Standardization News

A proposed ASTM standard guide will cover a heavily used procedure for assessing bone-grafting technologies in pre-clinical models. The standard (WK49454, Guide for in vivo Evaluation of Rabbit Lumbar Intertransverse Process Spinal Fusion Model) describes the process for implanting bone void filler and bone graft extender products into rabbits to test their effectiveness in assisting the process of bone formation.

The standard will support efforts to equitably compare bone void fillers and bone graft extender products to autograft. These devices are later designed to be surgically implanted into voids and gaps in people with bone injuries. During the healing process, these devices are absorbed by the body and replaced with new host bone.

Subcommittee F04.44 on Assessment for TEMPs (tissue engineered medical products) is developing the standard. F04.44 encourages individuals who have experience with these models, with histological assessment and/or with mechanical assessment expertise, to become involved.

CONTACT Technical Information: Jeffrey L. Scifert, Ph.D., Medtronic Spinal • Memphis, Tenn. • tel +1.901.344.0844 | ASTM Staff: Pat Picariello • tel +1.610.832.9720 | Upcoming Meeting: November 17-20 • November Committee Week • Tampa, Fla.