Unless someone you know has been injured, made ill or died because of a defective drug or medical device, you have no way of knowing about the dangers until either the FDA or the manufacturer issues a public recall notice. Sadly, sometimes hundreds or thousands of people suffer before the agency charged with protecting the public gets around to warning us. Case in point: the Stockert 3T Heater-Cooler System.
The Food and Drug Administration began receiving adverse events attributable to the Stockert device in January of 2010. Over the next five years, the federal regulatory agency received 32 such reports involving serious infections caused by the device, a third of which happened in the U.S. (the remainder took place in Europe).
In 2015, Swiss investigators reported on six cases in which patients undergoing open heart surgery became infected with a form of bacteria known as mycobacterium chimaera. While this species is commonly found in soil and water and does not normally cause diseases in humans, when introduced into the chest cavity during heart surgery, it can cause serious illness – sometimes, as long as 5 or 6 years after the surgery.
In July 2015, the medical journal Clinical Infectious Diseases published the results of a study highlighting the risks of bacterial infections during surgery that result from the use of heater-cooling devices such as the Stockert 3T. Over the next few months, stories appeared in the media about outbreaks of infections caused by antibiotic resistant bacteria as well as the defective design of the Stockert unit that makes it difficult to clean and sterilize.
Finally, after the Centers for Disease Control began recommending that health officials watch out for cases of such infections, the FDA wrote a warning letter to Stockert 3T manufacturer LivaNova PLC in December 2015. This warning came after inspections of the U.S. and European facilities revealed safety violations. However, it wasn't until six months later that the FDA finally acknowledge the adverse event reports and issued a public warning.
Last month, the FDA updated its earlier warning, advising health care facilities to take “additional steps to help mitigate the risk of infection associated with the use of these devices.” Acknowledging that nearly 30 patients have suffered infections as a result of the Stockert 3T, the FDA has also advised that as many as half a million open heart patients could be at risk.
The question remains: why did it take so long for the FDA to issue a clear warning about the infection risks?