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Orthopaedic Device
Forum Present:
Members of the Orthopaedic Device Forum introduced themselves and disclosed conflicts of interest. Approval of April 2-3, 2000 Summation Report Members reviewed, amended and approved the summation report from the April 2000 meeting of the Orthopaedic Device Forum. |
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| Presentation by Larry Kessler, Sc.D., and Don Marlowe
Don Marlowe, Director of the Office of Science and Technology, CDRH, discussed outcomes and activities that resulted from the NIH Device Retrieval Workshop held in January 2000. His comments focused on efforts to increase the number of devices retrieved through revisions and autopsy. In addition, Mr. Marlowe discussed efforts to develop a joint NIH/FDA web-based "credentialed (unbiased and verifiable) information" Internet site to allow potential implant patients the opportunity to evaluate the benefits and risks associated with the use of devices. Mr. Marlowe stated that the Device Forum might be helpful in assisting FDA in its efforts. Several issues were raised that could impede the development of this web-based consumer education effort. The legal implications for users and manufacturers are believed to be the largest hurdles to overcome. The composition of a peer-reviewed panel to critique documents containing information also was raised as a concern. Since some device abstracts are lengthy, questions were raised as to how the information could be summarized without adding bias. FDA and the Device Forum will look at successful efforts to model such as the intraocular lens experience. Dr. Larry Kessler, Director, Office of Surveillance and Biometrics, CDRH, addressed the Forum about how to improve FDA registries, implant retrieval data and postmarket surveillance. Dr. Kessler discussed a number of factors that have contributed to the lack of systematic data on implants in the postmarket period and FDA's efforts to improve its data collection. FDA hopes to improve its data collection of devices to evaluate their performance under actual conditions. Improvements in the current scheme could speed premarket approval. The Device Forum will reactivate the MDR task force to address issues such as confidentiality, sampling size, accuracy of data, and legal concerns. Dr. Kessler also addressed the FDA's work on the re-use of devices labeled for single use. He stated that this issue has been a significant challenge for FDA, however, he expects publication of a final guidance document this summer. Dr. Kessler stressed the critical importance of the continued development of standards and other research initiatives in this area. Dr. Kessler recommended that clinicians, manufacturers and reprocessors review the guidance and comment on its practical effects following its publication and implementation. Metal/Metal
Several companies within OSMA have drafted a petition for the downclassification of metal/metal semi-constrained hip joint prosthesis. A revised draft proposal was circulated to the Forum. Further information is needed on wear debris and biological response before the petition can be finalized.
Once the petition is revised, it will be distributed to selected ASTM and ORS representatives and to all Forum members. OSMA will aim to submit the petition in its final form to FDA in late August so that it may be included in the agenda of the October FDA Orthopaedic and Rehabilitative Devices Panel.
Labeling
Numerous concerns related to the creation of a generic indication statement for Class II orthopaedic devices were raised. This on-going project is intended to provide uniformity for manufacturers for packaging inserts and to speed premarket approval. CDRH would need a written proposal to allow consideration of the concept of generic labeling as currently discussed.
Key issues that need to be addressed and resolved include the legal ramifications of the use of a generic label, the regulatory requirements for the labeling, the impact of labeling on surgeon education and the impact of labeling on patient decision-making for orthopaedic procedures. The Labeling Task Force will review the goals of this project and redefine its focus.
ASTM/ISO Standards Issues
ASTM/ISO Technical Committee 150 will meet in Stockholm, Sweden Sept 10-15, 2000. Work groups and task forces will discuss simulator testing methods, materials, arthoplasty constructs for spinal data retrieval, and analysis protocol and registries. The reuse of devices labeled or intended for one use is a possible discussion topic.
Issues that may be addressed at the November meeting of ASTM include tissue adhesion and sealants in addition to a workshop on bone graft substitutes. The AAOS Biomedical Engineering and Biological Implants Committees will participate in the workshop.
Board Update
The Board has been working on revamping the AAOS' educational efforts focusing on the use of web-based products. This is a reflection of the changing make-up of Academy Fellows as well as concerns with time constraints and travel budgets.
The Board is considering adding a layperson to its membership.
The Board also is focused on the "Burden of Disease" and how to advance these interests in conjunction with the Bone and Joint Decade efforts. The AAOS will continue its work to secure a Presidential decree for the Bone and Joint Decade however, efforts will be made to instruct Federal Agencies to examine the "Burden of Disease" within the decree.
Organizational Principles
The Forum reviewed the draft of the Organizational Principles of the Orthopaedic Device Forum. Numerous corrections were made to the document and further revisions are necessary. The work group will continue drafting this document.
Education-Labeling
The work group updated the Forum on its progress to create a web-based product to enhance physician education about FDA-approved devices. Current activity is directed at PMA-approved products where the entire Summary of Safety and Effectiveness information with indications, contraindications, warnings/precautions and data that supported its approval would be placed on the AAOS website.
The work group agreed that the information must be currently available and that it should place as minimal a burden as possible on industry and the oversight group responsible for the program. The AAOS has agreed to post this information on its website. An education effort to inform physicians of this resource would be key to its success.
Cartilage Guidance Update
The fundamental and critical issue, related to the Cartilage Guidance document, deals with what is an appropriate control group. Generally, patients are not willing to participate in randomized testing. Other issues include what type of instrumentation will be used to evaluate outcomes and the length of time for evaluation periods. Animal data validation of human study may also be considered.
FDA Update
The FDA will hold a public meeting August 2, 2000, entitled "Human Bone Allograft: Manipulation and Homologous Use in Spine and Other Orthopaedic Reconstruction and Repair." The goal of the meeting is to gather information about human bone allograft in relation to FDA's proposed tissue rules. The meeting is being sponsored by the Center for Biologics Evaluation and Research (CBER) and the Center for Devices and Radiological Health (CDRH) who are looking for specific information concerning the characteristics of various bone products as they relate to the agency's definitions for minimal manipulation and homologous use. OSMA and AAOS will be included on the agenda for presentations at this meeting.
As reported at the last Device Forum meeting, reclassification of polymethylmethacrylate (PMMA) bone cement from Class III to Class II was signed on October 14, 1999 and Federal Register notice is pending. The Federal Register notice for uncemented shoulders also is pending.
Collagen/Bone Graft Guidance
The collagen guidance document is currently in balloting process of the ASTM Division F-04. The document will be circulated to Device Forum members once it is approved.
The bone graft guidance document is under development and will be the focus of the ASTM task force for the next three months.
Tissue Donation
A series of newspaper articles documenting tissue donation, tissue allotment, and profits associated with tissue processing and distribution have raised the profile of this issue.
The AAOS is revising its advisory statements on allograft tissue and cell-engineered products. Issues that may need to be addressed, in light of these newspaper articles include the definitions of reasonable recoverable costs as well as informed consent to the donor families.
OSMA Update
OSMA will be participating in the FDA's public meeting on "Human Bone Allograft: Manipulation and Homologous Use in Spine and Other Orthopaedic Reconstruction and Repair."
OSMA's next meeting will be held on August 2-3, 2000. The location of the meeting has been moved from the Washington, D.C. area to Denver, CO in order to encourage additional member participation.
The Medical Device Reporting (MDR) OSMA (Orthopaedic Surgical Manufacturers Association) document is being reviewed by OSMA legal counsel.
Future Agenda Items
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