General Hospital and Personal Use Devices Panel - September 27, 2005
Complete transcript will be available at http://www.fda.gov/ohrms/dockets/ac/cdrh05.html#GeneralHospitalPersonalUse
The General Hospital and Personal Use Devices Panel met on September 27, 2005 in Gaithersburg, MD, to make a recommendation to the Food and Drug Administration (FDA) the committee will discuss and make recommendations regarding general issues related to the model used for validation testing to support a claim of decontamination of potentially Transmissible Spongiform Encephalopathy (TSE)-contaminated surgical instruments. The Panel membership for this meeting consisted of a microbiologist, an epidemiologist, a family physician, a biomedical engineer, two Neurosurgeons, an industry representative, and a consumer representative.
The Panel heard four FDA presentations which included a general introduction to TSE with an emphasis on the iatrogenic transmission of Creutzfeldt-Jakob disease (CJD), the experimental design issues in the in-vivo models of TSE transmission, the basic statistical considerations needed to properly design and to evaluate large animal studies of product efficacy and a risk analysis of the risk for iatrogenic transmission of CJD by contaminated surgical instruments in the United States today. The FDA guest speaker, Mr. Alan Hidderley, Senior Medical Device Specialist from the Medicines and Healthcare products Regulatory Agency, UK discussed variant CJD in the UK and the regulatory approach of MHRA to the field of vCJD device decontamination. In the Open Public Sessions, the Panel heard presentations discussing the infection control aspects of CJD in hospitals and the advantages of the animal model used by InPro in studying CJD transmission. In the Industry Session, the Panel heard from 3 speakers. Dr. Peter Burke of Steris Corporation discussed studies sponsored by Steris on TSE transmission and advocated the use of several study models. Dr. Richard Marchand of TSO3, Inc. discussed sensitivity and result interpretation in in-vivo models of TSE. Dr. Stanley Prusiner of InPro and UCSF presented results from some of his studies of TSE and advocated the use of human sources of prions.
The Advisory Panel considered 6 questions. The Panel stated that it was reasonable to validate a claim for “reducing TSE infectivity” using in-vivo studies. The use of human prion sources and transgenic animals was most desirable in such studies and that animal studies should be compared to human source results. A claim for vCJD activity should be supported by vCJD data. Studies should be powered to achieve a “sufficient confidence level”. The “log reduction in infectivity” is the endpoint to be considered in data evaluation. Validating studies should examine “complex shapes” and “ingenuity” was recommended in evaluating this admittedly difficult technical issue. Studies of other materials besides stainless steel were also advised. In-vivo studies must approximate the conditions of clinical use of a product/process as closely as possible. A claim of “complete elimination of TSE infectivity” could not be validated at this time given the present state of the science. The panel noted that this may change in the future.
The FDA and Industry concluded with very complimentary statements to the panel regarding its work with the questions posed to the panel.
Contact: Scott A. Colburn, Executive Secretary, at 301-594-1287, ext. 177, or via email at: email@example.com.
Transcripts of this meeting may be purchased from:
Neal R. Gross
Court Reporters and Transcribers
1323 Rhode Island Avenue, NW
Washington, DC 20005
(202) 234-4433 or (800) 473-1433
The Food and Drug Administration
Freedom of Information Staff (HFI-35)
5600 Fishers Lane
Rockville, MD 20852
301-827-6500 (voice) or 301-443-1726 (FAX)