Standardization News

A proposed new ASTM guide will provide a standardized method for measuring the safety and effectiveness of hip replacements while also fostering a less-burdensome approach to the design, review and FDA approval of clinical trials and insurance coverage decisions involving these products.

Specifically, the new standard will bring more consistency and credibility to the information flowing from patient-reported outcome questionnaires (PROs) that record post-surgical joint function, activity levels, quality of life and more.

The standard (WK41469, Guide for Clinical Trial Design for Hip Replacement Systems) will be a valuable resource for those involved in the design, manufacture, testing and regulation of hip replacement systems for people with arthritis and fractures. Ultimately, this guide will serve as a tool to bring more life-enhancing medical products to market in a safe and expedient way.

"Manufacturers will be the primary users of this standard guide," says ASTM member Gregory Brown, M.D., an orthopaedic surgeon with Olympia Orthopaedic Associates. "The manufacturer's clinical trials should be accepted by regulatory bodies if the PROs used in the clinical trial are from the proposed standard."

All interested parties are welcome to participate in the ongoing development of the standard. The subcommittee is particularly interested in participation from manufacturers, regulatory agents and surgeons in the development of WK41469 and other standards.

WK41469 is being developed by Subcommittee F04.39 on Human Clinical Trials, part of ASTM International Committee F04 on Medical and Surgical Materials and Devices. F04.39 also plans to develop proposed clinical trial standards for knee replacement systems and lumbar spine surgery.

CONTACT Technical Information: Gregory A. Brown, M.D., Olympia Orthopaedic Associates • Olympia, Wash. • tel +1.360.491.4211 | ASTM Staff: Pat Picariello • tel +1.610.832.9720 | Upcoming Meeting: May 19-22 • May Committee Week • Anaheim, Calif.