University of PittsburghSenior Design - BioE 1160-1161

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

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 1910.134

• 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

Pass 7 9

Fail 4 2

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