Tens of millions of Americans have implanted medical devices such as surgical mesh, pacemakers, joint replacements and inferior vena cava filters. As patients, we assume that someone, somewhere, tested these devices’ safety and effectiveness. Unfortunately, that is not always true.
Back in 2011, a panel from the Institute of Medicine called for the FDA to overhaul its medical device “approval” and monitoring system because it failed to fulfill its purpose and to ensure patient safety before and after medical products are placed on the market. The FDA insisted, however, that the program served patients well. Now, a Senate Subcommittee investigation into infections caused by dirty duodenoscopes at hospitals across the country has again found that current FDA policies for monitoring medical device safety is still fatally flawed and puts patients’ lives at risk. Duodenoscopes are the flexible, lighted tubes that are threaded down a patient’s mouth, throat, and stomach and then into the top of the small intestine (duodenum). Duodenoscopes are used in more than 500,000 endoscopic retrograde cholangiopancreatographies—or ERCPs—in the United States each year.
Unfortunately, in terms of patient safety, the Senate Subcommittee report illustrates yet another instance in a long line of failures by the FDA and medical device manufacturers to take action when problems with a device develop. We can now add duodenoscopes to an ever growing list of problem products such as vaginal mesh, metal on metal replacement hips and inferior vena cava filters.
The truth is that simply because a device or implant has been “approved” does not mean it is safe or that it has been tested. The FDA does not test the vast majority of new medical devices. It simply reviews information provided by manufacturers who are seeking approval to sell the device; nor can patients rely on the fact that a device has been in use for a long time to determine its safety. This is because the adverse events reporting system that the FDA uses to monitor after-market device safety also relies heavily on manufacturers’ self-reporting of problems. But, manufacturers have enormous reasons to downplay or even hide safety problems with their devices both pre- and post-approval – the billions of dollars in annual profits made by these devices while they are sold.
As with the vaginal mesh and metal on metal hip cases, in the duodenoscope infection cases, the few adverse reports that were filed with the FDA were filed in a way that made them meaningless for purposes of the FDA’s monitoring responsibility. They did not include device specific information and the manufacturer reports pointed the finger at hospital sterilization procedures and “failures.” Indeed, it was not until two years into the outbreaks when the Los Angeles Times ran a story that the FDA issued warnings about the risk of infection transmission that the devices carried.
The ongoing governmental and corporate failures in the medical device industry serve as another reminder of why the civil justice system is necessary. It is the only effective check that we, as citizens, have against corporations who might seek to put profits over patient safety. It is why we need a system where federal safety programs and regulations work in conjunction with a vigorous and independent civil justice system that is fully available to consumers. This is because the civil justice system serves to enforce standards and shine a light on hidden device problems and regulatory weaknesses, while at the same time, deterring manufacturers from cutting corners or downplaying safety issues to increase profits.
Click here to read the complete subcommittee report regarding duodenoscope infections and the FDA.
In our next blog,Decof, Barry, Mega & Quinn will discuss hospital-acquired infections and what patients and their families can and should do.