Coronavirus has been rapidly spreading throughout the world. As of April 8th, there are nearly 1.5 million cases worldwide, as well as over 425,000 cases in the United States alone (Worldometers, 2020). With so many people contracting the virus so quickly, the health systems are inundated with patients, or they are preparing to be overwhelmed by the anticipated influx.
The best weapons the medical field has against the virus are ventilators, but there are not nearly enough to handle the projected number of infected in the country. As a result, the Emergency Use Authorization (EUA) has been enacted to help the health system prepare to fight COVID-19 by easing the Food and Drug Administration’s (FDA) normal regulations. The end goal of this policy is to produce more ventilators in different ways and/or with new materials. If the EUA is successful, it could result in the supply of respirators meeting the new overwhelming demand. This could result in hundreds of thousands of lives being saved.
The first major implication of the EUA is that companies who manufacture certain devices will be allowed to modify them to make them work well against COVID-19. These alterations to devices will be approved as long as they do not create any greater risk to the patients. The report states that the FDA will be flexible with modifications made to ventilators, anesthesia gas machines, and respirators. Hospitals will also be able to utilize ventilators that are beyond their shelf life.
There are two major caveats to the modifications. First, hospitals should still use FDA regulated products if they are available. Second, the FDA recommends that the modified devices be labeled as such to avoid confusion. There will also be new regulations that the modified products must meet. A full list of these can be found within the official FDA policy for the EUA. Overall this should help health systems that are threatened by an overwhelming number of patients and have less inventory.
Another major implication of the EUA policy is that products approved in other countries may possibly be used in American hospitals. Manufacturers looking to sell their products in the U.S. will need to go through an application process with the FDA. The products will also only be allowed to go into circulation as long as the pandemic persists. This means that manufacturers who have not yet started selling in the U.S., or were not approved by the FDA, can apply to help during the pandemic. This is mutually beneficial as it will provide manufacturers more potential customers and the U.S. will receive more desperately needed respirators.
The changes brought by the EUA should be welcomed by the medical community as they will help supply ventilators during these trying times. By allowing manufacturers to modify their devices and easing regulations for importing them, the FDA is aiding all health systems and the U.S. population. While the regulations have been eased, there are still some that need to be followed. To read more about these, there is a downloadable version of the guidance that can be found here. Hopefully the EUA will effectively address the problems that critical patients face as a result of COVID-19.
If you would like to learn more about GreenLight Medical and how it can help you in these difficult times, please click here for complimentary access.
Coronavirus Cases: (n.d.). Retrieved from https://www.worldometers.info/coronavirus/
U.S. Food and Drug Administration, U.S. Food and Drug Administration (2020). Retrieved from https://www.fda.gov/regulatory-information/search-fda-guidance-documents/enforcement-policy-ventilators-and-accessories-and-other-respiratory-devices-during-coronavirus