WORKSHOP CONCLUDES THAT REFERENCE DATA AND REFERENCE MATERIALS ARE NEEDED FOR BIOMATERIALS.

Needs for reference data and biomaterials were identified at a NIST organized workshop held in July 2000. The 65 registrants from industry, National Institutes of Health, Food and Drug Administration, and academia joined with NIST staff in six concurrent breakout sessions that considered reference data needs in orthopaedic, cardiovascular, ophthalmologic, tissue-engineered, dental, and general biomaterials. Although the workshop was organized with the focus on reference data for biomaterials, an over-arching conclusion from participants was the complementary role of reference data and reference biomaterials in facilitating deployment of new health-care delivery devices and for the development of national and international standards. Owing to the rapid pace of innovation, the timely availability of reference data and reference biomaterials was deemed more critical to progress than completeness in most situations. In general, data on properties of interest included mechanical properties, surface and bulk physic al and chemical properties, as well as biological and clinical responses to materials.

In addition to reference data, reference biomaterials for polymers, monomers, alloys, composites and ceramics were identified. The participants agreed that follow-up meetings should be held with the various constituencies for the purpose of exploring the formation of alliances to help meet the needs recognized in the workshop.