Faulty Ventilators that Caused Fires in Russia Reach NY and NJ Without FDA's Approval; Officials in Hot Water

Reuters reports that Aventa-M ventilators from Russia are now under investigation after the hospital equipment allegedly caused fires in Russia, killing at least six people. Furthermore, 45 pieces of the same machine were sent to the United States and distributed to hospitals in New York and New Jersey without passing reviews from the Food and Drug Agency.

The delivery of the ventilators was said to be a result of an agreement done by U.S. President Donald Trump and Russian President Vladimir Putin. The two reportedly had negotiations over the phone on March 30. On April 1, officers from the Federal Emergency Management Agency (FEMA) purportedly received the ventilators.

At the time, the coronavirus crisis was at its peak, and hospitals were filling up with patients needing mechanical ventilators. FDA regulators modified its rules to accelerate the procurement of the desperately needed hospital apparatus. The Kremlin and U.S. State Department acclaimed the 45 ventilators' delivery as a collaborative effort to combat a common enemy, which was COVID-19.

However, many speculate that the Russian ventilators did not even receive the FDA's expedited Emergency Use Authorization (EUA) before reaching New York and New Jersey.

Although fortunately, none of the 45 ventilators shipped to the U.S. were used, the imaginably combustible machines came perilously near American patients and hospital staff without warning from the FDA.

Also Read: U.S. Engineers Develop 8-pound 3D-Printed Ventilator That Costs only 1% of the Conventional Machines

Faulty Hospital Equipment

A few weeks ago, Russia deferred the use of some Aventa-M ventilators after six people reportedly died in hospital fires, which were thought to have involvement with the devices.

Officials claim that the ventilators were never supplied to local hospitals since they weren't needed just as initially anticipated. Furthermore, they say that the respirators will be returned to FEMA.

According to a medical official from New Jersey, the Aventa-M ventilators required an electrical voltage which is incompatible in the United States.

In interviews with The Moscow Times, some physicians and medical professionals working with the ventilators criticized the medical apparatus. They mentioned its technical shortcomings and compared the Russian-made model disparagingly against Western counterparts.

Desperate Times Call for Desperate Measures

The lack of oversight from the FDA on the Russian shipment adds to worries concerning the shortcuts taken by the U.S. government in addressing the coronavirus pandemic. Reuters says that the FDA has issued EUAs for mechanical ventilators coming from other sources.

The White House dismissed and left no comment regarding the issue. Instead, they referred to a FEMA statement released earlier this month, saying that the ventilators had not been used.

According to FEMA, the conclusions of the investigation by the Russian authorities will aid in their decision regarding the future use of the mechanical ventilators. Furthermore, in an email sent to Reuters, FEMA said the FDA and agency did not acquire all the details on the product before the shipment's arrival on April 1.

Moreover, FEMA said that FDA officers examined the goods upon arrival and permitted them into the country. The FDA noted that the Aventa-M ventilators were appropriated under a policy that allowed ventilators to be used in the United States without an EUA while the FDA works with the firms to get the required authorizations.

Following that policy, the FDA would notify the manufacturer that it does not intend to object to the distribution while the manufacturer is preparing, and the FDA is reviewing the EUA request.

The FDA would also request the manufacturer to provide information ahead of distribution of their product or goods, such as documentation depicting whether the device's power supply is compatible with U.S. standards, which the Aventa-M ventilators were not.

Furthermore, the agency refused to say whether it acquired such documentation for the Aventa-M ventilators.