Open Standard Industries, Inc. (OSI), manufacturer of the OSR-M1 non-valved reusable elastomeric face mask, is pleased to formally announce the launch of its first Institutional Review Board (IRB)-approved user feasibility study. The trial is being led by the departments of Biomedical Engineering and Infectious Diseases at Wake Forest School of Medicine, part of Wake Forest Baptist Health. Recruitment in the study is underway, and enrollment is expected to be completed by May 28, 2021.
Given mounting evidence of the airborne transmission and multiple variants of SARS-CoV-2, public health officials have advocated for improved respiratory personal protection equipment (PPE) that offers better protection over standard disposable masks, while being comfortable, reusable and easy to use.
A remote team led by Massachusetts Institute of Technology (MIT) alumnus Matt Carney, Ph.D., designed and prototyped the OSR-M1 in the spring of 2020. Wake Forest Baptist Health supported design, development, testing, and early manufacturing efforts, and has continued to be an active partner throughout the past year. Carney, Ph.D., CEO of OSI, comments, “Due to PPE supply constraints beginning in March of 2020, we set out to design a better mask for healthcare workers. The early input of clinicians, and health and safety managers was invaluable in designing the mask. We believe testing with the clinical staff at Wake Forest Baptist and Atrium Health will provide further verification of those efforts.”
The OSI team is currently submitting the mask to the National Institute of Occupational Safety and Health (NIOSH) aiming for certification as an N95 respirator. According to independent testing, OSR-M1’s design is already passing the necessary performance testing standards outlined in 42 CFR part 84 for elastomeric masks. The OSR-M1 mask filters more than 99% of airborne particles while being highly breathable, and easy to clean and re-use. The modular design of the OSR-M1 also uses on average four times less filter material than a disposable mask and pays for itself after 20-30 wears, making it ideal for large employers such as health systems which need to provide PPE to their staff.
For health systems in particular, 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.
Although the mass vaccine roll-outs this year have reduced transmission of SARS-Cov2, experts anticipate that masks will continue to be necessary until 2022. Werner Bischoff, M.D., Ph.D., co-principal investigator of the study and, professor of infectious diseases at Wake Forest School of Medicine remarks, “The SARS-CoV outbreak in 2002/4, the H1N1 Influenza pandemic in 2009/10, The MERS-CoV outbreak in 2012, and the ongoing SARS-CoV-2 pandemic also known as COVID-19 demonstrates the recurring risk of novel respiratory viruses to global health. 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. Providing effective and reusable respiratory protection is an essential element of our current and future preventive strategies to successfully control and suppress virus transmission.”
Given the importance of fit to performance, the Wake Forest Baptist study will focus on evaluating face-fit across a large, diverse clinical population. According to OSI co-founder Philip Brown, Ph.D., co-principal investigator of the study and assistant professor of biomedical engineering at Wake Forest School of Medicine, “Clinicians struggle to achieve a good fit with disposable respirators. 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.”
Conrad Emmerich, senior vice president of supply chain for Atrium Health, notes, “Even with the rollout of COVID-19 vaccines, we expect that respirators will continue to be used in a healthcare setting for an extended period of time. Safety of our health care workers is paramount, and we want to ensure we have a domestic source for a sustainable, diversified, resilient supply of PPE to best protect them now and into the future.”