Medical Device Injuries and Malfunctions in Non-Clinical Settings: an Analysis of the FDA’s Maude Database
Journal Title: Scholars Journal of Applied Medical Sciences - Year 2015, Vol 3, Issue 9
Abstract
The public health burden of adverse events from medical devices that are used in non-clinical settings is not well understood. To describe the frequency and characteristics of medical device events occurring in non-clinical settings. We analyzed 13,739 non-clinical reports occurring between January 2009 and December 2013 and reported in the Food and Drug Administration’s Manufacturer and User Facility Device Experience (MAUDE) database. In results the majority (85%) of reports in the MAUDE database during this time period were missing an event location. Those reports with a location describe a wide variety of non-clinical settings (home, school, public buildings, public venues, outdoors etc). The current study reveals that deaths 353 (2.6%) and serious injuries 3,494 (25.4) occurred from Class 1, 2 and 3 medical devices over the study period An evaluation of a device implicated in causing harm or malfunction was not conducted by the manufacturer in the majority of events 9077 (66.1%). In conclusion As the use of medical devices in the non clinical setting increases the number of adverse events associated can also be expected to increase. Efforts should be made to encourage the reporting of device-related problems occurring the non-clinical setting through the FDA Med Watch program. The collection of more complete and detailed device data may allow for better public health analyses. Keywords: public health, burden, Food and Drug Administration, Manufacturer and User Facility Device Experience (MAUDE)
Authors and Affiliations
Lee Meller
Keywords
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