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CDC and FDA Update (4/9/21): Add more N95s now

N95
N95

CDC and FDA Update (4/9/21): Add more N95s now

CDC and FDA are advising healthcare facilities it’s time to transition away from crisis capacity strategy for respirators.1,2 The CDC (Centers for Disease Control and Prevention) recently updated its published guidance for use of N95 respirators for healthcare professionals: “Once personal protective equipment (PPE) supplies and availability return to normal, healthcare facilities should promptly resume conventional practices,” reflecting the recent increase in available domestic supply of N95s.1  

CDC also stated that when it comes to extended use of N95 respirators among cohorted patients, respirators should be discarded immediately after being removed and not re-used. Considerations should include the ability of the N95 respirator to retain its fit as well as contamination concerns.1

While the FDA has not yet rescinded the EUAs for N95 decontamination systems, the agency instructed healthcare facilities in a letter, also published April 9: “Increase inventory of available NIOSH-approved respirators—including N95s and other FFRs…Even if you are unable to obtain the respirator model that you would prefer, the FDA recommends that you obtain and use a new respirator before decontaminating or bioburden reducing a preferred disposable respirator.”2

 

CDC: N95s offer highest level of protection5

While the vaccine roll-out continues, variants of concern like B.1.1.7 are becoming more prevalent, and COVID cases have risen again in some areas.3,4 To ensure clinicians are protected in every patient encounter where they face unknown risks, N95 respirators are now recommended by the CDC as the preferred respiratory protection.5 The agency’s updates have advised that the use of surgical face masks to care for a patient with suspected or confirmed SARS-CoV-2 infection should be avoided except as a last resort,1 declaring that NIOSH-approved N95 respirators “offer the highest level of both source control and protection against inhalation of infectious particles.”5

 

A crisis situation required a crisis response

Last year saw a dire shortage of N95 respirators, as demand for N95s spiked at least 17x usual, according to GPO estimates.7 Healthcare facilities turned to contingency and crisis PPE standards of care to compensate for the shortage. The good news is, over the past months, the industry has responded in a robust fashion, ramping up supply for the North America market to more than 175 million units per month, according to published statements from the largest domestic N95 manufacturers including 3M and Honeywell. This is a dramatic contrast to the pre-COVID typical usage of about 4 million per month during flu season, according to Honeywell estimates.

“Over the past months, we’ve been laser-focused on getting more N95s onto the faces of more care providers,” said Will Lange, Chief Commercial Officer, Honeywell PPE.  “To have any clinician be able to choose a fluid-resistant surgical N95 respirator in the clinical situations where needed — that’s been our goal. We stood up 5 new production lines to be able to produce around 70 million N95s per month in North America. It’s gratifying to see this finally come to fruition for our healthcare professionals,” he added. “They deserve the highest level of respiratory protection.”

 

FDA: “Increase inventory of available respirators”

Now healthcare organizations are well-poised to take full advantage of the industry’s response and finally improve their inventory to be able to help protect more clinicians than ever before with fluid-resistant N95 protection in the face of unknown risks.

 

Daily PPE calculator can help model utilization

Healthcare facilities can use this simple calculator, offered by The Covid Staffing Project, to quickly estimate daily N95 usage for specific patient care settings under various PPE protocols to determine the future supply they’ll need. It’s an easy way to model utilization under different infection control protocols and have a conversation with suppliers about the current and expected future supply that will meet the need.

https://www.covidstaffing.org/modules/daily-ppe-calculator/

Source: Vanderbilt University Medical Center and Michigan Medicine’s The Covid Staffing Project.6

 

Honeywell NIOSH-approved Surgical N95 Respirators are available now

From Honeywell, the trusted brand in respiratory protection for a wide variety of industries, NIOSH-approved Surgical N95 Respirators are available now.  Now is the time to increase N95 par levels to equip more clinicians with access to N95 level protection for the clinical situations where needed.

 

DC365 Surgical N95 Respirator is an easy-to-don and doff, high fluid-resistant surgical respirator designed for clinician satisfaction across the continuum of care. It’s been user-validated in the clinical environment.

·       A good choice for med-surg units, ambulatory care, and ED or critical care where fluid-resistance and quick donning are important.

·       Fluid-resistant at 160 mmHg.

·       Dye-free, non-sensitizing, with soft inner lining.

·       Flexible, light-weight construction minimizes pressure points.

·       Easy-don dual-bonded woven straps enable fast donning and easy doffing without tangling hair.

·       Compact style fits well under face shields.

·       Multi-layer absorption media designed for lower breathing resistance.

 

Honeywell delivers high-performance PPE solutions that are innovative and designed for exceptional fit. The company has spent decades researching and testing new materials to develop the best PPE for the broadest range of user needs.

 

Download the product data sheet here.  Contact a Honeywell representative here.                                                                                                                 

 

 

1 Strategies for Optimizing the Supply of N95 Respirators, CDC, April 9, 2021.

https://www.cdc.gov/coronavirus/2019-ncov/hcp/respirators-strategy/index.html

2 FDA Recommends Transition from Use of Decontaminated Disposable Respirators, U.S. FDA. April 9, 2021.

https://www.fda.gov/medical-devices/letters-health-care-providers/fda-recommends-transition-use-decontaminated-disposable-respirators-letter-health-care-personnel-and

 

3 More Contagious Virus Variant Is Now Dominant in U.S., C.D.C. Chief Says, New York Times, April 7, 2021.

More Contagious Covid Variant Is Now Dominant in U.S., C.D.C. Says - The New York Times (nytimes.com)

 

4 COVID Press Briefing, U.S. CDC, HHS, NIH, April 16, 2021.

https://www.whitehouse.gov/wp-content/uploads/2021/04/COVID-Press-Briefing_16April2021_for-transcript.pdf

 

5 Centers for Disease Control and Prevention, Interim Infection Prevention and Control Recommendations for Healthcare Personnel During the Coronavirus Disease 2019 (COVID-19) Pandemic.

https://www.cdc.gov/coronavirus/2019-ncov/hcp/infection-control-recommendations.html#useppe

 

6 Daily PPE Calculator, The COVID Staffing Project, Vanderbilt University Medical Center, Michigan Medicine, et al. 2020.

https://www.covidstaffing.org/modules/daily-ppe-calculator/

 

7 The State of PPE Supply One Year Into Covid-19, Premier Inc., April 1, 2021.  https://www.premierinc.com/newsroom/blog/premier-data-the-state-of-ppe-supply-one-year-in-to-covid-19