|New Protective Clothing Standard Addresses Approval Process for Surgical Gowns
A ruling from the United States Food and Drug Administration to change how the marketing of surgical gowns was regulated has led to the development of a new ASTM International standard. The new standard, F 2407, Specification for Surgical Gowns Intended for Use in Healthcare Facilities, was developed by ASTM International Committee F23 on Personal Protective Clothing and Equipment. Specification F 2407 is under the jurisdiction of F23’s Biological Subcommittee, F23.40.
Specification F 2407 establishes requirements for the performance, documentation and labeling of surgical gowns used in healthcare facilities. Specifically, the standard addresses the ability of gowns to protect healthcare workers from exposure to blood, body fluids, and other potentially infectious materials during surgery and other procedures.
In addition, F 2407 establishes uniform testing and reporting requirements for surgical gown manufacturers in order to provide information to end-users that can be helpful in making informed decisions when selecting and purchasing surgical gowns.
“There was no national standard that addressed the performance of surgical gowns and the FDA repeatedly stated that they believed the current regulatory approval process used to clear new gowns for marketing was no longer adequate,” says Janet Lewis, administrative director, surgical services, Burn Center, Outpatient and Renal Transplant Clinic, INTEGRIS Baptist Medical Center, Oklahoma City, Okla. “Thus, in accordance with the FDA Modernization Act, there was a need to develop a consensus standard.”
According to Lewis, F 2407 will be a guidance and reference document for non-barrier properties of surgical gowns. Barrier performance levels that are specified in the Association for the Advancement of Medical Instrumentation standard, PB70, Liquid Barrier Performance and Classification of Protective Apparel and Drapes in Health Care Facilities, are also included in F 2407 for reference purposes. Both surgical gown manufacturers and end users who are selecting gowns for appropriate uses will benefit from the use of Specification F 2407. The FDA will also use the standard in its regulatory market clearance process.
The task group that developed F 2407 comprised representatives of surgical gown manufacturers, testing laboratories, independent consultants and end users, but Lewis notes that many other interested ASTM members were present at the meetings and were instrumental in providing information and opinions.
Lewis says Subcommittee F23.40 welcomes participation in future revisions of F 2407 as well as in the development of other new standards. “There is a great need for increased participation from end users,” says Lewis. “On this task group we were fortunate to have nurses participate from FDA and the Association of Perioperative Registered Nurses as well as infection control practitioners from the Association for Professionals in Infection Control and Epidemiology.” //
Technical Information: Janet Lewis, INTEGRIS Baptist Medical Center, Oklahoma City, Okla.
ASTM Staff: Stephen Mawn
Upcoming Meeting: Jan. 30-Feb. 1, 2007, January Committee Week, Costa Mesa, Ca.