MITA Statement Responding To July 31st New York Times Story

08.01.10

The article accurately states that government officials say none of the overdoses described in the story “can be attributed to malfunctions of the CT scanners.”  In fact, medical imaging is heavily regulated by a wide range of federal, state, and international requirements, including the Food and Drug Administration (FDA), International Electrotechnical Commission (IEC) standards, State regulatory health agencies, among others, all of whom work to control radiation exposure and minimize dose.  Manufacturers of CT equipment also take the issue of radiation dose extremely seriously and have worked tirelessly to develop new technologies to reduce the amount of dose necessary for a clear image.

In addition to existing safeguards already in place, earlier this year manufacturers released a Radiation Dose Reduction Plan, which includes support for mandatory reporting of medical errors associated with ionizing radiation, certification of imaging technologists and accreditation of imaging facilities.

Further, CT manufacturers also have released the CT Dose Check Initiative, which is a commitment to include a new Dose Notification feature to reduce the dose levels associated with scans; a Dose Alert to prevent medical errors; and a new dose recording feature to help track dose and to develop reference dose levels to help providers understand how their facility compares to local and national standards.  Manufacturers are working closely with FDA to ensure these features will begin to be included on new CT machines this year.  Importantly, we have also committed to including these features on appropriately compatible scanners in the installed base as well.

Advances in imaging technology have revolutionized medicine, turning patients into survivors.  Like all technologies, there are risks associated with its use. Manufacturers take these risks seriously and will continue to do our part to ensure that every imaging procedure is both medically appropriate for the patient’s condition and safe.

David Fisher
Executive Director
Medical Imaging and Technology Alliance (MITA)