The Food and Drug Administration is investigating Providence St. Joseph Medical Center in Burbank, for possible overdoses to patients receiving CT Scans.
The FDA is investigating the hospitals procedures and machines used when administering CT profusion scans, which help diagnose damage caused by strokes.
“These findings have national implication and the FDA is coordinating the investigation to make a determination as to how much of the problem is due to operator error versus how much is due to protocols and equipment,” said Angelo Bellomo, Director of Environmental Health for the L.A County Department of Public Health.
The Department of Public Health, who is also investigating the hospital, says that there have been 34 claims of overdose in a 20 month period dating back from October of this year.
Officials at Providence St. Joseph released a statement saying, “While widespread media reports this week indicate 34 patients at Providence Saint Joseph Medical Center may have received more radiation than necessary during perfusion brain scans, to date, we have had no adverse reactions reported due to unnecessary exposure and no official reports have been issued to us by any county, state or federal agency.”
Unlike the overdose cases with Cedars-Sinai Medical Center and Glendale Adventist Medical Center, which use a General Electric CT Scan, St. Joseph uses a Toshiba machine to perform scans.
In addition to the St. Joseph investigation, an Alabama hospital has reported a case where a patient received an overdose of radiation at the Huntsville hospital.
“We have one confirmed report of side effects reported from the Huntsville Hospital,” said Jim McNess, Assistant Director of the Office of Radiation Control for the Alabama Department of Public Health. “We haven’t decided what we’re going to do with that report yet.”
Becky Coudert, 59, reportedly received a CT scan on September 8, to diagnose a case of Bells Palsy. According to Richard Patterson, a partner of Owen, Patterson and Owen who represents Coudert, after her CT scan she suffered memory loss, hair loss and balance issues, which are all symptoms of a radiation overdose.
Patterson claims that in Coudert’s case, the hospital informed her that she may have been given 1,200 to 1,400 percent the recommended dose, which is more than the 800 percent Cedars-Sinai Medical Center claims to have dosed its patients with.
In many cases the CT profusion scan, which is the procedure used when the overdoses occurred, is used in emergency situations to pinpoint the cause of the stroke within the brain.
The more quickly a stroke can be identified and fixed the greater the chances of recovery for the victim.
“All CT procedures deliver a significant amount of radiation to the patient, but what needs to be looked at is if the procedure could localize a blockage and allow it to be opened up sooner, would the side effects be worth it,” said McNess.
Bellomo would like to use the overdose investigations to establish a three tier system, where the protocols on CT scan machines are looked at to see if they are “tight” enough, to make sure that there are mechanisms at each of the facilities in place so that protocols are followed, and having a way to quickly identify whether or not there is non-compliance with the protocols.
“It’s not just instructing practitioners and making sure they follow the protocols. It’s actually having some sort of periodic audit,” said Bellomo. “That may be by the facility management itself, but also involving oversight from the regulatory agencies. Those are the levels we need to look at and determine what went wrong and what needs to be done to minimize this occurrence in the future.”