Study Finds Medical Device Companies Too Slow to Recall Products
Despite all the rules, regulations, and requirements necessary in order to approve a medical device for public usage, medical device manufacturers and the Food and Drug Administration cannot be 100% certain that a new product will work without a hitch when released to the public market. Even then, makers are required to monitor how their devices work in the public market. Now, a new study released by the University of Minnesota is suggesting that medical device companies, even when armed with the information, are still too slow to issue product recalls, leading to potential harm of even more patients.
“The reality is, if you look at the results, clearly there is under-reaction” said Kingshuk Sinha of the University of Minnesota’s Carlson School of Management, whose paper detailed the study in the journal Production of Operations Management. What the study essentially found is that the more adverse events were reported, the more likely a company would be slow to react and recall the product.
The study analyzed a registry of nearly 150,000 people who had undergone a small procedure to unblock a coronary artery. The study focused on a device called the Mynx, sold by Cardinal Health, and compared its results to other similar devices on the market. Just over 1.2% of all Mynx patients experienced some form of a complication from the device, while the other devices experienced a 0.76% complication rate. This difference may not seem like much, but when you consider the size of the population that had this particular procedure (more than 1.8 million people between January 2011 and September 2013), the Mynx saw thousands more issues than its competitors.
Dr. Zian Tseng from San Francisco also led a six-year project to study cardiac deaths in the city. His research showed that 5% of people who died of sudden cardiac issues between the years 2011 and 2013 had a pacemaker which should have prevented their death. In total, 11 devices were shown to have some sort of a manufacturing defect, including a prematurely deleted battery or busted lead wires.
If you or a loved one have suffered an injury or death as a result of a defective medical device, you should not hesitate to contact a skilled Fort Lauderdale medical malpractice attorney. Since 1955, Schlesinger Law Offices, P.A. has been dedicated to protecting the rights of those who have been unjustly injured through professional mistakes, defective products, and other medical malpractice suits. We are proud of our tradition of success and client service that we have developed through more than 60 years and thousands of cases of experience.Get assistance with your medical malpractice suit; contact Schlesinger Law Offices today at (954) 467-8800.