title: The Food and Drug Administration's Proactive toxic anterior segment syndrome Program.
abstract: Toxic anterior segment syndrome (TASS) is a rare inflammatory condition usually observed within the first 48 hours after uncomplicated anterior segment surgery. Over the decades since its initial description, a number of TASS outbreaks have been reported. For a few of these outbreaks, the inciting factors were identified, but for the majority, the precipitating factors were often postulated but not confirmed. In light of the limitations identified in these outbreak investigations, the Food and Drug Administration's (FDA's) Center for Devices and Radiological Health staff has embarked on a number of activities aimed at mitigating medical device-related TASS outbreaks. Under the FDA-designed Proactive TASS Program (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 FDA 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. Last, 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 PTP is an example of the FDA proactively developing test methods and disease surveillance methods geared toward protecting the public's health.
authors.affiliation: Food and Drug Administration, Center for Devices and Radiological Health, Office of Device Evaluation, Division of Ophthalmic, Neurological, and Ear, Nose, and Throat Devices, Silver Spring, Maryland 20993, USA. malvina.eydelman@fda.hhs.gov
authors.forename: Malvina B
authors.initials: MB
authors.lastname: Eydelman
authors.forename: Michelle E
authors.initials: ME
authors.lastname: Tarver
authors.forename: Don
authors.initials: D
authors.lastname: Calogero
authors.forename: Shelley Y
authors.initials: SY
authors.lastname: Buchen
authors.forename: Kesia Y
authors.initials: KY
authors.lastname: Alexander
mesh_terms: D000818:Animals; D000869:Anterior Eye Segment / Q000187:drug effects* / Q000473:pathology; D002387:Cataract Extraction; D004196:Disease Outbreaks / Q000517:prevention & control; D004731:Endotoxins / Q000009:adverse effects*; D004866:Equipment Contamination; D006801:Humans; D011159:Population Surveillance; D013577:Syndrome; D014481:United States; D014486:United States Food and Drug Administration; D014606:Uveitis, Anterior / Q000139:chemically induced* / Q000453:epidemiology / Q000517:prevention & control*
chemical_list: D004731:Endotoxins