Present:

A conference call was held in place of the scheduled meeting due to weather conditions necessitating the cancellation of a face-to-face meeting.

Review of Forum Priorities

Participants reviewed the list of Forum priorities that were developed at the July 31-August 1, 2005 meeting in Bethesda, MD. A member of the research community noted that these priorities are a recurrent theme in many of the items on the Forum agenda.

Orthopaedic Surgical Manufacturers Association (OSMA) Update

OSMA has reviewed the Forum priorities and is in agreement with the content:

1. Combination Products – address regulatory issues, develop an education plan, seek key personnel to attend Forum meetings to help shape the discussion
2. Clinical Performance Standards – development of guidance documents, defining appropriate clinical endpoints (including pre-clinical endpoints), focusing on safety
3. Technology Transfer – new technology assessment, small volume products, addressing conflict of interest, cost and reimbursement issues
4. FDA Orthopaedic and Rehabilitation Devices Panel Issues
5. Organizational Issues (Forum) – maintain an environment that is conducive to the exchange of information and ideas and allows for the development of novel approaches and solutions to current challenges in bringing products to market, attendance and membership issues
6. Research and Education – focus on educational efforts (Forum providing educational sessions to FDA and CMS staff), translational research

The organization also reviewed the list of guidance document priorities from the Division of General, Restorative, and Neurological Devices (DGRND) of the Food and Drug Administration (FDA). An FDA liaison noted that those priorities are not guaranteed a position on the Office of Device Evaluation or Center for Devices and Radiological Health (CDRH) priority list. Forum members requested that the list be circulated again for reference.

Guidance Documents and Petitions

OSMA is preparing a comment in response to the reclassification of the intervertebral body fusion device that appeared in the Federal Register on February 9, 2006. Comments will also be submitted on the “Clinical Data Presentations for Orthopedic Device Applications Guidance for Industry and FDA Staff.” OSMA members stated they are prepared to draft guidance documents for the mobile bearing knee and metal-on-metal total hip down classification when the FDA is ready to review these issues.

A FDA liaison indicated that the guidance documents could be drafted and submitted before they are formally requested. This will enable the FDA to move more quickly as topics move up the priority list. The FDA liaison will research opportunities for advancing items to higher priorities and will report back to the group. Information about what the branches are working on will be shared, as available.

The cartilage and xenotransplantation guidances are moving forward through their inter-center review and will be available for public comment shortly. Member organizations will submit comments, as appropriate.

Chantilly Subcommittee

Subcommittee members stated that the priorities list that they developed would be further refined on a subsequent conference call and shared with the larger group. A standards representative will be added to the subcommittee. Members expressed concern over loss of contact with the American Academy of Orthopaedic Surgeons (AAOS) presidential line and leadership. The AAOS first vice-president has been invited to the June 2006 Forum meeting and was sent a copy of the compilation document.

The Forum chairs will work on a strategy for re-establishing and maintaining access to the AAOS presidential line and leadership.

Replacement Parts Subcommittee

The subcommittee chair referred the members to conference call minutes in the agenda book. Members of the subcommittee are still researching the extent of the problem with availability and costs of replacement components. General questions about the issue include prevalence and incidence of the need for parts. A survey conducted via the American Association of Hip and Knee Surgeons (AAHKS) is being proposed. Members will explore the issues of availability and liability through the OSMA and the AAOS Corporate Advisory Council.

American Society for Testing and Materials (ASTM)

The F04 Committee Week meetings for 2006 will be held from May 16-19 in Toronto, Canada and November 14-17 in Atlanta, GA. The November meeting will feature a workshop on nanotechnology. The F04 Committee is seeking potential topics for future symposia and recommendations may be submitted to the ASTM representative. Topics currently under consideration for future symposia or workshops include bone cements beyond polymethylmethacrylate, tissue engineered medical products, scaffolds, and biomedical imaging.

Orthopaedic Devices for Sale on eBay

Device manufacturers stated that the products being offered on this website are often stolen from hospital inventory and manufacturers. Importantly, some may have been reprocessed in an unapproved or inappropriate manner. Manufacturers do not consider these devices valid for use, as there is no way to track for the purposes of performance or recall.

The FDA Office of Compliance is investigating the sellers, buyers, and conditions of these restricted medical devices. Possible actions were discussed, including an AAOS position statement advising orthopaedic surgeons about knowing their device supplier and what steps to take if such a device came into their possession. The group will research the problem to define the issues and make a policy recommendation. Staff will solicit input from the Forum, seek advice from legal staff, contact the American Hospital Association and possibly the American Medical Association, and determine a communication strategy.

Center for Devices and Radiological Health (CDRH) Update

The closing date for comments to the Global Harmonization Taskforce on Principles of Conformity Assessment for Medical Devices and Principles of Medical Devices Classification is February 18, 2006 (http://ghtf.org/sg1/sg1-proposed.html). An effort has begun to produce guidances for countries with developing regulatory processes.

Metal Ions

CDRH staff has recently reviewed literature on metal ions resulting from metal-on-metal devices. Forum members expressed their interest in reviewing this document when it becomes available. It was noted that this topic is a central theme of a National Institute of Biomedical Imaging and Bioengineering (NIBIB) sponsored research partnership that is examining outcomes.

Biologics Subcommittee Update

On a prior conference call, subcommittee members sought to differentiate between the scope of the Forum Biologics subcommittee and the scope of the AAOS Biological Implants committee. While there are areas of overlap, this group will focus on moving information from the scientific community to the FDA and address barriers to bringing biological products to the marketplace. The group would like to include a representative from Center for Biologics Evaluation and Research (CBER) and to identify an appropriate individual from the Center for Drug Evaluation and Research (CDER) to participate in the combination products workgroup.

ASTM has prepared a standard on demineralized bone matrix (DBM) which is undergoing balloting. The standard, which is primarily focused on evaluating the biological activity of DBM, includes mention of the sterilization process and its potential effects on biological activity. Two Forum workgroups have been formed; one to address combination products and the other will focus on xenotransplantation topics. CDRH staff recommended a colleague for the xenotransplantation workgroup. Two individuals from CBER were suggested as liaisons to the combination products workgroup.

Further discussion on these topics was deferred to the next meeting.

National Institute of Arthritis, Musculoskeletal and Skin Diseases (NIAMS)/National Institute of Biomedical Imaging and Bioengineering (NIBIB)

NIAMS has a flat budget for 2006 and 2007 with a $3.2 million dollar decrease in funding to the institute this year. These reductions affect the ability to fund new and competing grants, as well as larger grants. Historically, the institute has had a 20% success rate for funding requests, but the target for FY2006 is 18%. All non-competing grants have been cut 2.35% and 12% has been cut from study sections. The impact will likely be greatest on new, first-time investigators.

NIBIB has some funding initiatives under way, with three trans-NIH projects renewed for the coming year.

Center for Biologics Evaluation and Research (CBER) Update

CBER is actively working on the cartilage guidance, however there is not a timeline yet for its release for public comment. As a result of the investigation into the tissue recall from Biomedical Tissue Services, Ltd. (BTS) in October 2005, the tissue processor was ordered to cease manufacturing on January 31, 2006.

FDA Seminars

The educational seminars began in 2003 with a $5,000 grant from the FDA Staff College and delivered seminars on spinal implants and joint arthroplasty. A seminar on bone graft and bone graft substitutes was developed for 2005 but did not receive funding. Neurological topics have been funded for 2006, but not orthopaedics. A seminar covering issues in spine could be submitted under the neurological topics and presents an opportunity for participation in 2006. A proposal has been prepared for 2007 funding and will be submitted for that time frame.

Centers for Medicare and Medicaid Services (CMS) Update

A proposed determination that the evidence is not adequate to conclude that lumbar artificial disc replacement with the Charite lumbar artificial disc is reasonable and necessary is available for comment on the CMS website until March 16, 2006. (http://www.cms.hhs.gov/mcd/viewdecisionmemo.asp?id=170).

• There are no orthopaedic coverage issues or meetings scheduled at this time.
• 2006 has been deemed the Year of Quality, encompassing the pay-for-performance initiative. Details of that project are uncertain at this time.
• CMS is also experiencing budget cuts and proposed Medicare funding will be reduced by $36 billion over 5 years.
• Personnel changes will bring two new analysts to future Forum meetings.
• Members are needed for future Medicare Coverage Advisory Committees (MCAC).

New Business

The Forum briefly discussed options for rescheduling the February meeting, including meeting during the AAOS Annual Meeting in March. Any Forum members and liaisons who will be attending the AAOS Annual Meeting should forward their availability to AAOS staff so subcommittee meetings may be arranged as feasible.

Dr. Daniel Schultz, Director of CDRH, will be invited to attend the June meeting and speak at the Sunday night session.

The next regularly scheduled meeting will be Sunday, June 11 – Monday, June 12, 2006 at the Embassy Suites at Chevy Chase Pavilion, Washington, DC.

The call adjourned at 11:55 AM ET.