From Good to Great: Advancing Innovation and Assessments of Medical Devices and Related Interventional Technologies at WCMC


Dr. Mushlin; Ms. Laitman; Dean Gotto

The medical device field has grown drastically over the past few decades, as interventional procedures have evolved to include both device implantation and other non-implantable technologies. Given this evolution, the safety and effectiveness of medical devices currently affects about one quarter of the U.S. GDP. In recent years, over 1 million device adverse events have been reported to US regulators and the number of reports now exceeds those for drugs. The FDA MAUDE is one of the adverse event reporting systems and it is known that events are an underreported and unrecognized public health problem leading to disability and death often reaching epidemic proportions. The example of recent metal on metal device failure is only the tip of the iceberg. Importantly, the absence of unique device identification (UDI) internationally is camouflaging medical device problems under general health care safety and complications. .


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