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Orthopaedic Device
Forum Present:
Members of the Orthopaedic Device Forum introduced themselves and disclosed conflicts of interest. Approval of December 3-4, 2000 Summation Report Members reviewed and approved the summation report from the December 2000 meeting of the Orthopaedic Device Forum as written. |
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| New Technologies Discussion
The Forum entertained a discussion on how to develop new products in a timely fashion that also fulfills the FDA's requirements for safety and effectiveness. Three points of view were presented: a surgeon/device developer, a FDA representative and a manufacturer. Surgeon/Device Developer Prior to 1976, a surgeon, an engineer and a manufacturer collaborated to produce a new medical device. Since 1976, a similar development scenario remains in effect although the timeline has increased significantly. Most current orthopaedic devices are usually submitted as 510k applications, many were developed as custom devices and a few entered via the IDE-PMA route. Until approximately 2000, many devices were initiated through the manufacturers custom device program or were originally marketed in Europe, i.e.: metal on metal and ceramic on ceramic hip replacement prostheses. The latest resurfacing technologies were also initiated overseas. Obstacles to new technology development include regulatory hurdles, managed care, reimbursement issues, and the cost of development. There has been a recent thrust by the FDA to evaluate and regulate custom use. Humanitarian exemption has rarely been used. Of additional concern, the informed consent of patients involved in clinical trials continues to be a significant issue in the United States. Investigators contend that it is neither feasible nor practical to consult an Independent Review Board (IRB) at every juncture. Product development could be enhanced by more surgeon involvement in the development and FDA process. It is hoped that the FDA will be able to facilitate new development through unique mechanisms yet to be developed consistent with a least burdensome approach. Global harmonization efforts are a tremendous benefit for manufacturers, particularly in the standards area. Nonetheless, regulatory burdens do differ from country to country. FDA From FDA's perspective, the agency has made tremendous progress in meeting their deadlines. Review times are decreasing for both PMA applications and PMA supplements. In FY 2000, 76% of IDEs were accepted on their first review. FDA notes that there is a shared responsibility for public health that includes the FDA, industry, physicians, and patients. It is the FDA's intention to carefully evaluate claims and facts and communicate effectively with its stakeholders. The challenges the FDA faces in doing so include staffing, workload, the current hiring freeze, maintaining acceptable review times, meeting panel schedules, and working with industry prior to IDE submissions. Dr. David Feigal, the Director of the Center of Devices and Radiological Health, is most interested in assessing the Total Product Life Cycle (TPLC) of a device. The TPLC would follow a device from its inception to its obsolescence. Manufacturer An orthopaedic device manufacturer presented his perspective on new product development. Traditionally, product development proceeds in the following manner: an idea or concept is sketched, a prototype is made, the product undergoes review and adjustments are made. Next, a second prototype incorporating those adjustments is produced, a cadaver trial is initiated, more revisions are incurred, further trials proceed, and an IDE or a 510k application is submitted to FDA. Additional adjustments may or may not be attempted and finally an orthopaedic implant may be available for general use on the market. Device manufacturers and surgeons question how many times a custom device may be used. FDA's interpretation of the definition of a custom device is that a custom device can only be used once. There are other mechanisms for the developing a product or providing access to products such as a humanitarian use exemption program (HDE), sponsor investigator IDEs, and feasibility study IDEs. A typical product development track for a biological product proceeds in the following manner: an idea or concept is sketched, a laboratory develops the product, and cell culture and safety testing is performed. A cadaver trial or animal testing may be necessary, followed by an IDE or a 510k application with FDA and human trials. Finally, a PMA application may be submitted preceding the general marketing of the product. According to manufacturers, barriers to product development include cost of development, post-market surveillance, and inconsistent requirements for FDA and HCFA. General Discussion FDA encourages the use of IDE feasibility studies, sponsor investigator IDEs, and special 510ks. Feasibility and sponsor investigator studies can provide information to help design the clinical trial. Some surgeons contend that orthopaedic devices are not life threatening devices, and therefore should not be Class III devices. FDAMA and the Public Health Service (PHS) Act require that any device marketed after 1976 is automatically categorized as a Class III device. FDA will consider petitions for downclassifications on specific devices. FDA encourages the development of guidance documents for hips and knee devices. FDA supports the development of guidance documents that incorporate strategies that balance pre-market requirements with post-market practices to achieve a 'least burdensome' path to market. Forum members acknowledged that some technologies are being developed overseas due to the regulatory hurdles in this country. Representatives suggested that the cooperation of FDA and HCFA would provide huge benefit for manufacturers and users. It was also agreed that the overuse of antibiotics is expected to be a huge problem in this country. Registry Several of the Forum members participated in a conference call with members of the FDA Office of Surveillance and Biometrics, Office of Device Evaluation, and the Office of Science and Technology to discuss possible registry efforts. Members explored and discussed the possibilities of considering a balance of pre-market requirements and post-market requirements. The chairman of the AAOS Task Force on the Hip and Knee Registry gave a presentation to the Forum. AAOS leadership is assessing the feasibility of a national joint implant registry. It would be most innovative, as most registries currently functioning in this country tend to be disease specific. Rationale for a National Registry Adverse events can and do occur with device implants. With a national registry, information can be gathered earlier in the event of device failures or product recalls. HCFA Database HFCA's database is available to the public and includes the fields of age, gender, race and reimbursement. The rate of device revision is significantly higher in this country than in some foreign countries (ex. Sweden). If the HCFA data fields were modified, more research questions would be answered. Foreign Registries Some foreign registries are government financed and have flexibility in design and implementation. Prior legislative approval is not necessary. Sweden, Norway, Denmark, United Kingdom and Canada maintain orthopaedic implant registries. The Swedish registry is of particular interest to some surgeons in this country. The data fields in the Swedish registry represent 104 different questions. With this breadth of information, problems are caught early. Manufacturers in Sweden receive information from the registry administrators without other manufacturers being aware of adverse events or product comparisons. The Swedish registry was designed to discover problems early and benefit the patient. Benefits Potential benefits of a national joint registry include denominator value, contemporary information, early adverse event information and epidemiology. Surgeons suggested three important data fields to include in registry development: laterality, reason for revision and the specific device that is implanted. Obstacles Obstacles to a national joint registry include physician compliance, patient privacy issues, discoverability and liability issues, multiple party payers and financing. It is anticipated that a legislative remedy will be necessary to prevent discoverability/liability concerns. Additionally, manufacturers have grave concerns about possible product comparisons. Identifying ownership of the data is crucial to the financing, privacy, and litigation perspectives. A conservative estimate for the start up cost is $7 million with an additional $5 million per year to cover registry administration. In January 2000, the NIH Consensus Conference on Implant Device Retrieval concluded that a total joint registry was not a feasible option for the United States due to liability and privacy concerns. PMS Post market surveillance has historically provided limited information in the U.S. due to liability issues. FDA has an interest in the total product life cycle (TPLC) of a device. However, under the Food and Drug Administration's Modernization Act (FDAMA), post-market surveillance requirements (PMS) have are limited in length to three years, unless there is a compelling safety issue or the sponsor agrees to a longer period. The Next Steps The AAOS work group will design a pilot project with data capture at twelve centers. An Independent Review Board (IRB) will be consulted and legal input will be required. Discussion with Surveillance and Biometrics- FDA Members from the Office of Surveillance and Biometrics (OSB) attended the Forum for a brief discussion on the possible hip and knee registry. FDA representatives commented that all registries are different and may need to be treated in accordance with the nuances particular to the design of the registry. Registries work best when designed to answer specific questions. Cardiac Registry Prior to developing a registry for cardiac devices, FDA had informal discussions with the American College of Cardiology. Stakeholders decided to focus on patients and capitalize on the data to benefit public health. FDA held a workshop and identified generic needs of device manufacturers (ex. pacemakers and defibrillators). Initially, stakeholders chose heart valves, a technology that had been well developed, and focused on clinical questions. While many stakeholders agree that medical device reporting (MDR) has had a limited amount of success, members of the Forum suggested that information now be made public. Forum members recommended initiating a registry to provide information on the new technologies including cross-linked polyethylenes, metal/metal and ceramic/ceramic hip devices. OSB staff reminded the Forum that the MDR database can be downloaded from the Center's Web site. Furthermore, OSB staff has worked with manufacturers who routinely download the MDR database as a means to evaluate products. Members agreed that some information acquired post-market is even more important than pre-market information. While PMAs have a post market requirement, a Forum representative commented that once that requirement is met, funding for the study is probably discontinued. AAOS Committee Reports Biomedical Engineering Committee Members of the AAOS Biomedical Engineering Committee (BME) were faculty on the symposium at the AAOS 2001 Annual Meeting on alternative bearing surfaces. The symposium was very well attended. The committee has recently published articles in the Bulletin on health care technology assessment, clinical trials and cross-linked polyethylenes. The BME committee anticipates several more articles will publish in the next few months. The Biomedical Engineering Committee is currently working on three advisory statements: single use device reprocessing, cross-linked polyethylenes used for knee components and vertebroplasty/kyphoplasty. In accordance with the AAOS 2005 initiative, the BME committee intends to provide information on the regulatory status of devices used by surgeons. Information on specific regulatory requirements is very difficult to find. Due to developments occurring during pedicle screw litigation, surgeons want clarification on the regulatory status of devices. Members suggested that the toll-free numbers of manufacturer's regulatory affairs divisions be posted on the AAOS website. Biological Implants Committee The Biological Implants committee co-sponsored a workshop on bone graft substitutes at the November 2001 ASTM meeting. The workshop was extremely well attended and a monograph of the proceedings is anticipated. The committee has submitted two applications for scientific exhibits for Annual Meeting 2002. One exhibit will provide information on the latest developments in bone graft substitutes while the other exhibit will be a cooperative effort with the American Association of Tissue Banks (AATB) on tissue donation. A committee member submitted an application for an instructional course lecture (ICL) on the use of antibiotic bone cement. Additionally, an application was submitted for a symposium and an ICL on bone graft substitutes and their clinical applications. Cartilage Guidance Document Members reviewed and amended the proposed draft guidance document on the repair of hyaline articular cartilage. The work group anticipates a submission to FDA in the near future. Vertebroplasty and Kyphoplasty FDA notes that adverse events have been reported from vertebroplasty and kyphoplasty procedures. According to FDA, some of these were serious injuries and deaths. FDA encourages the collection of data and/or clinical studies. However, FDA does recognize that this procedure may be beneficial in the treatment of osteoporotic fractures not currently addressed by conservative means. Interventional radiologists, neurosurgeons and orthopaedic surgeons perform both of these procedures. Many surgeons are using cranioplasty cement, which has been cleared by FDA to form a patch on the skull. An Orthopaedic Research Society (ORS) study found that if a vertebra is filled with bone cement then the fracture rate for the vertebrae above and below the treated vertebra increased. It is unknown how many vertebrae may be treated during a single procedure. Members reported that many academic and clinical centers are advertising vertebroplasty and kyphoplasty procedures on their websites. HCFA maintains a specific code for vertebroplasty. No specific code for kyphoplasty currently exists. The American Association of Neurological Surgeons (AANS) has begun working on a guidance document for these procedures. The proposed document is anticipated to encompass both clinical and pre-clinical information. The Forum requested to be apprised of the proposed guidance document developments. AAOS representatives met with NIH officials to stimulate research efforts on vertebroplasty and kyphoplasty. NIH may discuss this topic at their spring 2001 retreat. Industry is already selling bone cement, and believes clinical trials for procedures inserting bone cement into the spine would be too expensive to support this indication for use. If clinical trials are undertaken, a Forum member suggested that small monkeys would be an appropriate animal model. Hip Guidance Orthopaedic Surgical Manufacturers Association (OSMA) has drafted two proposed hip guidance documents. "Class II Special Controls Guidance: Hip Joint Metal/Polymer Constrained Cement or Uncemented Prosthesis" and "Guidance Document for the Preparation of Premarket Notifications for Constrained Hip Prostheses" will be reviewed by the AAOS Committee on Biomedical Engineering and a number of Orthopaedic Research Society (ORS) members. Consultants A work group was formed to discuss the functions consultants might provide to the Forum. Some members are seeking external funding and this work group will discuss monetary issues as well as define duties expected of consultants. Metal/Metal Members of this work group held a conference call recently. The petition is addressing deficiencies identified by FDA reviewers and is expected to be reviewed by the FDA Orthopaedic and Rehabilitative Devices Panel in August 2001. Privacy The Health Insurance Portability and Accountability Act (HIPAA) has provisions that include controversial elements to fraud and abuse issues; Congress is expected to modify these provisions within the next two years. The final rule takes effect on April 14, 2001 however, compliance is expected in three years. AAOS has two areas of concern: the burden of administration for physician office staff and the effect of privacy constraints on clinical research. The Academy is aware of ongoing discussions at the National Institute for Arthritis and Musculoskeletal and Skin Diseases (NIAMS) with regard to the onerous burdens on researchers. A legal remedy is anticipated with the current presidential administration. FDA Update The document Class II Exempt Special Controls Guidance for Various Orthopedic Fixation Devices; Final Guidance for Industry was published on December 20, 2000. This document was inadvertently issued as a level 2 guidance and should have been published as a level 1 guidance with an opportunity for public comment. FDA recently published a guidance document on the acceptance of foreign clinical studies. The guidance states that foreign studies performed under an Investigational New Drug application (IND) or Investigational Device Exemption (IDE) must meet the same requirements of a US study. Also, FDA notes that revisions to the Declaration of Helsinki must be made prior to U.S. acceptance. As currently drafted, one provision allows a placebo control for life threatening illnesses. This provision is unacceptable to the U.S. when a treatment is available. Standards ASTM will hold a workshop at the November 2001 meeting on cross-linked polyethylenes. The November symposium topic is "Spinal Implants: Are we evaluating them appropriately?" International Standards Organization (ISO) will meet in Canberra, Australia in September 2001. International standards harmonization efforts continue to develop within different standards organizations. ASTM anticipates a more pro-active stance in the world-wide standards community harmonization efforts in the next couple of months. Furthermore, tissue standards continue to develop at ASTM and it is anticipated that a workshop on tissue engineering will be held in 2002. 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. OSMA Update Orthopaedic Surgical Manufacturers Association (OSMA) currently has 27 member companies. Biologics companies continue to join OSMA as member companies. For now, OSMA anticipates the August FDA Orthopaedics and Rehabilitative Devices panel meeting on metal/metal and is working on comments to the Good Tissue Practice proposed rule. Next Meeting
IDEs
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