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. 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)

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.

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

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.

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

CPIP Process CPIP Initiation CPIP Investigation Product considerations 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

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

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.

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.

NPPTL DRAFT SAFETY ADVISORIES

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).

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.

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.

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.

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.

RESTRICTED ACCESS BAG RECEIPT 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: __________

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 Good – states the need. Photos courtesy of NIOSH, DSR

Validation of Cleaning Procedures for Fire Fighter Personal Protective Equipment

Photo credit: NIOSH NPPTL

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

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

Outlined experimental plan Cut 4”x4” outer shell fabric swatches Laundered and unlaundered fabric Use pestle to grind standard into fabric swatch >0.2g metals-in-soil standard Soil removal using full metal digestion Blanks (no soil) Soil removal using water only Soil removal using water + Detergent 1 Soil removal using water + Detergent 2 ICP-MS Analysis Small-scale washes (e.g., sonication) or using laundry machine You can refer back to this slide for the outlined experimental plan, but I will go through the individual steps in the next few slides.

Establish laboratory soiling procedure to determine extraction efficiency Cut 4”x4” outer shell fabric swatches Laundered and pristine (new) fabric Use pestle to grind soil standard into fabric swatch >0.2g metals-in-soil standard Soil removal using water only (2 replicates) Soil removal using water + Detergent 1 Soil removal using water + Detergent 2 Soil removal using nitric acid digestion Blanks (2 replicates) ICP-MS Analysis First, both laundered and pristine outershell fabric was cut into 4”x4” fabric swatches. A mortar and pestle was used to grind the metal soil standard into the fabric swatches to simulate contamination, and to ensure a known amount on each swatch. Laundered Pristine Photo credit:

Artificially soiling fabric ~0.25 g soil SEM imaging* Using a high powered scanning electron microscope, images can be taken before and after the swatches are soiled. you can see the difference between the pristine fabric swatch and after it was soiled with the soil particles shown in these highly magnified images. One can even select an individual particle and identify the metals using this microscope. Pristine turnout gear fabric swatch *SEM=Scanning Electron Microscopy Photo credit: Diane Schwegler-Berry

Large and Small Scale Contamination Photo credit: NIOSH NPPTL

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 Currently, replicates are being conducted to determine the repeatability and reproducibility of the soiling method extraction efficiency of the laboratory-soiled fabric swatches. Soon, the samples from the WV State Fire Academy will undergo the acid digestion to determine the effectiveness of simulating contamination of FF turnout gear using structural materials.

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