250095 Public health implications when heart valves, hip replacements and other medical devices are not tested in clinical trials

Tuesday, November 1, 2011: 10:30 AM

Diana M. Zuckerman, PhD , National Research Center for Women & Families, Washington, DC
The Food and Drug Administration (FDA) requires companies making new prescription drugs to submit clinical trials to support an application for approval, but there is no similar requirement for more than 90% of medical devices. As a result, most medical devices that are sold in the U.S. are not proven safe in clinical trials, and no scientific clinical data are available to patients or physicians on effectiveness or safety. By law, clinical trials are required for FDA approval of high-risk medical devices, such as heart valves, defibrillators, HIV tests, and other devices that can sustain, save, or harm a life. However, the FDA has been criticized for not always following the law. Using the FDA's own data, we analyzed the devices that were subject to “high-risk recalls” from 2005 through 2009. We found that the FDA recalls of devices that were considered potentially fatal or seriously harmful were usually of devices that had not undergone clinical trials prior to FDA approval, or afterwards. Only 20% of these “high-risk recalls” had undergone clinical trials prior to sale. When our findings were published online in the Archives of Internal Medicine in February 2011 and reported on national TV news programs and national newspapers, the response from medical device manufacturers and several key Members of Congress was immediate. They stated that clinical trials were not necessary for most medical devices, that the current FDA system for devices was too burdensome rather than too relaxed, and that the changes we proposed would cause job losses as medical device businesses closed. In my proposed presentation I will provide new data on the public health costs of defective medical devices that are later recalled, focusing on implanted medical devices. I will provide data on deaths and serious injuries that were reported to the FDA, the risks of undiagnosed diseases from inaccurate diagnostic tests, as well as medical costs to patients and the medical care system. I will also discuss whether the FDA is appropriately classifying devices and recalls as “high risk;” for example, glucose test strips were classified as moderate risk by the FDA, but when they were found to be inaccurate, they were recalled as high risk.

Learning Areas:
Advocacy for health and health education
Clinical medicine applied in public health
Ethics, professional and legal requirements
Public health or related laws, regulations, standards, or guidelines
Public health or related public policy
Public health or related research

Learning Objectives:
1. Compare FDA standards of safety and effectiveness for prescription drugs and medical devices. 2. Identify implications for patients’ health and healthcare costs of the lack of clinical trials and other weak criteria for FDA approval for many heart valves, joint implants, glucose test strips, and other diagnostic and implanted medical devices. 3. Identify public health implications of standards of safety and efficacy of high-risk medical devices, including potentially life-saving or life-threatening devices.

Keywords: Quality of Care, FDA

Presenting author's disclosure statement:

Qualified on the content I am responsible for because: I am the lead investigator on this research.
Any relevant financial relationships? No

I agree to comply with the American Public Health Association Conflict of Interest and Commercial Support Guidelines, and to disclose to the participants any off-label or experimental uses of a commercial product or service discussed in my presentation.