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An ideal surveillance system for medical device safety would comprehensively collect data on adverse events across the life span of a device. Preferably, the system would be integrated into electronic health records to allow seamless identification, tracking, and real-time reporting of device-associated adverse events. Moreover, it would parse adverse events to detect substantial safety signals and underperforming devices. Such a system would also allow implementation of corrective actions in a swift and commensurate manner.
In this issue of JAMA Internal Medicine, 2 reports1,2 illustrate the importance of an improved surveillance system, particularly for life-sustaining medical devices. In one report, Davidsson et al1 present the nationwide experience of Iceland with the Riata defibrillator lead (St Jude Medical), which was recalled in 2011 because of the risk of serious injury or death. The study adds to prior experience about adverse events with the Riata lead.3 Davidsson et al1 used a proactive protocol to detect events, which ranged from externalization of the conductor to death, and compared these outcomes in patients with a control group of patients with other defibrillator leads. The report effectively illustrates the extent to which Riata leads underperformed; the lead failure rate was 37% (19 of 52), including 1 instance that resulted in death, compared with the 8% failure rate (4 of 50) for other defibrillator leads (hazard ratio, 4.67; 95% CI, 1.18-18.50). It is noteworthy that Iceland has exemplary record keeping; all adverse event data were captured and are available in a national registry.
In another study, Sengupta et al2 characterize the high burden of serious adverse events (including death) with another cardiac device, the InSync III model 8042 heart failure pacemaker (Medtronic). The report demonstrates considerable deficits in both the swiftness (19 months from first notice of pacemaker failure to recall) and the appropriateness of the response (the US Food and Drug Administration [FDA] classifying the recall as class II—a low probability of serious adverse events). This long unexplained delay before the recall and the inappropriate recall classification raise concerns about patient harms that could have been prevented by speedier and stronger regulatory actions.
Although the characteristics of an ideal surveillance system for medical device safety are easy to state, these 2 reports demonstrate the practical challenges. The reports add to a 2015 study by Tseng et al4 that used systematic interrogation and autopsy of sudden cardiac deaths in patients with cardiac implantable electronic devices and found that passive surveillance efforts may inaccurately estimate device malfunction. Unfortunately, cardiac devices represent the tip of the iceberg in inadequate surveillance and inappropriate reporting of medical device–related adverse events. A report called the Implant Files5 published by the International Consortium of Investigative Journalists estimated that there were nearly 2 million injuries and 80 000 deaths associated with medical devices from 2008 through 2017. A Netflix documentary, The Bleeding Edge, released in 2018, is another example showing the public concern and growing patient safety movement regarding the harms of medical devices.
When there is a device safety signal or recall, it is appalling that the United States, unlike Iceland, lacks even a rudimentary means to track medical devices. In 2007, the FDA committed to requiring a unique device identifier (UDI) for medical devices. The UDI, like a barcode, will be on the label of medical devices in human-readable and machine-readable forms. The goals are to improve patient safety, modernize device postmarket surveillance, and facilitate medical device innovation. The UDI is being implemented in a phased rollout; the labeling requirement went into effect in 2014 for class III (high-risk) devices and in 2016 for class II devices. The requirement for class I (low to moderate risk) devices is set to take effect September 24, 2020. The integration of UDIs into electronic health records, which is necessary for the identifier to be useful, is highly reliant on the vendors accommodating the FDA’s recommendations. In addition, devices may have multiple UDIs, which has created challenges that medical centers are addressing.
In 2013, the US Centers for Medicare & Medicaid Services, the FDA, and the Joint Commission met to start the process of adding UDIs to Medicare claim forms, a measure that is widely agreed would speed the adoption of UDIs. Six years later, in October 2019, the Centers for Medicare & Medicaid Services agreed to the FDA recommendations; implementation is expected to take 4 more years. Adoption of the use of UDIs is difficult to achieve because the FDA can only mandate it for device manufacturers, not for hospitals or physicians. So far, several hundred recalled devices have included UDIs and about 70 000 reported adverse events have contained a UDI, a small fraction of the 90 000 adverse events reported to the FDA each month.6
For 2016 through 2017, the FDA announced the National Evaluation System for Health Technology (NEST) system as a strategic priority.7 The agency sees NEST as generating real-world data to quickly identify new safety problems for devices on the market; thus, postmarket data collection would support product approvals in addition to information gathered before marketing approval. However, implementation of NEST has been slow, and questions remain about its ability to improve device surveillance.
The broader issue raised by the reports from Davidsson et al1 and Sengupta et al2 is that progress on medical device safety will not be possible in the United States unless the FDA makes data collection and data transparency priorities and takes prompt and commensurate regulatory actions when safety issues are identified. A 2019 investigative report by Kaiser Health News8 is particularly disturbing. The report demonstrated how the FDA allowed companies to hide millions of serious adverse events related to high-risk medical devices by placing them in summary adverse event reports.8 Starting in 1997, under the alternative summary report program, the FDA allowed manufacturers of qualifying devices to request exemptions from individual medical device report filing requirements and submit quarterly summary reports of certain events instead. In June 2019, following publication of the Kaiser Health News report,8 the FDA made public some, but not all, of the adverse event reports. For example, adverse event reports about surgical mesh and the da Vinci surgical robot were not released. For some devices, the agency also redacted the patient problem codes (outcomes); only the device problem codes were released, not narratives that supplemented the problem codes.
Many important questions remain to be answered about the surveillance of medical device safety. For example, what are the best ways to identify important safety signals? And how should devices that are inherently flawed be distinguished from devices that have the potential for lasting benefits to patients but with early adverse events related to clinical or operator variables? Finally, what should the threshold be for a device recall? However, there is no question that the current medical device surveillance system, which is based on the voluntary reporting of adverse events, requires substantial improvement to prevent avoidable serious illnesses and deaths.8 Patients deserve a robust medical device surveillance system that invariably puts patient safety first.
Corresponding Author: Rita F. Redberg, MD, MSc, Department of Medicine, University of California, San Francisco, 505 Parnassus Ave, M1180, San Francisco, CA 94143-0124 (firstname.lastname@example.org).
Published Online: December 20, 2019. doi:10.1001/jamainternmed.2019.5170
Conflict of Interest Disclosures: None reported.
Acknowledgements: We thank Madris Tomes, MBA, chief executive officer of Device Events, for her information on the history of unique device identifiers and data on the number of adverse events entered in the US Food and Drug Administration Manufacturer and User Facility Device Experience database. She was not compensated for this contribution.
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Salazar JW, Redberg RF. Leading the Call for Reform of Medical Device Safety Surveillance. JAMA Intern Med. Published online December 20, 2019. doi:10.1001/jamainternmed.2019.5170
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