Committee Accomplishments from January 2004 to December 31, 2004

1. Developed a guidance document to ensure a standardized method for designing clinical trials intended to measure the safety and efficacy of hip replacement systems. Submitted to the Food and Drug Administration (FDA) docket by April 1, 2004.
2. Revised guidance document on preparation of investigational device exemptions and pre-market approval applications for bone growth stimulator devices.
3. Initiated Chantilly revisited subcommittee to assess problems with bringing medical technologies to the U.S market.
4. Wrote and submitted comments to both the FDA and Health and Human Services (HHS) on their Critical Path Initiative to bring medical products to market more quickly. Also, wrote and submitted comments to the FDA on barriers to pediatric device development.
5. Developed “Pre-clinical and clinical trial design for cervical and lumbar disc replacement systems” guidance document. Will submit to the FDA in 2005.
6. Presented joint arthroplasty seminar for FDA reviewers on January 23, 2004. Drs. Cuckler, Rosenberg, Maloney, Jacobs, and Berry discussed assessing outcomes & understanding the data, the impact of evolving technologies & techniques on device regulation, alternative bearing surfaces, biological concerns, and clinical assessment.
7. Biologics subcommittee formed to address osteoinductivity of demineralized bone substitutes, biological standards issues, the off-label use of bone morphogenetic proteins.
8. Reviewed and provided input on the Orthopaedic Surgical Manufacturer’s Association mobile bearing knee petition.
9. Presented two scientific exhibits at the AAOS Annual Meeting 2004: “Musculoskeletal Tissue Transplantation in Orthopaedic Surgery: Safety and Donation. What Makes Tissue Safe and Where Does it Come From?” in conjunction with the Patient Safety Committee and the American Association of Tissue Banks. Also exhibited “Antibiotic-Loaded Bone Cement in Aseptic Total Joint Replacement: Whys, Wherefores & Caveats.”
10. Surveyed AAOS fellowship on antibiotic bone cement usage.
11. Presented poster exhibit and delivered an oral presentation on issues with computer assisted orthopaedic surgery (CAOS) at the June 16-19, 2004 CAOS meeting.
12. Attended Medical Device User Fee Modernization Act (MDUFMA) meeting in November 2004. The AAOS will provide a comment in 2005 to the FDA docket on single-use device reprocessing.
13. Presented ICLs at Annual Meeting 2004 on “Soft Tissue balancing of the Hip- A Concept which has Come of Age”, “Technology 2004: Alternative Bearing Surfaces: The Good, the Bad, & the Ugly” and “Current Concepts of Mobile Bearing Total Knee Arthroplasty.”

1. Continue to facilitate coordination between the Committee on Biological Implants and the Committee on Biomedical Engineering as they address their specific issues and in their interactions with FDA and American Society for Testing and Materials (ASTM).
2. Continued involvement in revisions to the International Standards Organization (ISO) hip wear standard.
3. ODF website maintained and updated after each meeting.
4. Continue to monitor and review federal legislation and regulatory policies on orthopaedic implants and biological issues.
5. Continued participation with standards organizations: ASTM and ISO.
6. Developing pediatric device development needs survey. Results will be shared with the FDA, NIH, American Academy of Pediatrics and a national pediatric stakeholders group.

1. Continue to explore opportunities for interaction among multiple federal agencies such as FDA, NIH, and CMS as appropriate to our activities/mission.
2. Development of educational initiatives for orthopaedic surgeons and health professionals to promote the delivery of high quality healthcare and reduce the regulatory burdens.
3. Develop and implement a strategy for new member transitions while maintaining continuity and knowledge base.