NCHR Comments on Adverse Events Program for Medical Devices, Medical Product Safety Network (“MedSun”)

National Center for Health Research, June 23, 2017

OMB CONTROL NUMBER # 0910-0471—EXTENSION FDA Docket 2017-10844
Office of Information and Regulatory Affairs, OMB
Attn.: FDA Desk Officer
Fax (202) 395-7285

The National Center for Health Research (NCHR) conducts research, uses research to inform public policy, and advocates for safe and effective drugs and medical products. NCHR supports the extension and continuation of collection of information relating to adverse events involving medical devices for the FDA’s MedSun program; however, the response rate is inadequate to help the FDA effectively detect or ascertain emerging patterns of device failure or malfunction.

The FDA’s “MDUFA” user fee agreement with industry, currently being finalized, contains no funding for the post-marketing surveillance of medical devices. All current device user fee funding focuses on the pre-market phase aimed at speeding medical device approvals.

While the CDRH user fee agreements spell out in great detail the required deadlines for FDA device approval-related actions, the Center’s current post-marketing surveillance programs are either voluntary (such as MedSun) or poorly enforced (such as mandatory reporting by device companies and hospitals). Unique Device Identifiers (UDIs) and other efforts are not yet usable. And yet, the lower standards for the clearance and approval of medical devices makes post-market surveillance of devices even more essential. For example, in 2009 an HHS Inspector General report stated that …..“Adverse event reporting enables FDA to take corrective action on problem devices and to prevent injury and death by alerting the public when potentially hazardous devices are discovered.”

In addition to what is a poor response rate, the FDA has not been transparent about the shortcomings of MedSun. For instance, when MedSun conducts a survey of facilities to gather information, the agency only reports on the number of responses (14 in a recent report of breast tissue extenders, for example); but did not report the number of facilities which did not respond. That information is essential for determining if the data from the 14 respondents are generalizable nationwide, although it is unlikely that they are.

We are also concerned that medical device manufacturers are being allowed to report required adverse events or malfunctions in “summary” form. This is insufficient to providing unbiased information to the agency.

According to published reports. During the user fee agreement negotiations, FDA and the industry group AdvaMed discussed changes in the condition of submission of medical device reports, or MDRs, which are critical to FDA’s ability to detect patterns of adverse events. It is currently unclear as to the status of any such possible reporting changes.
FDA’s reporting systems are intended to identify problems with medical products and take actions to prevent additional harm. However, voluntary programs, limited funding for reporting systems, and limited information about adverse event reported through these systems prevent the FDA from protecting patients as effectively as it should.

There are numerous examples where patients were harmed due to an agency failure to detect medical device malfunction or misuse in a timely manner. One such failure, on metal-on-metal hip implants, was not discovered initially by FDA, but rather by registries from smaller foreign countries that detected the high rate of failure of these hip implants worldwide before FDA did. Had the FDA had a better warning system in place, the much larger number of U.S. patients with the metal-on-metal hip implants would have been obvious in the U.S. much sooner than it was in the United Kingdom or Australia, which first reported them.

The resulting product recalls involved thousands of patients and hundreds of millions of dollars in additional medical care and lawsuit settlements. These demonstrated dangers make it all the more imperative that the medical device adverse event reporting systems that affect manufacturers, hospitals and device distributors be made mandatory and be enforced. If it is not possible to make the MedSun system mandatory, then the FDA must improve the incentives to greatly improve the response rate of clinicians and facilities.

Medical devices can and save lives, but they can also cause serious harm. The FDA needs to greatly improve post-market surveillance and MedSun should be part of that effort.

Thank you for the opportunity to comment.