Cedars-Sinai Under Investigation for CT Radiation Overexposure to 206 Patients
Additional double-checks and equipment protocols have been instituted "to ensure that this does not happen again."
Van said that although the hair loss or skin reddening would have occurred within six weeks of the scans, the hospital contacted 206 patients who had a scan between February 2008 and August 2009 in the interest of keeping those patients informed.
The problem also was reported to the California Department of Public Health as an unusual event.
The FDA said in an initial notice about the patient over-exposure that "instead of receiving the expected dose of .5 Gy (maximum) to the head, these patients received 3-4 Gy (a unit of absorbed radiation dose due to ionizing radiation).
"In some cases, this excessive dose resulted in hair loss and erythema (redness of skin). The facility has notified all patients who received the overexposure and provided resources for additional information," the agency said.
The FDA's Long emphasized that the FDA wants every facility that performs CT imaging to review its protocols "and be aware of the dose indices normally displayed on the control panel. These indices include the volume computed tomography dose index (abbreviated CTDI in units of "milligray" or "mGy") and the dose-length product (DLP, in units of milligray-centimeter" or "mGy-cm").
The warning continued to say that for each protocol selected and before scanning each patient, "carefully monitor the dose indices displayed on the control panel. To prevent accidental overexposure, make sure that the values displayed reasonably correspond to the doses normally associated with the protocol. Confirm this again after the patient has been scanned."
Cedars-Sinai officials also were not able to say what level of multi-slice machine or machines were linked to the overdoses. It also is unclear whether the patients are at increased risk of cancer or other medical problems months or years later.
They also did not explain whether the malfunction was caused by the protocol or the machinery itself. Cedars-Sinai officials did not say whether the patients are undergoing any follow-up care or whether they have received any compensation for any harm or risk of harm they may endure.
Cedars-Sinai is certified by the Joint Commission as a primary stroke center. It is listed as one of the U.S. News and World Report's best hospitals in 11 categories, including neurology and neurosurgery.
Cheryl Clark is senior quality editor and California correspondent for HealthLeaders Media. She is a member of the Association of Health Care Journalists.
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