Preventing Harm From Fluoroscopically Guided Interventional Procedures With a Risk-Based Analysis Approach.

Purpose: Fluoroscopically guided interventional (FGI) procedures often have lower complication rates compared with alternative surgical procedures, providing an option for patients with a high risk of perioperative mortality. Although severe radiation injuries are rare, patients receiving peak skin doses exceeding 3 Gy can suffer from radiation-induced tissue injuries, ranging from transient erythema to nonhealing wounds. As these iatrogenic injuries may manifest weeks to months postprocedure, proper diagnosis and timely medical intervention are less likely. Clinically, the lack of situational awareness for monitoring air kerma continues to be a challenge despite the recommendations of numerous organizations on ways to achieve fluoroscopy safety. For patient safety efforts, this study aimed to identify and mitigate systematic gaps associated with potentially high-radiation dose fluoroscopic procedures in US Department of Veterans Affairs (VA) and non-VA medical institutions.

Methods: In this study, a multi-institutional team utilized Healthcare Failure Mode and Effect Analysis (HFMEA) on an example implantable cardioverter defibrillator lead extraction procedure.

Results: With this approach, 29 interventions were devised and prioritized by feasibility, cost-effectiveness, and expected clinical impact. Five of the 29 interventions were recommended for immediate implementation or piloting.

Conclusions: This work demonstrates the application of formal risk-based analysis techniques in FGI procedures. These high priority interventions may be valuable for other facilities to consider when performing potentially high-radiation dose procedures and conducting risk-benefit analyses. Formal risk analysis techniques such as the HFMEA process are recommended for other facilities to use to improve safety for their high-risk procedures.