80,000 Deaths. 2 Million Injuries. It’s Time for a Reckoning on Medical Devices

The New York Times Editorial Board chimes in on “products meant to reside inside the human body would be used on patients without any proof of safety or efficacy.” The editorial board represents the opinions of the board, its editor and the publisher. It is separate from the newsroom and the Op-Ed section.

THE NEW YORK TIMES writes:

“Patients suffer as the F.D.A. fails to adequately screen or monitor products.”

“But that’s not to suggest that only women are affected: There have been metal hips that released poisonous debris into the body, implantable defibrillators that shock people at random (causing indescribable terror) and artificial heart valves with questionable shelf lives. In operating rooms, there have been staplers that misfire; temperature control machines that spray bacteria into open chest cavities; and robotic surgeons that slap, burn and, in some cases, maim patients.

In every one of these cases, a combination of dubious regulatory approvals, skimpy post-market surveillance, and faltering responses from regulators caused irrevocable harm that might have been avoided.”

READ THE FULL OPINION PIECE HERE AT THE NEW YORK TIMES:

https://www.nytimes.com/2019/05/04/opinion/sunday/medical-devices.html