Contents
Need Exploration and Identification
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 14 April 2020, more than 1.94 million cases have been reported across 210 countries and territories, resulting in over 123,000 deaths (https://coronavirus.jhu.edu/map.html). 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.
What is an N95 respirator?
- N: This is a Respirator Rating Letter Class. It stands for “Non-Oil” meaning that if no oil-based particles are present, it can be used in a work environment.
- 95: Masks ending in a 95, have a 95 percent filtering efficiency.
- .3 microns: The size of .3 microns of particulates and large droplets won’t pass through the barrier as stated by the CDC.
- Material: The filtration material on the mask is an electrostatic non-woven polypropylene fiber.
- Regulation: Title 42 of the Code of Federal Regulations (CFR), Part 84 from National Institute for Occupational Safety and Health (NIOSH) are the quality assurance standards that must be followed to manufacture and sell any respiratory device.
What is a surgical N95 respirator?
A surgical N95 respirator is NIOSH approved N95 respirator (adherent Title 42 of the Code of Federal Regulations (CFR) that has also been cleared by the Food and Drug Administration (FDA) as a surgical mask regulated under 21 CFR 878.4040.
How do surgical masks differ from N95 respirators?
- Additional Background on N95 Masks and Surgical Masks from the CDC
- OSHA Video: The Difference Between Respirators and Surgical Masks
This document details strategies to optimize supplies of N95 masks during this crisis:
Existing Solutions
Current supply chains
CDC Surgical N95 Respirators Trusted-Source Information includes manufacturer and instructions for use from every manufacturer.
Suppliers | Link/Contact Info |
3M | https://www.3m.com/
888-3M HELPS |
Aero Pro Company, Ltd. | http://www.aeropro.com.tw/zh-tw/
886-4-875-6141 |
Air Filtration Solutions, Ltd. | http://www.airfiltrationsolutions.co.uk/
44 (0) 1772 790820 (UK) |
Alpha Pro-Tech | http://www.alphaprotech.com/
800-749-1363 |
AOK Tooling Limited | http://www.toolingexpress.com/mask.aspx
86-755-84111912 |
Aswan International Corporation | http://www.aswan-safety.com.tw/
866-2-8369-2525 603-929-6000 |
Champak Enterprise Company, Ltd. | https://www.champak.com.tw/
886-3-3808818 |
Dentec Safety | https://www.dentecsafety.com/
888-533-6832 |
Dobu Life Tech | 314-743-6243
82-31-765-9311 |
Dräger Safety AG & Company | https://www.draeger.com/en-us_us/Chemical-Industry/Productselector
800-858-1737 |
Ever Green Company, Ltd. | 82-31-425-0596 |
Fido Industrial Safety Masks Manufacturer Company, Ltd. | http://www.fidomasks.com.tw/
886-37-741471 |
Foss Manufacturing Company | 603-929-6000 |
Global Safety First | https://readimask.com/
610-240-0909 |
Guangzhou Harley Commodity Company, Ltd. | https://harleymask.en.alibaba.com/
+86-20-36928707 |
GVS Filter Technology UK, Ltd. | http://www.gvs.com/
44 1524 847600 ext 262 (UK) |
Halyard Health | https://www.halyardhealth.com/
800-331-4112 |
Honeywell Safety Products | https://safety.honeywell.com/
800-430-5490 800-821-7236 800-343-3411 |
Industrias Saver S.A. | 57-5-382-16-16 |
Jahan Company t/a IREMA Ireland | https://www.irema.com/
+353 63 98544 |
Japan Vilene Company, Ltd. | http://www.vilene.co.jp/en/index.htm
81-3-3258-3355 |
Jiangyin Chang-hung Industrial Manufacturing Factory LLC of China (JCH) | http://www.grandemask.com/
86-510-8691-3080 |
Jinfuyu Industrial Company, Ltd. | http://www.jfymasks.com.tw/
886-2-2690-2271 |
JSP | https://www.jspsafety.com/link/en/respiratory-protection/c/
44-0-1993-824000 |
Kimberly-Clark Corporation | https://www.kimberly-clark.com/en/
800-524-3577 800-255-6401 (professional line) Direct contact: Brad Frankle- West Team Leader (Brad.Frankel@kcc.com ) |
Koken, Ltd. | http://www.koken-ltd.co.jp/english/top.htm
81-3-5276-1925 |
Louis M. Gerson Company, Inc. | https://www.gersonco.com/
800-225-8623 |
MacoPharma | http://www.macopharma.com/com/
33-3-59-03- 44-00 |
Magnum Medicare | http://www.magnumohs.com/
0091-9820050482 |
Makrite Industries, Inc.
|
http://www.makrite.com/
800-379-9929 617-964-1365 888-533-6832 |
Master and Frank Enterprise Co., Ltd. | http://www.master-frank.com/
886-2-23255066 |
Mine Safety Appliances Company | https://us.msasafety.com/detection?locale=en
800-672-2222 |
Moldex-Metric, Inc. | https://www.moldex.com/
800-421-0668 |
MSA de Brasil Equipamentos e Instrumentos de Seguranca Ltd. | https://br.msasafety.com/?locale=pt
55-11-4070-5999 |
NITTA Corporation, SA | https://nitta.com.co/
770-497-0212 |
Prestige Ameritech
|
https://www.prestigeameritech.com/
866-401-8972 817-427-2700 Direct contact: mike@prestigeam.com (Mike Bagley) |
Profit Royal Pharmaceutical, Ltd. | https://www.hktdc.com/manufacturers-suppliers/Profit-Royal-Pharmaceutical-Limited/en/1X0910PB/
+8520 2387 8926 |
Rizhao Sanqi Medical & Health Articles Company, Ltd. | http://www.sanqicn.com/
86-633-8537378 x 2178 |
San Huei United Company, Ltd. | https://www.sanhuei.com/
886-2-2683-0356 886-2-2683-5856 |
San M Package Company, Ltd. | https://www.san-m.co.jp/english/
81-547-45-4125 |
Shanghai Dasheng Health Products Manufacture Company, Ltd. | http://www.dashengmask.com/
86-21-5778-3126 |
Shanghai Gangkai Purifying Products Company, Ltd. | http://www.gangkai-mask.com/
86-21-5777-5401 |
Shigematsu Works Company, Ltd. | http://www.sts-japan.com/
81-3-6903-7525 |
Shining Star Electronic Technology Company, Ltd. | http://en.shiningstar-hz.com/
886 3 431 5486, 86 571 8618 1168 |
Shuenn Bao Shing Corporation | http://www.aeropro.com.tw/zh-tw/
886-4-875-6141 |
Suzhou Fangtian Industries Co., Ltd. | http://chinamasks.com/
+86 512 65586078 / 65586018 |
Suzhou Sanical Protective Product Manufacturing Company, Ltd. | https://www.cemask.com/
86-512-66100068 |
Valmy SAS of France (DIV) | http://www.valmy.eu/
1-450-844-3946 |
Venus Safety & Health | http://www.venusohs.com/
91-022-2769-2646 |
Willson Dalloz Safety Products | https://www.kimberly-clark.com/en/
800-345-4112 |
Xiantao Zhongyi Safety Protection Products | https://xtzhongyi.en.alibaba.com/
+86-728-3257535 / 3257635 |
Alternative supply chains
How to identify fraudulent or counterfeit N95 masks based on NIOSH guidelines: https://www.cdc.gov/niosh/npptl/usernotices/counterfeitResp.html
Market Analysis
- As of 7th April 2020, the total numbers of infected people from COVID-19 are 1,352,173, and total deaths are 75,294 in the world
- Due to the fear of COVID-19, there has been increased the purchase of N-95 mask across the globe → created a shortage for healthcare workers
- Key Players for Global N95 Grade Medical Protective 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
- Due to the Coronavirus, the demand is up to 100 times higher than regular demand for N95 masks in the world.
- Many factories have shut down their production, which has created a massive shortage of masks, may hamper the growth of the market.
- Many countries have also banned the exports of face masks to fulfil the global demand, further hindering the market growth.
- Pennsylvania is also experiencing shortage of supplies. Summary of requested PPE from the Federal Emergency Management Agency is as follows:
Requested | Received | Sent, Not yet Received | Shortfall/Surplus | |
Coveralls | 3990 | 480 | 0 | -3510 |
Face Shields | 110858 | 110880 | 62413 | +62435 |
Face/Surgical Masks | 582188 | 328500 | 287022 | +33334 |
Gloves | 690346 | 473725 | 0 | -216621 |
N95 Masks | 494392 | 112250 | 120900 | -261242 |
Surgical Gowns | 141761 | 86304 | 0 | -55457 |
Table: Jonathan Tamari Source: U.S. House Oversight and Reform Committee, FEMA (April 2nd, 2020)
Alternative Solutions
Operational
- NIOSH-approved N99, N100, R95, P95, P99, P100 facepiece respirators
- https://www.cdc.gov/niosh/npptl/topics/respirators/disp_part/respsource1quest3.html#half
- Advantages: FDA approved
- Disadvantages: meeting supply demands
- CDC: Strategies for Optimizing the Supply of N95 Respirators During the COVID-19 Response
- Decontamination and reuse of N95 masks (pros + cons)
Novel Design
- Reusable Elastomeric Respirator
- Made out of anesthesia mask, in-line filter, and elastic straps
- https://www.childrenshospital.org/research/departments-divisions-programs/departments/surgery/surgical-innovation-fellowship
- Advantages: components are ready-made parts with previous FDA clearance.
- Disadvantages: some of the components are potentially now in short supply due to the pandemic. The entire system has not received FDA CE under EUA. Total cost of the parts is higher than some of the other solutions.
- 3D printed masks –
- For information about 3D manufacturing of PPE that has been reviewed by the FDA : https://3dprint.nih.gov/collections/covid-19-response
- There are a variety of 3D printed masks, however many require sanding and other finishing. The Billings Clinic mask does not require finishing. According to the Billings Clinic, the mask takes ~2 hours to print and costs approximately $1. The mask has an insert for HEPA filter material (or a piece of surgical mask) and is rigid plastic so it can be disinfected. Due to the lack of seal, this may not qualify as an N95, but could work as a surgical mask option and could be a viable option to explore as we do have a 3D printer at HMC and likely additional at State College.
- Adaptation to readily available mask from alternative industry (i.e. scuba mask; firefighter mask) with similar level protective barriers required
- Advantages: reusable for longer periods and can withstand rigorous decontamination protocols unlike disposable N95 respirators
- Disadvantages: costs. Snorkel masks costs $50-100 per unit
- Prakash Lab at Stanford
- https://www.isinnova.it/easy-covid19-eng/
- Alternative Materials for Construction of N95
- Use of Haylard H600 propylene which blocks 99.9% of particulates
- Advantage: made out of readily available sterile material used to surround surgical instruments found in hospitals and medical facilities. Blocks aerosols, droplets, including water, bacteria, and other particles.
- Disadvantage: not certified as N95
Concept Screening
Clinical:
- Prevent oral nasal droplet transmission from human to human contact.
- Bacterial Filtration Efficiency: 95 percent of 0.3 micron test particles filtered
- Submicron Particle Filtration Efficiency: 99.9% filtered at 0.1 micron.
Engineering
- Performance Requirements: Designing and Engineering Effective PPE (includes specific performance requirements for N95)
- Guidance on PPE engineering considerations (including N95) in pandemics: IOM (Institute of Medicine). 2008. Preparing for an influenza pandemic: Personal protective equipment for healthcare workers. Washington, DC: The National Academies Press
Regulatory
- FDA Guidance on Face Masks and Respirators During COVID-19; FAQs on 3D Printing of Medical Devices, Accessories, Components, and Parts During the COVID-19 Pandemic
- Reach out to CDRH-COVID19-SurgicalMasks@fda.hhs.gov for assessing whether the device would be able to meet the EUA requirements
- For current face mask and respirator manufacturers whose product(s) are not currently marketed in the US, FDA recommends providing the following information:
- General information such as your contact information, name and place of business, email address, and contact information for a U.S. agent (if any) in addition to general information about the device such as the proprietary or brand name, model number, and marketing authorization in your country (or region).
- A copy of the product labeling.
- Whether the device currently has marketing authorization in another regulatory jurisdiction (including certification number, if available)
- Whether the device is manufactured in compliance with 21 CFR Part 820 or ISO 13485: Medical Devices – Quality Management Systems – Requirements for Regulatory Purposes or an equivalent quality system and the manufacturer or importer has documentation of such.
- Description of testing conducted on the device, including any standards met, such as liquid barrier protection, flammability, biocompatibility, and filtration performance, as appropriate. For surgical N95 respirators, FDA recommends including fluid resistance testing (liquid barrier performance).
- For any face mask or filtering facepiece respirator (including N95 respirators) issued an EUA, FDA will include appropriate conditions of authorization in accordance with section 564 of the FD&C Act. Although this is a case-by-case determination, based on current information and experience, we will likely include the following conditions:
-
- Appropriate conditions designed to ensure that health care professionals administering the device are informed
- that FDA has authorized the emergency use of the device;
- of the significant known and potential benefits and risks of the emergency use of the device, and of the extent to which such benefit and risks are unknown;
- of the alternatives to the device that are available, and of their benefits and risks.
- Appropriate conditions designed to ensure that individuals to whom the device is administered are informed—
- that FDA has authorized the emergency use of the device;
- of the significant known and potential benefits and risks of the emergency use of the device, and of the extent to which such benefit and risks are unknown;
- of the option to accept or refuse administration of the device, of the consequence, if any, of refusing administration of the device, and of the alternatives to the device that are available and of their benefits and risks
- Appropriate conditions for the monitoring and reporting of adverse events associated with the emergency use of the device. FDA intends to include conditions that are consistent with those promulgated under 21 CFR Part 803.
- For manufacturers of the device, appropriate conditions concerning recordkeeping and reporting, including records access by FDA, with respect to emergency use of the device.
- Appropriate conditions designed to ensure that health care professionals administering the device are informed
-
Intellectual Property
- The FDA classifies medical devices based on the risks associated with the device and by evaluating the amount of regulation that provides a reasonable assurance of the device’s safety and effectiveness. Devices are classified into one of three regulatory classes: class I, class II, or class III.
- N95 masks fall within the Class II device category. This link provides more information on the specific requirements for each class. For additional guidance on how to classify a device, please see this resource.
- The following links provide relevant intellectual property around N95 masks in a filterable and searchable format.
Strategic Development
Clinical
- Decontamination and reuse of N95s: Previous recommendations of the CDC and FDA recommend single utilization for clinical N95 masks due to risk of exposure and contamination (specifically the head band and the inner lining of the mask). Due to current pandemic, CDC guidelines are allowing reuse. See recommendations below for guidance on decontamination and reuse.
- Decontamination and reuse of N95s
- CDC: Disposable filtering facepiece respirators (FFRs) are not approved for routine decontamination and reuse as standard of care. However, FFR decontamination and reuse may need to be considered as a crisis capacity strategy to ensure continued availability. Based on the limited research available, ultraviolet germicidal irradiation, vaporous hydrogen peroxide, and moist heat showed the most promise as potential methods to decontaminate FFRs.
- There are no FDA approved, licensed, or cleared devices for decontaminating compatible N95 respirators.
- However, the FDA has authorized Emergency Use Authorizations to four medical device companies thus far to allow them to repurpose their sterilization systems to decontaminate N95 for reuse due to the pandemic. See links below for information pertaining to each device and decontamination method.
- Decontamination and reuse of N95s
Regulatory
- FDA Guidance on Face Masks and Respirators During COVID-19; FAQs on 3D Printing of Medical Devices, Accessories, Components, and Parts During the COVID-19 Pandemic
- Note: The standards for the N95 masks for clinical utilization are not 501K exempt unlike its industrial counterpart
Research & Development
- Material Design: N95 masks contain two layers. The top first layer is made of a mesh of synthetic polymer fibers that serve as a barrier for 95% of particles under 0.03 microns. For production, this layer utilizes a meltblown fabric technique requiring fine process management. The second inner layer is composed of a lining treated with copper and zinc ions with a positive charge which then interact with the negative charge of influenza viruses and cause them to denature. For this layer, ion charge, filtration efficacy and fit deterioration are the biggest barriers to utilizing N95 masks multiple times.
- The biggest challenge for R&D and quality management is within the production of the first layer. The material needs to be made in regular time intervals to ensure the diameter of less than one micron to meet NIOSH’s standards Obtaining appropriate machinery and equipment is a major challenge and requires extensive testing for fine particle sourcing. The following resource highlight the challenges:
Testing
- The CDC has published a set of 50+ testing procedures for air purifying respirators that can be found here: CDC Standard Respiratory Testing Procedures N95 protocols have to be created to maintain the standards of quality listed above.
- Determination of Particulate Filter Penetration
- Determination of Exhalation resistance
- Determination of Exhalation Valve Leakage
- Determination of Qualitative Isoamyl Acetate (IAA) Facepiece Fit Test
- Determination of Inhalation Resistance
- Determination of Air Flow For Powered Air-Purifying Respirators
- Determination of End-of-Service-Life Indicator (ESLI)
- Particulate Respirator Qualitative Fit Test Utilizing Saccharin or Bitrex Solutions
Quality Management
- Regulatory – Any repurposing of products, de novo creation of air-purifying respirators should comply with:
- Manufacturing of the products should comply with Quality System Regulation (21 CFR 820) (https://www.fda.gov/medical-devices/postmarket-requirements-devices/quality-system-qs-regulationmedical-device-good-manufacturing-practices) also known as “Good Manufacturing Practices” both for the manufacturing as well as the sterilization protocols.
Intellectual Property
- Please contact your institution’s legal department for guidance on matters related to IP during the COVID-19 pandemic