Regulatory Focus™ > News Articles > FDA Tightens Limits on Endotoxin Testing for Some Eye Surgery Devices

FDA Tightens Limits on Endotoxin Testing for Some Eye Surgery Devices

Posted 17 April 2014 | By Alexander Gaffney, RAC

The US Food and Drug Administration (FDA) is warning manufacturers of intraocular ophthalmic devices that they must do more to reduce the risk of their devices being contaminated with the endotoxins which cause Toxic Anterior Segment Syndrome (TASS) outbreaks.

The warning came in the form of a new draft guidance document, Endotoxin Testing Recommendations for Single-Use Intraocular Ophthalmic Devices, released on 17 April 2014.

The guidance notes that national outbreaks of TASS-a localized, inflammatory condition affecting the eye-have been associated with endotoxin contamination of ocular devices. The problem, FDA continued, is that TASS isn't a condition that causes inconvenience. It has been known to cause decreases in a patient's vision and require corneal transplants and glaucoma surgery to resolve its effects.

Based on the risks to patients, as well as the "increasing frequency" of TASS, FDA is now recommending that all manufacturers and sponsors of intraocular ophthalmic devices adhere to more stringent endotoxin testing requirements.

The new recommendations call for a limit of no more than 0.2 Endotoxin Units (EU)/mL for all ophthalmic viscosurgical devices (OVD), and 0.5 EU/mL for liquid endotamponades and posterior segment solid devices.

FDA said higher concentrations of EUs had been linked with greater risks of infection in patients.


Endotoxin Testing Recommendations for Single-Use Intraocular Ophthalmic Devices (FR)


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