“Historically, there were no medical grade standards for fiber production in the textile industry,” says Brenda Gilchrist, vice president operations, RxFiber LLC. “We are in the process of pulling together the leading biomaterial experts to discuss what medical grade fiber is and to begin setting standards for the industry. What does medical grade really mean?”
Currently ISO 13485 certification provides a quality management standard for medical devices, and ASTM’s (American Society for Testing and Manufacturing) medical device and implant standards are also available to assist in specifying and evaluating the design and performance requirements for several biomedical materials. But there’s a call for additional standards and guidelines, Gilchrist says.
“The history of medical devices is that they always used industrial grade yarns. They just worked with what they had and that’s where we’re trying to change that paradigm,” says Robert Torgerson, president of RxFiber. “Let’s make a yarn that makes a medical device better—let’s not design a device around the yarn.”