Wendy Stirnkorb, President & CEO of Stirnkorb Consulting, LLC and a registered radiographer, MRI technologist and Certified Radiology Administrator, presented the webinar “Scanning the Unscannable: Improving Patient Flow in MRI.” Ms. Stirnkorb addressed many common questions and we’ve highlighted the top Q&A below.
Does the advent of MRI conditional medical devices help simplify the screening process?
Simplify? No. But that labeling does give us a starting point. The technologists or the MR Safety Officer still have to assure that the conditions of the medical device can be met while maintaining diagnostic image quality. They can then share this information with the physician radiologist so a sound medical decision can be made after weighing the risks vs the benefits of the MRI procedure. Often, this may mean a physician to physician conversation prior to proceeding, or canceling the request. The key is that the patient, the technologist, the radiologist and the requesting provider are all working together to assure the patient receives the most appropriate care at the appropriate time.
There seems to be a lot of media attention on MRI contrast over the last several years. Can you share your thoughts on the safety of MRI contrast?
The approved gadolinium-based contrast agents (GBCAs) have historically been considered safe and well tolerated when used at recommended dosing levels. It was previously widely believed that GBCAs are rapidly and completely excreted from the human body in an intact state. In the early 2000’s, there was a lot of media attention directed toward MRI contrast agents due to their connection to Nephrogenic Systemic Fibrosis. This disease is contributed to the use of gadolinium based contrast agents in patients with reduced kidney function. As an industry, practice changes were made and guidelines set to reduce the risk of gadolinium issues within this patient population.
More recently, the media, with the help of high profile patients and their family members, have focused attention to the retention of gadolinium based contrast agents and the effects they feel that it is having on them physically. Newer reports have emerged regarding the accumulation of gadolinium in various tissues of patients who do not have renal impairment, including bone, brain, and kidneys. Despite the observations of gadolinium accumulation in tissues regardless of renal function, very limited clinical data regarding the potential for and mechanisms of toxicity is available.
Retention of gadolinium appears to increase in those who have repeated GBCA exposure. Patient-initiated survey results available through certain patient advocacy groups suggest the onset of a series of symptoms (including neurological, musculoskeletal, and dermal) in patients within a month of their last MRI with contrast. In 2015, given the increasing data available regarding tissue deposition in patients without renal impairment, the U.S. Food and Drug Administration (FDA) published a safety announcement that it was investigating the risk of brain deposits associated with the repeated use of GBCAs MRI (FDA Drug Safety Communication 2015). In the fall of 2017, the FDA announced in a drug safety communication the requirement for new warnings to be included on all GBCAs. The FDA also called for increased patient education and requiring gadolinium contrast vendors to conduct additional animal and clinical studies to assess the safety of these agents.
Toxicity of GBCAs has primarily been attributed to the dissociation of Gd3+ from the chelated complexes. This dissociation is believed to be related to differences in the stability of the complexes among the various types of GBCAs. However, there is data that suggest that competitive chelation with components in the extracellular matrix may also play a role in the tissue distribution and toxicity of GBCAs (Taupitz et al. 2013). Unequivocal data regarding the effects of multiple GBCA exposure are limited. However, the information regarding the stability constants for GBCAs and the emerging data regarding gadolinium tissue accumulation in those with normal kidney function indicate that the potential toxicity associated with GBCA must be seriously and urgently considered. Industry wide, we have taken notice. The use of certain agents has been banned in Europe. Research continues to definitively connect causality and explore the clinical significance of retention. My advice to patients is to make yourself knowledgeable about MRI contrast and have frank discussions with your provider about the risks and benefits of having MRI exams with contrast.
Is there a national or global standard for MRI Safety?
Global? No, not at all. Even nationally in the US, there are regulations by the FDA that are designed to ensure the safety and effectiveness of medical devices, including the MRI scanners themselves and any medically implanted devices—but for the operators of this equipment, there are only guidelines. Regulatory bodies such as the American Registry of Radiologic Technologists have standards of performance for MR registered technologists- competencies- that each technologist should be able to consistently perform to attain and retain their registry status. The Joint Commission, an accrediting body, revised Diagnostic Imaging Requirements in 2015 to include verbiage stating that facilities where MRI is performed must document ongoing annual education, including MRI safe practices, for MRI technologists—but there are minimal guidelines as to what that training should include. There is mention in the Element of Performance HR.01.05.03 about patient screening, proper positioning, response within the environment to emergent or urgent medical needs, use of hearing protection and assisting patients with anxiety or claustrophobia. There are specific guidelines about access control and signage, but less defined guidance about the education and training of the staff members performing the MRI procedures. There are no requirements of formal education to perform MRI. This is facility dependent and often is the same tired old video or PowerPoint used year after year. We can do better than that. Regardless of the lack of required standards, the surveying bodies such as the Joint Commission will certainly be thorough in assuring compliance with what they have outlined.