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Failure Modes and Effects Analysis of bilateral same-day cataract surgery
Neal H Shorstein1, Carol Lucido1, James Carolan1
1From Kaiser Permanente (Shorstein, Lucido), Walnut Creek, Kaiser Permanente (Carolan), San Rafael, Division of Research (Liu, Herrinton), Kaiser Permanente, Oakland, and the California Pacific Medical Center (Slean), San Francisco, California, USA.
Journal of Cataract and Refractive Surgery
|April 16, 2017
Summary
This study analyzed risks in same-day bilateral cataract surgery, identifying potential failures in sterile processing and documentation. Recommendations focus on improving safety protocols for this common procedure.
Area of Science:
- Ophthalmology
- Surgical Safety
- Quality Improvement
Background:
- Bilateral same-day cataract surgery is a common procedure with potential patient safety risks.
- Systematic analysis of process failures is crucial for enhancing surgical outcomes.
- Previous studies have highlighted the need for improved safety measures in ophthalmic surgery.
Purpose of the Study:
- To systematically analyze potential process failures in bilateral same-day cataract surgery.
- To improve patient safety by identifying and mitigating risks.
- To provide evidence-based recommendations for enhancing surgical reliability.
Main Methods:
- A retrospective cohort study was conducted across 21 surgery centers.
- Failure Modes and Effects Analysis (FMEA) was employed to evaluate processes including sterile processing, pharmaceuticals, and perioperative care.
- Rates of endophthalmitis, toxic anterior segment syndrome (TASS), and unintended intraocular lens (IOL) implantation were assessed.
Main Results:
- Fifteen significant potential failure modes were identified, including issues with instrument processing and medication compounding.
- Lapses in sterile processing and compounding errors could lead to endophthalmitis or TASS.
- Ambiguous IOL documentation posed a risk for unintended IOL implantation, with a rate of 2 per 10,000 eyes.
Conclusions:
- Failure Modes and Effects Analysis identified key areas for improvement in bilateral same-day cataract surgery.
- Recommendations include enhanced sterilization oversight, drug compounding separation, and improved IOL verification.
- Implementing these measures can enhance the safety and reliability of bilateral cataract surgery.