 |
 |
 |
Orthopaedic Device Forum Present:
A new OSMA representative was welcomed and introduced to the Orthopaedic Device Forum. Approval of April 18-19, 1999 Summation Report Members reviewed, amended, and approved the summation report from the April 1999 meeting of the Orthopaedic Device Forum. Discussion of RSA was tabled for a future agenda item. |
||||||
| Wear Workshop 2000 The preliminary proposal for the Wear Workshop 2000 is completed. Organizers anticipate additional support from AOA, ORS, the Hip Society, OSMA, NIST, and NIH. The deadline for the NIH grant is October 1, 1999 and this proposal may be folded into the 5-year submission from AAOS. Tentatively, the workshop is scheduled for June 9-11, 2000 however, the date may be changed to the fall of 2000. The Device Forum facilitates the Wear Workshop 2000. In 1995, participants were assigned questions prior to the workshop and discussed their answers during the proceedings of the weekend seminar. Subsequently, a book was drafted by the end of the workshop and published five months later. Organizers plan to post the contents of the 2000 workshop on the Internet allowing an administrator to update information about implant wear in the future. The site will have print on demand capability and hardcover books will also be available. AAOS may feature the resulting book in their catalog. MDR Discussion The Medical Device Reporting task force studies issues of medical device reporting (MDR) and post marketing surveillance (PMS). Originally, OSMA solicited responses to a document that listed device failures which would be exempt from being reported. The MDR task force reviewed the draft document and commented on the appendices of internal fixation devices and hip and knee joint replacements. For instance, one recommendation is that wear failures of greater than 8-10 years do not need to be reported. The purpose of the guidance is to have user facilities submit the best data. Traditionally, industry has over reported failures and user facilities have under reported. Forum members commented that a registry would be more helpful. OSMA has not discounted that possibility but realizes that a much more aggressive effort would be needed. NIH Technology Assessment Conference on Device Retrieval NIH is planning a conference to be held January 10-12, 2000 titled "Technology Assessment Conference on Improving Medical Implant Performance through Retrieval Information: Opportunities and Challenges." Website The Forum website is now functional and response has been uniformly positive. Additional summation reports will be posted and the web administrator will work on links with other sites. ASTM/FDA Seattle Seminar The ASTM/FDA Seattle seminar for Biomedical Engineering and Biological Implants committee members was successful. Members of ASTM and FDA each gave presentations lasting approximately two hours. ASTM/ISO Standards The fall symposium topic is "Synthetic Bioabsorbable Polymers for Implants." The meeting will be held November 16-19, 1999 in Kansas City, Mo. and Biological Implants and Biomedical Engineering committees will plan to attend if budgets allow. Biological Implants members have volunteered for the tissue- subcommittees of F-04.
International Standards Organization (ISO) ISO TC150 will be held in Germany in the fall of 1999. Several members of the Biomedical Engineering committee will be attending. It continues to be exceedingly important to be present at ISO meetings due to the majority-voting consensus. Unlike ASTM voting, ISO does not need to resolve negative votes. Hopefully in the future, ISO members will increase their electronic communication abilities. "Gordon Conference" This conference is held over one week and is a basic science format with a non-published outcome. The movement towards tissue engineering continues to grow. Board of Directors Update The Council on Education is working on a virtual simulator for arthroscopic procedures. The Board does not find simulators to be a practical teaching tool but the Council on Education is still investigating the possibilities. The Corporate Advisory Council decided to support the development of a basic course in clinical trials. This course will address issues concerning content, the design of the trials, and examine funding sources. The Directors of Research and Electronic Media will be working together on this project. ORS will work on producing a workshop at Annual meeting 2000 to address some of the issues surrounding clinical trials. ORS will design the course and the Academy will implement it. OSMA may be contacted for funding on this course. Orthopaedic Device Reference The Orthopaedic Device Reference was originally published in book format however, there is interest in producing an electronic version of it. The electronic version would be a more complete source and could constantly be updated. This reference would be very helpful in revision surgery and for radiological interpretation. The device reference could also be used for archival purposes. FDA Update David Feigal, Jr., MD, MPH is the new CDRH center director. Dr. Feigal is ex-Deputy Director of CBER in Drug Evaluation. Reengineering efforts continue at CDRH. The average total time to approve PMA’s has been cut by 25% from FY ’97 to FY ’98. Review times for 510(k)s continue to decrease in terms of the average total time to clearance and the average FDA review times. The Orthopedic and Rehabilitation Devices panel has recommended two fairly significant approvals:
Bone Dowels The Orthopedic and Rehabilitative Devices panel was scheduled to discuss bone dowels on Tuesday, July 19th however, that meeting has been postponed. The FDA suggests that products like bone dowels, while banked human tissues, may be more than minimally manipulated and therefore would be considered devices. There are factors that help determine whether the FDA will need to consider a bone graft a device. They include:
FDA recommends that the "Proposed Approach Use of Tissue" published in the Federal Register in January 1997 be used for reference on tissue guidelines. Reclassifications The reclassification for the shoulder joint metal/polymer/metal nonconstrained or semi-constrained porous-coated uncemented prosthesis is available for comment. The deadline on the comment period is August 26, 1999. HCFA Speaker Grant Bagley, MD, JD, Director of the Coverage and Analysis Group at HCFA, spoke to the Forum on Monday, July 19, 1999. When the HCFA central office receives a formal request, they may consider a device or service for a national coverage determination. HCFA will generally limit coverage to those items and services that are reasonable and necessary for the diagnosis and treatment of an illness or injury. Under the new coverage process Dr. Bagley outlined for the Forum, HCFA is actively holding public meetings, convening advisory panels, and performing technology assessments to help the Coverage and Analysis group evaluate the scientific evidence in the course of an analysis. In order for these advisory panels to be as representative as possible, they consist of a multi-disciplinary group of medical professionals and industry and consumer representatives. HCFA is also working to develop guidance documents for industry to help them prepare for submitting formal requests for coverage. Once a formal request has been accepted, HCFA will respond within 90 days with one of the following options:
HCFA does have the ability to embrace new technology. For instance, HCFA has taken a proactive approach to cryosurgery of the prostate even though it is a very difficult procedure to learn. FDA approval is important to HCFA, although it’s an entirely different issue than approving reimbursement. Off-label use is a significant matter for concern for HCFA. A coordinated effort is in everyone’s best interest and HCFA must consult FDA, CDC, among other groups of experts. Cartilage Repair Guidance Several members of the Forum continue to develop the "Guidance Document for the Repair of Hyaline Articular Cartilage." This guidance is limited to consideration of cartilage lesions of the knee. The cartilage repair guidance will address the device description: either chondro-potential cells, matrix or scaffold, or growth factor or another biologically active factor, the intended uses and indication for use, and preclinical data. The preclinical data will cover biocompatibility testing, bench/mechanical testing, shelf life, sterilization, and animal testing. Forum members questioned how much detail should be provided in the guidance document and if exclusionary provisions should be included. It was decided that histological information should be included: the smoothness of the cartilage, collagen pattern, composition of the tissue, and a stain for glycos amino glycans. Members of the Forum will provide opinions on the guidance draft. Bone Graft Guidance Members briefly reviewed the latest draft of the bone graft substitution guidance. Authors have consulted the text "Animal Models in Orthopaedic Research" by Drs. An and Friedman. The Forum will scrutinize the bone graft document in depth at the January meeting. A few members of the Biological Implants committee may be solicited to provide assistance on this document. It was decided a section on cytokines should be included. RSA Members questioned what obligation physicians have to inform their patients on tantalum beads. FDA considers 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 makers being used, the location of the markers, an their impact on that prostheses. An IDE may be required. The Biomedical Engineering committee may work on a statement on RSAs and implanting. Biologics Global harmonization efforts continue to be important. Products registered in the United States as devices are pharmaceuticals in other countries.
Next meeting: FDAMA is not consistent with a new judgement which ruled that non-approved uses of devices and drugs were appropriate as long as uses were quantified in peer-reviewed publications. |
|||||||