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Orthopaedic Device Forum Present:
Members of the Orthopaedic Device Forum introduced themselves and disclosed conflicts of interest. Approval of July 15-16, 2001 Summation Report Members reviewed and approved the summation report from the July 2001 meeting of the Orthopaedic Device Forum. New members and guests were introduced to the Forum. Disclosure statements were updated. | ||||||
| New Technologies Discussion
The New Technologies Subcommittee held two conference calls following the July 2001 Forum meeting. Members suggested that the Forum consider reviewing the progress made since the Chantilly meeting of 1995, to identify problem areas that would be areas upon which the Forum could focus. Most committee members felt that significant problems remain in the approval and marketing clearance process for new technologies.
Chantilly Symposium (Overview/Summary) In 1992, The President of the American Orthopaedic Association contended that technology transfer was an important issue for future developments in orthopaedics, and organized a conference in Chantilly, Virginia co-sponsored with the AAOS, the ORS, the orthopaedic business community, and the CDRH. Originally, all aspects of technology transfer were considered. Regulatory concerns were a primary focus of the workshop. Fifty people attended the Chantilly workshop, including eighteen orthopaedic surgeons.
Historically, most orthopaedic products are cleared for marketing through the 510(k) process. The IDE process is a more focused and onerous one, and has involved a 2-year window for determining the safety and efficacy of orthopaedic devices.
Typically, the market place and the clinical and scientific literature decide what products succeed or fail. Members at the conference realized that efforts were needed to enhance communication with federal agencies on a continual basis. The Orthopaedic Device Forum was formed to enhance ongoing communications with industry, government and the scientific orthopaedic community in January 1996.
Today, many new technologies continue to be developed overseas, as the legal and regulatory costs and burdens for developing such products domestically leads industry to find more streamlined and less expensive approaches. New ways to identify, study and introduce small volume products are also needed. Accomplishments of the Forum Since Chantilly 1995 Issues and Problems Suggestions to Increase FDA’s Resources For Combination Products:
Discussion Many products are currently being developed overseas for multiple reasons. The European approach for product approvals stresses that safety is an infinitely more important criterion than efficacy. A product typically takes approximately two years longer to be approved in the U.S. than in Europe.Some U.S. manufacturers suggest a change in thinking at the FDA on risk assumption for devices to include: life-threatening, life supporting, and non-life supporting categories. Additionally, FDA personnel must have a very broad range of expertise; and/or have very specific expertise that can be used by other areas of the division/agency. The Forum decided that many issues were worthy of a more lengthy discussion. Additionally, some issues are beyond the scope of the Orthopaedic Branch at the FDA, therefore the solutions cannot be readily accomplished. Some proposed solutions will clearly require a legislative remedy. Education and Fellowship Programs CDRH has expressed concern in providing continuing education for staff. Forum members suggested one to four hour educational seminars on specific topics for CDRH staff. One option is to have members make presentations immediately following Orthopaedic Device Forum meetings.FDA representatives responded positively to suggestions to create fellowships for service at the FDA. Optimally, the fellowships would encompass six months to one year. Funding questions remain but one member suggested a possible Orthopaedic Research and Education (OREF) grant. Note: Since the October 2001 meeting, CDRH has published the following report on Science in the Regulatory Process.
Science at Work in CDRH: A Report on the Role of Science in the Regulatory Process;
Legislative FDA will need a legislative mandate in order to recognize ISO certifications. Additionally, FDA requires a legislative mandate to use 3rd party reviewers for implanted devices.Panel Forum members suggested that the two-year rule to prove efficacy should be changed as the FDA’s Orthopaedic and Rehabilitative Devices Panel had previously suggested. Members noted that the Panel tends to elicit opinions that are academically oriented. Additionally, some members are concerned about the broad interpretation of FDA’s conflict of interest policy.Pre-market/Post-market Balance FDA will entertain discussion on options to the pre-market-post-market balance of safety and efficacy. The development of a guidance document would be beneficial for delineating possible mechanisms of interpretation.New Technologies/Next Steps The Forum will compile a list of issues and problems of mutual interest. Members should confer with their organizations to determine priorities.Electronic Submissions FDA encourages more electronic device and supplement applications. OSMA will communicate with their members accordingly.Standards ISO The International Standards Organization (ISO) annual meeting was held in Canberra, Australia in mid-September, 2001. An outpouring of international sentiments of sorrow was shared with the U.S. delegation after the September 11, 2001 tragedies. After discussion, the delegation decided to continue the progress of work as planned to honor the memories of those who had lost their lives in recent U.S. events. The U.S. delegation totaled 26 members, with 15 representing ASTM F-04 division.
ISO members are very interested in developing biological standards, and they intend to mount significant efforts in that area. Additionally, members expressed an interest in developing standards for single-use devices (SUDs).
The U.S. delegation continues to oppose the new ISO hip simulator standard. The standard was written specifically for UK hip simulator machines. Most U.S. hip simulators are not in compliance with the new ISO standard. The U.S. delegation is moving a parallel standard forward but the new ISO standard must first be published. Forum members are concerned that unlike ASTM, ISO need not resolve negative votes. A 2/3-majority vote is all that is needed to affirm approval of standards in ISO.
Minimum Data Sets A member of the U.S. delegation met with Arthur Brantwood in Australia. U.S. hospitals are misinterpreting the ISO standard, for instance, by labeling every bone screw. Numerator and denominator figures may be incorrectly determined through this inadvertent misinterpretation. A strategy will be devised to clear up the misinterpretation of the standard in the U.S. ASTM Future meetings and symposia at ASTM:
ASTM has 138 technical committees and produces many global standards. The American National Standards Institute (ANSI) continues to be the national representative for ISO. Forum members suggested that more participation from the clinical community in the standards development process would be beneficial.
Spinal Innovation An OSMA representative gave a presentation on “Innovation in Spine: Products and Challenges.”
As the U.S. population continues to age, spine is currently 11% of the orthopaedics market in the U.S. Spinal products are projected to increase to 14% of the market by 2004. Spine products can be categorized into either core or emerging technologies. Presently, the core sector represents 66% of spine market in the U.S. Examples of core products include hooks, rods, screws, internal fixation systems, interbody fusion devices, and vertebral body replacement systems. The reconstructive market is growing and is currently at 1.78 billion dollars per year. Hooks, rods and screws constitute 2/3 of that market.
The fastest growing segment in spine is interbody fusions, with the cervical spine becoming a larger market. Additionally, biological products are projected to increase exponentially by 2006.
FDA has well-trained reviewers, and communication between FDA and industry continues to be dependable. Nonetheless, challenges remain for off-label use of spine products, interbody fusion devices, and PMA/IDE pathways of 5-7 years.
Emerging Spine Products can be grouped into 4 categories:
Challenges for industry include combined reviews at FDA (CDRH+CBER), unpredictability at different review branches, reimbursement, and marketing claims. Typically, reimbursement is better for hard devices and instrumentation than for soft devices or combination products.
An OSMA member advocated that the FDA utilize the De Novo process and review discretion in order to move more orthopedic products to market. The DeNovo classification has not been used for implants, to date.
FDA’s databases of medical device approvals and adverse events must be upgraded in order to be of use to the general public. Currently, the databases do not have searchable indexes that provide useful results.
Guidances The cartilage guidance may be completed before the end of the year. After the Forum has finished the final draft, representatives of CBER and CDRH will review the document for compliance with good guidance practices.
The bone graft guidance will be submitted to ASTM for further development.
Antibiotic Bone Cement OSMA could submit a petition for the approval of antibiotic bone cement, however FDA intends to investigate some legal hurdles that the product incurred previously. FDA will conduct a comprehensive history of the product and identify a pathway to overcome some of the clearance or approval problems. The Forum will discuss possible pathways for clearance/approval of antibiotic bone cement at their January meeting. NIH Update NIH does not currently have a budget, but is on track to double the budget by 2003. The burden of disease data are very beneficial to NIAMS to provide statistics on the impact that musculoskeletal disease has on society.
The program announcement (PA) for orthopaedic implant wear was published on September 25, 2001. This PA is an outgrowth of the AAOS/NIH October 2000 workshop on orthopaedic implant wear. “Implant Wear” book summarizing the findings of the workshop, is currently available through AAOS customer service at 800/626-6726.
AAOS Biological Implants Committee NIH/AAOS workshop on molecular biology was held in Phoenix, AZ in September 2001. A book will be published by the AAOS and the proceedings of the breakout sessions will be published in the Journal of Bone and Joint Surgery (JBJS).
The Biological Implants committee has a full roster of educational activities planned for Annual Meeting 2002. The committee will present a symposium, scientific exhibit and instructional course lecture on bone graft substitutes. The committee has partnered with AATB to sponsor a scientific exhibit on tissue donation.
AAOS Biomedical Engineering Committee ORS/AAOS will present the symposium, “Wear: From Bench to Bedside” at the AAOS Annual Meeting in Dallas. The Biomedical Engineering committee will also sponsor two scientific exhibits, “Alternative Bearing Surfaces” and “New Polys for Old.”
The Orthopaedic Research Society will present a 2-part workshop on clinical research at their annual meeting. The workshop will focus on the quality of evidence and new developments in clinical trials. Unfortunately, clinician attendance is sparse at these workshops. ORS will examine ways to increase attendance at this event in the future. Additionally, Dr. James Weinstein will repeat his AAOS clinical trial workshop in April 2002.
SUD AAOS has formed a coalition with the American Hospital Association (AHA) and the Mayo Clinic to discuss single-use device (SUD) reprocessing issues. Other associations interested in joining the coalition will meet in October of 2001. Zirconia Heads St. Gobain Desmarquest recalled nine lots of ceramic zirconia heads on August 14, 2001. Lots were distributed worldwide by more than 51 companies. Fractures in some hip components were not evident until 13-28 months after implantation. Fortunately, the French post-market surveillance system picked up a higher than normal fracture rate. The company has determined that a change in the manufacturing process, specifically the furnaces, was the cause of the faulty zirconia heads. Registry Workshop The AAOS & the Agency for Healthcare Research and Quality (AHRQ) will co-sponsor a workshop to discuss the feasibility of a national joint registry. The workshop will be held in the Washington, DC area on December 10-11, 2001. FDA Update
OSMA Update OSMA recently held a meeting and discussed the metal/metal hip reclassification petition and FDA panel meeting. OSMA members will contact FDA to determine future steps in bringing this technology to a successful pre-market approval.
Due to the Sept. 11, 2001 tragedies, some companies have imposed moratoriums on company travel. As a result, key participants of the mobile bearing knee workgroup did not attend the OSMA meeting.
New deadlines for the privacy regulations will soon be in effect by the federal government. Under the new guidelines, industry is considered a “business associate’ of hospitals.
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