How to Assemble and Clean the Covid19_Moldable_Face_Shield

Single-user: Elastic Headband / Tubing Headband Appropriate Use Criteria

This supplementary face shield was created as an emergency action in an effort to protect people by providing backup Personal Protective Equipment (PPE) options if the standard PPE is unavailable. This device has not gone through the same regulatory approval process as standard PPE but is undergoing a special verification process expedited strictly for the response to the COVID-19 pandemic.

The use of this supplementary face shield should always come secondary to existing PPE equipment, standards, and protocol options if available. The decision to implement this device should be made with careful consideration and under the consultation of the corresponding institution’s occupational health and infection control departments. The information included in this document provides a best effort protocol to minimize risk of viral transmission during assembly and delivery, as well as to produce face shields whose quality is as consistent as possible. Emergency use procedures are rapidly evolving:

• FDA: Enforcement Policy for Face Masks and Respirators During the Coronavirus Disease (COVID-19) Public Health Emergency (Revised) April 2020

https://www.fda.gov/media/136449/download

• CDC: Strategies for Optimizing the Supply of Eye Protection (COVID-19) https://www.cdc.gov/coronavirus/2019-ncov/hcp/ppe-strategy/eye-protection.html

• NIH: COVID-19 Supply Response

https://3dprint.nih.gov/collections/covid-19-response

WARNING: The design is currently being verified for repeated use disinfection.

Step 1 - Introduction

This section will take you through the assembly of the Covid19_Moldable_Face_Shield.

The supplementary face shield consists of three (3) components: the shield, the visor, and an adjustable strap. The design supports two strap configurations. A tubing strap to facilitate re-use that is intended to be washed & disinfected. A buttonhole elastic strap is also supported and should be replaced when the shield is cleaned or if it becomes soiled.

A diagram of the components is shown below in Fig 1

Figure 1 Face Shield Components

Mounting pins

Clear Plastic Shield

Forehead Visor

Strap attachment o Cleat for elastic o Tipple holes for tubing

Step 2: Preparing the face shield parts

WARNING: Wash your hands and your surroundings first , before you start to assemble the face shield. It is recommended to wear a new pair of gloves during assembly

Remove the components from the package:

• Forehead visor • Strap (either tubing or buttonhole elastic) • Clear Plastic Shield

Step 3: Attaching the shield on the visor

• Place the clear plastic shield in front of you, turn the side with three(3) holes up. Place the visor near the top edge, see the three pins (protrusions). You will use them to attached the shield to the visor.

Note: The headband must be properly oriented. The pins must be on the bottom while the shield is assembled.

• Mount the shield on the visor using the middle hole as shown. Hold it with your thumb.

• Carefully straighten the right side of the visor along the shield and insert the pin. As soon as the pin is through, you can release the thumb. You will hear a snap.

• Continue on the other side of the headband, apply the same approach. Straighten the headband, avoid bending the shield.

Step 4: Attaching the strap to the visor

The kit will contain one strap that is either buttonhole elastic or tubing.

Buttonhole elastic

• Take either end of the elastic band and hook it around the cleat on the end of the visor’s headband.

• Place the other end of the elastic band on the opposite side of the headband. Adjust the length if needed.

• Push shield under headband clip.

Tubing strap

• Take either end of the tubing and push it through the top hole closest to end of the visor’s headband.

• Push the short end up through the hole closest to the shield. • Loop the short end down through the middle hole.

• Repeat for opposite side of head band and adjust for desired fit.

Step 4: Final check

As a final check ensure that shield and strap is firmly attached. Eye protection should be discarded if damaged (for example, if clear plastic shield can no longer fasten securely to the visor and/or if visibility is obscured)

(Optional) a strip of micro-foam surgical tape can be placed on the visor headband to increase comfort while wearing the face shield.

• The face shield is ready!!! Disinfect the shield before the use.

Cleaning (Clincal review needed)

Before you start cleaning Before you start cleaning the shield, it is important to protect yourself. Use gloves, a facemask and if possible, another face shield. For safety reasons, consider the shield you are about to clean contaminated at every possible surface and take appropriate measures!

In case the shield was contaminated directly by aerosol (e.g. cough) and you have another face shield(s) at your disposal, consider throwing this one into hazardous waste. If this is your only face shield, wash it thoroughly under running water first and make sure you have properly disinfected the sink, otherwise consider it contaminated and alert your colleagues.

Prepare your workplace, where you will clean the shield(s). Disinfect the surface of the desk properly before you start.

Don't clean multiple shields at once, separate them into several batches, avoid cross-contamination!

To ensure the shield is cleaned properly, we recommend disassembling it first:

Recommended Cleaning

1. Remove and properly dispose of the elastic strap and shield if exposed. Tubing straps can be re-used if not contaminated by aerosol.

2. Remove the Shield from the visor.

3. Using one of the recommended cleaning & disinfecting products from the list outlined in

Appendix A, prepare to perform steps 4-9 to disinfect the face shield.

4. Wipe down and disinfect the all faces and features on the Visor. 5. Wipe down and disinfect both sides of the clear plastic Shield. 6. Wipe down tubing strap. 7. Doff gloves, perform hand hygiene procedures, and don a new pair of gloves 8. Wipe down the entire face shield again making sure to cover all surfaces of the face

shield

(inside and outside) one more time.

9. Ensure the surface is visibly wet with the disinfectant product for the duration of the contact time as defined by the EPA guidelines in List N: Disinfectants for Use Against SARS-CoV- 2 (https://www.epa.gov/pesticide-registration/list-n-disinfectants-use-against-sars-cov-2).

10. Rinse disinfectant and dry the face shield components.

Preparing the Supplementary Face Shield for Reuse.

Once the face shield is dry, follow the assembly steps listed above for assembly of a new face shield.

Appendix A: Recommended Disinfectants

From FDA guidelines on Enforcement Policy for Sterilizers, Disinfectant Devices, and Air Purifiers During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency released March 2020 (https://www.fda.gov/regulatory-information/search-fda-guidance- documents/enforcement-policy-sterilizers-disinfectant-devices-and-air-purifiers-during- coronavirus-disease?utm_campaign=2020-03- 29%20FDA%20Issues%20New%20Enforcement%20Policy%20for%20Sterilizers&utm_medium =email&utm_source=Eloqua) it is recommended that “this policy is intended to remain in effect only for the duration of the public health emergency related to COVID-19 declared by the Department of Health and Human Services (HHS), including any renewals made by the HHS Secretary in accordance with section 319(a)(2) of the Public Health Service Act (PHS Act)”. The policy recommends to use an approved disinfection agent as it should “minimize the viability of SARS-CoV-2” on the surface of a Cradle and Shield.

From the EPA guidelines in List N: Disinfectants for Use Against SARS-CoV-2 (https://www.epa.gov/pesticide-registration/list-n-disinfectants-use-against-sars-cov-2)

and American Chemistry list of Novel Coronavirus (COVID-19)—Fighting Products the (https://www.americanchemistry.com/Novel-Coronavirus-Fighting-Products-List.pdf), based on the informal testing done, it is recommended to use the following four solutions for the disinfecting procedures of the face shield. Other disinfectants may work as well but have not

been evaluated. Note: the following list is in preferential order and have been tested with this device.

1. Quaternary ammonium; Isopropanol 2. Quaternary ammonium (Lysol) 3. Sodium hypochlorite10% chlorine bleach solution (*May fog Shield over time) 4. Hydrogen Peroxide 5. Soap and water

Appendix B: Recommended Shield Materials

The level of protection provided by the supplementary face shield will be determined in part by the shield material used. At the present time all clear shields included with the kit are:

8 inch x 13 inch x 0.007 inch PET (antifog) (polyethylene terephthalate)

Note: Other readily available materials may be suitable as a replacement but have not been tested and should be used as a last resort. The visor will accept a 3-hole punched standard US letter-sized transparency, 2-10mil (0.002-0.01”, 0.05-0.25mm) thickness NIH recommended Model ID 3DPX-013359

Appendix C: Materials in Direct Contact with Skin

Two components will be in direct contact with the user’s skin: the Visor, and the Strap. The device also allows for a strip of micro-foam surgical tape to be placed on the inside of the Visor to increase the level of comfort provided to the user.

Visor Material: Thermoplastic, FHR PP P5M6K-048 PP Random Copolymer

Color: Cornflower blue 3% (OC5UFM-UN55162)

Strap Material(s):

Tubing: Natural Latex Rubber, 0.20 inch OD

Buttonhole elastic: Polyester/Nylon blend