In recent weeks, we have received a lot of information about existing products to prevent Covid-19 infection, which can cause confusion, especially in masks, because there are several types of products that can be similar to each other. Therefore, we will summarize the main differences and requirements of each aspect.
A mask is a hygienic product whose purpose is to prevent the source of infection from spreading from the person wearing the mask to the environment, and is therefore recommended for people with symptoms.
The regulations applicable to them are Directive 93/42/EEC, which will be repealed by Regulation 2017/745, according to which they are classified as Class I medical devices. The applicable safety and function is the CE marking of the product.
Furthermore, according to the mask’s bacterial filtration efficiency (BFE ≥ 95% and BFE ≥ 98%, respectively), surgical masks are divided into types I and II (type II) that are resistant to splashed blood or other liquids. Biological, called type IIR.
Personal Protective Equipment (PPE)
On the other hand, PPE is designed to protect the people who use it from inhalation or contact with hazardous substances, and is suitable for protecting health care personnel.
These products are subject to regulation 2016/425 and are divided into 3 categories, and the PPE is III. As with medical equipment, the certification of compliance is CE marked, which may lead to confusion between PPE and medical equipment. However, the filtering mask (PPE) must be evaluated by the designated agency, so the number of the agency responsible for its evaluation will be shown next to the CE mark and then the classification of the mask (FFP1, FFP2 or FFP3).
At the same time, the filtering mask may be either disposable (NR) or reusable (R), the latter to be cleaned and disinfected according to the manufacturer’s instructions. They may also have an exhalation valve. It may provide greater comfort, but it cannot prevent the virus from being released to the outside.
There are other types of face masks that are not regulated by any previous regulation and therefore are not considered medical equipment or PPE. Although they may contribute to the containment of the pandemic along with other preventive measures, there are no precise data on their effectiveness.
We can also find “dual products” designed to protect workers and patients, so we must comply with both personal protective equipment and medical equipment regulations.
It is also important to remember that no individual mask can provide complete protection against infection, and must always be supplemented by hygiene and evacuation measures prescribed by health authorities.