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Orthopaedic Device
Forum Present:
Members of the Orthopaedic Device Forum introduced themselves and disclosed conflicts of interest. Approval of February 6-7, 2000 Summation Report Members reviewed, amended and approved the summation report from the February 2000 meeting of the Orthopaedic Device Forum. |
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| Presentation by David Feigal, MD, MPH
Dr. David Feigal, Director of the Center of Devices and Radiological Health (CDRH) addressed the Forum. He provided a historical perspective on Food and Drug Administration (FDA) regulation. Dr. Feigal also described the importance of FDAMA and highlighted FDA accomplishments in its implementation. Wear Workshop The grant for the Wear Workshop 2000 was submitted to NIH and has an excellent probability of being funded. Letters have been sent to speakers and moderators. Industry representatives are being contacted and submissions are currently out for ten Young Investigators to attend. Representatives met with AAOS Publications department members to organize the World Wide Web function. The current AAOS chairman of the Council on Research will generate a report on the proceedings of the Wear Workshop. MDR The Forum commented on the Medical Device Reporting (MDR) OSMA (Orthopaedic Surgical Manufacturers Association) document. Revisions were incorporated into the new draft; OSMA legal counsel is currently reviewing this draft. Organizational Principles
Forum members drafted the following organizational principles:
Reuse of Single-Use Devices Members of the single-use work group held a conference call in February 2000 to discuss a possible comment to FDA. FDA has encouraged physician involvement in this important issue. Since there cannot be consensus with in the Forum on this issue, AAOS members and staff will draft a comment on the latest FDA guidance documents, "Reprocessing and Reuse of Single-Use Devices: Review Prioritization Scheme" and "Enforcement Priorities for Single-Use Devices Reprocessed by third Parties and Hospitals." Comment deadline is April 11, 2000. Labeling The Device Forum Labeling Task Force met in Orlando during the AAOS Annual Meeting. The task force proposes to develop generic indication statements for Class II orthopaedics devices. The targeted products must have many years of clinical use and consensus within the medical community for the appropriate uses of these devices. The task force suggests that manufacturers of similar devices provide uniformity on package inserts and simplify the instructions. Candidate devices include total hip prostheses, uncemented hip, cemented and uncemented knee and total shoulder, IM rods, external fixators, bone plates and screws, and spinal fixation devices. The task force considers Class III devices to be outside of the scope of this initiative. Standards
ASTM The next meeting of ASTM will be held in Toronto, Canada from May 24-26, 2000. Division F-04 will present a seminar on the "Past, Present and Future" of ASTM. International harmonization and regulatory issues will be discussed. The AAOS Biological Implants committee will hold a conference call with the Chairman of the Tissue Engineered Medical Products (TEMPS) and the Chairman of F-04 of ASTM to discuss involvement in the development of biological tissue standards. ISO International Standards Organization (ISO) will hold their annual meeting in Sweden, in October 2000. ISO is not yet involved in biological tissue standards but it is presumed that they will develop standards in a relatively rapid period of time. The current ISO hip wear standard continues to be a contentious issue. The standard was voted in the affirmative; however, some members believe that flawed data was used to produce the standard. The U.S., U.K., and Japan voted against the standard. The U. S. delegation has proposed two work items: an immediate revision and development of a parallel standard. This ISO hip wear standard illustrates many problems with the international standard setting process. Majority voting rules with ISO whereas, ASTM has consensus voting with all negative votes needing to be resolved. Some members of industry declined to participate in the ISO hip wear standard early in the process and now are subjected to a standard that is not beneficial to American industry. Board Report In the past, managed care issues were primary concerns for the Academy. AAOS has rededicated its focus to the patient and patient care. The AAOS Board of Directors has approved a Complementary and Alternative Medicine Committee and a Volunteer committee to focus efforts on the patient. Humanitarian awards were presented to Charles H. Epps, MD and C. Scott Harrison, MD at the 2000 AAOS Annual Meeting for their efforts in education and volunteerism. The AAOS Board of Directors, Councils of Education, Communications, Research and Health Policy have approved lay members to serve as conduits to consumer viewpoints. AAOS has invested heavily in patient education. The AAOS website has been updated with patient education information. AAOS is providing all fellows with a free web site template that can be personalized for their practice to provide information to the public and their patients. Three Continuing Medical Education (CME) courses are available on the AAOS website. International attendance has increased substantially at the AAOS Annual Meeting 2000. 104 International Presidents represented their societies in Orlando, FL. FDA Update
Reclassification Efforts
Standards Recognition FDA will soon recognize standards related to the reclassification of elbows, shoulders, knees, and bone cement. RSA
FDA considers radiostereometric analysis (RSA) to be a research tool that should have Institutional Review Board (IRB) involvement and patient protection measures in place. Depending on the types of markers being used, the location of the markers, and their impact on a prosthesis, an IDE may be required.
Members stated that there are fifteen grades of tantalum. Chemical properties of different tantalum beads could provide different results.
Hard/Hard Bearings
Historically, OSMA has generated reclassification petitions and then submitted them to the FDA. Several companies within OSMA have drafted a petition for the reclassification of metal/metal semi-constrained hip joint prosthesis.
The Forum will initially review the petition. FDA reminded members that reclassification petitions must be submitted with data that is available in the public domain.
Educational Issues Members of the Forum suggested that it was more advantageous for the FDA to spend money on educational issues rather than on regulatory issues. It is the opinion of many surgeons that efficacy studies should encompass ten years worth of data. Members suggested that manufacturers cooperate and share data collected at six months and one year into a clinical trial; however, it is unclear if six-month data is predictive of 5 years of efficacy. A recommendation was made to utilize sampling methodology to extract beneficial information. This methodology may be more efficacious than compiling large amounts of data. OSMA members agreed to examine this proposal. Education-Labeling
An Education-Labeling subcommittee was formed to examine a web-based format that would provide PMA and 510k Summaries of Safety and Efficacy (SSE) of orthopaedic devices. Members will report to the Forum in July 2000.
HCFA Update HCFA representatives reminded members of the Forum that HCFA covers procedures and devices that are both reasonable and necessary. HCFA has evolved to become a more evidence-based center. The HCFA website is continuing to develop and become more comprehensive. The development of coverage policies' web address is www.lmrp.net. This site provides a catalogue of medical review policies. FDA's concerns are safety and efficacy while HCFA requires that services be both reasonable and necessary. Members of the Forum suggested that there might be a mechanism to satisfy both FDA's and HCFA's approval processes. After discussion, members of the Forum agreed to analyze data from PMA's of orthopaedic devices that have been approved within the last five years and examine reimbursement levels. Next Meeting
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