According to Consumer Reports, many dangerous medical devices were never tested for safety and effectiveness. The report claims that some manufacturers do nothing more than file paperwork and pay a fee to have their medical device approved by the Food and Drug Administration.
“Standards for devices exist, they just don’t make sense,” said Diana Zuckerman, Ph.D. and president of the National Research Center for Women & Families.
Congress goes backwards on Device Safety
In 2011, members of the Institute of Medicine stated that the FDA should revise its medical device approval procedure to help keep unsafe devices off the market. In response, Congress is aiming to get devices on the market even faster.
In a Consumer Reports investigation, doctors and patients expressed concern with respect to medical devices that are untested before they arrive on the market, the lack of a systematic method to discover problems with devices, and the fact that there is little consumers can do to protect themselves without a major change in the system.