FAKE or NOT? - Buying RPE During COVID19

No doubt the hot topic of the day is face masks. With a massive global demand and not nearly enough supply this is becoming a significant issue; not just due to availability of masks but also because many companies have sprung up offering masks simply out of ‘thin air’.

Articles you should see:

https://www.hse.gov.uk/news/face-mask-equivalence-aprons-gowns-eye-protection-coronavirus.htm https://www.hse.gov.uk/news/assets/docs/face-mask-equivalence-aprons-gown-eye-protection.pdf

You can see why the FFP1 is not acceptable for protection from the coronavirus. Looking at FFP2 you have 94% filtration AND 8% leakage vs FFP3 having 99% filtration and 2% leakage. Initially it was required to have FFP3 for aerosol generating procedures (AGP). It is important to note that no scientific evidence has been presented that even and FFP3 is ‘safe’ but it simply is the best available FFP mask. Under the latest guidance the mandatory requirement has been downgraded to FFP2! In addition they have stated that an N95 is considered equivalent by WHO. Note 2 issues with this. The first is that standard N95 masks are NOT tested against oil-based droplets (liquid paraffin) whereas FFP masks are. The second is that no ‘inward leakage’ values are given for N rated masks and also the flow rates used in tests are 2x greater for FFP demonstrating higher performance testing criteria.

Valved and non-valved masks is another component to consider. Valved masks will enable the user to be protected whilst anyone in the vicinity is still unprotected from air exhaled by the user. The benefit to the user is that the mask is generally easier to breathe through. The higher the protective factor of the mask, the more resistance to breathing. All guidance states that the maximum wear time of a mask (half, quarter and FFP masks) is LESS THAN ONE HOUR. These masks are not designed for continuous use. A mask is the last line of defence in all scenarios for various reasons and should not be considered a panacea that will protect you in all scenarios.

A half mask (EN 140) potentially offers greater protection with P3 filters fitted (EN143). This potentially has a 99.95% filtration rate. It is designed to be reusable and the filters can be replaced. The trade off is that strict decontamination protocols must be in place during the current pandemic, the mask is heavier (though likely more comfortable) and can also add bulk that interferes with other PPE e.g. visor.

How to spot a fake?

If any manufacturer or distributor claims equivalency against specific standards, that can only be confirmed with appropriate documentation in place. This would also including testing against that standard with accredited results. For example, an FFP mask would require certification in the European Union that includes a technical file, conformity assessment procedures and correct certification to demonstrate it complies with the accepted requirements (e.g. FFP2). Simply stating ‘it’s equivalent to FFP2’ in NOT in compliance. On the mask the relevant EN number (e.g CE 0194) should be readable. It should also have A1+2009 (to denote reusable R or NR non-reusable). Do not get confused with the cleverly thought out CE as ‘China Export’.

Note the only current exception is as mentioned above from genuine N95 masks being deemed (in a global pandemic) equivalent to FFP2. You decide from your own research what is appropriate based on the above. Other masks and terminology to be aware of.

KN95 is actually a Chinese standard of mask. This is broadly equivalent to N95 / FFP2 HOWEVER it is not recognised in the EU as equivalent even based on the latest guidance. Unless you have certified documentation and evidence that a KN95 has been re-certified to EU regulations (or at present N95) then it is not acceptable.

All masks provided to be used as RPE should be face fit tested. This is under all current guidance from the HSE and PHE. A surgical mask is the only exception, which does not claim any protection factors. This includes FFP1, 2 and 3, EN140 half mask with any filter fitted, quarter masks. These can be fit tested with qualitative or quantitative fit testing. Full face masks require quantitative fit testing. Note the trainer / fitter should be competent and demonstrate suitable skills, knowledge, qualifications and experience (see INDG479). Each type of mask used has to be fit tested for each person.

Before you buy anything:

Take reasonable precautions to ensure it is genuine. Most ‘fake’ sellers of masks will not have even the level of technical detail or understanding outlined in this article and to quote Judge Judy “If it doesn’t make sense, it’s probably not true”. Also any genuine testers/trainers would have relevant accreditation, skills, knowledge and experience for the service they are providing. Do your due diligence, remember ‘Caveat Emptor’ and while buying under pressure may seem like a good idea, the responsibility still lies with the buyer in this case to be able to prove they took reasonable precautions to source the right product and service.

Work Together ....... Keep 2M .......Apart


The First Principle Group Team

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