he now-infamous superbug outbreak related to a medical device that seriously sickened 350 people and killed at least 20 illustrates a huge problem in our medical system: poor monitoring of the safety of medical devices.
The episode in question lasted several years and involved a widely used duodenoscope, a flexible tube inserted in the mouth in order to reach the small intestine, made by Olympus. It began in January 2012 when Erasmus Medical Center in the Netherlands experienced an outbreak of a multidrug-resistant infection among 30 of its patients. An investigation linked the outbreak to the use of a specific Olympus duodenoscope, whose design flaws made it impossible to completely disinfect the device.
Although Olympus was aware of the design flaws, and had been actively warning European health facilities about this safety issue, executives at the company decided not to warn U.S. hospitals or the Food and Drug Administration.
In 2013, a hospital in Seattle began investigating its own string of highly resistant infections among patients undergoing a procedure called endoscopic retrograde cholangiopancreatography (ERCP for short), which is done via duodenoscope. A few months later, a hospital in Illinois was having the same problem. It was only after that hospital asked the Centers for Disease Control and Prevention for help that the FDA was finally alerted to the safety problems of this medical device. Thus, well over a year had passed before the FDA could even begin the process of looking into the problem, let alone adequately addressing it.
More than a half million ERCPs are performed each year in the U.S. At least 17 U.S. hospitals experienced similar outbreaks related to these scopes. Inexplicably, eight of them did not report these adverse events to the FDA, as required by law. An FDA investigation revealed a wide lack of awareness and training of hospital staff regarding the reporting requirement.
The FDA’s Center for Devices and Radiological Health has the task of evaluating and approving or rejecting new medical devices based on safety and effectiveness. Once a device earns FDA approval, post-market surveillance is supposed to gauge how well and how safely it performs in the real world. It is a mostly passive system in which manufacturers and users voluntarily report serious device-related adverse events.
Dr. Jeffrey Shuren, who directs the Center for Devices and Radiological Health, has acknowledged that the tools the FDA uses for post-market surveillance are limited. Passive surveillance, for example, “relies on people to identify that a harm occurred or a risk is present, recognize that the harm or risk is associated with the use of a particular device, and take the time to report it.”
Legislative solutions have been proposed to improve post-market safety reporting. One bill, the Disclosure and Encouragement of Verification, Innovation, Cleaning, and Efficiency Act of 2017, aims to strengthen requirements for device makers to report any changes made to a device or its reprocessing instructions. In apparent response to the failure of Olympus to alert the FDA in 2012, the bill would also mandate that manufacturers report to the FDA within five days any communication with foreign health care providers regarding safety concerns. One section of the 21st Century Cures Act also addresses reporting requirements and instructs the FDA to publish a list of reusable devices and their validation data for recommended reprocessing techniques.
These may help, but what’s really needed is for the FDA to move beyond passive surveillance processes.
In 2012, the same year that Olympus executives decided against notifying the FDA of safety concerns about its duodenoscope, the FDA began envisioning a national system that actively captures clinical data by leveraging analytic software. Called the National Evaluation System for health Technology (NEST), it could rapidly identify safety issues by aggregating data from electronic health records, existing device registries, and other sources to look for safety signals.
Writing in JAMA, Shuren and then-FDA director Dr. Robert F. Califf said that “when issues with medical technologies arise, they could potentially be quickly detected and understood” if a national evaluation system, such as NEST, was in place. Such a system would not only diminish the reliance on passive reporting, but it would also address another significant hole in the system, which is the lack of a suitable mechanism for the FDA to handle the several hundred thousand medical device safety reports it receives each year.
In a display of the strength of this active surveillance approach, an FDA-funded study examined a device called Mynx that uses gel to seal the incision made into an artery in the groin or wrist needed for cardiac catheterization. It had been used in more than 70,000 patients. Using an electronic surveillance system, the research team saw a significant safety risk within nine months of monitoring the use of this device. Specifically, the research found a higher absolute risk of complications such as significant bleeding compared to devices that use pressure or other mechanical means to close the incision.
Making NEST a reality requires successfully implementing many complex steps, such as ensuring interoperability between different electronic data sources and collecting the necessary information during the normal course of routine clinical care across the country. Another significant challenge is the need for financial and material cooperation between health care facilities, industry, and government.
Extending the reach of NEST from one device to the many already in use and those newly cleared or approved each year (42 in 2015 and 26 in 2016) would require substantial investment. With the current budget cuts proposed by the Trump administration (31 percent federal funding cuts to the FDA, supposedly offset by user fees paid by device makers) the near-term realization of NEST may be hard to reach.
Even so, it shouldn’t take more tragedies like the one linked to the faulty Olympus duodenoscope for us to insist upon a more effective active surveillance safety reporting system such as the one that NEST could provide.
Diana Alame, MD, is a clinical pathologist and medical microbiologist trained at Massachusetts General Hospital in Boston and a recent graduate of Harvard Medical School’s Master of Bioethics program.