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Dear Colleagues,
I am hoping that someone can help me with a question about KN95 masks.
I have been asked to look at a KN95 mask that has been given TGA approval.
I have spoken with the TGA and my understanding is that this approval would
be granted as the sponsor provided evidence in their TGA application that
that mask meets the requirements of AS 1716:2012.The mask as ear loops and I had 5 staff trial the product they were not
able to create or keep a seal on inhalation or exhalation because the ear
loops did not pull the mask tight enough towards their face.The Aust Guidelines for PCI in Healthcare state that a P2/N95 mask should
seal by ‘Ties at the crown and the bottom of the head, pliable metal nose
bridge’ (pg114). This is based on an article published by Gralton and
McLaws (2010). Is there anything in AS 1716:2012 or AS1715:2009 about this
requirement? I have not been able to locate it.Can anyone point me in the direction of published requirements for P2 masks
or equivalents to be fixed with ties or an elastic headband at the crown
and the back of the neck?Thank you in advance for your help.
Kind regards
Lori
*Lori McLeod-Mills*
National Quality Governance Officer
Healthcare Imaging
Healius Limited
+61 (0) 414 542 483
Tuesday to Friday
Suite 8b 486 Lower Heidelberg Rd,
Heidelberg VIC 3084
*lori.mcleod@healthcareimaging.com.au
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Good morning Lori,
First of all, KN95, N95, FFP2, and P2 respirators have all different standards.
* P2 (AS/NZS 1716:2012)
* N95 (NIOSH US classification)
* FFP2 (EN 149-2001, European standard)
* KN95 (China, GB2626-2006)If the product specification says the respirator is KN95 that meets NIOSH or AS/NZS 1716:2012, it is something suspicious.
Those respirators often considered as equivalent based on the 3M test result.
However, the company also stated:
prior to selecting a respirator, users should consult their local respiratory protection regulations and requirements or check with their local public health authorities for selection guidance.
Secondly, there are many counterfeit respirators, especially among KN95 respirators.
Here is the list of those unauthorised products, recognised by CDC: https://www.cdc.gov/niosh/npptl/usernotices/counterfeitResp.html
Please monitor them carefully as they may have a different box but same masks (NIOSH approval number TC-84A-XXXX or item number).
Signs that a respirator may be counterfeit:
* No markings at all on the filtering facepiece respirator
* No approval (TC) number on filtering facepiece respirator or headband
* No NIOSH markings
* NIOSH spelt incorrectly
* Presence of decorative fabric or other decorative add-ons (e.g., sequins)
* Claims for the of approval for children (NIOSH does not approve any type of respiratory protection for children)
* Filtering facepiece respirator has ear loops instead of headbandsLastly, even if they provide a full respirator test result, we also need to think critically as European Safety Federation stated:
We have the impression that manufacturers outside the EU (and probably even newcomers and importers in the EU) are not entirely familiar with the EU Legislation on PPE and thus believe that by paying the certificate from such an organisation, they are fully in compliance with the EU legislation. And most likely, also on the side of the customers (including health authorities), the knowledge about the exact requirements of the EU legislation is lacking and thus they judge those documents as accurate.
It has to be remarked that it is possible that the PPE are safe and offer the claimed protection, even if the documents are not correct and thus offer no solid proof of that. In those cases, testing of the PPE and following the correct procedures can be considered.
At this moment, it is clear that the priority is to get as much as possible masks (and other relevant PPE) into the EU so that the healthcare workers can be protected. On the other hand, it cannot be accepted that sub-standard masks which offer not the claimed protection are made available to healthcare workers that are now at high risk and thus deserve correct protection.(updated 07/05/2020)
Hope it helps.
Kind regards,
William Kim
BN, MPH, Clinical Coordinator Infection Control
Infection Prevention and Control Unit | Tasmanian Health Service
________________________________
Dear Colleagues,
I am hoping that someone can help me with a question about KN95 masks.
I have been asked to look at a KN95 mask that has been given TGA approval. I have spoken with the TGA and my understanding is that this approval would be granted as the sponsor provided evidence in their TGA application that that mask meets the requirements of AS 1716:2012.
The mask as ear loops and I had 5 staff trial the product they were not able to create or keep a seal on inhalation or exhalation because the ear loops did not pull the mask tight enough towards their face.
The Aust Guidelines for PCI in Healthcare state that a P2/N95 mask should seal by ‘Ties at the crown and the bottom of the head, pliable metal nose bridge’ (pg114). This is based on an article published by Gralton and McLaws (2010). Is there anything in AS 1716:2012 or AS1715:2009 about this requirement? I have not been able to locate it.
Can anyone point me in the direction of published requirements for P2 masks or equivalents to be fixed with ties or an elastic headband at the crown and the back of the neck?
Thank you in advance for your help.
Kind regards
Lori
Lori McLeod-Mills
National Quality Governance Officer
Healthcare Imaging
Healius Limited
+61 (0) 414 542 483
Tuesday to Friday
Suite 8b 486 Lower Heidelberg Rd,
Heidelberg VIC 3084
lori.mcleod@healthcareimaging.com.au
MESSAGES POSTED TO THIS LIST ARE SOLELY THE OPINION OF THE AUTHOR, AND DO NOT REPRESENT THE OPINION OF ACIPC.
The use of trade/product/commercial brand names through the list is discouraged by ACIPC. If you wish to discuss specific reference to products or services by brand or commercial names, please do this outside the list.
Archive of all messages are available at http://aicalist.org.au/archives – registration and login required.
Replies to this message will be directed back to the list. To create a new message send an email to acipclist@acipc.org.au
To send a message to the list administrator send an email to admin@acipc.org.au
You can unsubscribe manually from this list by sending ‘signoff acipclist’ (without the quotes) to listserv@aicalist.org.au
MESSAGES POSTED TO THIS LIST ARE SOLELY THE OPINION OF THE AUTHOR, AND DO NOT REPRESENT THE OPINION OF ACIPC.
The use of trade/product/commercial brand names through the list is discouraged by ACIPC. If you wish to discuss specific reference to products or services by brand or commercial names, please do this outside the list.
Archive of all messages are available at http://aicalist.org.au/archives – registration and login required.
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################################################################################################################MESSAGES POSTED TO THIS LIST ARE SOLELY THE OPINION OF THE AUTHOR, AND DO NOT REPRESENT THE OPINION OF ACIPC.
The use of trade/product/commercial brand names through the list is discouraged by ACIPC. If you wish to discuss specific reference to products or services by brand or commercial names, please do this outside the list.
Archive of all messages are available at http://aicalist.org.au/archives – registration and login required.
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