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Wake Forest Baptist participating in study on designed reusable N95 mask
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Wake Forest Baptist participating in study on designed reusable N95 mask

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Researchers with Wake Forest School of Medicine are collaborating on an effort to develop a reusable and more comfortable face mask for health care workers.

The testing of the potential personal protection equipment (PPE) product comes as the arrival of several global COVID-19 variants into North Carolina and the United States has drawn concerns in terms of new community exposures.

Just as worrisome: How do the variants affect the disposable masks worn by health care workers?

The COVID-19 pandemic has claimed the lives of thousands of medical providers in the U.S. alone, most who were exposed and infected as they treated infected patients.

One attempt at mitigating the variants’ impact on protective equipment involves the departments of Biomedical Engineering and Infectious Disease at Wake Forest School of Medicine and a remote team led by Massachusetts Institute of Technology alumnus Matt Carney.

They have developed a reusable mask being tested in a study at Wake Forest Baptist Health. Enrollment is projected to be completed by May 28.

Public health officials locally and nationally have advocated for improved respiratory PPP that also are more comfortable, easy to use and reusable.

Open Standard Industries Inc. is the manufacturer of the OSR-M1 non-valved reusable elastomeric face mask. Carney is Open Standard’s chief executive.

A prototype was developed about a year ago, with the Wake Forest medical school departments assisting in the design, development, testing and early manufacturing stages.

“We believe testing with the clinical staff at Wake Forest Baptist and Atrium Health will provide further verification of those efforts,” Carney said.

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OSI is in the process of submitting the mask to the National Institute of Occupational Safety and Health with the goal of being certified as an N95 respirator.

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OSI claims the OSR-M1 mask filters more than 99% of airborne particles. It says the modular design also uses on average four times less filter material than a disposable mask and pays for itself after 20 to 30 wears.

“Clinicians struggle to achieve a good fit with disposable respirators,” said OSI co-founder Philip Brown, a co-principal investigator of the study and assistant professor of biomedical engineering at Wake Forest.

“Without a good face seal, employees do not get adequate protection against airborne pathogens.

“This user-feasibility study will explore the potential benefits gained through elastomeric respirators to fit and protect a diverse clinical workforce.”

The Associated Press reported Friday that the Biden administration has taken the first step toward ending an emergency exception that allowed hospitals to ration and reuse N95 medical masks.

The shortage of critical protective equipment during the first months of the pandemic led the Trump administration to issue guidelines for providers to ration, clean and reuse disposable equipment.

Rather than disposing of a N95 mask after each use, the majority of medical providers treating COVID-19 patients have received a new mask on a weekly basis.

AP reported that since U.S. manufacturers have vast PPE surpluses for sale, and hospitals say they have three to 12 month stockpiles, federal health officials recommended hospitals and health care providers should try to return to one mask per patient.

However, for now, hospitals are legally permitted to sterilize and reuse N95s.

Wake Forest Baptist said that creating a diversified supply of durable, reusable masks will be critical to ensuring a resilient response to the end of the coronavirus pandemic and to future public health crises.

An infectious disease outbreak in 2002-04, the H1N1 flu pandemic of 2009-10 and the MERS outbreak of 2012 show that there is a need for improved and reusable masks beyond just COVID-19, said Dr. Werner Bischoff, co-principal investigator of the study and professor of infectious diseases at the Wake Forest medical school.

“Even with the highly accelerated development of vaccines, the initial response to these threats relies solely on preventive measures, such as social distancing, hand hygiene and respiratory personal protective equipment,” Bischoff said.

“Providing effective and reusable respiratory protection is an essential element of our current and future preventive strategies to successfully control and suppress virus transmission.”

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