ABSTRACT
Introduction The shortage of personal protective equipment (PPE) across the country has been widely discussed throughout the COVID-19 pandemic. Unfortunately, recent reports indicate that PPE shortages persist amidst continually increasing caseloads nationwide. Additionally, there have been reports of poor-fitting masks, a problem which is magnified by shortages. The lack of adequate access to conventional N95 masks pushed for some to pursue 3D printing and locally distributing their own manufactured masks as substitutes when PPE, including N95 masks, were not readily available. The design presented, the snorkel mask adapter, is one such design born from the local maker community in partnership with local physicians and hospitals. This article discusses the design, manufacturing, and validation of the snorkel mask adapter and its immediate use in the COVID-19 pandemic as well as future use as stopgap PPE.
Methods The design presented is an adapter which can be used with a commercially available snorkel mask in order to serve as a full face respirator in either the case of a PPE shortage or more pertinently for those who are unable to pass fit testing with the available N95 respirators at their respective facilities. Mask components were 3D printed, assembled, and then fit tested by qualitative fit testing (QLFT) at The University of Kansas Health System (TUKHS) in Kansas City, KS as a proof of concept.
Results At TUKHS, the mask was fit tested on 22 individuals who required an N95 mask but were not able to pass qualitative fit testing with the masks available to them at the time. Of the 22 tested, all 22 of them were able to pass QLFT with the snorkel mask, adapter, and viral/bacterial filter combination.
Conclusion The results of the fit testing at TUKHS is promising for this N95 alternative. More extensive testing can and should be done, including quantitative fit testing. Persistently increasing caseloads and PPE shortages necessitates an urgent dissemination of these preliminary results. The authors do not advocate for this design as a replacement of traditional N95 masks or other PPE but do endorse this design as a stopgap measure, proven to be effective in situations of dire PPE shortage or for individuals who have failed fit testing with conventional PPE.
Competing Interest Statement
The authors have declared no competing interest.
Funding Statement
No funding was provided.
Author Declarations
I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained.
Yes
The details of the IRB/oversight body that provided approval or exemption for the research described are given below:
IRB approval was not requested nor required for this study because this was essentially a proof of concept and quality improvement initiative. The design went through the proper channels at TUKHS for testing and approval of PPE during the height of the pandemic. Although further analysis and study to prove efficacy is required, the purpose of this study and article is to discuss the design, manufacturing, and validation of the snorkel mask adapter concept.
All necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived.
Yes
I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance).
Yes
I have followed all appropriate research reporting guidelines and uploaded the relevant EQUATOR Network research reporting checklist(s) and other pertinent material as supplementary files, if applicable.
Yes
Paper in collection COVID-19 SARS-CoV-2 preprints from medRxiv and bioRxiv
The Chan Zuckerberg Initiative, Cold Spring Harbor Laboratory, the Sergey Brin Family Foundation, California Institute of Technology, Centre National de la Recherche Scientifique, Fred Hutchinson Cancer Center, Imperial College London, Massachusetts Institute of Technology, Stanford University, University of Washington, and Vrije Universiteit Amsterdam.