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“Despite requirements for pre-marketing review, the investigation found few devices undergo rigorous clinical testing and the standards themselves haven’t changed in a generation.”
These drugs are also known as proton pump inhibitors
infections for coronary artery bypass surgery, knee and hip replacements, and abdominal hysterectomies have decreased but those for vaginal hysterectomies have increased.
Massachusetts public health officials have called together patient safety leaders to determine why hospitals reported a high rate of surgical infections among women who received vaginal hysterectomies over the past two years.
“In our view, the greatest challenge facing U.S. device regulation is the evaluation of high-risk devices through pathways intended for lower-risk devices, such as the 510(k) process.”
The Safe Patient Project is a Consumers Union campaign focused on eliminating medical harm, improving FDA oversight of prescription drugs and promoting disclosure laws that give information to consumers about health care safety and quality.

