Paige Pfleger / WOSU
There are several large metal containers in a warehouse under a large American flag. Their doors are ajar and the workers pour in and out, power tools buzzed.
These are not ordinary shipping containers: they represent a major scientific breakthrough in the fight against COVID-19.
“We’re looking at the Battelle Critical Care Decontamination System, which we developed to decontaminate PSA for healthcare workers at the forefront,” said Will Richter, a researcher at the Columbus, Ohio-based company.
Personal protective equipment such as masks, gloves and goggles are running low in hospitals across the country. The impending shortage puts healthcare workers at risk if they treat the influx of COVID-19 patients.
The Critical Care Decontamination System is the first of its kind with which up to 80,000 PSA (personal protective equipment) can be cleaned at the same time.
The Battelle system has a modular structure so that it can be easily dispatched and scaled. The more units in an area, the faster they can purge PSA and return it to where it is needed.
On Sunday evening, the Food and Drug Administration Battelle gave full approval to ramp up their systems to full capacity and to send devices to those parts of the country most affected by the coronavirus outbreak.
A system is on the way to New York City. Others are scheduled to start in Seattle, Chicago and Washington, DC.
Permission is given at the urging of Governor Mike DeWine and President Trump.
Even before Battelle’s equipment was shipped from Ohio, the state’s leading politicians advocated the system both behind the scenes and for the public.
DeWine spoke brightly about Battelle’s system at its regular Coronavirus press conference this weekend, calling it a “major breakthrough”. Lt. Governor Jon Husted said the state had worked with the FDA last week to get approval.
But the FDA’s decision was not what the Ohio leaders had hoped for.
At 8:00 am on Sunday, DeWine received the news: The FDA approved Battelle’s machines to sterilize only 10,000 surgical masks a day – well below their capacity – and only at the company’s headquarters in Columbus.
“The FDA’s decision to severely limit the use of this life-saving technology is ruthless,” DeWine wrote in a statement. “I am not only disappointed with this development, but also stunned that the FDA would refuse to do anything to protect this country’s front line workers in this serious time of need.”
DeWine then brought the topic to the White House. Later on Sunday tomorrowThe governor announced on Twitter that he had had a “good conversation” with Trump, who told DeWine that he would “do everything possible to approve it today”.
“The FDA must act quickly!” Trump card tweeted. Hours later, Battelle announced that it had received full approval.
“This is an example of everyone working quickly to find a solution,” said FDA Commissioner Stephen Hahn in a statement. “After receiving Battelle’s request today, we flipped it over within a few hours and issued a new permit that will enable them to improve their ability to decontaminate other respirators.”
Battelle thanked the FDA for approval in a statement on Sunday evening.
“Everyone who has worked on this project has the same goal of protecting first responders and healthcare workers who are at the forefront of the pandemic,” said Lou Von Thaer, Battelle President and CEO.
In a statement, DeWine thanked the FDA and the president for approving the technology.
In Battelle’s decontamination system
At Battelle’s headquarters in Columbus, WOSU exclusively examined how the technology works.
Hospitals collect used PPE and send it to the nearest decontamination machine. A team of four Battelle scientists will put on protective clothing and step into the containers. The outer chamber is an airlock, and the inner chamber sucks contaminated air out of the container through several HEPA filters and then through a vent in the rear area.
Used N95 masks are placed on metal frames on the walls. Other forms of PPE, such as B. safety glasses can be hung on metal bars. Once the unit is full, the scientists exit the main chamber into the airlock.
Paige Pfleger / WOSU
They spray themselves with ethanol to ensure that they are not contaminated before leaving the entire container and sealing it tightly.
The scientists then begin the decontamination process using hydrogen peroxide in the vapor phase.
“We inject the steam in the back of the chamber and then the fans ensure a homogeneous distribution,” says Richter, pointing to the fans in the upper corner of the device. “Then the lines run forward so that they have to extend the entire length of the chamber before they return and are returned to the generator.”
It takes approximately 12 hours to load the device, perform the decontamination process, ventilate it, and reload the cleaned PPE into boxes to be returned to the hospitals.
A forklift drives into the warehouse, lifts the shipping container and loads it onto a truck heading for New York City.
Richter observes how his scientific achievement is being prepared for use.
“It was a crazy two weeks, we worked around the clock,” he says. “We just want healthcare workers to have what they need. I don’t want to have healthcare workers without PPE who are faced with this choice and have to go into this room. So yes, it feels good.”