FDA Red Tape Blocks Lifesaving Coronavirus Device

The Wuhan coronavirus global pandemic is just getting started, but America is already facing a critical shortage of N95 masks due to significantly increased demand, compounded by disruption to the globalized supply chain. Patriots and entrepreneurs -like My Pillow CEO Mike Lindell, who yesterday announced at a Rose Garden press conference he was converting his factories to manufacture 50,000 masks a day by the end of the week- are stepping up to the plate, but it’s probably going to be a while before the estimated 3.5 billion needed masks can be produced.


In the meantime hospitals are being forced to ration and even reuse medical PPE, which likely puts their staff at an elevated risk of infection. American companies are jumping in with innovative solutions to sterilize used gear and help protect medical professionals, but they appear to be battling the same regulatory obstacles that delayed mass production of reliable COVID-19 tests for almost six weeks.



Two Ohio-based companies, Battelle and Daavlin, have come up with sterilization solutions that provide different ways of extending the useful life of critical PPE, but so far only the Battelle CCDS system’s Emergency Use Application has received FDA approval -and only after public intervention by both Ohio Governor Dewine and President Trump, while Daavlin’s application sits in FDA limbo:


Battelle’s system has an impressive capacity, but is a hydrogen peroxide-based 3 hour evaporative process that can only handle masks, requires courier shipping and return, and comes in a modified, 20 foot shipping container that requires four trained Battelle employees to properly operate it. Daavlin however, has developed a flexible, tabletop solution that can actually be deployed in hospitals, only takes scant minutes using ultraviolet light, and can handle essentially anything that can fit inside, including (but not limited to) phones, tablets, and HIPAA-protected forms and paperwork.

Battelle versus Daavlin options

Interviews about the Daavlin device:



These two systems individually appear to have alot of promise, and are different enough they seem to reinforce each other by fulfilling different roles. However, only one is currently helping lower the strain on our beleaguered medical system, while the easily-produced Daavlin machine is currently in limited use by a handful of hospitals; ostensibly due to many administrators being uncomfortable acting without FDA guidance.  Medical professionals are already dealing with severe risk, shouldn’t we give them every possible useful tool to increase their safety?


While these devices are aimed at the healthcare system as their target market, there are trickle-down effects to consider: namely how the sooner we lift current supply constraints by ensuring the medical community has a reliable supply of PPE via production and disinfection, the sooner we can provide the general public the option to engage in widespread adoption of those PPE measures as well. The most successful countries battling the Wuhan virus (so far) are doing it by relying heavily on mass testing and mask usage by citizens, and those tactics seem to offer the quickest path for a return to normality without unleashing mass infection.


I understand the need for testing and objective standards behind medical technology, but something is seriously wrong when we have a sclerotic and glacial bureaucracy that takes years to detect and stop scammers like Theranos’ Elizabeth Holmes, yet seems to have no problem hamstringing the people trying to fight a global pandemic.

If there’s any bright spot from this, will it be a growing realization amongst the populace about the wisdom of Federalism and decentralization? Only time will tell, but I think I sense the pendulum reversing course:



Erin Sith

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