New members of AAOS, AOA and FDA were welcomed and introduced to the Orthopaedic Device Forum. Members of the scientific community disclosed potential conflicts of interest.

Approval of January 10-11 Summation Report

Website:

The Forum website orthpaedicdeviceforum.org will soon be functional. The site will have links to AAOS, FDA, AOA, ASTM, NIAMS, and ORS. Representatives of each organization will provide written authorization to the Forum for a link to their site.

FDA Update

Forum members were updated on activities at FDA since the passage of the Modernization Act.

510K Pilot:

Orthopaedic device review times continue to decrease. Orthopaedic and restorative devices averaged a review period of 70-80 days in March of 1999. Part of the success is due to the Special 510K program. The abbreviated program is apparently not as successful. FDA continues to receive feedback on this program. Objections include the charge that application of a Special 501K immediately triggers an inspection and that manufacturers must complete tests before filing this application.

The three types 510K’s include: Traditional, Special and Abbreviated. Abbreviated 510K’s require standards and guidance document references.

 PMA Program:

The FDA will allow one agreement meeting or one determination meeting, however there can be many preagreement meetings. Review times continue to decrease and approvals continue to increase. PMA’s are either panel track or non-panel track and tend to be educational.

PDP:

Product Development Protocol are all panel reviewed and pre-establish safety and efficacy.

FDAMA:

FDA Modernization Act has been in effect for over one year. FDA is evaluating the success and is expanding the third party review system however, it will probably not be applicable to orthopaedics.

Mass Reclassifications:

Published in the Federal Register/ Volume 64. No. 49 on Monday, March 15, 1999/ Proposed Rules.

The FDA proposed to reclassify 38 preamendment class III into class II devices. Included in the reclassification petition are four orthopaedic devices:

Elbow joint metal/ polymer constrained cemented prosthesis

Knee joint patellofemoral polymer/metal semi-constrained cemented prosthesis

Shoulder joint metal/polymer non-constrained cemented prosthesis

Shoulder joint metal/ polymer semi-constrained cemented prosthesis

Individual Reclassifications:

FDA has additional reclassifications for devices from a class III to class II: shoulder, knee, PMMA, and calcium sulphate. Bone dowels will probably be sent to a panel for recommendations on reclassification. Metal to metal reclassifications are still being considered. The mobile bearing knee petition has been sent back to OSMA. Additionally, the petition for acrylic bone cement can go to final rule.

Reengineering:

Two new teams have been formed at the Center for Devices and Radiological Health: 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.

FDA Personnel:

The Center for Devices and Radiological Health is currently looking for a new director. Jane Henney, MD, Commissioner of Food and Drugs is committed to reengineering.

Labeling Update

The subcommittee on labeling must reformulate its composition due to new personnel from OSMA. The new OSMA representative will chair the subcommittee on labeling.

Standards Update

ASTM/FDA Seminar

The AAOS Council on Research approved additional funds for a joint meeting of the Biological Implants and Biomedical Engineering committees at the May ASTM meeting. The Biological Implants and Biomedical Engineering committees will meet for a FDA/ASTM seminar on Thursday, May 20, 1999 in Seattle, Washington. Members will be educated in the processes involved in the writing of standards and the potentials of collaboration between ASTM and FDA. Each committee will meet separately for committee business later in the day.

This meeting will provide a broader focus on the processes involved in writing a guidance document. For many reasons, it’s increasingly important to participate at the document development stage. Directors of ASTM and FDA will lecture and provide an interactive session. Chairs of the committees/Forum are working on a structured agenda.

As evidenced in the listed FDA orthopaedic device reclassifications, dated March 15, 1999, FDA site standards from ISO and ASTM in the proposed rule to reclassify. ASTM standards have become increasingly important in FDA reclassifications.

Industry and clinicians admit that writing standards is a difficult proposition. It is increasingly difficult to write biological guidance. Moreover, collagen has been on the market for many years without standards. A guidance document for collagen is currently being worked on. The Polyethylene guidance document is an example of a successful development guidance process and continues to serve as a defacto standard.

ASTM tends to be a consensus organization and the rate at which documents are approved at ASTM is slow. Orthopaedic surgeons usually want more immediate developments.

ASTM/ISO

The Academy has sent several representatives to ISO in the past years. As an organization, ISO may be more important in terms of setting standards than ASTM. In addition, ISO is setting standards much more quickly than ASTM.

There is increasing importance of Academy funding for ISO activities. ASTM does not have a base of funding therefore, financial support from the Academy is crucial. It takes several years to become acquainted with the International members and continuity of ISO representatives is preferable.

European standards tend to have the most commercial impact today. ISO has instituted device tracking, which ASTM has not yet implemented. If the US is not represented at meetings such as ISO, voting may result in a restraint of trade for certain orthopaedic devices. The US has one vote at ISO and often chooses the neutral position.

ASTM, on the other hand, cannot exclude manufacturers already on the market. ASTM must have a level of cooperation with manufacturers to prevent restraint of trade.

The Academy has not had a response from the International President’s organization regarding submissions of names for participants in an ISO work group.

MDR Task Force

The Forum has set up a Medical Device Reporting subcommittee to study issues related to orthopaedic device reporting. Federal regulations require both medical device manufacturers and user facilities to report product problems and adverse events. The OSMA MDR Task Force has a draft guidance that is written specifically for orthopaedic devices. The draft guidance proposes a list of failures involving TKA, THA, and fracture fixation that would be exempt from reporting on the basis that their occurrence is well documented and their cause is not directly related to the device. The Forum MDR Task Force is soliciting comments on the list.

NIH Consensus Conference

The Orthopaedic Device Forum was well represented on the planning committee for the NIH "Technology Assessment Conference on Improving Medical Implant Performance through Retrieval Information: Opportunities and Challenges". The conference is scheduled January 10-12, 2000 at the NIH campus. The planning committee suggested that the conference address five issues, in particular:

1. What are the patient, health care provider, and societal expectations of the lifetime, costs, risks, and benefits of medical implants?
2. What can the role of information data systems be in educating the public, medical community, and policy makers about medical implants and retrieval?
3. What are the legal, ethical, religious, cultural, public policy, and economic barriers to implant retrieval and reporting, and how can they be overcome?
4. What information is necessary to evaluate and improve implant and material performance and device design?
5. What future research and institutional support are necessary to ensure continuing advances in implantable devices?

Biological Guidance Updates

Cartilage Repair Guideline

Forum members reviewed a draft of a "Guidance Document for the Repair of Hyaline Articular Cartilage." The guidance addresses the description of the device, intended uses/indications for use, preclinical data, clinical outcomes, sterilization, and degradation. The work group developing the cartilage repair guidance document is holding monthly conference calls.

The devices intended usage is for the repair of hyaline articular cartilage deficits and substantial equivalents. It was noted that it is important to identify lesion inclusions and exclusions and that inflammatory arthritis will be excluded from consideration with regard to this guidance.

It is necessary to clarify whether the guidance will include biological devices. If the intended use of the document is biological as well as that of a device, then it would be reviewed by the Center for Biologics Evaluation and Research as well as the Center for Devices and Radiological Health of the FDA.

The FDA has a significant amount of guidance already published on the Internet, which are considered living documents. The cartilage repair work group will consult some of the guidance before the next Forum meeting.

The guidance document must not be too general in nature nor too prescriptive. If the guidance document is too inclusive, it will fail to provide proper guidance.

"Public Health Issues Posed by the Use of Nonhuman Primate Xenografts in Humans" was posted by the Center for Biologics in April 1999.

The AAOS Biological Implants committee will review a draft of the cartilage document at their May meeting. The Forum will review an updated draft of the document at the July meeting.

Bone Graft Guidance

The Forum will review a draft of the bone graft guidance document at the July meeting. The bone graft subgroup welcomes participation in the development of this document.

 OSMA Update

OSMA has narrowed the search for a new representative to the Forum down to three candidates. The new representative will be introduced at the July meeting.

OSMA has set up a task force to encourage a broader membership of small companies. In addition, OSMA supports membership of biological companies and has reduced their fee schedule.

RSA

Radiostereometric analysis (RSA) has been used for over twenty years in Sweden. Studies are on ongoing in the US. Radiostereometry can measure smaller changes in implant movement than current radiological methods and may predict a two-year clinical result in six months. Most studies are being done on patients in the supine position.

Questions remain whether radiostereometric analysis will enhance the ability to provide a controlled study or predict long term failure of joint fixation. FDA will allow sponsored IDE’s, but issues of implant modification to allow RSA studies and investigator obligations to patients undergoing RSA studies need to be addressed.

NIAMS/ NIH Update

NIAMS has identified three disadvantaged communities: bioengineering, clinical research, and social and psychological research. NIAMS encourages the use of review panels and has established the Working Group on Review of Bioengineering and Technology and Instrumentation Development Research to ensure a rigorous systematic review. The small grant program has received a great response.

The Bioengineering Consortium (BECON), established in 1997 by NIH, is composed of senior level representatives from each of the NIH Institutes, Divisions and Centers.

center for scientific review. BECON continues to address bioengineering issues which also include biological concerns.