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Nathan Shipley PPE Group Certification Manager at BSI explores the role of PPE and face coverings in the context of the COVID-19 pandemic.
Personal protective equipment (PPE) and face coverings have been a hot topic during the COVID-19 pandemic. Not only with frontline healthcare specialists, but also with professionals in the testing industry who have been working tirelessly to enable certified PPE to be placed on the market.
What is PPE and how does it help?
PPE is anything that is worn or held by a person to protect them from injury or infection and encompasses hundreds of products that stretch from head to toe, from protective clothing, helmets, hearing and respiratory protection to body armour and boots.
However, in the context of COVID-19, PPE relates to items that many key workers, like NHS staff, are wearing to help stop the spread of COVID-19. These items include:
- Face masks
- Medical gloves
- Protective clothing
- Eye protection
To keep people safe and to reduce health risks, PPE has to comply with all the requirements of the PPE Regulation and carry the CE marking to be sold legally in the EU.
PPE Regulation
To ensure PPE is fully compliant, products have to be certified to the requirements of the Regulation. This can be done through testing the product to a published harmonised standard or to a technical specification that meets the health and safety requirements of the regulation.#
Harmonised standards are listed in the Official Journal which is held on the European Commission website and is a ‘live document’ therefore updated on a regular basis.
A harmonised standard is a European standard developed by a recognised European Standards Organization: CEN, CENELEC or ETSI, created following a request from the European Commission. Non-harmonised standards comply with directives, but nonharmonised standards do not automatically comply with the essential requirements of the directives.
CE marking
Specifiers and purchasers of PPE can derive a measure of reassurance about the quality and safety of products from the presence of the ‘CE’ marking.
When it comes to distributing PPE in the European Union (EU), all products that fall under the European Regulation must carry the CE marking. This is a legal requirement and means that manufacturers are allowed to do business in all 28 EU member states. For instance, once a CE approval has been issued in the UK the product can be sold across Europe – from Portugal right through to Greece.
If a product bears the CE marking, it has been assessed against the essential safety performance criteria as specified in the EU Regulation. This mark also acts as the manufacturer’s confirmation that the product adheres to the specific requirements of all the Directives that apply to it and that it can be sold legally in the EU.
Previously the PPE Directive focused only on manufacturers placing products onto the market, but the PPE Regulation means the whole supply chain is involved. This means importers, distributors or anyone involved in the supply and distribution chain should take appropriate measures to ensure that PPE meets standard requirements and that they make available on the market only products which comply with the Regulation, and keep relevant documents for at least 10 years.
The European Commission guidance
On 13 March 2020 the European Commission issued recommendation 2020/403 to increase the amount of PPE that could be used by healthcare professionals in the fight against COVID-19. The European Commission encouraged Notified Bodies to process applications for CE marking swiftly and to consider non-harmonised standards for certification to enable more product be placed on the market in the EU more quickly.
The European Commission’s published recommendation also covered conformity assessment and market surveillance procedures for PPE. This includes face masks, gloves, protective coveralls and eyewear protection.
“the European Commission encouraged Notified Bodies to process applications for CE marking swiftly to enable more product be placed on the market”
Conformity assessments and market surveillance
To ensure compliant products can be placed on the market as quickly as possible, BSI is also supporting manufacturers with conformity assessments and market surveillance procedures within the context of COVID-19 with experts available to discuss the options for clients and other manufacturers.
Fake certificates
During the COVID-19 pandemic, BSI was notified that a number of manufacturers were selling medical face masks – and other PPE for healthcare applications – claiming conformity by using false certificates.
We recommend that prior to purchasing any form of safety equipment supported by a certificate appearing to be issued by BSI, you verify to ensure that such certificate is genuine. BSI can only advise on false certificates that appear to have been issued by the organisation, but potentially other certification/notified bodies and approved test houses may also be affected.
Purchasers of any form of safety equipment supported by a certificate that appears to be issued by BSI should verify that the document is genuine using the certificate or license number and the Verifeye database on BSI’s website prior to purchase.
BSI has notified the relevant regulators and law enforcement agencies about the false certificates that have been brought to its attention.
A global perspective
Different regions throughout the world have their own local certification processes for PPE. For example, the
UAE has ESMA certification which BSI is a certification body for, with Australasia, the USA and Canada all having their own product specifications and regulatory needs. Therefore, a potential exporter should be aware of any local requirements before shipping PPE to that region.
The UAE’s ESMA is very similar to the PPE Regulation in that it splits PPE into three different categories: Category I, II and III. There are two different certification modules to choose from, which are as follows:
- EQM involving a factory assessment and report review and is valid for three years
“as a result of the COVID-19 pandemic, we may see the development of standards specifically for PPE for healthcare workers as well as the general public” - ECAS which involves a report review and is valid for one year Benchmark certification is a BSI PPE certification scheme managed out of our Australian office and covers market access into Australasia. As with ESMA, a lot of the factory assessment activities can be run with CE and ESMA audits.
Most regions have their own standards for products, but as we are seeing a wider growth of ISO specifications, these are becoming more commonly adopted for European specifications.
“as a result of the COVID-19 pandemic, we may see the development of standards specifically for PPE for healthcare workers as well as the general public”
Looking ahead
As a result of the COVID-19 pandemic, we may see the development of standards specifically for PPE for healthcare workers as well as the general public.
In France and Germany there are standards being produced for barrier type masks for people to wear in public, so it may not be too long before these are standardised across several countries.
In the continual fight against the COVID19 pandemic, we are currently using standards that are designed to protect against different risks and hazards associated with different industries and applying them to healthcare situations. As the need for PPE amongst healthcare workers continues to take prominence, we will be seeing this as a factor in standards writing in the future.
One thing that has become apparent is that governments are looking to produce PPE domestically to be less reliant on imports which in some cases have been shown to be vulnerable to both quality and sustainability. Therefore, we might see more domestic manufacturing and perhaps more non-PPE manufactures making PPE as part of their portfolio as is the case with fashion designers including Burberry and Barbour.
BSI hosted a webinar to provide information to organisations wishing to support the efforts in placing more Personal Protective Equipment (PPE) on the market. The webinar is now available to watch – visit the BSI website for further information.
Face coverings
Another big topic during the COVID-19 pandemic has been face coverings, as they increasingly become part of our everyday lives. This is because wearing a face covering may reduce the spread of coronavirus droplets in enclosed public spaces (shops, supermarkets, shopping centres etc), helping to protect others.
“the performance and design of facemarks may differ significantly, which is why BSI recently launched a Kitemark™ for Face Coverings”
The wearing of face coverings is currently at its highest level since the new rules were enforced in the UK. In fact, a survey by the Office for National Statistics has revealed that almost all adults (96%) who had left their homes the week of 7 August 2020 said they had worn a face covering to slow the spread of the coronavirus (COVID-19) – an increase from 84% the previous week and 71% the week before that.
Face coverings differ to PPE because they are not assessed to the same regulatory requirements as PPE or Medical Device requirements. Therefore, face coverings are not considered PPE because they are intended to protect those in close proximity to the wearer, not the wearer themselves.
Whilst a vast number of face coverings are already available on the market, their performance and design may differ significantly, which is why BSI recently launched a Kitemark™ for Face Coverings to boost consumer confidence.
The new Kitemark assesses face coverings to a technical specification that requires 70% particle filtration and breathability tests to ensure consumer comfort whilst reducing the risk of spreading infection. On top of breathability and filtering, the new Kitemark provides independent approval of the quality of the fitting, and the instructions provided to the wearer to minimise the chances of transmission.
Specifically, it tests that products meet a minimum requirement in terms of:
- A basic level of protection against the transmission of infected droplets
- The manufacture, design and performance of the covering Other criteria that are assessed include whether:
- The head harness is designed to be put on or taken off easily
- It achieves 70% particle filtration when tested using the sodium chloride test method
- The wearer can breathe through the material to a certain resistance level
- It can be adjusted to fit different head shapes and sizes
- It has clear instructions for use/fitting
- Can withstand a minimum of five washing cycles (if a client’s product isn’t single use)
There is an overwhelming choice of face coverings available in the market. The challenge is knowing which claims they make are valid and whether they provide a basic level of protection to others. Face coverings that are independently assessed to schemes such as the Kitemark will allow consumers to make an informed decision and choose products they can trust.
“the performance and design of facemarks may differ significantly, which is why BSI recently launched a Kitemark™ for Face Coverings”
As we continue to pull together as a country to combat the impact of COVID-19, it is important that we all take appropriate measures to protect one another. Whilst a face covering can never provide the same level of personal protection as a PPE or medical grade face mask, it is neither necessary nor appropriate for such products to be diverted to general consumer use. Providing consumers with confidence that their face covering provides some level of protection for those around them will help reduce the spread of the virus whilst we emerge from lockdown.
