The FDA, CDC and the American Academy of Ophthalmology announced a plan to monitor medical devices used in cataract surgery to identify cases of toxic anterior segment syndrome and minimize those affected, according to an FDA news release.
TASS outbreaks over the past 11 years have affected patients from hundreds of surgery centers in North America. The FDA has been able to trace the cause of some of the outbreaks to contaminated products used during anterior segment surgery. As a result, several ophthalmic devices were recalled.
Research from the FDA's Center for Devices and Radiological Health confirmed that specific levels of certain contaminants lead to inflammation and identified the best methods for testing for contaminant levels. The program will include a registry to collect information about devices used and patient outcomes, standardized methods to test the level of contaminants and an agreement with the CDC to collect and transport samples from suspected TASS outbreaks to the FDA's lab for analysis.
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TASS outbreaks over the past 11 years have affected patients from hundreds of surgery centers in North America. The FDA has been able to trace the cause of some of the outbreaks to contaminated products used during anterior segment surgery. As a result, several ophthalmic devices were recalled.
Research from the FDA's Center for Devices and Radiological Health confirmed that specific levels of certain contaminants lead to inflammation and identified the best methods for testing for contaminant levels. The program will include a registry to collect information about devices used and patient outcomes, standardized methods to test the level of contaminants and an agreement with the CDC to collect and transport samples from suspected TASS outbreaks to the FDA's lab for analysis.
Related Articles on the FDA:
FDA Proposes Draft Guidelines to Improve the Representation of Women in Medical Device Clinical Studies
FDA Issues Draft Guidance on Humanitarian Use Device Classification
Commentary: Free the FDA