|
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))
* * * * *
|
