FDA leads on identifying reusable devices that can be safely reprocessed and incentivizing manufacturers to test the reprocessing of their device. This will require the FDA to strengthen its management of single-use and reusable device labeling. Further, the Veterans Health Administration, the nation’s largest healthcare system, should reverse the prohibition on reprocessed SUDs and become a national leader in the reprocessing of medical devices.
Challenge and Opportunity
While healthcare institutions are embracing decarbonization and waste reduction plans, they cannot do this effectively without addressing the enormous impact of single-use devices (SUDs). The majority of research literature concludes that SUDs are associated with higher levels of environmental impact than reusable products.
FDA regulations governing SUD reprocessing make it extremely challenging for hospitals to reprocess low-risk SUDs, which is inconsistent with the FDA’s “least burdensome provisions.” The FDA requires hospitals or commercial SUD reprocessing facilities to act as the device’s manufacturer, meaning they must follow the FDA’s rules for medical device manufacturers’ requirements and take on the associated liabilities. Hospitals are not keen to take on the liability of a manufacturer, yet commercial reprocessors do not offer many lower-risk devices that can be reprocessed.
As a result, hospitals and clinics are no longer willing to sterilize SUDs through methods like autoclaving even despite documentation showing that sterilization is safe and precedent showing that similar devices have been safely sterilized and reused for many years without adverse events. Many devices, including pessaries for pelvic organ prolapse and titanium phacoemulsification tips for cataract surgery, can be safely reprocessed in their clinical use. These products, given their risk profile, need not be subject to the FDA’s full medical device manufacturer requirements.
Further, manufacturers are incentivized to bring SUDs to market quicker than those that may be reprocessed. Manufacturers often market devices as single-use solely because the original manufacturer chose not to conduct expensive cleaning and sterilization validations, not because such cleaning and sterilization validations cannot be done. FDA regulations that govern SUDs should be better tailored to each device so that clinicians on the frontlines can provide appropriate and environmentally sustainable health care.
Reprocessed devices cost 25 to 40% less. Thus, the use of reprocessed SUDs can reduce costs in hospitals significantly — about $465 million in 2023. Per the Association of Medical Device Reprocessors, if the reprocessing practices of the top 10% performing hospitals were maximized across all hospitals that use reprocessed devices, U.S. hospitals could have saved an additional $2.28 billion that same year. Indeed, enabling and encouraging the use of reprocessed SUDs can also yield significant cost reductions without compromising patient care.
Plan of Action
As the FDA began regulating SUD reprocessing in 2000, it is imperative that the FDA take the lead on creating a clear, streamlined process for clearing or approving reusable devices in order to ensure the safety and efficacy of reprocessed devices. These recommendations would permit healthcare systems to reprocess and reuse medical devices without fear of noncompliance by the Joint Commission or Centers for Medicare and Medicaid Services that reply on FDA regulations. Further, the nation’s largest healthcare system, the Veterans Health Administration, should become a leader in medical device reprocessing, and lead on showcasing the standard of practice for sustainable healthcare.
- FDA should publish a list of SUDs that have a proven track record of safe reprocessing to empower hospitals to reduce waste, costs, and environmental impact without compromising patient safety. The FDA should change the labels of single-use devices to multi-use when reuse by hospitals is possible and validated via clinical studies, as the “single-use” label has promoted the mistaken belief that SUDs cannot be safely reprocessed. Per the FDA, the single-use label simply means a given device has not undergone the original equipment manufacturer (OEM) validation tests necessary to label a device “reusable.” The label does not mean the device cannot be cleared for reprocessing.
- In order to help governments and healthcare systems prioritize the environmental and cost benefits of reusable devices over SUDs, FDA should incentivize applications of reusable or commercially reprocessable devices, such as through expediting review. The FDA can also incentivize use of reprocessed devices through payments to hospitals for meeting reprocessing benchmarks.
- The FDA should not subject low-risk devices that can be safely reprocessed for clinical use to full device manufacturer requirements. The FDA should further encourage healthcare procurement staff by creating an accessible database of devices cleared for reprocessing and alerting healthcare systems about regulated reprocessing options. In doing so, the FDA can help reduce the burden on hospitals in reprocessing low-risk SUDs and encourage healthcare systems to sterilize SUDs through methods like autoclaving.
- As the only major health system in the U.S. to prohibit the use of reprocessed SUDs, the U.S. Veterans Health Administration should reverse its prohibition as soon as possible. This prohibition likely remains because of outdated determinations of risks, which comes at major costs for the environment and Americans. Doing so would be consistent with the FDA’s conclusions that reprocessed SUDs are safe and effective.
- FDA should recommend that manufacturers publicly report the materials used in the composition of devices so that end-users can more easily compare products and determine the environmental impact of devices. As explained by AMDR, some Original Equipment Manufacturer (OEM) practices discourage or fully prevent the use of reprocessed devices. It is imperative that the FDA vigorously track and impede these practices. Not only will requiring public reporting device composition help healthcare buyers make more informed decisions, it will also help promote a more circular economy that uplifts sustainability efforts.
Conclusion
To decrease costs, waste, and environmental impact, the healthcare sector urgently needs to increase its use of reusable devices. One of the largest barriers is FDA requirements that result in needlessly stringent requirements of hospitals, hindering the adoption of less wasteful, less costly reprocessed devices.
FDA’s critical role in medical device labeling, clearing, or approving more devices as reusable, has down market implications and influences many other regulatory and oversight bodies, including the Centers for Medicare & Medicaid Services (CMS), the Association for the Advancement of Medical Instrumentation (AAMI), the Joint Commission, hospitals, health care offices, and health care providers. It is essential for the FDA to step up and take the lead in revising the device reprocessing pipeline.
This action-ready policy memo is part of Day One 2025 — our effort to bring forward bold policy ideas, grounded in science and evidence, that can tackle the country’s biggest challenges and bring us closer to the prosperous, equitable and safe future that we all hope for whoever takes office in 2025 and beyond.
While healthcare institutions are embracing decarbonization and waste reduction plans, they cannot do this effectively without addressing the enormous impact of single-use devices.
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