27 May Fake Masks – COVID-19
Counterfeit Masks and Fake Masks COVID-19
UPDATE: 11.06.20. Further to the blog we released regarding counterfeit masks and fake masks, the HSE (Health and Safety Executive) have issued guidance regarding KN95 and advised “KN95 must not be used as PPE at work as their effectiveness cannot be assured”. They go on to say: “Masks that are not CE marked and cannot be shown to be compliant must be removed from supply immediately.”
The full details can be found here:https://www.hse.gov.uk/safetybulletins/use-of-face-masks-designated-kn95.htm
After the stresses and strains of the first 8 weeks of lockdown and facing up to the challenges of face fit testing and training for the NHS, our focus has now shifted to helping other sectors prepare for the return to work.
Work sectors who previously would have never used proper Respiratory Protective Equipment (RPE) in the past now find themselves with the daunting task of finding adequate and suitable RPE as well as arranging face fit testing.
There is a global supply issue with suitable RPE making it extremely difficult to get hold of any masks at all.
Companies who have never sold PPE/RPE before have tried to step in and source stocks of masks from across the world without understanding what they should and should not, be buying.
Ignorance from a supplier is not justification enough, they have a legal obligation to ensure that they are selling you 100% compliant masks – if they are not, then they should not be selling them.
In China since January 2020 over 25000 companies have sprung up to try and service the worlds demand for RPE and as you can imagine most of these companies will have never made a mask before.
Respiratory Protective Equipment is classified as Category 3 High Risk PPE in Europe and the design, manufacture, supply and distribution of category 3 products are governed by European Regulation EU 2016/425.
The Regulation requires amongst other things, that all economic operators involved in the manufacture, supply, import and distribution of PPE can prove that what they are supplying absolutely complies with the relevant EU standards for the product.
Accepting spurious paperwork from a distributor is not proof of compliance, category 3 PPE must have certain paperwork to accompany the product:
- Module B EU Type Examination Certificate
- Declaration of Conformity to EU Standards
- Instructions for use of the Product.
Before purchasing any category 3 PPE you must ask for numbers 1 & 2 above, number 3 should come with the product.
What to check for
Once the paperwork has been supplied you then need to check that it is legitimate and not falsified in anyway.
1. Module B EU type examination certificate should contain the following information:
- Certificate Number
- Notified body and number (the notified body is identified by a 4-digit number for example 0194)
- Manufacturer name & address
- Approval to PPE Regulation EU 2016/425
- Date of issue & date of expiry
- Product description & coding
- Subsequent pages with test details etc. referenced
- Name, address and number of the notified body
- Signature of authorised person at the notified body
2. Declaration of Conformity to EU Standards should contain the following information:
- Company logo
- Title and ID number
- Name and address of the manufacturer
- Description and code of the PPE
- Image of the product (optional)
- Declaration of compliance with PPE regulation
- Details of module B certificate
- Details of notified body who issued module B certificate
- Declaration of compliance with specific standards
- Details of notified body who conducted the QA assessment
3. Instructions for use of the product should contain the following:
- Instructions for the use, storage, cleaning, maintenance, servicing and disinfection
- Be available in the language of the country where the product is sold
- Performance as recorded during technical tests to check levels or class of protection
- Accessories that may be used with the PPE
- The significance of any markings
- The risks against which the PPE is designed to protect against
- Reference to the EU Regulation 2016/425
- Name, address and identification of the notified body
The product should also be marked with the following information:
Type (product code), Batch or serial number, Name of manufacturer, Registered trade mark, Postal address, CE mark, Notified body 4 digit code.
Where it is not possible to include all or some of this information on the product itself then it should be included on the packaging.
Ask the supplier for the module b certificate, check that the notified body is listed on the NANDO website and is a notified body for PPE.
Check with the notified body listed that the paperwork is genuine and relates to the products that have been supplied.
Check the EU declaration of conformity, make sure all the information on the declaration is there, check the notified body on the NANDO website again check with the notified body.
BSIF The British Safety Industry Federation who we are proud to be members of have produced a useful checklist to help ensure that you do not buy counterfeit product.
Check the European Safety Federations website for suspicious certificates:
In recent weeks the number of counterfeit face masks, in particular KN95 masks that we have seen is shocking.
Contrary to what may appear on the mask or what is on the counterfeit paperwork a KN95 mask is NOT a FFP2 mask and to be sold as FFP2 mask it would have been subjected to a lengthy testing process before being certified for sale in the EU.
The exception to this would be for use within the NHS where a fast track system is in place for certification, so the only place that could conceivably be using KN95 masks that are certified is within the NHS after them being tested and cleared for use by the government.
Whether it is John Smiths Safety Mask Emporium who set their business up online 2 months ago and sells masks from his garage at home or your usual supplier who has decided to sell RPE are not privy to the fast track system, so their KN95 masks and the rest that are being sold to the public, simply do not comply with the law.
In the last three weeks alone 100% of the KN95 masks that we have been presented with are counterfeit.
Not only are the cost implications enormous but more importantly the risk to human life is devastating.
BSIF recently ran a great webinar about checking counterfeit RPE. Below is a link to the question and answers section relating specifically to KN95/N95 masks together with a link to relevant paperwork and CE information.
KN95/N95 Questions: https://www.bsif.co.uk/bsif-webinar-kn95-n95-etc-q-as/
Documents and CE Information: https://www.bsif.co.uk/bsif-webinar-documents-ce-q-as/
RPE Supply Options
One customer asked me, “well what option do I have?” their justification is that at least they are putting their staff in masks.
I understand that the options are limited but returning to work should only be undertaken if it can be done safely, putting your staff in counterfeit masks is not safe.
We are facing severe difficulties at the moment with lack of credible and compliant RPE, lack of face fit testing kits and lack of solutions.
We do currently offer face fit train the tester for qualitative face fit testing, this can be delivered at our training centre or on your site or premises (subject to confirmation that your premises are COVID-19 secure).
This will enable you to conduct qualitative face fit tests on your staff. However, this can only be done if you can source a qualitative face fit test kit.
As I write, current stocks of test kits have been depleted and there is a national shortage of Bitrex and nebulisers which are some of the component parts of the test kits.
This also poses problems for continuing to be able to test, whilst our test kits come with a supply of solution (approximately 40 tests worth), you will require future supplies in order to be able to conduct more tests and currently this supply is not available.
We are more than happy to add our customers to a waiting list and as soon as stocks are available, we will contact you. In the meantime the only alternative to this situation is to either consider having us conduct Quantitative Face Fit Tests on your staff, or alternatively, we can train you/your staff up to conduct Quantitative face fit testing yourselves.
You would need access to a portacount machine, we can assist with these requirements as we are a TSI distributor – machines retail at approximately £6,000 + VAT and anyone attending one of our courses will receive a discount on this price.
I am disappointed that in a time of great national crisis, people are being put at further risk by purchasing counterfeit masks. If you are purchasing or selecting masks you have a legal obligation to be trained. We are in the process of creating an online RPE training programme – if you would like to be added to the waiting list please contact us today and we will be happy to help.
In the meantime, please ensure you are checking the certificates. The suppliers are doing a good job of ensuring we purchase this product, but ultimately the buck stops with you and them so if the masks are proved to be counterfeit, then you and the supplier are deemed liable.