Data sources: use in the epidemiologic study of medical devices.
Medical device epidemiology is the study of the prevalence and incidence of use, effectiveness, and adverse events associated with medical devices in a population. The identification of large data sources with medical device data provides a large population for epidemiologic studies. Two challenges in medical device epidemiology are the ability to find data on the specific device and the exposure of a patient to that device. This paper identifies data sources both from the govenment and from the private sector that can be used for epidemiologic studies of medical devices and, to a limited degree, studies of medical devices in women. Each source provides data for different types of devices and in differing specificity. The paper also discusses briefly the strengths and weaknesses of each data source. More data sources are needed to enhance the study of medical device epidemiology. Additional efforts and focus are needed to enhance the ability to study medical devices in women.
Torrence
Mary E
ME
Epidemiology Branch, Office of Surveillance and Biometrics, Center for Devices and Radiological Health, Food and Drug Administration, Rockville MD 20250-2220, USA. mtorrence@reeusda.gov
D002487:Centers for Disease Control and Prevention, U.S.; D003625:Data Collection / Q000379:methods*; D004812:Epidemiologic Methods; D004864:Equipment and Supplies; D006801:Humans; D006278:Medicare; D011358:Product Surveillance, Postmarketing; D014481:United States; D014486:United States Food and Drug Administration