Strong Regulation Reduces Cost, Waste

Thanks to strict regulation from the U.S. Food and Drug Administration (FDA), the reprocessing of medical devices labeled for “single use” has been standard practice in the United States for over two decades. The European Union and other regulatory bodies have followed suit so that reprocessing is federally regulated in the United Kingdom, Germany, and over a dozen other countries.

Prior to regulations on reprocessing, “single-use” devices (SUDs) were often cleaned and reused within hospitals – a practice that still takes place wherever strict regulations do not exist. Commercial reprocessors partner with hospitals and surgical suites to provide lower costs and environmentally superior options, with no increased risk to patient safety.

Commercial reprocessors that agree to follow a code of conduct and become members join the Association of Medical Device Reprocessors (AMDR). AMDR represents regulated, commercial reprocessing; promotes reprocessing as an important strategy to reduce cost, waste, and greenhouse gas emissions; and protects the interests of its members in regulation, legislation, and standard-setting worldwide.

AMDR continues to push the medical technology industry and lead the way for reprocessing to play a defining role in the evolution and use of new device technologies that lower costs and environmental impact.

Because of AMDR’s leadership, reprocessing of regulated medical devices labelled for “single-use” is the best example of government working with industry to reduce cost, waste, and greenhouse gas emissions in the health sector.

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