Battelle Decontamination System

Angie Szumlinski
|
September 9, 2020
Image

On March 30, 2020 Battelle announced they had received an emergency go-ahead from the FDA to deploy its decontamination system for personal protective equipment (PPE), allowing healthcare workers to clean and reuse scarce N95 respirator masks. They system is capable of processing up to 80,000 masks per machine, per day, within what looks like a large metal shipping container.

What is this device?

The Battelle Decontamination System is a self-contained decontamination device that uses vapor phase hydrogen peroxide (VPHP) for decontamination of compatible N95 respirators* that are contaminated or potentially contaminated with SARS-CoV-2 and other pathogenic microorganisms. Using concentrated hydrogen peroxide vapor, the filters are gassed for two and a half hours to destroy bacteria, viruses and other contaminants, including the novel coronavirus SARS-CoV2. N95 masks can be cleaned using this technology up to 20 times without degrading its performance. That’s amazing! Think of the PPE relief we could have by using this device!

Battelle previously engaged with the FDA from 2014 to 2016 to study the use of its decontamination machine in the midst of a potential pandemic and PPE shortage. Currently, the company is exploring its use outside the N95 masks to other equipment such as ventilator components.

What is known and potential benefits and risks of using decontaminated compatible N95 respirators that were decontaminated using the Battelle Decontamination System?

Potential Benefits Include:

  • May help prevent exposure to airborne pathogens and therefore reduce the risk of infection or illness
  • Extends the usability of compatible N95 respirators by allowing for decontamination and reuse

Potential Risks Include:

  • Failure of filtration efficiency
  • Reduced breathability
  • Strap failure and ineffective face-fit
  • Reused respirators may not have been effectively decontaminated of SARS-CoV-2 or other pathogens
  • Cross-contamination from ineffective decontamination.

*N95 respirators containing cellulose-based materials or exhalation valves are not compatible with the Battelle Decontamination System. This device is also not authorized to decontaminate respirators authorized under the EUA for FFRs manufactured in China.

Report Adverse events to MedWatch by submitting the online FDA Form 3500

https://www.accessdata.fda.gov/scripts/medwatch/index.cfm?action=reporting.home

or by calling 1-800-FDA-1088

Where can I go for updates and more information?

CDC webpages:

General:

https://www.cdc.gov/COVID19

Healthcare Professionals:

https://www.cdc.gov/coronavirus/2019-nCoV/guidancehcp.html

Infection Prevention and Control Recommendations in Healthcare Settings: https://www.cdc.gov/coronavirus/2019-ncov/infectioncontrol/control-recommendations.html

Infection Control:

https://www.cdc.gov/coronavirus/2019- ncov/infection-control/index.html

FAQ on PPE:

https://www.cdc.gov/coronavirus/2019-ncov/hcp/respiratoruse-faq.html

FDA webpages:

General:

www.fda.gov/novelcoronavirus

EUAs:

https://www.fda.gov/medical-devices/emergencysituations-medical-devices/emergency-use-authorizations


Related Posts

Image
Angie Szumlinski
|
May 30, 2024

Alzheimer’s Disease and Agitation

Image
Angie Szumlinski
|
May 21, 2024

Deep Breath!