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NIOSH Respiratory Protective Device Information							Updated May 18, 2020
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										**Subject:** Information regarding damaged or degraded head straps on previously stockpiled NIOSH-approved filtering facepiece respiratorsNIOSH CA 2020-1028
Revised May 2020
NIOSH is aware that many different NIOSH-approved filtering facepiece respirator (FFR) models were stockpiled for prolonged times and are now distributed for use during the COVID-19 response. These FFRs are made using different materials (e.g., filtering media and strap material), which may age or degrade over time and become damaged. Generally, FFRs are not designed for long-term storage, and many models may have shelf lives designated by the NIOSH approval holder. The shelf life information is generally found on the packaging or the approval holder’s website.
**Recently, NIOSH received multiple inquiries concerning the identification and replacement of damaged straps on large caches of NIOSH-approved N95 FFRs that have since passed their designated shelf life**. Users should perform a visual inspection of each respirator prior to donning per the user instructions. Additional questions and concerns related to the condition of the respirator should be directed to the approval holder.
**Modifications to NIOSH-approved respirators should not be made as part of conventional operations.**In accordance with the NIOSH regulation, 42 CFR Part 84, Approval of Respiratory Protective Devicesexternal icon, **any** **changes that modify the design (e.g., replacing damaged straps), as approved by NIOSH, voids the NIOSH approval.**In this case, adding new straps may affect the fit or filtration performance of the respirator with potential to negatively impact the respiratory protection provided to the user.
**Only as a contingency or crisis capacity strategy option when no respirators are left** other than those with damaged straps, consideration can be given to replacing the damaged straps and using these modified “respirators” as facemasks (i.e., NOT as a NIOSH-approved N95 FFR). The CDC crisis capacity recommendations for prioritizing the use of respirators vs. facemasks by activity type should be followed.
**Supplemental Information**
CDC NIOSH posted guidance on Stockpiled N95 Respirators on March 6, 2020. As of March 28th 2020, the FDA’s emergency use authorization (EUA)external icon allows the use of NIOSH-approved FFR models in healthcare settings that have since passed the manufacturer’s recommended shelf-life; however, if the product exhibits signs of damage, it should be discarded. The FDA Emergency Use Authorizations websiteexternal icon should be checked for the most up-to-date information.
Users can find information about stockpiled FFRs tested in NIOSH’s research study on NIOSH’s website. Each FFR tested was visually inspected, where damage was observedpdf icon for a number of straps for two particular models. All tested units with a designated shelf life were past the shelf life identified.Information regarding damaged or degraded head straps on previously stockpiled NIOSH-approved filtering facepiece respirators pdf icon[PDF – 142 KB]
							
					
						Page last reviewed:  May 18, 2020					Content source: 	National Institute for Occupational Safety and Health homeNPPTL
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