Blurred vision, clear concern: linking poor visualization with adverse events in minimally invasive surgery
Aysha Ameerah1, Mansi Patel2, Maansi Srinivasan3
1The College of Natural Sciences, The University of Texas at Austin, Austin, TX, 78712, USA.
Background:
While minimally invasive surgery (MIS) offers numerous benefits, ensuring patient safety remains paramount. This study examines the critical role of visualization in MIS safety by analyzing visualization-related adverse events reported in the FDA Manufacturer and User Facility Device Experience (MAUDE) database.
Methods:
We implemented a systematic search strategy within the MAUDE database using 165 unique three-word search phrases to capture a broad range of visualization challenges encountered during procedures.
Results:
Our analysis of over 12,000 MAUDE reports from 2014 to 2024 reveals a concerning prevalence of such challenges in laparoscopic surgery. A striking 72% of these reports were linked to patient injury, highlighting a strong association between suboptimal visualization and adverse outcomes. Further analysis revealed that over half of the specific visualization-related keywords examined were associated with adverse events resulting in patient injury rates exceeding 50%, indicating a high likelihood of harm when these challenges occur. The potential for significant underreporting in MAUDE suggests the true incidence rate could be drastically higher, potentially affecting over 120,000 patients annually. While reports associated with keywords linked to robotic surgery were considerably fewer in number, the proportion of those linked to patient injury was higher in robotic reports, emphasizing the persistent need for vigilance regarding visualization even with advanced surgical platforms.
Conclusions:
These findings underscore the urgent need for a critical reassessment of the current standard of care for visualization in MIS. Further research is crucial to explore potential causal relationships between suboptimal visualization and patient injury and to develop effective strategies to mitigate these risks, ultimately enhancing patient safety and optimizing surgical outcomes.
Insights
Suboptimal visualization in minimally invasive surgery (MIS) is linked to patient injury, with over 72% of reported events causing harm. Enhanced safety protocols are needed to address these critical visualization challenges in MIS.
Area of Science:
- Medical device safety
- Surgical technology
- Patient outcomes
Background:
- Minimally invasive surgery (MIS) offers benefits, but patient safety is critical.
- Visualization is a key factor in MIS safety.
- Adverse events related to visualization in MIS require thorough investigation.
Purpose of the Study:
- To analyze visualization-related adverse events in MIS using the FDA MAUDE database.
- To identify the prevalence and impact of visualization challenges on patient safety.
- To highlight the association between visualization issues and patient injury.
Main Methods:
- Systematic search of the FDA MAUDE database.
- Utilized 165 unique three-word search phrases to capture visualization challenges.
- Analyzed over 12,000 reports from 2014 to 2024.
Main Results:
- Over 12,000 MAUDE reports analyzed from 2014-2024.
- 72% of visualization-related reports in laparoscopic surgery were linked to patient injury.
- Over half of specific visualization keywords were associated with >50% patient injury rates.
- Underreporting in MAUDE suggests potentially over 120,000 patients affected annually.
- Robotic surgery reports had fewer events but a higher proportion linked to injury.
Conclusions:
- Urgent need to reassess current standards of care for MIS visualization.
- Further research required to establish causal links between visualization and injury.
- Development of strategies to mitigate visualization risks is crucial for patient safety.
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