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"Single use" mention on N95 respirators box

By Gaël CLAQUIN | 25 Mar, 2014

Dear colleagues,
though trivial I need your confirmation regarding the fact that on Neoguard N95 masks (in use at MoH) there is a "single use" mention, that some colleagues understand as "discard on same day".
I cannot imagine, based on N95 standard, that these would have to be used differently as other brands (cf. repeated posts from Ed Nardell on the issue).

Could some of you confirm or not Neoguard N95 masks can be reused as others (based on their integrity as per cited defined criteria) ?

Many thanks
Gaël Claquin
Mozambique

Replies

 

S. Mehtar Replied at 12:04 PM, 25 Mar 2014

Dear Gael
We have it in our TB-IPC policy that N95 respirators can be reused for at least two shifts and if well looked after, one week. We do not state a make or brand on purpose because as IPC Teams, we are looking at the principle of either storing or not storing N95 respirators. Currently we have moved to the V-flex (3M) one which is much more comfortable and easier to use and face fit. It also stores better because it becomes quite flat and fits in the paper bag very easily. All manufacturers will have to say, by law, that the face covers are “single use” but the decision was made several years ago to re-use N95 respirators because they were really very expensive then. In low TB burden countries it is not such a big problem but in high burden countries like South Africa, the cost really does escalate!
I hope this helps- it is our experience and seems to work for us.
BW
S

Prof Shaheen Mehtar

Buitengewoon Professor / Extraordinary Professor

[cid:image001.png@01CF4853.D19DAA10]

Eenheid vir Infeksievoorkoming en Beheer / Unit for Infection Prevention and Control
Fakulteit Geneeskunde en Gesondheidswetenskappe /
Faculty of Medicine and Health Sciences
Universiteit Stellenbosch University
Posbus / PO Box 19063; Francie van Zijl Rylaan / Drive
TYGERBERG 7505
Suid-Afrika / South Africa
Tel: +27 21 938-5054; Faks / fax: +27 21 931-5065
e-pos / e-mail: <mailto:>
Visit our website at www.sun.ac.za/uipc<http://www.sun.ac.za/uipc>
Infecton Control Africa Network: www.ICNetwork.co.za
ICAN Conference: 3-7 November, 2014, Harare, Zimbabwe

Paul A. Jensen, PhD, PE, CIH Moderator Replied at 2:31 PM, 25 Mar 2014

Greetings and thanks for starting this discussion!

I just checked the CDC/NIOSH N95 website (http://www.cdc.gov/niosh/npptl/topics/respirators/disp_part/n95list1.html) to look up the Neoguard N95 and could not find it. Would you please send me the manufacturer & model info as well as the CDC/NIOSH approval number? That will help me research it further.

I agree with you, Shaheen, and common sense!!!

42 CFR 84.2 (bb) states “Single-use respirator means a respirator that is entirely discarded after excessive resistance, sorbent exhaustion, or physical damage renders it unsuitable for further use.” 42 CFR are the US regulations for respiratory protection, including N95 filtering facepiece respirators that are often used for protection from airborne M. tuberculosis.

Edward Nardell, MD Moderator Replied at 4:54 PM, 25 Mar 2014

Paul Jensen recommends that if the filtering facepiece is not deformed, the
respirator can be used as long as the elastic bands provide a reasonably
tight fit. The weak link of disposable respirators is usually the elastic
straps which often stretch out with repeated use. This could occur in a
few days of heavy use, or weeks of light use. I agree with you that this
should not depend on the brand, although the elastic bands differ from
brand to brand. There is an obvious incentive for respirator manufacturers
to want users to replace their products often.

Norah Vere Replied at 2:21 AM, 26 Mar 2014

Dear Prof Shaheen,
Thank you for sharing your experiences. May you shed a bit more light on the fitting process for N95 respirators. Do you buy a whole range of masks and start fitting your staff to see which ones fit best? or do they have standard sizes ( small, medium , large) . if you have a big number of staff what is the best way to carry out the fitting process?

Gaël CLAQUIN Replied at 5:33 AM, 27 Mar 2014

Thanks so much for helping to clarify and thus avoid waste of time and resources.
The appropriate use of PPE remains a real challenge in many sites (I recently saw a cleaner with a facial transparent protection traditionally used for fibroscopy/surgery) and is still too often the main/only Infection control measures implemented.
The road is still long but travellers are united, easing the journey ;)

PS: Paul I asked our medical material procurement if they can provide solicited info.

Warm regards to all
Gaël Claquin, MD, MPH
Mozambique

Phasouk SENEPHANSIRI Replied at 10:19 PM, 27 Mar 2014

for N95 mask could be used for single one , could not reuse and imagine that if we reuse it could be contaminated.

Thomas Albuquerque Replied at 11:23 PM, 27 Mar 2014

I guess that's exactly what the manufacturer would like that we use it
only for one time, but respirator's cost money. , I have managed to
use mine for 2 weeks without any problems, I put my initials with the
date I have started using the Respirator at one corner .then just make
sure that I dont fold it ,nor leave it in a place where it would
collect dust, and if it does get a bit damp due to sweat I just let it
dry in the open.

Luciana Brondi Replied at 8:35 AM, 28 Mar 2014

Good practical advice...

Paul A. Jensen, PhD, PE, CIH Moderator Replied at 8:48 AM, 28 Mar 2014

Greetings all!

The weakest part of most respirators is the strap system. Some are very weak elastic bands while others are more like underwear elastic. While I cannot document the intent of any particular respirator manufacturer, those with the weakest straps will need replacement much more often than those with heartier bands. Some manufacturers recommend replacement very often . . . This is not supported by data nor is it supported by regulation. We must remember, however, that "hygiene" is one of the conditions for changing out respirators. If one is only exposed to airborne Mtb, reuse is not an issue. If one is also exposed to droplet- or contact-transmitted microorganisms (e.g., SARS, H5N1, normal influenza, BBPs, etc.), then droplet & contact precautions would require disposal of the respirator after exposure.

So, when we talk about reusing a respirator, we are limiting it to Mtb exposure only!

Thoughts!?

Zilma Rey Replied at 9:00 AM, 28 Mar 2014

Dear All,
Please see attached TB Biosafety Manual from WHO. A N95 respirator should be worn for a total of 8 hours and then discarded. As mentioned previously, the straps tend to stretch and with reuse the fit may be compromised. Always inspect the respirator before putting it on to verify there is no damage. Always do a fit check after putting on a respirator - place hand over the tropical valve (if the respirator has one), open mouth, take a deep breath and exhale sharply through mouth. You have a good fit if now air escapes from rom around the respirator such as the nose and the chin.
Do not write on the respirator - you are damaging the filter. Write on the strap.
If your respirator is wet - it is damaged and should be discarded.

Some labs are using powered air purifying respirators (PAPRS) and have N95s as options. The PAPRS are expensive in the first year but by the second year they are less expensive than the N95s. A costing exercise should be done to determne if PAPRs will work for your lab.

Attached resource:

Zilma Rey Replied at 9:10 AM, 28 Mar 2014

Sorry for the typos...

Dear All,
Please see attached TB Biosafety Manual from WHO. A N95 respirator should be worn for a total of 8 hours and then discarded. As mentioned previously, the straps tend to stretch and with reuse the fit may be compromised. Always inspect the respirator before putting it on to verify there is no damage. Always do a fit check after putting on a respirator - place hand over the tropical valve (if the respirator has one), open mouth, take a deep breath and exhale sharply through mouth. You have a good fit if no air escapes from around the respirator such as the nose and the chin.
Do not write on the respirator - you are damaging the filter. Write on the strap.
If your respirator is wet - it is damaged and should be discarded.

Some labs are using powered air purifying respirators (PAPRS) and have N95s as options. The PAPRS are expensive in the first year but by the second year they are less expensive than the N95s. A costing exercise should be done to determne if PAPRs will work for your lab

Edson Jasse Replied at 9:23 AM, 28 Mar 2014

thank you Zilma Rey..... i agree with you but here in mozambique we use the
masks for 2 weeks after that we discard. i will pass the book you atach to
the mail to other physicians who work directly with respiratory diseases
particulary TB. Best Wishes

S. Mehtar Replied at 9:47 AM, 28 Mar 2014

Agreed. We do not use N95 respirators for Droplet Precautions anyway so the single use surgical face mask is used and discarded after each use. The problem comes when the doctors want to look "sexy" and leave the bottom straps untied!!!
S

Prof Shaheen Mehtar

Buitengewoon Professor / Extraordinary Professor

[cid:image001.png@01CF4A9C.FB483240]

Eenheid vir Infeksievoorkoming en Beheer / Unit for Infection Prevention and Control
Fakulteit Geneeskunde en Gesondheidswetenskappe /
Faculty of Medicine and Health Sciences
Universiteit Stellenbosch University
Posbus / PO Box 19063; Francie van Zijl Rylaan / Drive
TYGERBERG 7505
Suid-Afrika / South Africa
Tel: +27 21 938-5054; Faks / fax: +27 21 931-5065
e-pos / e-mail: <mailto:>
Visit our website at www.sun.ac.za/uipc<http://www.sun.ac.za/uipc>
Infecton Control Africa Network: www.ICNetwork.co.za
ICAN Conference: 3-7 November, 2014, Harare, Zimbabwe

Dr Shanta Ghatak Replied at 5:40 AM, 2 Apr 2014

Hi
Disagree that any doctor would do that for the looks !
Come on we need to look at more technical issues like
"FIT TEST" and "SEAL TEST"

When we exhale and inhale inside the respirator to see /check any air flow
is happening - it is called a SEAL CHECK or SEAL test
and a fit testing is extremely scientific as it shows how only a FITTED
respirator may not be that protective after all !

And we are talking about helping us from other pathogens as well

Edward Nardell, MD Moderator Replied at 7:46 PM, 2 Apr 2014

A brief comment on Zelma referral to the WHO TB biosafety manual.
Guidelines are important, but they are only guidelines. Some guidelines are
evidence-based, others depend on expert opinion. Most (but not all) TB IC
guidelines are based on expert opinion, with indirect evidence. It is just
so difficult to prove efficacy. That is true of such recommendations like
wearing respirators 8 hrs, or fit testing respirators. Based on something,
but not usually hard evidence. What we are hearing from the field is
comments from users who simply cannot afford to use a respirator 8 hrs and
discard it. We are best guided by principles. If it looses structural
integrity, replace it. If the elastic is stretched out and it feels loose,
time for a new one. Remember too that disposable respirators when new and
fit tested are not close to 100% protective.

At their best, respirators are NOT the most effectively way to prevent TB
transmission - mostly because you are unlikely to be wearing one when
encountering an unsuspected case of TB, or a known case of TB with
unsuspected drug resistance. In both those cases the patient is likely to
be infectious because they are not effectively treated. We tend to wear
respirators for known cases of TB, most of whom should be on effective
therapy, and not infectious at all. There is the irony. I believe the
best approach to TB IC is actively looking for unsuspected TB and actively
looking for unsuspected drug resistance and getting those patients promptly
onto effective therapy. As I have written here before, we call this
refocused approach to TB IC: "FAST" for Find cases Actively by cough
surveillance and rapid molecular diagnostics, Separate temporarily, and
Treat effectively based on molecular DSTs. If there is no undiagnosed TB
in your hospital and no patients with undiagnosed drug resistance - that
is, all patients are on effective treatment - the use of respirators is a
minor concern. That is why they are 3rd on the list of interventions,
behind administrative controls (FAST) and environmental controls like less
crowding and good ventilation.

Dr Shanta Ghatak Replied at 8:48 PM, 3 Apr 2014

So true Ed
But then what do we do actually ? What do we advocate for ? How do we go
about the personal protective measures at all since we are unable to in
reality ? How do you propose to go about this please ? Would it be possible
to guide a bit ??

Edward Nardell, MD Moderator Replied at 11:21 PM, 3 Apr 2014

Would welcome comments from Paul, Grigory, and others. We have guidelines
and we have the reality of our own situations. The guidelines tend to be
ideal and general. Not all apply to every situation and not all can be
fully implemented everywhere. Try opening windows in Siberia in Winter. So
we have to assess our own situation, do a risk assessment - one of the
first steps in most guidelines - and also assess our resources and
potential for additional resources. And one must prioritize. I think that
WHO and CDC guidelines are so comprehensive that it is hard for programs to
decide what to do with limited resources. Do I triage and separate
patients, buy respirators, fix the broken ventilation system, improve the
lab, or renovate the hospital? I cannot do it all, at least not at once.
We have always said that administrative controls were most effective and
least expensive, but that has been a vague statement in my view with little
specific guidance as to what was meant. It could mean staggering clinics
throughout the day to reduce crowding or active case finding and effective
treatment. So, the job of the TB IC committee is to study the entire
guideline and prioritize. To help with that process we have developed the
FAST strategy, made possible by the advent of rapid molecular diagnostics
that can shorten the time from symptom detection and sputum collection to
the diagnosis of TB and resistance, allowing rapid, effective treatment -
by far the most effective of all interventions to stop transmission. The
problem with conventional TB IC is that it does tend to focus on suspected
TB patients - patients who should be on therapy quickly and not be
infectious, assuming treatment is effective. There is little evidence that
those patients are the source of most transmission. In the US we worry
about directional airflow and how many air changes in an airborne isolation
room, but these are rarely untreated, infectious patients. There is
evidence that it is unsuspected patients and unsuspected drug resistant
patients on no or ineffective therapy that transmit most.

My advice, have your TB IC prioritize. To the main discussion here, some
programs after prioritizing may decide that changing respirators after 8
hrs is an optimal use of limited resources, whereas others may choose to
use respirators longer if still intact and invest in active case finding,
rapid diagnosis and effective therapy instead. The same with environmental
controls.

Sorry to rehash the same advice, but these are my conclusions after many
years in the business of TB IC.

Paul A. Jensen, PhD, PE, CIH Moderator Replied at 7:21 AM, 4 Apr 2014

Greetings!

I apologize that I do not fully understand Dr Shanta's request; however, I will try!

As we think of the hierarchy of control, Personal Protective Equipment (PPE) is the third level. Yes, there's huge overlap between the different levels; however, respiratory protection is used when the administrative controls and environmental controls do not lower the risk of transmission to an acceptable level. The Assigned Protection Factor (APF) for half-facepiece (both filtering facepiece and elastomeric) respirators is 10. This means that there is at least a 10-fold reduction in inhaled concentration relative to outside the respirator, for a properly fitting respirator. The fit factor of an improperly fitted respirator or one without passing a fit test could be much less than 10. How do you get around this? It's tough! If the risk assessment leads to the conclusion that respirators are needed, then respirators are needed. Ideally, fit testing should be performed. Qualitative fit testing is relatively easy to do (as well as assemble the equipment & make the solutions). Whether you do fit testing or not, it's best if you can select a well-fitting respirator for the population of interest. There are many papers from NIOSH and other authors that address the issue of fit & fit testing.

Virginia Lipke RN, MHA, ACRN, CIC Replied at 11:44 AM, 4 Apr 2014

I agree with Ed's comments. You must carefully look at your particular circumstances, the population that you serve and the types of services you provide, along with identified problems, potential solutions, the types of supports and resources that might be available, and the timeline to achieve those solutions and as Ed said, prioritize those that are doable and those that may take longer to achieve.
I was recently in a country where renovation of an ART building was not possible to improve airflow and the volume of patients needing those services. Their solution was to improve the covered outdoor waiting area and to limit the number of patients in the building to 2 people at a time. They also provided a small play area outside for children who were accompanying their mothers. This solution reduced congestion in the structure and reduced the risk of TB transmission to patients and workers alike. The patients were made to understand the importance of waiting outside and the patients and children were comfortable while waiting their turn.
We have some planning tools that might provide some assistance as you prioritize your next steps. Please email me at <mailto:>
And I will send them to you.
Best wishes,
Ginny

S. Mehtar Replied at 2:17 PM, 4 Apr 2014

Use N95 resp for as long ad they are safe which is , they provide a good fit with an effective elastic band and undamaged filter
Shaheen


Sent from Samsung Mobile

Dr Shanta Ghatak Replied at 12:25 AM, 21 Apr 2014

Your guided comments are so much helpful technically .....from the
"do-ability " perspective in any kind of health care facility ....

Carlos Alberto Replied at 9:06 AM, 22 Apr 2014

Well, here in mozambique we use N95 at least 2 or 3 weeks. i dont really know if this practice is dangerous or how bad can it be. But that kind of masks are expensive making it difficult to early change it.

Gerald Mboowa Replied at 9:32 AM, 22 Apr 2014

Here in Uganda, we use N95 mask from 3M,the manufacturer however there are some factors we consider before discarding them. The number of times a lab personnel puts the mask on per day and other physiological factors - sweating which differs from individual to individual, though this would vary with individuals other parts of the world then some people do apply lots of make-up and vaseline, true for most ladies. But with all that we normally use them for 1 to 2 weeks on average.

VIDYANIDHI GUMMA Replied at 10:24 AM, 22 Apr 2014

Dear Colleagues

N series filters or respirators generally be used and reused, subject only to consideration of Hygiene, damage and breath resistance. I herewith attached very important document , which was released by CDC for further reference. All the details are clearly explained and also clearly mentioned length of usage of N95 respirator.

Many thanks for giving this oppertunity

Attached resource:

Edward Nardell, MD Moderator Replied at 12:59 PM, 4 Apr 2015

I am responding to this so that Gael CLAQUIN knows that his discussion was
posted as expected.

I am not familiar with NeoGuard N95 respirators, nor can I find anything on
the web other than reference to your posting. I am hoping Paul Jensen will
weigh in on this. They may be made by another company and rebranded
NeoGuard by the seller. Assuming that they are listed as certified
respirators by US or European standards (and not counterfeit, which we see)
they are PROBABLY like any other respirator. That is, as we have said
often, reusable as long as they are structurally intact (especially stiff
molded respirators) and most importantly, that the elastic bands still
provide enough pressure to assure a good face fit. It depends on how they
are worn and how they are put on and taken off in terms of overstretch, but
I agree that it is hard to believe that they would be usable only once.
That said, it is certainly in the interest of sellers to have users dispose
of respirators frequently and buy more!

Stephen Muleshe Replied at 1:15 PM, 4 Apr 2015

It all depends on the user, otherwise in resource poor settings, re-use is
acceeptable for as long as it is handled well. The condition of storage
also matters a lot.

Sofia Alexandru Replied at 2:24 PM, 4 Apr 2015

It is used until the elastic not "weaken"- 1-2 weeks, depend how often is
used
The condition of storage between uses is very important


2015-04-04 20:25 GMT+03:00 Stephen Muleshe via GHDonline <>:

Cedric Cheung Replied at 5:24 PM, 4 Apr 2015

Here at MSI, we reuse the N95 until the elastic doesn't keep a good seal. We estimate one could it for 2 weeks. I've used some for over a month. This depends on how long you wear it daily of course. We mainly use 3M brands.

Dr Shanta Ghatak Replied at 7:26 PM, 4 Apr 2015

if it is 8 hours of usage......the respirator needs to be changed
If worn for only sometime and not for a period of 8 hours or more then the N 95 can be used as long as it retains its shape and the elastic holds well. Btw we have requested people using such respirators ....to keep it inside the diaries they keep and not fold them or hang them on coat/hat stands....
And if there is moisture or oil spills then the respirator has to be discarded......and they need to be burnt.......after use ( but the metal nose clips doesn't burn :)

So......
Single use is only profiting the manufacturers......probably...
I have seen indiscriminate use of IMG respirators also ......only once and thrown away.....

They are incredibly good and doesn't cost so much as some others but each time I watched this I felt a tug inside.....hard to believe what effective marketing can do

Personally I have used for months ....one respirator ....working and advising in Infectious wards ....and Dr Grigory has been a constant inspiration......

Thank you Sir .....once again

Sent from Shanta's iPad

>

Dr Shanta Ghatak Replied at 7:28 PM, 4 Apr 2015

Duck bills .....small and large are mostly well fitted usually if we go by fit tests done regularly.....
Any thoughts ?


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