How did 45 Russian ventilators linked to deaths in Russia reach U.S. with no FDA oversight?
A: They didn’t, they arrived with reduced oversight.
Remember:
-
at the time governors were screaming for more ventilators
-
at the time Boing Boing was promoting rapid novel and DYI ventilator designs
(e.g.: FB group forms to open-source development of coronavirus-related medical hardware, MIT designs a $100 ventilator for those who can't afford to buy the $30,000 version, Vacuum and hand dryer maker Dyson designed a new ventilator for COVID-19 patients, Italian hospital needed an $11K part for its ventilators, volunteers 3D printed them at $1 each, original manufacturer threatened to sue -
this was a design that was in production, approved by FDA-equivalent regulators of other nations
Also note that:
-
The manufacturer of the problem ventilator had increased production by a factor of 10 from the normal output.
-
The fires where this ventilator is suspected happened after they were offered and shipped to the USA, so no-one knew that these were potentially defective hazardous units at the time.
And finally:
- These ventilators were in excess of actual need on this occasion, so they were not in fact used for patients
