Battelle received FDA Emergency Use Authorization (EUA) for the Battelle Critical Care Decontamination System for N95 respirator sterilization distributed to healthcare workers as of June 6th, 2020.
The Battelle Critical Care Decontamination System (CCDS) is a self-contained, mobile decontamination system that uses vapor phase hydrogen peroxide (VPHP) to decontaminate non-cellulose containing N95 masks during anticipated critical shortages. VPHP is a process used to fumigate hospital rooms, adapted to eradicate phages from N95 respirators. The Battelle CCDS includes custom designed decontamination chambers, each with a capacity to hold up to 5000 masks per decontamination cycle, with vapor concentrations required to achieve 6-log reduction in viral and bacterial agents. Hospitals collect appropriate N95 masks without soiling, marked with proper site and provider labels for mass sterilization in barcoded batches.
The FDA reviewed literature characterizing the effect of vaporous hydrogen peroxide (VHP) on compatible N95 respirators contaminated with viruses; filtration efficiency and breathability testing following multiple decontamination cycles; historical biological indicator inactivation data for VHP; testing regarding hydrogen peroxide residuals after decontamination; and fit testing for decontaminated, compatible N95 respirators.
In summary, respirator airflow function was not affected for up to 50 cycles, depending on N95 model. Elastic straps may lose elasticity at 20 cycles. By comparison thermal reprocessing methods deform respirators and alter fit, UV is hampered by shadowing, and HP gas plasma is absorbed by N95 filter material affecting filtration. In pre-FDA studies of similar VHP techniques, none of the studied viral phage particles were detectable following treatment.
Battelle received emergency use authorization from the FDA on March 28th, 2020. That scope was expanded based on available data on June 6th, 2020 to allow healthcare organizations with N95 respirator shortages to participate in Battelle’s sterilization process. Of note, there are no FDA approved or cleared devices for decontaminating compatible N95 respirators outside of the EUAs issued during the COVID-19 pandemic.
The FDA approved indications and recommendations include the following:
a. The CCDS is approved for non-cellulose containing respirators that do not have an exhalation valve, where no gross soiling is evident.
b. Up to 20 cycles on the same respirator is permitted.
c. Battelle can decontaminate up to 10,000 compatible N95 respirators per chamber load.
d. Strict chain of custody barcoding protocols ensure that hospitals receive only the masks they provided.
e. N95 respirators do not need to be returned to the individual healthcare worker from which it originated.
Contraindications include the following:
a. N95 respirators with gross soiling or damage.
b. N95 respirators containing cellulose based materials or exhalation valves.
c. N95 respirators not originating from designated healthcare workers.
d. N95 respirators with barcodes signaling more than 20 VPHP cycles.
References
1) Decontamination process on video. 04/02/2020. www.youtube.com/watch?v=II1Q_oMtsac
2) Battelle. Bioquell HPV Decontamination for Reuse of N95 Respirators. Submitted to FDA 07/05/2016. https://www.fda.gov/media/136386/download
3) Technical Report for H2O2 Based N95 Reuse Risk Management. 04/01/2020. www.n95decon.org
