Jeffrey Shuren, M.D., J.D., Director of FDA’s Center for Devices and Radiological Health
By: Jeffrey Shuren, M.D., J.D.
America’s hospitals and their dedicated staff helps us fight disease and suffering by delivering life-saving and life-enhancing care every day in an astounding variety of ways.
From helping set a broken leg or responding to an emerging viral threat, to assisting and performing delicate heart surgeries on tiny newborns, these hospital personnel are the front line of surveillance, vigilance, and intervention.
Throughout their work day, hospital staff use a variety of medical devices: imaging machines, EKGs and in vitro tests to make diagnoses; infusion pumps, ventilators and robotics to provide treatment, and an array of implants to replace diseased joints and organs. And, as the nation’s hubs for real-time health care data, hospitals are uniquely positioned to help identify new safety problems with devices as well as changes in the frequency of already known safety problems because they use these technologies in the real-world setting of clinical practice, outside of the more controlled setting of a clinical trial.
FDA is looking to improve the way we work with hospitals to modernize and streamline data collection about medical devices.
Given the greater diversity and complexity of medical devices today; the rapid technological advances and iterative nature of medical device product development; the interface between the technology and the user – including the learning curve associated with adopting new technology; and, in some cases, a relatively short product life cycle that can be measured in months, not years; FDA’s evaluation of medical device safety presents unique challenges not seen with drugs and biologics. Therefore, assuring the safety of medical devices depends on many factors and should a problem arise, it could be due to a variety of causes.
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.
FDA has several tools for watching devices once they are on the market, also called postmarket surveillance, all of which have inherent limitations. For one thing, we can require that a manufacturer conduct a post-approval or postmarket surveillance study that focuses on identifying potential longer-term issues noted at the time of clearance or approval or specific safety concerns that may arise after clearance or approval. However, conducting studies on a product after it’s already on the market can be challenging because patients often have little incentive to enroll in a study when the device is already available to them.
Likely the most well-known of FDA’s postmarket surveillance tools is medical device reporting, which FDA requires from certain entities, including device manufacturers and device user facilities, such as hospitals. Federal law requires hospitals and other user facilities to report when they become aware of information reasonably suggesting that a medical device has or may have caused or contributed to a death or serious injury to a patient. They must report these medical device-related deaths to both FDA and the manufacturer, if known; and device-related serious injuries to the manufacturer, or to FDA, if the manufacturer is not known. Such passive surveillance has important limitations because it 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.
Congress mandated this reporting by user facilities in 1990 to complement similar adverse event reporting by manufacturers. But then, in 1997, Congress required that FDA establish a reporting program that could limit user facility reporting to a subset of representative user facilities. As part of our efforts to develop this reporting program, FDA set up a large-scale network of about 300 hospitals, called MedSun (the Medical Product Safety Network), with whom we work interactively to better understand and report on device use in the real-world environment. Even with MedSun, all hospitals were required to continue reporting until FDA implements by regulation a program limiting user facility reporting to a subset of facilities.
Although FDA has recognized that requiring all hospitals and other user facilities to report may provide limited added value and could entail unnecessary costs that take away from patient care, we have not yet established the program limiting reporting to a subset of user facilities. In the past, we have not enforced universal reporting requirements for hospitals and other user facilities.
In light of several high-profile device safety issues occurring in hospitals, FDA, in December 2015, initiated inspections at 17 hospitals, chosen because there were reports of events at these facilities related to the spread of uterine cancer from the use of morcellators or the spread of infections associated with contaminated duodenoscopes. While these events appeared to be the kind that would have fallen under our current medical device reporting requirements, we did not see corresponding adverse event reports in our adverse event (MAUDE) database. From those inspections, we learned three important lessons:
- First, some hospitals didn’t submit required reports for deaths or serious injuries related to devices used at their facilities, and in some cases, they did not have adequate procedures in place for reporting device-related death or serious injury events to FDA or to the manufacturers. Based on the number of user facilities in the United States and the number of reports we receive, we believe that these hospitals are not unique in that there is limited to no reporting to FDA or to the manufacturers at some hospitals. We want to work with all hospitals to address these issues.
- Second, hospital staff often were not aware of nor trained to comply with all of FDA’s medical device reporting requirements.
- Third, we feel certain there is a better way to work with hospitals to get the real-world information we need, and we should work with the hospital community to find that right path, especially in light of developments in the creation and evaluation of electronic health information.
In order to effectively address these issues, we will work with the hospital community on what role they should play in assuring the safe use of medical devices. This work will include how they can effectively participate in the National Evaluation System for health Technology (NEST), and whether or not current reporting requirements should remain, be modified, or eliminated in light of more effective modern tools, such as software tools to conduct active surveillance of electronic health information that contains unique device identifiers. In many cases, our inspections of these 17 hospitals turned up violations of FDA’s medical device reporting regulation. For some hospitals with significant violations of the regulation, FDA received a response that we determined was not adequate to address those violations, and we engaged with these facilities to facilitate an effective path to compliance. These hospitals indicated their willingness to work with us and address the violations, and at this time, we do not believe any additional action with regard to these hospitals is necessary. Some hospitals also expressed willingness to work with us on more efficient and effective ways to collect the information we need.
On December 5, FDA will hold a public workshop to solicit input and advice on improving hospital-based surveillance systems and the broader role of using hospitals to evaluate how well devices work in the clinical setting. We encourage all hospital stakeholders—from clinicians to IT system managers—to attend and discuss current hospital-based surveillance efforts, the role of hospitals in evidence generation and future opportunities for hospital-based surveillance. We’d also like their input on the incorporation of unique device identifiers (UDIs) into electronic health records to aid in the future development of evidence generation efforts, including the support of better device development, surveillance and health care delivery.
We are already working directly with the Association of American Medical Colleges and the American Hospital Association to prepare for this workshop and help develop improvements to our systems.
Hospitals are our partners in building the infrastructure for NEST. Together we can build a state-of-the-art system that not only quickly identifies life-threatening problems caused by medical devices but also expedites patient access to crucial life-saving devices. Armed with such information, health care providers can help patients make more informed medical decisions that improve their health.
Jeffrey Shuren, M.D., J.D., is FDA’s Director of the Center for Devices and Radiological Health