Analysis of SteraMist ionized hydrogen peroxide technology in the sterilization of N95 respirators and other PPE: a quality improvement study

Abstract

Objective:

The COVID-19 pandemic has led to widespread shortages of personal protective equipment (PPE) for healthcare workers, including filtering facepiece respirators (FFRs) such as N95 masks. These masks are normally intended for single use, but their sterilization and subsequent reuse could substantially mitigate a world-wide shortage.

Design:

Quality assurance.

Setting:

A sealed environment chamber installed in the animal facility of an academic medical center.

Interventions:

One to five sterilization cycles using ionized hydrogen peroxide (iHP), generated by SteraMist® equipment (TOMI; Frederick, MD).

Main outcome measures:

Personal protective equipment, including five N95 mask models from three manufacturers, were evaluated for efficacy of sterilization following iHP treatment (measured with bacterial spores in standard biological indicator assemblies). Additionally, N95 masks were assessed for their ability to efficiently filter particles down to 0.3μm and for their ability to form an airtight seal using a quantitative fit test. Filtration efficiency was measured using ambient particulate matter at a university lab and an aerosolized NaCl challenge at a National Institute for Occupational Safety and Health (NIOSH) pre-certification laboratory.

Results:

The data demonstrate that N95 masks sterilized using SteraMist iHP technology retain function up to five cycles, the maximum number tested to date. Some but not all PPE could also be sterilized using an iHP environmental chamber, but pre-treatment with a handheld iHP generator was required for semi-enclosed surfaces such as respirator hoses.

Conclusions:

A typical iHP environment chamber with a volume of ~80 m ³ can treat ~7000 masks per day, as well as other items of PPE, making this an effective approach for a busy medical center.