Consumer Reports' Advocacy Arm Calls for Improved Medical Device Safety

Pressure continues to build on Congress to introduce more stringent regulation of medical devices. "Innovation should not trump safety," says the Consumers Union, the advocacy arm of Consumer Reports, which is bringing eight activists to meet with lawmakers in Congress and press for improvements in the Medical Device User Fee Act. Notably, the organisation is calling for more rigorous premarket testing of medical implants and a robust national monitoring system when safety problems arise. It lays out its recommendations in the Safe Patient Project Initiative, which was announced on the heels of H.R. 3847, the Safety Of Untested and New Devices Act of 2012 (SOUND Devices Act).

"The medical device industry has been heavily lobbying Congress, claiming that onerous regulation by FDA stifles innovation and threatens American jobs," notes an overview of the initiative. Citing recent high-profile device failures involving metal hip implants and surgical mesh, Consumers Union wants "all permanently implantable devices and life-sustaining devices" to go through the PMA process.

Reps. Edward J. Markey (D-Mass.), Henry A. Waxman (D-Calif.), Jan Schakowsky (D-Ill.), and Rosa DeLauro (D-Conn.) introduced H.R. 3847 to close a  loophole in the 510(k) that allows a new device to be placed on the market if it is substantially equivalent to an earlier product, even if the predicate device was pulled from the market for causing serious harm to patients. The Safe Patient Project Initiative goes well beyond that.

The recommendations of the Consumers Union to improve the processes for device approval are as follows:

•Require all permanently implantable devices and all life-sustaining devices to go through the PMA process rather than the expedited 510(k) process.
•Exclude pre-1976 devices from serving as predicates.
•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 in the 510(k) clearance process. Devices cleared based on a recalled predicate should be reviewed for similar problems.
•Eliminate the “least burdensome” requirement when FDA asks for additional information in its review of medical devices.
•Raise the standard for PMA approval of devices from “reasonable assurance” of safety to “substantial evidence” of safety to bring it in line with the standard for drugs.
•Give FDA adequate resources for thorough review of the increasing number and complexity of device applications.

Consumer's Union also recommends the following measures to improve postmarket monitoring of devices:

•Require a national system for tracking devices so that patients and doctors can be contacted when problems with a particular device are identified.
•Establish registries so patients can be notified directly if there is a problem or recall with a device.
•Enable FDA to use its recall authority more effectively and provide the agency with authority to require device makers to do long-term postmarket studies, regardless of the process that is used in the premarket phase.
•Give FDA adequate resources to fully implement existing patient protection programs for monitoring and reporting adverse events such as MedWatch, MAUDE and the Sentinel initiative.

— Norbert Sparrow