By Sean Keller, Managing Director, ASAP Innovations
The healthcare industry has always heavily relied on personal protective equipment (PPE), but the COVID-19 pandemic has meant that it is now part of every individuals’ daily routine. As such, there have been multiple issues for PPE supplies, including worldwide material shortages, factory closures, increased demand, Brexit and fraudulent products.
These issues pose a threat to the supply of protective equipment and it’s therefore essential that healthcare organizations get on top of this now to ensure they’re able to continue protecting their staff and patients.
At the end of 2020, it was revealed that the world’s number one manufacturer of medical gloves had experienced a control movement restriction order in Malaysia which resulted in over half (55%) of its factories being shut. Furthermore, the world’s third biggest supplier of medical gloves was forced to shut a quarter (25%) of its factories due to COVID-19 outbreaks among its staff.
As a result of these closures, the Klang Valley area in Malaysia, which is responsible for almost a third of the world’s supply of medical gloves is thought to be working at a 50% capacity. This poses a very serious risk to medical glove supply over the coming months as these manufacturers try to close the gap between supply and demand that’s been created.
The shortages of PPE at the beginning of the pandemic led to fraudsters producing fake, unregulated or inferior quality products, therefore posing a risk to the healthcare workers putting their lives on the line through inadequate protection.
We ourselves have seen fraudsters trying to replicate our brand over the past year as groups attempted to cash-in on the increased demand for protective equipment.
With this in mind, here are the five key areas that certified and registered PPE will fall under:
- Notified bodies – An organization 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 authorized 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.
As a result of significant increased demand for PPE due to the COVID-19 pandemic, the PPE industry is under threat from a worldwide shortage of nitrile – the material used for gloves that enables protection for longer periods of wear. Estimated presold quantity in Malaysia as at January 2021 is 160 billion gloves which is the equivalent of 6.86 months of production capacity thus leading to a long lead time until year end. In addition, according to the Malaysian manufacturers’ association MARGMA, worldwide demand is projected to rise from 296 billion in 2019 to 420 billion this year, an expected year-on-year annual growth of between 15-20%. With glove manufacturers flat out currently, this isn’t a deficit that will quickly be resolved.
Due to current shortages in nitrile raw materials, glove manufacturers are converting some production lines over from nitrile to latex, to ensure production capacity is kept running to a maximum and supply continues.
Following last minute Brexit agreements, and the pandemic having disrupted preparations, many organisations have been left scrambling and there is still much confusion post-Brexit. Just a few months ago, the British Chambers of Commerce found that only half of UK firms that trade internationally had considered the impact of Brexit on their business. But with PPE having never been more important than it is currently, it’s critical that hospitals and healthcare institutions protect their PPE supply by ensuring their suppliers are ready for the changes to come.
With the EU stockpiling emergency medical supplies, including PPE as part of its RescEU programme, there’s also a risk that the UK will be squeezed out as manufacturers favour ‘an easier option’, supplying to nations in which they are already accredited and don’t need to apply for further registration. In this instance, many UK organisations, and importantly, healthcare institutions will not be able to continue sourcing PPE from their previous suppliers.
We’re currently in a grace period, with CE markings continuing to be recognised in Great Britain until 30th June 2023, meaning certificates issued by EU-recognised Notified Bodies will continue to be valid for the Great Britain market until this date. However, after the 1st January 2021, the EU no longer recognises UK Notified Bodies such as the MHRA. This means that UK suppliers will need to register products with other EU Notified Bodies in order to export to the EU after this date. Additionally, manufacturers from outside the UK will need to appoint a single UK ‘responsible person’ who will take responsibility for the product.
Ensuring critical PPE supply is maintained
Hospitals and healthcare institutions have had multiple issues with PPE supplies since the start of the pandemic last year. The industry has, and continues to battle with worldwide material shortages, increased demand, fraudulent products, factory closures and Brexit challenges after the initial grace period of certifications comes to an end. It’s therefore essential that buyers get on top of this now to ensure they’re able to continue protecting their staff and patients.
Working with a supplier who is aware of these issues and has contingency plans in place to deter any potential shortages, along with the ability to spot fake PPE products are key to ensuring a consistent supply of credible and certified products.