Epidemiologic Studies of Medical Devices: Methodologic Considerations for Implantable Devices
Product Surveillance, Postmarketing
Quality of Life
Medical device epidemiology is well suited to study utilization, public health impact, patterns of device use in different populations, and benefit-risk profile of medical devices as they enter routine clinical practice. Modern medical device epidemiology is also charged with integrating and inferring effectiveness and safety using all available evidence from the growing body of heterogeneous data sources to ensure that the practice and policy decisions are based on the best available information. Methodologic issues unique to medical devices exist, including learning curve effect, hospital-operator-patient interactions, and long-term device performance characteristics. In this chapter we focus on implantable medical device methodologic challenges and considerations, discuss the existing safety tools, evolving infrastructure, innovative methods for combining data, and vision for the future epidemiologic efforts. © 2012 John Wiley and Sons, Ltd.
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