The FDA has been working to adapt its policies and restrictions to respond to the growing need for unconventional solutions like shortages of medical equipment needed for treating COVID-19 patients. A group of doctors, engineers and medical researchers from UC Berkeley, UCSF and working hospitals has devised a creative solution to the ventilator shortage they’re hoping will meet FDA standards for emergency use authorization (EUA), working with readily available hardware and a stockpile of medical breathing equipment that’s resting mostly unused under our noses.
The group, which includes pulmonary care physicians, medical and engineering professors, and many more, is calling themselves the COVID-19 Ventilator Rapid Response Team, and together they’ve figured out a way to modify existing CPAP machines typically used to treat sleep apnea to act as the kinds of ventilators needed for intubation to keep severe COVID-19 patients breathing in the ICU.
Sleep apnea machines are not designed for continuous use with patients who can’t breathe on their own — they basically just ensure that a patient’s airway doesn’t become blocked during sleep, which maintains oxygen levels, and prevents unwanted wake-ups and snoring. The group behind this new CPAP modification has adapted the hardware using a tube that can be used for intubation, led by Dr. Ajay Dharia, a critical care physician focused on pulmonary issues in the ICUs at three Bay Area hospitals, as well as an engineering graduate from UC Berkeley.
Already, the FDA has issued guidance stating that healthcare facilities and professionals should consider use of breathing devices not designed for use as ventilators in case of urgent need, so the Ventilator Rapid Response Team already has some leeway in its approach. It’s still seeking an emergency authorization from the agency, however, because it would like to work with suppliers and manufacturers at scale to start producing large quantifies of the modifications required.
It’s also enlisting the help of any individuals or organizations looking to donate CPAP or sleep apnea machines that aren’t currently in use to assist with the supply of the base hardware needed to make the modified ventilators. Anyone interested in that can check out their website for more info.
Source: Tech Crunch