Publish Date: June 10, 2020
Are you confused by the mountain of information circulating about respiratory protection during the COVID-19 pandemic? Have you been asked to determine if a filtering facepiece respirator that your organization has purchased during widespread shortages is effective? Guidelines’ editor in chief, Dr. Erin Kyle, provides recommendations.
Outside the context of a declared health emergency, only NIOSH-approved and FDA-cleared respiratory protection should be used in US health care organizations. The COVID-19 pandemic has necessitated the use of medical countermeasures to meet the personal protective equipment needs of health care workers across the country.
Organizations that have entered Phased reopening for elective procedures should be doing so only after an adequate supply of PPE is sustained in the organization. This guidance is intended for those organizations that remain in contingency or crisis capacity and are not performing elective procedures in their organization.
This decision flow chart is provided here to assist you in evaluating respirators before use in your facility. Each decision point has a hyperlink to additional resources that provide information that can inform you about how to move through this decision flow chart.
The first thing that you should determine is whether the respirator you are considering is NIOSH-approved. You can find this information in two ways. First, NIOSH approval numbers are included on the respirator label. Second, you can search for the product manufacturer and model on the NIOSH website. If the respirator is NIOSH approved, move to determining whether the respirator is FDA-cleared and has a fluid barrier rating which is included on the product label as an ASTM level 1, 2, 3, or 4. If the respirator is not NIOSH-approved or is NIOSH-approved but not FDA-cleared, the next determination is whether the respirator has an FDA Emergency Use Authorization (FDA EUA). Some respirators with FDA EUA have been vulnerable to counterfeit, making it essential to validate that the respirator that you are considering are not a counterfeit product.
Moving through the decision flow chart, next is looking for assessment data for the respirator. The National Personal Protective Technology Laboratory (NPPTL) has conducted numerous filtration effectiveness assessments and has posted these reports on its website. Once you have determined that the respirator has passed the >95% filtration threshold by looking at the report attached to the table of assessment results, you can move forward with using the respirator either with or without a fluid barrier shield if the respirator does not itself provide a fluid barrier.
Making decisions about how to adapt to challenges during the COVID-19 pandemic has been challenging and ever-changing. Resources that are available today were not available in the beginning, for example the NPPTL assessment reports. AORN will continue to monitor the situation and keep you informed about developments in best practices and new tools for decision-making.