FDA’s Proposed Medical Device Surveillance System and the Role of Unique Device Identification (UDI)

FDA’s Proposed Medical Device Surveillance System and the Role of Unique Device Identification (UDI)

The Food and Drug Administration (FDA) is responsible for regulating medical devices—a wide range of products used to diagnose, treat, monitor, or prevent a disease or condition. Problems related to medical devices can have serious consequences for patients. Defective devices, such as artificial hips and pacemakers, have caused severe patient injuries and deaths. FDA's premarket review process cannot be designed to completely ensure the safety of all medical devices before they enter the market. Therefore, it is necessary to have a strong surveillance system that monitors device safety. When a problem is identified, various corrective actions may be implemented, such as removing the device from the market, changing the device labeling and instructions for use, and improving user training.

A 2011 Institute of Medicine report recommended that FDA "develop and implement a comprehensive strategy to collect, analyze, and act on medical-device postmarket performance information." In response, FDA released a report in September 2012 outlining the parameters of a new national system. In its report, FDA stated: "Several high-profile medical device performance concerns have led some to question whether the current United States postmarket surveillance system is optimally structured to meet the challenges of rapidly evolving medical devices and the changing nature of health care delivery and information technology."

In some cases, foreign surveillance systems have identified serious device safety concerns much sooner than in the United States. For example, a Swedish registry found that drug-eluting stents were associated with an increased risk of death compared with bare-metal stents. An Australian registry was the first to identify the increased failure rates of metal-on-metal hip joints and found that many other new hip replacement products did not improve health outcomes compared to older devices. Patients and taxpayer-financed health care programs were receiving limited or no benefit for expensive new devices with a higher risk of adverse events. Postmarket data can be used to not only monitor device safety, but also to better understand and measure device innovation and cost-effectiveness.

FDA has requested $1.8 million in its FY2017 budget to start establishing the National Medical Device Evaluation System. The cost to implement and maintain the system over the first five years is estimated to be $200 million to $250 million.

Current Medical Device Surveillance

According to FDA, current U.S. postmarket surveillance of medical devices depends primarily upon the following sources for detecting potential problems:

Medical Device Reporting (MDR). FDA annually receives several hundred thousand reports of confirmed or possible medical device related malfunctions, serious injuries, and deaths. Limitations of this passive surveillance system include incomplete, inaccurate, and/or delayed data reporting; underreporting of events; and lack of information on the total number of devices in clinical use.

Medical Product Safety Network (MedSun). FDA receives about 5,000 higher quality reports each year on device use and adverse outcomes from a network of 280 U.S. hospitals. The network "can be used for targeted surveys and clinical research" and has specialty subnetworks that focus on particular device types or patients.

Post-Approval Studies. Such studies may be ordered by FDA as a condition of approval for certain high-risk devices. These studies are typically "used to assess device safety, effectiveness, and/or reliability including longer-term, real-world device performance."

Postmarket Surveillance Studies. FDA may order a manufacturer of a moderate- or high-risk device to conduct such a study if failure of the device is reasonably likely to have serious adverse health consequences, if it is expected to have significant use in pediatric populations, or if it is intended to be implanted for longer than one year or has life-supporting or life-sustaining use outside a device user facility.

FDA Discretionary Studies. FDA "conducts its own research to monitor device performance, investigate adverse event signals and characterize device-associated benefits and risks to patient sub-populations." Sources of privacy-protected data for these studies include "national registries, Medicare and Medicaid administrative and claims data, data from integrated health systems, electronic health records, and published scientific literature."

There are important limitations with the above sources: data on medical devices come from "disparate data sources with variable data elements, data definitions, data quality, and frequently from only limited subsets of patient exposures." Because of these limitations, FDA is attempting to create a new resource for all stakeholders—patients, physicians, hospitals, payers, manufacturers, and regulators—involved in the use of medical devices.

Proposed Surveillance System

The September 2012 report described "FDA's vision" for the creation of a national system focused on medical devices that "would augment, not replace, other mechanisms of surveillance such as FDA's MDR and MedSun." The new national system would conduct "active surveillance in near real-time using routinely collected electronic health information containing unique device identifiers," quickly identify "poorly performing devices," accurately characterize the "real-world clinical benefits and risks of marketed devices," and facilitate the "development of new devices and new uses of existing devices through evidence generation, synthesis and appraisal."

FDA's September 2012 report proposed four specific actions to strengthen the U.S. medical device postmarket surveillance system:

1. establish a UDI system and promote its incorporation into electronic health information;

2. promote the development of national and international device registries for selected products;

3. modernize adverse event reporting and analysis; and

4. develop and use new methods for evidence generation, synthesis, and appraisal.

In subsequent reports, FDA and its partners have further refined this vision and provided updates on efforts to create a new system for medical device surveillance and evaluation. The reports discuss recommendations for implementing the system as a whole, including a coordinating center, a seven-year implementation plan, and several pilot programs.

Incorporating UDI into patient electronic health records, health insurance claims, and registries would eventually allow for assessment of medical device performance in large patient populations. Some Members of Congress, the FDA, and others have called for the inclusion of UDI in Medicare claims. Although the Centers for Medicare & Medicaid Services (CMS) maintained that "including UDIs on claims would entail significant technological challenges, costs and risks," in May 2016 CMS said it supports including UDIs in claims.