Sunday, August 28, 2011

Safety of Medical Devices: Views From the Industry


The Sunday Review

Letters  Published: August 13, 2011

To the Editor:

Re “How Safe Are Medical Devices?” (editorial, Aug. 5), about the Institute of Medicine report on the Food and Drug Administration’s review process for medical devices:

The answer to your question is, Overwhelmingly safe. As you highlight, the institute found no evidence that medical devices reviewed through the current process pose a risk to public health. Yet the institute proposes abandoning the current review program — which has a strong track record of protecting American patients — and replacing it sometime in the future with a new, unspecified process.

Fortunately, the F.D.A. has indicated its support for the current review process and will move forward carrying out its own comprehensive improvement plan. If properly executed, the F.D.A.’s plan will address the lack of clarity and the inconsistencies plaguing the current review process, which negatively affect patients’ timely access to life-changing, lifesaving medical technology.

America’s medical technology companies are committed to working with the F.D.A. and Congress on these improvements.

STEPHEN J. UBL
President and Chief Executive
Advanced Medical Technology Assn.


Washington, Aug. 10, 2011

To the Editor:

Americans can be proud that one of our most innovative industries is also one of our safest. Medical devices have played a central role in increasing life expectancies and improving the quality of life for patients, and have a tremendous safety record.

In fact, Dr. William Maisel, before he became the chief scientist in the Food and Drug Administration’s medical device unit, conducted a study demonstrating that approximately 99 percent of medical devices cleared by the F.D.A.’s 510(k) process (the most common pathway for devices) were not subject to Class 1 recalls.

The medical device community considers even one adverse outcome unacceptable, and we constantly strive for perfection. Medical device manufacturers continue to work with the F.D.A. and other stakeholders to ensure that patients and providers have timely access to safe and effective products, and that the United States remains the global leader in innovation.

MARK LEAHEY
President and Chief Executive
Medical Device Manufacturers Assn.
Washington, Aug. 5, 2011

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