Heart Device Malfunction Casts Doubt on St. Jude Pledge to Monitor Safety
April 18th, 2012 tmccoy
The heart device industry has once again come under fire due to questions about how much they are really revealing when it comes to possible defects in their products. The industry, worth over $10 billion in total, was originally shaken in 2005 when one of its biggest producers, Guidant, failed to warn others in the industry, including doctors who used their defective products, that there were fatal flaws in certain devices.
Now, St. Jude Medical has felt similar heat after a product they produce, called a Riata, has been linked to over 20 patient deaths. The Riata is a wire, or lead, that connects a defibrillator to one’s heart. The malfunction occurs when the connecting wire has now been found to short circuit at times and even break through its protective outer coating and cause shocks.
The reason this news comes as such a concern is that after the Guidant fiasco seven years ago, the industry assured onlookers that they would take the responsibility to regulate themselves and ensure all potential product flaws would be scrutinized to the highest extent. With this recent news, there is now serious doubt as to whether this actually occurred or if the industry was just paying lip service to those who may have impose regulations themselves.
