As the spread of the 2019 Coronavirus Disease (COVID-19) continues to grow globally, the FDA and other global health organizations have had to put precautions in place to protect the public. With over 93,000 confirmed cases world-wide, a global shortage of crucial medical devices has forced the FDA to authorize additional EUA’s (which you can learn about in our blog post here).1 Specifically, there is a shortage of respirators that are used by healthcare workers to prevent exposure to pathogenic airborne particles.
The FDA currently regulates N95 Respirators as class II medical devices.2 They are common devices found across healthcare centers nationally, but with the onset of COVID-19, there has been an increased demand that manufacturers can’t keep up with. Considering that these devices are critical to protect both healthcare personnel and the general population from the continued spread of disease, on March 2nd, the FDA and the CDC issued an EUA for all disposable filtering facepiece respirators (FFR’s) that are approved by the National Institute for Occupational Safety and Health (NIOS). The EUA also grants authorization to use FFR’s that were NIOSH approved but have passed the manufacturer’s recommended shelf life.3 While these respirators are normally not authorized for use in healthcare settings, the FDA recognized the necessity of granting the EUA to protect healthcare workers. This authorization is intended to maximize the number of respirators and hopefully meet the current demand of the health care system.
Unfortunately, a shortage of additional medical supplies is on the horizon in light of the COVID-19 spread. On Tuesday, the World Health Organization (WHO) Director, Dr. Tedros Adhanom Ghebreyesus, stated that the WHO estimates that 89 million medical masks, 76 million examination gloves, and 1.6 million goggles will be required for an adequate response to the outbreak.4 The organization fears that the rapidly declining supplies of critical medical devices will leave healthcare personnel vulnerable and continue to ignite the spread of the disease. The organization is working with governments and manufacturers to try to boost production. It is predicted that the global supply will need to increase by at least 40% in order to meet demand.5
If you are looking to get your device on the global market to support the ongoing healthcare activities surrounding COVID-19, EMMA International has the expertise to assist. Give us a call at 248-987-4497 or email firstname.lastname@example.org to see how we can help.
1WHO (March 2020) COVID-19 Situation Dashboard retrieved on 03/03/2020 from: https://www.who.int/emergencies/diseases/novel-coronavirus-2019
2FDA (March 2020) Product Classification Database retrieved on 03/03/2020 from: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPCD/classification.cfm?ID=ONT
3FDA (March 2020) Emergency Use Authorizations retrieved on 03/03/2020 from: https://www.fda.gov/medical-devices/emergency-situations-medical-devices/emergency-use-authorizations
4Berlinger, CNN (March 2020) WHO warns of global medical equipment shortage as world braces for coronavirus spread retrieved on 03/04/2020 from: https://www.cnn.com/2020/03/04/asia/novel-coronavirus-covid-19-intl-hnk/index.html
5Nedelman, YU (February 2020) Health Care Braces for Shortages of Supplies due to Coronavirus retrieved on 03/04/2020 from: https://www.cnn.com/2020/02/29/health/fda-medical-device-mask-hospital-shortage/index.html