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dcyphr | Injection Molded Autoclavable, Scalable, Conformable (iMASC) system for aerosol-based protection: a prospective single-arm feasibility study

Abstract

This study tests the effectiveness of a new take on the mask shortage, using iMASC. The iMASC system (Injection Molded Autoclavable, Scalable, Conformable system) is a filter that can be used, removed, sanitized and reused in place of a single use N95 mask. The study used OSHA-approved testing and a questionnaire to assess the fit score, breathability, and user friendliness of the replaceable filter.


Aims

This study aims to measure the success of iMASC as an alternative to a single use N95 mask.


Introduction

In the current COVID-19 pandemic, there is a personal protective equipment (PPE) shortage. Healthcare workers are having to reuse and sanitize their PPE. Homemade, reused, and sanitized PPE may offer less protection to healthcare workers, which will put them at high risk for getting sick and prevent the hospitalized patients from getting the care they need. This research team created Injection Molded Autoclavable, Scalable, Conformable (iMASC) system. This is a mask that has reusable and sanitizable filters that can be replaced when necessary.  The mask was compared to traditional N95 standards, and may be the answer to the PPE shortage.


Results

Design and generation of injection-moulded LSI mask

The shape of the mask was designed after the traditional N95 mask, and includes two filters to increase breathability. 


Characterisation of mask material after sterilization

After the mask was autoclaved 10 times, bleached for 5 minutes, or soaked in 70% isopropyl alcohol for 5 minutes, there was no significant change in the mask overall.


FE analysis for mask deformation on different face shapes and sizes

A deformation test was done to see how much force was needed to keep the mask on and in place. In 20 different people tested, the straps were able to keep the mask in place.


Clinical trial evaluating mask fitting

20 people who had previously been fitted for an N95 mask participated in a fit test for the iMASC system. There was a 100% success rate for the fit test and being able to easily change the filter. A scale from 1 (excellent) to 5 (very poor) was used by the 20 participants to rate iMASC. The average fit score was 1.75, breathability was 1.6, and ease of changing the filter was 2.05. 15% of people would have preferred an N95 mask to the iMASC, but 25% preferred the iMASC and 60% had no preference.


Discussion

Using sanitized or reused masks are not safe for healthcare workers, so it is important we find another solution to the PPE shortage soon. The iMASC system can be easily produced and sanitized, making it a great solution to the PPE shortage. After additional testing and safety certifications, the iMASC may be useful in healthcare and other fields that are in need of sustainable masking options.


Methods

The masks were exposed to autoclaving, bleach, and isopropyl alcohol. Then they were tested for fitness in a clinical study. This test looked at how well the mask could filter particles, seal to the person’s face, resist deformation, and how easy it was to replace the filters.


Conclusion

The iMASC has had successful preliminary testing, and could be a great sustainable alternative to the disposable N95 masks after further safety certification.