ASTM International Committee F04 on Medical and Surgical Materials and Devices is developing two new proposed standards that will be used in the field of arthroplasty. Arthroplasties are surgical procedures that resurface, remodel, rebuild or replace arthritic or dysfunctional sites of the body with optimal goals including pain alleviation, a return to full range of motion, improvement in mobility and muscle strengthening.
The proposed standards, ASTM WK28231, Specification for Total Elbow Replacement Prosthesis, and ASTM WK28559, Guide for Assessment of Metal-on-Metal Total Hip Replacement Devices, are being developed under the jurisdiction of Subcommittee F04.22 on Arthroplasty.
According to Brian Kincaid, senior research engineer, Zimmer Inc., the increased use of arthroplasty for the upper extremities, combined with a shortage of international standards for such devices, has created the need for ASTM WK28231 on total elbow devices. “The proposed new standard is a guidance document and will provide information compiled from clinically successful elbow devices that includes materials, design philosophies, surface finishes and so forth,” says Kincaid. “It also provides some guidance for laboratory testing of these devices.”
The second proposed standard, ASTM WK28559, covers general test methods for the chemical, biocompatibility, mechanical and preclinical assessments of implantable devices with metal-on-metal articulation intended to replace a hip joint. According to Leslie Gilbertson, principal engineer, L. Gilbertson Consulting LLC, ASTM WK28559 will provide manufacturers with an understanding of what the tests do in a single document and, in turn, help them meet current and future regulatory requirements.
Subcommittee F04.22 welcomes participation from all interested parties and particularly members of the orthopedic surgical community. For more information on becoming an ASTM member, visit www.astm.org/JOIN.
ASTM Committee F04 Next Meeting: Nov. 16-19, November Committee Week, San Antonio, Texas
Technical Contact: (WK28231) Brian Kincaid, Zimmer Inc., Warsaw, Ind., Phone: 574-372-4016; brian.kincaid@zimmer.com; (WK28559) Leslie Gilbertson, L. Gilbertson Consulting LLC, Warsaw, Ind., Phone: 574-307-1532; l.gilbertson@lgilbertsonconsulting.com
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 #8670/Sept2010