FDA Update: COVID-19: FDA Reissues Emergency Use Authorizations Revising Which Types of Respirators Can Be Decontaminated for Reuse
Recently the FDA released news that they are reissuing EUAs revising which types of respirators that can be decontaminated for reuse. Based on the FDA’s further understanding of the performance and design of certain respirators, they have decided that certain respirators should not be decontaminated for reuse by health care personnel. As an example, the FDA has learned through the CDC’s NIOSH testing that authorized respirators manufactured in China may vary their design and performance. The FDA has thus determined that the available information does not support the decontamination of these respirators and has revised the EUAs accordingly. The FDA has also revised relevant EUAs to no longer authorize decontamination or reuse of respirators that have exhalation valves.
Decontaminated respirators should only be used when new FDA-cleared N95 respirators, NIOSH-approved N95 respirators, or other FDA authorized respirators are not available, recommends the CDC. Non-cellulose compatible N95 respirators are the only type authorized to undergo decontamination. Health care personnel should not reuse a respirator that is incompatible with an authorized decontamination system but has been decontaminated regardless.
The EUAs that have been reissued are:
- Non-NIOSH-Approved Disposable Filtering Facepiece Respirators Manufactured in Chinaby revising the Scope of Authorization such that authorized respirators listed in Appendix A will no longer be authorized if decontaminated.
- Multiple decontamination systems so that they
- are no longer authorized to decontaminate respirators manufactured in China, where applicable,
- only authorize decontamination of non-cellulose respirators that do not have an exhalation valve that are either authorized in the NIOSH-Approved Air Purifying Respirators for Use in Health Care Settings During Response to the COVID-19 Public Health EmergencyEUA or that are authorized and identified in Exhibit 1 of the EUA for Imported, Non-NIOSH-Approved Disposable Filtering Facepiece Respirators to be decontaminated.
For the full news release please go to the FDA’s website
You have to understand that the FDA is learning and constantly in a state-of-flux. Companies who are presently involved with these EUA and PPE will need to understand the possible changes and make sure that where they stood one day marketing their product could change on the spur of the moment. Looking for the long range one must understand what it requires to be in full FDA compliance.
mdi Consultants can assist with FDA authorization and compliance for your respirators as well as answer questions you may have.
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