March 23, 2020

Responses to the Current Ventilator Shortage: FDA’s Recommendations and Guidance for Industry and Health Care Providers

The Society of Critical Care Medicine estimates that the United States has over 200,000 ventilators, although other organizations have lower estimates. According to Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, the federal government emergency stockpile has around 12,700 ventilators. Manufacturers of medical ventilators are immediately increasing production because it appears current inventory of ventilators will not be sufficient to treat a surge in coronavirus patients. For example, GE Healthcare is hiring more people and increasing the number of shifts it operates so that it can produce ventilators around the clock, and Medtronic said that it has already boosted ventilator production by 40% and is on track to more than double its ventilator production capacity.

The U.S. government has invoked the Defense Production Act of 1950 (DPA), which allows the federal government to direct businesses to produce specific goods that are critical to the national defense. The DPA allows the president to require businesses to prioritize and accept contracts for required materials and services and to provide incentives for the domestic industrial base to expand the production and supply of critical materials and goods.

During a White House briefing President Donald Trump said that the DPA was being invoked “just in case we need it.” In North America, General Motors and Ford have shut down auto production and are beginning to evaluate whether they can help with the production of ventilators or other equipment. The British government is working with a number of manufacturers to build a “basic, functional ventilator” that is far cheaper and easier to produce than a standard model. The timeline for automakers to retool and receive regulatory approval to produce medical equipment is unknown; however, it is unlikely to provide additional ventilator production in the short term.

With an anticipated shortage of ventilators looming as more patients with COVID-19 present for treatment, the Food & Drug Administration (FDA) on March 22 published a set of recommendations to health care providers (HCPs) meant to help lessen the shortfall.

While HCPs should, whenever possible, use conventional FDA-cleared ventilators to support patients with respiratory failure, providers may use alternative devices if the number of ventilators is running low. Examples of such alternative devices include ventilators labeled for home use, emergency transport ventilators, anesthesia gas machines, noninvasive ventilation patient interfaces and airway pressure devices used for treatment of sleep apnea. FDA further recommended contacting the manufacturer of the device being used outside of its labeled instructions for specific guidance and taking appropriate precautions with environmental control and additional filtration, if feasible.

HCPs also may have the option of using ventilators from outside the United States. FDA explained that it is seeking to make ventilators that are not currently legally marketed in the United States available to boost supply during the public health emergency.

With respect to ventilator accessories, FDA advised HCPs to consider extending the shelf life and duration of use of these products. Specifically, FDA recommended extending the duration of use of passive humidifiers (heat-moisture exchangers) for up to one week depending on patient condition and available resources.

HCPs are to report potential or actual shortages to FDA at deviceshortages@fda.hhs.gov.

FDA’s letter to health care providers can be found here.

FDA’s recommendations to HCPs are based upon the agency’s policy to expand the availability of ventilators, other respiratory devices and accessories that will remain in effect only for the duration of the public health emergency related to COVID-19. FDA presented the policy as a guidance document, “Enforcement Policy for Ventilators and Accessories and Other Respiratory Devices During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency.”

In sum, FDA does not intend to object to limited modifications to the indications, claims, functionality, or to the hardware, software, or materials of FDA-cleared devices used to support patients with respiratory failure or respiratory insufficiency, without prior submission of a premarket notification, where the modification will not create an undue risk in light of the public health emergency. The guidance provides a table of the types of devices and their accessories to which the policy applies. FDA also provides examples of the types of modifications that FDA currently believes would not create undue risk for modifications that involve the following:

  • FDA-cleared indications, claims or functionality
  • Hardware, software and material changes to FDA-cleared ventilators and anesthesia gas machines
  • Use of ventilator and anesthesia gas machine breathing circuit devices beyond their indicated shelf life and duration of use
  • Validation of changes made to hardware, software, materials or duration of use

With respect to labeling of modified devices, FDA recommends, in part, that the manufacturer describe the device’s new indications and delineate FDA-cleared indications and claims from those that are not FDA-cleared.

As noted in the letter to HCPs, the guidance states that health care facilities should use FDA-cleared conventional/standard full-featured ventilators when necessary to support patients with respiratory failure. Alternatively, health care providers should use a device subject to an Emergency Use Authorization (EUA), if any; however, at this time no EUAs have been issued for ventilators.

FDA also states its interest in interacting with manufacturers of ventilatory support devices that are not currently legally marketed in the U.S. as well as manufacturers who have not previously been engaged in medical device manufacturing with capabilities to increase supply of these devices. FDA asks that such manufacturers email details listed in the guidance to the provided address. FDA will work interactively with manufacturers through its Emergency Use Authorization (EUA) process.

Even if production is able to ramp up to meet demand, there are other issues that hospitals will confront. The first is whether hospitals can find enough staff to operate additional ventilators. The U.K. is currently drafting emergency legislation to bring students and recently retired nurses in to practice. The second is the amount of lead time needed to fill orders for ventilators. According to Premier Inc., a group purchasing organization, the typical timeframe for filling ventilator orders is eight weeks.

Some recent reports have mentioned the possibility of modifying one ventilator so that it can serve multiple patients in the event of a disaster surge. Dr. Greg Neyman and Dr. Charlene Babcock addressed this possibility in an article for the Society for Academic Emergency Medicine in 2006, and Dr. Kevin Menes used one ventilator to treat two patients after the mass shooting in Las Vegas in 2017. This method has various drawbacks, including the increase of cross infection risk between patients; however, one infectious disease expert has said, “Normally I would worry about possible cross infection between the patients using the same device, but if it is a choice between certain death for half the patients and the possibility of a subsequent chest infection, I do not think there is any debate.” FDA’s recent letter to HCPs and guidance, described above, do not suggest that concurrent use of a ventilator for multiple patients is acceptable, rather FDA’s apparent focus is on modifying existing ventilators, expanding potential uses of existing equipment and interacting with potential equipment manufacturers who could supply additional ventilators.

Brett Warner of Innovative Health Strategies contributed to this update.

As the number of cases around the world grows, Faegre Drinker’s Coronavirus Resource Center is available to help you understand and assess the legal, regulatory and commercial implications of COVID-19.

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