Present:

The new Chairman of the Committee on Biological Implants of AAOS was welcomed and introduced to the Orthopaedic Device Forum.

Two new teams are being formed: the Bioresearch monitoring team and Postmarket team. The Bioresearch monitoring team will consider how to improve the inspection process, manage and make decisions, and interface with the Bioresearch monitoring program. The Postmarket team will select appropriate scientific and regulatory strategies for public health decisions and will take an active approach to postmarket issues.

The FDA is downclassifying 38 devices and will publish the reclassifications in the Federal Register. The knee reclassification document is moving through the FDA process. The shoulder reclassification petition, which includes the cemented shoulder, must be reviewed by the regulatory staff. The elbow reclassification is part of the mass down classification effort.

The 510k pilot program is apparently successful. FDA is receiving a lot of Special 510k’s, but not too many Abbreviated 510k’s. By declaring conformity to standards, the FDA thought it would reduce their workload. FDA received 30 abbreviated 510k’s in one year. The FDA had one PDP (Product Development Protocol) go to completion.

Special 510k’s require a 30 day internal review. Abbreviated or traditional 510 k’s are a 90-day review process. If a manufacturer declares conformity to standards of 50%, the FDA will focus its review on the other 50%. In the U.S., ASTM, ANSI, AATB produce consensus standards.

Orthopaedic implants were excluded from possible third party reviews by the FDA Modernization Act. FDA’s definition of a permanent implant is anything that is implanted longer than 30 days. Third party reviews are not allowed on these devices therefore, IM rods and external fixators are excluded.

A slide presentation illustrated the increased level of Bioengineering research support from NIH for FY 1997. Harold Varmus, MD, PhD, National Institutes of Health Director, is currently focusing on the "burden of disease" to society. Dr. Katz, Director of NIAMS, appears to be committed to musculoskeletal concerns. There are four types of grants: Bioengineering Research Partnerships (BRP’s), Tissue Engineering RFA, R03 Small Grants (RFA), and Bioengineering Research Grants (BRG’s) which are through an R01 mechanism. NIAMS has internally identified three disadvantaged communities: bioengineering, clinical research, and social and psychological research. They are particularly interested in the field of bioengineering and want to be responsive to that community. NIAMS may partner with medical societies to develop musculoskeletal registries.

The mission statement was approved. Forum members had a discussion about changing the term "orthopaedic scientists" to "physicians". The term orthopaedic scientist will remain on the FDA recognition statement and will not be changed.

The Device Forum website has been set-up. The domain http://www.orthpaedicdeviceforum.org has been registered. It was decided to have a three-month trial run beginning March 1, 1999, where Forum members will have access to the site before it is available to the general public. The Orthopaedic Device Forum Proclamation, which includes the mission statement, operational principles, and the FDA recognition award statement, will be included on the Forum page. Individuals will not be identified in the body of the report but will be identified as being present on the first page of the summation report. The Orthopaedic Device Forum website will link to the ASTM, ORS, FDA, AOA, NIH, AAOS and Arthritis Foundation websites after the trial period.

Future meeting dates will be posted, however the location will not be listed. Jeanie Kennedy will be listed as the contact person with AAOS phone number and email address provided. Future agendas will be posted two weeks prior to the meeting on the website. Sunday speakers will not be identified.

A new AAOS policy has been drafted and will be placed on the website. Members will have the agendas approximately two weeks before the meeting and will be given ample opportunity to review agenda items for potential conflict. Academy members will disclose once a year, and at the beginning of each meeting, as appropriate.

An update on the polyethylene guidance document was presented. Manufacturers are working on new forms of polyethylene and that fact was taken into consideration in the drafting of the document. There are a plethora of new processes for polyethylene in last few years. Different processes can change the mechanical characteristics of UHMWPE. A manufacturer would need to file a new claim (510k) if there are 4-5 modifications in substance, changes in spectrum range or performance, or are outside of ranges of approved substances.

FDA felt that the UHMWPE guidance document was helpful and gave them ranges to follow. Manufacturers are also using the guideline, but are mindful that laboratory data cannot be used to develop clinical conclusions. There is still much to learn about polyethylene even though manufacturers have been working with it for decades.

The International President’s breakfast will be held during the Academy’s annual meeting in February 1999. Members attending the breakfast will receive a handout that solicits help in identifying orthopaedic surgeons from the international membership who will work to develop ISO standards for orthopaedic surgical implants.

The Chairman of ASTM F-04 division’s term ends in 1999. Openings for chairs of F-04 subcommittees still exist. The next meeting of ASTM will take place on May 19-21, 1999 in Seattle, Washington. The following meeting will be in Kansas City, Missouri in November 1999. The Committee on Biological Implants and Biomedical Engineering are proposing a joint meeting to be held in May in conjunction with the ASTM meeting. FDA and ASTM will educate members of both committees about processes involved in writing standards and the potentials of collaboration among various groups. The Forum Chairman will present a proposal for the joint committee meeting at the AAOS January Council on Research.

ASTM serves as liaison but also serves to provide coordination to other standards. The Society of Tissue Engineering, Tissue Culture Society, Pharmacopia, and others want to coordinate the writing of standards regarding cell, tissue, and biologics with ASTM.

A handout was presented from an ORS workshop agenda on FDA: Policies and Protocols for Device Approval. Topics covered were an overview of the FDA regulatory aspect relative to biologics, safety and efficacy of biologics, how a company would address the needs of the surgeon and FDA, and the role of the ORS.

The Forum was updated on the soon to be released book, "Animal Models in Orthopaedic Research" edited by Yuehuei H. An and Richard J. Friedman. The editors consulted many experts and the work is very comprehensive. An and Friedman’s books begins with safety and efficacy of animal models and encompasses bone conditions, articular cartilage and joint conditions, joint replacement, ligaments and tendons, spinal conditions, and microsurgical technique.

Articular cartilage and fracture repair guidance documents are currently being drafted. The resulting guideline can be used in the development of ASTM standards. After discussion, it was suggested that the scientific community might be able to help the FDA develop guidance documents. It was noted that some products have been on the market for years without standards.

Progress continues on the cartilage resurfacing guidance. A draft will be available at the April meeting. It was mentioned that the only way to understand the process of writing a guidance document is to actually write the document. It’s imperative to have something in writing in order to be able to critique it. Conference calls were suggested to coordinate ongoing efforts on guidance documents.

FDA mentioned that the spinal guidance document was ready to go out for comment.

Forum members were briefed on suggestions from a FDA representative. FDA suggests that the Forum define and justify exemptions on internal fixation, THR, and TKR. Members of the Forum will solicit suggestions from both the Hip and Knee Societies.

The Forum was updated on the symposium "Regulatory Aspects in Orthopaedics" which will be held Thursday, February 4, 1999 at the AAOS annual meeting. Speakers will be allotted approximately 13 minutes each and a question and answer period will follow. This symposium will address the evolution of the regulatory process, moving new products and technologies through the regulatory process with the FDAMA of 1997, the role of device standards in the orthopaedic product approval process, custom, special products and off label device usage, and surveillance: insuring the safety of orthopaedic devices, and the role of the Orthopaedic Device Forum.

An application will be submitted through the Bioengineering committee for a symposium on polyethylene for the 2000 AAOS annual meeting.

The possibility of developing a new approach to orthopaedic device labeling was discussed. The fact that some physicians do not read inserts is of some concern. Manufacturers try to minimize continual label changes and seek to condense labels. Further, class III labels are significantly different than class II. Orthopaedic device labels need to be translated into many different languages as well.

There exists a wide variance of labeling in class II and special recommendations would need to be noted on the labeling. It was decided to form a labeling work group, which will consist of three Forum members to further study the issue of uniformity in labeling.

A brief update was presented on the proposed downclassification of metal-metal devices. IDE studies are ongoing and one has already been completed.