Radiation Dose Comparison 1 CT abdomen scan = 400 chest x-rays 2 dental x-rays = 1 chest x-ray Photo by iSTOCKPHOTO

After a series of incidents in which patients received excessive doses of radiation from CT machines, the Medical Imaging & Technology Alliance (MITA) has announced an industry-wide plan to improve patient safety.

“Manufacturers have revolutionized CT scanning by developing technology that delivers quality images at a radiation dose far below what it was just 20 years ago,” says Dave Fisher, executive director of MITA. “[This] commitment builds on that history of innovation and our longstanding dedication to ensuring the safe, appropriate, and effective use of our industry’s cutting-edge medical technologies.”

Recent radiation exposure incidences have prompted an FDA investigation into the matter. In February, the agency unveiled an initiative to reduce unnecessary radiation exposure from medical imaging.

“The amount of radiation Americans are exposed to from medical imaging has dramatically increased over the past 20 years,” says CDRH director Jeffrey Shuren. “The goal of FDA’s initiative is to support the benefits associated with medical imaging while minimizing the risks.”

A news release from the agency says that FDA “intends to issue targeted requirements for manufacturers of CT and fluoroscopic devices to incorporate important safeguards into the design of their machines.” The agency also demands that manufacturers develop safer technologies and provide appropriate training to practitioners. A public meeting on the topic was held March 30–31 to garner input on what the appropriate requirements should be.

Fisher says that imaging manufacturers are already making improvements, and in some cases, these upgrades have already been implemented. He says that CT imaging manufacturers “will be able to include [the safeguards] on new releases of CT products and [will] begin deploying them to currently installed CT systems before the end of this year.”

MITA says that the plan builds on current safety measures, including equipment safety standards, provider education programs, quality and safety checks, and protocol development (see the sidebar, "The Eight Principles."). One improvement is a radiation dose check feature, which is designed to alert CT machine operators when a recommended radiation dose level has been exceeded. Imaging centers and hospitals would predetermine the appropriate level. Called the reference dose, MITA and its member companies plan to work with regulatory bodies, professional organizations, and individual clinicians to help establish reference dose values.

Medical device OEMs have also pledged to include an additional safeguard that will enable hospitals and imaging centers to set maximum radiation dose limits. Establishing maximum limits would prevent technicians from conducting the scans at hazardous levels, which could cause injuries such as burns and hair loss.