Stephen J. Ubl, president and CEO
Advanced Medical Technology Association
To the editor:
I am concerned Bob Buckley’s recent column, “Robotic medical devices need to be monitored” (The Examiner, Jan. 11), paints an inaccurate picture of medical device safety and of the Food and Drug Administration’s rigorous review standards.
Patients and the public should know that recall rates for medical devices cleared by FDA are extremely low, 0.45 percent or less for serious issues, according to several studies.
In addition, the FDA’s review process for medical devices involves extensive review by the agency of scientific information before it determines whether a device can be made available for patients. It is common for submissions to include hundreds or thousands of pages of documentation from batteries of tests – biocompatibility, shelf life, shock and vibration, temperature cycling, animal studies, etc. In many cases, manufacturers also must submit clinical data.
The FDA’s review process is risk based, science driven and rigorous. Americans should continue to have confidence the FDA has robust processes in place to ensure the safety and effectiveness of medical devices and to protect and promote the public health.