Consumers Union’s Safe Patient Project Recommendations

for Strengthening Medical Device Safety Oversight

 Improve review of devices before they enter the market.

• Insure that all permanent implants and all life-sustaining devices do not go through the 510(k) process. Instead, these devices should go through the Pre-Market Approval (PMA) process, which requires more rigorous testing for safety and effectiveness.
• Predicate removal: Once a device is found to be unsafe (either recalled or when FDA issues a warning), that device should no longer be allowed to be used as a predicate for device makers to use in the 510(k) clearance process.  Devices cleared based on a recalled predicate should be reviewed for similar problems.
• When FDA believes additional research is needed to assure safety and effectiveness, give the agency authority to require device makers to conduct post-clearance studies, including long-term studies.
• Raise the standard for devices going through Pre-Market Approval (PMA) from “reasonable assurance” of safety to “substantial evidence” of safety, bringing it in line with the standard used for prescription drugs.
• Give the FDA adequate resources for thorough review of the increasing number and complexity of device applications.

 Improve monitoring of devices after they enter the market.

• Require a national system for tracking devices so that patients and health care providers can be contacted when problems with a particular device are identified. Currently, there is no universal way to find out which devices went into which patients. The Institute of Medicine estimated that if the United States had a registry for hip-replacement surgery, it could avoid about $2 billion in total costs for these surgeries in 2015.

• Ensure that the FDA has adequate resources to fully implement existing patient protection programs for monitoring and reporting problems such as MedWatch, MAUDE and the Sentinel Initiative. Used effectively, these programs can create an early warning system to help the FDA identify medical devices that are causing harm to patients.

Retain current conflict of interest standards for federal advisory committees.

• Five years ago, consumer organizations, including Consumers Union, advocated strongly for these standards to ensure the integrity of the advisory committee process. Decisions regarding new drugs and devices must be free from even the perception of bias. These standards should not be relaxed, as there are many qualified experts without conflicts.

For more information:

Lisa McGiffert, Consumers Union Safe Patient Project

lmcgiffert@consumer.org

512-477-4431 ext. 115

February 8, 2012