The inaugural meeting of the AANS-CNS Neurosurgical Device Forum was held on July 30-31 in Gaithersburg, Md. The Forum was established to facilitate communication and input to the Food and Drug Administration (FDA) as well as with representatives from industry. One primary goal is to provide feedback on newly developing products and technologies relevant to neurosurgery. This activity is intended to provide the FDA with initial input for decision-making processes related to the review and approval of neurological devices or procedures, as well as for ongoing guidance document and standards development. A similar group in orthopedic surgery has significantly impacted the communication among various organizations to the benefit of all involved.
Representatives Selected
Neurosurgeons involved in research and development of devices in the rapidly changing fields relevant to neurosurgery were selected as members. Richard G. Fessler, MD, PhD, chairs the Forum with additional participation from Allan Friedman, MD; Phillip L. Gildenberg, MD; Alan R. Cohen, MD; Kevin T. Foley, MD; Isabella Germano, MD; and Ted Jacobs, MD.
Representatives at the CEO or chief of regulatory affairs level from seven of the major device manufacturers attended the initial meeting, including Sofamor Danek, Medtronic Neurologic, Codman, Target Therapeutical, Stryker, Sulzer-Spine Tech and Integrated Surgical Systems.
FDA Highlights
David Feigal, MD, Director of the Center for Devices and Radiological Health (CDRH), opened the Forum by expressing his appreciation for neurosurgery’s effort to provide review, insight and input into FDA’s process. Several other high-ranking CDRH officials joined the meeting including Bernard Statland, MD, the new Director of the Office of Device Evaluation (ODE); Larry Kessler, ScD, Director of the Office of Surveillance and Biometrics; and Donna Lochner, CDRH Deputy Director. Representatives from all Division Branches (Plastic and Restorative, Orthopedic and General Surgery) that review neurological devices presented summaries of the devices they oversee and discussed current related branch activities.
Celia Whitten, MD, presented an overview of the FDA mission, the structure of ODE and the roles and responsibilities of the Division of General, Restorative and Neurological Devices that she directs. Janine Morris, a biomedical engineer and Reviewer for the General Surgery Device Branch, provided an explanation of the device process, classification system, use of guidance documents and consensus standards as well as a rundown of existing neurological device items. FDA staff also provided updates on several important issues currently affecting neurosurgery. Larry Kessler, MD, Director of the Center for Biologics Evaluation and Research, presented an overview of the new guidance document, “Reuse of Single Use Devices.”
Recent activities in the oversight of Institutional Review Boards and the protection of human research subjects were also discussed. Particular concern was expressed regarding HHS’s efforts to authorize the FDA to levy civil monetary penalties of up to $250,000 per clinical investigator and up to $1 million per research institute for violations of patient protection agreements. Such penalties would not be covered by malpractice insurance, leaving surgeons with no ability to indemnify themselves. Members advised FDA that this would cause research to become a huge personal gamble. The end result would be a dramatic halt of biomedical research in the United States.
Future Areas of Need
At the request of FDA, an overview and report of personal experiences with vertebroplasty procedures was given to FDA staff. FDA has been conducting ongoing review of this procedure looking at how the bone cement is mixed and applied as well as its safety and efficacy. The Forum agreed that it would begin exploring the possible development of a Good Guidance Document for Vertebroplasty. A work group comprised of Forum members and members from grroups such as the AANS/CNS, the American Society for Neuroradiology, the American Association of Orthopaedic Surgeons and the North American Spine is currently being formed. Once in place, this group will work with the FDA to define specific areas that need to be addressed regarding vertebroplasty after which guidance development would commence.
Also discussed at the meeting were the many neurological device standards and guidance documents that have become outdated or even obsolete. Forum members agreed that they should be reviewed. Stereotactic related items are particularly outdated and Dr. Gildenberg has agreed to initiate their review and revision.
Conclusion
Panel members finalized a Forum Mission Statement, which has now been approved by the Joint Officers of both AANS and CNS. Participants agreed that the initial meeting was extremely successful and well received by FDA staff. A follow-up meeting will be scheduled for spring 2001.
Richard G. Fessler, MD, PhD, is Chairman of the AANS/CNS Neurosurgical Device Forum. Cherie L. McNett is Senior Manager, Regulatory Affairs, _AANS-CNS Washington Office.