Universal Facemask Adapter (UFA) N. Burns, M. Callahan, L. Flournoy, G. Ramus

1. 0.50” 1.0” 1.0” 0.75” Figure 1. Final design of the UFA with associated dimensions Figure 2. Polyacrylamide gel filled adapter • Testing Methodology • Qualitative Fit Testing • The testing used to validate the success of the prototypes involved a three stage process: Bitrex™ detection with sensitization, testing without the adapter, and testing with an adapter. • Initially ten subjects who failed a respirator fit test without the use of the UFA was desired for testing • Success of the Phase I prototypes would be based on the aforementioned subjects passing the qualitative fit test only when using the UFA. Universal Facemask Adapter (UFA) N. Burns, M. Callahan, L. Flournoy, G. Ramus • Results • Currently, eleven subjects have been tested using the Bitrex™ method, four of which have failed the qualitative fit test without the use of the UFA • Three of the four subjects who failed the fit test without the use of the UFA subsequently passed the fit test with the use of our product • One subject who passed the initial fit test without the adapter failed the second fit test with the UFA • A table summarizing the results of the Bitrex testing can be found below. • Design Methodology • Design Development • The initial design and shape were created in SolidWorks 2006 (SolidWorks Corp., Waltham, MA) • A prototype was created and the SolidWorks model was refined several times until the final shape and design was determined • Foam Adapter • Using the Solidworks models as a guide a prototype was created by hand out of Airtex high density foam. • The dimensions of the foam adapter are show in Figure 1 below. • The foam adapter costs approximately $0.60 to produce by hand, but with further refinement mass production could greatly reduce this cost • Polyacrylamide Gel Adapter • The desired shape of the adapter was transferred onto thin vinyl (PVC) sheeting, and a second sheet was then glued and heat sealed on top of it • Non-toxic polyacrylamide gel was then injected into the space between the two vinyl sheets • The cost per adapter is approximately $1.80, but this would decrease dramatically with larger scale production The Impetus Widespread flu pandemics crippled the country and the world in 1918, 1957, and 1968. There is generally acceptance that whether a similar pandemic will occur is not a question of, “if” but rather, “when”. The next strain of influenza that may make the jump to pandemic status is hypothesized to be H5N1, more commonly known as avian influenza or the bird flu. Based on consultation with clinical advisors, the original intention for this senior design effort was design and development of a improved disposable particulate respirator that would effectively prevent passage of H5N1 virus-containing particulates into a healthcare providers’ airway while not impairing their ability to function in their particular job. Because it is not known what form the virus may take if it becomes capable of human-to-human transmission, this non-pharmaceutical intervention would likely be a highly desirable source of protection. After several reviews of possible designs, the concept was re-geared toward the creation of a gasket-type adaptor that would sit in between the user’s face and a preexisting mask to better seal any gaps that naturally exist due to the populations differing facial structures. This approach would allow existing masks—as well as any masks that may yet be developed— to be immediately improved allowing more effective and adequate protection from both avian flu and a variety of other infectious diseases. Figure 3. Participant of the fit testing procedure. Discussion Although further testing must be done, the preliminary fit testing that was performed with the use of the Universal Facemask Adapter indicates the potential for success of the product. However, the Bitrex™ testing—due to its qualitative nature—is relatively subjective, and relies heavily on the perception of the subject being tested. It is recommended that for further testing a more quantitative test—such as PortaCount testing—is used. This would remove any potential bias that a subject may have, and would give the exact number of particulates that pass beyond the respirator. Also, the use of an adhesive to secure the UFA to both the mask and the subjects face should be tested for potential use with a final prototype. Further, to truly call this product universal, different styles of particulate respirators that are on the market must be tested with the adapter. Although only in a preliminary stage of development, results suggests the product warrants further pursuit. The economic benefit that may potentially arise due to the eventual elimination of fit testing, as well as the health and safety benefit to the intended user that the adapter would bring demand that the development of the Universal Facemask Adapter be continued. Acknowledgments Special thanks to the generous gift of Drs. Hal Wrigley and Linda Baker, the BioEngineering Department, Andy Holmes, Virginia Dato, MD, MPH—PA Department of Public Heath, and Eric Toner, MD—UPMC Center for Biosecurity