Committee Accomplishments from
October 31, 1998, through October 31, 1999

• The ODF initiated, organized and participated in an AAOS symposium entitled "Regulatory Aspects in Orthopaedics, Anaheim, Feb 1999 - included AAOS members, Industry and FDA members;
• An ORS Workshop was arranged under ODF auspices by a Forum ORS representative relating to regulatory and standards issues for biological products;
• Organized joint meeting of AAOS Biological Implants and Biomedical Engineering Committees at May 10, 1999 meeting of the ASTM. The focus of the meeting was to educate committee membership on techniques and goals of standards writing for bioengineering and biologics, and for interaction with the FDA, to more effectively assist in the development of guidance documents for orthopaedic devices and biological products;

• ODF members (3) participated as members of the steering committee for development of an NIH sponsored Technology Assessment Conference (TAC) on the Retrieval of Failed Medical Devices (ultimately entitled "TAC on Improving Implant Performance through Retrieval Information: Opportunities and Challenges;"
• Forum members initiated and have subsequently led efforts to hold a follow-up workshop on "Wear" of orthopaedic implants. This follow-up symposium (now entitled Wear Workshop 2000) has become the first of 5 one-year proposals to NIH for sponsorship. It has received funding support from a number of appropriate specialty societies and will plan to publish its findings in electronic format.

• The official name of the Forum was confirmed as the "Orthopaedic Device Forum" (ODF) and all summation reports were refined to omit specific references to names/organizations or other specific identifiers;
• All AAOS members and non-industry or FDA members, provide yearly disclosure along AAOS format, and are asked at each meeting to disclose any potential conflicts of interest for particular products to be discussed;
• Established and made functional the ODF website. The Forum site links to many other orthopaedic specialty societies and governmental agency sites;
• Formally welcomed the Medical Director of the Arthritis Foundation as a Full member of the ODF;
• Formally offered membership to and have now included representatives from the Center for Biologics, Evaluation and Research (CBER) of the FDA;
• Formally offered membership to and have now included representatives from HCFA to help elucidate issues related to reimbursements for new technologies;
• With FDA's encouragement, formally entertained representatives from 2 other specialty societies (Neurosurgery, and Plastics and Reconstructive Surgery) who hope to develop Forum-style exchanges among industry, FDA and their related specialty groups.

• Reclassification of Elbow joint metal/polymer constrained cemented prosthesis (without reclassification this product may not have remained in the marketplace);
• Reclassification Knee joint patellofemoral polymer/metal semi-constrained cemented prosthesis (without reclassification this product may not remained in the marketplace);
• Reclassification Shoulder joint metal/polymer non-constrained cemented prosthesis/semi-constrained cemented prostheses (without this reclassification a new PMA/IDE would be necessary, and fewer product types would be available in the marketplace);
• Reclassification PMMA bone cement (without this reclassification a new call for PMAs/IDE's would have been required);
• Reclassification of hip joint metal/polymer constrained cemented or uncemented (acetabular) prostheses (without this reclassification these products would have been removed from the market);
• Reclassification of metal/polymer knee joint, uncemented (without this reclassification many currently implanted devices could be subject to liability evaluations);
• Letters appropriate to supporting these reclassifications were written on behalf of the AAOS;
• Guidance Documents development was focused on addressing the complexities of bringing biologic products to the marketplace in a safe and effective manner that is fair to the manufacturer and in the consumers' best interest. Three major efforts are ongoing: "The Repair of Hyaline Cartilage Defects", "Bone Graft Substitution for Long Bone Healing" and "Specification of Collagen for Surgical Implants".

• Continue to develop the cartilage, bone graft, and collagen guidance documents.
• Continue to interact with FDA and other governmental agencies on issues of mutual interest.
• Continue to participate in the reclassification of orthopaedic devices.