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Orthopaedic Device
Forum Present:
Members of the Orthopaedic Device Forum introduced themselves and disclosed conflicts of interest. Approval of April 1-2, 2001 Summation Report Members reviewed, amended and approved the summation report from the April 2001 meeting of the Orthopaedic Device Forum. New members and guests were introduced to the Forum. |
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IDE Discussion
A Food and Drug Administration (FDA) representative gave a presentation to the Forum on the approval for the conduct of clinical investigations. The staff member addressed off-label use, the definition of the practice of medicine, custom devices, investigational use, significant risk vs. non-significant risk, sponsor investigation vs. manufacturer IDE, sponsor investigator trials, manufacturer/sponsor feasibility trials, and patient registries. Traditionally, manufacturers have made special devices for small populations; custom devices have evolved from this process. According to FDA, a custom device can only be manufactured once. Forum members contend that it is very difficult under the present regulatory framework to bring new technology to market in this country. Many new technologies are being developed overseas because of these difficulties. The Forum decided that the issue of bringing new technologies to market is extremely important. A subcommittee will be formed to consider options. Resource Links
IDE Manual
CMS The Health Care Financing Administration (HCFA) has been renamed the Centers for Medicare and Medicaid Services (CMS). The administration has been restructured into three large units:
Arthritis Foundation In January 2000, the Arthritis Foundation held a meeting with other organizations to develop a key advocacy group. The Arthritis Foundation realized that it was both necessary and beneficial to partner with other musculoskeletal organizations. A new director will begin working with the organization in August 2001. In 2000, the Arthritis Foundation spent approximately $28 million on research. Researchers specializing in the musculoskeletal system are in great demand and the Arthritis Foundation is supportive of funding researchers in this field. The Arthritis Foundation projects huge growth in targeted research areas that are funded with a specific gift. For instance, last year research for osteoarthritis biomarkers was funded with an endowment. Additionally, lupus research received a $15 million donation. Future research may target genetic diseases and tissue engineering. The Arthritis Foundation may consider partnering with NIH on these and other areas of research. To date, no device research has been proposed to the foundation. NIAMS Update The Secretary of the HHS established the National Institute of Biomedical Imaging and Biomedical Engineering (NIBIB) on April 20, 2001. No additional funds are to be allocated to this new institute of NIH during the 2001 fiscal year. 40-60 million dollars worth of projects may be transferred to NIBIB from NIAMS. The mission of the NIBIB is to improve health by promoting fundamental discoveries, design and development, and translation and assessment of technological capabilities in biomedical imaging and bioengineering, enabled by relevant areas of information science, physics, chemistry, mathematics, materials science, and computer science. AAOS Board of Director's Report AAOS has developed an Academic Affairs Council. The six committees that report to the new council include Resident Education and Curriculum, Resident and Academic Advocacy, Academic Business Practice, Development of Orthopaedic Clinician Scientists and Educators, Diversity, and Candidate Member Services. The AAOS clinical committees have been disbanded which may provide a greater opportunity for COMMS participation in AAOS committees. Hip & Knee Registry The AAOS BOD will receive a presentation on the findings of the task force in September 2001. AAOS staff and the task force chairman met with representatives of AHRQ (Agency for Healthcare Research and Quality), NIAMS, and CMS to discuss interest in a possible national joint registry. AAOS will meet with FDA in the future. AAOS is developing a national workshop to further investigate the obstacles to a national registry. The AAOS may try to partner with AHRQ on the workshop to be held later in 2001. Problems in devising a national joint registry include privacy, identification/deidentification issues, governance issues, and liability issues. Benefits of a national hip and knee registry would include an access to data, an early problem warning system, and possibly more timely recalls of problem devices. FDA admits that their post-market surveillance program has been less successful than they had hoped. Senators Jeffords and Kennedy are advocating legislation on patient safety reflecting that patient safety is tremendously important to the government. However, the statutes surrounding the collection of data vary with each state. Forum members suggested that the recommendations of the NIH Technology Assessment Conference on Improving Medical Implant Performance Through Retrieval Information: Challenges and Opportunities be revisited. Members suggested adding laterality to the CMS database. Additionally, developers of the proposed registry must decide what research questions need to be answered. http://odp.od.nih.gov/consensus/ta/019/019_statement.htm SUDs Members of the Forum have widely divergent perspectives on the regulation of devices labeled for single-use. However a member proposed that perhaps the Forum could reach a consensus opinion on some issues relating to the reprocessing of single-use devices (SUDs). AAOS realizes that some devices cannot be safely reprocessed. Nonetheless, many Forum members believe that some orthopaedic devices, such as drill bits and saw blades, can be safely reprocessed. The basis of the single-use FDA guidance document is public safety. However, the guidance only pertains to hospitals and third-party reprocessors. Therefore, in application, some Forum members believe the guidance appears to be inconsistent in FDA's intent of addressing the public safety issue. The patient safety aspect has two components: infection and function. Hospitals have traditionally sterilized burrs, staple drivers, sinks, or monoblock metallic devices. Reprocessed single-use orthopaedic devices have not been implicated in any adverse events. One concept that was addressed at the 1995 Chantilly conference is that the use of devices will always entail some degree of risk. There are only 3-4 comprehensive reprocessors in the United States, currently. FDA released a list of 207 commonly reprocessed devices; comprehensive reprocessors only reprocess approximately 45 of those 207 devices. Very few hospitals intend to become manufacturers, therefore, hospitals will either have to throw devices away or send devices to a reprocessor after August 14, 2001. Some forum members believe that an unintended consequence of this FDA guidance document is that the increased costs could adversely affect patient care. AAOS intends to file a formal letter of petition to delay implementation of the enforcement provisions of the SUD guidance prior to the hospital registration deadline of August 14, 2001. Consultants Subcommittee OSMA approved funding for two consultant members during 2002. Members suggested that "at- large" and "consultant" members be defined in the draft document from this subcommittee. Web Education
The web education subcommittee has agreed to disband and possibly revisit the issue of compiling an electronic catalogue of orthopaedic devices at some future time. The subcommittee cited four basic problems.
ASTM/ISO
ISO Fifteen members will represent the U.S. delegation at the September 10-14, 2001 International Standards Organization Technical Committee 150 (TC 150) meetings in Canberra, Australia.ASTM The fall ASTM meeting will be held in Dallas, Texas from November 6-9, 2001. The F-04 symposium will be "Spinal Implants: Are we evaluating them appropriately?" A symposium on bone graft substitutes is planned for 2002. ASTM is attempting to have a greater acceptance in the global standards community. The Tissue Engineered Medical Products (TEMPS) standards are currently up for ballot including one for collagen. ASTM is hopeful that TEMPS standards may be accepted as ISO standards in the future.Cartilage Guidance
The repair of hyaline cartilage guidance document is currently out for comment. The preclinical guidance standard for articular cartilage was well received. Hopefully, this document will be submitted to FDA during this calendar year.
Bone Graft Guidance The work group has been delayed due to unforeseen circumstances. Work will proceed on a draft and the Forum may review it at the October 2001 meeting. GTP Proposed Rule
A member of OSMA gave a presentation on the content of their comment on the proposed rule "Current Good Tissue Practice for Manufacturers of Human Cellular and Tissue-Based Products; Inspection and Enforcement." OSMA has strong reservations with the use of the terms "function" and "integrity" throughout the rule and believes the terms are very broad and open to interpretation. Furthermore, OSMA recommends that the FDA replace the terms with concrete, well-defined terms based on a risk-based system. OSMA's other areas of concern include:
AAOS Committee Reports
Biologics The Biological Implants committee recently worked on drafting a comment to the FDA on the Good Tissue Practice proposed rule. AAOS raised the issue that companies and the FDA must address proof of osteoinductivity in demineralized bone products. The committee continues to work on the minimal manipulation document. The committee will have a large presence on bone graft substitutes during the 2002 AAOS Annual Meeting including an instructional course, a symposium and a scientific exhibit. Additionally, the committee has partnered with the American Association of Tissue Banks (AATB) on an allograft brochure and will present a scientific exhibit in conjunction with them. The AATB annual meeting will be held in late August 2001. AATB is planning on including a symposium on demineralized bone as part of its program.Biomedical Engineering The AAOS Biomedical Engineering (BME) committee is currently drafting a position statement on the reprocessing of devices that are labeled "single-use only". The committee will participate in writing comments on the SUD guidance to the FDA by August 30, 2001. The BME committee will present two scientific exhibits at the AAOS Annual Meeting 2002. The application for the symposium "Wear: From Bench To Bedside" was accepted in the 2002 program. A BME committee member recently published a Bulletin article on clinical research. The BME committee is working on an advisory statement on vertebroplasty/kyphoplasty. Additionally, the committee is also working on an advisory statement on cross-linked polyethylenes for knee replacement systems. The committee is concerned that data on knee wear is not nearly as mature as data on hip wear.FDA Update
The reclassification of the hip joint metal/polymer constrained cemented or uncemented prosthesis should be published in the Federal Register in the near future.
FDA suggested that spinal cages and semi-constrained toes might be fairly good candidates for reclassification. The knee, hip, and cross-linked polyethylene guidances need to be updated to comply with GMPs requirements. Classification efforts are being addressed for calcium sulfate at FDA.
OSMA
OSMA's petition to reclassify metal/metal hip prostheses is scheduled to be discussed at the August 8-9, 2001 Orthopaedic and Rehabilitative Devices Panel of the FDA .
OSMA's membership now includes 36 member organizations including bone banking organizations.
Mobile Bearings Knee replacements are undergoing round-robin testing at laboratories in this country with ASTM specifications. The kinematics of joints are both difficult to describe and define at this time. Next Meeting
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