FDA Announces Plans to Improve Safety of Radiation Therapy

Tuesday, February 9—the Food and Drug Administration recently announced that it would take steps to more closely regulate three of the most potent and potentially dangerous forms of radiation: CT scans, nuclear medicine studies and fluoroscopies.

The FDA first began an investigation into overdoses of radiation after over 300 patients at four hospitals were over-radiated by CT scans. The overdoses were discovered when patients at Cedars-Sinai Medical Center inexplicably began losing their hair. Doctors soon discovered that these patients received up to 8 times as much radiation as was intended. In fact, patients receive far more radiation than they once did: in fact, the average lifetime dosage has increased sevenfold since 1980. The dangers of overexposure to radiation are very serious, particularly to more vulnerable populations like women and children. For example, The New York Times recently documented some dramatic incidences of over-radiation and the resulting harm that resulted when radiation machines were programmed incorrectly or safety procedures were not correctly followed.

In its announcement, the FDA suggested that it might require radiation machine manufacturers to incorporate new safeguards to prevent over-radiation as well as better training on how to use the machines to medical personnel. Moreover, other proposals under consideration include that radiation devices be required to display, record and report equipment settings and doses, that an alert occur when the radiation dose exceeds the appropriate level for a patient, and that devices be required to record and transmit dosage information to a patient’s electronic file. The FDA plans to hold a public meeting on March 30 and 31 to further discuss the proposed changes.