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Jay L. Tarley

NIOSH/NPPTL’s Post-Market Activities: Certified Product Investigation Process (CPIP) and the Importance of Evidence Collection. Jay L. Tarley. Post Approval Activities. Steps that continue after respirator is granted NIOSH Approval.

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Jay L. Tarley

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  1. NIOSH/NPPTL’s Post-Market Activities: Certified Product Investigation Process (CPIP) and the Importance of Evidence Collection Jay L. Tarley

  2. Post Approval Activities • Steps that continue after respirator is granted NIOSH Approval. • Ensure that respirator continues to be produced according to NIOSH criteria. • Post Certification activities include: • Product Audits • Site Audits • Certified Product Investigation Process (CPIP) • Long Term Field Evaluation (LTFE) • Fire Fighter Fatality/Injury SCBA Evaluation Program (FFFIP)

  3. Certified Product Investigation Process (CPIP) • PURPOSE: • To ensure the quality of NIOSH approved respiratory units by promptly investigating and resolving reports of product nonconformance issues.

  4. Examples of Nonconformance Issues • Performance failure • Failure to maintain quality control requirements • Misleading advertising • Manufacturing under a private label without prior approval from NIOSH

  5. When is a CPIP Needed? • When an approved NIOSH respirator is in nonconformance with the specified requirements in Title 42, Code of Federal Regulations, Part 84 (42 CFR 84). • A nonconformance is a failure to comply with specified requirements – in this case, failure to comply with 42 CFR 84.

  6. CPIP Goals • Maintain quality of NIOSH approved units. • Investigate potential nonconformance issues. • Document findings of the approval holder’s investigation and their corrective actions. • Address inventory units, field units and future production, when necessary: • Quarantine affected inventory units • Manufacturer or NIOSH issued notice for field units • Corrective actions to reduce likelihood of occurrence for future production

  7. CPIP Process • CPIP Initiation • Reported Externally, Internally or by approval holder • CPIP Investigation • NIOSH contacts approval holder and requests them to conduct an investigation • Product considerations • Field Units, Inventory, Future Production • Follow-up actions • When a product nonconformance has been verified

  8. CPIP Process • Contact the Approval Holder (manufacturer): • Provide test reports and photos, if applicable • Confirm NIOSH approval numbers affected • Request a full investigation including, reason for failure and extent of nonconformance • For SCBA units, also contact SEI (Safety Equipment Institute) • Joint investigation • Review investigation report from manufacturer • Evaluate root cause and corrective actions • Ensure actions are being taken to addresses inventory units, field units and future production

  9. Possible Follow-Up Actions • User Notices • Typically issued by manufacturer and reviewed by NIOSH • Link posted to NPPTL website • On occasion, NIOSH will issue a notice: • Covers multiple approval holders units • Agreement not reached that one is needed or the message • Stop Sales • Recalls/ Retrofits • NIOSH Application to make changes to: • Quality Control Process • Production Process • Product Modifications • In extreme cases, rescission of Approval Numbers, when resolution is not foreseeable.

  10. CPIP Closing • Has approval holder properly identified the cause of the nonconformance? • Has approval holder developed effective corrective actions to resolve nonconformance? • Has approval holder successfully addressed inventory units, field units and future production? • When NIOSH determines investigation can be closed, Approval Holder receives closing letter.

  11. NPPTL DRAFT SAFETY ADVISORIES

  12. Sample SOP – Restricted Access for PPE/SCBA/Equipment PURPOSE • To provide the mechanism for the chain of custody, sealed access, and prevention from contamination of evidence, which may assist in determining the cause of malfunction, failure, accident or casualty. SCOPE • This applies to all Fire Department personnel, equipment, and personal protective equipment (PPE).

  13. Sample SOP continued CONTENT • The intent of these guidelines is to isolate equipment/PPE which, for the purpose of investigation, must be sequestered in as close to the same condition as at the time of the event. Information gathered from this process will assist the investigating officer(s) or agency(s) in cause determination.

  14. Sample SOP continued PROCEDURE • Any equipment/PPE (non-vehicular) that fails to operate in its designed and prescribed fashion, whether in training or on an emergency incident, shall be sequestered. Employees shall immediately notify either the Shift Safety Officer or a Battalion Chief to secure the item. The item(s) shall be maintained, as close as possible, in the same condition in which it malfunctioned or failed in order to preserve any evidence for investigation purposes.

  15. Sample SOP continued When securing SCBA units the air will be turned off, the system bled down, and the “PASS” device turned off. Additionally, when sequestering a SCBA unit, the following shall be noted on the receipt: remaining air in tank; position of air cylinder valve (open/closed/1/2 open); Pass device status; and was the emergency bypass on or off. If the malfunction was due to free-flowing air, sequester the user’s mask also. All equipment sequestered will be placed into the Restricted Access Bag, zippered shut, and sealed with a “zip” tie around the zipper tabs. To prevent cross contamination, separate items should be placed in separate bags. The sequestering officer will issue a receipt with a detailed inventory (to include all identifying inventory numbers) to the supervisor responsible for the equipment/PPE.

  16. Sample SOP continued • Once an item has been sequestered, the Shift Safety Officer will take control of the bag. Any time the Restricted Access Bag changes hands, a new receipt, as outlined above, will be issued. The Battalion Chief of Safety will maintain all original receipts at Fire Administration. Entry into the bag will be limited to only those parties authorized by the Battalion Chief of Safety, the Shift Safety Officer, or the Battalion Chief of Resource Management. An inventory of the Restricted Access Bag will be conducted any time the seal is broken and recorded on the inventory form.

  17. Sample SOP continued RESTRICTED ACCESS BAG RECEIPT Date: _____________ Time: __________ Incident #: ____________________ Location Item/Equipment Received: ___________________________________ Item/Equipment Sequestered: _______________________________________ City/Department ID#: ___________________________ SCBA Information: remaining air in tank; _______ psi. PASS: ON/OFF _______ Position of air cylinder valve (open/closed/1/2 open): _________ Emergency bypass on or off: _________ Item/Equipment Assigned To: ________________________________________ Reason for Sequestering: (Be as Specific as Possible) Item/Equipment Received From: _____________________________________ Date: __________ Time: __________

  18. There is an emerging issue regarding increased exposure of firefighters through contaminated gear. • Studies show persistent contaminants • Documented increases in firefighter cancer • Relatively little understanding on what methods and agents work to remove contaminants • NFPA 1851 parameters over past 15 years • Limited in parameters addressed (pH, g-force, temp.) • No demonstration of cleaning effectiveness Photos courtesy of NIOSH, DSR

  19. Validation of Cleaning Procedures for Fire Fighter Personal Protective Equipment

  20. Photo credit: NIOSH NPPTL

  21. WHAT SHOULD HAPPEN – CHEMICALS AND SOILS SHOULD BE REMOVED FROM FABRIC WASH WATER DETERGENT GEAR BUT DOES IT??? DRAIN Photo credit: NIOSH NPPTL

  22. Chemical Contaminants • Phthalates • Aromatics • Carbonyls • Nitriles • Phenols • Furans • Alkanes • Alkenes • Chlorinated compounds • Metals • Others???

  23. Outlined experimental plan • Small-scale washes (e.g., sonication) or using laundry machine

  24. Establish laboratory soiling procedure to determine extraction efficiency Pristine Laundered Photo credit:

  25. Artificially soiling fabric ~0.25 g soil SEM imaging* Pristine turnout gear fabric swatch *SEM=Scanning Electron Microscopy Photo credit: Diane Schwegler-Berry

  26. Large and Small Scale Contamination Photo credit: NIOSH NPPTL

  27. Current work undergoing data analysis: extraction efficiency • Conduct analysis on additional replicates of laboratory-soiled fabric • Deliverable: Determine reproducibility/repeatability of laboratory soiling method and extraction efficiency • Results from WV State Fire Academy Burn • Deliverables: • Compare how particles are distributed on/in outer shell (SEM image) • Determine effect of simulating contamination of turnout gear using structural materials

  28. Contact Information Jay Tarley, CFEI Physical Scientist NIOSH National Personal Protective Technology Laboratory Evaluation and Testing Branch Morgantown Testing Team jst9@cdc.gov 304-285-5858 Visit us at: http//www.cdc.gov/niosh/npptl

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