Availability of the FFP2 mask in Germany: A commentary

In early 2020, face protection was still widely considered unnecessary. Now, mask use shifted to compulsory FFP2 use in public. Can we entrust such implementation to citizens with a clear conscience?

esanum’s medical editor explores the current masks “ecosystem”

At the beginning of the pandemic, mouth-to-nose protection was still widely considered unnecessary. Now, mask use shifted to a FFP2 mask requirement in public. Can we entrust such implementation to citizens with a clear conscience?

It borders on a miracle: A year ago, at the beginning of the pandemic, mouth-to-nose protection was still widely considered unnecessary, precisely because there were not enough masks in stock. As of this week, the mask “ecosystem” has now been replaced by the FFP2 mask requirement in public areas in Germany. Still, there is some space for improvement regarding their correct use by citizens. More critically of course is the scarcity issue. It is not always easy, even for experts and pharmacies to distinguish fake FFP2 masks from the certified ones. But even after these hurdles, can we entrust the selection of the right mask to the citizens with a clear conscience? 

Bavaria (Germany) has led the way and now the mask requirement is a nationwide policy. The FFP2 mask obligation in public transport as well as when shopping is in effect across all German states. From the federal government's point of view, this seems like a “bull’s eye” in the fight against the COVID-19 pandemic. But experts are already beginning to warn that this sort of ‘outsourcing’ of medical mouth-nose protection into the hands of the public does not necessarily mean greater safety. Do these experts have a point?

Problem 1: Leaving the nose free to breathe

An uncovered nose, a mask left as “chin coverage” or the mask being left wrapped around the wrist: We have observed many wrong and discretionary styles of mask usage during this pandemic. It is hard to believe that everything will be different with the FFP2 mask.

As Germany’s Robert Koch Institute (RKI) announced as early as January 14, 2021, the FFP2 masks previously used only in the medical environment are not without risks. Correctly put on, they close the mouth and nose by producing something as close as possible to an "airtight" space, so that the respiratory flow can only take place through the optional three- to five-layer mesh of the mask. Elderly people and patients with impaired lung function could well experience breathing problems with such air flow.

In addition, breathing difficulties or contact dermatitis have been described even among healthcare personnel as a result of the masks’ tight fit. Properly fitted and worn, on the other hand, these masks provide a high level of protection against viruses. But any person that may feel discomfort by such an unnatural breathing sensation through the FFP2 may instinctively lead people to make discretionary movements to catch a bit of fresh air. It seems okay to just quickly lift the mask to ventilate for a second or briefly let the nose get out of this “airtight” space right? Unfortunately, this is not the case for ensuring an effective protection against infection.

Problem 2: FFP2 masks are disposable products

What makes it even more difficult is that FFP2 masks are intended for single use and therefore actually have to be replaced every day. Since they are also more expensive compared to the beloved and washable textile masks that have become so popular, they definitely need to be used more carefully, and less frequently by the citizens that are not part of the medical or front line community.

Sure, it is good news that there are already instructions on the Internet about how FFP2 masks could be recycled. Simply buy seven masks, label each with a different day of the week and then hang them dry on the line in the evening for seven days of airing. If it's Monday again, just take the Monday mask off the line and go shopping again at the supermarket. Great, infection protection with the FFP2 mask can be so simple.

Anyone who thinks that this is a misleading or an irresponsible suggestion for reuse, is unfortunately mistaken. What alternative do pensioners have when it is hard for them to make ends meet with their low incomes, specially as they wait for weeks, or maybe even months, for their free initial package of FFP2 masks that has been offered in Germany to the elderly? Or what about families relying on unemployment programs, whose coverage for medical expenses amounts to about 20 euros a month? What about the children whose faces are actually much too small for the masks? These issues, little or simple as they are, should have been discussed and clarified last summer when the infection rates seemed under control in Germany.

Problem 3: FFP2 masks in a “frugal consumer” market

Even those who earn well will probably at least think about buying their FFP2 masks at bargain prices. Germany is a country of savers. So why pay €5 per mask when you can get them in a bargain pack for less than €1? Economies of scale guide German consumers.

The problem is that there are many “con-artists” making shady offers on the Internet. Masks that do not carry a certificate, have been relabeled, or do not even have approval for the European healthcare market standard, are roaming freely on and offline. From the outside, these "false FFP2 masks" are no different to the untrained eye, which has become quite tired of the constant change of mask use guidelines. But in terms of infection protection, and more specifically their filtering function, they differ quite considerably.

The German Federal Institute for Occupational Safety and Health (German acronym: BAUA) recommends the following for selecting the right mask:

Obviously, it does not matter that a mask has many numbers and letters and serials printed on it. It may still be a pirated mask, so attention to the indications above are crucial. Also, the mask should also always match the packaging.

Masks that are standardized and can be used as replacements for one another in the COVID-19 context are the European FFP2, the Chinese KN95, or the US N95. This marking should also be printed next to the manufacturer on the mask. In addition, there is the EU-wide CE marking consisting of the letters CE followed by a four-digit number, e.g. the widely used 2163, which stands for the testing institute “Universal Uygunluk Değerlendirme Hizmetleri ve Tic. A.Ş.” in Turkey. In Germany, the “TÜV Rheinland LGA Products GmbH” does mask testing certifications with the CE number 0197. The EU Commission has also published a list of all test centers certified in Europe.

Of particular help is a list of Germany’s BAUA, which is continuously updated under the keyword "FFP2" and currently lists the 53 known non-certified "FFP2 masks" or those classified as hazardous to health (as of Jan. 21, 2021). Consulting your masks with this list is recommended in any case, because especially for the layperson - with a tight health budget - the "false" masks are often indistinguishable from the "real" ones.

Conclusion

All in all, the introduction of compulsory FFP2 masks in public areas is certainly a step in the right direction in terms of epidemiology and public health management, in order to be able to control this pandemic. There is now sufficient scientific evidence that surgical masks, FFP2 and FFP3 masks in ascending order also offer protection against viral pathogens.

However, other standards and requirements apply to the use of medical masks. Here, however, the German government leaves the users in the dark with the regulations guiding the compulsory use of FFP2 masks. While some are still waiting for the announced voucher from their health insurance company (which is supposed to grant them free access medical mouth-nose protection), others have long been coping with their daily lives by using a wide range of FFP2 masks. And are the public transport drivers and salespeople supposed to control these standards? Or is it entirely a compulsory national mandate that relies on citizens self-regulation? Or is any other authority in charge of overseeing the compulsory standards and ensuring penalties? I´m having a bit of a health policy headache, and I think I´m not the only one.

References:
Federal Institute for Occupational Safety and Health (baua)
EU Commission: CE testing institutes
Robert Koch Institute: Infection protection site

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