Standardization News

A new ASTM International guide addresses variable labeling within the orthopedic implant industry. F2943, Guide for Presentation of End User Labeling Information for Orthopedic Implants Used in Joint Arthroplasty, was developed by Subcommittee F04.22 on Arthroplasty, part of ASTM International Committee F04 on Medical and Surgical Materials and Devices.

"During an orthopedic surgery, the patient-specific implant is often selected from a large inventory of different sizes of implants with different characteristics," says Kent Lowry, M.D., an orthopedic surgeon with the Biomedical Engineering Committee for the American Academy of Orthopedic Surgeons, Ministry Medical Group, and an F04.22 member. "The identification labels for these implants are variably formatted and organized not only across different manufacturers but also across different brands from the same manufacturer."

While the system of selecting an implant prior to surgery has checks and balances built into it, F2943 will provide uniform formatting and consistent presentation of information.

"Manufacturers will be the ones who ultimately embrace and implement the standard," says Lowry. "End users such as surgeons, operating room nurses and product representatives will see the benefits of F2943. Patients will ultimately benefit by an implant delivery system optimized to ensure the correct implantation of an implant for a specific patient."

F2943 presents a universal label format of content and relative location of information necessary for final implant selection within an implant's overall package labeling. The guide identifies high priority label content and indicates a specific section of an implant's labeling where this crucial information is to be placed. Examples of the labeling format are presented in the standard.

Lowry notes that the subcommittee welcomes participation in its standards developing activities. Manufacturers, surgeons, patients, operating room nurses, product sales representatives, hospital material managers and quality improvement representatives are all encouraged to join the subcommittee.

"With successful completion of F2943, our next goal is to expand the basic concept of the standard to all orthopedic implants," says Lowry. "We will be having discussions about expanding the standard to include spine, trauma and other individually packaged sterile orthopedic implants."

To purchase ASTM standards, visit www.astm.org and search by the standard designation, or contact ASTM Sales (phone: 877-909-ASTM; sales@astm.org).

CONTACT Technical Information: Kent Jason Lowry, M.D., Ministry Medical Group • Rhinelander, Wis. • Phone: 715-369-2300 | ASTM Staff: Pat Picariello • Phone: 610-832-9720 | Upcoming Meeting: Nov. 12-15 • November Committee Week • Jacksonville, Fla.