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© 2018 F.A.B.R.I.C.

 

132 E. 6th St.

Tempe, AZ 85281

602-743-4638

Hours of Operation:

Monday - Friday

9am to 5pm by appointment

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HOMEMADE MASKS?

With grassroots movements to make Personal Protective Equipment (PPEs) in homes and US factories, and the debate on whether the public should be wearing masks, FABRIC has been working on safe and effective solutions for the community. After extensive research on CDC and FDA guidelines for PPE, FABRIC seeks to manufacture surgical and barrier gowns and has concluded that making masks outside of the normal government-regulated standards could not only be futile, (1) but could potentially be harmful to Health Care Professionals (HCP) if used for protection against COVID-19. 

It is our opinion that homemade facemasks should not be used by healthcare workers dealing directly with COVID 19. However, home made masks could potentially be used by the public and healthcare workers not dealing with the virus as "social comfort" with the understanding that they do not provide adequate protection to the wearer from the virus. They could be better than nothing to protect you from spreading any virus you may have. Special caution should be taken when making home made masks, and fabrics like cotton should be avoided. These masks should be labeled properly to warn the wearer and protect the maker.

In regards to surgical masks and N95 Respirators (6), both of these masks are made from multiple layers of medical grade material, currently in extremely short supply, that require extremely rigorous approval and testing (7). These surgical grade masks are manufactured using regulated procedures in cleanrooms (8), are packed in cleanrooms, and tested and intensely inspected before shipping.  A recent study on infectious disease and protection in regards to cloth masks (1) compared to FDA-approved masks for HCP cautioned against the use of cloth masks with outcomes of roughly 97% of pathogen penetrating the mask.  FDA surgical and N95 respirator masks are 225% more effective. As hospitals run out of PPE supplies and ask the public to sew masks from scrap fabric, the safety of the nation’s extremely valued healthcare workers could be at great risk.

In consideration of the required FDA and CDC guidelines as well as the evidence of the ineffectiveness of cloth masks made without these guidelines, it has become clearly event to our team that the nations healthcare workers should not be using these masks for protection and that it would be reckless and harmful for us to provide home sewn masks to HCP.

 

Would you bungee-jump from a building knowing your cord didn't meet safety specs? Do you think it's fair to ask health-care workers to take that plunge?

 

We are not medical experts.

 

As of March 2020, we have not seen a request for home-sewn masks from the healthcare industry to be used to protect healthcare workers dealing directly with COVID 19. As of April 2020, the CDC and White House has suggested that the public could wear homemade and/or non-medical masks. They acknolwedged that this may only prevent the wearer from spreading the virus and that there is concern that without proper knowledge, wearing a social comfort mask may give the wearer a false sense of security.

 

We have not seen a CDC compliant or CDC endorsed pattern.

 

We do not want to create an unnecessary burden on already stressed hopsital staff by sending them items they may not be able to use. Though well intentioned, donations can take a lot of time and energy to accept, organize and distribute. 

We do understand that home made masks may provide a sense of comfort to the wearer and that they may also prevent the wearer from spreading germs when they breathe. Research shows they do not protect against COVID 19. Therefore the concern is that without proper knowledge, wearing a social comfort mask may give the wearer a false sense of security. 

We recommend that sewists and factories across the country who want to sew masks should only make them for the public as social comoft with the understanding that they are "social comfort masks" to wear in an attempt to protect from spreading their own germs, prevention of face touching, and psychological well being only. In this case, we believe they should be clearly labeled in a way to clarify that they do not only protect the wearer from COVID 19. This is also in an attempt to protect the maker from liability.

 

Read more in the FDA's recently released Enforcement Policy for Face Masks and Respirators During the Coronavirus Disease (COVID-19) Public Health Emergency Guidance for Industry and Food and Drug Administration Staff. Download this document below:

References:

  1. MacIntyre CR, Seale H, Dung TC, et alA cluster randomised trial of cloth masks compared with medical masks in healthcare workersBMJ Open 2015;5:e006577. doi: 10.1136/bmjopen-2014-006577

  2. U.S. Food and Drug Administration. 2020. Faqs On Shortages Of Surgical Masks And Gowns. [online] Available at: <https://www.fda.gov/medical-devices/personal-protective-equipment-infection-control/faqs-shortages-surgical-masks-and-gowns>

  3. U.S. Food and Drug Administration. 2020. Personal Protective Equipment For Infection Control. [online] Available at: <https://www.fda.gov/medical-devices/general-hospital-devices-and-supplies/personal-protective-equipment-infection-control

  4. Cardinalhealth.com. 2020. [online] Available at: <https://www.cardinalhealth.com/content/dam/corp/web/documents/brochure/cardinal-health-infection-control-apparel-brochure1.pdf

  5. U.S. Food and Drug Administration. 2020. Premarket Notification 510(K). [online] Available at: <https://www.fda.gov/medical-devices/premarket-submissions/premarket-notification-510k#se

  6. U.S. Food and Drug Administration. 2020. N95 Respirators And Surgical Masks (Face Masks). [online] Available at: <https://www.fda.gov/medical-devices/personal-protective-equipment-infection-control/n95-respirators-and-surgical-masks-face-masks#s4> [Accessed 23 March 2020].

  7. Pharmamedtechbi.com. 2020. [online] Available at: <https://www.pharmamedtechbi.com/~/media/Images/Publications/Archive/The%20Gray%20Sheet/30/010/01300100042_b/040308_surgical_mask_final_guidance.pdf

  8. American Cleanroom Systems. 2020. Medical Device Cleanroom | American Cleanroom Systems. [online] Available at: <https://www.americancleanrooms.com/medical-device-cleanrooms/