- The Washington Times - Monday, March 23, 2020

The Food and Drug Administration issued a guidance Sunday to help increase the availability of ventilators and other medical equipment amid concerns and reports of supply shortages for health care workers responding to the growing coronavirus pandemic.

The guidance includes the FDA’s plan to exercise “enforcement discretion for certain modifications” for approved devices. For example, this could apply to a manufacturer who modifies a ventilator device by adding wireless capability for remote monitoring, which would normally have to undergo a premarket review that can delay the time it takes for devices to get to the bedside.

The policy also adds production lines or alternatives sites for manufacturers to ramp up manufacturing. The FDA suggested turning to non-medical device manufacturers such as automobile makers to produce ventilator parts.

To “ease regulatory burden on manufacturers,” the FDA is not enforcing premarket reviews for either of these types of modifications.

Hospitals and health care professionals may also use ventilators intended for other environments, according to the FDA policy. The federal agency suggests ventilators normally used for transporting patients in an ambulance could be repurposed for long-term use. Other alternatives could include continuous positive airway pressure devices, which are used to treat sleep apnea.



Health care facilities could use ventilators beyond their indicated shelf life to increase ventilator capacity, the FDA said.

The agency is also encouraging both domestic and foreign manufacturers to pursue emergency use authorization, which would allow them to distribute ventilators in the U.S.

By providing “maximum regulatory flexibility,” the policy will help very ill patients access lifesaving ventilators they need,” said FDA Commissioner Stephen Hahn.

“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 lifesaving medical devices,” Dr. Hahn said.

As concerns about medical supplies rise with climbing COVID-19 cases, the FDA assured it has been working with personal protective equipment manufacturers to understand their supply capabilities and to alleviate the shortages that health care facilities are already experiencing.

Regarding gowns, masks and gloves, the FDA said it shared conservation strategies with health care providers including using non-sterile disposable patient exam gloves for patient care or using medical gloves beyond the designated shelf life in a setting that has a lower risk of transmission.

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