PPE CASE Reports

This report summarizes NIOSH assessments of filtration efficiency, manikin fit performance, and strap performance of NIOSH Approved^® N95 FFRs that have undergone various decontamination techniques. Based on the knowledge gained from these assessments, this report discusses important considerations when selecting techniques of FFR decontamination for occupational use as part of crisis capacity strategies during respirator shortages.

• Assessment of Filtration Efficiency, Manikin Fit Performance, and Strap Performance for Decontaminated N95 Filtering Facepiece Respirator: Evaluation of a convenience sample of 1,354 N95 FFR units across 29 models found that 42% of the decontamination techniques evaluated (8 of 19) negatively impacted fit and/or filtration efficiency.

The reports below summarize the filtration performance results from the assessments that took place as a result of an Emergency Use Authorization issued by the United States Food and Drug Administration. They also discuss important considerations when purchasing non-NIOSH Approved international respiratory protective devices temporarily authorized for occupational use in the United States.

• Filtration Efficiency Performance of Non-NIOSH-Approved International Respiratory Protective Devices: Phase One: NIOSH evaluations show that many non-NIOSH Approved international respiratory protective devices have inconsistent filtration performance, and most assessments resulted in filtration efficiencies less than 95%.
• Filtration Efficiency Performance of Non-NIOSH-Approved International Respiratory Protective Devices: Phase Two: NIOSH evaluations show that 26% of non-NIOSH Approved international respiratory protective devices have inconsistent filtration performance and 60% of assessments found filtration efficiencies less than 95%. The NIOSH Approved N95^® FFR standard is 95%.
  

The Strategic National Stockpile and state and local stockpile personnel asked NIOSH to evaluate the effect of stockpile conditions on the viability of respirators. NIOSH collected samples of stockpiled N95^® FFRs from ten geographically dispersed facilities with varying storage conditions from 2017-2019. Approximately 4,000 FFRs were collected and tested in accordance with NIOSH performance requirements. Below are reports from the site visits.

• Evaluation of Fit and Strap Extension Performance of Stockpiled Filtering Facepiece Respirators from One U.S. Facility: This report details the fit testing performance of N95 FFRs collected from Facility Four. NIOSH evaluated 293 stockpiled N95 FFRs from a single facility to determine if long-term storage (9-13 years) affected fit. Using human subjects, quantitative fit testing identified product- and lot-specific differences between the control and stockpiled respirators.
• Overall Performance of Nearly 4,000 Respirators Sampled from Ten Stockpile Facilities: NIOSH found that 98% of the air-purifying respirators tested from ten stockpile facilities and manufactured between 2003-2013 maintained their inhalation and exhalation resistance and filtration performance in accordance with NIOSH performance standards.
• Facility One of Ten: Inhalation and Exhalation Resistance and Filtration Efficiency Performance: NIOSH found that 344 of 344 N95 FFRs stockpiled at Facility One that were 8-11 years old maintained their inhalation and exhalation resistance and filtration performance in accordance with NIOSH performance standards.
• Facility Two of Ten: Inhalation and Exhalation Resistance and Filtration Efficiency Performance: NIOSH found that 301 of 301 N95 FFRs stockpiled at Facility Two that were 8-11 years old maintained their inhalation and exhalation resistance and filtration performance in accordance with NIOSH performance standards.
• Facility Three of Ten: Inhalation and Exhalation Resistance and Filtration Efficiency Performance: NIOSH found that 256 of 258 N95 FFRs stockpiled at Facility Three that were 8-11 years old maintained their inhalation and exhalation resistance and filtration performance in accordance with NIOSH performance standards.
• Facility Four of Ten: Inhalation and Exhalation Resistance and Filtration Efficiency Performance: NIOSH found that 540 of 574 N95 FFRs and P95^® filters stockpiled at Facility Four that were 8-12 years old maintained their inhalation and exhalation resistance and filtration performance in accordance with NIOSH performance standards.
• Facility Five of Ten: Inhalation and Exhalation Resistance and Filtration Efficiency Performance: NIOSH found that 602 of 602 N95 FFRs and P95 filters stockpiled at Facility Five that were 8-12 years old maintained their inhalation and exhalation resistance and filtration performance in accordance with NIOSH performance standards.
• Facility Six of Ten: Inhalation and Exhalation Resistance and Filtration Efficiency Performance: NIOSH found that 387 of 387 N95 FFRs stockpiled at Facility Six that were 11-12 years old maintained their inhalation and exhalation resistance and filtration performance in accordance with NIOSH performance standards.
• Facility Seven of Ten: Inhalation and Exhalation Resistance and Filtration Efficiency Performance: NIOSH found that 519 of 559 N95 FFRs stockpiled at Facility Seven that were 5-12 years old maintained their inhalation and exhalation resistance and filtration performance in accordance with NIOSH performance standards.
• Facility Eight of Ten: Inhalation and Exhalation Resistance and Filtration Efficiency Performance: NIOSH found that 344 of 344 N95 FFRs stockpiled at Facility Eight that were 9-12 years old maintained their inhalation and exhalation resistance and filtration performance in accordance with NIOSH performance standards.
• Facility Nine of Ten: Inhalation and Exhalation Resistance and Filtration Efficiency Performance: NIOSH found that 172 of 172 N95 FFRs stockpiled at Facility Nine that were 15 years old maintained their inhalation and exhalation resistance and filtration performance in accordance with NIOSH performance standards.
• Facility Ten of Ten: Inhalation and Exhalation Resistance and Filtration Efficiency Performance: NIOSH found that 430 of 430 N95 FFRs stockpiled at Facility Ten that were 12-13 years old maintained their inhalation and exhalation resistance and filtration performance in accordance with NIOSH performance standards.

• Performance of Stockpiled Level 3 Surgical Gowns Sampled from Six Stockpile Facilities: End user protections will be enhanced by revisions to the Association of the Advancement of Medical Instrumentation (AAMI) PB70 to define minimum critical zone boundaries and include guidance for post-market quality assurance sampling and data interpretation for third party entities.
  
• Testing of Stockpiled ANSI/AAMI PB70 Level 3 Surgical Gowns: NIOSH did not find evidence that the stockpiled gowns tested no longer met AAMI PB70 Level 3 requirements. However, only the manufacturer can set or extend the shelf life of their products. NIOSH does not recommend the use of these gowns without conducting representative testing of the stockpile and consulting with the manufacturer about the shelf life.
• Testing of Stockpiled ANSI/AAMI PB70 Level 4 Surgical Gowns: NIOSH determined that existing surgical gown test methods require greater clarification to ensure consistent evaluations and conclusions. Additionally, NIOSH recommends that a post-market conformity standard be developed.

• Point-of-Use Assessment for Closed-Circuit Escape Respirators Sampled from Mines that use both Subpart O and Subpart H Approved Units: First Phase: Carriable Subpart H approved CSE SRLD self-contained self-rescuers (SCSR) units that passed the manufacturer’s inspection all demonstrated the expected life support capacity over the course of the manufacturer’s specified service time. NIOSH identified two Subpart O approved CSE SR2000 SCSR units that did not conform and notified the approval holder who withdrew approval due to changing market conditions while testing continued.
• Point-of-Use Assessment for Self-Contained Self-Rescuers Randomly Sampled from Mining Districts: Third Phase: NIOSH’s point-of-use assessments for SCSRs found that mine operators are largely compliant with SCSR manufacturer-specified requirements and the devices tested appear to be sufficiently designed for mining use conditions.
• Point-of-Use Assessment for Self-Contained Self-Rescuers Randomly Sampled from Mining Districts: Second Phase: NIOSH’s point-of-use assessments for SCSRs found that mine operators are largely compliant with SCSR manufacturer-specified requirements and the devices tested appear to be sufficiently designed for mining use conditions.
• Point-of-Use Assessment for Self-Contained Self-Rescuers Randomly Sampled from Mining Districts: First Phase: NIOSH’s point-of-use assessments for SCSRs found that mine operators are largely compliant with SCSR manufacturer-specified requirements and the devices tested appear to be sufficiently designed for mining use conditions.

• Point-of-Use Assessment of Emergency Escape Breathing Devices for the U.S. Navy: NIOSH recommends compliance with manufacturer-specified requirements. Proper storage and visual inspection practices are crucial to the safe use of Emergency Escape Breathing Devices. Any apparatus that fails the visual inspection should be removed from service.

Evaluations of a Self-Contained Breathing Apparatus for Potential Contribution to a Fatal Event in the Fire Service

• Lower Merion Fire Department
• Frederick County Fire and Rescue
• New Haven Connecticut Fire Department
• Watertown Fire Department, 2021
• Worcester Fire Department, 2020
• Christopher Illinois Fire Department
• Worcester Fire Department, 2019
• Clinton Fire Department
• Watertown Fire Department, 2018
• Howard County Department of Fire and Rescue Services
• San Antonio County Fire Department
• Wilmington Delaware Fire Department
• Pineville, North Carolina Fire Department
• Valley Springs, South Dakota Fire Department
• Houston, Texas Fire Department
• Hamilton, Ohio Fire Department
• Kansas City, Missouri Fire Department

Evaluations of a Self-Contained Breathing Apparatus Involved in a Near Miss in the Fire Service

• Bedford County, Virginia, Fire and Rescue
• Clinton Fire Department
• East Hartford, Connecticut Fire Department
• Loudoun County, Virginia Fire Department
• Rock Creek, Idaho Fire Department
• Birmingham, Alabama Fire Department
• Indianapolis, Indiana Fire Department