Standardization News

In order to address highly variable labeling within the orthopedic implant industry, ASTM International Committee F04 on Medical and Surgical Materials and Devices is developing a proposed new standard that will create a uniform labeling system for implant manufacturers.

The proposed new standard, WK27458, Guide for Presentation of End-User Information on Implant Package Labeling, is under the jurisdiction of Subcommittee F04.22 on Arthroplasty.

"The current effort is geared to orthopedic joint replacement implants," says Kent Jason Lowry, M.D., orthopedic surgeon with Northland Orthopedic Associates and the biomedical engineering committee of the American Academy of Orthopedic Surgeons. "However, this proposed standard could easily be expanded into other areas of orthopedic implants and even implantable medical devices in general."

The proposed new standard will provide instructions for a uniform subset of the implant label that, consistently and with easy readability, presents necessary information to device end users. This information will further ensure that the right implant has been selected for a procedure.

Lowry says that surgeons, operating room circulators, product sales representatives, hospital materials management personnel and patients will all benefit from WK27458 once it has been approved.

Subcommittee F04.22 hopes to have a preliminary draft prepared for discussion at their May meeting and invites all potential stakeholders to attend and participate."Our current challenge is determining the scope of the proposed standard," says Lowry. "For example, do we set aside a portion of the label for information to be presented to the end user, or do we standardize the whole label?" Another area to be discussed is standardized symbology for implant identification.

CONTACT Technical Information: Kent Lowry, M.D., Northland Orthopedic Associates • Rhinelander, Wis. • Phone: 715-369-2300 E-mail: klortho@newnorth.net O ASTM Staff: Daniel Schultz • Phone: 610-832-9716 • E-mail: dschultz@astm.org O Upcoming Meeting: May 18-21 • May Committee Week • St. Louis, Mo.