Genesis Plastics Welding, Fortville, Ind., a leading contract manufacturer of radio frequency (RF) welded products, has announced a collaboration with REDpoint Intl., Vancouver, Wash., a medical device company, to produce the company’s latest product, the StedLine™ IV sleeve, a stabilizing device that eliminates the need for glue or tape to secure an intravenous line to skin.
REDpoint’s primary manufacturing goal was to eliminate PVC while keeping the product cost-efficient, safe and patient-friendly. Genesis led REDpoint to lower-cost PE and PET materials well-suited for single-use medical products such as the IV sleeve and robust enough to provide the desired product strength. A PVC-free medical device was important to REDpoint because medical devices made of certain PVCs can leach DEHP, which has been found to cause organ damage in animals, according to the American Medical Association. The U.S. FDA has advised health care providers to reduce DEHP exposure for certain vulnerable populations, including infants and other patients receiving multiple medical treatments.
Throughout the initial production process, REDpoint went through multiple clinical trials and focus groups to test both the quality and comfort of the IV sleeve for patients. After each research round, Genesis’ engineering team worked with REDpoint executives to make needed changes to materials and processes while keeping manufacturing as efficient and economical as possible.
“We were honored to be selected by REDpoint to help them bring this innovative single-use medical device to market,” said Tom Ryder, Genesis Plastics Welding president and CEO. “And with the help of Genesis’ proprietary RF welding technology, ecoGenesis™, the finished product also features durable and attractive welds.”
The REDpoint StedLine IV Sleeve is rapidly acquiring distribution within the disposable medical device arena. The sleeve has proven especially beneficial for elderly and pediatric patients, as it absorbs yanks and tugs that commonly cause IV catheters to fail. In addition, the Vancouver Business Journal selected REDpoint for their 2010 Business Growth Awards’ Innovator of the Year.