Public Health Effectiveness of the FDA 510(k) Clearance Process Measuring Postmarket Performance and Other Select Topics: Workshop Report (2011) / Chapter Skim
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3 Non–Food and Drug Administration Sources of Adverse Event Data
3 Non–Food and Drug Administration Sources of Adverse Event Data
Pages 23-38
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From page 23... ...
The committee requested information from some of FDA's partners as well as other groups that collect adverse event information related to medical devices. The committee was presented with overviews of four non-FDA sources of adverse-event data with a focus on the collection of information about specific clinical activities or specific kinds of devices.
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From page 24... ...
• Followup for adverse events. The mission of the NCDR is "to improve the quality of cardiovascular patient care by providing information, knowledge, and tools; implementing quality initiatives; and supporting research that improves patient care and outcomes." Although the NCDR was not set up primarily for postmarket surveillance, Masoudi said, it is one of its benefits.
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From page 25... ...
Both findings were statistically significant, Masoudi noted, even after risk adjustment based on a wide array of patient characteristics that are collected in the registry. Another example Masoudi cited used the CathPCI Registry to assess the rates of bleeding complications associated with different closure devices used at the groin site after angiography and percutaneous coronary intervention (PCI)
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From page 26... ...
This is particularly relevant in light of the limitations on patient identifiers as a result of the Health Insurance Portability and Accountability Act privacy rule. Masoudi referred to a recent report from the Institute of Medicine that concluded that the privacy rule does not do enough to protect patient privacy in all situations and substantially impedes research or efforts to improve public health.
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From page 27... ...
THE DEPARTMENT OF VETERANS AFFAIRS CARDIOVASCULAR ASSESSMENT, REPORTING, AND TRACKING PROGRAM: INTEGRATION OF REAL‑TIME DATA COLLECTION INTO THE PROCESS OF CLINICAL CARE Paul D Varosy, director of cardiac electrophysiology in the VA Eastern Colorado Health Care System and assistant professor of medicine at the University of Colorado Denver, provided an overview of the VA CART program, describing it as a new paradigm for cardiovascular-disease surveillance and a potential model for medical-device surveillance.
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From page 28... ...
With regard to heart function, for example, left ventricular ejection fractions can be measured in various ways, including echocardiography, radionuclide ejection fraction measurement, radionuclide myocardial perfusion study, cardiac catheterization, and magnetic resonance imaging. Results can be reported in different places in accordance with different standards, such as a specific number of an ejection fraction, for example, 36.7% as measured with one of the various methods; an estimate of 35–40%; or a qualitative estimate, such as "moderately depressed left ventricular function." The need to collate information from different sources based on different studies and different ways of codifying the results makes it difficult to interpret the data.
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From page 29... ...
Linkage of remote monitoring programs to electronic health records is problematic, and there is a lack of infrastructure to connect remote and in-clinic device followup. Most important, he said, the ascertainment of long-term clinical outcomes is challenging (outcomes data are necessary for quality improvement, device performance and surveillance, and health-services research)
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From page 30... ...
There are also monthly site quality-assurance reports, monthly and biannual national procedure and adverse-event count reports submitted to the VA central office and the CART Quality Management Committee, and quarterly regional reports submitted to the network administrators and chief medical officers. Beyond the original CART-CL application, VA is creating modules to
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From page 31... ...
USE OF REGISTRIES FOR POSTMARKET DEVICE SURVEILLANCE Eric D Peterson, professor of medicine and associate director of the Duke University Medical Center and director of cardiovascular research at the Duke Clinical Research Institute, reiterated some of the issues that can arise after a device reaches the market, including rare events not observed in premarket evaluation, downstream safety events and long-term followup of devices that remain in patients for long periods, use in a wider array of highrisk patients, off-label use, device–drug interactions, and device–health-care provider interactions (the "learning curve")
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From page 32... ...
Efforts are now under way to build more in-depth device information capacity into each of those registries progressively and to link data from clinical registries with claims data (particularly Medicare claims) to provide information on longitudinal outcomes, such as rehospitalization and device explantation.
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From page 33... ...
Automating prospective postmarket surveillance involves integration of high-quality data sources, appropriate safety expectations, monitoring systems, and secure data exchange. Challenges Resnic concurred with previous speakers regarding the array of challenges associated with device safety monitoring.
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From page 34... ...
There are also the issues of data ownership, data security, and patient privacy. Another major concern is signal detection and methods.
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From page 35... ...
Figure 3-1 hospitals in the state to submit data to the NCDR CathPCI Registry and the Society of Thoracic Surgery database and to harvest and report those data quarterly to the state registry. At the state level, reports are rigorously adjudicated and audited, and outcomes are linked to vital statistics and inpatient claims data (Resnic noted that this is a direct link, not a probabilistic link)
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From page 36... ...
Summary Detection of low-frequency postmarket safety signals for medical devices challenges traditional methods of statistical surveillance, Resnic concluded. The ideal surveillance system is a time-efficient, high-sensitivity alert system that is designed to trigger detailed investigations of potential safety concerns.
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From page 37... ...
Future DELTA studies include a more in-depth exploration of the Massachusetts cardiac quality data focused on longitudinal outcomes, pilot studies with the VA CART-CL and the NCDR CathPCI Registry, an Orthopedic Implant Registry study, and a cardiac surgical valve safety-surveillance pilot study. REFERENCES Dewland, T
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