Medical devices are becoming commonplace in our society today, but they may be causing unnecessary harm to thousands of patients. According to an article from Kaiser News, the Food and Drug Administration (FDA), has a hidden repository of reports on injuries and deaths caused by medical devices. In the Kaiser Health News investigation, it was learned that there have been at least 1.1 million incidents involving medical devices since 2016. Why have you never heard about this, you ask? For starters, the FDA has been keeping mum about these incidents, locking away the information in a hidden database rather than the public database known as MAUDE that medical experts rely on to identify various problems that could put patients at risk. While device-related deaths are still reported in MAUDE, the hidden database has countless reports about serious injuries and malfunctions involving more than 100 different medical devices.
FDA Keeping Information from Experts
This discovery is shocking, to say the least, as it shows the FDA can’t be as trusted as once thought. One FDA official contacted during the investigation said that the hidden database is “for issues that are well-known and well-documented with the FDA and that it was reformed in 2017 as a new voluntary summary reporting program.” However, the program appears to be so obscure that doctors and engineers whose sole job is to improve medical device safety have never heard of it.
This is a huge problem, as the FDA appears to be keeping information from the very experts in place to protect patients from malfunctioning devices. By failing to make this information public knowledge, it is only putting more people at risk every single day. In addition to reports of injuries and device malfunctions, this hidden database also has insight about device risks. The public has a right to know about the risks and problems associated with medical devices, as do doctors and the very medical experts tasked with protecting patients.
Contact a Medical Malpractice Attorney Today
Shockingly, many medical devices on the market today did not have to go through any clinical testing before being used on a patient. With this in mind, it should come as no surprise that medical devices can lead to a wide range of preventable side effects, injuries, and deaths. As medical malpractice and negligence continue to remain a concern in the United States, it is imperative we hold those charged with this information accountable. Doctors are often at the center of malpractice cases, but this new discovery shows that medical device manufacturers and others may also be responsible. By failing to make this information public knowledge, the FDA is putting patients at-risk in a major way. If you have been injured by a medical device, please contact Wormington & Bollinger today and schedule a free consultation to discuss your case.