FDA Suggests New CT Scan Procedures To Prevent Radiation Overdoses

Federal regulators are calling on the radiation therapy industry to make a number of equipment and training changes after determining that hundreds of cases of radiation overexposure uncovered last year were all caused by operator error. 

At the end of a year-long investigation into radiation therapy procedures, the FDA has determined that there is nothing wrong with radiation-emitting CT scanners, and that when patients receive an overdose of radiation exposure, it is usually due to human error.

This week the agency announced that it had sent a letter to the Medical Imaging and Technology Alliance (MITA), the primary radiation-emitting equipment manufacturers’ trade organization, calling for a number of industry changes that might minimize the risk of radiation overexposure to patients.

The proposed changes include the addition of an alert feature on CT scanners when it is about to emit a high radiation dose; training on brain-perfusion procedures for all facilities that purchase CT scanners; clarification on the parameters of the CT scanners that affect radiation dose, and clear instructions on how to set those parameters; and user manuals that have all of the dose-related information in one dedicated section.

The suggestions come several months after MITA and the Advanced Medical Technology Association (AdvaMed), which represents medical device manufacturers, announced an industry-led initiative to address the problem, which included the addition of specific checkpoints to radiation therapy plans and equipment changes that would include pre-treatment verification and approval systems, verification of beam modifying accessories and patient positioning confirmation systems.  

CT scan procedures and other forms of radiation therapy across the country are under close scrutiny by the FDA after the discovery that a number of patients have suffered radiation overexposure from CT Scans performed incorrectly.

The recent FDA investigation was sparked by the discovery of CT scan radiation over-exposure problems that may have affected more than 200 patients at Cedars-Sinai Medical Center in Los Angeles last year. In the course of the investigation, the FDA found that at least 385 patients had received excessive radiation while undergoing CT brain perfusion scans at a number of hospitals in California and Alabama.

The FDA released interim guidance for health care professionals and radiologists in December. The guidance advised radiation therapy technicians to review procedures and CT scan settings, and to be thorough in checking the amount of dosage prescribed for each CT scan patient.