The coronavirus/COVID-19 pandemic has seen many companies pivot their business to support the efforts to protect those having to work in a potentially exposed environment. It will be important for you to know which sources are reliable, as we have continued to see large recalls happen for various medical products supplied during the global crisis. To help you navigate these things here are some important pieces of information and when possible the link to the appropriate Health Canada website.
Hand Sanitizers
Hand Sanitizers are Natural Health Product and require a NPN# from Health Canada, which in most cases you should be able to find on the packaging. Health Canada keeps a list of approved Hand Sanitizers with a searchable database that you can reference at any given time (https://www.canada.ca/en/health-canada/services/drugs-health-products/disinfectants/covid-19/hand-sanitizer.html).
Some have been recently recalled and you can find the updated list here from Health Canada (https://healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/2020/73269a-eng.php).
Masks and Respirators
There has been a massive increase in the need by the Health system in every country for masks and respirators and we should note that because of the shortage Health Canada has directed that any surgical masks and N95 respirators should be kept for healthcare providers and others providing direct care to COVID-19 patients (Site reference: https://www.canada.ca/en/health-canada/services/drugs-health-products/covid19-industry/medical-devices/personal-protective-equipment/medical-masks-respirators.html)
When it comes to respirators, currently the FDA has limited their manufactures to the this list of companies (https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-authorizations-medical-devices/personal-protective-equipment-euas). This list also includes the respirators no longer authorized by the FDA due to the inability to filter to the appropriate standards.
NIOSH, who certifies respirators, keeps a database of approved ones that can be found here (https://wwwn.cdc.gov/niosh-cel/). The N95 designation means that NIOSH has certified its ability to filter 95% of particulates. KN95 is a designation from a governing body in China. The FDA has given approval for some KN95 masks to be imported which is shown in the list above.
With regards to respirators, Health Canada suggests you doing the following:
- Confirm that your product has been certified by NIOSH by entering the approval number, which can be found on the respirator, in the NIOSH database.
- Review the product package and respirator to ensure it has the appropriate markings and details, as required by NIOSH. This includes the TC (Testing and Certification) approval number (a number set by NIOSH), the name of the manufacturer, the NIOSH name or logo, the model number, and filter efficiency (N95).
- Look at product markings, such as the name of the manufacturer, to determine whether there are any obvious signs that the product is counterfeit (e.g., incorrect spelling).
- If your mask is fraudulent or uncertified, stop using it.
- Report information on the potential false or misleading advertising or sale of unauthorized products to Health Canada.
(Reference Page: https://healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/2020/72707a-eng.php)
Licensing
Class I Medical Devices includes such items as masks, gowns, face shields and gloves, when used to protect a person from a disease or virus, whether in a healthcare setting or personal use. The exception here is for use in another say industrial manner, i.e. respirators with the intended use within construction.
Health Canada monitors these products through a Medical Device Establishment License (MDEL), which is required for the manufacture, importation or distribution of these products. If you are not purchasing your PPE from a standard retailor, you can check here (https://health-products.canada.ca/mdel-leim/) with Health Canada to ensure the licenses have been obtained.
Beware Fake and Fraudulent Products
There has been an increased amount of fraudulent products on the market and these products can put you or others at a greater risk to the virus, so doing your due diligence is important. Health Canada, while working diligently to protect the Canadian public, may not have had time to unearth all of the bad actors, so here are some pointers;
The Food & Drug Administration does not allow for the use of its logo or trademark on products as it could be seen as to endorse those individual products, even if approved by the FDA as referenced on their website(https://www.fda.gov/consumers/consumer-updates/it-really-fda-approved). If you see the use of the logo to sell a product on a website, box or other packaging, this may be an indication that the item of personal protective equipment is not a valid product.
No KN95 respirator or any respirator with an ear loo (versus full head tie) have been approved by NIOSH at time of writing. Therefore if you see these types of products indicating they are NIOSH approved, it may be an indication as to the products legitimacy.
NIOSH have also started a webpage with a list of the fake and counterfeit products that they have discovered with company names and pictures to help you navigate which can be found here (https://www.cdc.gov/niosh/npptl/usernotices/counterfeitResp.html).
There is also a list of masks NIOSH have tested for efficacy, including those that do not pass here (https://www.cdc.gov/niosh/npptl/respirators/testing/NonNIOSHresults.html).
Note: That Health Canada does suggest wearing any face covering (https://www.canada.ca/en/public-health/services/diseases/2019-novel-coronavirus-infection/prevention-risks/about-non-medical-masks-face-coverings.html) and it is seen as having some benefit.
Note: CHES SR has put this together for reference purposes only, and individuals and companies should seek the relevant advice and resources of the appropriate authorities.
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