Risk Management

OMIC Recommendations for Diagnosis and Prevention of Endophthalmitis and TASS

On Dec 21st, the FDA established a registry for devices used in cataract surgery and a program for identifying and evaluating suspected device contaminants.

Called the Proactive TASS Program, the initiative has three key components:

• A registry developed by FDA and AAO to collect information about devices used in cataract surgery and patient outcomes
• Standardized testing methods to identify TASS-related contaminants in ophthalmic devices
• An agreement with CDC to collect and transport samples from sites of suspected TASS outbreaks to FDA laboratories

The reporting mechanism for the program will be integrated with the AAO-sponsored Physician Quality Reporting System. The Academy also will collaborate with a private quality-assurance company to develop the registry and make recommendations about the type of data collected. They also will recruit cataract surgeons to participate in the program.

To see OMIC’s Risk Management Recommendation Guide for Endophthalmitis and TASS and other related documents, see below.

• Endophthalmitis/TASS Recommendations and AAO/ASCRS Reports
  • Endophthalmitis/TASS Investigation Protocol

For link to article on FDA Study click here.