Quality of certain N95 respirators
Started by Ana Serralheiro on 01 Mar 2010
Dear all,
I have seen the respirator named "Dura Mask N95" in use in Swaziland.
This mask is apparently produced in China and is labelled as NIOSH N95 (http://www.regencymed.com/itoolkit.asp?pg=products&specific=jqpmqmg4). Is the first time I see this respirator.
Is this a certified one? Does someone have information on quality and how reliable this producer is?
Also, in Swaziland the respirators previously in use by MoH were the 3M (green) respirator. However it seams this respirator is very expensive and not easily affordable by MoH in quantity enough. Can someone advise on other kinds of respirators, good quality and easily purchased in countries like South Africa and Swaziland?
Thank you
Ana
Attached resource: Evaluation of N95 respirator use as a tuberculosis control measure in a resource-limited setting
Grigory Volchenkov, MD
Dear Ana,
I have not found this "Dura Mask N95" in the official NIOSH-Approved N95 Particulate Filtering Facepiece Respirators list http://www.cdc.gov/niosh/npptl/topics/respirators/disp_part/n95list1.html
For HCW I would recommend to use only respirators certified according to US42CFR84 standard (US) or EN12469 standard (European union).
If these respirators are already procured, I would do the fit test to make sure that they can provide some filtration protection. If they fail fit test, they can be used only as surgical masks to prevent droplet infections transmission.
Kind regards,
Dr. Grigory V. Volchenkov
Head Doctor
Vladimir Oblast TB Dispansery
12:55 AM, 2 Mar 2010 | Permalink
Helen Cox
Dear all,
We have seen these masks in use here in South Africa. While we did not verify whether they are actually certified or not, we recommended that they not be used based on a poor seal and weak elastic. Staff report that they are more comfortable than other certified masks, but this is based on the lack of a tight fit.
Regards,
Helen Cox
Epidemiologist
Burnet Institute,
MSF, South Africa
2:33 AM, 2 Mar 2010 | Permalink
S. Mehtar
Dear All
We have specifically made sure that the masks and respirators have a Lot number, FFP or N95 category and clear markings and have stated that in the tender- those are the only ones we use at TBH. We do have four types available to us and we find these cover most situations adequately.
Regards
Shaheen
Prof Shaheen Mehtar
MBBS, FRC Path (UK), FCPath (Micro) (SA), MD (Lon)
Chair IPCAN
Head of Academic Unit for Infection Prevention and Control
Tygerberg Hospital & Stellenbosch Uni
2:37 AM, 2 Mar 2010 | Permalink
Ana Serralheiro
Hi all,
Thank so much for all the replies and for sharing your experiences,
Following Dr. Grigory reply it is strange that they are labelled with NIOSH symbol (plus TC – 84A – 4244 number)and not mentioned in their website. Are all the respirators listed there?
In the same line as Helen, this kind of mask also have a poor fit here in Swaziland (very easily seen just by looking because they are too big/loose) and elastics seam to be weak too. Consequently we will discourage their use and try to procure different ones/different sizes.
Following Prof. Shaheen answer, once you have already fit-tested the staff at Tygerberg Hospital & Stellenbosch Unit, would it be possible to have the respective specifications?
We are introducing fit-test here in Swaziland next April and we need to identify 4 types of N95 masks that could be used during that month and that could be procured locally by MoH in the future.
Thank you once again
Best
Ana
3:23 AM, 2 Mar 2010 | Permalink
S. Mehtar
Dear Ana
We have moved from fit testing every one to a particular face cover type as you quite rightly point out. We have suggested that with continuous use, an N95 respirator may be used for one week with all the usual stipulations. The next ones are of the same brand (usually) or shape and are "press fitted" for lack of a better term, for maximum effect. We have a duck-bill, with and without an expiratory valve, a cone shaped one similarly equipped. We are now using the valve face covers for extensive periods of contact and seem to be working quite effectively. However, their distribution is very controlled.
Thanks
Shaheen
Prof Shaheen Mehtar
MBBS, FRC Path (UK), FCPath (Micro) (SA), MD (Lon)
Chair IPCAN
Head of Academic Unit for Infection Prevention and Control
Tygerberg Hospital & Stellenbosch Uni
Tel: +27 21 938 5051
Fax: + 27 21 938 5065
website: www.ipcanafrica.org
Joint IPCAN/IFIC conference
website: www.ipcan.co.za.
Conference organisers:
-----Original Message-----
From: GHDonline (Ana Serralheiro) [mailto:]
Sent: 02 March 2010 10:23
To: Mehtar, S, Prof <>
Subject: Re: [TB Infection Control] Quality of certain N95 respirators
Ana Serralheiro replied to the discussion "Quality of certain N95 respirators" in the TB Infection Control community.
Reply contents:
"Hi all,
Thank so much for all the replies and for sharing your experiences,
Following Dr. Grigory reply it is strange that they are labelled with NIOSH symbol (plus TC - 84A - 4244 number)and not mentioned in their website. Are all the respirators listed there?
In the same line as Helen, this kind of mask also have a poor fit here in Swaziland (very easily seen just by looking because they are too big/loose) and elastics seam to be weak too. Consequently we will discourage their use and try to procure different ones/different sizes.
Following Prof. Shaheen answer, once you have already fit-tested the staff at Tygerberg Hospital & Stellenbosch Unit, would it be possible to have the respective specifications?
We are introducing fit-test here in Swaziland next April and we need to identify 4 types of N95 masks that could be used during that month and that could be procured locally by MoH in the future.
Thank you once again
Best
Ana"
--
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4:15 AM, 2 Mar 2010 | Permalink
Nonkqubela Bantubani
Dear all,
I do agree with you Helen, I have seen the NOISH, white in colour used
in some of the hospitals in KZN and I was concerned about quality, by
the look they are not good quality respirators.
KR
Nonkqubela Bantubani
Clinical and Biomedical TB Research Unit
Medical Research Council of SA
4:32 AM, 2 Mar 2010 | Permalink
Ana Serralheiro
Hi Nonkqubela,
Thank you for your reply. It's interesting to hear from you because the scenario here in Swaziland is very similar to KZN...
I'm wondeinrg about the quality of this other respirator:
Brant: Image Europe BV - IMG R 020 FFP2
"Fold Flat" model, 20/box
I've tried to find this on-line but no infomration at all. Does someone knows this company and if they are certified?
Thanks
Ana
1:00 AM, 18 Mar 2010 | Permalink
Menno Goedhart
Hi Ana,
The respirator: "Image Europe BV - IMG R 020 FFP2" is a certified mask,
when you look closely you'll see the EU EN 149:2001 marking and the
website: (in Dutch) www.imgeurope.nl. See the pictures if we're talking the
same article: http://www.imgeurope.nl/?__target__=IMG_Disposables
You can mail or call them in English.
MSF (Médecins sans Frontières using this type of respirator.
cheers,
Menno
-----------------------------------------------------------------
Menno Goedhart ,
Field Support Unit
MSF OCA (Operational Centre Amsterdam)
Plantage Middenlaan 14, 1018 DD Amsterdam
5:46 AM, 18 Mar 2010 | Permalink