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Orthopaedic Device Forum
1998 Annual Progress Report
Committee Accomplishments from
January 1, 1998, through December 31,1998
Reclassification Efforts
- Formed a Metal-metal work group to develop a reclassification petition for metallic orthopaedic devices.
Guidance Document Development
- Formed a Fresh fracture repair work group.
- Developing a cartilage resurfacing guidance document.
- Developing a bone graft substitutes guidance document.
Biologics
- OSMA (Orthopaedic Surgical Manufacturer's Association) has invited biological orthopaedic companies to join its organization.
- Worked on report from ORS workshop.
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Liability Issues
- Issued a Task Force Liability report to the Board of Directors.
- Changed the name of AAOS/FDA/OSMA Device Forum to Orthopaedic Device Forum.
- Reviewed and amended the Forum's Mission Statement and Operational Principles.
- Representatives from NIAMS and the Arthritis Foundation have become new members of the Forum.
- Worked on the development of an Orthopaedic Device Forum website.
Standards
- Developed an introductory letter for the International President's Breakfast to identify personnel who may be interested in working towards international standards for devices.
- Implemented procedure that all members of the Biological Implants committee and Biomedical Engineering become members of ASTM.
Educational Initiatives
- Presented the symposium, " Regulatory Aspects in Orthopaedics" at the AAOS annual meeting.
- Scientific exhibits, "Alternative Bearing Surfaces: The Good, Bad, and the Ugly and "Limits of UHMPE Longevity: Design, Material and Clinical Factors" at AAOS annual meeting.
- Wrote an article for JAAOS.
Device Reporting and Postmarket Surveillance
- Formed a work group to study the reporting of postmarket surveillance issues with members of FDA.
Communication
- Continued development of a working communication network with affiliated societies (AOS, AOA, ASTM, ORS) as relates to Device Forum interactions. This is important to the process of FDA guidance document development, and to the reclassification of orthopaedic devices.
- Continued interaction with the FDA which allows for the timely notification of both parties of activities that pertain to orthopaedic devices and provides the FDA with a regularized communication link with AAOS.
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