For patients suffering from severe asthma, the inability to properly manage symptoms using drug-based therapies such as inhaled corticosteroids (ICS) and long-acting beta-agonists (LABAs) may take the ...

An ECRI, a healthcare sector research firm focused on device safety testing, report found that some devices labelled as “single use” may be safely reused. The report found that while single-use ...

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 ...

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.

Single Pass Inc.’s Kronos Electrocautery device hit the U.S. market last Wednesday. The Lake Forest-based medical device maker said on April 29 that it received clearance from the Food and Drug ...

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 ...

Specialty polymers and advanced materials company Syensqo announced today the launch of a new medical-grade polyphthalamide (PPA). The glass-filled Amodel-branded polymer is engineered for advanced ...

COLUMBIA, Md.--(BUSINESS WIRE)--Ambu Inc., a rapidly growing medical device maker and pioneer of sterile, single-use endoscopes, introduced today a new single-use cystoscope. The Ambu® aScope™ 4 Cysto ...