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.

Nuclear/radiological terrorism: emergency department management of radiation casualties.

Recent world events have increased concern that hospitals must be prepared for radiological emergencies. Emergency departments (EDs) must be ready to treat patients suffering from injuries in combination with radiation exposure or contamination with radioactive material. Every hospital should have a Radiological Emergency Medical Response Plan, tested through periodic drills, which will allow effective handling of contaminated and injured patients. Treatment of life-threatening or severe traumatic injuries must take priority over radiation-related issues. The risk to ED staff from radioactive contamination is minimal if universal precautions are used. The likelihood of significant radiation exposure to staff under most circumstances is small. Educating medical staff on the magnitude of the radiological hazards allows them to promptly and confidently provide the necessary patient care. Measures must be taken to prevent the "worried well" and uninjured people with radioactive contamination from overwhelming the ED.

A reassessment of radioactive material security in health care and biomedical research.

The medical facilities of the U.S. Department of Veterans Affairs (VA) use radioactive material for health care and biomedical research. In the past, a single level of security for all radioactive material was generally deemed to be adequate. The events of 11 September 2001 prompted a reassessment of security. Based on site visits to VA facilities possessing a range of radioactive material typically used in health care and biomedical research, the VA National Health Physics Program has compiled recommendations for the security of radioactive material. A primary recommendation is to evaluate radioactive material from a risk perspective and use security measures commensurate with risk. The risk evaluation should consider activity, half-life, exposure rate constant, ALI, ease of removal/portability, and dispersibility. We concluded that current security measures are likely adequate for the risks associated with most nuclear medicine departments and biomedical research laboratories. However, for radioactive material of higher risk, particularly multicurie sources of long half-life, the radiation safety staff should consult with police/security experts to determine if additional security measures are warranted. This focus on risk should help optimize resource allocation. We also recommend that security evaluations consider both physical security and personnel security, training of staff with unescorted access to higher-risk radioactive material emphasize security issues, and disposal of higher-risk material not likely to be used. Finally, we note that the goals of security can be in conflict with hazard awareness and hazard communication.