The US healthcare system produces 5 million tonnes of waste each year. Or about 29 pounds per hospital bed every day. Approximately 80% of the healthcare industry's carbon footprint comes from the production, transportation, use and disposal of single-legged devices (SUDS) spread across hospitals. In particular, 95% of the environmental impact of disposable medical products is due to the production of these products.
The Food and Drug Administration (FDA) oversees new devices that are on the market, but it is up to the manufacturer to determine whether the device will be sold as disposable or for multiple uses. Manufacturers have financial incentives for sale devices for “disposable” or “disposable” to market reusable devices.
To reduce healthcare waste and environmental impact, the FDA has led to identifying reusable devices that can be safely reprocessed and encouraging manufacturers to test device reprocessing. Masu. This requires FDA to enhance its management of labeling disposable and reusable devices. Additionally, the country's largest healthcare system, the Veterans' Health Bureau, should reverse the ban on reprocessed SUDS and become the national leader in reprocessing medical devices.
Challenges and opportunities
Healthcare organizations have adopted decarbonization and waste reduction plans, but they cannot do this effectively without addressing the major impacts of disposable devices (SUDS). The majority of the research literature concludes that SUDs are associated with higher levels of environmental impact than reusable products.
FDA regulations governing SUD reprocessing make it extremely difficult for hospitals to reprocess low-risk SUDs. This contradicts the FDA's “lowest burdensome provision.” The FDA requires hospital or commercial SUD reprocessing facilities to act as a device manufacturer. This means that you must assume the relevant liability in accordance with FDA regulations regarding medical device manufacturer requirements. While hospitals are not keen to assume the responsibility of manufacturers, commercial reprocessing does not provide many low-risk devices that can be reprocessed.
As a result, hospitals and clinics are able to administer SUDS in methods such as autoclaving, despite documents indicating that sterilization is safe and that similar devices have been safely sterilized and reused over many years without adverse events. I don't want to sterilize it. Many devices, including pessaries for pelvic organ prolapse and tips for titanium lens breasts for cataract surgery, can be safely reprocessed for clinical use. These products do not need to be subject to the requirements of a complete FDA medical device manufacturer, given their risk profile.
Additionally, manufacturers are encouraged to bring SUDs to the market faster than they could be reprocessed. Manufacturers often sell devices as a single use, not only because the original manufacturer chose not to perform expensive cleaning and sterilization verification. The FDA regulations governing SUD should be well tailored to each device to ensure that frontline clinicians can provide appropriate and environmentally sustainable healthcare.
Reprocessed devices will cost 25-40% less. Therefore, the use of reprocessed SUDS can significantly reduce hospital costs – approximately $465 million in 2023. According to the Medical Device Re-Inspection Association, if reprocessing practices of top 10% performers are maximized in all hospitals using reprocessed devices, US hospitals will have an additional 2.2 billion in the same year. It could have saved $80 million. In fact, enabling and encouraging the use of reprocessed SUDs can result in significant cost savings without compromising patient care.
Action Plan
As FDA began regulating SUD reprocessing in 2000, it has been clearly and streamlined to ensure the safety and effectiveness of reprocessed devices by FDA to clear or approve reusable devices. It is essential to create a process. These recommendations allow the healthcare system to reprocess and reuse medical devices without fear of violations by the Joint Committee responding to FDA regulations or the Centers for Medicare and Medicaid Services. Additionally, the country's largest healthcare system, the Veterans' Health Administration, must become a leader in reprocessing medical devices and lead in introducing standards of practice for sustainable healthcare.
The FDA should publish a list of SUDSs with a proven track record of safe reprocessing to enable hospitals to reduce waste, costs and environmental impacts without compromising patient safety. The FDA is reusable by hospitals and requires multipurpose labeling of single-use devices when verified via clinical research. This is because it promoted the false belief that SUDs cannot be safely reprocessed. According to the FDA, disposable labeling means that a particular device has not undergone the original equipment manufacturer (OEM) verification tests required to label a device as “reusable.” Labels do not mean that you cannot clear the device for reprocessing. To help governments and health systems prioritize the environmental and cost benefits of reusable devices over SUDS, the FDA has announced that it has the potential to reusable or commercially reprocessable devices, such as rapid reviews. Applications should be encouraged. The FDA can also encourage the use of reprocessed devices through payments to hospitals to meet reprocessing benchmarks. The FDA should not target low-risk devices that can be safely reprocessed for clinical use in full device manufacturer requirements. The FDA should further encourage medical procurement staff by creating an accessible database of cleared devices to reprocess and alert health care systems about regulated reprocessing options. In doing so, the FDA will help reduce the burden on hospitals in reprocessing low-risk SUDS and encourage healthcare systems to sterilize SUDS via methods such as autoclaving. As the only major health system in the United States to ban the use of reprocessed SUDs, the U.S. Veterans Health Bureau should reverse that ban as soon as possible. This ban is likely to remain for outdated decisions of risk, and is costly for the environment and for the Americans. Doing so would be consistent with the FDA's conclusion that reprocessed SUDs are safe and effective. The FDA should recommend that manufacturers publish the materials used in device configurations so that end users can compare products more easily and determine the environmental impact of the device. As explained by AMDR, the practices of some original equipment manufacturers (OEMs) prevent or completely from using reprocessed devices. It is essential that the FDA vigorously track and block these practices. Not only will it require configuration of public reporting devices, it will help healthcare buyers make more informed decisions, but it will also promote a more circular economy that will increase sustainability efforts It is also useful for.
Conclusion
To reduce costs, waste and environmental impact, the healthcare sector must urgently increase the use of reusable devices. One of the biggest barriers is the FDA requirements that bring unnecessarily stringent requirements for hospitals, preventing adoption of wasteful, less expensive, reprocessed devices.
The FDA's important role in labeling, clearing, or approving medical devices is to reuse more devices, including the Centers for Medicare & Medicaid Services (CMS), the Association for Advancement in Medical Devices, and others. It affects and affects many regulatory and oversight agencies. (AAMI), Joint Committee, Hospitals, Medical Institutions, and Healthcare Providers. It is essential that FDA step up and lead the revising of device reprocessing pipelines.
This action-enabled policy memo is part of the first day 2025. Efforts to bring bold science-based policy ideas can address the nation's greatest challenges and bring us all closer to a fair and safe future, with us all thriving. Hope for someone to take office after 2025.
