by
Barbara Kram, Editor | August 05, 2008
Stephen J. Ubl,
President & CEO
of AdvaMed
WASHINGTON, D.C. - Stephen J. Ubl, President and CEO of the Advanced Medical Technology Association (AdvaMed), released the following statement regarding the introduction of the Medical Device Safety Act of 2008:
"This bill will not improve patient safety but will result in needless delays in patient access to essential medical technologies, more lawsuits and ultimately higher health care costs.
"If enacted, this legislation would create a patchwork approach to medical device approvals where state courts would effectively review and regulate medical devices. It would likely result in a dizzying array of conflicting labeling and indications for use and ultimately may result in life-saving, life-enhancing technologies simply not being available for patients.
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"Congress provided express authority relative to FDA device approvals in 1976 because lawmakers recognized that a central, expert authority at the federal level would best serve the interests of public health and safety for all Americans.
"For 30 years, this system has provided patients and providers with access to innovative medical devices while providing access to the courts for patients with legitimate claims. Congress should leave the current system in place.
"The Supreme Court's 8-1 decision in Riegel v. Medtronic re-affirmed what most federal courts have regarded as settled law -- that FDA, not differing state regulations and multiple jury verdicts -- should determine the safety and effectiveness of medical technology."
AdvaMed member companies produce the medical devices, diagnostic products and health information systems that are transforming health care through earlier disease detection, less invasive procedures and more effective treatments. Our members produce nearly 90 percent of the health care technology purchased annually in the United States and more than 50 percent purchased annually around the world. AdvaMed members range from the largest to the smallest medical technology innovators and companies. For more information, visit http://www.advamed.org/.
