The Trump administration has approved the first system for sterilizing specialized face masks worn by front-line health workers battling the coronavirus, potentially easing the severe shortage of the protective gear.
The FDA also reversed course on a daily cap for the decontamination system, less than 24 hours after Ohio’s Republican governor criticized the FDA on Sunday morning for the limit.
As of Sunday night, the agency will let the machines be deployed to sites around the country and there won’t be a limit on the number of masks they’re allowed to clean each day.
At issue was the FDA’s decision to allow emergency use of a Battelle system that decontaminates specialized N95 face masks, allowing doctors and nurses to safely reuse them. On Saturday, the FDA approved Battelle’s Columbus headquarters to sterilize 10,000 masks per day, even though the company says its machines have the capacity to decontaminate 80,000.
“The FDA’s decision to severely limit the use of this life-saving technology is nothing short of reckless,” Gov. Mike DeWine, whose state is home to the company that makes the technology, said in a statement Sunday morning.
DeWine said he appealed directly to President Donald Trump to allow broader adoption of the system, and Ohio’s attorney general threatened to sue if FDA didn’t act quickly to authorize more extensive use.
The thing is, Trump can intervene in these things, but there’s still delay, and there’s only so much a President can do to chivvy along the bureaucracy. I think he should announce that he’ll have a team of managers from outside government evaluate the performance of the FDA, CDC, NIH when this is over, with those found to have under-performed to be sacked.