Face Masks as Medical Devices, To Be or not To Be

It has been a difficult year. An atypical year in which within all the challenges we encounter we have to adopt new habits. One of those, that most affects our daily lives is having to wear face masks almost as a new piece in our wardrobe. We not only have to choose a shirt and pants but a matching face mask. From the health regulations point of view, INVIMA from the beginning of the pandemic stated that face masks would be considered as medical devices and included them in a special category that would require full market approval.

This concept of not full market approval applies to products (pharma products and medical devices) that, although they normally would need health registrations (market approval procedure), are exempted from this requirement, but can still be manufactured and imported in the country. In other words, it is still considered that they are -in this case- medical devices but due to special circumstances the general requirement for these products is suspended. The most frequent products under this program are pharma products used for treatments for orphan diseases, those that, due to the low number of cases, are usually “abandoned” by manufacturers or importers because they are not profitable.

During the pandemic, INVIMA declared a fair number of products under this program, to guarantee that there were no supply problems with products essential for the management of the pandemic. Along with thermometers and ventilators, alcohol and other medications, face masks were included.

But this leads us to a question: If masks are medical devices, even if they do not temporarily require market approval, is any piece of cloth with two strings for the ears a medical device? Because if the answer were positive, that "piece of cloth" would need to be manufactured in facilities that meet the ISO 13485 standard, or another quality management system approved by INVIMA, and submit a considerable amount of documentation related to its design, risks management, a list of technical standards used in its manufacture, among various other requirements.

The situation begins to become clear when the statements of the Ministry of Health and INVIMA are looked into detail. In these it is clearly noted that the only face masks considered as medical devices are the “conventional face masks with indication of use for the prevention or protection of the respiratory system against microorganisms present in hospital care or those for medical use”. If we want to get more technical, the Ministry of Health has issued the following definition:

“Non-hospital general use face mask: Product for the protection of the respiratory tract that covers the mouth, nose and chin provided with a head harness that can surround the head or be attached to the ears. They are not considered a medical device. "

We see then that from the health regulations point of view not all face masks are considered medical devices. At the end, the important thing is to use a product, homemade if there is no other option, for general use or in environments that require a hospital use, to take care of ourselves, take care of others and overcome this situation together.