University of Pittsburgh Senior Design - BioE Universal Facemask Adapter Nicole Burns Mike Callahan LaDahvia Flournoy Gabrielle Ramus Advisor: Dr. Virginia Dato, M.D./M.P.H

Project Evolution 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 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

Overview We designed a gasket type adapter to fit between the users face and a preexisting particulate respirator The facemask adapter is designed to attach to preexisting masks to increase the fit factor of the mask. The adapter will be used primarily by healthcare professionals and those in medical related fields

The Need The concept for a facemask adapter was explored due to different facial structures of individuals making it difficult or almost impossible to obtain a fit from preexisting masks Also considered was the expense of fit testing and the time and money spent by companies to fit people

User and Requirements The customer is a healthcare provider that is in close contact with a high volume of infected patients In the year 2000 there were approximately 5.98 million healthcare practitioners in the U.S. Requirements Disposable and available in large quantities Must conform to the user’s face Must block floating particulates as well as the mask Must be comfortable enough for continuous wear and not prevent the user from seeing, speaking, or breathing normally The adapter must meet NIOSH requirements

Regulatory Standards FDA Regulation—Classification Class II Medical Device Based on predicate devices such as surgical face masks and disposable respirators Applicable Standards NIOSH 42 CFR 84 N95 At least 99.7% of particles will be filtered from any environment containing no oil1. The particles expelled from the body during a cough, sneeze, or even when talking range in size from less than one to five micrometers.

Quality System Considerations Human Factors Improper positioning of the adapter Symmetrical in the frontal and lateral planes The adapter is only intended to be used for the life of a mask The adapter should not be used by individuals with facial hair

Competitive Analysis There are currently no manufacturers of a facemask adapter but the mask manufacturers themselves may object to the need for such a product The fact remains that not all masks are compatible with all face shapes and some people can not be properly fit with any kind of mask—illustrating the need for our product

Project Objectives Initial design of a prototype – SolidWorks model Fabrication of several prototypes Refinement of SolidWorks model Adapter testing Analysis of testing results

Project Timeline

Engineering Technologies/Methodologies Computer aided engineering (CAE)  SolidWorks Digitization of preexisting mask  Geomagic Hand made fabrication of prototype

The Design

Foam Adapter Two types of foam were considered Memory foam Airtex High density foam Phase I prototypes were created by hand due to the irregularity of the SolidWorks designs

The Design Problems The two prototypes were hand- designed/made This raises issues of inconsistency and its impacts on quality and reliability of the product Reproducibility is low

The Design Product Cost eFoamStore quote Die of shape  $375 Exact price per piece not given High Density Foam Slab is 1" x 18" x 96" $29.99 ~ 50 adapters can be produced per slab ~ $0.60 per adapter

The Design Polyacrylamide Gel-Filled Vinyl Prototype

The Design Issues with Gel-Filled Vinyl Prototype Mass- ~80grams / 2.8 ounces Likely cannot be used/tested without adhesive Volume of acrylamide Phase I manufacturability Acrylamide viscosity

The Design Manufacturing and Price Analysis Raw materials ~$8.00 Manufacturing Equipment ~$30.00 Scale up Reduced cost Reproducibility—heat sealing issues

The Design Theoretically better able to conform to various facial structures IHA—existing technology No issues with mechanical/material failure, allergies Human Factors—symmetrical  ease of application Vinyl covering meets pore size constraints

Prototype Testing OSHA 29 CFR Qualitative Fit Test (QLFT) Quantitative Fit Test (QNFT)

Qualitative Fit Test Bitrex

Prototype Testing cont… 3 Experiments per subject Sensitization, Without Adapter & With Adapter Goals when testing with adapter Pass or Fail w/o Adapter – Pass with Adapter ~10 subjects who have failed Preliminary Results Total: 11 subjects tested 3 out of 4 that failed without adapter passed the fit test with the adapter W/O Adapter With Adapter Pass79 Fail42

Preliminary Conclusions and Recommendations Preliminary results indicate potential for success More testing needs to be completed Due to subjective nature of the Bitrex test, PortaCount is recommended Testing with adhesive Different masks must be explored and further refinement of UFA will likely be needed The economic benefit arises due to the eventual elimination of fit testing with further development of the adapter

Acknowledgments Sources of Funding Generous gift of Drs. Hal Wrigley and Linda Baker Department of Bioengineering Andy Holmes Dr. Virginia Dato, PA Department of Health Dr. Eric Toner, UPMC Center for Biosecurity

Questions

Appendix A: Individual Project Work Nicole Burns DHF, SBIR Material Selection Testing Mike Callahan DHF, SBIR Material selection Prototype manufacturing LaDahvia Flornoy DHF, SBIR Material Selection Testing Gabrielle Ramus DHF, SBIR SolidWorks design Geomagic modeling Material selection Prototype manufacturing