Volume 7 • 2020 • Issue 4

Tips to Spot Counterfeit Masks • Look for misspelling of ‘NIOSH’ on product markings. • The product does not have an approval number. • The product has no markings. • The product has ear loops instead of a headband/ head harness. • The product offers claim approval for use by children and/or have decorative add-ons. criteria of 95%. These masks may still be available for sale, but should be re-labelled as “face masks,” and not “respirators.” What to Do Check to see if your N95 respirator has been certified by NIOSH by entering the approval number, which can be found on the respirator itself, in the NIOSH database. If your mask is fraudulent or unauthorized, stop using it. For KN95 respirators that you may have already purchased, check the recently revised FDA-approved manufacturers listing (see “N95 Resources”). Beware of Importing Personal Protective Equipment (PPE) As the health care industry continues to struggle with PPE shortages, individuals should take steps to ensure the supplies they are purchasing meet all the applicable regulatory requirements, because this is the only way to ensure that the products will perform as expected. Buyers are advised to exercise extreme caution before importing any type of PPE from international manufacturers. Note that anyone who imports medical devices usually inherits the responsibilities of the foreign manufacturer to comply with Canadian regulations. These responsibilities can be extensive and result in significant liabilities for the importer, if issues arise. In Canada, N95 respirators are regulated by Health Canada as Class I medical devices. N95 respirators do not require a Medical Device Licence to be sold in Canada if the manufacturer or importer holds a Medical Device Establishment Licence. Tips to Spot Suspicious Sellers • The primary email contact of the seller uses a free email service. • Look for typos and bad grammar in advertisements, website content or email marketing. • Look for broken links, unfinished content or other errors in advertisements, website content or email marketing. • Terms such as legitimate and genuine are red flags. • Prices are “too good to be true.” • The seller makes claims of having “unlimited stock” during times of global shortages. N95 Resources CDA Oasis Interview with Dr. Aaron Burry, CDA Associate Director, Professional Affairs oasisdiscussions.ca/2020/05/16/32159 Health Canada website (up-to-date resources about respirators, medical device licence listings, complaints process for health products and devices) canada.ca/en/health-canada.html NIOSH N95 alternatives buyandsell.gc.ca/specifications-for- COVID-19-products#100 NIOSH database cdc.gov/niosh-cel FDA-approved KN95 manufacturers listing fda.gov/media/136663/download 13 Issue 4 | 2020 | CDA at W ork