The idea behind the program, to be known as the Proactive TASS Program (PTP), is to reveal the outbreaks early and minimize the number of patients effected and 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.
"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 is an inflammation that usually occurs within two days of cataract surgery and affects the front area of the eye, including the cornea, iris, lens, and the fluid-filled space between the lens and the cornea (anterior chamber). Many cases do, in fact, resolve without treatment, but patients experience a range of symptoms from blurry vision to redness from swelling of the cornea.
The problem seems to be caused by a build up of white blood cells, protein and firbin deposits in the anterior chamber. In some cases it can lead to serious complications and loss of vision.
With around one in every six people over forty experiencing a cataract and more than three million procedures performed in the US every year, it's obviously a priority to make every possible effort to insure the simple procedure is safe and effect and avoids possible after-effects and problems.
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 said :
"As the baby boomers continue to age, the number of cataract surgeries will increase ... 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 problem of TASS has affected post operative patients from hundreds of surgical centers in the US and in some cases, the FDA was able to trace the problem to contaminated products used during the procedures.
Scientists at the FDA have now developed new methods to determine the extent that medical devices are involved in the problem.
It is hoped that by monitoring and evaluating the issue in closer detail the FDA can monitor and assist ophthalmic device manufacturers to improve manufacturing and safety standards with the aim of eradicating TASS.
The PTP program is a collaboration between the FDA, Centers for Disease Control and Prevention (CDC), and the American Academy of Ophthalmology (AAO). It 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.
Written by Rupert Shepherd