For many decades, certain healthcare professionals have borne the risks of exposure to ionizing radiation. This includes those who assist with and care for patients undergoing fluoroscopy procedures, as well as workers who operate fixed X-ray machines. As a modern alternative to traditional lead radiation shielding, the Radiaction Smart Shield was created to offer a safer, more effective solution.
Part of that ongoing commitment involves maintaining a close relationship with industry partners and the customers we seek to serve. In this light, Radiaction Medical has established a Center of Excellence (CoE)—a partnership between an industry and an institution that aims to facilitate, optimize, and enhance the development of technology that addresses barriers to adoption.
Too often, companies try to save time and money by rushing to enter the market before completing necessary feasibility work, even though it is essential to the success of any new product or device. For example, traditional first-generation radiation reduction barriers often lack the adaptability to meet specific workflow requirements. Adjusting to the idiosyncrasies of each interventionist's workflow can be difficult, and complicated by dynamic variables including patient BMI, procedure access sites, and different camera angles. A CoE can foster innovation and help healthcare teams to address these workflow challenges.
Radiation exposure has been an urgent concern in medical imaging for some time. But while traditional lead aprons effectively reduce exposure, they can be heavy and bulky, and often result in orthopedic injuries with long term use. This is where the Radiaction system comes into play — a revolutionary dynamic robotic radiation protection solution. The Radiaction system has obtained FDA Class II clearance because it ensures safety and effectiveness by encapsulating the imaging beam at the source. This design blocks scatter radiation before it can enter the room, thereby reducing exposure to everyone within the room.
The Class II designation reflects a higher standard of regulation and accountability over static, first generation Class I barriers. Due to this lower classification, these devices are largely unregulated, like band-aids, and their marketing claims should be scrutinized. The industry must demand independent studies to validate their effectiveness.
While striving for 100% radiation protection is a commendable goal we all share, achieving it will take time. We need to be held accountable for our claims, and until all systems are classified as Class II devices, progress may be slow. Nonetheless, all systems currently on the market represent significant advancements in the field, and everyone should investigate what options are available to enhance safety. We must be truthful about why many of these systems have not been widely adopted. Most panel discussions and presentations in the past three years have concentrated on raising awareness and addressing costs, but these remain crucial factors that the industry has largely tackled.
The most significant barrier to adopting radiation safety technology is not the acquisition cost, as many may believe. The main concern is workflow. In today's medical environments — particularly cardiology, interventional radiology, and operating rooms in general — many different procedures are performed, each with unique workflow requirements. A successful solution must allow the physician to access a patient at all times and without delay, and with no reduction in the ability to see what’s going on. These are critical features, yet often overlooked.
Addressing workflow challenges through a Center of Excellence (CoE) for feasibility is a worthwhile investment that prepares healthcare teams for what to expect during formal commercialization. One valuable advantage of the Radiaction Smart Shield technology is its ability to move with the physician and the X-ray camera (X-ray ii). It follows you wherever you go. The result is minimal disruption to workflow, allowing for immediate patient access, easy setup, and quick case turnover. With this advanced system, healthcare providers can focus on what matters most — delivering exceptional patient care while maintaining safety at the forefront.
St. Francis Hospital—The Heart Center in Roslyn, NY, is an excellent example of the first U.S. Center of Excellence for Cardiology. At this facility, the Radiaction system has effectively reduced radiation exposure for the physician, scrub tech, circulator, and anesthesiologist. In fact, the team throughout the room is protected. Many first-generation static barrier systems often forget about the interventional teams that work at the head of the table, including anesthesiologists and echo technicians. Addressing this oversight is a specific focus at St. Francis.
We have also introduced the innovative Burlington Medical product, EtherealShield, a 0.125mm apron designed for lightweight comfort and radiation protection. This reinforces our commitment to using light lead as a responsible first step towards eliminating lead altogether and reducing strain without compromising safety. When paired with the Radiaction system, this groundbreaking combination significantly reduces scatter radiation for medical professionals.
Evan Shlofmitz, DO, explains, “While we’re eager for lead-free options, our main priority is ensuring that our procedures are both effective and safe for a diverse range of patients. We recognize that factors like BMI play a crucial role in operator exposure, and we are dedicated to rigorously validating that the solutions we select meet their promises. Our objective is to enhance safety to the entire cath lab staff and efficiency overall without compromising workflow, and Radiaction is accomplishing just that."
St. Francis serves as a beacon of innovation, seamlessly integrating cutting-edge technology with a diverse team of experts. This powerful combination enhances patient outcomes and protects the well-being of everyone involved in cath lab procedures.
Establishing Centers of Excellence provides more than just protection. They function as crucial hubs for education, equipping healthcare professionals with vital knowledge about risk factors and the critical importance of radiation safety. Working together, we can transform scatter radiation’s occupational health risk and lay the groundwork for a brighter, healthier future. With the expansion of the Radiaction Center of Excellence, we can meaningfully reduce exposure to scatter radiation for even more physicians and staff.
Evan Shlofmitz, DO, is an Interventional Cardiologist and the Director of Intravascular Imaging at St. Francis Hospital—The Heart Center in Roslyn, NY. Dr. Shlofmitz completed a fellowship in interventional cardiology at Georgetown University/MedStar Washington Hospital Center. He is a co-director of the OPCI series of educational meetings, serves on the SCAI and CRT program committees, and is Chair of SCAI's Ischemic Heart Disease Council. His background and interests have focused on intravascular imaging and PCI optimization, with more than 150 publications in peer-reviewed journals.