Standardization News

A proposed ASTM International standard will support the growing potential for small “scaffolds” to regrow tissue around the knee joint after a meniscus injury. The standard (WK54939, Guide for Characterization and Assessment of Tissue Engineered Medical Products (TEMPs) for Knee Meniscus Surgical Repair and/or Reconstruction) is being developed by ASTM’s committee on medical and surgical materials and devices (F04).

Menisci are fibrous, wedge-like structures in the knee that help with stability, lubrication, and distribution of forces across cartilage, according to ASTM member Suzanne Maher. Scaffolds can be stitched into the location where an injured meniscus has been removed by surgery, encouraging the body to refill tissue in the damaged area.

“Injuries to menisci are common,” notes Maher, an associate scientist at the Hospital for Special Surgery in New York City. “In many injuries, the menisci cannot be repaired, so the only solution is to remove the area of damaged tissue. Removed tissue can significantly alter the ability of the meniscus to function properly and can lead to degeneration of the entire knee.”

The proposed standard will outline tests that scientists, surgeons, and manufacturers should consider performing as they develop and test scaffolds for meniscal repair. In addition, regulatory bodies will use the standard to understand the types of tests considered important by a multi-disciplinary team of experts in meniscus care.

All interested parties are invited to join in the development of WK54939 and other proposed TEMPs standards.

ASTM Committee F04 on Medical and Surgical Materials and Devices Next Meeting: May 9-12, 2017, May Committee Week, Toronto, Ontario, Canada

Technical Contact: Suzanne Maher, Hospital for Special Surgery, New York, New York, tel +1.212.606.1083

ASTM Staff Contact: Kathleen Chalfin, tel +1.610.832.9717