Nearly 70% of KN95 Masks Fail To Meet Minimum U.S. Standards

PLYMOUTH MEETING, PA—“An analysis by the nation’s largest patient safety organization shows that up to 70 percent of KN95 masks it tested do not meet U.S. standards for effectiveness, raising risks of contracting COVID-19 for care providers and patients at hospitals and other healthcare organizations that imported masks from China.”1 Beginning in early August, researchers at the ECRI Institute tested over 200 masks from 15 different Chinese manufactures that were labeled as KN95 masks. Alarmingly, the ECRI researchers “….found that 60 to 70 percent of imported KN95 masks do not filter 95 percent of aerosol particulates, contrary to what their name suggests.”2 For those who might not be familiar with the organization, ECRI Institute is an independent, nonprofit research organization that studies and then publishes the best approaches to improving patient care and patient outcomes. Since 1971, ECRI Institute has been producing publications (i.e., Health Devices), reports and materials to help improve the effectiveness, safety, and economy of health services. Through its comparative equipment evaluations, product ratings, patient safety alerts, and guidance articles, ECRI Institute provides independent, objective judgment for selecting, purchasing, managing, and using medical devices, equipment, and systems.3   What were the underling events that led up to all of these inferior masks being imported from China? On August 5, 2020, the FDA issued an Emergency Used Authorization (EUA) for several types of single use, disposable surgical masks; including KN95 masks (see previous blog). This EUA was issued in response to healthcare workers’ concerns relating to the availability and a potential lack of adequate supply for such masks due to the ongoing threat posed by the Covid-19 pandemic.   According to the FDA, their August 5^th EUA “….authorizes the emergency use of surgical masks that meet certain performance requirements for use in healthcare settings by health care personnel as personal protective equipment to provide a physical barrier to fluids and particulate materials to prevent HCP exposure to respiratory droplets and large particles during surgical mask shortages resulting from the COVID-19 pandemic.”4 Recall that during the initial stages of the Covid-19 pandemic, there was a severe shortage of personal protective equipment (PPE) in the United States, including KN95 masks. Healthcare workers were often forced to use whatever was available, including masks that lacked the aerosol protection from Covid-19 droplets afforded with KN95 masks. In response to this problem, healthcare facilities turned to a lot of newly-registered companies in China to provide additional sources of supply for KN95 masks. This huge increase in demand required the FDA to issue the EUA in August to permit the use of these masks from China. While a lot of the KN95 masks from China don’t meet FDA filtration standards for KN95 masks, ECRI Institute does point out that “KN95 masks that don’t meet U.S. regulatory standards still generally provide more respiratory protection than surgical or cloth masks and can be used in certain clinical settings,” said the vice president for technology and safety at ECRI. “Hospitals and staff who treat suspected COVID-19 patients should be aware that imported masks may not meet current U.S. regulatory standards despite marketing that says otherwise.”5 To read the entire ECRI Institute press release on these Chinese made KN95 masks that do not meet FDA standards. Click here1. Your personal safety, along with the safety of your co-workers and patients, is greatly impacted by the efficacy and effectiveness of the PPE products, including KN95 masks, which you use in your healthcare facility. Please share this important information with all of your co-workers to help ensure their safety and the safety of patients.   1 https://www.ecri.org/press/up-to-70-of-chinese-kn95-masks-tested-by-ecri-dont-meet-minimum-standards 2 IBID “ECRI Press” 3 ECRI website (https://www.ecri.org ) 4 https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-authorizations-medical-devices/personal-protective-equipment-euas#appendixasurgicalmasks   5 IBID “ECRI Press”