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Orthopaedic Device
Forum Present:
HCFA representatives were introduced and welcomed to the Orthopaedic Device Forum. Members of the American Association of Neurological Surgeons, Congress of Neurological Surgeons, and the American Society of Plastic Surgeons were in attendance as guests of the Forum.
The Food and Drug Administration (FDA) has promoted the success of the Orthopaedic Device Forum. The FDA has encouraged other medical specialty societies to use the Forum as a model to increase communication between the scientific community, government, and related industry.
Approval of October 17-18, 1999 Summation Report
Members reviewed, amended, and approved the summation report from the October 1999 meeting of the Orthopaedic Device Forum.
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| Liability Issues
Members briefly discussed the past liability issues with regard to the Orthopaedic Device Forum. The summation reports are now public on the website www.orthopaedicdeviceforum.org. Board Report
Bone and Joint Decade The Bone and Joint Decade was launched at an international event in Geneva, Switzerland from January 13-15, 2000. Activities included a press conference, reception, and scientific meeting that focused on measuring the burden of musculoskeletal diseases on societies. The AAOS Washington office commented on the Bone and Joint negotiations with the White House. Since the toll-free number was established, the White House has received an influx of calls and faxes in support of a U.S. proclamation. To date, sixteen nations and four U.S. states have endorsed the Bone and Joint Decade. Standards The AAOS has embraced standards development since the inception of the American Society of Testing and Materials (ASTM) Medical/Surgical division, F-04 in 1962. Meetings are held twice a year. The next meeting will be held in Toronto, Canada on May 24-26, 2000. The symposium will address the topic, "Past, Present, and Future of ASTM." ASTM is currently considering efforts to decrease the amount of time that standards development requires. ASTM is suggesting with more widespread use of the Internet, standards development may be able to rival the international model of one year. Members suggested that initially standards organizations must agree on nomenclature. The Academy is still supportive of involvement with the International Standards Organization (ISO) as many significant standards developments are occurring in the international arena. NIH Consensus Conference
The NIH Technology Consensus Conference on Improving Medical Implant Retrieval Information: Challenges and Opportunities was held January 10-12, 2000. Several Forum members participated in the conference and a draft statement was released on January 21, 2000.
The panel addressed the following key questions:
Organizational Issues Since the Forum membership has increased significantly during the past year, members thought it timely to consider organizational issues. One of the keys to the success of the Forum is that organizations have sent representatives from their highest levels. The Forum may need to consider member transition issues. It was observed that one member does not currently possess funding and that this issue may be a problem in the future for additional members. Financial issues were raised, in that Forum members may consider alternate funding in the future. Governmental agencies must consider the appearance of conflict of interest. AAOS Board of Directors tend not to be familiar with Forum activities, which is why it is vitally important to have Board representation on the Forum. Members stated that they were not comfortable with adding more structure to the Forum. The Forum was initially formulated to provide interaction between governmental agencies and associations and to facilitate new devices coming on to the marketplace. Forum interactions have helped focus the review of reclassification efforts, market applications, and guidance documents. A work group was formed and will consider future developments of organizational issues. Wear Workshop 2000 The location in Chicago has been secured for October 21-23, 2000. The date, however, may be pushed back one day to accommodate some of the participant's schedules. Proceedings will hopefully be posted on the World Wide Web by November 2000. National Institutes of Health (NIH) will review the grant application in March 2000. Questions have already been circulated and participants will arrive at the workshop with prepared answers. Organizers of the Wear Workshop 2000 would like to solicit help from the Biomedical Engineering committee to review the web site on a regular basis, to ensure that the information will stay current with technological advancements. Approximately ten Young Investigators will be invited to the workshop. Industry representatives will be decided on in the very near future. Medical Device Reporting (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. Global Harmonization
The Director of the Division of Dental, Infection Control, & General Hospital Devices of CDRH/FDA spoke briefly about their Global Harmonization Task Force (GHTF). The GHTF is a voluntary international consortium of public health officials responsible for administering national medical device regulatory systems.
The purpose of the GHTF is to encourage convergence in regulatory practices related to ensuring the safety, efficacy, performance and quality of medical devices and to promote technological innovation and facilitate international trade. Primarily, this is accomplished through the publication and dissemination of harmonized guidance documents on basic regulatory practices. The GHTF has four study groups: premarket, vigilance, quality systems, and audits.
The idea for an international partnership between medical device regulatory authorities and related industry began in 1992. The founding members of the GHTF are the U.S., Canada, EU, Australia, and Japan.
The GHTF has signed a Memorandum of Understanding with ISO/TC 210 with the agreement that they will:
Single-use Device Reprocessing The reprocessing of single-use devices (SUD) continues to be a complex issue. FDA mentioned that they published a guidance document in April 1996, "Labeling Reusable Medical Devices for Reprocessing in Health Care Facilities: FDA Reviewer Guidance". Two more guidance documents will be forthcoming. Data on the reprocessing of single-use devices are inconsistent. FDA has attempted to gain a greater perspective on this issue by holding public meetings. From FDA's perspective, reprocessors of single-use devices will be held to the same standards as the original equipment manufacturers. The focus of the new guidances, "Reprocessing and Reuse of Single-Use Devices: Review Prioritization Scheme," and "Enforcement Priorities for Single-Use Devices Reprocessed by Third Parties and Hospitals" is third-party reprocessors and hospitals. The risk prioritization scheme does not include opened but unused devices or implantable devices (which are considered high-risk devices by FDA). FDA is looking at the reprocessing of single-use devices with an eye towards the future. For example, prions could become a significant issue. The Forum has formed a subcommittee to study this issue in greater detail. AAOS will comment to FDA through the Biomedical Engineering Committee. Comment deadline is April 11, 2000. Guidance Documents In the early 90's, medical device companies complained that the FDA guidance process was not sufficiently open to public comment. As a result, the FDA developed the Good Guidance Practice (GGP). Level one guidance documents are a new type of guidance and are published in the Federal Register and do not have to originate from FDA. Level one guidance documents must have a public comment period, usually sixty days from the day the notice is available in the Federal Register. FDA will then examine the comments, finalize the guidance and make it available on their website. A level two guidance document could be a rewrite of an existing guidance document and does not have to be listed in the Federal Register. Guidance documents are considered living documents and are always available for comment. Cartilage The introduction of the guidance document for the repair of hyaline articular cartilage has been greatly expanded. Members noted that it is difficult to measure the safety and efficacy of biological tissues. Authors continue to work on the clinical portions of the document. Forum members suggested discussing the different disease states or different patient population within the document. Other members suggested adding time frames for important events. It was noted that the "Mass Cell" CBER guidance document stipulates 1 year and 3 year data. Several members remarked that many clinical studies are having problems with enrollment, in that patients are opting out of them. Patients regularly object to invasive procedures to document efficacy, as well as to being randomized. Bone Graft A brief update of the bone graft guidance document was presented. Members suggested that smoking needs to be included in covariant analysis due to the fact that smoking has been shown to affect fracture healing. Collagen Members are encouraged to provide feedback on this document and to solicit opinions from colleagues. FDA Update
Bone Cement The Device Forum plans to initiate discussions related to the regulatory requirements of bone cement with antibiotics for marketing and use. Data from the Norwegian hip registry may be useful as a starting point for these discussions. Bone Dowels The Orthopaedic and Rehabilitative Devices panel is not scheduled to discuss bone dowels in the near future. CBER is moving forward with tissue regulations and changes in tissue regulation may affect the regulation of bone dowels. NIAMS Update
HCFA Update
Next Meeting
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