ASAP Innovations outlines the cost of fake PPE and how distributors and purchasers can identify fraudulent products
Following a raft of stories this year on fake Personal Protective Equipment (PPE) that doesn’t protect users, and untold millions that have been spent on said products; leading glove and face mask manufacturer, ASAP Innovations advises distributors and purchasers on how to identify certified providers.
The UK government recently outlined that during the COVID-19 pandemic, the average monthly number of PPE masks distributed to health and social care services increased from 1-2 million to 85-95 million – an increase of 4,700% 1. However, with reports from the National Audit Office stating that hundreds of millions has been spent on unsuitable items that could not be used 2, it’s imperative that those purchasing PPE understand how to ensure they are buying legitimate and certified PPE.
ASAP Innovations – a leading manufacturer of medical PPE – has itself seen fraudsters trying to replicate its brand this year as groups attempted to cash-in on the increased demand for protective equipment. Sean Keller, Managing Director, ASAP Innovations illustrates the five key areas that certified and registered PPE will fall under:
- Notified bodies – An organisation designated by an EU country to assess the conformity of certain products before being placed on the market. All notified bodies which are designated to assess PPE are listed on the EU Commission’s NANDO 3 (New Approach Notified and Designated Organisations) website which is updated regularly, so purchasers should look for products that have been certified by notified bodies.
- CE Markings 4 – Indicate that the product has been assessed by the manufacturer and deemed to meet EU safety, health and environmental protection requirements – a requirement for products placed on the EU market that are manufactured anywhere in the world. The Manufacturer providing the EU market with the product is obligated to issue a declaration of Conformity, meaning they take full responsibility for placing the product on the EU market.
- Technical file 5 – Provides information on the design, manufacture, and operation of a product and must demonstrate the product conforms to the applicable requirements. The technical documentation is necessary to prove the product meets the essential requirements to justify and support an EU declaration of conformity.
- EU declaration of conformity – A mandatory document that a manufacturer or the authorised representative need to sign to declare the products comply with the EU requirements. The document must reflect: manufacturer, the address, implementation standard, ingredient content, production batch number, production date and expiration date, to name a few. Suppliers of gloves and masks should provide the technical file and EU Declaration of Conformity.
- EN standards 6 – Medical products on the EU market should comply with EN standards. For example, masks should comply with EN 14683 and EN149 standards and gloves should comply with EN 455 and EN 374 standards. A lot of businesses that are supplying fake and unsuitable PPE will have the wrong standard in relation to the given masks or gloves.
Sean comments, “This year has been an extraordinarily challenging period for everyone, with none having felt it more than frontline health workers. For those workers, it’s essential they have the right protection. Purchasers of masks and gloves should take time to look at the packaging of the equipment they’re buying and be sure to ask providers to show the technical file and EU declaration of conformity. On many fakes, there will be no CE marking whatsoever and also the ‘issuing body’ will not be listed on the EU Commission’s NANDO website, meaning the product is not registered or certified, rendering it unprotective.
“Sadly, the demand for PPE this year has presented opportunities for fraudulent activities. However, now that the initial rush on PPE has settled, purchasers mustn’t fall foul to uncertified products. Partnering with a credible, reliable and most importantly, certified manufacturer of PPE will ensure that healthcare institutions protect of all their staff and patients,” concludes Sean.
Based in Ireland and Malaysia, with over 30 years’ experience manufacturing disposable products and a commitment to hygiene control and quality assurance, ASAP Innovations has 150 certified product lines of masks and gloves available to UK organisations. If you are looking for certified protection for your functional and practical needs, choose ASAP Innovations, where transparency and legitimacy are the priority.