The use of face masks, gloves and other protective clothing has been all over the news in recent weeks. For obvious reasons, we all want to protect ourselves against the airborne coronavirus disease Covid-19 and many people will be looking to buy them online or elsewhere.
But it’s important to know if the piece of equipment has been designed for its intended purpose, otherwise we will not only be wasting our money, but exposing ourselves to a higher risk of infection.
Medical professionals involved in sourcing equipment will be familiar with the terminology and regulations. Below we set out a short explanation for members of the public as it is a confusing area.
The equipment we need to protect ourselves are regulated as Personal Protective Equipment (PPE) and are specifically designed as a barrier against ‘harmful biological agents’.
In the UK and EU, these products currently need to comply with the European PPE regulation and will have a CE marking on their packaging.
However, beware as the CE marking will also be on masks that won’t protect you. This is because not all masks for medical use are primarily intended to protect the wearer. Surgical masks are primarily intended to protect the patient during an examination or clinical procedure. These products will need to comply with a regulation based on the European Medical Device directive and will also have a CE marking.
Masks can also be designed for duel use, both as a PPE and a Medical Device. In this case the manufacturer will need to comply with both regulations.
So, if the CE marking is not a clear indicator of intended use, what else can we look out for should we buy a mask for protection.
Most PPE will refer to technical standards. These will specify materials to be used or test methods but may be difficult to interpret for most consumers.
The packaging of the product should be used by manufacturers to convey intended use to be compliant with all the applicable regulations, but sometimes the information is not easy to understand.
Where else can we get useful information about these essential devices and their intended use?
The Global Medical Device Nomenclature (GMDN) has provided the healthcare world with specific generic descriptions concerning all medical products for nearly 20 years and provides manufacturers and regulators a standard way of describing products and their intended purpose.
In the following examples of masks we discussed above, the GMDN has several relevant descriptions.
For PPE use there is:
Public respirator, single-use – GMDN Code 57793
A form-shaped filtering mask designed to be placed over the nose and mouth of a member of the general public to permit normal breathing while protecting the wearer from large particles (e.g., blood, body fluids, and airborne particulate materials) and small particles (e.g., bacteria and viruses) when considered necessary (e.g., viral epidemic). It is typically made of multiple layers of non-woven polymers to produce a soft, flexible mask that will create an airtight seal against the user’s face and typically secured using elastic head straps or ties; it may incorporate a forming nosepiece (metal wire) and/or an exhalation valve. This is a single-use device.
For Medical Device use there is:
Surgical/medical face mask, single-use – GMDN Code 35177
A flexible, loose-fitting mask designed to be placed over the mouth and/or nose of a healthcare worker to permit normal breathing while protecting the patient and wearer from the transfer of large particles (e.g., blood, body fluids, and airborne particulate materials) during medical procedures and patient examination; it is not a form-shaped filtering device (i.e., not a respirator). It is made of a flexible, porous fabric or paper material and is typically secured using elastic head straps or ties; it may incorporate a forming nosepiece (metal wire) and/or transparent face/eye visor intended to protect the upper face/eyes from debris/fluid. This is a single-use device.
Surgical/medical face mask, reusable – GMDN Code 37713
A flexible, loose-fitting mask designed to be placed over the mouth and/or nose of a healthcare worker to permit normal breathing while protecting the patient and wearer from the transfer of large particles (e.g., blood, body fluids, and airborne particulate materials) during medical procedures and patient examination; it is not a form-shaped filtering device (i.e., not a respirator). It is made of a flexible, porous fabric or paper material and is typically secured using elastic head straps or ties; it may incorporate a forming nosepiece (metal wire) and/or transparent face/eye visor intended to protect the upper face/eyes from debris/fluid. This is a reusable device.
For combined PPE and Medical Device use there is:
Surgical/medical respirator – GMDN Code 57794
A form-shaped filtering mask designed to be placed over the nose and mouth of a healthcare worker to permit normal breathing while protecting the wearer and patient from large particles (e.g., blood, body fluids, and airborne particulate materials) and small particles (e.g., bacteria and viruses) during medical, surgical, dental, and isolation procedures. It is typically made of multiple layers of non-woven polymers to produce a soft, flexible mask that will create an airtight seal against the user’s face and typically secured using elastic head straps or ties; it may incorporate a forming nosepiece (metal wire) and/or an exhalation valve. This is a single-use device.
This is not an exhaustive list of GMDN Terms available on this subject and we work continuously with regulators to ensure that we have product descriptions that meet their needs.
All the GMDN Terms have definitions that accurately describe the product and its intended purpose. It has a unique 5-digit Code too.
Can we find the GMDN Names, Definitions or Codes on the product packaging to make sure we have the right product? No, these descriptions are not intended to be on the packaging for several important reasons. The definitions are a bit wordy, the GMDN is published in over 25 languages and it would take up too much space on the packaging. Also, these technical descriptions are subject to change over time as new medical innovations become available and are therefore dynamic in nature.
Fortunately, all medical devices now have unique bar-codes or UDIs in the USA and some other countries and we can use a mobile application (such as UDidentify) to scan the bar-code and link instantly to the GMDN description and other important safety information. This type of application is not yet available for most devices on the European market because the requirement to use a UDI has not been fully implemented yet, but it is expected in the next few years.
In the absence of such an app, people should be wary of face masks being sold online. A reliable supplier will have a long-established track record of supplying medical equipment and will be able to provide the CE marking information and instruction for use. Ideally, they will include the GMDN too.
The descriptions above help to standardise the name of products and group products together that carry out the same function. This helps the management and supply of all the products needed, especially important in these challenging times.
