Mar 26, 2010

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, ASTM 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 expand into other areas of orthopedic implants and even implantable medical devices in general.”

The proposed 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 the right implant has been selected for the right patient.

Lowry says that surgeons, operating room circulators, product sales representatives, hospital materials management personnel and patients will all benefit from ASTM 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 to 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 up for discussion is standardized symbology for implant identification.

ASTM International welcomes and encourages participation in the development of its standards. For more information on becoming an ASTM member, visit www.astm.org/JOIN.

ASTM Committee F04 Next Meeting: May 18-21, May committee week, St. Louis, Mo.
Technical Contact: Kurt Lowry, M.D., Northland Orthopedic Associates, Rhinelander, Wis., Phone: 715-369-2300; klortho@newnorth.net
ASTM Staff Contact: Daniel Schultz, Phone: 610-832-9716; dschultz@astm.org
ASTM PR Contact: Barbara Schindler, Phone: 610-832-9603; bschindl@astm.org

Release #8533