Several cases of counterfeiting have already been reported. The Center for Disease Control and Prevention (CDC) has listed out some suspect characteristics of counterfeit respirators. Table 1 below summarizes the main suspect characteristics of counterfeit compared to appropriate FFR. Among the suspect features, there are ear loops designs, the absence of markings or references to national regulation or approval number on the FFR or the presence of flawed ones, the presence of decorative add-ons, a declared approval for children or multiple packaging.
The CDC has provided additional tips for the users to detect unreliable sellers, for example when unlimited stocks are declared or if websites contain bad grammar and other errors. The European Commission offers an alert system for dangerous products, including FFR, to receive reports from the authorities of the member states about suspected products found on the market. Through the EU commission portal, users can search for alerted products, seeing pictures, characteristics and if measures were ordered by public authorities. It is also provided a list of contacts to make a report to national authorities.
To date, the risk of infection associated with the use of counterfeit FFR has not been estimated since no specific data are available. However, it is reasonable to believe that counterfeit FFR pose an additional risk of contagion to healthcare workers due the potentially lower protecting capacity. An analysis conducted by the U.S. National Personal Protective Technology Laboratory (NPPTL) demonstrated that the filtering capacity of not NIOSH-approved FFR can vary considerably, from 24.1% to equal to the standard (minimum level >95% for N95 type).
Healthcare workers should alert local competent authorities when in doubt about the appropriateness of FFR in use. Should healthcare workers’ safety rely on the individual ability to detect counterfeit FFR before using? Are institutions making all the possible efforts to avoid making these products available to healthcare workers?
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| Legitimate | Potentially counterfeit | |
|---|---|---|
| Design | Headbands | Ear loops |
| Markings | Approval number | No approval number |
| Brand name or registered trademark | No name or altered name | |
| Filter class and filtering efficiency level | Filter class and filtering efficiency level can be both present or absent or spelled incorrectly | |
| Clear referring to national regulation | No markings or flawed reference | |
| External appearance | No decorations | Decorative materials or adds-on |
| Declared approval | For adults only | For adults or children |
| Seller | Authorized, consistent prices and items over time, email address connected to the website as primary contact, | Previously trading different items (i.e. trendy items), price fluctuations, hidden contacts or free email as primary contact, blank pages, broken links or errors in the website. |