By Jonathan Springston, Editor, Relias Media
The FDA this week issued updated guidance regarding the agency’s policies on producing, modifying, and using ventilators in response to potential shortages as healthcare professionals continue treating COVID-19 patients.
First, the agency said it will use discretion regarding modifications to FDA-approved ventilators. Usually, when someone modifies one of these machines, that can trigger an FDA premarket review, which can lead to treatment delays. On a related note, the agency said it will allow non-medical device manufacturers (e.g., car factories) to produce ventilator parts.
Second, the updated guidance allows medical facilities to use ventilators past their prescribed shelf life date, and to use machines that might be designated for one practice area. For example, the agency noted ventilators used in ambulances could be moved into a facility for long-term use.
Third, the agency encouraged ventilator makers to apply for an emergency use authorization, which can help speed machine production and lead to wider distribution.
“We are providing maximum regulatory flexibility to facilitate an increase in ventilator inventory, while still providing crucial FDA oversight,” FDA Commissioner Stephen Hahn, MD, said in a statement. “We believe this action will immediately increase ventilator availability. We will continue to engage with both traditional medical device manufacturers and other manufacturers about ways we can facilitate a ramping up of production of these life-saving medical devices.”
While speaking to reporters on Monday, Vice President Mike Pence addressed the nation’s ventilator supply and how the Trump administration is working with state governors to distribute extra machines where needed.
“We determined that the devices that are used by anesthesiologists could be easily converted to ventilators that could be used for people struggling with the coronavirus,” Pence said. “We directed all of our governors again today to survey all of their outpatient clinics to identify what we believe are tens of thousands of these devices, which could add to our nation’s resources for ventilators for people that might be severely impacted by the coronavirus.”
Later in the day, during his COVID-19 update with the media, New York City Mayor Bill de Blasio confirmed that 400 ventilators had arrived in New York City from the federal stockpile.
“That's going to make a huge difference,” de Blasio said. “Our need for ventilators is in the thousands, but we're going to fight every day to stay ahead of this curve. We're going to literally be in a race against time, so [receiving] even 400 ventilators is a huge step forward to help us get through this weekend into next.”
In other related news, the Department of Health and Human Services announced Tuesday it has awarded $100 million to more than 1,300 health centers across the country to help facilities increase testing and telehealth capabilities as well as purchase additional equipment and supplies. This funding is available through the Coronavirus Preparedness and Response Supplemental Appropriations Act 2020, which President Trump signed into law on March 6.
Several current and upcoming issues of various Relias Media publications include in-depth coverage regarding how COVID-19 is affecting many practice areas. For even more updated breaking news about the pandemic, please keep checking in with ReliasMedia.com.