The General Hospital and Personal Use Devices Panel met on Tuesday, August 9, 2005 in Gaithersburg, MD, to make a recommendation to the Food and Drug Administration (FDA) on the methods to assess the potential of disease transmission by multiple-use nozzle jet injectors (i.e., jet injectors for which the fluid path for the injection is used more than once).. The Panel membership for this meeting consisted of a microbiologist, an epidemiologist, a nd pediatrician, a family physician, a biomedical engineer, a device industry representative, and a consumer representative.
The FDA presented information on the safety and effectiveness of the device, what is currently applied to the review of MUNJIs and testing methods currently used by sponsors to demonstrate assess splash back. Following FDA, WHO presented with a summary of its clinical and statistical findings related to MUNJI use and recommendations to the panel related to their concerns of MUNJI devices. The principal concern relating presented regarding MUNJI use is the potential for disease transmission when a jet injector nozzle is contaminated with infected blood or serum during an injection. When contamination of the MUNJI occurs on the skin-contacting surface of the jet injector or in the fluid path, the residual infected blood or serum can be injected into the subsequent patient potentially infecting that patient with a blood borne disease. Industry followed with a presentation from PATH demonstrating studies being implemented in demonstrating the safety of a device through the ability to identify a significant decrease in the amount of contamination that can be detected using these new testing methods (e.g. Fluorescein Test).
After deliberations, the Panel discussed FDA’s questions presented to the panel. FDA’s main concern was to identity if there are any testing methods that can be used to identity determine a significant decrease in splash back of blood/contaminant and to identify what would be an acceptable threshold level of contamination to demonstrate the safe use of these devices.
The Panel believed testing methods presented by PATH would potentially be a good laboratory model to test that the device is safe under the conditions for use. However, the panel did indicate that the studies (Fluorescein Study) will need to be validated before FDA would be able to effectively use this data from a sponsor or to put into a guidance document. The Panel also deliberated and came to a majority decision that based on current technologies, a non detectable level of contamination would be the only acceptable level to effectively demonstrate that MUNJI devices are safe when used as intended. The non-detectable level should be based on the most sensitive methods currently available. General comments were brought up by the panel stating that the risk/benefit should be considered when evaluating MUNJIs (e.g. – bioterrorism). Also mentioned was that preamendment and precleared MUNJIs must meet the current expectations to remain on the market.
The FDA, WHO and Industry concluded with very complimentary statements to the panel regarding its work with the questions posed to the panel.
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