[William Kim]

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 headbands

Lastly, 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

http://www.healius.com.au

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[William Kim]

Good morning Kristie,

Not 100% sure if this is what you were looking for, but this might be it.
Resource found here: https://www.cdc.gov/vhf/ebola/healthcare-us/ppe/calculator.html

Please let me know, I will dig a little further.

Best regards,
Woo Ju (William) Kim.

Sent from iPhone

Hello,

I am looking for a PPE calculator that would be helpful in relation to coming up with PPE requirements for COVID-19. In addition to normal use, we could like to calculate surgical and maternity requirements should we have COVID-19 query or positive patients in those areas too.

I have heard from a few reliable colleagues that there was one around some years ago for pandemic planning, however no one can find this.

Would be grateful for any assistance.

Warm regards,

Kristie

Kristie Popkiss | Quality & Risk Manager
St John of God Midland Public and Private Hospitals
T: (08) 9462 4883 | | F: | E: Kristie.Popkiss@sjog.org.au
1 Clayton Street, Midland WA 6056 | PO Box 1254, Midland WA 6936
http://www.sjog.org.au/midland | Twitter | LinkedIn | Facebook

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