U.S. Senator Orrin Hatch (R-Utah), Ranking Member of the Committee on Finance, today announced an amendment to S. 3187, the Food and Drug Administration Safety and Innovation Act, to repeal the job-killing medical device tax that was included in the $2.6 trillion health spending law enacted last year.
Moog Medical Devices Group (MMDG) is issuing a voluntary recall for certain lots of Curlin Intravenous Administration Sets. Use of the affected sets may cause desanguination (blood loss), an under-delivery of prescribed medication/fluid, or a potential delay in therapy. Continued use of the affected administration sets may cause a potential risk of serious injury or death.
The following REF (catalog) and lot numbers, which were sold and distributed in the U.S. between December 2011 and May 2012, are included in the recall:
TriReme Medical, Inc. (TMI) today announced approval by the U.S. Food and Drug Administration (FDA) of the Glider PTCA Catheter, indicated for treating the stenotic portion of coronary arteries or bypass grafts to improve myocardial perfusion.
Glider is the world's only torqueable PTCA balloon catheter. Combined with its state of the art tip technology, Glider is designed to perform, even in the most challenging conditions. It is also available in an ultra short balloon length of 4mm designed for focal lesions.
The POWERWAND (from Access Scientific Inc., San Diego), an extended-dwell peripheral IV catheter (PIV), substantially outperforms other catheters in both patient satisfaction and safety, according to a presentation at the recent annual meeting of the Infusion Nurses Society (INS).
The presentation was by Teresa Darst, RN, Director of Vascular Access at Huguley Memorial Medical Center. Huguley (Burleson, Texas) was the first hospital in the nation to fully implement the new technology.
FDA is asking for public comments on the Institute of Medicine’s (IOM) new report, “Medical Devices and the Public’s Health: The FDA 510(k) Clearance Process at 35 Years.” FDA commissioned the report in September 2009.
Barger Packaging Inc., an affiliate of Welch Packaging Group Inc., has announced the addition of two professionals to its team. Brad Miller and Rob Haley will help support Barger’s growth and commitment to customers providing sterile and non-sterile thermoform packaging solutions to the medical device and pharmaceutical markets worldwide.
The Global Harmonization Task Force (GHTF) has released its proposal for a draft guidance on a Unique Device Identification (UDI) system that could be used around the world. The goal of the guidance is to provide a common global framework for identifying medical devices, which could facilitate recognizing recalled items and reporting specific devices involved in adverse events. Comments on the draft are welcomed through April 30.
TOPAS Advanced Polymers (Frankfurt, Germany) has introduced new resin technology for TOPAS cyclic olefin copolymer (COC) offering improved processability, high purity, and high heat resistance for applications in the medical and food industries.