Safety Outcomes Following Implementation of a Systematic Cataract Surgery Protocol at a Tertiary Referral Eye Center

Area of Science:

• Ophthalmology
• Surgical Safety
• Quality Improvement

Background:

• Incorrect intraocular lens (IOL) implantation is a significant concern in cataract surgery.
• Standardized protocols are crucial for mitigating surgical errors.
• The Healthcare Failure Mode Effect and Analysis (HFMEA) offers a systematic approach to identify and address potential failures.

Purpose of the Study:

• To assess the long-term safety outcomes of cataract surgery following the implementation of a standardized operating procedure (SOP).
• To evaluate the effectiveness of a specifically devised SOP in preventing incorrect intraocular lens (IOL) implantation events.
• To highlight a critical yet under-documented aspect of ophthalmic surgical safety.

Main Methods:

• A retrospective analysis of a quality improvement initiative was conducted.
• The study involved the Healthcare Failure Mode Effect and Analysis (HFMEA) to develop a standardized operating procedure (SOP) for cataract surgery.
• Safety events post-SOP implementation were analyzed from 2018 to 2023.

Main Results:

• The HFMEA identified 170 process steps, 177 potential failure modes, and 75 root causes, revealing 29 system vulnerabilities.
• Despite the SOP, 8 incorrect IOL safety events occurred between 2018 and 2023.
• These events necessitated subsequent revisions to the standardized protocol.

Conclusions:

• Continuous evaluation and refinement of standardized cataract surgery protocols are essential.
• Proactive identification of system vulnerabilities through methods like HFMEA can improve patient safety.
• Ongoing vigilance is required to minimize the occurrence of incorrect IOL implantation.