WASHINGTON, October 23. /TASS/. The Russian Aventa-M ventilators shipped to the US in April were disposed in the country as a precaution, the US Federal Emergency Management Agency (FEMA) said in a statement obtained by TASS Thursday.
"Commodities deployed for the response to COVID-19 and all other disasters require regulatory review and approval. To be distributed for use in the U.S., all ventilators - whether manufactured in or outside the U.S. - require either a 510(k) clearance or, for distribution during the COVID-19 pandemic, authorization under the ventilator Emergency Use Authorization (EUA). The ventilator models included in this shipment of supplies did not have either an EUA or 510(k) clearance. In May, there were reports that Aventa-M ventilators have caused fires in Russia," the statement reads.
"Out of an abundance of caution for the safety of those impacted by COVID-19 as well as medical professionals and institutions, the ventilators in question were disposed in July in accordance with General Services Administration (GSA) and Environmental Protection Agency (EPA) guidelines," FEMA added.
The agency clarified that the Food and Drug Association (FDA) and FEMA were in general aware of the shipment that was sent to the US but did not have all information until the flight landed in the country on April 1. FDA officers inspected the goods upon arrival to get more information and followed FDA policy to allow entry of the ventilators without an emergency use authorization into the U.S. while working interactively with the firms to get the required authorizations. The agency also explained that the ventilators had variable voltage from 110 to 220V.
In spring, Russia procured a shipment of medical equipment to the US as assistance to fight the coronavirus spread. The Russian Air Forces’ An-124 plane delivered the shipment on April 1 to New York’s John F. Kennedy International Airport.
Earlier, Kremlin spokesman Dmitry Peskov ruled out any possibility that Russia could have shipped faulty ventilators to the US. He recalled that the assistance was delivered to the US in a critical moment of the coronavirus pandemic.
On May 9, a woman died in a Moscow hospital in a fire, while six people died in similar circumstances in St. Petersburg’s St. George’s hospital on May 12. On May 13, Russia’s healthcare watchdog suspended circulation and use of the Aventa-M ventilators produced on April 1 in Russia. These machines were used in the hospitals where the fires occurred. An inspection carried out by the watchdog’s specialists found problems in their operation. However, a quality and safety inspection of the machines did not establish a direct connection with the fires in Moscow and St. Petersburg.
On July 22, the Russian healthcare watchdog reissued registration to the Aventa-M ventilators and allowed their use.