FDA Drops the Ball, Allows Infected Duodenoscopes to be Used
The role of the Food and Drug Administration (FDA) is to keep dangerous drugs and products away from consumers. So the question on the minds of many people is why the FDA allowed hospitals and other medical facilities to continue using tainted duodenoscopes, even after it was known that these medical instruments had caused serious infections that led to fatalities, in some instances.
The reason? The FDA misplaced an important report. This report detailed a deadly superbug outbreak that occurred in 2012 at a Pennsylvania hospital. It was determined that the outbreak was caused by tainted duodenoscopes, due to their defective design which made it difficult to clean and disinfect between uses. Because the devices were not properly sterilized, bacteria were able to spread from patient to patient. As a result of losing the report, the FDA was unable to timely inform medical providers of the infection risk associated with the design of certain duodenoscopes. Without this important information, doctors continued to use the medical devices for three more years, until the FDA finally notified medical providers through a safety alert.
The FDA counts on manufacturers and hospitals to properly report any issues with medical devices. However, most fail to do so because they’re afraid of being sued by injured consumers. Often, medical device companies will go to great lengths to cover up patient illnesses or injuries. Of the sixteen hospitals with infected duodenoscope outbreaks, not one properly submitted an adverse event report. Some hospitals do send reports to the manufacturer, but some manufacturers subsequently edit the report and falsify information, prior to forwarding the report to the FDA.
Further complicating reporting of adverse events is the FDA’s outdated database. The FDA has even admitted that its current system for monitoring the safety of medical devices is flawed. The agency is working to create a new reporting system, but some of the necessary components are too costly. It is anticipated that upgrading to a new and accessible database could take another ten years.