Radiation Exposure Concerns Lead To New Industry Standards

Radiation therapy equipment manufacturers have launched an initiative to implement new industry-wide safety standards in the face of FDA scrutiny and growing concern over the radiation risks of CT scans and radiation-emitting medical devices. 

The Medical Imaging & Technology Alliance (MITA) and the Advanced Medical Technology Association (AdvaMed) announced the “Radiation Therapy Readiness Check Initiative” on Wednesday. The goal of the initiative is to add safety features to radiation equipment that would confirm patients were receiving the prescribed doses of radiation, and that the equipment was properly positioned to deliver that radiation to the correct areas of the body.

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

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. Since then, the FDA has uncovered at least 50 more radiation CT errors.

The FDA has said it has received more than 1,200 complaints since 2000 from patients who received radiation therapy, and urged the industry to add new radiation safeguards.

A number of errors discovered by FDA have involved massive doses of radiation being directed at the wrong parts of the body, and machines being set incorrectly, resulting in overly large radiation doses.

The initiative adds the following additional checkpoints to radiation therapy plans, with appropriate systems to be added to radiation therapy equipment:

• Pre-treatment verification and approval systems
• Verification of beam modifying accessories
• Patient positioning confirmation

“Building on a long track record of manufacturer innovations that enhance patient safety, these additional readiness check features serve as redundant safety checks so a user can verify that a patient is not about to receive inappropriate levels of medical radiation,” said AvaMed Executive Vice President Janet Trunzo.