US accepted Russian ventilators linked to hospital fires without FDA approval, models under investigation
When the new coronavirus was expected to batter New York and New Jersey, the US received ventilators from an unlikely source -- Russia. The shipped model is now under investigation in Russia, as they may have set off fires in two hospitals that killed six Covid-19 patients. A new Reuters report suggests that the US authorities accepted them without getting a stamp of approval from the Food and Drug Administration (FDA). The development highlights the consequences of fast-tracking products without vetting. The US, in its defense, said they had stockpiled them and had not put any of them to use.
The model in question is Aventa-M ventilators: Russia sent 45 of these to the US. Leaders from both countries celebrated the move, calling it a collaborative effort to defeat the virus. On April 1, the Federal Emergency Management Agency (FEMA) received them and shipped them over to local hospitals, according to Reuters. Typically, the FDA oversees the approval process of new devices and drugs. To speed up the process, the federal agency greenlights new products under its Emergency Use Authorization (EUA). But the Russian ventilators did not go through the approval stage, even as ventilators from other sources did.
“In this case, the FDA was rendered irrelevant,” Michael Carome, director of health research for the non-profit watchdog Public Citizen, told Reuters. “Here we have the wild, wild West with Trump going out and negotiating deals in other countries without coordinating with public health experts," he added. Commenting on the matter, the federal agency told Reuters that its March 22 policy allows Aventa M machines to distribute their products to ventilators without EUA. But manufacturers will have to keep the FDA informed before distributing them.
They will have to provide the FDA with information, including documentation showing the device’s power supply is compatible with US standards. The agency will review the product and issue EUA if it passes muster. The agency declined to say whether it obtained such documentation for the Aventa-M, according to Reuters.
What do we know of the fires in Russia?
On May 12, a fire broke out in two hospitals. Russian authorities have since linked Aventa-M ventilators to the accident and are investigating the same. The Russian authorities say that a short-circuit in the ventilators may have resulted in an explosion. "The ventilators are working to their limits. Preliminary indications are that it was overloaded and caught fire, and that was the cause," a source at St Petersburg emergency department told the Interfax news agency.
The country has since banned the use of the model. According to a statement from the Fema spokeswoman Janet Montesi, hospitals had not deployed Aventa-M. "Out of an abundance of caution, the states are returning the ventilators to Fema," she added. FEMA has said that it will put the machines on hold until the investigation is complete. "The conclusion(s) of the investigation being conducted by the Russian authorities into the fire in St Petersburg will help inform our decision regarding any future use of the ventilators," the agency told CNBC.