Contents
Need Exploration and Identification
COVID-19 pandemic and statistics, increased resource utilization, and overseas outsourcing of supply production have led to a supply shortage for this item.
Coronavirus disease 2019 (COVID-19) is an infectious disease caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). The disease was first identified in December 2019 in Wuhan, the capital of China’s Hubei province, and has since spread globally, resulting in the ongoing 2019–20 coronavirus pandemic. As of May 1st, 2020, more than 3.3 million cases have been reported across 187 countries and territories, resulting in over 235,000 deaths (Johns Hopkins). The pandemic has resulted in travel restrictions and nationwide lockdowns in several countries. With the sudden surges in patient volume during the COVID-19 outbreak, closing of borders and restrictions on international shipping, and temporary shutdown of manufacturers for medical supplies, personal protective equipment (PPE), ventilators and associated consumables, as well as many other medical supplies have become a scarce resource.
Face Masks vs. N95 Respirators
Simple face masks are produced according to ASTM standards and are rated based on fluid resistance, bacterial and particle filtration efficiency, breathability (pressure drop through the mask), and flame resistance. The masks often contain multiple filter layers as well as additional components to help form a seal to the face.
N95 masks are rated by NIOSH and designed to provide ≥ 95% filtration efficiency of 0.3 micron of non-oily particles. A subset of N95 masks, the surgical N95 respirator, is also approved by the FDA as a surgical mask and provides fluid resistance. According to the CDC surgical mask is not considered respiratory protection for healthcare providers, only droplet protection.
Existing Solutions
Current supply chains for surgical masks (ASTM Level 1)
Alternative manufacturers
New Balance | Pending Factory to Make Simple Masks | https://www.newbalance.com/made-medical-letter-landing-page/?ICID=CTA_HP_H1_LP__10757_MW |
Kaas Tailored | SMS Polypropylene Masks (Surgical Wrap) | https://kaastailored.com/ppe-at-kaas/ |
Seamstresses Unite | Cotton Fabric Masks | https://seamstressesunite.org/ |
Other: Index of Cloth Mask Manufacturers | Fashion Companies Making Cloth Masks | https://www.gq.com/story/where-to-buy-face-masks |
Local Community PPE and Disinfectant Sources
- Medical
- Dental Offices
- Outpatient Surgery Centers
- Veterinarians
- Construction/Remediation
- Asbestos/Mold Remediation
- Insulation Contractors
- General Contractors
- Painters
- Other Sources
- Cosmetic Centers/Medical Spas
- Janitorial Companies
- Manufacturing
- Mechanics/Body Shops
- Nail Salons
- Tattoo Parlors
- Vocational Schools
PPE Donation Organizations
Market Analysis
- Due to the fear of COVID-19, there has been increased the purchase of masks across the globe → created a shortage for healthcare workers
- Due to the Coronavirus, the demand is up to 100 times higher than regular demand for N95 masks in the world.
- Many manufacturers of these masks are in Asia so many of these factories have shut down their production due to the pandemic or face export restrictions, creating a shortage of masks.
- Top suppliers of N95/surgical masks:
- 3M, Hakugen, Ansell, Sinotextiles, Shanghai Dasheng, Te Yin, Gerson, Honeywell, Vogmask, Kimberly-clark, Cardinal Health, KOWA, DACH, CM and among others
- 3M is the biggest supplier of masks and is currently in short supply
- U.S. has 12 Million of N95 respirators and 30 million surgical masks stockpiled but would need significantly more in the event of an outbreak.
- U.S. health officials have predicted a need for 300 Million facemasks in the incident of a domestic coronavirus outbreak
Alternative Solutions
DIY Sewn Solution | Material Required | Estimated Efficacy | Notes |
Providence Mask | Surgical Wrap (Preferably AAMI 3, 4) | Unknown | Here’s a video from the same health system- https://vimeo.com/400118073/8a7eb657ab |
Deaconess Face Mask | Cotton Fabric | Unknown | |
Single Ply Face Mask | Cotton/Polyester Fabric | Unknown | |
Suay Mask | Tight woven cotton fabric with oil absorbent and/or shop towel filters | Variable filtration efficacy up to 87% of viral-sized depending on filters. Measured with a particle counter. | |
Maker Mark Polypropylene Face Mask | Hydrophobic non-woven polypropylene fabric | Unknown | |
Olson Mask Pattern | Cotton weave fabric
All-purpose thread Hair ties Pipe Cleaner Hepa Material/Vacuum bag filter Double-sided skin safe adhesive |
Dependent on filter used | Vacuum bag filters: |
HEPA filter vacuum bag mask | HEPA bags (from vacuums) – traps 99.9% of dust and pollen
Glue gun Glue stick Pipecleaner Pencil Elastic Thread Template |
Unknown | May be difficult to breathe in due to the pressure drop through the bag. |
Open Source COVID19 Medical Supplies (OSCMS) has also compiled a list of solutions
NIH 3D PPE Print Exchange: NIH site for open source 3D printed PPE including masks and face shields
Alternative Filter Materials/Test Results:
- Missouri Institute of Science and Technology
- Bandanas
- HVAC Filters
- Pillow Case
- Scarves
- Smart Air Filters
- Bandana
- Canvas
- Coffee Filter
- Cloth (Many)
- Cotton
- Denim
- HEPA Filter
- HVAC Filter
- Kitchen Towel
- Polypropylene Bag
- Scarf
- Sheets
- Shop Towel
- **Many more not listed here due to space
- Wake Forest Baptist
- Cotton
- Flannel
- Quilter’s Fabric
- US Army
- Polyester Bandanas
- Microfiber Cloths
Manufacturer Statements on alternative mask use
- 3M (HVAC Filters):
- “Our filters are designed to be used in HVAC systems, and the filter media has not been tested to be used as a face mask for respiratory protection. Altering any of our 3M Filtrete™ Air Filters is not recommended or supported by 3M or the Filtrete™ Brand. Customer safety is our number one priority.”
- Halyard (Surgical Sterilization Wrap):
- “We have seen reports that healthcare workers and consumers are producing homemade masks due to the PPE shortage. Some reports indicate they are using O&M Halyard proprietary products (e.g. Sterilization Wrap) to make face masks which is an off-label use of the product. O&M Halyard cannot recommend the use of any of our products off-label nor can we facilitate the purchase of products for off-label use.”
Concept Screening
Clinical
- FDA-cleared surgical masks are designed to protect against splashes and sprays and are prioritized for use when such exposures are anticipated, including surgical procedures.
- FDA recommends performance in these 4 areas:
-
- Fluid Resistance
- Differential Pressure
- Filter Efficiency
- Flammability
-
- FDA recommends performance in these 4 areas:
- Considerations when selecting mask for use:
- Filtration
- Fluid Resistant
- Securing Method
- Fit and appropriate coverage
Engineering
- The American Society For Testing and Materials (ASTM) has defined mask levels based off F2100-19 Standard Specification for Performance of Materials Used in Medical Face Masks
- Level 1: low barrier protection
- Level 2: moderate barrier protection
- Level 3: maximum barrier protection
ASTM 1 | ASTM 2 | ASTM 3 | NIOSH N95 | Surgical N95 | |
Fluid Resistance | 80 mmHg | 120 mmHg | 160 mmHg | None | 120 mmHg- 160mmHg |
Bacterial Efficiency | ≥ 95% | ≥ 98% | ≥ 98% | ||
Particulate Efficiency | ≥ 95% @ 0.1 micron | ≥ 98% @ 0.1 micron | ≥ 98% @ 0.1 micron | ≥ 95% @ 0.3 micron | ≥ 95% @ 0.3 micron |
DeltaP (Breathability) | < 4.0 mm H2O/cm2 | < 5.0 mm H2O/cm2 | < 5.0 mm H2O/cm2 | ||
Flame Spread Class | 1 | 1 | 1 |
Strategic Development
Clinical/Regulatory – industry standards
- Typical Simple Mask Construction:
- Non-woven filter layer with fluid resistance
- Meltblown filter layer
- Inner liner/absorbent layer
- Rated in ASTM Levels based on:
- Fluid Resistance
- Bacterial and Particulate Efficiency
- Breathability (pressure drop through mask)
- Flame Resistance
- An ASTM 1 mask meets the following:
- Low Fluid Resistance of 80 mmHg
- Filtration Efficiency of
- Bacterial Filtration Efficiency ≥ 95%
- Particulate Filtration Efficiency ≥ 95% @ 0.1 micron
- Breathability Delta < 4.0 mm H2O/cm2 Class 1
- Flame Spread Class 1
- Reuse Masks:
- Cloth masks: launder regularly. Soaps and detergents are sufficient to remove most viral particles. Only use if completely dry as moisture hinders filtering efficiency.
- Filters should be replaced when moist/dirty.
- Guidelines can be found here
Quality Management
- For homemade masks, the most important factors to consider when evaluating materials are their filtration efficiency, breathability (pressure drop through the mask), fluid resistance, and safety of the materials for use in a mask (some materials may not be safe to breath or irritate the face). Additionally, durability and ability to disinfect the materials should be considered. For examples, please see the alternative solutions section above.
- Please contact your institution’s legal department for guidance on matters related to IP during the COVID-19 pandemic.