NPPTL and Personal Protective Technology Program Update

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 Good morning. I am delighted to provide you an update on our PPT Program Evaluation and Surveillance Activities. Today you will hear a program overview describing where we are currently relative to our program activities within our strategic goal areas. I am going to set the stage for what has been recommended for our future and briefly describe our approach to addressing the recommendations. The intent is that through my overview, the subsequent goal overviews, and the supporting presentations and posters will enable you to provide input relative to the relevance of our activities to addressing workforce needs to help us identify gaps. We are pleased to have a number of extramural grant recipients participating in our meeting today and look forward to hearing about their research as well. These are exciting times, and we hope this overview gives you a sense of our priorities and direction in these areas. August 4-5, 2011

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.

PPT Program Logic Model
Environmental Assessment Production Inputs Planning Inputs Surveillance Data Sector-cross sector Coordination External Factors NAS COPPE Stakeholders Evaluations Outcomes Transfer Activities r2p Respirator Certification Policy and Standards Communications Current Activities Research Surveillance Performance Metrics and Measures Outputs Emergency Response This provides the black magic between inputs and activities

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.

NIOSH Program Portfolio
NORA / NIOSH Industry Sectors (N=10) NIOSH Cross Sector Programs (N=24) Agriculture, Forestry, and Fishing Construction Healthcare and Social Assistance Mining Oil & Gas Extraction Manufacturing Services Public Safety Transportation, Warehousing, and Utilities Wholesale and Retail Trade Authoritative Recommendations and Development Cancer, Reproductive, & Cardiovascular Diseases Communications and Information Dissemination Economics Emergency Preparedness and Response Engineering Controls Exposure Assessment Global Collaborations Health Hazard Evaluation (HHE) Hearing Loss Prevention Immune and Dermal Diseases Musculoskeletal Disorders 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) Traumatic Injury Work Organization & Stress-Related Disorders Updated 6 June 2011 from NIOSH websites

NIOSH Program Portfolio PPT involvement
NORA / NIOSH Industry Sectors (N=10) NIOSH Cross Sector Programs (N=24) Agriculture, Forestry, and Fishing Construction Healthcare and Social Assistance Mining Oil & Gas Extraction Manufacturing Services Public Safety Transportation, Warehousing, and Utilities Wholesale and Retail Trade Authoritative Recommendations and Development Cancer, Reproductive, & Cardiovascular Diseases Communications and Information Dissemination Economics Emergency Preparedness and Response Engineering Controls Exposure Assessment Global Collaborations Health Hazard Evaluation (HHE) Hearing Loss Prevention Immune and Dermal Diseases Musculoskeletal Disorders 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) Traumatic Injury Work Organization & Stress-Related Disorders Updated 6 June 2011 from NIOSH websites

Participation in NORA LOIs Endorsed FY08 FY09 FY10 FY11 FY12 NPPTL 3
FY08 FY09 FY10 FY11 FY12 NPPTL 3 $397,333 1 $250,000 9 $1,373,111 $385,340 4 NIOSH Totals 76 $9,517,633 120 $12,576,250 98 $12,270,637 96 $11,948,214 70 LOIs Called $146,500 $210,000 2 $325,340 2* 42 $5,066,792 57 $7,159,358 44 $5,545,157 38 $4,722,710 32 Proposals Funded $62,813 $0 $72,000 NIOSH Totals 18 $2,398,345 21 $2,752,674 14 $2,095,585 $1,759,652 * One proposal received highest score in Healthcare and received funding through PanFlu

Research to Consensus Standard

ASTM F Standard Test Method for Measuring the Transmitted and Stored Energy of Firefighter Protective Clothing Systems NFPA 1999: Standard on Protective Clothing for Emergency Medical Operations, Edition: Protective-Clothing-for-Emergency-Medical- O&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 ASTM F Standard Practice for Determining the Physiological Responses of the Wearer to Protective Clothing Ensembles ASTM F Standard Practice for Chemical Permeation through Protective Clothing Materials: Testing Data Analysis by Use of a Computer Program

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?

ASTM F Standard Test Method for Measuring the Transmitted and Stored Energy of Firefighter Protective Clothing Systems Bill Haskell

Stored Thermal Energy : 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.

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 ) 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.).

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.

Stored Thermal Energy : 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 ( 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 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.

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 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.

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 F 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). (

Research to Consensus Standards Development NFPA 1999: Standard on Protective Clothing for Emergency Medical Operations, 2008 Edition Angie Shepherd

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

Research - Background Cleaning gloves Single use garments
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

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

Partners National Fire Protection Association (NFPA)
International Personnel Protection, Inc. Emergency Medical Services (Users) PPE Manufacturers Independent Test Labs

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

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

Dissemination Presentations Participation at Trade Shows
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

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

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

Research to Consensus Standards Development
NFPA 1984: Standard on Respirators for Wildland Fire Fighting Operations, 2011 Edition Jonathan Szalajda Our mission is to provide world, national, and Institute leadership for prevention and reduction of occupational disease, injury, and death for those workers who rely on personal protective technologies … through partnership, research, service, and communication. Courtesy C. Austin & SOPFEU

Project Goal Develop new certification criteria for the approval of respirators for wildland fire fighting operations Courtesy L. Naeher

Standards Scope Dual NIOSH/NFPA Certification for APRs and PAPRs, for use in Wildland Fire Fighting Operations similar to certifications issued for SCBAs

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

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

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

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

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 ,

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

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 Tim Rehak Updated: 30 Mar 09

NIOSH Gas and Vapor tests:
A multi-gas approval Carbon Monoxide Organic Vapors Sulfur Dioxide Nitrogen Dioxide Formaldehyde Acrolein Tim Rehak Courtesy C. Austin Updated: 30 Mar 09

Partners National Fire Protection Association (NFPA)
US Forestry Service (Users) PPE Manufacturers Independent Test Labs

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

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

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

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

Assessment of New Technologies
NIOSH will identify or develop test procedures to evaluate the performance of new or novel technologies intended to provide the multi-gas 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

Commercial VLE Technology Evaluation Objective
Conduct a technical assessment of a non-NIOSH 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.”

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

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)

Commercial VLE Technology Evaluation Infrared Imaging
Qualitative examination of flow patterns with infrared imaging system Image analysis Flow generally concentrated in tight area around mouth Some bypassing around sides ABMS Inhalation ABMS Exhalation

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

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) (TEB-APR-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

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

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

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

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

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

ASTM F Standard Practice for Determining the Physiological Responses of the Wearer to Protective Clothing Ensembles W. Jon Williams

Next Generation Structural Fire Fighting PPE Ensemble Project HEROES FY09
Objective Applicable Standards ASTM F WK8818 Standard Practice for the Physiological Evaluation of Protective Clothing ASTM F Standard Test Method for Man-In-Simulant Test (MIST) for Protective Ensembles NFPA 1971 (structural fire fighting ensembles) NFPA 1994 (CBRN ensembles) 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. Key Partners Stakeholders 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 Outputs Manuscripts published or submitted to peer review journals (approx. 3) Presentations at conferences (approx. 9) Final report to TSWG (Feb 2008) TRB CAN 927Z4FY / W. Jon Williams Outcomes Research resulted in an ASTM standard test practice on physiological testing “ASTM F 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 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 Updated: 27 Ma r 09

ASTM F Standard Practice for Chemical Permeation through Protective Clothing Materials: Testing Data Analysis by Use of a Computer Program Pengfei Gao

AIHA guideline for CPC and equipment decontamination
Degradation and Decontamination Efficacy of Chemical Protective Clothing (CPC) – FY11 (927PP28) Objective Permeation Calculator Applicable Standards ASTM F23.30 ANSI/ISEA Key Partners ASTM F23 Committee: develop the standard practice using the “Permeation Calculator” ISEA Hand Protection Group: update project progress AIHA guideline for CPC and equipment decontamination 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. Stakeholders ASTM ISEA and manufacturers Protective clothing users 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. 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 F 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. TRB CAN 927PP28 / Pengfei Gao Four Journal Publications Gao, P, EI-Ayouby N, and Wassell JT[2005]. Change in Permeation Parameters and the Decontamination Efficacy of Three Chemical Protective Gloves after Repeated Exposures to Solvents and Thermal Decontaminations. American Journal of Industrial Medicine, 47(2): Gao, P and Tomasovic B [2005]. Degradation of neoprene and nitrile chemical protective gloves after repeated acetone exposures and thermal decontaminations. Journal of Occupational & Environmental Hygiene, 2(11): Xin F, Gao P, Shibamoto T, Sun G [2006]. Pesticide detoxifying functions of N-halamine fabrics. Archives of Environmental Contamination and Toxicology, 51: Gao, P, Weise T, and Tomasovic B [2009]. Development of a computer program for permeation testing data analysis. Journal of Occupational & Environmental Hygiene, 6: 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 Research findings resulted in a new ASTM standard practice F 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

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?

NPPTL Organization Update Maryann D’Alessandro

PPT Program Activities
Management Scientific evaluations Program evaluations & assessments Emergency response Technology Evaluation Policy & Standards Development Technology Research Surveillance and Communications Respirator Certification Program Quality Audit Program Certified Product Investigations Long Term Field Evaluation Program Enhancements to 42 CFR Part 84 CBRN respirator standards development Consensus standard development Guidance Document Development Respiratory Protection Protective Clothing & Ensembles Integration of Sensors & Electronics Human Performance Outreach Surveillance Health Communications Web management The import of this is that we have 4 main activities. A few key examples are provided under each of our main activities Covering the breath of what the organization does.

NPPTL Resource Position
Typically operates with PS&B 60% - 70% of base budget allocation. Insufficient laboratory capacity is program limiting Implementing Plan to: Use laboratory NIOSH-Morgantown Existing personnel reassigned from DRDS (7) and HELD (2 [1 pending] ) to NPPTL

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

NATIONAL PERSONAL PROTECTIVE TECHNOLOGY LABORATORY
Office of the Director Boord, L., Director Buller, S., Secretary Berry Ann, R., DeputyDirector Coffey, C., ResChemist Zubasic, D., Secretary(OA) Administrative Support Miller, M., Lead Mgmt&ProgAnal Stolze, A., AdminOfficer LaFond, R., Mgmt&ProgAnal Scientific Excellence Focus D’Alessandro, M., AssocDirectorForScience Sporrer, J., PublicHealthAnalyst 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) Technology Evaluation Branch Ahlers, H., BranchChief Peterson, J, Deputy Branch Chief Harvey, K., ProgOperAsst Bell, A., DocMgmtSpec Reeder, A., EngTech Brannen., J., QA Spec Rottach, D., PhySci Gavel, K., GenEng (TL) Sheets, R., QA Spec Hurd, E., QA Spec Shubilla, J., EngTech Jacobs, R., EngTech Snyder, D., DocMgmtSpec Kochenderfer, V., QA Spec Stein, R., GenEng Kyriazi, N., BiomedEng Thornton, T., PhySci (Acting TL) Luncinski, L., AdminSupAsst Thunhorst, M., Mgt&ProgamAsst Neiderhiser, C., PhySci Welsh, E., EngTech Parker, J., PhySci Wiltanger, P., PhySci Pouchot, T., GenEng Wolfe, C., GenEng Powelko, R., QA Spec Yekich, M., Mgt&ProgamAsst Policy and Standards Development Branch Szalajda, J., BranchChief 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 Surveillance, Communication and Scientific Support Team Fries, E., GenEng (TL) 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 83 Title 42 Fellows 9 Total FTE 92 July 2011

NPPTL FY12 Strategic Planning and Budget Formulation Process Maryann D’Alessandro

Program Budget Formulation Steps
Mid-year review of FY 2011 projects Summit preparation Summit meetings and discussions Post-summit activities

Midyear review of projects
Clear project objectives and milestones Partnerships established Outputs produced and anticipated Intermediate outcomes Descriptions provided in NPPM

Strategic inputs External Internal Good Organizational Health
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

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

NPPTL GPRA Goals: Respirator Audits
Measure FY Target Result/Reporting Date Ensure the quality of NIOSH certified respirators by increasing the number of audit activities completed 20XX? (out- year) 88 audit activities sustained for the life of the program. Annual reporting requirement beyond 2015 88 audit activities Dec 31, 2015 2014 80 audit activities Dec 31, 2014 2013 73 audit activities Dec 31, 2013 2012 66 audit activities Dec 31, 2012 2011 60 audit activities Dec 31, 2011 2010 [trend data] Insert result 2009 2008 Baseline

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

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. % of NPPTL publications are published in peer reviewed journals with an influence score greater than 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.

FY12 Requests from Midyear Review
Submitting Branch Total # of Projects Total $ Requested OD (2 NS) $629,199 PSD 20 (0 NS) $2,135,825 TEB 13 (0 NS) $1,478,620 TRB 23 (3 NS) $1,609,900 SCSST (2 NS) $2,268,500 Total Requested 70 (7 NS) $8,122,044 Available Discretionary Funds* $4,795,273 Notes: Assumes Flat line funding FY2010, FY2011, & FY2012 * Does not Includes Projected $265,500 Reimbursable Certification & CBRN Testing fees NS = New Start for FY12

Summit Preparation Relevance Impact Risk External Factors
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

Project Scoring Relevance 1 → 5 5 = High Relevance Impact
5 = High Impact Risk 5 = Low Risk External Factors 1 → 3 3 = Positive External Factors Relevance Impact Risk External Factors

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

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 full level if <$250K

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

Final Projected Budget Produced in May 2011
Submitting Branch Total # of Projects Total $ Projected OD 4 $713,699 PSD 18 $757,054 TEB 12 $1,492,620 TRB 23 $967,900 SCSST 7 $864,000 Total Requested 64 $4,795,273 Available discretionary funds May 2011: $4,795,273 Note: By Aug 2011, 7.5% of overall projected budget had to be cut: ~$500K discretionary ~$500K PS&B ***these decreases are not reflected in the May 2011 $*** Aug 2011: ~ $4,295,912 See Millie about total AFRL funding available

End of Service Life Indicators Roland Berry Ann

End of Service Life Indicators
OSHA standard (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 Chemoresistive sensors: Material “swells” when exposed to challenge agent, changing its electrical resistance proportionally to the amount of challenge agent present. Currently used to track quality of foodstuffs (artificial “nose”) Plan to put in respirator cartridge to measure loading. An array of such sensors produce data related to a time vs. concentration profile. When combined with knowledge of cartridge performance, the user could use a computer to determine the remaining life of the cartridge. Use scenarios include plugging the cartridge into a “reader” after a period of use, or including onboard intelligence and signaling capability to produce real-time information. Nanostructures or Micro-Electromechanical (MEM) devices: Currently being developed by the Univ. of California San Diego and CMU Generally targeted to measure CWAs or isocyanates Permits measurement of changes by multiple means ( ) to accomplish discrimination of challenge agents. Sensors are chemically “tunable” for specific agents Typical size is 60 micrometers—human hair is typically xx micrometers

Overview of NIOSH Research on Decontamination and Reuse of Filtering Facepiece Respirators (FFRs)
Ronald Shaffer

NPPTL HCW PPE Research Program Summary
Ensembles Research Surgical/isolation gowns Filtration Research Nanoparticles / Bioaerosols Respirator Fit Research Facial anthropometrics Frequency of fit testing Respirator fit test research (user seal check, novel methods, multiple donnings) Respirator Comfort Research Physiology studies Project BREATHE Commit to Worker Safety and Appropriate Use of PPE Demo and Sentinel Surveillance Public Health Practice studies Best practices, outreach Respirator Performance & Usability Research Performance against cough generated aerosols PPE combinations Respirator clinical effectiveness Influenza Pandemic Risks of handling a contaminated respirator Decontamination of filtering facepiece respirators Assessing modes of transmission Now- scientific focus.

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?

Long-Term Storage Results
Survival of MS2 deposited as droplet nuclei (♦) or droplets (□) on FFR coupons. Viable MS2 were enumerated after storage. 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 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

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

Effectiveness of Biological Decontamination Methods
Key findings from several studies include: 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) Project data supported the development of two test methods: ASTM E and E Bleach n = 3 LPF = low protection factor (organic load) HPF = high protection factor (organic load)

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

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

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 E and E Manufacturer acceptance & develop regulatory implementation plan

Recent Papers Viscusi et al. Effect of Decontamination on the Filtration Efficiency of Two FFR Models. J. Int. Soc. Resp. Prot., (2007) 24: Viscusi et al. Evaluation of the filtration performance of 21 N95 FFRs after prolonged storage. Am. J. Infect. Control, (2009) 37: Viscusi et al. Evaluation of Five Decontamination Methods for FFRs. Ann. Occup. Hyg., (2009) 53: Fisher et al. Development of a test system to evaluate procedures for decontamination of respirators containing viral droplets. Appl. Environ. Microbiol., (2009) 75: 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: 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), (2010). Bergman et al, Evaluation of Multiple (3-Cycle) Decontamination Processing for Filtering Facepiece Respirators, Journal of Engineered Fibers and Fabrics 5(4), (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), (2011). Fisher et al, “Evaluation of Microwave Steam Bags for the Decontamination of Filtering Facepiece Respirators”, PLoS ONE 6(4):e doi: /journal.pone (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), 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.

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)

CSE SR-100 Mine escape Respirator update Roland Berry Ann

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.

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

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

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 the sample size is 500 pieces, accept on 18 defects, reject on 19 defects. For LQ 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.

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

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

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

Surgical Masks and N95 Filtering Facepiece Respirators
Roland Berry Ann

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)

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

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

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

Conformity Assessment Maryann D’Alessandro

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 We chose some new items for reasons and some traditional items for other reasons. The first is an organizational decision, we have a complex organization and want to cover all of our activities. Secondly, we can get to some new things yet focus on old as well and demonstrate it through these reports. This can be broken into two, some of these are traditional or an ongoing part of the PPT Program. There are new activities in here as well. We are pushing the envelope here in that the PPT Program traditionally has emphasized respiratory protection. These are ambitious objectives, but we have made the decision that we believe we can show signifcant progress

High Priority Issues Selected for BSC Implementation Tracking
Oversee certification of all PPT, including an assessment of certification mechanisms NA Report Recommendation 1 PPT Program Activity: Technology Evaluation

Develop a conformity assessment framework
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)

Conformity Assessment Conduct assessment of various certification mechanisms and their potential applicability to non-respiratory PPT

Conformity Assessment Develop a conformity assessment framework

Conformity Assessment Complete either the development of a voluntary standard and/or establish an audit/oversight function based on developed framework

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?

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

Public Information Campaign Ed Fries

Public Information Campaign
SCSST FY11 Mid Year 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

Public Information Campaign Progress
SCSST FY11 Mid Year Public Information Campaign Progress

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

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)

216 Stakeholders participated in person in 2011
239 personnel were registered to attend in person on the day of the meeting in 2010 Several people cancelled at the last minute and there were 30 “No shows” along with 10 “Walk-ins” the final attendance was “216” in addition to ~ 64 NPPTL Staff. 79 people registered for live meeting and 5 were unable to attend at the last minute due to other commitments. Total external participation = ~ 280. 2010 participants – 137

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

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

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

74% of respondents prefer annual meeting
2011 PPT Stakeholders Meeting Desired Frequency of meeting by Survey Participants n=155 64% surveys returned 74% of respondents prefer annual meeting Majority of respondents would like to keep annual meetings. Some responded that they would like it more often and at varying locations if possible. Some thought it was better to have every other year. (It seemed somewhat repetitious and a rehash of old material. If new material wasn’t being presented then no need to have annually).

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

FY10 & FY11 PPT Stakeholders Meetings
The information for the 2011 meeting can be found at: The information for the 2010 meeting can be found at: Question to IOM: This method of disseminating meeting information was chosen to expedite availability of meeting content.

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

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 (?)

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?

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.

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.

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.

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

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

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.

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)

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

Construction The PPT Program is working with the NIOSH Construction Sector Management and CPWR to develop the Objectives for the Construction Sector

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

Development of Performance and Design Criteria for Isolation Gowns
Ron Shaffer

Development of Performance and Design Criteria for Isolation Gowns - FY12 (NPPTL001)
Applicable Standards OSHA 1991 ASTM F23 AAMI PB 70 AATCC Stakeholders Healthcare workers Infection control professionals Manufacturers SDO’s Objective To provide the basis for and recommend appropriate design and performance criteria for isolation gowns Key Partners ASTM F23 Committee Vestagen Technical Textiles Kimberly Clark UC Davis APIC The Joint Commission AORN AAMI 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 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. 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 Updated: 6 April 2011

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, January 2011

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

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

Proposed Method Investigate HCW needs to determine specific hazards
Identify current products in use or products that could be used Determine the specific properties that can be assessed Select the appropriate test methods Carry out the test plan and analyze the test results Evaluate “acceptable” and “unacceptable” products to aid in setting recommended requirements Prepare recommended design assessment and performance criteria Document study findings, publish and present

For additional information about the Isolation Gowns project please contact:
F. Selcen Kilinc, PhD NIOSH / NPPTL Pittsburgh, PA 15236 Phone:

Effectiveness Comparison of N95 Respirators and Surgical Masks Against Influenza: Respiratory Protection Effectiveness Clinical Trial (ResPECT) Ron Shaffer

Why Hospital Staff Catch the Flu: Assessing Modes of Transmission – FY12 (NPPTL004)
Objective 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 lab-confirmed influenza in healthcare workers in the Respiratory Protection Effectiveness Clinical Trial (ResPECT) study. Applicable Standards ASTM E2720 – 10 / E2721 – 10 NIOSH 42 CFR Part 84 ISO TC94/SC15 OSHA Key Partners Johns Hopkins University Veterans Administration Air Force Research Laboratory CDC/DHQP NIOSH (DSHEFS, HELD) Stakeholders Healthcare workers Hospital administrators Policy makers Project Scope 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) FY Manuscripts, presentations, etc. Outputs Manuscripts published in peer review journals Presentations at conferences Contractor reports TRB CAN FY12 NS NPPTL004 / Ron Shaffer 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 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) Updated: 6 April 2011

NPPTL HCW PPE Research Program Summary
Ensembles Research Surgical/isolation gowns Filtration Research Nanoparticles / Bioaerosols Respirator Fit Research Facial anthropometrics Frequency of fit testing Respirator fit test research (user seal check, novel methods, multiple donnings) Respirator Comfort Research Physiology studies Project BREATHE Commit to Worker Safety and Appropriate Use of PPE Demo and Sentinel Surveillance Public Health Practice studies Best practices, outreach Respirator Performance & Usability Research Performance against cough generated aerosols PPE combinations Respirator clinical effectiveness Influenza Pandemic Risks of handling a contaminated respirator Decontamination of filtering facepiece respirators Assessing modes of transmission Now- scientific focus.

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 H1N1 outbreak were controversial

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): 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.

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)

ResPECT Study – Pilot Phase
A pilot study was conducted at 4 locations in the Baltimore, MD area for 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

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)

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

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

Healthcare Respiratory Protection Program Toolkit
Ed Fries

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 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. Milestones Develop toolkit by 2Q FY12 Develop training guidelines by 4Q FY12 Pilot test by 2Q FY13 Outputs Presentations at conferences Standards committee/stakeholder presentations Published manuscript in peer-reviewed journal Toolkit resources posted to web Outcomes Results incorporated into healthcare respiratory protection programs SCSST FY12 NS NPPTL005 / Debbie Novak Updated: 11 Apr 11

Mobile Application Suite
Ed Fries

Mobile Application Suite FY 12 (NPPTL002)
SCSST FY11 Mid Year 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) NIOSH Mobile Apps Confidence, Reliability, and Recognition of NIOSH information, products, and services Agility and flexibility of information, products, and services for field operations and COOP Interact and communicate information collaboratively in real-time Ability to reach a large audience pool via Smart Phones Greater interoperability and support for Partners, Stakeholders, and Manufacturers NIOSH Business Intelligence, Metrics, Dashboard, and Logistics Support NIOSH Certification and Concurrence for products 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. 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. Outputs Electronic information products formatted as Mobile Apps in commonly-used platforms to augment products tailored for emerging Social Media SCSST New Start/ Perrotte / 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.) Updated: 11 Apr 11

Quality Partnerships Enhance Worker Safety & Health
Visit Us at: NPPTL Verified Photo Library: (L – R) A1-Draeger / A5-Inovel 3000 / A3-Gas Mask / A6-Mold 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

NPPTL and Personal Protective Technology Program Update

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