AMDR is the global trade association consisting of members of the commercial single-use device reprocessing and remanufacturing industry. AMDR represents commercial reprocessing, promotes reprocessing as an important healthcare strategy that helps hospitals and healthcare providers increase quality, reduce costs and improve patient care, and protects the interests of its members in regulation, legislation and standard-setting world-wide. Having played a key role in the establishment of the reprocessing industry, AMDR continues to push the medical technology industry and lead the way for reprocessing to play a defining role in the evolution and utilization of new device technologies…..
AMDR members must agree to support and abide by the AMDR Bylaws, Mission Statement, Credo, Antitrust Policy, and Code of Conduct, as adopted by the Board. AMDR members strive to achieve the highest possible standards of quality, including abiding by laws, regulations or other requirements that ensure, for our healthcare provider partners and their patients, that reprocessed and remanufactured products are safe and effective….
The Joint Commission International (JCI) is a well-respected organization and we know that hospitals look to JCI Resources for guidance. The subject of single-use device (SUD) reprocessing can be complex and we share JCI’s goal to provide helpful resources to international hospitals on the subject. However, while perhaps unintentional, we believe the paper inaccurately intermingles the concepts of unregulated hospital reuse of single-use devices with regulated, commercialized reprocessing of single-use devices. AMDR sent the attached letter to JCI outlining our concerns and we urge those who may have sought guidance from JCI on the SUD reprocessing issue to also review our responsive comments.
The U.S. Food and Drug Administration issued a recall of reprocessed Agilis Steerable Introducers from SterilMed, a unit of Johnson & Johnson, on product lots manufactured between January 1 and May 5, 2017. Agilis Introducer Sheaths reprocessed by AMDR member companies Innovative Health, Stryker Sustainability Solutions and Vanguard AG are NOT the subject of this recall and remain on the market.
“….You’re doing all you can to reduce your expenses, but then a vendor shows up in the operating room with a ‘surprise’ implant. Or an expensive piece of technology breaks down, and you have to call in the vendor to repair it. Ambulatory surgery programs are getting creative in how to address these problems, which can blow up your budget before your year has barely begun… Columnist Steve Earnhart has 10 money-related ideas… including how to save money by reprocessing single-use devices…..”
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Most hospitals reprocess single-use devices (SUDs) to maximize savings and divert medical waste from landfills. Some device companies bundle new and reprocessed SUDs as ‘comprehensive or circular device programs,’ claiming to offer consistent, predictable supply and pricing. However, these bundled programs can negatively impact your savings and waste reduction potential.
In the United States, where reprocessing has been regulated for over a decade, a number of different sources have confirmed the significant cost-savings hospitals achieve through reprocessing select “single-use” medical devices (SUDs). Hospitals not only save about 50% for every reprocessed device they purchase and spend less on waste disposal, they also…
AMDR’s “best clinical practice” document provides information on reprocessing including legal, regulatory and historic details and how SUD reprocesing has become a best practice for most American hospitals.