The medical device industry grew 9 percent annually from 2001-2009, but serious adverse events — death, life-threatening condition, disability or hospitalization — grew 17 percent during that same time period, according to an FDA report.
The report also found cardiovascular, in vitro diagnostic and general hospital/surgical devices accounted for 60 percent of all adverse events reported. Twenty of the 1189 active product codes accounted for 65 percent of all serious adverse events reported between 2005 and 2009.
The report is part of an FDA initiative with the Center for Devices and Radiological Health to assess and understand gaps in medical device quality and create a plan for improvement.
"Attempts to improve quality are hindered by challenges within the industry as well as specific aspects of the Agency's regulatory approach. Moving toward greater visibility into device quality and properly aligning FDA's regulatory approach will be important to catalyzing industry movement towards improved device quality. Investment by FDA now in a holistic quality infrastructure will support a next generation of medical devices that are as safe and well made as they are innovative," the report said.
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The report also found cardiovascular, in vitro diagnostic and general hospital/surgical devices accounted for 60 percent of all adverse events reported. Twenty of the 1189 active product codes accounted for 65 percent of all serious adverse events reported between 2005 and 2009.
The report is part of an FDA initiative with the Center for Devices and Radiological Health to assess and understand gaps in medical device quality and create a plan for improvement.
"Attempts to improve quality are hindered by challenges within the industry as well as specific aspects of the Agency's regulatory approach. Moving toward greater visibility into device quality and properly aligning FDA's regulatory approach will be important to catalyzing industry movement towards improved device quality. Investment by FDA now in a holistic quality infrastructure will support a next generation of medical devices that are as safe and well made as they are innovative," the report said.
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Is There a Middle Ground for Medical Device Approval?
Report: New Challenges for the Medtech Industry