Results of an Active Controlled Clinical Simulated Use Study confirm that RMS High-Flo™ Subcutaneous Needle Sets are "safety sets," according to the manufacturer Repro-Med Systems, Inc., (REPR.PK) dba RMS Medical Products of Chester, N.Y. The U.S. Food and Drug Administration (FDA) has reviewed the protocol for the study. The needle sets are now known as RMS High-Flo™ Subcutaneous Safety Needle Sets.
"We had been confident from the beginning that the design of the butterfly wing closure on our High-Flo™ sets functionally encases the needle after use to protect against accidental needlesticks," said Andy Sealfon, President of RMS Medical Products. "Results of the study which encompassed more than 500 simulated administrations demonstrated there were no needlestick issues and no other safety issues," he added.
Leading nurses, pharmacists and other infusion health professionals attending the March 2012 Annual Conference of the National Home Infusion Association (NHIA) in Phoenix, AZ, participated in the study. Participants were asked to insert and remove the infusion needles, using inanimate materials to substitute for portions of the human anatomy.
The medical community has focused on the prevention of needlestick injuries with many published studies showing the benefits of needle safety devices (i.e., The New England Journal of Medicine, Feb. 16, 2012: Phillips, Conway, and Jagger – Letter to Editor), and the continued significance of legislation such as the federal government's Needlestick Safety and Prevention Act (NSPA).
"Needlestick prevention is critical and we're excited to confirm this safety feature in our subcutaneous needle sets," Sealfon said. "High-Flo™ has been praised by patients for consistent needle tip sharpness, unrivaled flow performance, and outstanding comfort due, in part, to butterfly wings designed to prevent the needle from 'popping out' after insertion. The safety designation complements an already superior design for the patient and health professional," Sealfon concluded.
RMS High-Flo™ Subcutaneous Safety Needle Sets are available in a variety of needle lengths, gauges and configurations for infusions involving single or multiple sites.
SOURCE RMS Medical Products