US States Following Canadian Lead and Recalling Imported KN95 Respirators Amid Quality Concerns
In May, the Canadian health authority Health Canada issues a recall of all KN95 filtering facepiece respirators imported from China, citing quality concerns and the risk of fraudulence devices. Now, many US States are also issuing similar warnings and recalls amid growing concerns of the rapidly changing global marketplace. Missouri has recalled 48,000 masks after the imported KN95s failed to meet safety testing standards from the state's Department of Health and Senior Services.
Unfortunately for some states, however, these imported masks had already been distributed to many facilities before quality testing was complete. After the CDC said earlier in April that KN95 respirators could be a safe alternative to previously approved N95 respirators now in short supply, the state of Illinois spent $17 million importing KN95 masks from China and began distributing the devices to healthcare organizations across the state.
The Illinois Department of Public Health subsequently had to issue an emergency electronic notification warning statewide agencies about the potential safety concerns, primarily regarding fraudulent devices that have flooded the market. The SIREN alert issued by Kane County, a suburb of Chicago, specifically stated "KN95 masks from China may not meet performance standards, counterfeit KN95 masks are reportedly flooding the marketplace, [and] Illinois has distributed KN95 masks throughout the state."
These examples highlight growing challenges facing the worldwide medical device supply chain amid the COVID-19 pandemic. The PPE marketplace has seen an large number of new players, and with healthcare purchasing groups scrambling to find supplies, organizations are often having to turn to unknown suppliers and distributors, paying much higher prices than normal for unproven goods.
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For a complete list of devices recalled by Health Canada, reference this Canadian Government article.