A multisociety panel led by the Society for Cardiovascular Angiography & Interventions called for routine implementation of enhanced radiation protection devices in fluoroscopy laboratories, arguing that conventional protective apparel and movable shields no longer fully satisfy the “as low as reasonably achievable” principle in light of newer technologies.
The expert consensus statement does not establish a new federal or state regulation. Instead, it urges regulators, health care institutions, equipment manufacturers, and professional societies to adopt enhanced radiation protection devices as standard components of contemporary fluoroscopy laboratory safety.
The statement was endorsed by the American College of Cardiology, American Society of Echocardiography, Heart Rhythm Society, Society of Interventional Radiology, and Society for Vascular Surgery. It was published jointly in the Journal of the Society for Cardiovascular Angiography & Interventions, JACC: Cardiovascular Interventions, and the Journal of Vascular and Interventional Radiology.
Writing-group members conducted literature reviews for individual sections and developed consensus statements through a modified Delphi process requiring 75% agreement. A draft underwent public comment in May 2025, and all participating societies endorsed the final document in May 2026.
The process did not include a reported systematic review, formal risk-of-bias assessment, or evidence-certainty grading framework. The supporting evidence also varied substantially by device, procedure, comparator, dosimeter location, and study design.
Exposure Reductions Varied by Device
The panel reviewed commercially available devices designed to contain scatter radiation, place fixed or mobile barriers between the source and staff, or transfer the weight of protective apparel away from the operator.
Across the cited studies, reported reductions in measured operator exposure generally ranged from approximately 80% to greater than 99%. Much of the evidence came from single-center observational studies, small randomized procedural studies, or phantom testing rather than trials designed to evaluate long-term clinical outcomes such as cancer, cataracts, or musculoskeletal outcomes.
In a 450-patient observational study of percutaneous coronary intervention and transcatheter aortic valve replacement, use of a configurable radiation barrier was associated with a greater than 99% reduction in measured operator exposure compared with standard shielding.
One 100-patient randomized trial of a panel-based transparent barrier reported a 97% reduction in operator exposure. A separate 100-patient trial reported reductions of 86% at the head, 80% at the collar, and 100% at the waist.
In a prospective electrophysiology study, use of a device-mounted source-attenuating system was associated with 87% lower exposure during ablation procedures and 83% lower exposure during device implantation.
A single-center observational study of 1,054 coronary procedures reported that a suspended protection system was associated with a 98% reduction in median operator head-level exposure compared with conventional protective apparel. The system transfers the weight of its shielding to the floor rather than the operator.
The panel noted that protection varies by device. Some systems protect only the operator wearing them, whereas others extend protection to additional staff positions but may require supplemental shielding elsewhere in the room.
Long-Term Clinical Benefits Remain Uncertain
The panel argued that newer shielding technologies could reduce both occupational radiation exposure and reliance on heavy lead apparel associated with musculoskeletal injury.
The writing group cited observational occupational studies reporting cancer, cataracts, reproductive concerns, and musculoskeletal disorders among personnel who work in fluoroscopic environments.
Surveys cited in the statement found orthopedic symptoms related to protective apron use in 62% of technicians and 66% of physicians. Another study reported a 67% higher adjusted risk of work-related pain among personnel working in radiation environments compared with nonexposed workers.
However, the reviewed enhanced radiation protection device (ERPD) studies primarily evaluated radiation dosimetry rather than health outcomes. The statement did not establish that adoption of these devices reduces cancer incidence, cataracts, spinal disease, pain, disability, or adverse reproductive outcomes.
The panel called for prospective studies examining cataract formation, cumulative occupational exposure, and musculoskeletal outcomes among operators using ERPDs or performing procedures without heavy protective apparel.
The panel also recommended validation in procedural settings beyond interventional cardiology, including interventional radiology, neuroradiology, orthopedics, urology, pain management, and peripheral vascular procedures.
Dosimetry Recommended During Implementation
The panel strongly advised real-time dosimetry during ERPD implementation and ongoing use. Such monitoring can identify gaps in the protected zone, provide immediate feedback, and help account for a learning curve with unfamiliar shielding systems.
In one cited study of pediatric interventional radiology personnel, visible real-time exposure data were associated with a sixfold reduction in the rate of measured exposure compared with blinded monitoring.
The panel said reduced-weight or no-apron practice may be considered only when an ERPD has demonstrably maintained exposure within regulatory limits, the protected zone is clearly defined, real-time institutional monitoring is rigorous, and applicable state requirements are followed.
The statement also called for standardized state regulations, national certification of fluoroscopy personnel, uniform radiation-monitoring platforms, and a national occupational dose registry. Those proposals represent the panel’s recommendations and have not been adopted as nationwide requirements.
“This multisociety expert consensus statement … affirms a collective commitment to immediate implementation of regulation-mandated enhanced radiation protection,” the writing group concluded.
Disclosures: James A. Goldstein owned equity in and served on the board of ECLS, which licenses Protego technology to Image Diagnostics. David G. Rizik consulted for ECLS. Dean J. Kereiakes owned stock options in Egg Medical. William J. Nicholson owned equity in and advised Rampart. Kenneth Rosenfield owned stock options in Radiaction and SALUS Scientific and advised Philips. Nadia Sutton advised Radiaction and Philips. Andrew M. Goldsweig consulted and spoke for Philips. Gabriel Bartal consulted for TexRay AB. The remaining authors reported no financial interests. Rizik, Goldstein, Goldsweig, Kereiakes, and Alexandra J. Lansky held editorial leadership positions at JSCAI but were not involved in the peer-review process or publication decision following submission. The work received no external funding.
Source: Journal of the Society for Cardiovascular Angiography & Interventions
