PPE Equipment & COVID-19: Do they conform to the right standards?

PPE

Question: What do Germany, The Netherlands, Spain, Czech Republic and (amongst others) the UK have in common?
Answer: All have been duped into purchasing unsafe, non-conforming and dangerous Protective Safety Equipment (PPE) needed for essential workers in the fight against coronavirus.

The normally super-efficient German government was probably the most ‘notorious’. It was defrauded out of €14.7 millions worth of PPE. 600,000 face masks had to be returned by hospitals in The Netherlands for being faulty. 400,000 medical gowns flown into the UK by the RAF from Turkey were impounded as being “not fit for purpose”.

These are just some examples of how some unscrupulous operators are taking advantage of the ‘opportunities’ brought about by supply shortages during this pandemic.

However distasteful and disgusting taking advantage of our frontline workers might seem, by placing them in greater danger than they are already in, unfortunately, examples of unapproved, counterfeit and fake products are available from countless suppliers simply by searching the Internet.

Suppliers are unaware that products, including ‘surgical’ gowns, ‘surgical’ face masks, ‘sterile’ or ‘nitrile’ gloves, are not all they seem.

In fact, many rely on counterfeit credentials, fake certificates, spurious test reports and quote meaningless and unrelated Safety Standards.

Does your PPE have the right approvals?

Take a recent advertisement in a leading “Cleaning and Hygiene” publication that claimed it had ‘CE Approved’ and ‘Fully Compliant’ face masks showing a picture of a health worker wearing a mask, protective head cover and gown.

The CE certification was shown not to be from an EU Approved testing facility. Therefore the CE mark was false and should not have been on the product packaging. The Chinese manufacturer was not approved by the Chinese government for the production of medical face masks.

In another example, an advertiser/supplier for ‘Medical Disposable Surgical Masks’ quotes bacterial filtration rates and particle filtration rates. The supplier quotes standards that are not relevant for CE Approvals. Also, they offer spurious ISO Certification that has no relevance to the surgical mask. They also claim that it is CE Compliant for Europe and the UK. No reference to any of the applicable standards is made. Similarly, unfortunately, this is the same for ‘Surgical Gowns’ too.

However, should we blame these suppliers of PPE? Even though they are clearly taking advantage of the supply issues? Even with they are profiteering from the potential that exists due to demand shortages?

Or, do we blame the purchasers for not actually checking the validity of what they are buying? Not asking for proof of the claims being made and that the product is what it is claimed to be?

Or third, is there not enough information readily available? Do we make it easy for someone to simply check that what they are getting is actually fit for purpose?

Actually, all three!

PPE

Due diligence

What is even more frustrating, is that there are reputable companies out there that have done the necessary due diligence. They have forensically checked the validity of all of the testing data and claims. Ensured that the CE Approvals are bona-fide and carried out by a recognised, certified and approved testing facility to the correct and most up to date and relevant standards – and most of all, are doing so, to ensure that the user is safe in the knowledge, that the equipment is not only fit for purpose, but could ultimately, save lives.

PPE Supplies

One very well-known, and highly reputable, PPE supplier was recently asked by a leading British manufacturer to verify the paperwork for a large supply of face masks it had procured for its workforce. Its technical experts identified that the lab that had tested and certified the products, were not actually approved to carry out these kinds of tests. Unfortunately, this is a typical example of poor practice many organisations are at risk of falling prey to.

So, are we in danger of falling foul and at risk of becoming prey to these types of PPE suppliers ourselves?

Well, the simple answer is “Yes we are!” unless we ask some simple and straightforward questions before we commit to our purchase.

For CE Approval, ask for sight of the CE Certificate. The CE Certificate should state the testing standard to which the Approval was based. If it does not, buyer beware!

Check if the CE Certificate was issued by an Approved CE Testing facility (a list of Approved Testing Facilities can be found here:

www.ce-marking.org

From the CE Approved Facility List check that the Testing House concerned has been approved for testing medical devices.

If you are looking for medical or surgically approved products, never be afraid to ask your supplier for evidence of the approvals. Not only Certificates but with the supporting documentation showing the Certification comes from a suitable Approved CE facility.

Original article about PPE written for The Cleanzine.

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