Development, manufacturing, and preliminary validation of a reusable half-face respirator during the COVID-19 pandemic

Autor: Joshua Qua Hiansen, Kate Kazlovich, Jessica Trac, William C. K. Ng, Arnaud Romeo Mbadjeu Hondjeu, Zixuan Xiao, Azad Mashari, Vahid Anwari, Edem Afenu
Jazyk: angličtina
Rok vydání: 2021
Předmět:
Viral Diseases
0209 industrial biotechnology
business.product_category
Epidemiology
Computer science
Silicones
Electronics engineering
3D printing
02 engineering and technology
Respirators
Seal (mechanical)
Cartridge
Medical Conditions
020901 industrial engineering & automation
0302 clinical medicine
Materials Testing
Medicine and Health Sciences
Public and Occupational Health
030212 general & internal medicine
Respiratory Protective Devices
Respirator
Virus Testing
Distributed manufacturing
Multidisciplinary
Equipment Design
Chemistry
Infectious Diseases
Printing
Three-Dimensional
Physical Sciences
Engineering and Technology
Medicine
Safety Equipment
Safety
Research Article
Biotechnology
N95 Respirators
Science
Equipment
Bioengineering
03 medical and health sciences
Diagnostic Medicine
Occupational Exposure
Equipment Reuse
Humans
Prototypes
Pandemics
Personal Protective Equipment
Personal protective equipment
Ventilators
Mechanical
SARS-CoV-2
business.industry
Chemical Compounds
COVID-19
Biology and Life Sciences
Covid 19
Reliability engineering
Technology Development
Filter (video)
Face
Medical Devices and Equipment
business
Filtration
Zdroj: PLoS ONE, Vol 16, Iss 3, p e0247575 (2021)
PLoS ONE
ISSN: 1932-6203
Popis: Introduction The COVID-19 pandemic has led to widespread shortages of N95 respirators and other personal protective equipment (PPE). An effective, reusable, locally-manufactured respirator can mitigate this problem. We describe the development, manufacture, and preliminary testing of an open-hardware-licensed device, the “simple silicone mask” (SSM). Methods A multidisciplinary team developed a reusable silicone half facepiece respirator over 9 prototype iterations. The manufacturing process consisted of 3D printing and silicone casting. Prototypes were assessed for comfort and breathability. Filtration was assessed by user seal checks and quantitative fit-testing according to CSA Z94.4–18. Results The respirator originally included a cartridge for holding filter material; this was modified to connect to standard heat-moisture exchange (HME) filters (N95 or greater) after the cartridge showed poor filtration performance due to flow acceleration around the filter edges, which was exacerbated by high filter resistance. All 8 HME-based iterations provided an adequate seal by user seal checks and achieved a pass rate of 87.5% (N = 8) on quantitative testing, with all failures occurring in the first iteration. The overall median fit-factor was 1662 (100 = pass). Estimated unit cost for a production run of 1000 using distributed manufacturing techniques is CAD $15 in materials and 20 minutes of labor. Conclusion Small-scale manufacturing of an effective, reusable N95 respirator during a pandemic is feasible and cost-effective. Required quantities of reusables are more predictable and less vulnerable to supply chain disruption than disposables. With further evaluation, such devices may be an alternative to disposable respirators during public health emergencies. The respirator described above is an investigational device and requires further evaluation and regulatory requirements before clinical deployment. The authors and affiliates do not endorse the use of this device at present.
Databáze: OpenAIRE
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