respiratory protection and the role of niosh judi coyne, mba, ma health communication specialist...
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Respiratory Protection andRespiratory Protection and the Role of NIOSH the Role of NIOSH
Judi Coyne, MBA, MAHealth Communication Specialist
National Institute for Occupational Safety and HealthNational Personal Protective Technology Laboratory
Pennsylvania Governors Occupational Safety and Health Conference
October 3 – 4, 2011
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Objectives
At the end of this presentation, attendees should know
- What NIOSH is and the role in respirator certification
- What NIOSH approval / certification means
- How respirators become approved /certified
- What happens when certification standards are not met or maintained
- Why it’s important to use NIOSH-certified respirators
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What is NIOSH?
National Institute for Occupational Safety and Health
Mission is to prevent workplace illness, injury, and death
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HHSHHS
CDCCDC
NIOSHNIOSH
Div/LabsDiv/Labs
Department of Health and Human Services
Centers for Disease Control and Prevention
National Institute for Occupational Safety and Health
NIOSH Divisions / Labs
Organizational Structure
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Why is NIOSH involved with Respirators?
Federal mandate for NIOSH to test and certify all respirators used in the workplace
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What does NIOSH approval or
certification mean?
What does it mean?
The respirator has been stringently tested prior to earning the NIOSH
certification.
Post-certification, the product continues to perform at the high level of standards to which it was originally
tested.
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What kinds of tests?
Testing requirement are specified in 42 CFR Part 84
Examples: breathing resistance – inhalation and exhalation, gas flow, leakage, service time, climactic, filter efficiency
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Where the testing happens ..
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Silica Dust Chamber
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Vibration table
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Environmental Chamber
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What is NIOSH Approval?
- formal document issued by NIOSH for a specific respirator
- issued when a respirator meets the minimum requirements of chapter Title 42, of the Code of Federal Regulations, Part 84 (42 CFR 84)
- approval holder may label and advertise the approved respirator as NIOSH-approved
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Applying for Approval
APPLICANT SUBMITS
Standard Application Form
Drawings including assembly matrix
Payment
Respirators for testing
No prototypes
Pre test data
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Performance
NIOSH tests and approves only complete respirators not parts or sub-assemblies of respirators
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NIOSH Approval Processing
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NIOSH Certificate of Approval
Allows the listed applicant to produce the listed approved respirator
Requires production under the quality control provisions specified in the approval
Requires the respirator label as specified in the approval
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Required Product Markings
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NIOSH Certificate of Approval
DOES NOT ALLOW
Changes without notifying NIOSH for a modification of approval
Including
changes to the label
changes to user instructions
changes to QA plans
changes to materials or design
Changing / moving manufacturing site
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NIOSH Site Audits
NIOSH audits the manufacturing site
At least every two years
Full compliance with parts and drawings
Full compliance with all quality plans
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Product Audits
Product is purchased through commercial distribution
Tested to performance specifications of approval
Failures will result in a Certified Product Investigation Process
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Certified Product Investigation Process
Failures of approved product to perform
During customer use
During product audit
Based on manufacturer self report
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Certification Standards Not Met … Now what?
User notice is issued
By NIOSH or by manufacturer
Approval is revoked
- Cannot be advertised at NIOSH-approved
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User Notices on Web Site
Why is it important to use NIOSH-certified Respirator?
It’s been tested and meets standards
It is going to work as supposed to
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Misleading Advertising
False claims of NIOSH certification
Sale of products that have had approval revoked
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Check it Out
List of NIOSH-approved products on website
Filtering facepiece respirators in table format
http://knowits.niosh.gov
Can call to verify 412 386 4000
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Where to get additional info
www.cdc.gov/niosh/npptl
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Thank You
Disclaimer:
The findings and conclusion 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.