FAQ
Thank you for all of your emails. We do apologize if we couldn’t respond to you individually or are late in our response. We’re simply overwhelmed with the flood of emails and requests. We hope the following statements would answer most if not all of your questions.
Regarding Safety
Q. Have these been used in clinical settings?
Currently the prototypes are sent to clinicians to test under non-clinical settings, and we are collecting feedback from clinicians about whether the usage of Pneumask is practical under long-term use (~3-4 hours minimum). We have been given partial clearance from the FDA to ship Pneumasks as class 1 devices (only snorkel and adapter). The addition of appropriate filters onto the assembly are currently at the discretion of each individual. With this understanding, some of the physicians who we’ve engaged with are already using Pneumask in clinical settings.
If you would like to know more about Pneumask and engage with other clinicians who have tested these either in non-clinical or in clinical settings, please fill out your information in this form so we can easily relay information to you.
Q. Are these FDA approved? Where are you on the FDA approval process? Do these apply for all masks?
Currently, a snorkel mask in combination with an adapter (NOT including the breathing circuit filter component) does not require FDA approval prior to deployment, as long as it is distributed as a “single-use or single-user face shield” by FDA. If a clinician attaches a breathing circuit bacterial/viral filter to it, it is categorized as an improvised PPE and the clinician would be responsible for his/her own safety. This may apply to other snorkel mask-adapter configurations.
We are still working toward getting FDA EUA approval for the full assembly (including the filter component) as an emergent substitute for N95 respirator, and we will post our updates here once we get further notice from FDA. Currently, this FDA submission is specific to the Dolfino Frontier model and matching adapter. If we hear otherwise in the near future, we will also post those findings.
Q. Have you dealt with the chin valve? Is it safe to leave it functional or should I seal it completely?
Please refer to the “Evaluating Potential Leaking from Chin Valve” section of our open document. The main issue of leaving the chin valve functional is that you cannot maintain a sterile field. There is also concern for when this valve is accidentally obstructed and left in its open position, which may cause a risk of infection. We’re currently looking for alternative means to either block the valve or attach a second adapter that can receive a second filter. Please also be aware that sealing the chin valve can increase the breathing resistance significantly, and appropriate modifications on the inhalation port may be required.
Q. I have seen another document/article which questions the seal of a snorkel mask. Does Pneumask provide a robust seal?
After seeing that document, we have done extensive testing and evaluation on the proper methodology and interpretation of quantitative fit tests on two models, Dolfino Frontier and Subea V1. Please refer to the “Quantitative Fit Test” section of our open document.
Q. I am concerned with CO2 retention during long surgery. Is Pneumask safe?
Please refer to the “Carbon Dioxide Level Test” section of our open document.
Q. Is the adapter part autoclavable as well?
The latest injection molded adapters, which use polypropylene, are autoclavable. However, a PPE does not have to be initially sterile, it only needs to be decontaminated. Please refer to the decontamination protocol of our open document, or check the regulations of OSHA on elastomeric respirator.
How to Obtain a Pneumask
Q. I am a physician/dentist/RT/RN and am in critical need. Can I request for a Pneumask?
Please fill out the following form so we can include you on our next clinician calls - we cannot promise the shipment of the next wave of prototypes, but please fill out your information in this form so we can easily relay information to you. Our goal is to equitably distribute these units as much as possible.
Q. I have a Dolfino Frontier mask, how can I make my own adapter?
Please refer to the “Makers” page for more info.
Q. Can I purchase the adapter/Pneumask?
We are not selling Pneumasks. We are partnering with entities who are either directly or financially helping us acquire masks, manufacture adapters, and distribute them to healthcare workers and institutions who are in need. We have partnered with manufacturing companies who can deliver high-quality products and hence ensure the safety of use in the final implementation. All of these efforts from our end have been done philanthropically and with no financial incentives from any of the partnered entities and we aim to deploy these in the most transparent and equitable fashion. Our primary target is to produce these for healthcare workers who are most at risk of being infected. We don’t yet have the capacity to provide these to the general public.
If you’re a clinician, currently the best way is to fill out your information in this form so we can easily relay information to you.
Q. Where can I source breathing circuit bacterial/viral filters?
We encourage you to contact your hospital to source those viral filters. We are also working with PALL Corporation to find ways to produce and donate these filters to healthcare workers who need them.
Q. Have you considered using other filters? We are concerned with the additional shortage of viral filters.
We are deeply aware of this problem, but we want to make sure that we can at least bridge this PPE shortage issue with existing medical products such as breathing circuit bacterial/viral or ventilator inline filters. We are also in the process of evaluating the filtration efficiency of P100 filters and other alternative filter materials typically used for industrial purposes.
Testing Requests
Q. We have a different full-face snorkel brand/model and have developed an adapter for it. Can your team help test other mask brands/models along with their matching adapters?
Due to our limited bandwidth, we generally cannot accept testing requests unless it is an important test that our current efforts have totally omitted. We are aiming to make sure one solution is rigorously checked and safe for use, rather than spreading out our limited time and resources on a series of different models. All of the tested models/filters/protocols are listed in our open document. If it is not stated as being “tested” or excluded from the document, it is very likely that we have not tested that yet.
Please refer to the “Makers” page for details about developing your own adapters.
Q. We’re exploring alternate ways of decontamination. Can we share them with you and have your team verify these methods?
We are open to alternative suggestions and feel free to share them with us via pneumask@gmail.com. However, we do not have capacity within our lab to test decontamination methods. Our current protocols are per the OSHA regulation on the cleaning protocol of elastomeric respirator, and the EPA suggestion on decontamination products.
Q. Do you have a list of recommended filters?
There are a variety of breathing circuit filters that are commonly available within hospitals/institutions. However, from our laboratory tests, mechanical viral filters (which do not rely on electrical charge) and are HEPA rated or certified to be N100 equivalent are the most reliable. See filter selection page for more details on our filter particle testing data.
Q. How long do these filters last and how can we obtain new filters thereafter?
Please refer to the instruction manual or testing datasheet of each specific filter (some filters can last about 28 days of use, assuming 6-hours of use per day). We are still looking into options for supplying filters. Currently, they are still available within most institutions.
Q. I have a snorkel mask and a 3D-printed adapter already. However, I cannot perform a fit test.
We encourage you to reach out to local healthcare facilities which have the capacity to perform a qualitative or quantitative fit test. In the worst case scenario that you cannot find anyone who can provide this test, you can consider (but we are not encouraging) hacking it by following this YouTube video describing the fit test procedure, but you will have to take your own risks by doing so. Please keep in mind the level of risk you may be imposing on yourself or on others to whom you give your mask to if improper tests are conducted. The goal is to provide safe solutions rather than a false sense of protection. Please refer to the “Makers” page for more details on adapter fabrication.
3D Printing
For all 3D-printing related questions, please refer to the “Makers” page for more information.
Collaboration
Q. We are working on similar projects/efforts and would like to help/share our progress.
Please send us an email at pneumask.covid19@gmail.com with the subject “Slack channel joining request”. Please include a brief description of your current effort, and your slack account in that email.
Q. I own a snorkel mask company and I would like to share our CAD file and testing results done on our snorkel mask.
Please send us an email at pneumask.covid19@gmail.com and let us know your supply chain status. We will share these information on our open document, and we deeply appreciate your help.
Donations
Q. I have a new/barely used full face snorkel mask and I would like to donate it. Where can I drop these off?
Thank you so much for your generosity, however we have yet to organize this grassroots donation pool, but when we do, we will reach out to you.
The main reason for this is to convert the mask to an N95-equivalent PPE, we'd need to 3D print a custom adapter that matches your mask model. Currently, we have a limited number of models/adapters modeled, as you can see on our public document. We're asking the community to help in this effort by CAD models of these adapters that fit the various snorkel mask models with the community. Please also refer to the “Makers” page for more details on adapter fabrication.
Q. I have many N95 masks and I would like to sell/donate. How can I do so?
We are not sellers nor distributors of N95 masks. Please directly contact local hospitals, hospital associations or organizations who are working on sourcing qualified N95 masks.
Q. Can I make an individual contribution?
Due to the complexity of organizing multiple efforts, currently, the most helpful individual contribution for us would be financial support to help with deployment. Click here to donate.
Miscellaneous
Q. Have you used this for non-invasive ventilation (i.e. CPAP, PAPR)?
No. we are currently focusing on modifying snorkel masks as an alternative PPE solution, and we are aware of other efforts trying to convert snorkel masks for CPAP. Please directly contact those groups for more information. Some of our data, however, may benefit other groups’ efforts pursuing other projects that also involve snorkel masks.