Frequently Asked Questions

Is this another home-grown, 3D printed PPE solution?

No. We are using high quality, full-face snorkel masks which seal entirely around the wearer’s face and adapting these snorkel masks to use the standard anesthesia and ventilator circuit filters used in hospital operating rooms and ICU’s, to create a face shield for medical purposes. The project was initiated by physicians at the Brigham and Women’s Hospital in Boston, and we are continuously improving the device through real-world testing and feedback from our clinician users.

Are MasksOn.org Reusable Face Shields meant to replace N95 Respirators?

No. If proper, FDA cleared PPE is available, clinicians should use them. The MasksOn.org Reusable Face Shield is NOT FDA cleared or approved and may only be used when FDA cleared masks are unavailable, as recommended by the FDA, CDC, and Joint Commission.

MasksOn.org Reusable Face Shields were designed with the goal of providing full-face, sealed protection in which incoming air passes through a standard 15mm bacterial/viral filter. We are targeting use by clinicians and HCW experiencing PPE shortage who are exposed to aerosolized virus and/or performing the highest risk procedures such as intubation, central and arterial line placements, and emergency surgical procedures on COVID+ patients.

	N95 Respirator	MasksOn.org Reusable Face Shield Kit
Description	Close fit respirator that covers nose and mouth and filters 95% of test particles .3 microns or larger.	Integrated full-face recreational snorkel mask seals around the entire face including the eyes, nose, and mouth. Users install their own 15mm bacterial/viral filter using the MasksOn.org custom manufactured adaptor. These filters often provide 99.99% viral and bacterial retention, sometimes even 99.999%. Users should confirm through their specific filter suppliers or product labeling.
Reusability	Intended to be used once per patient encounter and then disposed of. Before the N95 shortage, COVID clinicians were using several per day. Emergency reuse now permitted, but safety under reuse is unclear.	Face shields (snorkel masks and adaptors) are reusable and sanitizable. Filter is disposable and replaced per your institutional recommendations for emergency use.
Cost	Current market prices between $3-$9.	Approximately $50 for Face Shield Kit plus $2/filter. (Note: the Reusable Face Shield Kit is donated free of charge to clinicians, HCW, first responders and their facilities).
60 Days Use Cost	$180 – $1080 depending on amount of reuse, and not inclusive of sanitization costs. Does not include cost of face shield and eye protection.	$92-$195 depending on whether filter is replaced 1/week vs 1/day.

Is the face shield approved by the FDA or other authority?

No. Unfortunately clinicians are operating under emergency conditions due to the extreme PPE shortage. However, the FDA has handed down clear guidance for emergency face shields that do not have FDA clearance or approval, and FDA has also issued an Emergency Use Authorization (EUA) to outline the requirements for distribution of face shields for a medical purpose that do not have FDA clearance or approval. MasksOn.org reusable Face Shields are following the requirements of the FDA guidance and the EUA. Clinicians should recognize that these are not FDA cleared or approved devices, and they should use at their own risk and only when FDA cleared PPE are not available. We are closely monitoring the regulatory response to the crisis.

Are you pursuing regular FDA approval?

Not at this time. We are operating under the FDA’s guidance and Emergency Use Authorization (EUA) for face shields.

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/enforcement-policy-face-masks-and-respirators-during-coronavirus-disease-covid-19-public-health

https://www.fda.gov/media/136842/download

At this point we are not pursuing traditional FDA authorization. We hope that the need for our face shields will be over by the time we could run through the full FDA process.

Are hospitals supportive of using alternate gear during this shortage?

Each individual hospital is crafting their own policy with regard to emergency use of non-cleared and non-approved PPE. In many cases, hospitals are allowing their clinicians to use their own PPE when they are unable to provide them. The Joint Commission Announcement on Use of Face Masks Brought From Home recommends that hospitals allow clinicians to use their own PPE in emergency shortage conditions.

Are the face shields reusable?

Yes. The mask and adaptor that constitute the face shield can be sanitized through a 2-step detergent and bleach solution process and used again and again. Detailed instructions on sanitization procedures are provided with each kit.

Are the face shields meant to be shared?

To be consistent with the FDA face shield EUA, the MasksOn.org Face Shield Kits are single-user, multiple-use devices. Therefore, please allocate face shields for individual use.

How are you distributing face shields?

Both institutions and individual clinicians are requesting face shields via the MasksOn.org site. We are providing them free of charge through the generosity of our donors. Please feel free to share with anyone in need of PPE, or with individuals that might be willing to donate.

We are only providing face shields to healthcare professionals on the front lines of this pandemic. This means professionals working in hospitals, nursing homes and other institutions where they regularly interact with COVID-positive patients.

Are others working on the same full-face snorkel mask type face shield solution?

Yes! We are actively liaising with similar efforts around the world, and everyone is sharing designs and learning in a cooperative effort. We are dedicated to getting to the best possible solutions as quickly as possible, and will do everything in our power to get safe, effective protective gear into clinicians’ hands as soon as possible.

How have the face shields been tested?

Our clinicians and engineers have performed the following tests to validate performance:

Bitrex respirator fit test
OSHA saccharin fit test
Exertion saccharin test
Extended clinician exertion tests (3 mile run, 45 minutes Peloton)
Capnography testing
NIOSH exhalation leak
Detailed clinician feedback on fit and function while in use

How fast can you make them?

We plan to ramp up production to at least 1,000 Face Shield Kits per day.

I am a physician who is interested in purchasing this for myself. I don’t want to get it for free. However, if I were to make a donation for say, 2 face shields, could I have one of them sent to me?

We want to keep a simple model: donating to everyone who has a need. Rather than purchasing a face shield, please sign up to have one sent to you. If you have the means, please follow through with a donation through our website. And tell you friends to do the same!

I already have a full face mask or face shield. Can you just send me the adaptor?

No. There are two important reasons for this:

The adaptor is specifically designed for a single snorkel mask model. Using the wrong adaptor will allow leakage.
We modify the purge valve port on the snorkel mask to prevent any leakage. This requires both the skill to not damage the existing umbrella valve and appropriate blocking material.

Can you ship internationally?

Not at the moment. We’re working on this.

What is the recommended length for ensuring the filter's safety?

Research published by The National Center for Biotechnology Information suggests filters similar to those users supply to mate with the MasksOn.org face shield can be used for up to seven days before replacing. (See: Miocrobiological safety and cost-effectiveness of weekly breathing circuit changes in combination with heat moisture exchange filters: a prospective longitudinal clinical survey.) Healthcare providers are encouraged to ask their specific filter suppliers.