Thursday, July 28, 2011
WASHINGTON, D.C. – In response to an article on an Institute of Medicine study regarding medical device regulation featured today in The New York Times titled “Study of Medical Device Rules Is Attacked, Unseen”, Consumers Union, the nonprofit publisher of Consumer Reports, issued the following statement.
Lisa Swirsky, senior health policy analyst for Consumers Union said, “The Institute of Medicine is a highly-regarded, independent organization that has gathered respected experts from across a variety of fields to evaluate medical device standards, an important health issue that affects millions. Consumers deserve to know that products are safe and have been tested at the highest level, especially when it comes to their health and physical wellbeing. The IOM was tasked with making important recommendations regarding the approval process for devices. Unfortunately, some devices that have not undergone clinical trials, including implantable devices, are not living up to the standards consumers expect. If a drug is recalled, patients can stop taking it. When a device is recalled, patients must endure additional physical, emotional and financial stress. It is critical that the results of the IOM study are not prejudged and are given a fair and thorough examination.”
David Butler, Kara Kelber: 202-462-6262