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 ...
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 ...
WASHINGTON--(BUSINESS WIRE)--A new report from The U.S. Department of Health and Human Services (HHS), issued by the Agency for Healthcare Research and Quality (AHRQ), urges hospitals to reprocess ...
Of the literature cited by reprocessors to support SUD reuse, few documents, if any, provide indisputable evidence of the safety of reprocessing. David N. Cowan, Stephen O. Cunnion, and Tina M. Swift ...
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 ...
Late last month, FDA's Center for Devices and Radiological Health (CDRH; Rockville, MD) issued updated guidance on the reprocessing of single-use devices (SUDs). Under the new guidelines, reprocessors ...
This article is written by Jason Wandersee, CEO of MEDISISS, a Medline-owned reprocessing company. MEDISISS is the leader in reprocessing to surgery centers throughout the United States since 1997.By ...
STEMart now offers Reprocessing Validations services in accordance with ISO, AAMI and ASTM standards to validate reprocessing instructions for reusable devices. The full range of medical device ...
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