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.
[2] In addition, AMDR advocates for reprocessing for benefits including reduced costs, waste, greenhouse gas (GHG) emissions[6] and greater supply chain resilience.
[9] 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.
[15] 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.
[19] 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.
The Food and Drug Administration (FDA) and the independent U.S. Government Accountability Office (GAO) have concluded that there is no evidence of harm to patients from FDA-regulated reprocessed SUDs.
[25] 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.
[31] A variety of otherwise reprocessable raw materials that end up in a hospital's RMW include stainless steel, aluminum, titanium, gold, polycarbonate and polyurethane.
[32] Worldwide, hospitals and surgical centers that used reprocessed devices diverted more than 20 million pounds medical waste from landfills in 2021.
Even in developed nations, including those that have reprocessing prohibitions in place, hospitals routinely reuse SUDs in an unregulated manner.
According to Article 17 of the Regulation (EU) 2017/745 (MDR) on medical devices, reprocessing is only possible if permitted by national law within individual Member States.
EU countries have the obligation to notify the European Commission of the national laws on reprocessing of single-use devices introduced by Article 17(3) of MDR.
Institutions, which want to reprocess single-use medical devices, must adopt and implement a quality management system according to DIN EN ISO 13485:2007.
Compliance with the quality management requirements is monitored annually by "Notified Bodies" that have been accredited by the Central Authority of the Länder for Health Protection with regard to Medicinal Products and Medical Devices (ZLG).
In the Middle East, available data indicates that reuse of SUDs is common throughout Arab countries (particularly for cardiac catheters), despite the absence of a regulatory framework.
[60] Israel does not have regulations in place specific to the reprocessing of SUDs, but as a general matter, medical devices must be registered with the Ministry of Health (MOH) before they can be sold in the country.
[67] Similar to the U.S., in Australia, all reprocessors (third-party, hospital, and OEM) must conform to medical device manufacturer requirements as regulated by the Therapeutic Goods Administration (TGA).
Health Canada since 2016, regulates reprocessed single-use devices from third-party companies as manufacturers, as with the US FDA, Europe and Japan.
[68] A number of provinces have adopted similar positions that allow for the reprocessing of SUDs if the third party reprocessor is regulated by the FDA.
[70] Alberta Health Services issued a policy in 2012 prohibiting the reuse and reprocessing of both critical and semi-critical single-use medical devices.