FDA approves nonsurgical balloon device for bariatric patients
Editor's Note The Food and Drug Administration on July 28 approved a new balloon device to treat obesity without the need for a surgical procedure. The ReShape Integrated Dual Balloon System (ReShape Medical Inc, San Clemente, California) is inserted into the stomach endoscopically and then filled with saline. Patients are…
Senate bill would let Medicare patients self-pay for medical devices
Editor's Note Four US Senators (two democrats, two republicans) are sponsoring legislation—The Accelerating Innovation in Medicine (AIM) Act—that would increase Medicare patients’ access to new medical devices. Currently, Medicare patients who are interested in self-paying for a device not covered by Medicare face significant administrative obstacles. Under AIM, once a…
Baxter recalls two lots of 0.9% sodium chloride injection
Editor's Note Baxter International Inc has announced a recall of two lots of 0.9% sodium chloride injection, USP, 50 mL and 100 mL, because of the presence of particulate matter. The lot numbers are P319921 and P327635. The particulate matter was determined to be an insect and was identified as…
FDA: Class I recall of Medtronic’s Covidien Shiley pediatric trach tubes
Editor's Note The Food and Drug Administration on June 15 issued a Class I recall, the most serious, of certain Covidien Shiley neonatal and pediatric tracheostomy tubes by Medtronic. The recalled tubes were formed with a wider-angle bend than standard models. The company has received reports that patients switching tubes…
FDA issues draft guidance on requirements for surgical gowns
Editor's Note The Food and Drug Administration has issued a draft guidance to describe its premarket regulatory requirements and performance testing needed to support liquid barrier claims for gowns used in health care settings. In the past, a number of terms have been used to refer to gowns intended for…
FDA: Class I recall of Maquet FLOW-I Anesthesia Systems
Editor's Note The Food and Drug Administration on July 1 issued a Class I recall, the most serious, of FLOW-I Anesthesia Systems by Maquet. Maquet has received 10 reports of patient cassettes (ie, the center of gas flow in the system) coming loose. The cassette locking device may accidentally release…
First step taken in FDA-issued unique device identification system
Medical device manufacturers have taken the first step in complying with the 7-year unique device identification (UDI) process mandated by the Food and Drug Administration (FDA). The UDI system establishes a consistent way to label and track medical devices from production to use, and is intended to improve patient safety…
FDA, Joint Commission cite safety concerns with power morcellation
Reports about problems associated with power morcellation in gynecologic surgery led to safety warnings in November 2014 by the Food and Drug Administration (FDA) and the Joint Commission. The FDA on November 24 updated its Safety Communication on the use of laparoscopic power morcellation in hysterectomies and myomectomies. The previous…
FDA issues Unique Device Identification final rule
The Food and Drug Administration (FDA) on September 24 published the final rule for its Unique Device Identification (UDI) system to provide a consistent way to identify medical devices throughout their distribution and use. “A UDI system for medical devices is an important step towards increasing patient safety, modernizing postmarket…
ORs could see benefits from FDA's UDI system
Your OR could see real benefits from the Food and Drug Administration’s (FDA) proposed unique device identification (UDI) system. But will your systems be ready to capture, record, and retrieve UDI information? Comments on the FDA’s UDI proposed rule are due by November 7, 2012. The proposal was published July…
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