FDA’s Proactive TASS Program

This article describes the role of the U.S. Food and Drug Administration (FDA) in helping to evaluate and mitigate toxic anterior segment syndrome (TASS) through its Proactive TASS Program (PTP). The program was created in response to the July 2006 TASS epidemic, when more than 100 surgical centers in North America reported cases but the cause of the outbreak was never identified.

Specifically, the PTP is designed to detect a national outbreak earlier than during previous outbreaks, assist in the identification of the cause of the outbreak and initiate appropriate regulatory action when necessary.

Through PTP, FDA scientists have conducted animal studies to better explore the inflammatory potential of suspected ophthalmic device contaminants implicated in prior cases of TASS. For contaminants displaying a TASS-like reaction in these animal models, the scientists have developed analytic test methods to measure the level of those contaminants in or on ophthalmic devices. Moreover, FDA researchers have developed methods to better capture the clinical information necessary to assist investigations of potential future outbreaks.

The FDA has partnered with the Centers for Disease Control and Prevention to facilitate a potential TASS investigation, including expediting the analysis of potentially contaminated medical devices.

The ultimate goal of the PTP is to minimize injuries from future medical device–related TASS outbreaks and to prevent future outbreaks by disseminating to manufacturers and health care providers information generated by the PTP.