Device Event Summary Reporting Supported by AdvaMed
A CDRH and CBER proposal on Voluntary Malfunction Summary Reporting Program for manufacturer reporting of certain device malfunction medical device reports (MDRs) has gained the backing of device industry trade group AdvaMed and drawn criticism from women’s health advocates. The proposed program is intended to streamline malfunction reporting and was outlined in last year’s device user fee negotiation and reauthorization (see earlier story). FDA believes that quarterly summary reports would allow it to collect sufficient detail to monitor devices effectively.
In comments on the proposal, AdvaMed said summary malfunction reporting will “facilitate FDA’s and industry’s increased focus on the subset of device malfunctions that are more likely to identify new information about device safety or efficacy. Summary malfunction reports will greatly reduce the volume of reports that manufacturers would need to submit to FDA, streamline the information FDA receives, which will facilitate more efficient understanding of potential malfunction issues, and for the public, will allow event trends for a particular device to be more readily transparent.”
AdvaMed told the agency that the program should not weaken reporting of important device events. “We agree that the type of device malfunctions that should be eligible for summary reporting should be limited to those already known to the manufacturer and FDA,” the group said. “In this regard, when a new type of malfunction occurs that the manufacturer has not previously reported to FDA, the manufacturer would submit an individual report. This proposal represents a common-sense approach to summary malfunction reporting because, typically, the most common malfunctions for a device have been thoroughly investigated and assessed by the company, frequently reviewed by FDA, and are often identified in the device labeling.”
Still, some stakeholders worry that abuses in reporting could take shape. Women’s health advocacy group National Center for Health Research health director Jack Mitchell recently told the Star Tribune: “When companies have submitted summary reports in the past, it has resulted in less transparency, with neither FDA nor the public able to have access to adequate information about patients who have been seriously harmed by medical devices. This proposal would further weaken the current post-market safety surveillance system for devices, which is already passive and inadequate.”
Star Tribune investigations into current FDA summary reporting practices found that Medtronic was allowed to summarize a study that revealed more than 1,000 malfunctions of its Infuse bone graft in three sentences within a single “marker report” when they allegedly were required to report individually. The agency was also criticized for redacting total number of injuries and complications as a “trade secret” until the newspaper appealed the decision. Medtronic said it should have submitted data sooner, but the study was misplaced and then reported as soon as it was found. The company says it then complied with all requests FDA made for information about the study.