NPPTL and Personal Protective Technology Program Update

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NPPTL and Personal Protective Technology Program
Update IOM COPPE Meeting NPPTL In
person Maryann DAlessandro Roland Berry
Ann NPPTL Via envision Ed Fries, NPPTL
SCSST Bill Newcomb, NPPTL PSD Debbie Novak,
NPPTL SCSST Ray Roberge, NPPTL TRB Ron Shaffer,
NPPTL TRB Angie Shepherd, NPPTL TRB Jon
Szalajda, NPPTL PSD
December 1-2, 2011
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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.

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Conformity AssessmentMaryann DAlessandro
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Oversee certification of all PPT, including an
assessment of certification mechanismsProgress
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Conformity Assessment Strategy focused around
five central questions

• What is the basis for establishing a national
  framework to address the conformity assessment of
  non-respiratory PPE? What approach will best
  balance the private and public sector interests
  in protecting the health and safety of the
  American worker?
• What implementation mechanisms and authorities
  must be used, enhanced, or developed to ensure
  effective national conformity assessment
  implementation, coordination, and compliance?
• What level of conformity assessment is necessary
  under various circumstances?
• Using a cost/benefit approach, what will the
  marketplace, particularly PPE purchasers and end
  users, be realistically willing and able to
  support?
• What complementary activities could be undertaken
  to support the intended objectives (e.g. claims
  management, product labeling, global
  interoperability, field failure reporting,
  web-based communications, etc)?

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Oversee certification of all PPT, including an
assessment of certification mechanismsImpact

• This effort will provide a framework for the
  national strategy for nonrespiratory PPE
  conformity assessment

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Oversee certification of all PPT, including an
assessment of certification mechanismsFuture
Plans

• Conduct two public meetings to discuss PPT
  conformity assessment
• Develop national PPE Conformity Assessment
  Framework and Strategy

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Conformity Assessment questions the PPT Program
would like the IOM COPPE to consider

• Do the five central questions described in the
  PPT CA Strategy document provide sufficient
  context to develop a PPT CA Framework?
• Are there additional tasks that should be
  incorporated in the strategy document?
• What additional content should be incorporated in
  the strategy document?

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ISO TC94 SC15 Update William E. Newcomb
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• TC94 SC15 Background
• Established 2001
• 21 Voting Member Countries
• 6 Observing Member Countries
• First meeting in March 2002
• Over 400 meeting days involving over 15 man-years
  of effort to date

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• TC94 SC15 Background
• Resolutions
• to write the requirements for complete devices
  with one exception
• to write the standards around the needs of the
  users not around products

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ISO Outputs Standards Normative Technical
Specifications Non-Normative Technical
Reports Non-Normative
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Responsible for the RPD Standard for APR
Standard
Standard
Guide
Technical Specification
Standards
Responsible for the atmosphere supplying RPD and
the combination atmosphere supplying and APR
Standard
Technical Specifications
Technical Report
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• WG1 PG1 Terms and Definitions
• ISO 169722010 Respiratory protective devices -
  Terms, definitions, graphical symbols and units
  of measure
• Published

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• WG1 PG2 Selection Use and Maintenance
• ISO 16975-1201x Respiratory protective devices
  Selection and use Part 1
• Cancelled by ISO, but being prepared for a 2nd
  NWIP
• ISO 16975-2201x Respiratory protective devices
  Guide for Selection and use Part 2
• Being prepared for a CD

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• WG1 PG3 Marking and Information
• ISO TS 169742011 Respiratory protective devices
  Marking and information provided by the
  manufacturer
• Published

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• WG1 PG4 Test Methods
• Timelines

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• WG1 PG5 Human Factors
• Timelines

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• WG1 PG6 Classification
• ISO TS 16973201x Respiratory protective devices
  Classification
• Ballot as a DTS just closed

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• WG3 PG3 RPD Systems
• ISO 17420-1201x Respiratory protective devices
  Performance requirement Part 1 - Breathable gas
  devices and combination filtering and breathable
  gas devices
• New Work Item approved

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• WG2 PG3 RPD Systems
• ISO 17420-2201x Respiratory protective devices
  Performance requirement Part 2 - Filtration
  devices
• New Work Item approved

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• WG2 PG3 RPD Systems
• ISO 17420-3201x Respiratory protective devices -
  Performance requirement Part 3 - Thread
  connection
• DIS approved

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• What is not in ISO 17420-1 2
• Requirements for individual components with the
  exception of specific APR using a standard
  connector
• Certification requirements
• Quality assurance requirements
• Requirements that are covered by Local or
  National regulations, e.g. definition of oxygen
  deficiency, assigned protection factors

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• Timelines
• The International Standards for RPD, ISO 17420-1
  2, are expected to be published between 2013
  and 2015

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• NIOSH Plans to Adopt ISO Requirements
• Create a plan to adopt applicable portions of
  the ISO standards through rulemaking
• Include applicable performance requirements from
  finalized ISO standards in the technical module
  updates included on the regulatory agenda
• Build the infrastructure necessary to carry out
  testing
• Obtain ISO 17025 and ISO Guide 65 laboratory
  certification
• Explore feasibility and benefit of entering into
  a MOU with a European Notified Body

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Discussion on challenges and next steps

• What are some of the barriers to be overcome in
  the development of the respiratory protection
  standard?
• How does ANSI envision the selection and use
  standard to be adopted by the U.S?
• How should users be educated on each of the
  product standards prior to the respiratory
  protection standard being completed and upon its
  completion?
• How is the transition to the new standard
  envisioned with the introduction and availability
  of product meeting the new standards on the
  market?
• In this age of streamlined regulations, what is
  the necessity and benefit of the approach
  introduced by the ISO standards?
• How are the ISO standards expected to improve
  worker protection?
• How can we train people to understand the complex
  requirements introduced in the ISO standards?

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Perioperative Laser Safety Recommended Practices
Debra A. Novak, DSN, RN CDC/NIOSH Mary J.
Ogg, MSN, RN, CNOR Perioperative Nursing
Specialist Nursing Department
Association of periOperative Registered
Nurses Denver, CO
Wava Truscott, PhD Director Scientific Affairs
and Clinical Education
Kimberly-Clark Health Care Roswell,
Georgia
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Clinical Example

• Mon 11/21/2011 1038 AM
• I have a case in about 30 minutes and have staff
  requesting information regarding laser masks and
  the TB N95 mask. 
• Could you tell me what is recommended with laser
  evaporation of condyloma (HPV)? 
• The TB (N95) masks are specially fit and tested
  for air leaks. 
• The laser masks have higher filtration and are a
  routine fit.
• RN, Clinical Coordinator
• Flint, MI

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OR Smoke Plume- - Setting the Stage - -

• Over 500,000 workers are exposed to surgical
  smoke every year.
• Over 3 decades of studies document that surgical
  plume contains hazardous substances.
• Smoke plume exposures have been linked to adverse
  health symptoms and effects.

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Smoke Plume Evidence

• Surgical smoke is made up of 95 water however
  the remaining 5 contains potentially hazardous
  inspirable particles.(Wentzell)
• Blood fragments
• Bacteria
• Lung damaging dust
• Intact and viable Human papilloma virus (HPV) and
  Human immunodeficiency virus (HIV) have been
  shown to be present in smoke plume. (Sawchuk,
  Alp)

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Smoke Plume Evidence

• Without controls, OR baseline concentrations
  increased from 60,000 to over 1 million
  particles/ft3 within 5 min of electrocautery
  during breast reduction. It took 20 min for
  concentrations to return to baseline. (Brandon
  Young)
• Burning 1 gram of tissue releases the same
  mutagenic contaminants as 3-6 cigarettes.(Tomita,
  Shaf)
• Small particles less than 1.1 micron constitute
  77 of electrocautery particulate matter with a
  mean size of 0.07 microns. (Kunachak,
  Bruske-Hohlfeld)

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Are Recommended Practices Being Followed?

• In a Sept Nov 2010 on-line follow-up to a 2007
  survey of 1356 AORN members, major findings were
• There was a statistically significant increase in
  the use of wall suction for all surgical
  procedures.
• The use of smoke evacuators has not changed
  significantly since the 2007 survey.

Edwards Reiman 2007, 2010
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• Secondary Control Measures

• Surgical masks
• Laser (high filtration) masks
• NIOSH-approved N95 respirators

• The AORN survey also showed that
• The use of high filtration (laser) masks has
  increased for nearly all procedures.
• The use of NIOSH - approved respirators has not
  changed significantly since the 2007 survey.

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Most importantly..

• The filtration performance of surgical masks for
  capturing particles varies widely.
• None of 9 surgical masks tested with particles
  the size of viruses and bacteria provided the
  minimum level of protection recommended by
  OSHA.(Lee)
• Filtration performance of surgical masks varies
  widely. (Oberg, Rengasamy)
• Surgical and laser masks do not seal to the face
  and allow airborne contaminants to enter the
  wearers breathing zone.
• Surgical masks act as a barrier to direct sprays
  but they do not reduce exposure from surgical
  smoke plume as well as respirators.
• Evidence Oberg and Brosseau 2008 Rengasamy,
  Miller, Eimer and Shaffer 2009

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Common Pathogen Particle Sizes and Associated
Type of Protective Facemasks
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NIOSH Research Efforts

• DSHEFS - National Exposures at Work Survey (NEWS)
  Survey conducted in March 2011 Data analysis in
  progress
• NPPTL - Filtration Efficiency of Surgical Laser
  Mask Study- Completed in 2011 - Showed that
  marketing of laser masks provides a false sense
  of security
• HELD and NPPTL - Residual Air Quality Study-
  Study to look at residual air quality in an OR in
  a high plume case. Intent is to submit
  intramural NORA proposal for 2013 funding

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Questions the PPT Program would like the IOM
COPPE to consider

• 1. How could we best achieve educational outreach
  to wearers?
• 2. How could we best achieve collaborative
  endeavors with laser mask manufacturers to relay
  accurate marketing information?
• 3. How can we best partner with healthcare
  regulatory and accrediting agencies to update
  surveyors knowledge of the issue and recommended
  practices?
• 4. For ambulatory surgical settings, outside of
  the hospital setting, how could we best achieve
  educational outreach of recommended practices for
  smoke plume, laser surgery electrosurgery?

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Research to Consensus Standards
DevelopmentNFPA 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
• NFPAs five year revision cycle resulted
• in a 2008 Edition of NFPA 1999

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Research Background, 2003 Edition

• Cleaning gloves
• Certain criteria mutually exclusive, preventing
  certification
• Single use garments
• Physical property criteria dont 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

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Dissemination

• Presentations
• NFPA Technical Committee throughout the project
• IAFF Redmond Symposium
• TSWG PPE Conference
• NPPTL Stakeholders Meeting
• Participation at Trade Shows
• Public Proposals and Public Comments within the
  NFPA revision process
• R2P Handout
• Featured in NIOSH Science Blog
• Project Final Report available

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Project 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 and state grant money

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Measuring Project Success

• Results of effort incorporated into NFPA 1999,
  2008 Edition
• Increased the 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 isolation gowns
• Project approach for affecting standards
  development can be applied in other projects
  -e.g., similar approach can be applied for
  ensembles for Mine Rescue Teams

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Challenges and Next Steps

• User understanding and training on hazards
• Volume of business for manufacturers
• Knowledge of federal and state grant programs
  (FEMA, DHS, and Federal Fire Act Grant) for
  NFPA 1999 Certified gear
• Comfort and ease of use for products
• Economic concerns for departments
• NIOSH resources for education and awareness

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Questions the PPT Program would like the IOM
COPPE to consider

• What role does the PPT Program have in
  incentivizing manufacturers to meet the standards
  and informing workers/consumers about the
  standards?

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Wildland Firefighter Respirator Standard Recent
Successes
Courtesy C. Austin
Courtesy C. Austin SOPFEU
IOM COPPE Meeting November 10, 2009
Roland Berry Ann
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Research Background

• 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

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Background for Wildland Respirator Standard
Development

• Sacramento Metro FD firefighters personal
  request for standard
• NFPA Standards Council considers hazards and
  risks
• Feb 2007 - 2 letters from NIOSH identify science
  and supporting considerations
• Wildland firefighters experience acute
  respiratory effects, including respiratory
  symptoms and decrements in pulmonary function
• Intermittent, infrequent, short term exposures
• Wide range of facemasks marketed without an
  appropriate standard

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Wildland Firefighter Exposures

• Airborne toxins from smoke particulates and fire
  gases
• carbon dioxide benzene
• carbon monoxide aldehydes (e.g. formaldehyde,
• nitrogen oxides acrolein)
• sulfur dioxide free radicals
• respirable particulate matter
• Fluctuating concentrations in an outdoor
  environment
• ventilation dependent on wind speed and direction
• Low concentration exposures under Ideal
  conditions
• Short term high exposures due to changing
  conditions

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Wildland Firefighter Respiratory Protection

• Currently Used Devices
• Devices not approved by NIOSH
• NIOSH-approved filtering facepiece
• respirators
• No protection
• Inadequate or no protection against encountered
  health risks
• Multi-gas and particulate protection needed

Courtesy L. Naeher
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NIOSH Contributions to Standards Successful
Development

• National Fire Protection Association (NFPA)
• NIOSH NPPTL participation on Technical Committee
  on Respiratory Protection Equipment
• Exposure scenarios included science from 2 NIOSH
  divisions
• Tiered approach to use NIOSH approved respirator
  platform as basis for NFPA certified wildland
  respirator.
• Developed requirements for NIOSH approved air
  purifying respirator (powered and non-powered)
• NFPA 1984 Standard on Respirators for Wildland
  Fire Fighting Operations
• Current Edition 2011 Next Edition 2016

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• Standards Development Success
• 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

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Challenges and Next StepsUsers/Workers/Consumers

• Perception of need
• Recognize need for protection
• Recognize inadequacy of current devices
• Employment of other mitigation techniques
• Varying fire management strategies
• Availability of conforming product
• Consumer demand for compliant product
• Regulatory justification for compliant product
• Feasibility of product use in fire scenarios

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Challenges and Next StepsManufacturers

• Incentivizing compliant products
• Removal of inadequate product
• New product development
• Conformity declaration
• Assessment of market demand for protection
• User perception of need
• Other controls for mitigation

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Questions the PPT Program would like the IOM
COPPE to consider

• What role does the PPT Program have in
  incentivizing manufacturers to meet the standards
  and informing workers/consumers about the
  standards?

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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