The following HTML text is provided to enhance online
readability. Many aspects of typography translate only awkwardly to HTML.
Please use the page image
as the authoritative form to ensure accuracy.
Safe Medical Devices for Children
included failures in aortic connector devices that resulted in hemorrhage and death, meningitis associated with cochlear implants, aneurysm-related deaths associated with endovascular grafts, hospital bed fires, toxic shock syndrome associated with a particular brand of tampon, off-label use of an adhesion barrier, and saline leakage in the access port of the lap band adjustable gastric band (FDA, 2004b). Some of these problems were identified through relatively short-term analyses of a few event reports, whereas others were the result of a retrospective analysis of up to 10 years of reports. Responses included FDA public health notifications or manufacturer withdrawals of products.
“International vigilance reports” are also a high priority for staff review. These reports are transmitted by agencies (“national competent authorities”) responsible for surveillance in other countries. They typically involve the recall of products that have significant potential for harm.
The next priority for review is reports of events that are not in the high-priority category but that are also not so familiar that they are either reported through the summary report option described in Chapter 3 or identified by an automated report screening process (see below). These intermediate-priority reports account for about a third of the total. Again, reviewers may determine that no follow-up action is needed or they may recommend follow up.
The lowest priority for review applies to summary reports and reports flagged by an automated screening process that searches for certain well-recognized device-event combinations (e.g., silicone breast implants and capsular contracture, which is a tightening of the scar tissue surrounding an implant). Summary reports now account for about half of all reported events. The automated screening procedure picks up or flags about 15 percent of individual reports, and about 10 percent of these reports are reviewed by staff each month but only as a check that the screening tool is performing as intended.
Although FDA staff generally do not look for trends or changes in the summary reports and the reports flagged by the automated screening process, manufacturers (under the quality systems regulations described in Chapter 3) are supposed to monitor their event reports for trends and changes in frequency or severity of adverse events. Such monitoring could prompt further investigation and action (e.g., a recall).
Except for the small group of high-profile events, no specific rules define when a single report or series of reports should prompt further investigation of MAUDE reports, follow-up inquiries to manufacturers or facilities, epidemiologic study, or review of the clinical literature. Reviews and assessments of reports and other information about device hazards and judgments about appropriate FDA responses have a considerable subjective component. Resource constraints limit the agency’s ability to