Medical Device Didn't Meet Federal Standards. Gov't Bought More. - Medscape
( January 7, 2022; Medscape )
Description: "For years after federal inspectors found serious problems with the HeartWare heart pump, agencies like the VA and CMS continued paying to implant it in patients."
In 2014, when the Food and Drug Administration found serious problems with a life-sustaining heart pump, its warning letter to the manufacturer threatened to notify other federal health agencies about the inspection's findings.
But for years, no such alert ever went out. Instead, the agency added the warning letter to an online database alongside thousands of others, following its typical procedures, an FDA spokesperson said.
Testing. Please ignore.
Read the rest from Medscape: Medical Device Didn't Meet Federal Standards. Gov't Bought More.