The U.S. Food and Drug Administration and other government and professional organizations today unveiled a program to monitor medical devices used in cataract surgery in an effort to stem outbreaks of a rare, inflammatory condition associated with the procedure.
The Proactive TASS Program (PTP) is designed to reveal outbreaks of Toxic Anterior Segment Syndrome (TASS) early with the goal of minimizing the number of people affected.
Outbreaks of TASS over the past 11 years have affected patients from hundreds of surgical centers in North America. In some cases, the FDA traced the cause to contaminated products used during anterior segment surgery, resulting in recalls of several different ophthalmic devices. In other cases investigators were unable to determine the cause.
Researchers in FDA's Center for Devices and Radiological Health (CDRH) conducted studies to confirm the causes of TASS and were able to develop new testing methods to determine what role medical devices may play in the development of the condition .
Specifically, research findings confirmed the level of certain contaminants that lead to inflammation and the best methods for testing at specific contaminant levels. This information can be used by ophthalmic device manufacturers to improve the safety of their devices and help to prevent TASS outbreaks from happening.
The program is a collaboration between the FDA, Centers for Disease Control and Prevention (CDC), and the American Academy of Ophthalmology (AAO), and is one of the first surveillance programs in the United States to monitor the medical devices used in cataract surgery and to aid in early identification of a national TASS outbreak.