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About Trends In

Medical Device Adverse Events


US FDA has recognized that Medical Device adverse reflect quality manufacturing systems.


The number of adverse event reports has increased dramatically and outpaced overall industry growth by a wide margin.


The risk of adverse events is not evenly distributed across the industry. Certain therapeutic areas and product segments comprise a larger share of total adverse events; others have attributable adverse events growing at a faster rate than average.


Cardiovascular, IVD, and general hospital/surgical devices make up most adverse event reports. General hospital/surgical and cardiovascular devices account for more than half of reported serious adverse events. Radiology (diagnostic imaging) and neurology are the areas growing most quickly.


Taken together the top 20 product codes with the most serious adverse event reports between 2005 and 2009 account for 65% of all serious adverse event reports in this time period. Eleven of the 20 product codes with the most adverse events between 2005 and 2009 were related to cardiovascular devices.


(Report on “Understanding Barriers to Medical Device Quality” by the United States Food and Drug Administration (FDA), Center for Devices and Radiological Health (CDRH))

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