Fire Fighter Fatality/Injury SCBA Evaluation Overview

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Post Certification OverviewKim C. Gavel Lead
General Engineer

• Fire Fighter Fatality/Injury SCBA Evaluation
  Overview
• Thomas Pouchot
• General Engineer
• National Institute for Occupational Safety and
  Health
• National Personal Protective Technology
  Laboratory
• Technical Evaluation Branch

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Post Certification

• Steps that continue after respirator is granted
  NIOSH Approval.
• Ensure that respirator continues to be produced
  according to NIOSH criteria.
• Post Certification activities include
• Product Audits
• Site Audits
• Certified Product Investigation Process (CPIP)
• Long Term Field Evaluation (LTFE)
• Fire Fighter Fatality/Injury SCPA Evaluation
  Program (FFFIP)

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Product Audits

• Purchase units commercially to test and ensure
  performance to applicable criteria.
• Typically filtering facepiece units.
• Verify performance of all units through default
  to test program.
• Shelf life testing
• Verify performance up through expiration date.

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Product Audit Testing

• Tests conducted on filtering facepiece
  respirators
• Respirator Performance
• Filter efficiency and leakage (for valve)
• Quality assurance evaluation
• Check labeling, user instructions, visual
  inspection
• NIOSH submits report to Approval Holder
• Pass or Fail

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Product Audit Outcome

• If unit passes testing
• No action required by Approval Holder.
• Approval Holder can continue to manufacture and
  control quality of product to NIOSH approval
  criteria.
• If unit fails testing
• Certified Product Investigation Process (CPIP) is
  initiated and NIOSH sends letter to open
  investigation.
• Approval Holder must identify cause of failure
  and provide resolution.

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Site Audits

• WHERE
• All manufacturing site locations, including
  approval holder subcontractors.
• WHEN
• Typically every 2 years (every year in some
  cases).
• WHO
• NIOSH or Contract representative.
• HOW
• Evaluate against Title 42, Code of Federal
  Regulations, Part 84 (42 CFR 84) NIOSH Approved
  Quality Control Plan at facility.

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Site Audit Report Outcome

• Following the Site Audit, NIOSH sends a report
  documenting to the Approval Holder.
• Overall result of Site Audit
• Acceptable No corrective actions required.
• Provisionally Acceptable Production of
  respirators may continue while the required
  corrective actions are implemented.
• Not Acceptable Failure to promptly complete
  corrective actions may result in Stop Sale and/or
  Revocation of NIOSH approvals.

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Site Audit Process Follow-up

• Approval Holder provides NIOSH with documentation
  to show corrective actions have been completed.
• At next site audit visit, NIOSH will verify that
  corrective actions were put into place.

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Certified Product Investigation Program (CPIP)

• PURPOSE
• To ensure the quality of NIOSH approved
  respiratory units by promptly investigating and
  resolving reports of product nonconformance
  issues.

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Examples of Nonconformance Issues

• Performance failure
• Failure to maintain quality control requirements
• Misleading advertising
• Manufacturing under a private label without prior
  approval from NIOSH

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When is a CPIP Needed?

• When an approved NIOSH respirator is in
  nonconformance with the specified requirements in
  Title 42, Code of Federal Regulations, Part 84
  (42 CFR 84).

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CPIP Goals

• Maintain quality of NIOSH approved units.
• Investigate Internal, External and Self-Reported
  issues.
• Document findings of the approval holders
  investigation and their corrective actions.
• Address inventory units, field units and future
  production.

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Possible Follow-Up Actions

• User Notices
• Stop Sales
• Recalls
• NIOSH Applications to make changes to
• QA Manual
• Production Process
• Engineering Design
• Request to voluntarily rescind Approval Numbers

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CPIP Closing

• Has approval holder properly identified the cause
  of the nonconformance?
• Has approval holder developed effective
  corrective actions to resolve nonconformance?
• Has approval holder successfully addressed
  inventory units, field units and future
  production?
• When NIOSH determines investigation can be
  closed, Approval Holder receives closing letter.

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Long Term Field Evaluations (LTFE)

• Purpose
• To evaluate long term field performance of
  self-contained self-rescuers (SCSR) units
  certified by NIOSH.
• Method
• Randomly selected units are collected from mines
  and are tested on the Automated Breathing and
  Metabolic Simulator.

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LTFE

• Outcomes
• Comparisons are made between deployed units and
  new units.
• If a nonconformance to 42 CFR Part 84 is
  identified, a CPIP is opened.
• Results of the LTFE testing are reported to mine
  operators, MSHA, and Manufacturers.

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Fire Fighter Fatality/Injury SCBA Evaluation
Program Overview (FFFIP)

• Purpose
• To determine the conformance of SCBA involved in
  fire fighter injuries or fatalities to the NIOSH
  approval requirements found in Title 42, Code of
  Federal Regulations, Part 84
• Inspection
• Testing
• To provide information resulting in the reduction
  of firefighter injuries and fatalities

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FFFIP

• History
• Evaluations have been conducted as part of
  respirator certification program since 1972
• Congress included language in FY1998 budget
  directing NIOSH to investigate firefighter
  fatalities
• Average of 7 SCBA investigations annually since
  FY1998

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User-Reported Problems
Any Respirator User Fire Departments Law
Enforcement Chemical Industry Mining Healthcare
Firefighter injury or fatality with SCBA involved
Malfunction reported with any respirator
Field Problem Investigation
Firefighter SCBA Evaluation
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Fire fighter Project Initiation
Fire Department State/Local Fire Marshals
Office Law Enforcement Agency Other
Cardiovascular Event NIOSH Division of
Surveillance, Hazard Evaluations, and Field
Studies Cincinnati
Traumatic Injuries NIOSH Division of Safety
Research Morgantown
SCBA Performance Evaluation NIOSH
NPPTL Technology Evaluation Branch Pittsburgh
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FFFIP Inspection

• Condition of major components
• Approved configuration
• Identifying information
• Suitability for testing

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FFFIP Air Sampling and Testing

• Air Sampling
• Sample taken if air remaining in cylinder
• Tested against CGA G-7.1
• Dewpoint OSHA 29 CFR 1910.134(i)(4)(iii)
  requires -50F,NFPA 1500 standard requires
  -65F
• Testing
• 7 tests are performed if SCBA unit is suitable.
• 6 NIOSH, 1 NFPA
• May replace cylinder and/or facepiece for testing
  depending on damage.

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NIOSH Tests Performed

• Rated Service Time Test/ Positive Pressure Test
• How long can SCBA provide air?
• Does SCBA maintain positive pressure in
  facepiece?
• Gas Flow Test
• Continuous airflow provided by SCBA while still
  keeping positive facepiece pressure.
• Requirement is 200 lpm at full rated pressure and
  at 500 psig.

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NIOSH Tests Performed

• Remaining Service Life Indicator Test(Low-Air
  Alarm)
• RSLI provides user with warning of air exhaustion
• Must alarm at 20-25 or 23-27 of service life
  (pressure)
• Six runs performed, average determines pass or
  fail

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NIOSH Test Performed

• Static Pressure Test / Exhalation Resistance Test
• Static pressure is facepiece pressure at zero
  flow condition ( 1.5H2O)
• Exhalation resistance is facepiece pressure at 85
  lpm continuous flow ( 2H2O above static)

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NFPA Air Flow Performance Test

• NFPA 1981 breathing machine
• Test parameters 103 lpm, 30 breaths/minute
• Facepiece Pressure must remain between 0 and
  3.5H2O

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FFFIP Outputs

• Report of inspection and testing results
• Report provided to entitythat submitted unit
  andSCBA manufacturer
• Results provided to NIOSH -DSR or DSHEFS (if
  involved)
• Field problem investigationinitiated if warranted

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FFFIP Key Findings

• Few evaluations result in a Field Problem
  Investigation
• lt 5, based on sample from last five years
• Maintenance, maintenance, maintenance
• Most common test failure is remaining service
  life indicator (usually set high)

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Disclaimer The findings and conclusions in this
presentation have not been formally disseminated
by the National Institute for Occupational Safety
and Health and should not be construed to
represent any agency determination or policy.