More than 230,000 medical device-related adverse events were reported to the Food and Drug Administration in 2010 alone, approximately 30,000 of which had "very serious" outcomes such as hospitalization or death, according to research conducted by Clarimed.
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In addition, research shows serious adverse events have been growing 24 percent annually since 2007. Here are the top 5 categories with the highest number of adverse events in 2010:
1. Needles, syringes and infusion supplies: 23,000 adverse events (4,200 serious events)
2. Pacemaker and defibrillator pulse generators: 20,000 adverse events (3,500 serious adverse events)
3. Sugar test systems: 19,000 adverse events (3,600 serious adverse events)
4. Pacemaker and defibrillator electrodes: 13,000 adverse events (2,700 serious adverse events)
5. Implanted spinal cord stimulators: 9,000 adverse events (500 serious AEs adverse events)
Researchers attribute the increased incidence of device-related adverse events to four factors: improved reporting compliance, more devices in the market, complexity errors and higher risk procedures.
Related Articles on Adverse Events:
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