
Over a recent 10-year period, more than 1.7 million injuries and 83,000 deaths in the U.S. have been potentially linked to faulty medical devices, ranging from surgical masks to implantable pacemakers, according to the U.S. Government Accountability Office. Concerns have been raised about the FDA's oversight of medical devices, with criticisms of the agency being overly deferential to industry and failing to ensure timely recalls of harmful devices. The FDA's recall process has been criticized as targeted devices often remain in use. Dr. Jeffrey E. Shuren, a key figure in regulating medical devices, faced ethics scrutiny as he did not always recuse himself from matters involving clients of his wife's law firm, despite ethics rules barring such involvement. This situation highlights the potential conflicts of interest within federal regulatory bodies.
The FDA calls them ‘recalls,’ yet the targeted medical devices often remain in use https://t.co/0CW3L610JA https://t.co/Zo6J2iczNu
The FDA calls them ‘recalls,’ yet the targeted medical devices often remain in use https://t.co/SWbjCcY9bW
Ethics rules barred Dr. Jeffrey E. Shuren from working on matters involving clients of his wife’s law firm. But he did not always step aside. https://t.co/FcrDqNynBQ