Respiratory Protective Equipment (RPE) Performance Requirements

Transcription

1 Respiratory Protective Equipment (RPE) Performance Requirements Respiratory protective equipment approved to the United States NIOSH standards is acceptable in every jurisdiction Some allow RPE with other approvals such as European Norms if equivalent, or in the absence of NIOSH standards covering the requirement So there is no Canadian Approval for RPE performance Health Canada (federal) approves certain types of equipment for medical use, but for personal respiratory protective equipment, their approval is only verification of vendor practices such as record-keeping and alerting users of recalls it is not a product certification WRONG! Simon s HandyMask TM is Canadian Government Approved as a N95 Respirator

2 Current Canadian Standards related to Respiratory Protection Title CSA Z94.4 CSA Z180.1 CSA/CGSB Z1610 CSA Z1640 SelectionUse and Care of Respirators Compressed Breathing Air and Systems Protection of first responders from chemical, biological, radiological, and nuclear (CBRN) events Emergency Target Community GeneralWorkforce General Workforce Responders and medical staff LatestIssue Date Under Revision? Yes Yes Revison Starting 2017 Personal Protective Equipment for Investigating and Dismantling Clandestine Drug Laboratories LawEnforcement. Firefighters. Municipal Workers and Contractors In Preparation target issue 2017

3 CSA Z94.4: Selection, Use and Care of Respirators Created 1982, updates 1993, 2002, 2011 Provides guidance in parallel with information in OSHA New in 2011: Matches Assigned Protection Factors to OSHA Enhances section on training to address qualification of trainers Addresses protection from biohazards outside CBRN (warfare agents Chemical-Biological-Radiological-Nuclear) For CBRN - standard CSA Z covers these Special Feature: Guidance on respirator selection for bioaerosols using control banding

4 CSA Z94.4: Selection, Use and Care of Respirators Main Content Respiratory protection programmes Roles and responsibilities Hazard assessment Respirator selection (flowchart) Training Respirator fit testing Use of respirators Cleaning, inspection, maintenance, and storage Health surveillance Programme evaluation Recordkeeping Informational Annexes User seal checks, Qualitative respirator fit tests (QLFT). Quantitative respirator fit tests (QNFT) Use of SCBA in low-temperature environments Health surveillance Procedures for cleaning and sanitizing respirators Respirator classification, characteristics, and limitations Reduced oxygen concentration Buddy breathing Checklist of competency for respirator fit testers Scenarios using bioaerosol selection wheels, classification of biohazardous agents by risk group Illustrations of acceptable and unacceptable facial hair for tight-fitting respirators 99 Additional guidance for qualified persons on respirator selection in health care

5 Respirator Selection for Bioaerosols There are well-established accepted methods for respirator selection for materials with exposure limits Hazard assessment necessary elements are defined in the standard A flow chart directs selection of appropriate RPE based on conditions and nature of exposure But no selection process for hazards without defined exposure limits CSA Z introduces respirator selection guidance for biological aerosols based on control banding

6 Possible Approaches for RPE Selection for Biohazards Method Advantages Disadvantages Guidelines Expert Opinion Quantitative Modelling (e.g. ANSI Z88.12) Control Banding Often authoritative sources Well recognised Supports wide range of scenarios Accuracy Relatively simple Covers range of scenarios May cover specific circumstances but also leaves gaps Sources guidance may be inconsistent with each other Sometimes inconsistent with occupational hygiene principles Needs numeric data as inputs which may be hard to obtain Acceptable Probability of Infection? Relies on qualitative assessment of some inputs May lead to over-simplification or wrong assumptions by users

7 Approach for Biohazard RPE Selection Proposed for CSA Z Process fits under a respiratory protection programme (and an infection control programme if applicable) Hazard Assessment is by a qualified person: Assess all possible hazards such as: Oxygen deficiency Chemical hazards Factors driving other PPE requirements In the absence of other guidance use Control Banding Incorporates Public Health Agency of Canada Guidelines identify: Known infectious micro-organisms Likelihood of biohazard exposure due to environment and procedures Likelihood of infection Then proceed with Control Banding approach

8 Respirator Selection for Bioaerosols Semi-quantitative assessment of factors Two Workplace Categories Healthcare indoor, with characterized ventilation General Workplace indoor and outdoor, less controlled ventilation Risk Group from Guidance sources Four bands Generation Rate Four bands Control (Ventilation) Four bands Output a Protection Level (0-5) with corresponding Assigned Protection Factor

9 Classification of Biohazards by Risk Group Risk Group Risk Group 1 (R1) Risk Group 2 (R2) Risk Group 3 (R3) Risk Group 4 (R4) Health impacts (transmissibility, infectivity and adverse health effects of the biohazard) Agents that are not associated with disease or serious adverse health effects in healthy adult humans Agents that are associated with human disease or adverse health effect which is rarely serious and for which preventive or therapeutic interventions are often available Agents that are associated with serious or lethal human disease or adverse health effect for which preventive or therapeutic interventions may be available (high individual risk but low community risk) Agents that are likely to cause serious or lethal human disease or adverse health effect for which preventive or therapeutic interventions are not usually available (high individual risk and high community risk) Classifications correspond with the US National Institutes of Health Guidelines for Research Involving Recombinant DNA Molecules (March 2013)

10 Generation and Control Inputs Generation Inputs Rank Healthcare G1 G2 G3 G4 Qualitative Example Patient not coughing or sneezing Patient coughing or sneezing with mouth covered Patient coughing or sneezing with mouth uncovered Aerosol generating procedure General Workplace G1 G2 G3 G4 Low - Vacuuming with a HEPA filter Medium - Soaking then shovelling pigeon droppings High Misting then shovelling pigeon droppings Very High Dry Sweeping pigeon droppings Control Inputs (Ventilation) Level ACH Qualitative Example Healthcare C1 <3 Storage Area C2 3-6 Patient Room/Corridor C Autopsy C Surgery General Workplace C1 <1 Indoor/Poor Ventilation C2 1-4 Indoor Natural Ventilation C3 4-6 Indoor Mechanical Ventilation/Outdoor low wind C4 >6 Outdoor moderate wind

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12 CSA Z Hierarchy of Respiratory Protection

13 CSA Z180.1 Compressed Breathing Air and Systems Requirements for the purity of compressed air and the equipment which provides it Currently being updated, with focus on Ambient Air Systems De-Fragmentation Protection Storage vessel and cylinder requirements and inspection procedures Air purity with respect to: Oil & Particulates Hydrocarbon content and related analytical methods Unknown un-halogenated hydrocarbons High Pressure Systems Air Intakes Sample Collection

14 Z Protection of first responders from chemical, biological, radiological, and nuclear (CBRN) events Covers combined respiratory and dermal personal protective equipment (PPE) performance and usage requirements for CBRN Responders Created through work by a CSA Committee Relevant stakeholders including manufacturers, researchers, regulators and high proportion of first responder users World-class expertise in protective equipment development and evaluation for CBRN agents Supports needs of all levels of government, industry and first responders directly Intended to accelerate implementation of technologies Z1610 covers Multiple equipment types Classification Selection Use Performance Requirements Lab Testing Practical performance

15 CSA Z Unique Features Among the small list of world-wide CBRN PPE standards, CSA Z stands out in that it: Addresses the complete protective ensemble, not respiratory and body protection separately Contains substantial information on CBRN events and responder roles in these Classifies PPE in terms of protection and provides guidance selection and use Provides detailed descriptions of practical performance tests While accommodating an existing standard for RPE (NIOSH), it sets unique broad performance requirements for filter performance that if met allow filter use in certain conditions hitherto classed as immediately dangerous to life and health

16 CSA Z1640: Personal Protective Equipment for Investigating and Dismantling Clandestine Drug Laboratories In preparation, expected issue 2017 A world-first! Primary target users are law enforcement and fire services, municipal employees and contractors Uses a risk assessment approach in providing recommendations for whole-body protection (respiratory, ocular, and dermal)

17 CSA Z Scope In Scope PPE selection by first responder organizations and other agencies with responsibility for, or involvement in Investigation, Dismantling Of: Clandestine Synthetic Drug Laboratories (CDLs) and Marihuana Grow Operations (MGOs) Integration with other PPE / equipment and provides guidance on the capabilities and limitations of PPE used in CDLs and MGOs. Out of Scope Operational or tactical procedures for responding to a CDL or MGO, except where they have a direct impact on the selection of PPE. Sampling procedures or analytical methods for illicit drugs / chemicals Remediation phase of a CDL or MGO, However the guidance provided in this standard can be used by agencies involved in remediation activities Does not supersede legislation from the jurisdiction having authority

18 Concept and Current Status Text of standard is close to finalization Software for selection guidance for PPE is in preparation Aim: Guidance of use for PPE selection in preparation for deployment and on-scene for intervention in clandestine drug operations supported by data and logical decision protocol Intended for laptop and mobile device application readily suitable for field use, capable of rapid updates as new hazards emerge For drug and intervention scenarios, will provide information on Best proposal for respiratory and dermal protection Less suitable but still protective equipment which may be chosen for limited use Unacceptable systems Applicable for deployment planning and equipment sourcing purposes

19 Input Form on Paper, Tablet or Laptop Data input interface for use by first responders Accommodates entry of known factors and suspected hazards Based on Hazard assessment and recognition plan used by police forces Uses knowledge of applicable synthesis methods to derive anticipated respiratory, dermal, flammable, corrosive and other hazards

20 Example of Possible Output Level Dermal Respiratory A NFPA Flash Fire Option CBRN SCBA A NFPA 1991 CBRN SCBA A NFPA Flash Fire Option Industrial SCBA+Level A suit A NFPA 1991 Industrial SCBA+Level A suit B NFPA Flash Fire Option CBRN SCBA Z1610 S B NFPA 1992 CBRN SCBA Z1610 S B Z1610 C2 CBRN SCBA Z1610 S B NFPA 1994 Class 2 CBRN SCBA Z1610 S B NFPA 1992 Industrial SCBA B EPA Level B Industrial SCBA C NFPA 1992 ± Flash Fire TF PAPR+CBRN/MG filter C NFPA 1994 Class 2 TF PAPR+CBRN/MG filter C NFPA 1994 Class 3 TF PAPR+CBRN/MG filter C EPA Level B TF PAPR+CBRN/MG filter C NFPA 1992 ± Flash Fire LF PAPR+CBRN/MG filter C NFPA 1994 Class 2 LF PAPR+CBRN/MG filter C NFPA 1994 Class 3 LF PAPR+CBRN/MG filter C EPA Level B LF PAPR+CBRN/MG filter C NFPA 1992 ± Flash Fire FF APR+CBRN/MG filter C NFPA 1994 Class 2 FF APR+CBRN/MG filter C NFPA 1994 Class 3 FF APR+CBRN/MG filter C EPA Level B FF APR+CBRN/MG filter C NFPA 1992 ± Flash Fire HM APR+MG filter + Eye Protection C NFPA 1994 Class 2 HM APR+MG filter + Eye Protection C NFPA 1994 Class 3 HM APR+MG filter + Eye Protection C EPA Level B HM APR+MG filter + Eye Protection C Particulate Protective Coveralls TF PAPR+HE filter C Particulate Protective Coveralls LF PAPR+HE filter C Particulate Protective Coveralls FF APR+P100 filter C Particulate Protective Coveralls FFP N95 D Standard Workplace-Type Protection No Requirement Respiratory Protection Dermal Protection Duration of Use Task Impedance Overprotection with impeding factors identified Optimum protection range Unacceptable underprotection Noise

21 Thank you! For more information: Simon J. Smith 3M Canada Company 1360 California Avenue, Brockville, Ontario K6V 5V8 CANADA