1 NPPTL and Personal Protective Technology Program Update IOM COPPE Meeting NPPTL In person Maryann...

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NPPTL and Personal Protective Technology Program Update

IOM COPPE MeetingNPPTL In person

Maryann D’AlessandroRoland Berry Ann

NPPTL Via envisionEd Fries, NPPTL SCSSTBill Newcomb, NPPTL PSDDebbie Novak, NPPTL SCSSTRay Roberge, NPPTL TRBRon Shaffer, NPPTL TRBAngie Shepherd, NPPTL TRBJon Szalajda, NPPTL PSD

December 1-2, 2011

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An estimated 20 million workers use PPE on a regular basis to protect themselves from job hazards.

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).

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Conformity Assessment

Maryann D’Alessandro

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

Progress

May 2011AIHce session

on CA

February 2011Initiate CA framework

development

May 2011 - Oct 2011Open Docket and analyze comments

October 2011 - October 2013Conduct WG activities

and continue stakeholder and public involvement

February 2011Meetings withISEA & NIST

October 2011Establish

working group(WG)

October 2013Publish Final Report on CA Framework

and Processes

August 2012Public Meeting I

May 2013Public Meeting II

February 2013Prepare

Draft Framework

December 2012WG Face-to-Face

Meeting

Dec 2011 - Jan 2012WG Face-to-Face

Meeting

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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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Impact• This effort will provide a framework for the national

strategy for nonrespiratory PPE conformity assessment

CONFORMITY ASSESSMENTFRAMEWORK

AND PROCESSES

(WORKING GROUP)

PROJECTDEFINITION

AND ORGANIZATION

(WORKING GROUP)

PRODUCTSAND

STANDARDS(SUB-GROUP)

LEVELS OF

RISK(SUB-GROUP)

SURVEILLANCE DATA

(SUB-GROUP)

PRIORITIZATION

(WORKING GROUP)

PROJECT MANAGEMENT(NIOSH/NPPTL CHAIR)

PPT CONFORMITY ASSESSMENT WORKING GROUPPROJECT ORGANIZATION and WORKFLOW

TERMINOLOGY(SUB-GROUP)

COMPLIANCE AND

ENFORCEMENT(SUB-GROUP)

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Future Plans

• Conduct two public meetings to discuss PPT conformity assessment

• Develop national PPE Conformity Assessment Framework and Strategy

May 2011AIHce session

on CA

February 2011Initiate CA framework

development

May 2011 - October 2011Open Docket and analyze comments

October 2011 - October 2013Conduct PCAWG activities

and continue stakeholder and public involvement

February 2011Meetings withISEA & NIST

October 2011Establish

working group(PCAWG)

October 2013Publish Final Report on CA Framework

and Strategy

August 2012Public Meeting I

May 2013Public Meeting II

February 2013Prepare

Draft Framework

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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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ANSI-accredited U.S. TECHNICAL ADVISORY GROUP

INTERNATIONAL ORGANIZATION FOR STANDARDIZATION ISO/TC94/SC15 – Personal safety – Protective clothing and equipment – Respiratory protective devices

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

1111



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 OutputsStandards

Normative

Technical SpecificationsNon-Normative

Technical ReportsNon-Normative

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TC94 / SC15 Respiratory Protective

Devices

WG1 General

WG2 Filtration Devices

WG3 Supplied Breathable Gas

Devices

PG1 Terms and Definitions

PG2 Selection, Uses and

Maintenance

PG3 Marking and Information

PG4 Test Methods

PG5 Human Factors

PG6 Classification

PG1 Filtration

PG3 Respirator Systems

PG1 Air Supply Chain

JPG2 Human Interfaces


Anthropometrics

Ergonomics

Physiology

JPG3

JPG3

Standard

TC94 / SC15 Respiratory Protective

Devices

WG1 General

WG2 Filtration Devices

WG3 Supplied Breathable Gas

Devices

PG1 Terms and Definitions

PG2 Selection, Uses and

Maintenance

PG3 Marking and Information

PG4 Test Methods

PG5 Human Factors

PG6 Classification

PG1 Filtration


PG1 Air Supply Chain

JPG2 Human Interfaces


Anthropometrics

Ergonomics

Physiology

JPG3

JPG3

Standard

GuideTechnical Specification

StandardsTechnical Specifications

Technical Report

Responsible for the RPD Standard for APR

Responsible for the atmosphere supplying RPD and the combination atmosphere supplying and APR Standard

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1515



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

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WG1 PG4 Test MethodsTimelines

DocumentISO 16900-1 Inward LeakageISO 16900-2 Resistance ← PublishedISO 16900-3 Particle filter effi ciencyISO 16900-4 Gas filter capacityISO 16900-5 Test equipmentISO 16900-6 Mechanical testsISO 16900-7 Practical performanceISO 16900-8 Air flow rateISO 16900-9 Carbon dioxideISO 16900-10 Flame and heatISO 16900-11 Field of visionISO 16900-12 Work of breathingISO 16900-13 Closed circuit gasesISO 16900-14 Leaktightness

2014

Published

2011 2012 2013

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WG1 PG5 Human FactorsTimelines

DocumentISO TS 16976-1 Metabolic rates ← PublishedISO TS 16976-2 Anthropometrics ← PublishedISO TS 16976-3 Oxygen and carbon dioxideISO TS 16976-4 Physiological limitsISO TS 16976-5 Thermal effectsISO TS 16976-x Ergonomics

2014

Published

2011 2012 2013

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WG1 PG6 Classification

•ISO TS 16973:201x Respiratory protective devices – Classification

•Ballot as a DTS just closed

2020

PL6

3 3

2 2

1 1

PL5

3 3

2 2 2

1 1 1

PL4 F4

3 180

2 60

1 1 20

PL3 F34 4

3 3

2 2

1 1 1

PL2 F2 SXXXX4

3 3

2 2

1 1 1

PL1 F1 SY4

3 3

2 2

1 1 1

Protection Level (PL)

Filtration 95

10000

Basic System Performance

Minimum Particle Filter

Efficiency [%]

Work rate

Work min vol [l/min] (Peak

flow)[l/min]

Mode of Operation

Filtration PerformanceBreathable Gas

Supply Performance

Maximal 135 (340)

Very heavy 65 (180)

As

sp

ec

ifie

d

Filters are additionally validated and classified by application work rate and are marked “w1”, “w2” “w3”

or "w4" accordingly.Undefined

specific substances

Hydrogen Fluoride

CO

CD

HF

2000

99

Cla

ssGas Filter Type C

lassSpecific Gas Filter Type

ETO

Formal-dehyde

AcidicChlorine Dioxide

MB

Organic Vapours

Hydrogen Cyanide

FM

Ozone

NOX

Nitrous oxides

OZ

HCNAC

Basic

Basic Characteristics

OG

Rest 10 (50)

30Moderate 35 (110)

250Heavy 50 (150)

10Light

20 (70)

4Breathable gas supply

Y = indication for air line devices

Nitrogen Dioxide

Arsine80

Extremely heavy

105 (270)

W4

W3

W2

W1

Chemical symbol

PhosphineMercury

Very, hery heavy

85 (225)

99.99Organic Gases

Methyl Bromide

Carbon Monoxide

HG PH

Ethylene Oxide

Respiratory Interface Class

Mouth only

Mouth and

nose

Face

Body

Head

Note: XXXX equals the amount of breathable gas available for respiration

in Litres based on a specific validation test,

rounded down to 10 litres up to 1000 litres and 100 liters above 1000 litres

Breathable gas volume in XXXX

litres

AH

Supplied Breathable Gas Capacity

OV

BC

ND

T

L

T

L

Type (tight) (loose)

a1

a2

b

c

Barrier lines

Nose only

e

L

T

T

L

T

L

T

L

d

SFTILPL

MAX

1*100*

1

2121

Note: Each special application may require minimum protection levels (PL n ) and application workrate (W n )

ES MN (t)

FF 4 ES MA (t)

FF 3 MN 3 ES CBRN (t)

FF 2 MA 2 MN 2 PW 2 ES FF (t)

FF 1 CBRN x MA 1 MN 1 AB 1 WE 1 PW 1 ES (t)

Mining Escape

Marine Escape

CBRN Escape

Escape from fire

Structural Firefighting

Underground Mining

Explosive

Lower than atmospheric

Mining Fire Fighting

CBRNHazardous Materials

Higher than atmospheric

WeldingAbrasive Blasting

Underground Mining Non- Explosive

Special Application Performance Requirements

Abrasive Blasting

WEFF Fire Fighting

Special Applications

Marine (Shipboard and

Offshore)MN Mining ABMA

Escape [nominal service life

in "t" minutes]ESPW

Abnormal Pressure Work Environment

Welding

Chemical Biological

Radiological Nuclear

Escape General Filtering or Supplied

Breathable Gas

CBRN

Rescue

Hazardous Materials

Marine Fire Fighting

Note: for CBRN several levels will be defined by PG3

Wildland Firefighting

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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

2323



WG2 PG3 RPD Systems

•ISO 17420-2:201x Respiratory protective devices – Performance requirement – Part 2 - Filtration devices

•New Work Item approved

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WG2 PG3 RPD Systems

•ISO 17420-3:201x 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, RNCDC/NIOSH

Mary J. Ogg, MSN, RN, CNORPerioperative 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

NPPTL Year Month Day Initials BRANCH

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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

Clinical Example


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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:

1. There was a statistically significant increase in the use of wall suction for all surgical procedures.

2. The use of smoke evacuators has not changed significantly since the 2007 survey.

Edwards & Reiman – 2007, 2010


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Secondary Control Measures

The AORN survey also showed that:

1.The use of high filtration (laser) masks has increased for nearly all procedures.

2.The use of NIOSH - approved respirators has not changed significantly since the 2007 survey.

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


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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 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


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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 Development

NFPA 1999: Standard on Protective Clothing for Emergency Medical

Operations, 2008 Edition

Angie Shepherd

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Research - Background

NFPA 1999, Standard on Protective Clothing for Emergency Medical Operations, 2003 Edition Minimum requirements of protective clothing for emergency patient

care and transportation prior to arrival at hospital or health care facility

17,000 transporting ambulance services

26,000 fire departments

52,000 ambulances

600,000 EMTs

142,000 paramedics

1,009,000 firefighters NFPA’s five year revision cycle resultedin 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 don’t distinguish single use/reusable products consistent with field requirements

Eye and face protection

Criteria do not match user needs or address all product types used by EMS providers

Respiratory protection

No current requirements requested by NPPTL

Head protection

No current requirements requested by peer review

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Research - Project Objective

To provide the basis for and recommend appropriate design and performance criteria for “cleaning” gloves, single-use protective garments, eye/face protection devices and head protection devices for emergency medical operations

To recommend appropriate flammability and visibility criteria

To recommend appropriate respiratory protection for CBRN emergency medical operations ensemble

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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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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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IOM COPPE MeetingNovember 10, 2009

Wildland Firefighter Respirator StandardRecent Successes

Roland Berry Ann

Courtesy C. Austin Courtesy C. Austin & SOPFEU

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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 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

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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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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

Thank you

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.

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