(navigation image)
Home American Libraries | Canadian Libraries | Universal Library | Community Texts | Project Gutenberg | Children's Library | Biodiversity Heritage Library | Additional Collections
Search: Advanced Search
Anonymous User (login or join us)
Upload
See other formats

Full text of "Respirator Certification, March 2-3, 2010"

Respirator Certification and 
Post Certification Activities 




J eff Peterson 




ational Institute for Occupational Safety and Health 
ational Personal Protective Technology Laboratory 
PPT Stakeholder Meeting 



March 3, 2010 



CDC 



Safety and Health 



NPPTL 



Respiratory Protection Regulations 



OS HA Respiratory Protection Standard 
(29 CFR 1919.134) requires use of NIOSH 
approved respirators 



NIOSH authority to approve respirators 
found in 42 CFR 84 



CDC 



Safety and Health 



NPPTL 



Respirator Certification of Systems 

NIOSH approves 'individual, 
completely assembled 
respirators' 

-42CFR 84.30(a) 

NIOSH will not issue 
approval of 'any respirator 
component or for any 
respirator subassembly' 

-42CFR 84.30(b) 

Concept makes it easy to 
track actual configurations J 
and identify critical 
performance characteristics 



CDC 




Safety and Health 



NPPTL 



Respirator Certification 
Program Elements 

Activities 



Technical assistance 



Post 
Activities 

- Certified Product 
Investigations 

- Firefighter Investigations 

- Product Audits 

- Manufacturing Site Audits 

- Long Term Field Evaluation 





CDC 



Safety and Health 



NPPTL 



Respirator Certification Process 



Hardware received 



Electronic application 
package received 



Fees received 



Initial administrative review 



Initial engineering review 




Lab testing 



QA review 




Final engineering review 



Final documentation 



CDC 



Safety and Health 



NPPTL 



Final Engineering Review 
Final Review 

Final review of all documentation supporting 
approval request 

Review of NIOSH approval test data 

Finalize approval labels 

Recommendation made for approval /denial and 
documentation generated 

Update NIOSH internal databases (DEIMS) 

Insures that Certified Equipment List (C EL) is 
updated 



These approval activities confirm certification. 



CDC 



Safety and Health 



NPPTL 



Post Certification Activities 



Manufacturing Site Audits 

-Two year schedule 

- Evaluating approval holder against approved QA 
plan submitted 

Product Audits 

-40-50 per year 

- Equipment bought from open market 



CDC 



Safety and Health 



NPPTL 



Post Certification Activities 



Certified Product Investigations 

- Initiated by users/approval holder/NIOSH 

- Can result in Stop Sale request/recall/retrofit or some other 
corrective action 



Fire Fighter Fatality and Injury Prevention Program 

- Collaboration with NIOSH DSR 

- Reported by Fire Department or State Agency 

- Evaluation as to whether unit is in an approved condition 



CDC 



Safety and Health 



NPPTL 



Current NIOSH post certification activities 
focused on filtering facepiece respirators 

• 42 Code of Federal Regulations Part 84, 
Section 84.34 (c) Revocation of certificates of 
approval 

• Typical Factors contributing to revocation 

• Performance Failures 

• Failure to Maintain a Quality System 

• Misleading Advertising 

• Misuse of approval labels 



CDC 



Safety and Health 



NPPTL 



Surgical mask being sold through WalMart Stores in 
Canada as N95 mask - NIOSH notified Feb 2010 

J iangsu Teyin Nonwoven Fabrics Co., Ltd (J TN) 



sppporo 



^ff^fflm 






M l HU B T**HN 




L'aururi pir ^Iih— 
I iiviii T-sn eiiaf 



SURGICAL MASK 




N95 



MASQUE CHIRURGICAL 



™PP°S8 




u Lk. ■:■: L"n I-im ul ii>- !■■ '!'.' •■ 



: iimi in-ill^ bi «*■ I 



* (has* km. m frmftfrter rtttity Htnl. 



I un Lh r« iumJ -tvutYtdf \?( Mm lirilti 



Ptaw " [tain dfv iwsfq 

Liu De-riUt ft** lh* ITilM irtl A ton nifli^i Wfh mf Nn 



j iOi bin dML bKHiia. -i'i*. mrlii pwW. nm^im. iiz 



■r 41 UK hihj !"*(->}* [wii' »■ himim ran ii mnliin 
Mft Of 1 toh p**fii*"i tin -panh iii=iiiIk:ii irin ill 



•-praiiih-n rLHrilfl ■ II ul u-ilmi— uji iti vi« 

■¥ KWR n l l 'T''' 1 '! 
I hW It mdmt -IIMhfrllfcir [ta IF IP 



nqJMUUPi-iTlrimkt, EHJttflSKrc-inmflir^ ■ 



CDC 



Safety and Health 



NPPTL 



Misleading Information 

Misleading Representation: DuraMax Pro EN149 FPP1 Dust 
Mask advertised as NIOSH approved N95 - May 5, 2009 






NIOSH N95 




M_ i„ „ 


i 




"^* 


I rjufoittji;*/' 





■im 




3 uft 

wmtm 


t— . masques comim If 




' M 


iPOf 


KRt 


IL1P 


wn w 


ii«OUiltlALC JALFTT « WlLHj IH&rttMLH 




P. 









CDC 



Safety and Health 



NPPTL 



Mainstays mask previously sold at Walmart 



Packaging claimed 
NIOSH N95 

No certified products 
available by "Mainstays" 

NIOSH investigators 
searched through photos 
of numerous failed 
applications 

It appeared that J TN sold 
products that had not 
passed NIOSH testing 
and tried to sell them 
under a different name 




CDC 



Safety and Health 



NPPTL 



Recent NIOSH Revocations 



J iangsu Teyin Nonwoven Fabrics Co., Ltd (J TN) 

J une 22, 2009 



14 approvals revoked for 
failure to maintain an 
acceptable quality control 
plan 

Can no longer be listed as 
NIOSH approved 

Can no longer be 
manufactured, assembled, 
sold or distributed 




CDC 



Safety and Health 



NPPTL 



Recent NIOSH Revocations 

BeiBei Safety Company, Ltd. (BBE) - J uly 1, 2009 



7 approvals revoked for 
failure to maintain an 
acceptable quality control 
plan 

Can no longer be listed as 
NIOSH approved 

Can no longer be 
manufactured, assembled, 
sold or distributed 






^ 





~ar 



CDC 



Safety and Health 



NPPTL 



NIOSH Approved Respirators altered to 
create non-approved Aloha Masks 





Disclaimer added to web site: "Our colored masks are made 
from white stock masks that are N95 certified from the 
manufacturer in unaltered form. We then apply the decorations 
in Hawaii and the masks are not resubmitted to NIOSH orthe 
manufacturer for recertification." 



CDC 



Safety and Health 



NPPTL 



Technical Assistance 



Many calls, letters, emails, faxes 

Variety of issues: selection, training, 
enforcement, verify approval, APF, 
interchanging parts, etc. 

Inquiries from organizations, labor, other 
government, contractors, general public 



CDC 



Safety and Health 



NPPTL 



Information Dissemination 



• Letters to All Manufacturers 

- Policy Changes 

- Clarifications 

• User Notices developed by NIOSH 

- Inform users of product failures or recalls 

• User Notices developed by Approval Holders 

- Inform users of product failures or recalls 

• Letters to all Interested Parties 

- Inform all customers of new initiatives at NIOSH 

• Certified Equipment List and Trusted Source Page 

- Record of approved products 



CDC 



Safety and Health 



NPPTL