- As ventilator manufacturers scale up production across the U.S. to address a critical need for the breathing machines, AdvaMed on Tuesday sent a letter to the Federal Emergency Management Agency asking for designation of a single agency to make allocation decisions to ensure the devices get to those who need them most.
- Device manufacturers across the country are racing against time to increase ventilator production to meet demand as the number of coronavirus cases continues to rise nationwide. In response to the COVID-19 outbreak, FDA on Sunday issued guidance permitting ventilator manufacturers to modify hardware and software without first submitting a premarket notification.
- AdvaMed said it believes the most effective way to distribute the devices is under the direction of a lead agency, such as FEMA, with input from clinical experts including the CDC and other stakeholders in the face of "unprecedented demand" for the equipment.
A major effort is underway to ramp up production of ventilators as the spread of COVID-19 accelerates across the country amid warnings of a looming shortage. In an article published Monday in the New England Journal of Medicine, Robert Truog, director of the Harvard Center for Bioethics and a professor of anesthesia, and colleagues said the U.S. is not yet facing a shortage of the devices, but whether rationing of ventilators becomes necessary in this country will depend on the pace of the pandemic's spread.
The authors point to a limited window in which a patient can be saved once breathing deteriorates to the point where a ventilator is needed. "The decision about initiating or terminating mechanical ventilation is often truly a life-or-death choice," they said.
The NEJM article cites numbers from the Johns Hopkins Bloomberg School of Public Health indicating U.S. hospitals have about 62,000 full-function ventilators and 98,000 basic ventilators, with an additional 8,900 in the Strategic National Stockpile. CDC estimates that 2.4 million to 21 million Americans will be hospitalized during the pandemic. Italy's experience suggests 10% to 25% of hospitalized patients will require ventilation, the authors wrote.
U.S. manufacturers are racing to produce enough ventilators for those who need them, but face a challenge in determining how to allocate supplies among purchasers, according to AdvaMed. "Many healthcare providers, as well as state and local governments, are trying to buy ventilators. Some of these potential purchasers should have a higher priority than others based on the acuity of patient needs in their areas. It is difficult for manufacturers to establish these priorities," the industry group said.
A single federal agency would be in the best position to assess individual users' needs and determine whether a particular manufacturer or the Strategic National Stockpile should be the supplier, AdvaMed said in its letter to FEMA.
A number of medtechs are stepping up to boost supplies of ventilators to meet the increased demand. On Tuesday, Zoll Medical said it is gearing up to produce 10,000 ventilators per month, a 25-fold increase in its production volume. The company said it is prepared to expand its supply base as necessary. "We have received many unsolicited offers of help from not just medical companies, but industries including aerospace, automotive, and information technology," CEO Jon Rennert said.
Ventec Life Systems is collaborating with GM to expand its ventilator production, with the device maker tapping into GM’s logistics, purchasing and manufacturing expertise, the companies said. ResMed said it is working to double or triple its ventilator output and scale up ventilation mask production more than tenfold.
Medtronic said it is aiming to more than double its ventilator manufacturing workforce and production capacity in response to the crisis. GE Healthcare has added manufacturing lines and relocated employees to ventilator production sites, while Philips said its Chinese manufacturing capacity is rebounding as it also works to boost ventilator production.