Goal: To help industry develop tools to improve safety of eye surgery medical devices
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.
“As the baby boomers continue to age, the number of cataract surgeries will increase,” said Malvina Eydelman, M.D., director of the Division of Ophthalmic, Neurological, and Ear, Nose, and Throat Devices within the Office of Device Evaluation in CDRH. “Information collected by the program will lead to the earlier investigation of national TASS outbreaks and determination of whether a medical device is the source of the outbreak.”
The program includes:
collaboration between the FDA and the AAO on a registry designed to collect information about the devices used in cataract surgery and patient outcomes following cataract surgery
standardized methods to test the level of TASS-related contaminants in ophthalmic devices
an agreement with the CDC to collect and transport samples from suspected TASS outbreaks to FDA’s lab for analysis
Improved coordination and communication will be emphasized in the program.
“CDC investigation of outbreaks can be helpful to other government agencies working on patient safety,” said Judith Noble-Wang, Ph.D., lead microbiologist of the CDC’s Division of Healthcare Quality Promotion. “The program is an additional way for us to share information designed to protect patients with our colleagues at FDA.”
TASS usually occurs within 48 hours after cataract surgery on the front portion of the eye that includes the cornea, iris, lens, and the fluid-filled space between the lens and the cornea (anterior chamber). Symptoms include blurry vision and redness resulting from swelling of the cornea and a build up of white blood cells, protein, or fibrin deposits in the anterior chamber. While many cases resolve in a few weeks without treatment, some people can develop serious complications leading to additional surgeries and vision loss.
It is estimated that 1 in every 6 people over 40 in the United States have a cataract. More than 3 million cataract surgeries are performed nationwide every year.