The European Commission this week issued regulations establishing common specifications for the reprocessing of single-use medical devices under the Medical Device Regulation (MDR). Under MDR, ...

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 ...

The Minnesota Department of Health has issued a memo to healthcare facilities regarding proper reprocessing of endoscopes. According to the memo, several healthcare facilities have contacted the ...

The Association for the Advancement of Medical Instrumentation and the FDA hosted the 2011 Medical Device Reprocessing Summit to discuss challenges of reprocessing reusable medical devices. 1. Define ...

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 ...

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 ...

Congress's investigative arm said yesterday that it will investigate the safety of using reconditioned medical devices designated for one-time use and the government's oversight of the practice. In a ...

Allow me to set the stage. Our plaintiff claims he felt a nagging pain in his shoulder for months and finally went to see the local orthopedic surgeon. The surgeon apparently informed him that the ...

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 ...