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Three years ago, the COVID-19 pandemic brought the use of Personal Protective Equipment (PPE) into the public spotlight as it was used to help prevent the transmission of infection. During the peak of the pandemic there was a huge demand for quality PPE – in fact, 32bn PPE items were procured to support the management of COVID-19 in the UK alone from February to July 20201.
However, as the demand for personal protection lessens, three years on PPE remains at the forefront of protecting healthcare professionals, along with workers from other industries, who could face serious workplace injuries or illnesses resulting from physical, electrical, mechanical, chemical, or other workplace hazards.
What is PPE and what is it used for?
When we think of PPE we often think of masks. In fact, PPE encompasses hundreds of products that stretch from head to toe, from protective clothing, helmets, hearing and respiratory protection to body armour and boots. From a legal and regulatory perspective, PPE is defined more specifically as:
a. Equipment designed and manufactured to be worn or held by a person for protection against one or more risks to that person’s health or safety
b. Interchangeable components for equipment referred to in point (a) that are essential for its protective function
c. Connection systems for equipment referred to in point (a) that are not held or worn by a person, that are designed to connect that equipment to an external device or to a reliable anchorage point, that are not designed to be permanently fixed, and that do not require fastening works before use.
PPE Regulation
To keep employees safe in the workplace and 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 or the UKCA mark to be sold within the UK.
A Notified/Approved Body is an independent organization designated by an EU country or the UK to assess the conformity of certain products before being placed on the market. These bodies carry out tasks related to conformity assessment procedures set out in the applicable EU/UK legislation, when a third party is required.
There is an ever-rising need for organizations to comply with health and safety regulations; therefore, exploring the use of PPE can be beneficial. However, with a variety of PPE on the market – each with its own use and application – how do organizations invest in the right protection? Understanding the PPE Regulation (EU) 2016/425 can offer some guidance around making the right choices.
The PPE Regulation groups all products into three main categories depending on the level of risk in the workplace.
Category I: Simple
Minimal risks are present, and employees can identify and assess the level of protection that the product offers. Such risks might include superficial mechanical injury, contact with hot surfaces not exceeding 50°C and atmospheric conditions that are not of an extreme nature. To fall into this category, products must comply with the Essential Health and Safety requirements and bear the CE marking or UKCA marking through the manufacturing self-certification route.
Category II: Intermediate
Neither complex nor simple, products in this category should be certified by a Notified Body/Approved Body, to prove that they meet the technical requirements of the PPE Regulation’s relevant specifications.
Category III: Complex
PPE in this category is designed to protect workers against dangers that could cause serious harm to their health and in some instances, death. These products are designed to safeguard employees against electrical risks, dangerous voltages and provide insulation during high-tension work. To meet the requirements of this category, manufacturers not only need to get their products certified by an accredited body, but also undergo constant surveillance. Their chosen accredited body will select and test samples to ensure all products meet the required standards.
“there is an ever-rising need for organizations to comply with health and safety regulations”
How can you tell if PPE is up to standard?
Specifiers and purchasers of PPE can derive a measure of reassurance about the quality and safety of products from the presence of the ‘CE’ mark and ‘UKCA’ mark.
To keep employees safe in the workplace and reduce health risks, PPE has to comply with all the requirements of the PPE Regulation and carry the CE mark to be sold legally in the EU, as well as the UKCA mark.
UKCA marking
Following the UK’s departure from the EU two years ago, the UK introduced United Kingdom Conformity Assessed marking, known as UKCA marking. This replaces the CE mark on some products placed on the market in Great Britain.
Products sold in Great Britain from the start of the year require UKCA marking. The exception to this is manufacturers in Northern Ireland, who were still able to place products on the market in Great Britain with CE marking after this deadline. Placing products in Northern Ireland will differ because the CE mark or the UKNI mark is required.
This presents some challenges. Currently, there are roughly ten times fewer UK Approved Bodies who can provide the UKCA mark than there were able to provide the CE certification.
CE certification. Whilst not every company will decide to sell their product in Great Britain, we expect a majority to do so, and thus there may be a build-up of work for these UK Approved Bodies.
PPE in the European Union (EU)
When it comes to distributing PPE in the European Union (EU), all products that fall under the European Regulation must carry the CE mark. This is a legal requirement and means that manufacturers are allowed to do business in all 27 EU member states.
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 or Regulations that apply to it and that it can be sold legally in the EU.
The PPE Directive was previously focused only on manufacturers placing products on to 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. They must also keep relevant documents for at least 10 years.
BSI’s status as a Notified Body for many European Directives and Regulations enables it to offer third party testing and factory production control assessments to issue CE marks in the Netherlands. The level of involvement of BSI is determined by the category the product falls under in the Regulation.
The cost of counterfeits
There are some excellent PPE products available on the market, however there are also numerous counterfeit and illegal products. The concern is that these fake products will not perform as they should, potentially putting employees’ lives at risk and exposing their organization to prosecution.
From laboratory to factory floor, PPE is vital to workplace well-being and it is imperative that it meets or exceeds health and safety standards. The new regulation is designed to help prevent companies from selling sub-standard PPE without being accountable. Under this, any organization importing or distributing PPE products will have to ensure they meet the regulation and keep records.
A step forward for PPE and diversity
In industries where women remain under-represented, it hasn’t historically been judged to make economic sense to provide PPE in a range of smaller sizes that cater for women. This can mean, in construction for example, that some female workers may find that most PPE doesn’t fit them or is otherwise unsuitable, because boots and gloves don’t come in their sizes and suits are too large and poorly ventilated. Additionally, in some sectors maternity wear does not exist. With the workplace changing, the way PPE is made is also changing, with the driving force being the evolution of standards to ensure that PPE is designed to keep everyone safe.
Standards written for PPE need to account for a more diverse end user. Health and safety is an industry which has a predominately male demographic, although this is changing. The experts who developed previous standards have tended to come from this demographic, leading to a potential lack of diversity on the committees writing PPE standards around the world.
In a positive development, this is changing. The standards that committees are responsible for developing are increasingly accounting for all types of diverse users. In fact, BSI has a project to identify all standards that need to have a ‘personal’ aspect to them –and this includes not only gender and cultural diversity but also religious, disability, medical and other forms of body differences such as amputees.
The most effective solution to deal with PPE that does not meet the needs of a diverse workforce is to remove the need for PPE wherever possible. Where it isn’t possible, there are still ways for organizations to make clear they prioritize and value their diverse workforce. An organizational culture that involves effective consultation and participation of the workforce to remove obstacles and barriers, such as discrimination or embarrassment (real or perceived), can have a huge impact.
These principles are clearly seen in the international standard on health and safety management – ISO 45001. Organizations that implement this standard will be on the path to empowering their people to participate in good health and safety. In could well be that those people will themselves come up with effective solutions to PPE challenges.
Fabric testing for PPE
When it comes to the textile materials that are used as PPE, it is crucial that they are able to cope with the most extreme requirements. Depending on the area of application, PPE must fulfil a variety of functional requirements. In addition, certain statutory regulations and testing requirements must be observed by the manufacturers and users of PPE.
There are two umbrella standards that BSI tests fabrics against, including:
Protective clothing. General requirements (BS EN ISO 13688:2013+A11:2021)
Part of this Standard tests materials including Chromium VI content in leather, Nickel in metallic fasteners, pH of fabrics and Azo dyes for colours to ensure whatever the wearer has on will not cause a reaction on them.
Protective clothing against chemicals. Test methods and performance classification of chemical protective clothing materials, seams, joins and assemblages (BS EN 14325:2018)
This standard looks at the performance of the material against hazards, from abrasion to chemical protection. However, it does not look at the protective performance of the overall clothing product; these requirements will be stipulated within the applicable standard for that product.
“an organizational culture that involves the workforce to remove barriers can have a huge impact”
Standards in use for biological hazards
Protective clothing against infective agents (EN 14126:2003) is a harmonised standard for the PPE Regulation (EU) 2016/425) and must be combined with other garment standards such as EN 943-1 (Type 1), ISO 16602 (Type 2), EN 14065 (type 3&4) or EN 13034 (Type 6) to demonstrate compliance with the PPE Regulation.
Protective clothing against infective and chemical agents
There are five basic types of protective clothing against chemical and microbiological hazards. Based on the different groups of applications, these five types include:
- gas-tight,
- air-fed non-gas-tight suits,
- suits against pressurized liquids,
- suits against sprayed liquids,
- suits offering limited protective performance liquid chemical spray and splashes.
The level of protection can be generally considered to reduce from Type 1, which offers the highest level of protection, to Type 6, which offers the least protection. For example:
- Type 1 suits fall into 2 classes, 1a & 1b.
- Type 1a – Fully encapsulated gas tight suit with self-contained breathing apparatus inside.
- Type 1b – A gas tight suit with self-contained breathing apparatus outside
- Protection of hands and feet are usually incorporated into the suit.
- Type 2 suits were similar to Type 1 but not gas tight.
- Types 3 to 6 suits are normally worn with gloves, respirators, and protective boots that meet the requirements of PPE Regulation 2016/425
*Type 5 – This suit provides protection to chemicals in the form of dry particles and is therefore not compatible to EN 14126.
Standards for infective agents (EN 14126:2003)
This is considered to be an “add-on standard”, to be used in conjunction with the standard for the individual product and is used to demonstrate the performance of protective garments against infective agents.
Types 3, 4 and 6 garments can also be partial body protection “PB”, the products might be described as gowns. These garments would not be subjected to the “spray” testing but would need to comply with the rest of the requirements of their standard.
Manufacturers should not be confused by the term chemical protective suit for the above types of protective garment. The type of protective garment claimed will be relative to the type and severity of protection claimed for the garment.
The marking of the garment to indicate compliance with EN 14126 would contain a suffix “-B” to the garment type description, for example:
– Type 4 whole body protection – Type 4-B
– Type 4 partial body protection – Type [PB]4-B
If the protective garment does not claim to provide protection against chemicals, it should be clearly stated. The term chemical also includes strong cleaning agents and pharmaceuticals, wherever there is a risk from the effects of immediate or long-term cumulative exposure. The most common protective garments used in medical scenarios are Types 3, 4 and 6 including partial body ‘PB’ garments.
“understanding what PPE is available may prevent accidents from happening”
The choice of which type to claim is dependent on the intended use and degree of exposure. Partial body garments (e.g. gowns, aprons, jackets, etc.) is an area that can be confusing within EN 14126, EN 14605 and EN 13034. However, in order to comply with the requirements for EN 14126, Clause 4.3, the garment still has to comply with all of the applicable requirements of EN 14605 or EN 13034.
Protective clothing may seem complicated, however, understanding what PPE is available may prevent accidents from happening and ultimately protect people and organizations. Certification to key product standards through CE or UKCA marking can help PPE manufacturers clear regulatory hurdles, while differentiating their proven products from poor quality competitors and fakes. Most importantly, however, it can give peace of mind to consumers and commercial buyers that the quality, safety and reliability of PPE products is guaranteed.
References
- https://www.nao.org.uk/wp-content/uploads/2020/11/The-supply-of-personal-protective-equipment-PPE-during-the-COVID-19-pandemic-Summary.pdf
