Analysis of SteraMist ionized hydrogen peroxide technology in the sterilization of N95 respirators and other PPE

Cramer, Avilash; Plana, Deborah; Yang, Helen; Carmack, Mary; Tian, Enze; Sinha, Michael S.; Krikorian, David; Turner, David; Mo, Jinhan; Li, Ju; Gupta, Rajiv; Manning, Heather; Bourgeois, Florence T.; Yu, Sherry H.; Sorger, Peter K.; LeBoeuf, Nicole R.

doi:10.1038/s41598-021-81365-7

Cited by 33 publications

(20 citation statements)

References 25 publications

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“…However, during the first SARS pandemic, the CDC stated that “health care facilities may consider reuse as long as the device has not been obviously soiled or damaged (e.g. creased or torn)” and “if a sufficient supply of respirators is not available [ 41 ].” Multiple mask decontamination methods were tested and implemented during the COVID-19 pandemic and have further expanded on this concept, including UV germicidal irradiation, vaporous and ionized hydrogen peroxide (VHP/iHP) and moist heat [ 42 – 49 ], all of which promise to enable N95 reuse (for instance, the FDA EUA for the Battelle decontamination system permits up to 20 vaporous hydrogen peroxide decontamination cycles per respirator [ 50 ]). However, mask reuse is generally limited by breakage or degradation of the malleable nose clips and other components that are bent to form a seal around a user’s nose and the elastic bands that hold a mask in place.…”

Section: Discussionmentioning

confidence: 99%

3D Printed frames to enable reuse and improve the fit of N95 and KN95 respirators

et al. 2021

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Background In response to supply shortages caused by the COVID-19 pandemic, N95 filtering facepiece respirators (FFRs or “masks”), which are typically single-use devices in healthcare settings, are routinely being used for prolonged periods and in some cases decontaminated under “reuse” and “extended use” policies. However, the reusability of N95 masks is limited by degradation of fit. Possible substitutes, such as KN95 masks meeting Chinese standards, frequently fail fit testing even when new. The purpose of this study was to develop an inexpensive frame for damaged and poorly fitting masks using readily available materials and 3D printing. Results An iterative design process yielded a mask frame consisting of two 3D printed side pieces, malleable wire links that users press against their face, and cut lengths of elastic material that go around the head to hold the frame and mask in place. Volunteers (n = 45; average BMI = 25.4), underwent qualitative fit testing with and without mask frames wearing one or more of four different brands of FFRs conforming to US N95 or Chinese KN95 standards. Masks passed qualitative fit testing in the absence of a frame at rates varying from 48 to 94 % (depending on mask model). For individuals who underwent testing using respirators with broken or defective straps, 80–100 % (average 85 %) passed fit testing with mask frames. Among individuals who failed fit testing with a KN95, ~ 50 % passed testing by using a frame. Conclusions Our study suggests that mask frames can prolong the lifespan of N95 and KN95 masks by serving as a substitute for broken or defective bands without adversely affecting fit. Use of frames made it possible for ~ 73 % of the test population to achieve a good fit based on qualitative and quantitative testing criteria, approaching the 85–90 % success rate observed for intact N95 masks. Frames therefore represent a simple and inexpensive way of expanding access to PPE and extending their useful life. For clinicians and institutions interested in mask frames, designs and specifications are provided without restriction for use or modification. To ensure adequate performance in clinical settings, fit testing with user-specific masks and PanFab frames is required.

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Section: Discussionmentioning

confidence: 99%

3D Printed frames to enable reuse and improve the fit of N95 and KN95 respirators

et al. 2021

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“…We were also unable to assess the efficacy of different methods for sterilizing PanFab PAPRs, but materials used in the designs are compatible with alcohol-based wipes (e.g., acrylonitrile butadiene styrene ( Industrial Specialties Mfg and IS MED Specialties, 2019 ) allowing CDC recommendations for disinfecting PAPRs to be followed ( CDC, 2020b ). Previous research also suggests that ionized hydrogen peroxide techniques would be compatible with PAPR sterilization ( Cramer et al, 2021 ). Additional usability, durability and sterilization testing await the availability of additional PAPR units assembled during production scale-up.…”

Section: Discussionmentioning

confidence: 99%

De Novo Powered Air-Purifying Respirator Design and Fabrication for Pandemic Response

Kothakonda

Atta

Plana

et al. 2021

Front. Bioeng. Biotechnol.

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The rapid spread of COVID-19 and disruption of normal supply chains has resulted in severe shortages of personal protective equipment (PPE), particularly devices with few suppliers such as powered air-purifying respirators (PAPRs). A scarcity of information describing design and performance criteria for PAPRs represents a substantial barrier to mitigating shortages. We sought to apply open-source product development (OSPD) to PAPRs to enable alternative sources of supply and further innovation. We describe the design, prototyping, validation, and user testing of locally manufactured, modular, PAPR components, including filter cartridges and blower units, developed by the Greater Boston Pandemic Fabrication Team (PanFab). Two designs, one with a fully custom-made filter and blower unit housing, and the other with commercially available variants (the “Custom” and “Commercial” designs, respectively) were developed; the components in the Custom design are interchangeable with those in Commercial design, although the form factor differs. The engineering performance of the prototypes was measured and safety validated using National Institutes for Occupational Safety and Health (NIOSH)-equivalent tests on apparatus available under pandemic conditions at university laboratories. Feedback was obtained from four individuals; two clinicians working in ambulatory clinical care and two research technical staff for whom PAPR use is standard occupational PPE; these individuals were asked to compare PanFab prototypes to commercial PAPRs from the perspective of usability and suggest areas for improvement. Respondents rated the PanFab Custom PAPR a 4 to 5 on a 5 Likert-scale 1) as compared to current PPE options, 2) for the sense of security with use in a clinical setting, and 3) for comfort compared to standard, commercially available PAPRs. The three other versions of the designs (with a Commercial blower unit, filter, or both) performed favorably, with survey responses consisting of scores ranging from 3 to 5. Engineering testing and clinical feedback demonstrate that the PanFab designs represent favorable alternatives to traditional PAPRs in terms of user comfort, mobility, and sense of security. A nonrestrictive license promotes innovation in respiratory protection for current and future medical emergencies.

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“…Investigation into sterilization methods include UV light, 12 steam, 13 humid heat, 14 autoclaves, 15 and hydrogen peroxide. 16 , 17 UV light has been used to scale production to 12,000 sanitized respirators per day. 18 Yale researchers found that hydrogen peroxide vapor could be used for five cycles on respirators without any deformation.…”

Section: Reuse Of Existing N95 Respiratorsmentioning

confidence: 99%

Recent developments in filtration media and respirator technology in response to COVID-19

et al. 2021

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The COVID-19 pandemic triggered a surge in demand for N95 or equivalent respirators that the global supply chain was unable to satisfy. This shortage in critical equipment has inspired research that addresses the immediate problems and has accelerated the development of the next-generation filtration media and respirators. This article provides a brief review of the most recent work with regard to face respirators and filtration media. We discuss filtration efficiency of the widely utilized cloth masks. Next, the sterilization of and reuse of existing N95 respirators to extend the existing stockpile is discussed. To expand near-term supplies, optimization of current manufacturing methods, such as melt-blown processes and electrospinning, has been explored. Future manufacturing methods have been investigated to address long-term supply shortages. Novel materials with antiviral and sterilizable properties with the ability for multiple reuses have been developed and will contribute to the development of the next generation of longer lasting multi-use N95 respirators. Finally, additively manufactured respirators are reviewed, which enable a rapidly deployable source of reusable respirators that can use any filtration fabric. Graphic abstract

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Analysis of SteraMist ionized hydrogen peroxide technology in the sterilization of N95 respirators and other PPE

Cited by 33 publications

References 25 publications

3D Printed frames to enable reuse and improve the fit of N95 and KN95 respirators

3D Printed frames to enable reuse and improve the fit of N95 and KN95 respirators

De Novo Powered Air-Purifying Respirator Design and Fabrication for Pandemic Response

Recent developments in filtration media and respirator technology in response to COVID-19

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