Transcript NPPTL Participation in NORA

NPPTL and Personal Protective
Technology Program Update
IOM COPPE Meeting
In person
Maryann D’Alessandro
Roland Berry Ann
Via envision
Ed Fries
Bill Haskell - by phone
Ron Shaffer
Angie Shepherd – by phone
Jon Szalajda
August 4-5, 2011
1
NIOSH PPT Program
Vision and Mission
The VISION is to be the leading provider of quality, relevant, and
timely PPT research, training, and evaluation.
The MISSION of the PPT program is to prevent work-related injury,
illness and death by advancing the state of knowledge and
application of personal protective technologies (PPT).
An estimated 20 million workers use PPE on a regular
basis to protect themselves from job hazards.
2
PPT Program Logic Model
Inputs
Production
Inputs
Current
Activities
Planning Inputs
Sector-cross sector
Coordination
Surveillance Data
Policy and
Standards
Respirator
Certification
Outcomes
NAS COPPE
Research
Outputs
Stakeholders
Surveillance
Environmental
Assessment
Evaluations
Transfer
Activities
r2p
Communications
Emergency
Response
External Factors
Performance Metrics and Measures
3
NPPTL Participation in NORA
 NPPTL strategy to participate on sector
and cross sector committees related to
NPPTL focus
 Strategic effort to increase number of
NORA LOI submissions related to
Strategic goals and focus.
4
NIOSH Program Portfolio
NORA / NIOSH
NIOSH Cross Sector Programs (N=24)
Industry Sectors (N=10)
• Agriculture, Forestry, and
Fishing
• Construction
• Healthcare and Social
Assistance
• Authoritative
Recommendations and
Development
• Cancer, Reproductive, &
Cardiovascular Diseases
• Mining
• Communications and
Information Dissemination
• Oil & Gas Extraction
• Economics
• Manufacturing
• Services
• Emergency Preparedness
and Response
• Public Safety
• Engineering Controls
• Transportation,
Warehousing, and Utilities
• Exposure Assessment
• Wholesale and Retail Trade
• Health Hazard Evaluation
(HHE)
• Global Collaborations
• Nanotechnology
• Occupational Health
Disparities
• Personal Protective
Technology (PPT)
• Prevention Through Design
• Radiation Dose
Reconstruction
• Respiratory Diseases
• Small Business Assistance
and Outreach
• Surveillance
• Training Grants
• Total Worker Health (formerly
WorkLife Initiative)
• Hearing Loss Prevention
• Traumatic Injury
• Immune and Dermal
Diseases
• Work Organization & StressRelated Disorders
• Musculoskeletal Disorders
5
NIOSH Program Portfolio
PPT involvement
NORA / NIOSH
NIOSH Cross Sector Programs (N=24)
Industry Sectors (N=10)
• Agriculture, Forestry, and
Fishing
• Construction
• Healthcare and Social
Assistance
• Authoritative
Recommendations and
Development
• Cancer, Reproductive, &
Cardiovascular Diseases
• Mining
• Communications and
Information Dissemination
• Oil & Gas Extraction
• Economics
• Manufacturing
• Services
• Emergency Preparedness
and Response
• Public Safety
• Engineering Controls
• Transportation,
Warehousing, and Utilities
• Exposure Assessment
• Wholesale and Retail Trade
• Health Hazard Evaluation
(HHE)
• Global Collaborations
• Nanotechnology
• Occupational Health
Disparities
• Personal Protective
Technology (PPT)
• Prevention Through Design
• Radiation Dose
Reconstruction
• Respiratory Diseases
• Small Business Assistance
and Outreach
• Surveillance
• Training Grants
• Total Worker Health (formerly
WorkLife Initiative)
• Hearing Loss Prevention
• Traumatic Injury
• Immune and Dermal
Diseases
• Work Organization & StressRelated Disorders
• Musculoskeletal Disorders
6
Participation in NORA
FY08
LOIs
Endorsed
$397,333
FY09
NPPTL
3
1
NIOSH
Totals
76
NPPTL
1
NIOSH
Totals
42
$5,066,792 57
NPPTL
1
$62,813
NIOSH
Totals
18
$2,398,345 21
$9,517,633 120
$146,500
1
FY10
$250,000
9
$12,576,250 98
$250,000
1
FY11
$1,373,111
FY12
3
$385,340
4
$12,270,637 96
$11,948,214
70
2
$325,340
2*
$5,545,157 38
$4,722,710
32
$210,000
LOIs Called
Proposals
Funded
0
$7,159,358 44
$0
0
$2,752,674 14
$0
1
$72,000
$2,095,585 14
$1,759,652
* One proposal received highest score in Healthcare and received funding through PanFlu
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Research to Consensus Standard
8
Research to Consensus Standard
-
ASTM F2731 - 11 Standard Test Method for Measuring the Transmitted and Stored
Energy of Firefighter Protective Clothing Systems
http://www.astm.org/Standards/F2731.htm
-
NFPA 1999: Standard on Protective Clothing for Emergency Medical Operations,
2008 Edition: http://www.nfpa.org/catalog/product.asp?title=Code-1999-2008Protective-Clothing-for-Emergency-MedicalO&category%5Fname=&pid=199908&target%5Fpid=199908&src%5Fpid=&link%5Fty
pe=search
-
NFPA 1984: Standard on Respirators for Wildland Fire Fighting Operations, 2011
Edition http://www.nfpa.org/catalog/product.asp?pid=198411&cookie%5Ftest=1
ASTM F2668 - 07 Standard Practice for Determining the Physiological Responses of
the Wearer to Protective Clothing Ensembles
http://www.astm.org/Standards/F2668.htm
ASTM F2815 - 10 Standard Practice for Chemical Permeation through Protective
Clothing Materials: Testing Data Analysis by Use of a Computer Program
http://www.astm.org/Standards/F2815.htm
-
-
9
Research to Consensus Standard
 How could the current NPPTL research to consensus standard
development approach be enhanced?
 What additional approaches should NPPTL consider to most
effectively identify barriers to PPE use that could be addressed
through NPPTL research projects and incorporated in consensus
standards?
 What processes could be used to better validate and prioritize the
research needs identified among the numerous SDO committees
and standards where limited NPPTL resources participate?
 Would collaboration with SDOs to create a matrix of organizational
responsibility for standards add value to NPPTL and the PPT
Program?
10
ASTM F2731 - 11 Standard Test
Method for Measuring the Transmitted
and Stored Energy of Firefighter
Protective Clothing Systems
Bill Haskell
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Stored Thermal Energy
 2003-2004: IAFF requested NPPTL investigate several incidents where
firefighters’ protective clothing resulted in serious burn injuries.
 Contract issued to NC State University (NCSU) to assist NPPTL in the
investigation of unusual burn patterns observed in fire fighters’
protective clothing during several structural fire suppression incidents.
 NCSU report “Testing and Evaluation of Duralite ® Turnout Gear” to NCSU,
delivered January 14, 2004 and revised September 28, 2006 after peer review.
 Final Report Recommendations: Initiate a study into the thermal protective
performance, the moisture absorption characteristics, and stored energy transfer
characteristics in fire fighter protective clothing composites (i.e. outer shell,
moisture barrier, and thermal liner).
 Research demonstrated urgent need for research to better understand these
phenomena.
 Identified need to develop test methods and performance criteria to better predict
the consequences of these phenomena.
12
NIOSH initiated a contract to NC
State University in 2005
 Objective: develop performance criteria and a
laboratory test method for measuring stored energy in
firefighter protective garments
 Final Report: “Development of a Test Method for Measuring
Transmitted Heat and Stored Thermal Energy in Firefighter Turnouts”
(NIOSH Contract No. 200-2005-12411) dated April 29, 2008.
 Research successfully developed and demonstrated a laboratory
apparatus and test procedures for measuring transmitted and stored
thermal energy in turnout materials exposed to sub-flashover level
radiant heat (< 0.3 cal/cm2 sec.).
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Stored Thermal Energy
 Outcome: Procedures developed for preconditioning test
samples in a manner that permits evaluation of absorbed
moisture on stored energy test results.
 The testing concept and procedures were developed in light of available
field information on observed firefighter scenarios that may be
associated with phenomena sometimes referred to as stored energy
burn injuries.
 A robust instrumented testing device has been demonstrated for
measuring transmitted and stored thermal energy in turnout materials. A
draft standard of the method is well advanced in ASTM Committee F23
on Protective Clothing.
 Tests conducted to determine the inter-laboratory precision of repeated
tests produced consistent results with little variability in repeated tests.
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Stored Thermal Energy
 2007-2008: Research project managed by the NFPA Fire Protection
Research Foundation and was funded by the DHS Assistance to
Firefighters Grant (AFG) Program Office.
 Final Report: “Thermal Capacity of Fire Fighter Protective Clothing” dated October
2008 (http://www.nfpa.org/assets/files/PDF/Research/PPE_Thermal_Energy.pdf)
prepared by NIOSH/NPPTL, NIST and NCSU.
 Research conducted in collaborations with partners
 Fire Protection Research Foundation (FPRF)
 National Institute of Standards and Technology (NIST)
 North Carolina State University (NCSU)
 NIOSH/NPPTL
 The two stored energy test apparatuses and the burn prediction software
used in this project were developed under NIOSH Contract No. 200-200512411 with North Carolina State University (NCSU).
 NIOSH/NPPTL made these test apparatuses available for the inter-
laboratory testing conducted under the NFPA Fire Protection Research
Foundation project.
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Stored Thermal Energy
Outputs 2007-2008
 The laboratory based study shows that the Stored Energy Test
(SET) method provides information not provided by any other
protective performance test method currently incorporated in NFPA
1971 Standard on Protective Ensembles for Structural Fire Fighting
and Proximity Fire Fighting.
 It supports a hypothesis that sub-flashover burn injuries may occur
as the result of two different heat transmission mechanisms, or
combination of two thermal phenomena.
 Information was gathered during firefighter stakeholder meetings
held in conjunction with meetings of the NFPA 1971 Committee on
Standards for Structural Firefighting Clothing and Equipment.
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Stored Thermal Energy
Outcomes 2007-2008
 These three (3) research projects provided the information and data
that lead to the development and release of “ASTM F2731-11
Standard Test Method for Measuring the Transmitted and Stored
Energy of Firefighter Protective Clothing Systems.”
 This three (3) research projects will result in the incorporation of the
ASTM F2731 test method and performance criteria in the next
edition of NFPA 1971 Standard on Protective Ensembles for
Structural Fire Fighting and Proximity Fire Fighting.
 The next edition of NFPA 1971 is scheduled for release in early
2012.
 Personnel from NPPTL and NCSU participate as members of the
NFPA Technical Committee on Structural and Proximity Fire
Fighting Protective Clothing and Equipment (FAE-SPF).
 (http://www.nfpa.org/aboutthecodes/AboutTheCodes.asp?DocNum=1971)
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Research to Consensus Standards
Development
NFPA 1999: Standard on Protective
Clothing for Emergency Medical
Operations, 2008 Edition
Angie Shepherd
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Research - Background
 NFPA 1999, Standard on Protective Clothing for
Emergency Medical Operations, 2003 Edition
 Minimum requirements of protective clothing for emergency patient
care and transportation prior to arrival at hospital or health care facility
 17,000 transporting ambulance services
 26,000 fire departments
 52,000 ambulances
 600,000 EMTs
 142,000 paramedics
 1,009,000 firefighters
 NFPA’s five year revision cycle will
result in a 2008 Edition of NFPA 1999
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Research - Background
 Cleaning gloves
 Certain criteria mutually exclusive, preventing certification
 Single use garments
 Physical property criteria don’t distinguish single
use/reusable products consistent with field requirements
 Eye and face protection
 Criteria do not match user needs or address all product
types used by EMS providers
 Respiratory protection
 No current requirements  requested by NPPTL
 Head protection
 No current requirements  requested by peer review
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Research - Project Objective
 To provide the basis for and recommend
appropriate design and performance
criteria for “cleaning” gloves, single-use
protective garments, eye/face protection
devices and head protection devices for
emergency medical operations
 To recommend appropriate flammability
and visibility criteria
 To recommend appropriate respiratory
protection for CBRN emergency medical
operations ensemble
Directly relates to the Personal Protective
Technology (PPT) Cross Sector
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Partners
 National Fire Protection
Association (NFPA)
 International Personnel
Protection, Inc.
 Emergency Medical Services
(Users)
 PPE Manufacturers
 Independent Test Labs
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Researcher-Partner Relationship
 Selection of Partners
 Responsible Standards Development Organization (SDO)
 Contractor with demonstrated industry experience and expertise
 PPE users
 Incentives of Partnership
 Memorandum of Understanding (MOU) with NFPA
 Continued development of NIOSH NPPTL relationship with NFPA
 Organizational strengths and networking ability with stakeholders
 Resources
 NIOSH provided funding for project
 User groups provided substantial feedback within and outside of the NFPA
process and participated in wear trials
 NFPA certification lab provided limited no cost testing
23
Researcher-Partner Relationship
 Establishment of Rapport and Trust
 NFPA membership and representation on committee
 Previous experience with selected contractor
 Level of Interaction
 Intense level of communication required by strict timeline and
scope of project
 Contract Office issues required additional support
 Division of Responsibilities
 Utilized established relationships with numerous test labs and
user groups
 Aligned with strengths including speed, technical expertise,
and standards development process
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Dissemination
 Presentations
 NFPA Technical Committee throughout the project
 IAFF Redmond Symposium
 TSWG PPE Conference
 Participation at Trade Shows
 Public Proposals and Public Comments within the
NFPA revision process
 NIOSH Technical report / articles
25
Evaluation
 Increase in Number of Certified Products
 New designs and technologies
 Broader range of products
 Additional manufacturers
 Greater User Acceptance
 Specification and purchase of
NFPA 1999 Certified clothing
 Use of Federal Grant money
26
Measuring project success
 Results of effort incorporated into NFPA 1999,
2008 Edition
 Project impact will be measured by increase in
number of certified products and expanded use
of certified products
 Results of project have direct impact on related
standards development processes – e.g., similar
criteria can be applied for chemotherapy gowns
 Project approach for affecting standards
development can be applied in other projects
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Research to Consensus Standards
Development
NFPA 1984: Standard on
Respirators for Wildland
Fire Fighting Operations,
2011 Edition
Jonathan Szalajda
Courtesy C. Austin & SOPFEU
Project Goal
Develop new certification
criteria for the approval of
respirators for wildland fire
fighting operations
Courtesy L. Naeher
29
Standards Scope
Dual NIOSH/NFPA Certification for APRs
and PAPRs, for use in Wildland Fire
Fighting Operations similar to
certifications issued for SCBAs
30
Research Background
 The combustion products wildland firefighters are
exposed to can vary greatly in characteristics due to the
type and amount of material being burned, soil conditions,
temperature and exposure time
 Smoke inhalation is one of the greatest concerns for
firefighter health and it has been shown that the smoke
consists of a large number of particles
 These smoke particles contain intermediates of hydrogen,
carbon and oxygen free radicals which may pose a
potential health risk
31
Research Background
• The work environment of firefighters is unlike that of other occupations,
not only because of the physical hazards but also due to the respiratory
and systemic health hazards of smoke inhalation resulting from
combustion
• Research devoted to studying municipal firefighters may not be useful
in wildland firefighter exposures because the two work environments are
so different
•Thousands of Wildland Firefighters are exposed to different combustion
products with different exposure profiles
• Gas and vapors, as well as high particulate concentrations are the
major toxins encountered
32
Research Background
Wildland Fire Fighters use:
•NIOSH respirators not suitable for the
anticipated hazards;
•NIOSH approved filtering facepiece respirators
– do not provide protection against fire gases
that can be encountered; or
•No protection
33
Research Background
 NFPA received a request from the California Department of
Forestry to develop a performance standard for a wildland
respirator
 In March 2004, a study was initiated by NIOSH to assess the
feasibility of collecting medical and environmental exposure
data preseason, in a wildfire setting, and post-season
 NIOSH health studies indicate that wildland firefighters
experience acute respiratory effects, including respiratory
symptoms and decrements in pulmonary function
34
Selected Background Material Used
by the Task Group
•Austin, C. (September 2008). Wildland Firefighter Health Risks. Montreal
(Quebec): IRSST.
•NIOSH, 2005a. Wildland firefighter symposium. National Institute for
Occupational Safety and Health. Unpublished work, Morgantown, West
Virginia.
•Reinhardt, T.E. and Ottmar, R.D. (July 2000). Smoke Exposure at
Western Wildfires. Portland, OR: U.S. Department of Agriculture, Forest
Service, Pacific Northwest Research Station.
•Luke P. Naeher, e. (2007). Woodsmoke Health Effects: A Review.
Inhalation Toxicology , 67 - 106.
35
NFPA Process
•NFPA Technical Committee on Respiratory Protection Equipment
established a Task Group to review Wildland Fire Fighting Operations
in 2007
•Task Group was Chaired by David V. Haston, P.E. – Mechanical
Engineer, U.S. Forest Service
•Draft NFPA 1984 “Standard on Respirators for Wildland Fire Fighting
Operations” ROP – August 2009
•Technical Committee processed 1984 ROCs – March 2010
•NFPA 1984 Standard published in 2011
36
NFPA Standard Scope
NFPA 1984 Design/Performance Requirements:
•Minimum protection factor of 10
•Heat Resistance
•Flame Resistance
•Respirator Storage Integrity
•Lens Abrasion Resistant
•Donning Performance
•Communication Performance
•Corrosion Resistant
•NIOSH Certified APR or PAPR
Updated: 30 Mar 09
37
NIOSH Gas and Vapor tests:
A multi-gas approval
•Carbon Monoxide
•Organic Vapors
•Sulfur Dioxide
•Nitrogen Dioxide
•Formaldehyde
•Acrolein
Courtesy C. Austin
Updated: 30 Mar 09
38
Partners
 National Fire Protection
Association (NFPA)
 US Forestry Service (Users)
 PPE Manufacturers
 Independent Test Labs
39
Researcher-Partner Relationship
 Selection of Partners
 Responsible Standards Development Organization (SDO)
 Motivated PPE users
 Incentives of Partnership
 Memorandum of Understanding (MOU) with NFPA
 Continued development of NIOSH NPPTL relationship with NFPA
 Organizational strengths and networking ability with stakeholders
 Resources
 NIOSH provided subject matter experts for project
 User groups provided substantial feedback
40
Researcher-Partner Relationship
 Establishment of Rapport and Trust
 NFPA membership and representation on committee
 Level of Interaction
 Intense level of communication required by strict timeline
and scope of project
 Division of Responsibilities
 Aligned with strengths including speed, technical
expertise, and standards development process
41
Dissemination
 Presentations
 NFPA Technical Committee throughout the project
 TSWG PPE Conference, December 2010
 PPT Stakeholder Meeting, March 2011
 Public Proposals and Public Comments
within the NFPA revision process
42
Path Forward
 NFPA issued NFPA 1984 Standard on
Respirators for Wildland Fire Fighting
Operations, 2011 Edition
 NIOSH can certify, under 42 CFR 84, for the
NFPA identified performance requirements
and protections
 NIOSH will issue a Federal Register Notice on
test procedures for the NFPA performance
requirements and protections
43
Assessment of New Technologies
 NIOSH will identify or develop test procedures
to evaluate the performance of new or novel
technologies intended to provide the multigas protections of NFPA 1984
 NIOSH will conduct benchmark testing of
products using new and novel technologies
with intention of meeting the multi-gas
protections of NFPA 1984
44
Commercial VLE Technology Evaluation
Objective
Conduct a technical assessment of a nonNIOSH approved product employing
unconventional technology to validate
product performance claims
Wildland Fire Fighting
“Xcaper smoke filters were originally developed for use
by Wildland Firefighters. Firefighters in wildlands are
unable to use the traditional SCBA. However, they are
exposed to the same dangerous toxins and particulate
matter that occur in structural fires. Xcaper provides
protection while being lightweight and easy to use.”
http://www.thekeytosurvival.com/storetitles/terrorismfire/
xcaper.html
45
45
Commercial VLE Technology Evaluation
Introduction
 Used commercially available VLE product
 Testing challenges with VLE technology
 Dynamic testing required for continuous
exposure of new gel surface and
regeneration with moisture and CO2
 Interference of sodium in VLE gel with
results of sodium chloride particulate tests
 Standard tests and novel methods
46
46
Commercial VLE Technology Evaluation
Ambient Particulate Challenge
 Dynamic test utilizing automated breathing and metabolic
simulator (ABMS) to provide exhalation gas with enriched
moisture and CO2
 PortaCount® used to determine fit factors
 Only ambient particulates present to address
manufacturer concerns about sodium chloride
 Various configurations tested
 Escape mask
 Professional as both mask and
bandana
 Consistent fit test results
 Fit generally 1 – 3 (100 to pass)
47
47
Commercial VLE Technology Evaluation
Infrared Imaging
 Qualitative examination of
flow patterns with infrared
imaging system
 Image analysis
 Flow generally
ABMS Inhalation
concentrated in tight
area around mouth
 Some bypassing around
sides
ABMS Exhalation
48
48
Commercial VLE Technology Evaluation
CO2 Deadspace Test
 Determine degree of buildup of CO2 in breathing zone
of escape mask
 Three separate donnings performed
 CO2 concentration profile indicated retention in mask
structure
 5% CO2 at start of inhalation removed by inhalation
 Average inhalation CO2
concentration of 1.5 –
2%
 Approximately 1 to 2
hours of allowable
wearing time
Sheffield Head headform & mask during testing
49
49
Commercial VLE Technology Evaluation
Standard NIOSH Tests
 Breathing resistance test
 High breathing resistance suspected from ABMS data
during ambient particulate testing (70+ mmH2O)
 High resistance again indicated during standard NIOSH
test (127 wet, 69 dry, NIOSH requires <35mmH2O) (TEBAPR-STP-0007)
 Particulate testing (TEB-APR-STP-0051 through 0059)
 Sodium chloride (80-
88% penetration)
 Dioctyl phthalate (DOP)
(90-100% penetration)
Sample holder for particulate testing
50
50
Commercial VLE Technology Evaluation
HELD/Morgantown Chamber
 Migration of sodium ions from VLE gel
detected as penetrating solids
 Removal of particulates from room by
circulation through HEPA filter
 Start breathing machine on headform
 Negligible particle count increase in
breathing zone experienced
 Penetration of potassium chloride aerosol
 Removal of particulates as above
 Simulated cough to provide burst of
potassium chloride
 Penetration high in all cases
51
51
Commercial VLE Technology Evaluation
Removal of Combustion Products (NO2)
 Intertek PARC contracted to build and operate test
apparatus
 VLE vessel mounted on vibrating panel
 25ppm and 500ppm NO2 in air available for tests
 Regeneration capability
 NO2 analyzer
 Flow control &
measurement
 Resistance measurement
 Adaptable to test
activated carbon based
technology
52
52
Commercial VLE Technology Evaluation
Removal of Combustion Products (NO2)
 VLE commercial technology
tests
 All tests carried out with 25ppm
challenge gas
 Tests carried out at 64 and 30Lpm
 Tests carried out on contents of
commercial devices plus one intact
device
 Regeneration procedure used as
activation and repeated between
runs
 All test failed on initial challenge
when gas reached VLE vessel
53
53
Commercial VLE Technology Evaluation
Removal of Combustion Products (NO2)
 Activated carbon technology tests
 Tear gas canister
 CBRN canister
 Contents of CBRN canister
 Tear gas canister begun at 25ppm &
30Lpm for 15min then increased to
500ppm & 64Lpm for 48.5min
 CBRN canister tested at 500ppm &
64Lpm for 30min
 Contents of fresh CBRN canister tested
at 500ppm & 64Lpm for 27min
 No breakthrough in any test
54
54
Commercial VLE Technology Evaluation
Report of Investigation / Final Report
 Final report under development
 Summary of work and conclusions in body of
report
 Raw data and reference material included in
appendices
 Internal and external reviews to be conducted
 Final product expected to be completed in FY12
55
55
ASTM F2668 - 07 Standard Practice
for Determining the Physiological
Responses of the Wearer to Protective
Clothing Ensembles
W. Jon Williams
56
Next Generation Structural Fire Fighting PPE
Ensemble Project HEROES FY09
Objective
The goal of the project is to develop test
methods to assess the performance of
prototype PPE ensemble for firefighters
that provides improved protection
against chemical and biological agents.
Applicable Standards
 ASTM F23.6 - WK8818 Standard Practice for the Physiological
Evaluation of Protective Clothing
 ASTM F2588-06 Standard Test Method for Man-In-Simulant Test
(MIST) for Protective Ensembles
 NFPA 1971 (structural fire fighting ensembles)
 NFPA 1994 (CBRN ensembles)
Stakeholders
Key Partners
 Firefighters/emergency responders
 Standards organizations (NFPA,
ASTM)
 Manufacturers of materials and
ensembles
Funded in part by TSWG
Project Scope
 Develop physiological test protocol and conduct ergonomic and
physiological testing to assess the performance of the HEROES
ensemble.
 Support the development of test methods to ensure all ensembles
and materials are tested appropriately
 Supply language and support to NFPA to remove design restrictions
and allow advanced technologies to be incorporated and possibly
certified
Milestones FY09
 Q1 Submit 2nd HEROES ergonomics manuscript for peer review
 Q2 Submit 1st HEROES physiology manuscript for peer review
 Q3 Resubmit 2nd HEROES ergonomics manuscript back for
consideration
 Q4 Submit draft 2nd HEROES physiology manuscript for
consideration
Outputs
 Manuscripts published or submitted to peer review journals (approx. 3)
 Presentations at conferences (approx. 9)
 Final report to TSWG (Feb 2008)
Outcomes
 Research resulted in an ASTM standard test practice on physiological
testing “ASTM F2668-07 Standard Practice for determining the
Physiological Responses of the Wearer to Protective Clothing Ensembles”
 NPPTL contributed significantly to the 2007 revision of NFPA 1971 and
1994
Updated: 27 Ma r 09
57
ASTM F2815 - 10 Standard Practice
for Chemical Permeation through
Protective Clothing Materials: Testing
Data Analysis by Use of a Computer
Program
Pengfei Gao
58
Degradation and Decontamination Efficacy of
Chemical Protective Clothing (CPC) – FY11 (927PP28)
Objective
Applicable Standards
 To develop suitable methods
and procedures for
decontaminating and extending
the useful life of CPC;
 To develop test criteria for
evaluating decontamination
efficacy of CPC; and
 To provide users with
guidelines for reuse, retirement,
and disposal of protective
clothing.
 ASTM F23.30
 ANSI/ISEA 105-2000
Key Partners
 ASTM F23 Committee: develop the standard
practice using the “Permeation Calculator”
 ISEA Hand Protection Group: update project
progress
Permeation Calculator
http://www.cdc.gov/niosh/n
pptl/PermeationCalculator/
permeationcalc.html
Project Scope
 Studies on decontamination efficacy of heat extraction (thermal
decontamination), water/detergent, and self-decontamination
 Studies on CPC reusability following thermal decontamination
 Develop software to automate permeation data analysis
Milestones FY11
 The ASTM F2815-10 titled “Standard practice for chemical
permeation through protective clothing materials: testing data
analysis by use of a computer program” was published in
February 2011, and the Permeation Calculator was included as
an adjunct to this practice.
 Another manuscript titled “Performance evaluation of twenty
six combinations of chemical protective clothing materials and
chemicals after repeated exposures and decontaminations “
was submitted to JOEH for peer-reviewed publication.
Stakeholders
 ASTM
 ISEA and manufacturers
 Protective clothing users
AIHA guideline for CPC and
equipment decontamination
Outputs
 Manuscripts
published in peer-reviewed journals (4) plus one submitted
 Presentations at conferences (approx. 12)
 Developed “Permeation Calculator” to provide faster and more consistent
results for permeation testing data analysis. The software received NIOSH
r2p award and CDC Director’s Innovation award.
 Employee invention report, a U.S. provisional patent, and a Canadian
copyright.
Outcomes
 Research
findings were incorporated into a guideline written by the AIHA
Protective Clothing & Equipment Committee for decontamination of CPC
and equipment. The project officer was the lead author. Nov. 2005.
 Research findings resulted in a new ASTM standard practice F2815-10
that has been published.
 Permeation Calculator used by CPC manufacturers and test laboratories.
More than1,800 copies of the software have been requested or
downloaded from NPPTL website for use in 88 countries.
Updated: 8 APR 11
59
Questions to IOM
 How could the current NPPTL research to consensus standard
development approach be enhanced?
 What additional approaches should NPPTL consider to most
effectively identify barriers to PPE use that could be addressed
through NPPTL research projects and incorporated in consensus
standards?
 What processes could be used to better validate and prioritize the
research needs identified among the numerous SDO committees
and standards where limited NPPTL resources participate?
 Would collaboration with SDOs to create a matrix of organizational
responsibility for standards add value to NPPTL and the PPT
Program?
60
NPPTL Organization Update
Maryann D’Alessandro
61
PPT Program Activities
 Scientific evaluations
PPT Program
Management
 Program evaluations &
assessments
 Emergency response
Technology
Evaluation
 Respirator
Certification Program
 Quality Audit Program
 Certified Product
Investigations
 Long Term Field
Evaluation Program
Policy & Standards
Development
 Enhancements to 42
CFR Part 84
 CBRN respirator
standards development
 Consensus standard
development
Technology
Research
Surveillance and
Communications
 Respiratory Protection
 Outreach
 Protective Clothing &
Ensembles
 Surveillance
 Integration of Sensors &
Electronics
 Health
Communications
 Web management
 Human Performance
 Guidance Document
Development
62
NPPTL Resource Position
 NPPTL
 Typically operates with PS&B costs @ 60% - 70% of base
budget allocation.
 Insufficient laboratory capacity is program limiting
 Implementing Plan to:
 Use laboratory space @ NIOSH-Morgantown
 Existing personnel reassigned from DRDS (7) and
HELD (2 [1 pending] ) to NPPTL
63
Impact of Plan
 NPPTL Impact:
 NPPTL will continue to have good financial health

With added PS&B costs, percent discretionary funds will decrease
from 30-40% to 25-35% of base budget
 Travel Burden incurred by NPPTL staff
 DRDS / HELD Impact:
 Reduced Laboratory Space
 Access to funds to address critical needs
 NIOSH Impact:
 Enhanced research capability
 Enhanced opportunity for research collaboration
64
NATIONAL PERSONAL PROTECTIVE TECHNOLOGY LABORATORY
Office of the Director
Boord, L., Director
Administrative Support
Miller, M., Lead Mgmt&ProgAnal
Stolze, A., AdminOfficer
LaFond, R., Mgmt&ProgAnal
Technology Research
Branch
Shaffer, R., BranchChief
Thompson, D., ProgOperAsst
Benson, S., PhySci (Fellow)
Boutin, B., ProgOperAsst
Coca, A., Physiologist(Fellow)
Commodore, M. EngTech
Day, G., ResIndusHyg
Fisher, E., Biologist (Fellow)
Gao, P., PhySci
Kilinc-Balci, F., PhySci (Fellow)
Kim, K., HealthSci (Fellow)
Monaghan, W., GenEng
Murray, D., PhySci
Powell, J., PhySci (Fellow)
Roberge, R., MedicalOfficer
Rozzi, T., Chemist (Fellow)
Sbarro, D., IndusHyg
Shepherd, A., GenEng (TL)
Sheppard, B., OA Asst
Sinkule, E., PhySci
Turner, N., Physiologist (TL)
Viscusi, D., Chemist
Vo, E., PhySci
Williams, W., Physiologist
Zhuang, Z., GenEng (TL)
Buller, S., Secretary
Berry Ann, R., DeputyDirector
Scientific Excellence Focus
Coffey, C., ResChemist
D’Alessandro, M., AssocDirectorForScience
Sporrer, J., PublicHealthAnalyst
Zubasic, D., Secretary(OA)
Technology Evaluation Branch
Ahlers, H., BranchChief
Peterson, J, Deputy Branch Chief
Harvey, K., ProgOperAsst
Bell, A., DocMgmtSpec
Brannen., J., QA Spec
Gavel, K., GenEng (TL)
Hurd, E., QA Spec
Jacobs, R., EngTech
Kochenderfer, V., QA Spec
Kyriazi, N., BiomedEng
Luncinski, L., AdminSupAsst
Neiderhiser, C., PhySci
Parker, J., PhySci
Pouchot, T., GenEng
Powelko, R., QA Spec
Reeder, A., EngTech
Rottach, D., PhySci
Sheets, R., QA Spec
Shubilla, J., EngTech
Snyder, D., DocMgmtSpec
Stein, R., GenEng
Thornton, T., PhySci (Acting TL)
Thunhorst, M., Mgt&ProgamAsst
Welsh, E., EngTech
Wiltanger, P., PhySci
Wolfe, C., GenEng
Yekich, M., Mgt&ProgamAsst
July 2011
Policy and Standards
Development Branch
Szalajda, J., BranchChief
Surveillance,
Communication and
Scientific Support Team
Fries, E., GenEng (TL)
Jennings, C., ProgOperAsst
Book, D., PhySci
Calvert, C., PhySci
El-Ayouby, N., PhySci
Haskell, W., PhySci
Hudnall, J., PhySci
King, W., PhySci
Miller, C., PhySci
Newcomb, W., GenEng
Palcic, J., GenEng
Palya, F., GenEng
Powell, C., Mgt&ProgamAsst
Rehak, T., GenEng
Rengasamy, A., Chemist
Snyder, J., PhySci
Vojtko, R., GenEng
Walbert, G., GenEng
Begandy-Dolby, G., Clerk
Cloonan, T., PhySci
Coyne, J., HealthCommSpec
Faulkner, K., Stat(Fellow)
Kovac, J., ResPhySci
Krah, J., HealthCommSpec
Novak, D., HealthSci(Fellow)
Oke, C., Epidemiologist
Perrotte, J., ComputerEngr
Senk, M., IT Spec
Williams, K., PhySci
Permanent FTE
Title 42 Fellows
Total FTE
83
9
92
NPPTL FY12 Strategic Planning and
Budget Formulation Process
Maryann D’Alessandro
66
Program Budget Formulation Steps
 Mid-year review of FY 2011 projects
 Summit preparation
 Summit meetings and discussions
 Post-summit activities
67
Midyear review of projects
 Clear project objectives and milestones
 Partnerships established
 Outputs produced and anticipated
 Intermediate outcomes
 Descriptions provided in NPPM
68
Strategic inputs
 External
• Good Organizational Health
FY 2011
FY 2012
PS&B
60% - 70% Base Budget 65% - 75% Base Budget
Discretionary 30% - 40% Base Budget 25% - 35% Base Budget
• NPPTL GPRA Goals

NA Evaluation

Respirator Audits
• CDC QPR
 Internal
•
•
•
•
•
Midyear Review Presentations and NPPM
PPT Cross Sector 2012 Portfolio Planning Guidance
PPT Program Implementation Plan (May 2010)
PPE for HCW Action Plan (Jan 2010)
NPPTL Operational Metrics
69
NPPTL GPRA Goals Based on NA Evaluation
 Participate in policy development and standards



setting across all types of PPT
Oversee certification of all PPT, including an
assessment of certification mechanisms
Conduct outreach programs for optimal use and
acceptance of PPT by workers
Define barriers to and facilitators of PPT use
Develop innovative PPT designs and test methods to
improve comfort, fit and usability
70
NPPTL GPRA Goals: Respirator Audits
Measure
FY
Ensure the
quality of NIOSH
certified
respirators by
increasing the
number of audit
activities
completed
20XX?
(outyear)
2015
2014
2013
2012
2011
2010
2009
2008
Result/Reporting
Date
88 audit activities
Annual reporting
sustained for the life of requirement beyond
the program.
2015
88 audit activities
Dec 31, 2015
80 audit activities
Dec 31, 2014
73 audit activities
Dec 31, 2013
66 audit activities
Dec 31, 2012
60 audit activities
Dec 31, 2011
[trend data]
Insert result
[trend data]
Insert result
Baseline
Insert result
Target
71
CDC Quarterly Program Review
 Support the Development of Global Respirator
Standards: NIOSH Respirator Approval Standard,
Total Inward Leakage (TIL)
 Personal Protective Equipment Technology
Development and Standards Setting: Fire Fighter PPE
Ensembles
 Increase Research on the Use and Usability of PPT:
Use and Usability of Respiratory Protection for
Healthcare
72
NPPTL Metrics
PROGRAMS

1.1 Number of 42CFR, Part 84 Respirator Standards Notice of Proposed Rule Making (NPRM) elements developed.

1.2 Number of PPT information products produced.
RELEVANCE & EFFECTIVENESS

2.1 Number or outcomes and intermediate outcomes resulting from PPT Program outputs.

2.2 Number of respirator approval decisions.
CUSTOMERS/STAKEHOLDERS

3.1 Conference Posters submitted and Conference Presentations delivered.

3.2 Presentations other than Conferences. , including outreach participation.

3.3 Program and PPT Information products posted to the NIOSH/NPPTL website.
SCIENCE

4.1 Number of articles published in peer reviewed journals and NIOSH numbered documents.

4.2 66% of NPPTL publications are published in peer reviewed journals with an influence score greater than 0.400.
BUSINESS EXCELLENCE – Respirator certification related

5.1 Respirator approval time of processing for filtering facepiece respirators (FFRs).

5.2 Respirator approval time of processing for all other respirators except FFRs and CBRN respirators.

5.3 Number of respirator program audit activities completed.
EMPLOYEES

6.1 Percent of employees with Individual Development Plans (IDP)

6.2 Percent of Individual Learning Account (ILA) funds expended.
73
FY12 Requests from Midyear Review
Submitting Branch
Total # of Projects Total $ Requested
OD
PSD
TEB
TRB
SCSST
6
20
13
23
8
(2 NS)
(0 NS)
(0 NS)
(3 NS)
(2 NS)
$629,199
$2,135,825
$1,478,620
$1,609,900
$2,268,500
Total Requested
70
(7 NS)
$8,122,044
Available
Discretionary Funds*
$4,795,273
Notes:
1.
2.
Assumes Flat line funding FY2010, FY2011, & FY2012
* Does not Includes Projected $265,500 Reimbursable Certification & CBRN Testing fees
NS = New Start for FY12
74
Summit Preparation
 Project categories established
Reimbursable
Entitlement
Commitment
Management
Non-Categorized
 NPPTL Strategic Focus established
GPRA
QPR
Metrics
 Funding levels established
Fully
Partially
Minimally
 FY2011 rating criteria applied
Relevance
Impact
Risk
External Factors
75
Project Scoring
Relevance
Impact
Risk
External Factors
Relevance
1→5
1→5
1→5
1→3
Impact
5 = High Relevance
5 = High Impact
5 = Low Risk
3 = Positive External Factors
Risk
External Factors
76
Summit Day 1
 Managers discussed project categories,
strategic goals/focus, and project
ratings
 Managers identified levels of funding
 Fully funded
 Partially funded
 Minimally funded
 Voting members ranked projects
77
Strategic decisions incorporated in process
•PS&B funding dedicated to potential Morgantown collaboration
•FFFIPP SCBA Evaluations transitioned from TEB to TRB
•$500K proposed for grants determined to be fiscally prohibitive
•$20K dedicated to NPPTL innovation initiative
•Projects scored by voting members
•Maximum possible score of 108
-Highest
score 102
-Lowest
score 56
•Initial funding allocations included the following:
-Entitlements funded fully
-Projects scoring ≥90 fully funded
-Projects scoring ≥80 partially funded
-Projects scoring <80 minimally funded
-Panflu projects funded @ full level if <$250K
78
Summit Day 2: The tabulated results from the
scoring were reviewed and discussed by all
 Progress on FY 2011 project activities discussed
 Total proposed project scores assessed
 Entitlements assessed
 Commitments discussed (e.g. EOSTI)
 Low scoring projects discussed and adjusted
 Travel restrictions anticipated
 FY11 Travel budget $429,999
 Current FY12 Travel on the books
 Domestic
$514,803
 Foreign
$130,000
 Reviewed current and anticipated contracts
79
Final Projected Budget Produced in
May 2011
Submitting Branch
OD
PSD
TEB
TRB
SCSST
Total Requested
Total # of Projects
4
18
12
23
7
64
Available
discretionary funds
Note:
By Aug 2011, 7.5% of overall projected budget had to be
cut:
~$500K discretionary
~$500K PS&B
Total $ Projected
$713,699
$757,054
$1,492,620
$967,900
$864,000
$4,795,273
May 2011: $4,795,273
Aug 2011: ~ $4,295,912
***these decreases are not reflected in the May 2011 $***
80
End of Service Life Indicators
Roland Berry Ann
81
End of Service Life Indicators
 OSHA standard 1910.134(d)(3)(iii)(B)(2)
requires a method to determine end of service
life when the capacity of a chemical absorbing
cartridge has been expended
 Research to Develop/Integrate Chemical
Sensors for Real-Time Determination of
Respirator Cartridge Service Life initiated in
2003
 NIOSH intramural and extramural research
has demonstrated feasibility of real-time ESLI
 Manufacturers have demonstrated viability of
embedding sensors in a cartridge
 NIOSH introduced draft requirements for ESLI
use on PAPR cartridges/filters as part of
PAPR standard concept
 Decision to transfer activity to policy and
standards made in February 2011
82
Overview of NIOSH Research on
Decontamination and Reuse of Filtering
Facepiece Respirators (FFRs)
Ronald Shaffer
83
NPPTL Year Month Day Initials BRANCH
NPPTL HCW PPE Research Program Summary
 Ensembles Research

Surgical/isolation gowns
 Filtration Research

Nanoparticles / Bioaerosols
 Respirator Fit Research
 Commit to Worker Safety and Appropriate
Use of PPE
–
Demo and Sentinel Surveillance
–
Public Health Practice studies
–
Best practices, outreach
 Respirator Performance & Usability
Research

Facial anthropometrics

Frequency of fit testing

Performance against cough generated aerosols

Respirator fit test research (user seal check,
novel methods, multiple donnings)

PPE combinations

Respirator clinical effectiveness
 Respirator Comfort Research

Physiology studies

Project BREATHE
 Influenza Pandemic

Risks of handling a contaminated respirator

Decontamination of filtering facepiece
respirators

Assessing modes of transmission
84
NPPTL Year Month Day Initials BRANCH
Critical Questions
 Can infectious aerosols survive on FFRs
long enough to present a fomite hazard?
 Would FFRs that incorporate
antimicrobial technologies prevent the
FFR from becoming a fomite?
 Would the use of biological
decontamination methods allow for
disposable FFRs to be reused?
 Can decontamination methods render infectious
material on an FFR inactive?
 Does decontamination affect FFR performance?
85
NPPTL Year Month Day Initials BRANCH
Long-Term Storage Results
Log10 PFU/coupon
Log10 PFU/coupon
6
8
6
4
2
0
2
4
6
8
10
Time (days)
Survival of MS2 deposited as droplet nuclei (♦) or droplets
(□) on FFR coupons. Viable MS2 were enumerated after
storage.
4
2
0
0
1
2
3
4
5
Time (days)
Survival of MS2 deposited as droplet nuclei on the exterior
layers (♦), internal filtering media (■) and interior layers (Δ)
of FFR coupons. Viable MS2 were enumerated for each
layer after storage.
• All coupons had detectable levels of MS2 after
10 days of storage at 22°C and 30% RH.
• MS2 survivability was similar for each layer
• FFRs have the potential to serve as a fomite
86
NPPTL Year Month Day Initials BRANCH
Antimicrobial Respirators
22ºC and 30% RH
37ºC and 80% RH
* Significantly different (p < 0.05)
from the control N95 respirator.
Antimicrobial respirator effectiveness is dependent upon the
antimicrobial agent and storage conditions
87
NPPTL Year Month Day Initials BRANCH
Effectiveness of Biological
Decontamination Methods
 Key findings from several
studies include:
Bleach
 Decontamination efficacy
increases as a function of dose
and time
 Increased organic/soil load
(protection factor) in the MS2 viral
aerosol challenge reduces
decontamination efficacy of some
methods (e.g., bleach, UVGI), but
not others (e.g., heat, steam)
n=3
LPF = low protection factor (organic load)
HPF = high protection factor (organic load)
 Project data supported the
development of two test
methods: ASTM E2720-10 and
E2721-10
88
NPPTL Year Month Day Initials BRANCH
Does Decontamination Affect FFR performance?
Experimental Design (5 phases)
Laboratory
2 models
20 decon methods
1 cycle
Laboratory
9 models
5 decon methods
1 cycle
Laboratory
6 models
8 decon methods
3 cycles
Human Subject
6 models
3 decon methods
1 cycles
Human Subject
3 models
3 decon methods
3 cycles
 Summary of Findings:
 FFRs tested have differences in their design (e.g., # of layers, face seal enhancements) and
materials (e.g., hydrophobicity), which affects their ability to withstand some decon conditions
 Autoclave, >100º C heat, isopropyl alcohol, microwave (dry heating), hydrogen peroxide gas
plasma, and soap & water caused significant physical or filter degradation to some or all of
the models tested, while bleach had noticeable odor and some off-gassing
 FFRs treated by UVGI, hydrogen peroxide vapor, microwave generated steam, moist heat
incubation, and ethylene oxide had expected levels of laboratory filtration performance
 UVGI, microwave generated steam, and moist heat decontamination resulted in clinically
insignificant changes in fit, odor, comfort, and donning ease
89
NPPTL Year Month Day Initials BRANCH
One Concept for Regulatory Implementation
 Decontamination capability is not expected to be a
requirement (optional)
 Manufacturer determines capabilities by including
decontamination procedure instructions
 Model dependent
 Avoids product liability concerns
 Announcement of research results does not
constitute approval
90
NPPTL Year Month Day Initials BRANCH
Concluding Remarks
 FFRs have the potential to serve as a fomite; Some
biological decontamination methods will render trapped
MS2 virus inactive
 For the FFR models tested, decontamination by UVGI,
moist heat, and microwave generated steam did not
significantly reduce FFR fit or filtration performance
 Some potential next steps
 Field testing
 Inter-laboratory testing & comparison of ASTM E2720-10 and
E2721-10
 Manufacturer acceptance & develop regulatory implementation
plan
91
NPPTL Year Month Day Initials BRANCH
Recent Papers

Viscusi et al. Effect of Decontamination on the Filtration Efficiency of Two FFR Models. J. Int. Soc. Resp. Prot., (2007) 24: 93-107.

Viscusi et al. Evaluation of the filtration performance of 21 N95 FFRs after prolonged storage. Am. J. Infect. Control, (2009) 37:381-386.

Viscusi et al. Evaluation of Five Decontamination Methods for FFRs. Ann. Occup. Hyg., (2009) 53: 815-827.

Fisher et al. Development of a test system to evaluate procedures for decontamination of respirators containing viral droplets. Appl.
Environ. Microbiol., (2009) 75: 1500-1507.

Vo et al. Development of a Test System to Apply Virus Containing Particles to FFRs for the Evaluation of Decontamination Procedures.
Appl. Environ. Microbiol., (2009) 75: 7303-7309.

Rengasamy et al. Evaluation of the survivability of MS2 viral aerosols deposited on FFR samples incorporating antimicrobial
technologies. Am. J. Infect. Control, (2010) 38: 9-17.

Fisher E, Shaffer R, Survival of Bacteriophage MS2 on Filtering Facepiece Respirator Coupons. Journal of Applied Biosafety 15(2), 71-76
(2010).

Bergman et al, Evaluation of Multiple (3-Cycle) Decontamination Processing for Filtering Facepiece Respirators, Journal of Engineered
Fibers and Fabrics 5(4), 33-41 (2010).

Fisher, E., and Shaffer, R.E., A Method to Determine the Available UV-C Dose for the Decontamination of Filtering Facepiece
Respirators, J. App. Microbiol., 110(1), 287-295 (2011).

Fisher et al, “Evaluation of Microwave Steam Bags for the Decontamination of Filtering Facepiece Respirators”, PLoS ONE 6(4):e18585.
doi:10.1371/journal.pone.0018585 (2011).

Viscusi et al., Impact of Three Biological Decontamination Methods on Filtering Facepiece Respirator Fit, Smell, Comfort, and Donning
Ease, Journal of Occupational and Environmental Hygiene (in press) 8(7), 426-436.

Bergman et al. [2011]. Impact of multiple consecutive donnings on filtering facepiece respirator fit. American Journal of Infection
Control (in press).

Fisher et al. Reaerosolization of MS2 Virus from NIOSH-Certified Filtering Facepiece Respirators. Submitted to Annals of Occupational
Hygiene.

Bergman et al. Impact of Three Cycles of Decontamination Treatments on Filtering Facepiece Respirator Fit, In press.
92
NPPTL Year Month Day Initials BRANCH
Acknowledgments
 NPPTL Research Staff Working on These Projects:
− TRB Respiratory Protection Research Team: Ziqing Zhuang, Samy
Rengasamy, Evanly Vo, Dennis Viscusi, Ed Fisher, Jessica Williams
− TRB Research Medical Officer: Ray Roberge
− TRB Human Performance Research Team: Jeff Powell
− URS Staff: Ben Eimer, Mike Bergman, Andy Palmiero
− Health Communications Team: Debbie Novak
− Statistical Support: Kim Faulkner
 Other collaborators
 Air Force Research Laboratory, Battelle Memorial Institute
 Funding for this project was provided by NPPTL and the Technical
Support Working Group (TSWG)
93
NPPTL Year Month Day Initials BRANCH
CSE SR-100 Mine escape Respirator
update
Roland Berry Ann
94
CSE SR-100 Schematic Diagram
The purpose of the oxygen starter is to provide sufficient oxygen to the user for breathing in
the start up phase of operation until the reaction of the chemical bed, serving as the primary
source of oxygen, is fully reacting.
95
NPPTL 2010 September 24
SR-100 Starter Oxygen Investigation
Certified Product Investigation # 1
December 2009 NIOSH LTFE Testing
Certified Product Investigation # 2
February 2010 CSE Self Reported Test Failure
Investigation Objectives
Identify Cause
Identify Corrective Action
Validate and Implement Corrective Action
CSE Investigation Final Report
Cause Pipe Thread & Sealant
Claimed Less than 1% of new mfg.
Sub-Population of Affected Units Can Not be Identified
No field level Correction
96
NPPTL Year Month Day File name
SR-100 Starter Oxygen Investigation
NIOSH / MSHA Positions
Pipe Thread Likely Cause
Core Problem has not been addressed
Sampling of Deployed Units Required to Assess Prevalence
Sampling Plan for Field Deployed Units
ANSI/ASQC Sampling by Attributes
Accurate in range of 1% for specific characteristic
Minimum sample size required 500 for population of 70000
Limiting Qualitiy (LQ) of 1.25 % to 12.5 % Prevalence
Tested Population Includes Only Units Passing Inspection
Tested Solely for Presence of Starter Oxygen
Peer Reviewed Sampling Procedure
97
NPPTL Year Month Day File name
Sampling Plan Statistics
For a quantity of 35,000 to 100,000 deployed SR-100 respirators and Limiting
Quality (LQ) levels ranging from 1.25 to 12.5, the proposed sampling criteria
are:
• For LQ 1.25 the sample size is 500 pieces, accept on 3 defects, reject on 4 defects.
• For LQ 2.0 the sample size is 200 pieces, accept on 5 defects, rejects on 6 defects.
• For LQ 5.0 the sample size is 500 pieces, accept on 18 defects, reject on 19 defects.
• For LQ 8.0 the sample size is 315 pieces, accept on 18 defects, reject on 19 defects.
• For LQ 12.5 the sample size is 200 pieces, accept on 18 defects, reject on 19 defects.
For example, an ‘accept’ at an LQ of 1.25% means that the tested lot contains no
more than 1.25% errors, i.e. the tested characteristic, at a 95% confidence
interval.
98
NPPTL 2010 September 24
SR-100 Sample/Collection Process
MSHA Inventory List
500 SR-100 Serial Numbers
Random Order & Availability of SR-100s
Discussed & Accepted by Peer Review Panel
Participation Voluntary
Compensation, $$$ or Exchange SCSR
Several Rounds to MSHA Districts for Collection
391 SR-100s Tested
4 SR-100s with Insufficient Starter Oxygen
99
NPPTL 2010 September 24
SR-100 Starter Oxygen Investigation
Unit Collection / Testing
Unit Collection Started October 2010
Unit Collection Completed June 2011
500+ Units Collected 500 Units Tested
5 Units with Insufficient Oxygen
>1.25% to 2% Deployed Units with
Insufficient Starter Oxygen
Consequences
Insufficient Starter Oxygen – Critical Failure
Replace Deployed SR-100s
100
NPPTL 2010 September 24
SR-100 Inspections
28 Collected Units Failed Inspection
 ASMD Test (20)
 Heat Color Indicator (14)
 Physical Damage (4)
Corrective Actions – CSE developed new training materials
 Daily Inspection Guide
 90 Day Inspection Guide
 Daily & 90 Day Inspection Guide Video
 Disseminate to SR-100 users
101
NPPTL 2010 September 24
Surgical Masks and N95 Filtering
Facepiece Respirators
Roland Berry Ann
102
Surgical Masks and N95 Filtering
Facepiece Respirators
 Measures to mitigate shortages
 What is the most appropriate device for
protecting health care workers
 Interest in use of a lower level
respiratory protection device (e.g. N50)
103
Conditions of Reuse for Surgical Masks
and N95 FFRs
 Surgical mask use is limited to disposal after one time
usage (single encounter)
 Continued wear of N95 FFRs can be through multiple
patient encounters (Extended Use)
 Reuse with care of handling, hand hygiene, and integrity
of FFR
 N95 FFR use and reuse is limited only to considerations
of hygiene, damage, and increased breathing resistance

8 hour use in dirty workplaces

Can be extended beyond 8 hours only if
 demonstrate extended use will not degrade filter
efficiency
 total mass loading of filter is less than 200 mg
104
Use Limitations
 Respirators can be approved with manufacturer-
specified cleaning/decontamination treatments
 Approval status is retained when user performs
manufacturer-specified procedures
 Novel for N95 FFRs
 Model and process dependent decontamination
possibility has been shown
 Effective cleaning of FFRs, which is required by FDA for
reuse, has not been demonstrated
 Cleaning/decontamination of surgical mask considered
to be reprocessing
 Suitability of resultant product responsibility of the
reprocessor
 Generally not viewed as normal procedure
105
Issues of Protection
 Controversy continues as to type and
level of protection needed for pandemic
influenza (e.g. bioaerosols)
 Suggestions of lower efficiency filter
acceptance of lower protective devices
(e.g. N50)
 Protection is based on exposure reduction, not
filter efficiency
 Minimum acceptable exposure reduction ratio
undetermined
106
Conformity Assessment
Maryann D’Alessandro
107
Selection of Sub–set of Recommendations
for BSC Implementation Tracking
 Chosen to address high priority issues within
each of the PPT Program’s four activities
 Addresses a stakeholder need
 Provides a mix of on-going and new initiatives
 Ambitious, but realizable targets
108
High Priority Issues Selected
for BSC Implementation Tracking
1. Oversee certification of all PPT, including
an assessment of certification mechanisms
 NA Report Recommendation 1
 PPT Program Activity: Technology
Evaluation
109
Oversee certification of all PPT, including
an assessment of certification
mechanisms

Conduct assessment of various certification
mechanisms and their potential applicability
to non-respiratory PPT

Develop a conformity assessment framework

Complete either the development of a
voluntary standard and/or establish an
audit/oversight function based on developed
framework
Refer to Conformity assessment file (handout pages 10-12)
110
Conformity Assessment
Conduct assessment of various certification
mechanisms and their potential
applicability to non-respiratory PPT
July 2009
NIOSH decision
to conduct assessment
September 2009
Engage IOM
January 2010 - July 2010
IOM conducts meetings,
including public workshop
November 2010
IOM delivers
prepublication report
February 2011
IOM delivers final report
111
Conformity Assessment
Develop a conformity assessment
framework
February 2011
Initiate CA
framework
development
May 2011
AIHce session
on CA
February 2011 May 2011 - October 2011
Meetings with
Open Docket and
ISEA & NIST
analyze comments
October 2011 - October 2013
Working group activities and continued stakeholder and public involvement
December 2011
Public Meeting I
July 2012
Public Meeting II
October 2013
Complete CA framework
Dec 2012
Public Meeting III
October 2011
Establish
working group
112
Conformity Assessment
Complete either the development of a
voluntary standard and/or establish an
audit/oversight function based on developed
framework
March 2013 - October 2013
Participate in
various SDOs
October 2013
Decide on voluntary standard
and/or audit/oversight approach;
Select SDO
October 2013 - October 2014
Participate in SDO activites
October 2014
CA development
activity completed
113
What are the conformity assessment
challenges?
 How is the interest in protecting the health and
safety of the American worker shared by the private
and public sectors maximized?
 What mechanisms must be developed or enhanced
to ensure proper coordination among those federal
agencies having authorities in this area?
 Using a cost/benefit approach, what will the
marketplace, particularly PPE purchasers and end
users, be realistically willing and able to support?
 Under what circumstances is a level of independence
needed in a PPT conformity assessment system?
114
Organizing and Operating Philosophy:
“First, do no harm.”
The committee recognizes that many
conformity assessment processes already
in place can fit this framework.” (p. 114,
IOM report)
NIOSH PPT Conformity Assessment Docket # 237
available May 2011 – July 2011
Next step: Establish PPT Conformity Assessment
Working Group
115
Public Information Campaign
Ed Fries
116
Public Information Campaign
 Emphasis on disseminating
information to Healthcare
about false advertising, web
resources
 Emphasis on disseminating
information to Public Safety
Sector on replacement part
issues
117
Public Information Campaign Progress
118
Moving forward
• Continue Marketing Campaign ($100K per year)
• Obtain Domain Name (KnowItsNIOSH.gov)
• Develop partnership with Consumer Protection Agency
• Utilize Intranet for improved internal communications
• Communication intern to help with photo gallery, organization
/ update of donning processes for FFRs, dissemination of
publications post-conferences
• National Safety Month (June 2012)
– Family Safety Day
• Reduce exhibits from 23 to 12 for FY 12
119
NIOSH Personal Protective Technology
Stakeholder Meeting 2011 Results and
2012 Plans
Maryann D’Alessandro
Sector leads
Construction – Colleen Miller (assisted by Tim Rehak)
Healthcare - Roland Berry Ann (assisted by Debbie Novak)
Mining – Rohan Fernando and Bob Stein
Public Safety – Bill Haskell (assisted by Angie Shepherd)
Pesticide Handlers – Kim Faulkner (assisted by Jay Parker)
120
216 Stakeholders participated in person in 2011
~ Number of attendees
Number of surveys returned
74
65
56
51
45
38
34
28
22
21
AG
2010 participants – 137
HC
MN
PS
Live Mtg
~ Number
of
Attendees
Number of
Surveys
returned
Percentage
of Surveys
Completed
In Person
216
132
64.1%
Live Meeting
74
22
29.7%
Total
Participation
280
154
55.0%
121 121
2011 PPT Stakeholders Meeting
What worked?
• Gordon Graham as Key Note Speaker
• Great venue for networking – variety of
Sectors represented
• Quality of presentations
• Discussions during Breakout sessions
well moderated
122 122
2011 PPT Stakeholders Meeting
What didn’t work?
• Presentations not available for note taking
• Focused on problems but not solutions
• Too much lecture and not enough interactive
discussion
• Poster sessions too cramped, second
session not needed (39 posters)
• Lunch too long and too expensive
123 123
2011 PPT Stakeholders Meeting
What should we do differently?
• Allow for sector “hopping” to allow cross
over between sectors
• Increase demonstrations and more “hands
on” activities
• Improve remote access to allow more
participation from viewers
124 124
2011 PPT Stakeholders Meeting
Desired Frequency of meeting by Survey Participants
n=155
140
• 64% surveys
returned
120
115
100
80
60
• 74% of
respondents prefer
annual meeting
40
30
20
10
0
Annually
Annually
Biennially
Biennially
No Response
No Response
125 125
2011 PPT Stakeholders Meeting
What topics should be discussed at future meetings?
•
•
•
•
•
Heat stress in PPE
Focus on EMS issues in healthcare
Certification criteria vs. real protection criteria
New technology related to compliance issues
Interface between users, manufacturers, and
agencies
• Trends, legislation, fiscal impacts
126 126
FY10 & FY11 PPT Stakeholders Meetings
• The information for the 2011 meeting can be found at:
http://www.cdc.gov/niosh/npptl/resources/certpgmspt/meetin
gs/03292011/PresentationsPosters03292011.html
• The information for the 2010 meeting can be found at:
http://www.cdc.gov/niosh/npptl/resources/pressrel/letters/lttr03022010.html#presentations
Question to IOM:
This method of disseminating meeting
information was chosen to expedite availability
of meeting content.
127 127
2012 PPT Stakeholders Meeting
March 20-21, 2012
• 5 Sector Focus
–
–
–
–
–
Construction
Healthcare
Mining
Pesticide Handlers
Public Safety – EMS Workers
• Training Focus on Day 2
128 128
Agenda Day 1 - March 20, 2012
Draft PPT Stakeholder Meeting Agenda
8:00 – 8:15 am
Welcome and opening
8:15 – 8:45 am
Theme based presentation(s)
8:45 – 9:00 am
Break
9:00 – 10:30 am
Breakout sessions
10:30 – 10:45 am
Break
10:45 – 11:30 am
Theme based presentation
11:30 – 12:00pm
Lunch
12:00 – 1:30 pm
Keynote Speaker
1:30 – 3:00 pm
Poster session
3: 00 – 4:30 pm
Breakout session
4:30 – 5:00 pm
Wrap-up
5:00 – 5:30 pm
Break
5:30 – 7:00 pm
Reception (?)
129
Agenda Day 2 - March 21, 2012
 What training should be conducted on day two?
 Respirator fit testing
 Hearing protection fit testing
 Heat stress
 CBRN Respirator Guidance
 Transient Workforce challenges
 Capacity versus duration
 Should training cross all sectors or be sector specific?
130
Healthcare
 PPE selection, use and expectations will be
discussed with an emphasis on dispelling the
myths and misconceptions regarding ensemble
component (e.g. respirators, surgical masks,
gloves and gowns) identification and usage.
 A presentation will introduce the topic.
 A panel of experts who will answer questions
regarding current technology and their
capabilities.
131
Healthcare
 After attending the meeting, HCSA Sector participants
will understand the following concepts:
 The role of various enforcement agencies involved in the clearance
and use requirements for procedure masks, surgical masks and
respirators used for infection control.
 When to use and the different types and levels of protection provided
with the use of respirators, surgical masks and procedure masks.
 The contents and best practices of a respiratory protection program
for healthcare workers.
 Matching the proper choice of gloves and gowns for the task.
132
Mining
 PPE selection, use and expectations will be discussed
with an emphasis on dispelling the myths and
misconceptions regarding self-contained self rescuer
(SCSR) duration and capacity.
 The presentations will be followed by a panel of experts
who will answer questions regarding current technology
and concepts for future technology.
 The PPT Program will solicit perspectives regarding
SCSR technology knowledge gaps to direct the
program’s future research initiatives.
133
Mining
 After attending the meeting, participants will understand the following
concepts:
 The difference between ‘capacity’ and ‘duration’ of a self-contained self
rescuer.

The work rate determines the oxygen consumption and hence the
duration the SCSR will last.

Distance travelled is dependent on the person’s weight, body posture
and travel path grade; but independent of the travel speed.

Different SCSRs contain different quantities of oxygen.
 Feasibility of dockable SCSRs
 Possibilities of full face mask or hood adaptations to SCSRs
 Mine escape with SCBA in conjunction with air refill cascade systems
 Concepts for electronic control applied to rebreathers
 Feasibility of modern cryogenic rebreathers for mining
134
Pesticide Handlers
 To build on the problems identifieed in 2011, Solutions
will be the focus to address:
 1) inadequate pesticide PPE training,
 2) Difficulty in identifying correct pesticide PPE in the purchasing
process,
 3) inadequate workplace safety culture, and
 4) Pesticide PPE is not comfortable.
 The participants will have a better understanding of how
to translate PPE requirements on the pesticide label and
of the issue of heat stress as it relates to correct PPE
practices.
 Objective is to expand to pesticide handlers across all
industry sectors
135
Public Safety – EMS Workers
 Focus on issues related to PPE used by the
emergency medical service (EMS) and medical
first receivers.
 Research conducted in support of the NFPA
Technical Committee on Emergency Medical
Services Protective Clothing and Equipment.
 A panel session of invited EMS stakeholders
including EMS responders and manufacturers that
will present and discuss the realities of the use of
EMS PPE such as performance, practicality,
availability, limitations, and cost.
136
Public Safety – EMS Workers
 After attending this breakout session the participants
will have a better understanding of the following:
 The scope, purpose and application of NFPA® 1999 Standard on
Protective Clothing for Emergency Medical Operations, 2008 Edition
 NPPTL research on improved performance criteria for emergency
medical protective clothing supporting the revision to NFPA® 1999,
2008 Edition
 EMS responder and product manufacturer stakeholder input on the
applications and use of compliant and non-compliant EMS personal
protective equipment (panel session)
137
Public Safety – EMS Workers
 Presentations and discussions related to NIOSH fire fighter fatality
investigations.
 Presentations will also be given other federal agencies and
laboratories supporting the revisions to fire and emergency services
PPE performance and certification standards.
 After attending this breakout session the participants will have a
better understanding of the following:
 NIOSH/DSR Fire Fighter Fatality Investigation and Prevention Program
(FFFIPP)
 SCBA and protective ensemble evaluations in support of FFFIPP
 Research efforts supporting performance improvements fire service PPE and
consensus standards
138
Construction
 The PPT Program is working with the
NIOSH Construction Sector
Management and CPWR to develop
the Objectives for the Construction
Sector
139
New Projects
 NPPTL001 - Development of Performance and Design
Criteria for Isolation Gowns
 NPPTL004 - Why Hospital Staff Catch the Flu:
Assessing Modes of Transmission
 NPPTL005 Healthcare Respiratory Protection
Program Toolkit
 NPPTL006 – Mobile Application Suite
140
Development of Performance and Design
Criteria for Isolation Gowns
Ron Shaffer
141
NPPTL Year Month Day Initials BRANCH
Development of Performance and Design Criteria for
Isolation Gowns - FY12 (NPPTL001)
Objective
To provide the basis for and
recommend appropriate
design and performance
criteria for isolation gowns
Applicable Standards
• Healthcare workers
• ASTM F23
• AAMI PB 70
• AATCC
• Infection control professionals
• Manufacturers
• SDO’s
Key Partners
• ASTM F23 Committee
• Vestagen Technical Textiles
• Kimberly Clark
• UC Davis
Project Scope
• Identify the specific hazards and use conditions
• Determine the performance, design and integration
properties needed to demonstrate effectiveness
• Select and develop appropriate test methods to measure
performance properties
• Establish design and performance criteria for isolation gowns
including integration and interoperability that ensure an
appropriate level of protection based on the results and user
expectations
• Communicate recommended test methods and criteria to the
ASTM F23 Committee on isolation gowns and other industry
stakeholders for use in standards
Milestones FY12
• Q1 Write protocol
• Q2 Submit protocol for external peer review, receive comments
• Q3 Address reviewers’ comments, submit protocol to HSRB,
select and order test samples, and develop test plan
• Q4 Receive HSRB approval, initiate subject recruitment, set the
equipment, and initiate the testing
Stakeholders
• OSHA 1991
• APIC
• The Joint Commission
• AORN
• AAMI
Outputs
• Final report with technical data used by ASTM F23 Committee
• Manuscripts published in peer-reviewed journals (approx 2)
• Presentations at national/international conferences (approx 2)
Outcomes
• Healthcare workers use project outputs to select and use ensembles
• Manufacturers use the outputs to develop and /or improve current
isolation gowns
• Consensus standards development organizations (ASTM, ISO, ANSI,
AAMI), government agencies (FDA, etc.) and professional
organizations (AORN, APIC, The Joint Commission) use
recommended performance requirements to develop standards and /
or guidance documents
•Other researchers utilize the findings to initiate research on more
effective healthcare worker personal protective ensembles.
Updated: 6 April 2011
142
Background
 PPE is a critical component in the hierarchy of controls used to
reduce HCW exposures to infectious hazards.
 Gowns are the second-most-used piece of PPE, following gloves in
the healthcare setting(*).
 According to the CDC’s Guideline for Isolation Precautions:
Preventing Transmission of Infectious Agents in Healthcare Setting
2007, isolation gowns should be worn to protect the HCWs’ arms
and exposed body areas during procedures and patient-care
activities when anticipating contact with clothing, blood, bodily
fluids, secretions and excretions.
 Although AAMI has published guidance documents on gown
selection and liquid barrier performance, there are currently no
existing standards for isolation gowns which includes performance
and design criteria and addresses interface problems.
(*)
Holguin M., “Standard Precautions for Healthcare Workers and the Role of Isolation Gowns, Education & Training, http://healthvie.com, January
2011
143
NPPTL Year Month Day Initials BRANCH
Background
 Recent feedback from stakeholders has indicated a strong need
for performance requirements for isolation gowns.
 A new Task Group was formed in March 2011 in ASTM’s F23
Committee on Protective Clothing and Equipment to work on a
new specification standard on isolation gowns with FDA’s
participation.
 NPPTL was asked to participate in that work group and proposed
an FY12 new start (internally funded) to provide the scientific
basis for this new specification standard
144
NPPTL Year Month Day Initials BRANCH
Goals for Proposed NPPTL FY12 Project
 Provide the basis for and to recommend appropriate minimum
design and performance requirements for isolation gowns which
also addresses the interface problems
 Ultimately improve isolation gown selection & use compliance
 Evaluate currently used isolation gowns to determine existing
performance, performance & design limitations, and interface
issues
 Specifically,
 determine the protection, comfort level, tolerability and interface issues
with the most common isolation gowns currently in use
 define performance and design requirements based on the results and
end user feedback
145
NPPTL Year Month Day Initials BRANCH
Proposed Method
Investigate HCW
needs to determine
specific hazards
Evaluate “acceptable”
and “unacceptable”
products to aid in setting
recommended
requirements
Identify current
products in use or
products that could
be used
Carry out the test
plan and analyze the
test results
Determine the
specific properties
that can be assessed
Select the
appropriate test
methods
Prepare
recommended design
assessment and
performance criteria
Document study
findings, publish and
present
146
NPPTL Year Month Day Initials BRANCH
For additional information
about the Isolation
Gowns project please
contact:
F. Selcen Kilinc, PhD
NIOSH / NPPTL
Pittsburgh, PA 15236
Email: [email protected]
Phone: 412-386-4086
http://www.cdc.gov/niosh/npptl/
pdfs/PotentialBarriersPPE.pdf
147
NPPTL Year Month Day Initials BRANCH
Effectiveness Comparison of N95
Respirators and Surgical Masks Against
Influenza: Respiratory Protection
Effectiveness Clinical Trial (ResPECT)
Ron Shaffer
148
NPPTL Year Month Day Initials BRANCH
Why Hospital Staff Catch the Flu: Assessing
Modes of Transmission – FY12 (NPPTL004)
Applicable Standards
Key Partners
 To assess the relative contributions of droplet, droplet nuclei
and direct contact transmission of influenza in healthcare
settings by measuring the level of influenza contamination of
the environment (air and surface) and healthcare worker
PPE (gloves, surgical masks, and filtering facepiece
respirators) and comparing that to the incidence of labconfirmed influenza in healthcare workers in the Respiratory
Protection Effectiveness Clinical Trial (ResPECT) study.
 ASTM E2720 – 10 / E2721 – 10
 NIOSH 42 CFR Part 84
 ISO TC94/SC15
 OSHA 1910.134
 Johns Hopkins University
 Veterans Administration
 Air Force Research Laboratory
 CDC/DHQP
 NIOSH (DSHEFS, HELD)
Project Scope
Outputs
Objective
 FY11 – write proposal, initiate contract with JHU (NPPTL)
 FY12 – Correlate influenza environmental sampling to PPE sampling in
the lab (HELD)
 FY13 – Pilot field study. Measure environmental and PPE influenza
contamination in healthcare setting (DSHEFS)
 FY14 – Full-scale field study. Measure environmental and PPE
influenza contamination. Relate contamination to influenza rates of
subjects in the ResPECT study (JHU)
 FY15 – Laboratory study to assess the potential for contact
transmission from contaminated PPE using MS2 phage and human test
subjects (NPPTL)
 FY12-15. Manuscripts, presentations, etc.
Milestones FY12
 Q1 Finalize peer-review comments.
 Q3 Obtain IRB/HSRB for FY13 pilot field study
 Q4 Complete laboratory studies to correlate environment and PPE
contamination (HELD)
Stakeholders
 Healthcare workers
 Hospital administrators
 Policy makers
 Manuscripts published in peer review journals
 Presentations at conferences
 Contractor reports
Outcomes
 Outputs will be used by other government agencies for
guidance in using non-pharmacological interventions for
influenza transmission
 Other researchers will use the findings of this project to
explore the modes of influenza transmission and examine the
efficacy of PPT
Updated: 6 April 2011
149
NPPTL HCW PPE Research Program Summary
 Ensembles Research

Surgical/isolation gowns
 Filtration Research

Nanoparticles / Bioaerosols
 Respirator Fit Research
 Commit to Worker Safety and Appropriate
Use of PPE
–
Demo and Sentinel Surveillance
–
Public Health Practice studies
–
Best practices, outreach
 Respirator Performance & Usability
Research

Facial anthropometrics

Frequency of fit testing

Performance against cough generated aerosols

Respirator fit test research (user seal check,
novel methods, multiple donnings)

PPE combinations

Respirator clinical effectiveness
 Respirator Comfort Research

Physiology studies

Project BREATHE
 Influenza Pandemic

Risks of handling a contaminated respirator

Decontamination of filtering facepiece
respirators

Assessing modes of transmission
150
NPPTL Year Month Day Initials BRANCH
Background
 Prevention strategies are critical in limiting the
transmission of respiratory viruses such as
influenza
 Among non-pharmaceutical interventions, there is
intense interest in the use of surgical masks (SMs)
and NIOSH-certified N95 filtering facepiece
respirators (FFRs)
 FFR recommendations for healthcare workers
(HCWs) during the 2009-10 H1N1 outbreak were
controversial
151
NPPTL Year Month Day Initials BRANCH
Background
 Many laboratory studies show higher levels of
protection provided by FFRs compared to SMs, but
few have be conducted in clinical settings
 Conflicting findings from Loeb et al. (2009) and
MacIntyre et al. (2011) studies
 Study limitations made acceptance among some
stakeholder groups difficult
• Loeb, Dafoe, Mahoney, et al, (2009) Surgical Mask vs. N95 Respirator for Preventing Influenza Among Health Care Workers: A Randomized Trial, JAMA;
302(17):1865-1871
• MacIntyre, Wang, Cauchemez, et al. (2011), A cluster randomized clinical trial comparing fit-tested and non-fit-tested N95 respirators to medical masks to
prevent respiratory virus infection in health care workers. Influenza and Other Respiratory Viruses, 5(3): 170–179.
152
NPPTL Year Month Day Initials BRANCH
ResPECT Study
 Collaboration between CDC/NIOSH, CDC/DHQP,
Veterans Health Administration (VHA), and Johns
Hopkins University (JHU)
 Principal Investigators: Trish Perl (JHU), Lew Radonovich
(VHA)
 Primary question being addressed: How well do
respirators (N95 FFRs) protect HCWs in the
outpatient setting against influenza, influenza-like
illness (ILI), acute respiratory illness (ARI) and other
respiratory illnesses, as compared to SMs?
 Approach: prospective, unblinded, cluster
randomized evaluation of N95 FFRs (arm #1) and SMs
(arm #2)
153
NPPTL Year Month Day Initials BRANCH
ResPECT Study – Pilot Phase
 A pilot study was conducted at 4 locations in the
Baltimore, MD area for 2010-2011 influenza season
 Johns Hopkins Hospital, Howard County General Hospital,
Johns Hopkins Bayview Medical Campus, and Johns Hopkins
Community Physicians - Wyman Park
 Subject recruitment began Dec 2010
 139 subjects (HCWs) enrolled
 Baseline data collection began 1/4/11
 Training, fit testing, blood draw (serology), and a pre-study
baseline and attitudes, beliefs, and opinions survey
154
NPPTL Year Month Day Initials BRANCH
ResPECT Study – Pilot Phase
 Study activation date was 1/26/11 and continued for 12
weeks (4/30/11)
 Weekly nasal swabs, weekly symptom form surveys
 110 subjects completed the pilot study
 50% in FFR arm and 50% in SM arm
 34 nasal swabs from self-reported symptomatic subjects
 All post-study surveys and blood draws were completed in
June and is currently being analyzed
 JHU is analyzing the nasal swab samples for the presence
of 17 respiratory viruses, including influenza A and B
(primary clinical outcomes)
155
NPPTL Year Month Day Initials BRANCH
Next Steps
 Study will expand to VA New York Harbor Healthcare
System during the next influenza season (VHA funded)
 Protocol is being revised based upon lessons learned
 The goal is to have enough independent clusters spanning
multiple seasons to provide enough data to determine if
subjects in the FFR arm were 25% less likely to experience
lab-confirmed influenza than subjects in the SM arm
 Internal NIOSH funding was obtained to study modes of
influenza transmission
 Sample air, surfaces, and gloves, FFRs, and SMs from ResPECT
participants for influenza
 Target date for pilot field study is fall 2012
156
NPPTL Year Month Day Initials BRANCH
Acknowledgments
 Collaborators
 Lew Radonovich, Aaron Eagan,
and Trish Perl to name a few…
 ResPECT scientific advisory
group
 Funding for the ResPECT
pilot study was provided
by the CDC through the
Pandemic Influenza
Science Agenda
157
NPPTL Year Month Day Initials BRANCH
Healthcare Respiratory Protection
Program Toolkit
Ed Fries
158
NPPTL Year Month Day Initials BRANCH
Healthcare Respiratory Protection Program Toolkit
FY12 (NPPTL005)
Objective
To develop a
Respiratory Protection
Program toolkit that will
be applicable to
hospitals across the US
and provide new content
information to better
educate healthcare
workers.
Applicable standards
 29 CFR Part 1910.134
Key Partners
 CDPH
 Univ of Minn
 Univ North Carolina
 OSHA
 Joint Commission
Stakeholders
 Manufacturers
 Healthcare workers
Project Scope
To provide proper respirator use guidelines to
ensure end user protection utilizing the
resources from REACH contracts and COPPE
workshop.
Outputs
Milestones
Outcomes
 Develop toolkit by 2Q FY12
 Develop training guidelines by 4Q FY12
 Pilot test by 2Q FY13




Presentations at conferences
Standards committee/stakeholder presentations
Published manuscript in peer-reviewed journal
Toolkit resources posted to web
 Results incorporated into healthcare respiratory protection
programs
Updated: 11 Apr 11
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Mobile Application Suite
Ed Fries
160
NPPTL Year Month Day Initials BRANCH
Mobile Application Suite FY 12 (NPPTL002)
Objective
Develop and “Test Market” Mobile Apps software to allow
NPPTL information products to be available on
stakeholders’ electronic communication devices
Applicable Standards
 CDC IT Security requirements
Key Partners
 NIOSH/OD
 Max Lum, communications
 Ken McKneely, Computer Scientist (Security)
 CDC Informatics R&D Unit (IRDU)
Stakeholders
 PPE Manufacturers
 Employers and workers in Sector(s) to be determined based on
selection of pilot Apps
Project Scope
Pilot project to prototype and test a suite of related mobile
applications (Apps) for stakeholder selection of NPPTL
information products to be resident on their communication
devices.
Outputs
 Electronic information products formatted as Mobile Apps in
commonly-used platforms to augment products tailored for
emerging Social Media
Milestones
 Determine appropriate platforms
 Determine products suitable for pilot development (e.g. User
Notices, Letters to Interested Parties)
 Demonstration Apps developed by programming partner
 Solicit stakeholder within appropriate sectors for test of apps
usability.
Updated: 11 Apr 11
Outcomes
 Worker safety and health is improved by availability of up-to-date
NIOSH PPT information being readily available on employers and
employees’ portable communication devices (e.g. iphones,
blackberries, etc.)
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Quality Partnerships Enhance Worker
Safety & Health
Visit Us at: http://www.cdc.gov/niosh/npptl/
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.
Thank you
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