The Huffington Post reports on the recent release of studies by the Journal of the American Medical Association (JAMA) and the American Journal of Therapeutics, which show “how the FDA lacks stringent scientific standards to evaluate cardiovascular medical devices. This underscores the need to pass the Medical Device Safety Act (MDSA).” The MDSA aims to allow hundreds of thousands injured by faulty medical devices to hold the manufacturers accountable for their defective products and end the policy of preemption of consumer lawsuits.
The study by JAMA showed that premarket approval of several kinds of cardiovascular devices was based on small studies, with significantly less scrutiny than that needed to approve pharmaceutical drugs. The American Journal of Therapeutics found that about 40 percent of the heart studies examined lacked specific safety targets and failed to follow patients over the long-term.
Read the full article on the Huffington Post website.