Throughout the healthcare community, the reuse of medical products designated by original equipment manufacturers as single-use devices (SUDs) remains a controversial topic. In the reprocessing ...
Innovative Health, Inc. today announced that the company has received its 50th clearance from FDA to reprocess single-use medical devices used in electrophysiology and cardiology labs. This latest ...
WASHINGTON & BERLIN--(BUSINESS WIRE)-- Association of Medical Device Reprocessors issued the following statement: Friday’s unanimous verdict by a federal jury in Santa Ana, California for Innovative ...
In 2000, the FDA began to view and regulate all companies reprocessing single-use medical devices in the same way it viewed and regulated original equipment manufacturers (OEMs). Before returning ...
In 2000, when FDA led the U.S. to become the first country in the world to regulate the use of reprocessed single-use devices, the agency responded to concerns from manufacturers and physicians that ...
Jack Egnatinsky, MD, medical director of the AAAHC and a retired anesthesiologist, discusses what ASCs must do to meet AAAHC standards if they reprocess single-use devices and equipment. Dr. Jack ...
Every healthcare facility faces the same challenge: to reduce costs without sacrificing the delivery of quality care. As a result of dwindling healthcare reimbursements, and increased awareness of ...
The lifespan of medical devices is growing longer as more and more hospitals are turning to device reprocessing to cut costs, reduce waste and maximize potential use of these items. Millions of single ...
Title 21 of the U.S. Code, Section 321 (the Federal Food, Drug, and Cosmetic Act) includes the following definitions pertinent to the issues of single-use and the reprocessing of medical devices.
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