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Orthopaedic Device
Forum Present:
Members of the Orthopaedic Device Forum introduced themselves and disclosed conflicts of interest. Approval of July 16-17, 2000 Summation Report Members reviewed, amended and approved the summation report from the July 2000 meeting of the Orthopaedic Device Forum. |
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| National Institutes of Health (NIH) Wear Workshop
A workshop analyzing wear-related failures of total joint arthroplasties was held Oct. 21-23, 2000. The workshop, entitled Wear 2000, was sponsored by the National Institute of Health (NIH) and the American Academy of Orthopaedic Surgeons (AAOS). Participants in the workshop represented the clinical and research communities, orthopaedic implant manufacturers, the Food and Drug Administration (FDA), National Institute for Standards and Technology (NIST) and the NIH. The workshop was an update to one that was held in 1995. Total joint arthroplasty is an effective treatment for relieving pain and restoring function for patients with diseased and damaged joints. Despite this clinical success, many patients require painful and costly revision surgery because their joint replacements loosen secondary to implant wear and the associated bone loss termed osteolysis. Wear of the surfaces of the manufactured materials that form the joint implant is now recognized as the major obstacle to long-term success of joint replacements and has been the focus of considerable research aimed at understanding the clinical, biological, engineering and materials factors that influence the wear process. Recent advances, however, have markedly improved our understanding of the generation and consequences of wear debris and have led to new means for addressing the problem of wear-related osteolysis. This workshop was organized around a series of clinical, biological, and engineering topics concerning implant wear. Invited participants represented the clinical and research communities, the orthopaedic implant manufacturers, and governmental agencies. Results of the workshop will be published in both electronic and printed versions during Spring 2001. As future advances in wear problems are made, peer-reviewed revisions will keep the electronic proceedings current. Standards
ISO The ISO Technical Committee 150 met in Stockholm, Sweden on Sept 10-15, 2000. Issues discussed at the workshop included animal model testing as well as the continued development of standards. The hip wear issue continues to be contentious due to the fact that most U.S. simulators will not conform to the current international standard. The U.S. delegation hopes to have input at the voting level on a revised standard to accommodate U.S. hip wear simulators. If successful, the effort would be groundbreaking in ISO history. The next ISO meeting will be held in Canberra, Australia. Issues that may be addressed include spine/osteosynthesis and tissue engineering standards. ASTM A symposium addressing a wide variety of issues related to bone graft substitutes was held at the November meeting of the ASTM in Orlando, FL. The AAOS Biomedical Engineering and Biological Implants Committees participated in this workshop. Other participants included FDA and industry. A summary of the workshop is being compiled and will be made available to the Forum. ASTM will meet next in Phoenix, AZ on May 9-11, 2001. The Tissue Engineered Medical Products (TEMPS) division of ASTM continues to make progress on draft standards for biological products. A standard for scaffolds is expected to be available for balloting in February of 2001. The AAOS Biomedical Engineering and Biological Implants Committees continue to be active in educational efforts. The Biological Implants Committee is finalizing advisory statements on cell- and tissue engineered products and musculoskeletal tissue allografts. A brochure on tissue donation also is being completed by the Committee in conjunction with the American Association of Tissue Banks (AATB). The Committee will hold a bone graft substitutes scientific exhibit at the AAOS 2001 Annual Meeting. The Biomedical Engineering Committee intends to draft an advisory statement on the re-use of medical devices labeled or intended for only one use as well as author a number of articles for the AAOS Bulletin. Cartilage Guidance Work continues on a guidance document for cartilage lesions of the knee. A revised document will be circulated to Device Forum members in February 2001 with the expectation that a final draft may be available for review at the AAOS Annual meeting beginning on February 28, 2001. The document could be submitted to the FDA according to Good Guidance Practices sometime in Spring 2001. Vertebroplasty The Forum was given a presentation on vertebroplasty. Vertebroplasty is a surgical procedure recently introduced into the United States used to treat osteoporotic vertebral compression fractures where bone cement with a radiopaque agent is injected into a vertebral body to provide mechanical stability or restore vertebral body height. While the procedure currently is not very common in the United States, with approximately 400,000-700,000 individuals suffering from osteoporotic spine fractures annually, its usage is predicted to increase dramatically over the next five years. FDA considers the procedure to be off label and no clinical trials have been completed nor have any investigational device exemption (IDE) applications been approved. A similar procedure to vertebroplasty is also being performed to treat vertebral compression fractures. This procedure, kyphoplasty, also is an off-label procedure with no clinical trials having been conducted. In a note of interest, on October 25, 2000, the FDA issued a warning letter to Kyphon, Inc. with regard to medical claims made on its web site concerning the use of kyphon inflatable bone tamp. Alternative Clinical Studies for Hips and Knees The Device Forum discussed whether predetermined objective performance criteria (OPC) can be developed for hip and knee devices. OPC could possibly serve as an alternative to randomized or concurrent controlled study designs and shorten evaluation time for standardized devices. OSMA is working on a guidance document for total hip replacements using OPC. RSA Studies/Bone Cement/Mobile Bearings Smith and Nephew is conducting a roentgen stereophotogrammetric analysis (RSA) study on Versabond cement in Sweden using Palacos cement as a control. Initial data is favorable. FDA Report
The FDA held 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 was to gather information about human bone allograft in relation to FDA's proposed tissue rules. FDA proposed the following questions prior to the meeting:
HCFA Report A representative from the Department of Health and Human Services (HHS) Health Care Financing Administration (HCFA) presented the Device Forum with a detailed review of the Medicare coverage decision-making process. Coverage of Carticel was used as an example to illustrate the steps necessary for a procedure or device to receive a coverage decision from HCFA. The presentation reviewed HCFA's coverage authority and coverage decision-making process as well as the issues addressed for a reconsideration of coverage decisions made by HCFA. In addition, the HCFA representative highlighted the June 7, 2000 Executive Memorandum issued by President Clinton directing the Secretary of Health and Human Services to "explicitly authorize Medicare payment for routine patient care costs...and costs due to medical complications associated with participation in clinical trials." Web Education Workshop Efforts continue on developing a web-based educational tool that would allow physicians to review key information about medical devices. Such a system could serve as a physician's desk reference for surgeons. The FDA is in the planning stages of developing a one-page document for PMA-approved devices that would include a device's indications, description, pictures and pertinent web links. Custom Devices Device Forum members discussed issues related to improving device product development. A number of issues were raised regarding the use of custom devices and how their use may be hampering the development of new products. A recommendation was made that the Forum bring together key figures within industry to improve product development. According to the FDA's Investigational Device Exemption Manual, custom devices are exempt from certain statutory requirements. For example, manufacturers of custom devices are not required to comply with premarket approval requirements (Section 515) and are exempt from premarket notification requirements [Section 510(k)]. Custom devices are not exempt from the GMP requirements. Current FDA policy however, is not to inspect manufacturers of custom devices. Manufacturers of custom devices should comply with the GMP requirements while considering the flexibility allowed. Post-Market Surveillance The FDA issued a proposed rule on August 29, 2000 to implement the postmarket surveillance provisions of the FDA Modernization Act of 1997. The purpose of the proposed rule is to provide a framework for the collection of useful data or other information on the safety and effectiveness of devices. Forum members are interested in seeing that the system remains effective and does not unduly burden researchers and manufacturers. OSMA Update OSMA filed its metal on metal reclassification petition with the FDA. OSMA hopes to present its petition at the next FDA device panel meeting on Jan. 18-19, 2001. The guidance on exemptions from Medical Device Reporting (MDR) for orthopaedic devices prepared by OSMA has been finalized and was presented to the Device Forum. |
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