Oregon prof backs newer is not always better belief
June 6th, 2008 joshua
An Oregon Health and Science University professor has published an editorial in The Seattle Times which makes an argument for the medical device industry to undergo the same - albeit already under-scrutinized - federal approval process for its new products the same a prescription drug company would.
Dr. Richard Geyo cites the Medtronic leads used in implanted heart defibrillators, since recalled but which originally gained regulatory clearance based on the fact that it was supposedly an upgrade on an existing product.
Drugs fitting this description undergo a less stringent review process from the FDA, but when you consider the already lax scrutiny the device industry receives, a mimic device is almost a rubber stamp away from making its way into patients.
Unfortunately that rubber stamp bounced defective leads to life-saving devices to thousands of patients and caused the needless deaths in many patients.
The FDA says at least 300,000 deaths a year can be associated with a medical device, according to the op-ed.
Geyo says this should put an underscore on the notion that newer is not always better in the medical device industry.
