NPPTL and Personal Protective Technology Program Update IOM COPPE Meeting NPPTL In person Maryann D’Alessandro Roland

NPPTL and Personal Protective Technology Program Update IOM COPPE Meeting NPPTL In person Maryann D’Alessandro 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

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.

Standing Committee on Personal Protective Equipment for Workplace Safety and Health December 1-2, 2011Thursday, December 1st (Agenda) 8:00 – 8:30 a.m. Continental Breakfast (Room 204) 8:30 – 8:45 a.m. Welcome and Introductions Linda Hawes Clever, Chair 8:45 – 8:50 amMeeting Objectives Maryann D’Alessandro,NPPTL 8:50 – 9:30 a.m. Discussion with John Howard, Director, NIOSH 9:30 – 10:30 a.m. Update and Discussion – Occupational Information and Electronic Health Records Overview of the IOM recommendations – SundaresanJayaraman Update from NIOSH – Eileen Storey, NIOSH (via video conference) Discussion - PPE information in EHR 10:30 – 10:45 a.m. Break

Standing Committee on Personal Protective Equipment for Workplace Safety and Health December 1-2, 2011Thursday, December 1st (Agenda) Continued 10:45 – 12:00 p.m. Conformity Assessment Update on PPT Conformity Assessment Activities Maryann D’Alessandro, NPPTL International PPT Experiences – Lessons Learned Bob Weber, 3M (invited) User Perspective Paul Smith, Raytheon (invited) COPPE input to the PPT Conformity Assessment Working Group Activities and Plans 12:00 – 12:45 p.m. Lunch – Keck Atrium 12:45 – 1:45 p.m. ISO Respirator Standards (Recent successes) Bill Newcomb, NPPTL (via video conference) Bob Weber, 3M Jim Johnson, How does ANSI envision the ISO standards moving forward in the U.S.?

Standing Committee on Personal Protective Equipment for Workplace Safety and Health December 1-2, 2011Thursday, December 1st (Agenda) Continued 1:45 – 2:45 p.m. Association of periOperative Registered Nurses (AORN) Recommended practices for laser safety in perioperative practice settings. 2011 Perioperative standards and recommended practices. 2011;125-142. Recent successes Debbie Novak, NPPTL Mary Ogg, AORN Wava Truscott, Kimberly Clark Challenges and next steps: Informing workers/consumers about the standards 2:45 – 3:00 Break

Standing Committee on Personal Protective Equipment for Workplace Safety and Health December 1-2, 2011Thursday, December 1st (Agenda) Continued 3:00 – 4:00 NFPA 1999 Standard on Protective Clothing for Emergency Medical Operations, 2008 edition. Recent successes Michael Aries, IAFF (invited) Angie Shepherd, NPPTL (via video conference) Challenges and next steps: Incentivizing manufacturers to meet the standards Informing workers/consumers about the standards 4:00 – 5:00 WildlandFirefighter Respirator Standard Recent successes Roland Berry Ann, NPPTL Dave Haston, USDA Forest Service (invited) Challenges and next steps: Incentivizing manufacturers to meet the standards Informing workers/consumers about the standards

Conformity AssessmentMaryann D’Alessandro

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

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)?

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

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

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?

ISO TC94 SC15 Update William E. Newcomb

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

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

ISO Outputs Standards Normative Technical Specifications Non-Normative Technical Reports Non-Normative

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

WG1 PG1 Terms and Definitions ISO 16972:2010 Respiratory protective devices - Terms, definitions, graphical symbols and units of measure Published

WG1 PG2 Selection Use and Maintenance ISO 16975-1:201x Respiratory protective devices – Selection and use – Part 1 Cancelled by ISO, but being prepared for a 2nd NWIP ISO 16975-2:201x Respiratory protective devices – Guide for Selection and use – Part 2 Being prepared for a CD

WG1 PG3 Marking and Information ISO TS 16974:2011 Respiratory protective devices – Marking and information provided by the manufacturer Published

WG1 PG4 Test Methods Timelines

WG1 PG5 Human Factors Timelines

WG1 PG6 Classification ISO TS 16973:201x Respiratory protective devices – Classification Ballot as a DTS just closed

WG3 PG3 RPD Systems ISO 17420-1:201x Respiratory protective devices – Performance requirement – Part 1 - Breathable gas devices and combination filtering and breathable gas devices New Work Item approved

WG2 PG3 RPD Systems ISO 17420-2:201x Respiratory protective devices – Performance requirement – Part 2 - Filtration devices New Work Item approved

WG2 PG3 RPD Systems ISO 17420-3:201x Respiratory protective devices - Performance requirement – Part 3 - Thread connection DIS approved

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

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

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

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?

Standing Committee on Personal Protective Equipment for Workplace Safety and Health December 1-2, 2011Thursday, December 1st (Agenda) Continued 1:45 – 2:45 p.m. Association of periOperative Registered Nurses (AORN) Recommended practices for laser safety in perioperative practice settings. 2011 Perioperative standards and recommended practices. 2011;125-142. Recent successes Debbie Novak, NPPTL Mary Ogg, AORN Wava Truscott, Kimberly Clark Challenges and next steps: Informing workers/consumers about the standards 2:45 – 3:00 Break

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

Clinical Example Mon 11/21/2011 10:38 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

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.

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)

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)

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

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.

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 wearer’s 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

Common Pathogen Particle Sizes and Associated Type of Protective Facemasks

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

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?

Research to Consensus Standards DevelopmentNFPA 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 resulted in a 2008 Edition of NFPA 1999

Research – Background, 2003 Edition Cleaning gloves Certain criteria mutually exclusive, preventing certification Single use garments Physical property criteria don’t distinguish single use/reusable products consistent with field requirements Eye and face protection Criteria do not match user needs or address all product types used by EMS providers Respiratory protection No current requirements  requested by NPPTL Head protection No current requirements  requested by peer review

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

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 Dissemination

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 Project Evaluation

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 Measuring Project Success

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

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?

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

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

Background for Wildland Respirator Standard Development Sacramento Metro FD firefighter’s 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

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 concentrationsin an outdoor environment ventilation dependent on wind speed and direction Low concentration exposures under Ideal conditions Short term high exposures due to changing conditions

WildlandFirefighter 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

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

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

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

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

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?

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

NPPTL and Personal Protective Technology Program Update IOM COPPE Meeting NPPTL In person Maryann D’Alessandro Roland