MRI safety regulation: Lessons from ionizing radiation standards

Consider, for a moment, if ionizing radiation were unregulated -- if technologists administering x-rays, CT scans, and fluoroscopy could make decisions based solely on personal judgment rather than established safety standards. The concept seems absurd, yet this hypothetical scenario mirrors the current reality of MRI safety oversight in many facilities across the U.S.

Kelly Brock of Hackensack Meridian Health in Paramus, NJ.Kelly Brock

In stark contrast to MRI, the regulation of ionizing radiation in the U.S. represents one of healthcare's most comprehensive safety frameworks. A multilayered system of federal and state oversight governs every aspect of its use. Federal agencies like the Nuclear Regulatory Commission (NRC) and the Food and Drug Administration (FDA) establish strict, legally enforceable standards for everything from equipment manufacturing to personnel training and credentialing. 

These regulations set quantifiable maximum permissible radiation doses for both workers and the public. State-level bodies, such as New Jersey's Bureau of X-Ray Compliance, add another layer of control, mandating technologist licensure, regular facility inspections, and adherence to specific quality assurance protocols.

The regulatory infrastructure surrounding ionizing radiation reflects decades of scientific research, documented injuries, and recognized biological harm from exposure. These regulations exist because radiation's dangers are well-established, quantifiable, and potentially devastating. No one questions the necessity of these safeguards.

Yet MRI operates in a starkly different regulatory environment. Despite documented incidents of projectile injuries, burns, implant heating, acoustic damage, and even fatalities, MRI safety remains largely unregulated at the federal level. The FDA regulates MRI scanners as medical devices and sets limits on specific absorption rate (SAR) and static field strength, but these standards address equipment performance rather than comprehensive operational safety. There are no federal requirements for personnel credentialing specific to MRI safety, no mandated screening protocols, no standardized policies for accompanying persons, and no enforceable facility design standards beyond general guidelines.

The American College of Radiology (ACR) provides extensive recommendations through its "Manual on MR Safety," widely considered the gold standard for best practices. However, these remain

recommendations, not requirements. Facilities may adopt them, modify them, or ignore them entirely without regulatory consequence. The result is an inconsistent patchwork of safety practices that vary dramatically from one facility to another, often determined by individuals without specialized training in MRI safety principles.

This regulatory vacuum creates an environment where corporate policies may prioritize convenience or cost savings over patient safety, where nonspecialists make critical safety decisions, and where frontline technologists who recognize hazards may be overruled by administrators unfamiliar with the unique risks of the MRI environment. The absence of accountability and enforcement mechanisms means that dangerous practices can persist unchallenged.

The contrast is striking: ionizing radiation, whose risks are well-controlled through regulation, operates under multiple layers of oversight, while MRI -- with its powerful magnetic fields, radiofrequency energy, gradient fields, and cryogenic systems -- operates largely on the honor system. Until MRI safety receives comparable regulatory attention, with mandated credentialing, standardized protocols, facility inspections, and enforcement mechanisms, it will continue to pose preventable risks to patients and healthcare workers alike. The question is not whether MRI needs regulation, but rather how many more incidents must occur before the regulatory framework catches up to the reality of the hazards.

A recent experience highlights the broader systemic challenges in MRI safety implementation. During a policy review discussion, concerns were raised regarding discrepancies between existing corporate protocols and the recommendations outlined in the ACR Manual on MR Safety. Two specific proposals were presented: first, the introduction of a patient heat risk waiver to document situations where patients decline to change clothing or remove jewelry, and second, the adoption of a standardized screening form for accompanying personnel. Both proposals aligned with current ACR guidelines and represented evidence-based best practices in the field.

The discussion concluded quickly, with leadership choosing to maintain existing policies. What emerged from this experience was an observation worth noting: Many of the decision-makers in these policy discussions, including radiology managers and directors, come from backgrounds outside of specialized MRI safety training. While these administrators bring valuable expertise in operations and management, they may not hold board certification as MR safety officers or credentials as MRI technologists.

This situation illustrates a broader pattern in healthcare facilities. When safety protocols are determined primarily by individuals without specialized training in the modality's unique hazards, the resulting policies may not fully reflect current evidence-based guidelines. The absence of regulatory requirements that mandate specific safety credentials for decision-makers means that facilities have considerable latitude in how they establish and maintain MRI safety standards. This variability across institutions underscores the need for a more structured approach to MRI safety governance -- one that ensures those making critical safety decisions have appropriate specialized knowledge and that evidence-based guidelines translate consistently into operational practice.

Kelly Brock is a radiologic technologist and clinical supervisor of ambulatory imaging at Hackensack Meridian Health in Paramus, NJ.

The comments and observations expressed are those of the author and do not necessarily reflect the opinions of AuntMinnie.com.