Medical textiles must comply with medical industry regulations

By Holly O’Dell

Compliance, like performance characteristics, is a vital consideration of medical textiles. First, a medical textile manufacturer needs to determine if a particular product is regulated by the FDA, which then has to approve the way in which a product is labeled. “That means we have to prove that a product does what we say it does, that people can use it the way they’re supposed to use it, and that it does not cause any adverse health effects,” Michielsen says. Because it produces surgical textiles, Standard Textile must meet the federal government’s regulatory requirements. “Our surgical gowns, drapes and wrappers must be registered with the FDA prior to commercialization, a process referred to as a 510(k) registration,” Bushman says. “Each individual facility that manufactures the finished product must also obtain a facility registration from the FDA.”

Standard Textile also uses a performance standard called ANSI/AAMI PB 70:2003, which provides guidance on test methods, minimum barrier performance requirements and acceptable quality levels for manufacturers.

For its testing of antimicrobial textiles, Medline uses the AATCC 100 test, established by the American Association of Textile Chemists and Colorists. This test method provides a quantitative procedure to evaluate the degree of antibacterial activity on a textile. Other methods used include ASTM E 2149 and AATCC 147.

Holly O’Dell is a freelance writer based in Rush City, Minn.