FFP respirators with defects
The BFU and Suva have opened proceedings against importers and distributors who placed defective FFP respirators (not to be confused with hygiene masks) on the market in Switzerland. Recalls and sales bans are expected for the affected models. Importers, distributors and employers are urged to exercise increased caution. BFU and Suva show which features to look for when purchasing FFP respirators.
The BFU and Suva have an effect in Switzerland in accordance with Product Safety Act PrSG as market surveillance authorities for personal protective equipment (PPE), which also includes respirators of the FFP type. These respirators - recognizable, among other things, by their curved shape - are not to be confused with hygiene masks, which have a rectangular shape (cf. pictures). Swissmedic is the responsible market surveillance authority for the latter.
Within a short period of time, the Covid 19 pandemic led to an increased Demand for respirators. In order to ensure the necessary supply, especially in the healthcare sector, the Federal Council eased the import conditions for personal protective equipment with a special regulation at the beginning of April. With a simplified test, it is now possible to place respiratory protection masks on the market. Subsequently, Suva and BFU noticed on the basis of license applications, inquiries and reports that numerous defective products had come into circulation.
Over 60 percent with insufficient protective effect
As part of the above-mentioned legal mandate for market surveillance, the BFU and Suva jointly inspected around 60 respirators available in Switzerland in a concentrated random sampling program. The products, most of which were purchased online and most of which were labeled KN95, were tested for effectiveness in a Suva laboratory. Most of the results are now available: More than 60 percent of the tested models do not offer sufficient protection. The BFU and Suva therefore call on all players who currently import, sell or use respirators to exercise increased caution.
This is what you need to pay attention to
The exact test results are part of ongoing proceedings on which no comment is possible at present for legal reasons. However, there are typical characteristics, the absence of which raises doubts about the quality of FFP respirators:
- The respirator should bear the CE mark followed by a four-digit number corresponding to the identification number of the supervising notified body. For example: CE 0121
- The packaging should bear the CE mark with the same identification number as on the mask, plus the standard designation "EN 149:2001+A1:2009" and the address of a distributor in the EU or Switzerland.
- The user information should be accompanied by a copy of the declaration of conformity with reference to a type examination according to EN 149:2001+A1:2009 - or an internet address where the declaration of conformity can be accessed.
- Identical information on the manufacturer and company address should be present on the packaging and in the declaration of conformity.
Alternatively, a Corona Pandemic Respirator (CPA), which does not have the above features, is also possible for infection protection.
The BFU and Suva recommend that FFP masks be purchased from specialty stores or approved suppliers.
Recalls and sales bans expected
Official proceedings have been opened against the distributors (importers and dealers) of FFP respirators classified as defective by the BFU and Suva. In the process, measures are being defined to Users from possible health risks. Recalls or sales bans are planned for products with proven defects. Public recalls are published on the website of the Consumer Affairs Bureau BFK.
In parallel to the ongoing proceedings, the BFU and Suva process further notifications regarding defective products. Products that are the subject of a complaint can be subjected to an inspection in individual cases; if necessary, measures are ordered. The AAIB is responsible for the market surveillance of products used outside the company, while Suva is responsible for the control of products used in operations. The State Secretariat for Economic Affairs SECO is the supervisory authority.
For working environment only FFP respirators are sufficient
Respirators that have not been placed on the market in accordance with the PPE Ordinance or EN149, e.g. KN95 masks, are not suitable for work situations involving dust emissions. In addition, respirators that have been placed on the market under the facilitated import conditions decided by the Federal Council are limited to infection protection and must not be designated as FFP respirators. Where an FFP respirator is prescribed for reasons of occupational safety, it is mandatory that such a respirator be used.
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Info from the editorial office
The current SAFETY-PLUS 3/20 of 16.09.2020 will include a technical article on the subject of FIT testing of respirators. Subscribe today to the SAFETY-PLUS.
