FDA Loosens Strings On Ventilator Guidelines To Cope With COVID-19 Outbreak

03/22/2020
Ventilator

On Sunday, March 22, 2020, the FDA published a guide that eases up on ventilator processes and uses to meet the demand of the devices amid the COVID-19 outbreak. The guide allows ventilator manufacturers to modify the machine’s software and hardware without submitting a premarket notification first. The guide also outlines suggestions for non-medical industries who seek to use their facilities to produce the breathing machines. The FDA encourages automakers and other manufacturing buildings to take part in the fight against the coronavirus. Some lawmakers want President Trump to use the Defense Production Act as incentive. However, the president stated that this was not necessary.

The demand for ventilators has increased since the COVID-19 outbreak first began. Medical personnel use the breathing machines to save patient’s lives in worst case scenarios. However, medical systems within the United States are worried they won’t be able to meet the overwhelming demand of its patients and desperately need more machines in place to save as many people as possible. The FDA is stepping in to help by loosening guidelines on how the machines are made and used. Additionally, the Society of Critical Care Medicine also issued advice for hospitals to help them have a plan in place. The document includes data on projected ICU occupancy rates as well as crisis beds for the critically ill. 

The FDA guidelines allow manufacturers and organizations to use and construct ventilators easier without the restraints and restrictions that are normally placed on these processes. As a result, medical equipment makers can make changes to existing products, which would allow more devices to get into the hands of those who need them quicker. This may include changes to materials or supplies. These new guidelines would also allow automakers to easily repurpose their production area to make ventilators and increase supplies all over the United States. The guide clears companies to make changes to ventilators without first making a premarket 510(k) notification.

Specifically, the policy stated that changes to the ventilator motor allowing an alternative supplier to meet the required design specification is permitted. Also, changes to the material in the ventilator tubing to allow for more flexible material sourcing is permitted. Waiving this notification does not put the public at risk, according to the FDA. They list modifications to motors that can be done. The FDA also suggests introducing remote monitoring to help keep users away from sick patients while controlling the device. These types of changes do not put the device or the public at risk. Other notable changes included in the policy include the use of the following FDA-approved alternatives to ventilators:

  •  Powered emergency ventilators and anesthesia machines are approved for use
  • Ventilators can be used outside of their cleared environment (such as using a ventilator in a hospital when it is cleared for home use only)
  • Devices used for sleep apnea, including non-continuous ventilators, can be used to deliver continuous positive airway pressure or bilevel positive airway pressure to treat patients with COVID-19
  • Oxygen concentrators can be used when medically necessary
  • Software and hardware changes, such as modifications to electrical components and the capability for remote monitoring, are permitted


 

These actions are directed toward companies that already make ventilators for the United States. The FDA also plans to target companies that sell ventilators in other markets or industries to obtain their devices under the Emergency Use Authorization process. The guide was part of a series of announcements regarding ventilator production by non-medical industries to help meet the overwhelming demands for the device. Recently, General Motors and Seattle-based ventilator maker Ventec Life Systems agreed to collaborate to drastically increase ventilator production in the United States.


 

Other large companies, such as Ford and Tesla, are also set to use their facilities to make ventilators. Medical industry manufacturer Medtronic stated that they are hoping to double their ventilator production. The goal of the new FDA guidelines is to ensure that hospitals across the United States have enough ventilators during the COVID-19 pandemic. Additionally, the FDA is relaxing on rules regarding the use of alternative devices that are capable of delivering pressure support or breaths. This includes continuous positive airway pressure devices and anesthesia gas machines. Hospitals and medical professionals can use these devices if a ventilator is not available.

 

However, many hospitals and medical staff want a more forceful approach. According to a letter addressed to President Trump on March 20, 2020, America’s hospitals and health systems urge the president to use the DPA to increase production of medical supplies and disposables to all front-line workers. The guide is part of a series of policies that regulators are using to respond to the healthcare emergency to speed up production and use of critical diagnostics and devices.