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Medical imaging's use of contrast agents enhances diagnostics but carries legal risks. Lawsuits often involve anaphylactic reaction mismanagement, contrast agent errors, and inadequate referrals. Read on to learn how you and your team can mitigate concerns.
Tether Supervision
Nov 26, 2024
In the realm of medical imaging, the use of contrast agents plays a pivotal role in enhancing diagnostic accuracy by improving image quality and enabling more precise diagnoses in procedures such as CT or MRI scans. However, these benefits come hand in hand with potential risks. Errors or mistakes in contrast agent administration, allergic reactions, renal injuries, and challenges in managing severe reactions constitute the spectrum of liabilities faced by healthcare providers.
A recent analysis published September 19th, 2023 in Radiology, a journal by RSNA, has shed light on the legal complexities surrounding imaging contrast agents, emphasizing the need for meticulous care in their administration. This article explores the key findings of this analysis (Contrast Agent Administration as a Source of Liability: A Legal Database Analysis) and offers insights into mitigating liability in the context of contrast-related imaging procedures.
Understanding the Legal Landscape
Radiologists, as integral members of the medical imaging process, find themselves among the specialties frequently implicated in medical malpractice claims. While radiologists are acutely aware of the risks associated with missed findings or communication lapses, it's crucial to recognize that liability related to the use of contrast agents in imaging procedures may be underappreciated.
The analysis reveals that medical malpractice lawsuits related to imaging contrast agents often revolve around allegations of failure to diagnose or treat anaphylactic reactions promptly. Moreover, issues related to monitoring the administration of contrast agents and referring patients for urgent contrast media extravasation treatment were recurrent themes in these legal actions.
Key Findings and Takeaways
The study's methodology involved querying two comprehensive online legal data repositories, spanning back to their inception, using keywords such as "contrast," "radiology," and "radiologist." The results were screened to include cases within the practice area of healthcare law where at least one claim of medical negligence was made against a provider or institution.
Out of the 151 lawsuits examined, 51% went to trial, and 32% resulted in a verdict in favor of the plaintiff, typically the patient, against the medical defendants, which include healthcare organizations and providers.
The most common allegations in these lawsuits were as follows:
Failure to Diagnose or Treat Anaphylactic Reactions: An alarming 93% of claims related to anaphylactic reactions were attributed to a provider's failure to diagnose or treat the reaction promptly.
Inappropriate Management of Contrast Media Extravasation: In 27% of cases, inappropriate management of contrast media extravasation was cited as a significant medical complication.
Contrast Agent-Induced Acute Kidney Injury: Allegations of contrast agent-induced acute kidney injury accounted for 13% of the examined lawsuits.
In other words, severe allergic reactions among patients, coupled with clinicians' failure to promptly diagnose or treat these reactions, make up the majority of malpractice suits tied to contrast media use. These cases underscore the critical need for proactive measures to ensure patient safety and reduce the incidence of such claims.
Mitigating Liability: A Holistic Approach
To address the multifaceted challenges associated with contrast agents in medical imaging, healthcare providers can implement the following measures:
Provider Education: Enhancing provider education efforts on anaphylaxis triggers and management is paramount. By equipping clinicians with a deeper understanding of severe allergic reactions and their timely management, healthcare facilities can reduce the likelihood of diagnostic delays or inadequate treatment.
Advanced Technology: The utilization of sophisticated technology, such as epinephrine autoinjectors, can significantly improve the management of severe allergic reactions. Equipping healthcare providers with the tools they need to respond swiftly and effectively is crucial in safeguarding patient well-being.
Adhering to the Standard of Care: One of the most effective ways to mitigate liability is by ensuring that all radiologists adhere to the established standard of care. Hospitals and healthcare institutions should have written policies in place, explicitly delineating the expectations of ordering physicians, radiologists, and patients. This includes comprehensive documentation of allergic reaction histories and premedication requirements.
Instituting Professional Contrast Supervision: Given the legal complexities surrounding contrast agents, professional on-site or virtual contrast supervision can provide an added layer of assurance. By entrusting contrast supervision to experts, healthcare providers can enhance patient safety and minimize liability risks.
In Conclusion
Contrast agents have undoubtedly transformed the landscape of medical imaging, offering unparalleled diagnostic capabilities. Nevertheless, their use entails risks that cannot be ignored. The prevalence of malpractice suits related to contrast agents emphasizes the urgency of adopting a holistic approach to patient care.
By prioritizing provider education, leveraging advanced technology, implementing internal policies, and upholding the standard of care, healthcare facilities can minimize liability risks and safeguard patient well-being. As the medical community continues to harness the benefits of contrast agents, it is imperative to remember that patient safety should always remain our top concern.
Read more from Tether Supervision
Why is Epinephrine Crucial for Outpatient Imaging Centers?
For outpatient imaging centers, ensuring patient safety during contrast-enhanced procedures is paramount. Given the potential for severe allergic reactions to iodinated contrast media, every facility must be equipped with epinephrine to manage anaphylaxis effectively. Epinephrine is the first-line treatment for anaphylaxis. No other medication stops the life-threatening effects of anaphylaxis.
Allergic contrast reactions are rare (0.2–0.6% of all injections) and can range from mild rashes to life-threatening anaphylaxis.1,2 Although the vast majority of these are self-limited, delayed epinephrine administration can be fatal in cases of severe reactions.
Epinephrine typically takes effect within three to five minutes, with intramuscular injection into the anterolateral thigh being the preferred route.3 In outpatient settings, epinephrine auto-injectors offer a practical advantage, allowing for faster administration and reducing the risk of dosing errors.4 When used at recommended doses, epinephrine is highly safe, with common side effects including agitation, anxiety, tremors, or headache. There are no absolute contraindications for its use in anaphylaxis. Because the progression of an allergic reaction is unpredictable, early administration should be strongly considered, even for mild symptoms or single-system involvement.4
Intramuscular Epinephrine: The Foundation of a Smart Contrast Reaction Protocol
Intramuscular (IM) administration of epinephrine for anaphylaxis is the preferred route due to its proven safety profile and ease of use, as endorsed by multiple international guidelines.4–7 IM injection is widely recognized as a safe and effective method in both clinical and non-clinical settings—even school teachers have been successfully trained to administer it.8,9 While the American College of Radiology’s Manual on Contrast Media now requires only IM epinephrine as part of its minimum equipment standards.10
Why Protocolization Matters
In high-stakes environments, from aviation to surgery, checklists and standardized protocols are essential in preventing errors and improving outcomes. The same applies to contrast reaction management—having a clear, step-by-step process eliminates guesswork and reduces the risk of critical mistakes.
Without standardized protocols and education, providers can struggle with epinephrine administration. Studies have shown that in the absence of structured guidelines, errors occur such as
Administering IV epinephrine instead of IM.
Failing to administer epinephrine at all.11,12
These mistakes delay life-saving treatment and increase risks for patients. However, a simple, well-designed protocol—complete with checklists and auto-injectors—ensures that every provider can act confidently and correctly in an emergency.
Benefits of Auto-Injectors
Compared to manual epinephrine administration, auto-injectors offer several advantages:
1. Faster Administration
A study comparing manual injection vs. auto-injector in a simulated contrast reaction found that auto-injectors cut administration time by more than half (38.7 vs. 108.8 seconds)13
In an emergency, every second counts—delays in administration increase the risk of fatality.
2. Reduced Risk of Dosing Errors
Epinephrine auto-injectors come preloaded with a fixed dose, eliminating the risk of drawing up the wrong amount.
Manual injections require calculating and measuring doses, leaving room for human error—especially under stress.
3. Easier for Non-Physician Staff to Use
Auto-injectors require fewer steps and provide step-by-step instructions during use.
This makes it easier for nurses, technologists, or administrative staff to administer the injection correctly.
Outpatient imaging centers should be aware of various epinephrine delivery options in case of contrast-related anaphylaxis. The EpiPen is the most widely recognized auto-injector, while Auvi-Q offers voice-guided instructions and a retractable needle for added safety. Adrenaclick provides a lower-cost alternative but requires slightly different administration steps, and Neffy, a new needle-free nasal spray, may be preferred by patients with needle aversion. Symjepi and Epinephrine Snap Kit require manual injection and are generally lower-cost but demand more training and confidence in administration.
Final Recommendation
For most outpatient imaging centers performing contrast studies, epinephrine auto-injectors are the safest, most effective option with a proven track record. Given the potential for anaphylaxis, quick, error-free administration is essential.
At our organization, we prefer to work with centers that stock auto-injectors to ensure:
Faster administration.
Fewer medical errors.
Increased staff confidence.
Better patient outcomes.
Make the right choice for your imaging center.
References:
1. Wang CL, Cohan RH, Ellis JH, Caoili EM, Wang G, Francis IR. Frequency, Outcome, and Appropriateness of Treatment of Nonionic Iodinated Contrast Media Reactions. Am J Roentgenol. 2008;191(2):409-415. doi:10.2214/AJR.07.3421
2. Cochran ST, Bomyea K, Sayre JW. Trends in Adverse Events After IV Administration of Contrast Media. Am J Roentgenol. 2001;176(6):1385-1388. doi:10.2214/ajr.176.6.1761385
3. Muraro A, Roberts G, Worm M, et al. Anaphylaxis: guidelines from the European Academy of Allergy and Clinical Immunology. Allergy. 2014;69(8):1026-1045. doi:10.1111/all.12437
4. Simons FER, Ebisawa M, Sanchez-Borges M, et al. 2015 update of the evidence base: World Allergy Organization anaphylaxis guidelines. World Allergy Organ J. 2015;8:32. doi:10.1186/s40413-015-0080-1
5. Cardona V, Ansotegui IJ, Ebisawa M, et al. World Allergy Organization Anaphylaxis Guidance 2020. World Allergy Organ J. 2020;13(10):100472. doi:10.1016/j.waojou.2020.100472
6. Pflipsen MC, Vega Colon KM. Anaphylaxis: Recognition and Management. Am Fam Physician. 2020;102(6):355-362.
7. Lieberman P, Nicklas RA, Randolph C, et al. Anaphylaxis—a practice parameter update 2015. Ann Allergy Asthma Immunol. 2015;115(5):341-384. doi:10.1016/j.anai.2015.07.019
8. Donovan P, O’Connor P. The confidence and competence of primary school staff to administer an adrenaline auto-injector. Eur J Pediatr. Published online 2024:1-6.
9. Lejtman P, Hetroit-Vasseur E, Morello R, Vial S, Brouard J. Evaluation of a video training program’s impact on primary teachers’ knowledge of allergies and skills in using an adrenaline autoinjector during the 2021–2022 school year. Arch Pédiatrie. 2024;31(5):299-305. doi:10.1016/j.arcped.2024.03.003
10. ACR Manual on Contrast Media. Published online 2024. https://www.acr.org/-/media/ACR/Files/Clinical-Resources/Contrast_Media.pdf
11. Lightfoot CB, Abraham RJ, Mammen T, Abdolell M, Kapur S, Abraham RJ. Survey of Radiologists’ Knowledge Regarding the Management of Severe Contrast Material–induced Allergic Reactions. Radiology. 2009;251(3):691-696. doi:10.1148/radiol.2513081651
12. Nandwana SB, Walls DG, Torres WE. Radiology Department Preparedness for the Management of Severe Acute Iodinated Contrast Reactions: Do We Need to Change Our Approach? Am J Roentgenol. 2015;205(1):90-94. doi:10.2214/AJR.14.13884
13. Asch D, Pfeifer KE, Arango J, et al. JOURNAL CLUB: Benefit of Epinephrine Autoinjector for Treatment of Contrast Reactions: Comparison of Errors, Administration Times, and Provider Preferences. Am J Roentgenol. 2017;209(2):W363-W369. doi:10.2214/AJR.16.17111
