Universal Facemask Adapter - Pitt



Universal Facemask Adapter

Human Factors Analysis

4/15/2007

Nicole Burns

Mike Callahan

LaDahvia Flournoy

Gabrielle Ramus

CONTENTS

Purpose 3

Scope 3

Device Characteristics 3

Device Use 4

User Population 4

Device Environments 5

Human Use Related Hazards 5

Validation and Verification 6

Purpose

This document was created to identify potential operator hazards during the device’s intended use.

Scope

• This document is to be used as a guide for device-related research and development. It was compiled for the sole use of direction. It is not intended to function as a formal product specification. Documents referenced within may be included in the formal design history file at a later date.

• The proposed design solution must undergo validation, review, and complete testing. This document is to be used to identify the potential hazards, design function, and user requirements necessary for incorporation into the final design.

• There are hazards outside of the reasoning used to create the following document. Novel errors may be encountered before a final design is selected.

1. Device Characteristics

a. Primary function: create a seamless seal between the user’s face and mask

i. Currently there is an issue with expensive fit testing techniques for health care professionals. This device will eventually negate the need to fit test all hospital staff

1. adapter will function to improve fit tests on users that would otherwise fail a fit test with a disposable mask

ii. This adapter potentially could save hospitals millions

1. The procedure for fit testing for a mask requires placing numerous masks on the user and running various tests. It is common to cycle through ten different masks and still not find one that fits properly. This method will potentially be eliminated with our adapter.

b. Intended Users:

i. Clinicians

1. Hospital personnel

a. Primary

i. Doctors

ii. Nurses

b. Support personnel

i. Janitors

ii. Clerical

iii. PRN staff

ii. Visitors of patients that are quarantined via droplet precautions and require the use of masks to enter the hospital room

iii. With further development the adapter could be marketed to all professionals required to wear a mask while working.

c. Physical Description

i. The device will be made of a soft pliable material, high density foam, that will be able to conform to the user’s face while blocking an excess amount of air from entering the mask from the bridge of the nose

ii. The adapter will conform to the general shape of N-95 and N-100 masks. It will act as a gasket or O-ring.

iii. Device consists of:

1. Double –sided layer of adhesive

2. Internal memory foam with pliable metal to increase adherence to the user’s face

3. One strip of protective paper per side- to prevent loss of adhesiveness

iv. Weight: Less than 1 ounce

d. Comparison to existing products

i. No other product currently exists on the market that provides the function proposed.

ii. There are masks that claim to have features to improve fit. This includes addition of wires, but ultimately this does not solve the problem of fit for many users.

2. Device User Interface

a. Physical Characteristics of the User interface

i. The adapter has adhesive strips that are covered by paper and must be removed by the user. The adapter will be attached to the mask first and then positioned by the user on the face. It will be recommended that the user place the mask and adapter on their face, to receive a general idea of placement, before removing the paper covering the adhesive.

ii. The side of the adapter that attaches to the face will be indented to fit the bridge of the nose.

iii. The adapter will be symmetrical in the medial and sagittal planes to improve ease of use

b. Operating Logic

i. The adapter will be positioned into existing mask by the user, making sure that a secure seal is created between the mask and the adapter. The second adhesive backing then could be removed and the mask would then be positioned by the user onto their face; again ensuring a tight seal.

c. There will be red letters that denote:

i. Removal of adhesive covering

1. “Remove Before Use”

d. Existing or anticipated labeling materials that will be provided to the user with the device, e.g., labels on the device itself, packaging, operating instructions, and training materials:

i. Each adapter will be individually packaged and labeled with the manufacture date, a suggested shelf life, adapter size, and suggested compatible mask brands

ii. Booklet: A booklet will be included with the adaptor, instructing the user on how to apply the adapter and optimally shape the device to the nose and high check area. The booklet will have warning labels that instruct the user to discard after one use, with the mask.

1. There will be an added section explaining how to do a fit test. This test will be recommended for the first use of the product but will not be necessary for subsequent use thereafter.

2. The Instructions will include the following

a. Remove the adhesive backing covering the side of the adapter marked mask and apply to the inner portion of the disposable mask

b. Contour the adapter to fit around the nose and cheeks

c. When the appropriate fit has been reached, remove the second adhesive backing and apply to the face.

d. Adjust the fit as needed

3. Device Use

a. How the user interacts with the device

i. The user will remove the packaged device and protective strips, then properly position the adapter on the nose and face. The adapter will need to be discarded after use with a mask.

b. How the device is set up and maintained

i. After removing the device from the individual pouch that includes the adapter, the adhesive backing should be removed and applied to the face and mask. The user shapes the adapter to the contour of the face. There is no maintenance involved due to the disposable nature of the product.

c. Primary tasks the user is expected to perform

i. Removal of adapter from packaging/pouch

ii. Remove adhesive backing from both sides of adapter

iii. Apply adapter to the mask and then the face

iv. Contour adapter and mask unit to the face

v. Perform optional pretest

4. User Population

a. Intended population of device users

i. The adapter is intended for healthcare professionals and their support staff and those who are visiting hospitalized patients who are under droplet precautions.

ii. Further development of the product will allow for distribution and use to all professionals who are required to wear a mask at work.

b. Characteristics of device user population that were considered during the design

i. Users who are not in the hospital setting frequently enough to require formal fit testing procedures that are very costly

ii. Persons who have undergone fit-testing but have not found a mask that appropriately ensures no gaping between the face and mask

1. Wide range of facial structures of users-the population of users have very different facial structures; the adapter will fit masks of all sizes

2. With a Phase II product, anthropometric data will be collected to ensure the product addresses all problem areas of fit.

c. Training and Information tools that the user population will require to operate the device safely and effectively

i. An instruction booklet will be included. There is no technical training required to use the adapter.

ii. Bold letters will be labeled on the adhesive coating to remind users to remove the strips

iii. Warning labels will be included on the packaging in bold

1. New adapter required after every use

2. Adapter works only on clean surfaces

d. The population of users for which the device is not intended to be used

i. Any persons that incur an allergic reaction to the adhesive material must discontinue use

ii. Persons with facial hair (stubble, mustache, beard)

1. Facial hair renders the adapter ineffective

iii. Children

1. Improper placement is certain to occur if applied by themselves

5. Device Environments

a. Intended Environments

i. This device is intended for use in hospital settings only but will be extended to other environments with further testing

1. Hospital

2. Emergency Rooms

3. Ambulances

b. Prohibited Environments

i. Humid environments that generate moisture are not recommended. This may cause the adhesive to fail

ii. Extremely hot environments that would generate large amounts of perspiration are prohibited

iii. Environments where copious amounts of water is present are not recommended

6. Human Use Related Hazards

a. Use-Related Hazards that have occurred with similar devices

i. Electrode products

1. Have been known to case allergic reactions in some users

2. Long periods of use may cause irritation

b. Processes used to identify and prioritize use-related hazards

i. Skin tests

1. Determine severity of possible allergic reactions

ii. Blind Trials

1. Prototype will be given to several individuals with no knowledge of its use in order to identify potential problems that may result with its application

iii. Literature searches on material

1. Determine the reactivity of material used

c. Potential hazards associated with the device being developed

i. Improper placement of adapter causing gaps

ii. Improper disposal causing contamination

iii. Neglect to remove adhesive backing—could case adapter and mask slipping

iv. Application to an unclean surface causing ineffectiveness of adhesive

d. How significant use-related hazards were controlled during the design and development of the product

i. The product was designed so that if necessary the user would not necessarily need to use the adhesive backing—adapters would be available with or without adhesive to service a larger user population

ii. Materials used in everyday products were used to decrease the incidence of allergic reaction to users

7. Validation and Verification

a. Possible testing and evaluation processes that could be used to determine whether device use design considerations have been achieved

i. Fit tests will be done on a number of individuals who volunteer to try the new product. These tests will be performed with and without the adapter. Success of the project will be determined by the increase in the number of masks that pass the fit test with the adapter versus those that pass without.

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