In Pursuit of Device Safety or a Call for Whistleblowers?

Late last year, Jeffrey Shuren, M.D., J.D., the U.S. Food and Drug Administration’s (FDA) director of the Center for Devices and Radiological Health, penned a blog for the FDA Voice (http://bit.ly/mpo031750) regarding the coordination between the FDA and hospitals to collect data on medical devices. While a process is already in place to enable hospitals and doctors to report information on a medical device to the manufacturer and/or FDA when it is responsible for an adverse event, there is no check in place to ensure this is happening. Unfortunately, based on a review of 17 hospitals by the FDA, it appears not to be occurring in a significant number of instances.

In December 2015, the FDA initiated inspections on 17 hospitals due to incidents related to morcellators (tied to the spread of uterine cancer) and duodenoscopes (associated with the spread of infections). Neither event generated a corresponding adverse event report within the agency’s MAUDE (manufacturer and user facility device experience) database. According to Shuren, the FDA did, however, gain valuable insight into a number of challenges regarding medical device incident reporting. These included:

• There is a significant lack of reporting by hospitals to the FDA and/or manufacturers overall. Some healthcare facilities even lack the procedure for this reporting to take place.
• Hospital staff has not been properly trained to report device incidents.
• A new system to enable better lines of communication between the hospital and the FDA is required.

While device safety is the ultimate goal of any such reporting system, there is one aspect of Shuren’s message that did give me pause—does the agency have a possible ulterior motive for improving the reporting system? In his FDA Voice blog, Shuren stated, “At the time of premarket evaluation, however, it is not feasible to identify all possible risks or to have absolute certainty regarding a technology’s benefit-risk profile. Among other reasons, studies required to do so would likely be prohibitively large in order to capture less frequent and more unpredictable effects or consequences. In addition, such larger studies still may not reflect the true benefit-risk profile of the device. Once a device is on the market, for example, doctors may use it beyond the FDA cleared intended use. In addition, subsequent modifications to the device or changes in how the device is used in practice can result in new safety risks or greater frequency of known risks.”

Sure, off-label use is a problem and manufacturers should be made aware of any such use of their device. If it hasn’t been cleared for a therapy for which it is being used, it could certainly create a headache for the manufacturer, even if they aren’t found to be promoting such use. Might a revised reporting system not only review events where a device may have caused an injury or death, but also be used to seek out off-label use of medical devices in the healthcare environment? Of course, depending upon with whom you speak, a system that looks for such use cases would not necessarily be a bad thing. If the result of such a review simply leads to a penalty against the manufacturer, then I don’t see it as a positive; however, if the review could be used to potentially better position the manufacturer to seek clearance for the off-label use with the FDA, that would ultimately be a benefit—an extension of real-world data collection, if you will.

Ultimately, a revision to the current reporting system would likely be welcomed by all stakeholders. Putting in place a solution that reduces the burden on hospital personnel to conduct the reporting would alleviate the need for training on the system and proper procedures being put in place. The manufacturer could be made aware of a potential flaw in a device and enable them to address it before the problem becomes more widespread. The FDA would gain more information on medical devices already on the market, enhancing their postmarket surveillance efficiency.

One tool that might be leveraged to accomplish this would be electronic health records (EHRs) and the data provided from them. If an algorithm could be created to comb through EHRs to seek adverse events that might be tied to medical devices, great value could be gained. What’s done with this information will then be the next challenge to be solved. Does the manufacturer face a penalty or would the system be used to truly enhance the quality of care that’s being delivered with the information being effectively utilized by both device maker and FDA?

Let’s first fix the reporting system and then that next challenge can be addressed.