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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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WHAT WE ARE DOING TO SOLVE THE PROBLEM

FABRIC is pivoting its manufacturing efforts to fill a need amid COVID19 crisis and educate the public and other manufacturers on CDC/FDA regulations necessary to make safe PPE

 

As local healthcare facilities begin to place orders totaling over a million units, FABRIC is gearing up to manufacture reusable isolation gowns and other needed PPE items for multiple healthcare agencies.

With grassroots movements to make PPEs in homes and US factories, FABRIC has been working tirelessly on safe and effective solutions for the community. After extensive research on CDC and FDA guidelines for PPE, FABRIC seeks to manufacture reusuable 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 HCP.

As the call for action (2) to make masks and other PPE items for HCP virally spreads on social media and the FDA itself, FABRIC, a community resource, feels an obligation to help share information that may help uphold the safety standards that have been set in place by the CDC and the FDA (3) for a good reason. With FABRIC’s skilled labor force, industrial cutting and sewing equipment, design development expertise, and connections to a large eager community, FABRIC hopes to lead by example.

FABRIC has spearheaded a taskforce internally to research PPE standards. We've been particpating in a special task force appointed by the AZ governor along with many local healthcare facilities, the AZ Commerce Authority, the Arizona Department of Health Services, the Department of Emergency and Medical Affairs, and countless government and healthcare organizations to offer its manufacturing resources and facility to aid in this crisis. With FDA-approved fabrics in adherence to AAMI standards (4) in short supply, FABRIC is actively securing these scarce fabrics and working with a Qualitiy and Regulatory Consultant specializing in medical devices to secure FDA certification and to approve substantially equivalent materials that might be readily available as needed.  It is imperative that these efforts to provide PPE items such as surgical and barrier gowns, are deemed safe and effective for Arizona’s deserving HCP, as long as they meet certain substantial equivalence standards (5). 

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/