From the Hastings Bioethics Forum:
Dangerous Medical Devices
Early one morning in March 2002, in preparation for a procedure to treat my wifes irregular heartbeat, a cardiologist at Johns Hopkins Medicine opened a sterile package that revealed a Biosense Webster Lasso Mapping Catheter and ultimately laid bare a fundamental flaw in the Food and Drug Administrations process for approving many medical devices.
The FDAs so-called 510(k) system has come under fire recently, with a report by the Institute of Medicine (IOM) calling for the FDA to scrap it altogether for failing to reliably screen many medical devices for safety and effectiveness. The executive editor of The New England Journal of Medicinereached the same conclusion. But device manufacturers are dismissing the report and the FDA announced that it will seek public comment.
Both lives and money are at stake, and the outcome of the debate will say much about the values of our society.
Read more: http://www.thehastingscenter.org/Bioethicsforum/Post.aspx?id=5486&blogid=140#ixzz1WEvZR3FF
Dangerous Medical Devices
Early one morning in March 2002, in preparation for a procedure to treat my wifes irregular heartbeat, a cardiologist at Johns Hopkins Medicine opened a sterile package that revealed a Biosense Webster Lasso Mapping Catheter and ultimately laid bare a fundamental flaw in the Food and Drug Administrations process for approving many medical devices.
The FDAs so-called 510(k) system has come under fire recently, with a report by the Institute of Medicine (IOM) calling for the FDA to scrap it altogether for failing to reliably screen many medical devices for safety and effectiveness. The executive editor of The New England Journal of Medicinereached the same conclusion. But device manufacturers are dismissing the report and the FDA announced that it will seek public comment.
Both lives and money are at stake, and the outcome of the debate will say much about the values of our society.
Read more: http://www.thehastingscenter.org/Bioethicsforum/Post.aspx?id=5486&blogid=140#ixzz1WEvZR3FF
