Committee Updates

Devices and Technology Committee
Education Committee
Washington Committee
Web Site Committee

Devices and Technology Committee
Mark R Proctor, MD

The Devices and Technology Committee met with the FDA in San Diego on Sept. 15. The previous meeting with the FDA was in April during the AANS meeting in Washington, D.C.

To recap the September meeting, Jeff Blount, MD, gave an excellent presentation to the FDA regarding the use of vagal nerve stimulators in the pediatric population. This presentation was essentially informational, and no action items were generated. There were some suggestions on how to proceed to obtain FDA approval of pediatric use for this device, but since it is already on the market and the process would be so cumbersome, it seems unlikely that this will occur. Compassionate use options were discussed.

There also was a recap of our rejected FDA “Petition to Exempt Cranial Orthoses from Premarket Notification Requirements.” To briefly summarize, this petition was jointly submitted to the FDA by the Pediatric Section and the Washington Committee of the AANS/CNS in an effort to make helmets more accessible (both financially and geographically). Despite an initial enthusiastic response from the FDA, the petition ultimately was rejected. A law firm, which presumably represented the large helmet manufacturers, objected to our motion in a late filing; the wording of the FDA’s final ruling was remarkably similar to that of the filing.

At the April meeting the new chief of the neurological devices committee at the FDA had informed us that the petition was rejected because we failed to submit medical device reports that outline the risks of the helmets. To the best of our knowledge no MDRs were in existence, which is why none was submitted with the petition. In short, for five months now we have been attempting to obtain the MDRs for the FDA. We have done an exhaustive search of all available public records and cannot find a single MDR that reports an adverse effect of helmet use to the FDA. We have asked the FDA on several occasions to help with this search. At the September meeting we elected to file a Freedom of Information Act with the FDA to locate the alleged MDRs. If in fact the FDA is unable to produce an MDR, the rejection of our petition was without basis and we will have to decide how to proceed (potential options include resubmission, producing our own scientific statement in our literature on the safety of the helmets, or producing a public statement critical of the FDA for rejecting the petition without basis). I propose that we await the results of the Freedom of Information Act filing before proceeding further.

Education Committee
Paul Steinbok, MD, BSc

The Pediatric Section’s Education Committee is cosponsoring two courses in 2007. The first, cosponsored with FLANC, is a neuroendoscopy and pediatric neurosurgery course to be held in Baranquilla, Colombia, Oct. 27-31. Section participants are Paul Steinbok, MD, Jeff Wisoff, MD, Dale Swift, MD, and Mark Souweidane, MD. The second course, cosponsored with the ISPN, will be held in Beijing, China, Dec. 8-9. Section participants are Tad Tomita, MD, Paul Steinbok, MD, and Enrique Ventureyra, MD.

The committee also is conducting two surveys. George Jallo, MD, has completed a survey of international activities that have been carried out by section members, and Phil Aldana is surveying section members to identify the educational needs of pediatricians. The latter information will assist in developing educational programs in pediatric neurosurgery for pediatricians.

Washington Committee
Andrew Parent, MD

The Washington Committee met July 13 in Washington, D.C., and discussed the following topics.

The third edition of the Traumatic Brain Injury Guidelines has been released. The guidelines include some significant modifications specifically alluding to the option of anticonvulsants in head injuries, suggesting that in low-risk patients, their utilization may not be needed. These guidelines do not change the pediatric neurotrauma guidelines that have previously been released.

The Centers for Medicare and Medicaid Services is changing its usage of “comparative effectiveness research” as a measure of success in its pay-for-performance program. It appears that patient outcomes will be utilized in the future to determine a portion of physician payment. The efficacy of this approach has certainly not been demonstrated, especially in the surgical arena. Its relevance seems to be related to the prophylactic use of antibiotics, prevention of deep venous thrombosis, wound healing and the control of other medical conditions.

The Washington Committee’s subcommittee to determine the value of a neurosurgeon to a hospital has had its first meeting. At this particular meeting, James Ausman, MD, made a presentation defining the value of a neurosurgeon as the "contribution margin" to a hospital. This is defined as the difference between what a hospital collects as a result of the work of a neurosurgeon minus the cost. Although this contribution margin will clearly vary depending upon the types of cases performed, the payer mix of patients, as well as geographic location of the contribution margin may vary between $5,000 and $12,000 per case, based upon data in the year 2004. The contribution margin is highest in tumor, vascular and trauma cases, moderate in epilepsy, stereotactic, spine and pediatrics and low in peripheral nerve cases. The total neurosurgery hospital contribution margin, per neurosurgeon, ranges from $1.5 million to $2 million per year for an average practicing neurosurgeon, according to the case data that was presented.

There was a presentation by the American College of Surgeons regarding its National Surgical Quality Improvement Program, ACS NSQIP, which is based upon a similar program that had been developed in the U.S. Department of Veteran’s Affairs system. At present, there is no pediatric program, although a pilot program is planned in the near future. Nationally, there are over 160 hospitals collecting data with greater than 200 cases regarding 136 variables in surgical patient care.

There was a report from the American Board of Neurological Surgery, the Congress of Neurological Surgery and the American Association of Neurological Surgeons on the coordination of data collection from ABNS Maintenance of Certification into a single database, allowing the development of outcome reports. At present, it is anticipated that there will be 14 key cases that will be monitored, among which will be aneurysms, tumors, anterior cervical discectomies, tethered cord, Chiari malformation and intracerebral hemorrhages. From this data will be developed risk analysis benchmarks as well as outcome data. Data will not be identifiable by practitioner. This data system may be online as early as September 2007 and the Washington Committee will play an important role in the coordination of data collection, although the system will continued to be owned by the American Board of Neurological Surgery.

Web Site Committee
Douglas Brockmeyer, MD

The Web Site Committee continues to refine and modify the new Web site, www.pedsneurosurgery.org, in an effort to better serve the Pediatric Section membership.

One such refinement is the Shunt X-ray Project submitted by S. Scott Lollis, MD, and Ann-Christine Duhaime, MD. For the first time, X-rays that show how various shunts appear radiographically are organized in one place. You can view these images at pedsneurosurgery.org. We hope this project is a helpful service to our members!