Complete transcript will be available at http://www.fda.gov/ohrms/dockets/ac/cdrh07.htm
The General Hospital and Personal Use Devices Panel met on Friday, May 4, 2007 in Gaithersburg, MD, to make recommendations to the Food and Drug Administration (FDA). The committee was to discuss and make recommendations on the scientific and clinical issues raised by the addition of antimicrobial agents to personal protective equipment (PPE). The PPE to be discussed are surgical masks/respirators, medical gloves, and surgical/isolation gowns. The Panel membership for this meeting consisted of a medical doctor, a biomedical engineer, an infection control practitioner, two infection control nurses, a surgeon, an infectious disease medical doctor, a microbiologist, an epidemiologist, an industry representative, and a consumer representative.
The Panel heard six FDA presentations which included Dr. Sheila Murphey M.D., Branch Chief of the Infection Control Devices Branch (INCB), who presented a general overview of the clinical and scientific concerns related to antimicrobial agents on PPE. Mrs. Michelle Rios, reviewer in INCB, discussed the current review process for non-PPE devices and the current FDA thinking on the data needed on antimicrobial agents added to non-PPE devices. The Panel next heard from three INCB reviewers who discussed the current review process for different PPE devices and issues related to the application of antimicrobial agents to these devices. These presentations included Mr. Terrell Cunningham R.N., who discussed medical gloves, Dr. R. Kapil Panguluri, Ph.D., who discussed surgical masks and surgical N95 respirators, and Dr. Geetha C. Jayan Ph.D. who discussed surgical and isolation gowns. The FDA presentations concluded with Dr. Sheila Murphey who discussed the clinical considerations of antimicrobial agents on PPE due to the illness of Dr. Spooner. In the Open Public Sessions, the Panel heard presentations from Mr. George Laventure, Jr. and Mr. Brain Heimbuch of the Air Force Research Laboratory who discussed the difficulties in developing standardized aerosolized test methods for assessing antimicrobial activity on products. Mr. Karl Perkes of Nelson Laboratories discussed the commercially available test methods for antimicrobial activity. Dr. Samy Rengasamy, Ph.D, of NIOSH discussed the particulate criteria for N95 respirators. Mr. Bob Weber of 3M Corporation discussed particulate size discrepancies in test methods. In the Industry Session, the Panel heard from 5 speakers. Mr. Tom Page of Cupron Inc. presented information related to their copper impregnated respirator, Dr. Wava Truscott, Ph.D. of Safe Life Corporation presented information and studies related to their Triosyn iodinated resin incorporated into respirators, Dr. Stephen Rothenburger Ph.D. of Ethicon presented their assays for measuring in-vivo antibacterial activity of sutures. Dr. Derek Warneke Ph.D. of MicroActive Corporation indicated they are a manufacturer of delivery systems for chlorine dioxide gas and discussed the need for fair evaluation of study data. Dr. Konstantin Goranov, Ph.D. of Noveko International Inc. discussed their mask with an antimicrobial agent.
The Advisory Panel considered 6 questions. The Panel agreed that three possible indications for antimicrobials on PPE could be prevention or reduction of contamination, colonization, and/or infection in the healthcare personnel and/or patient. They noted that prevention or reduction of colonization on the PPE device was not a clinically relevant indication. They recommended that these indications for reducing colonization/infection of patients should be supported by clinical data with the final finished device compared to the untreated device. The Panel recommended that in vitro and/or in vivo testing should evaluate antimicrobial efficacy under wet and dry conditions, with clinically relevant short time points, and with a variety of clinically relevant organisms. Results for the antimicrobial treated PPE should be compared to the untreated PPE device. The Panel stated that significant reduction of an aerosol of an infectious inoculum compared to the control device or a simply demonstrating an ability to kill microbes on the surface of the device could be both applicable testing criteria depending on the indication for masks/respirators. Since the toxicology and long terms risks of antimicrobials on PPE are not known, the Panel recommended that rigorous evaluation of biocompatibility and safety data be provided for both patients and device users. This safety data should also address the potential leach off or physical detachment of the antimicrobial into body sites or onto objects. In addition, special attention should be provided for safety of at risk populations such as pediatric, neonatal, immunocompromised, or pregnant women. The Panel said that labeling of antimicrobial agents on PPE should recommend compliance with infection control procedures; educational programs for health care users may be needed.
The FDA and Industry concluded with very complimentary statements to the panel regarding its work with the questions posed to the panel.
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Under normal circumstances, panel summary minutes are available 60-90 days post meeting. Summaries are also available on the CDRH web site.