12 | 10 | 2009 Posted By Regan Zambri & Long

FDA UPDATE: EXCESS RADIATION TO PATIENTS FROM CT SCANNERS

By Catherine D. Bertram, Partner                                             

The FDA issued an update about the safety investigation they are conducting regarding CT perfusion scanners and patients' overexposure to radiation. The FDA's initial notice was issued October 8, 2009.

Earlier  there were reports of patients who were accidentally exposed to eight times the normal radiation dose during diagnostic CT scans at Cedars-Sinai Medical Center in Los Angeles are prompting safety warnings to be issued across the country.

According to the FDA, over an 18-month period, 206 patients at the center received 3 to 4 Gy to the head instead of the expected 0.5-Gy dose during perfusion CT imaging.

"Until we get through whether we're dealing with errors that people are making (or) whether these are problems with the CT scanners themselves, we're saying go back to basics," said Jeffrey Shuren, MD, acting director of the FDA's Center for Devices and Radiological Health.

The FDA released a set of recommendations which include:

  • Imaging facilities should review their radiation dosing protocols for all CT perfusion studies to ensure that dosing is correct for each study.
  • They should implement quality control procedures to ensure that protocols are followed and correct radiation is used.
  • For each patient, technologists should check the CT scanner displays to make sure the radiation to be delivered is appropriate.
  • If more than one study is performed during one session, practitioners should adjust the radiation dose so it is appropriate for each study.

The FDA also urged imaging facilities to check whether any patients who underwent CT perfusion scans have received excess radiation.

"We're reminding (practitioners) of good practices that they should be employing routinely," said FDA representative Charles Finder, MD.

Tragically, I have specific experience with several cases involving excessive exposure to radiation. Patients can suffer extremely serious and irreversible injuries.   Of course, these are patients who are already fighting challenging medical conditions, including cancer.   We have top notch national experts in radiation oncology who review these cases to determine if the care provided was unsafe and caused the patient harm.  These cases can be a result of an  unsafe medical device or can be caused by the improper conduct of the health care team, or both.

 

 

 

About the author:

Catherine Bertram is board certified in civil trials and was recently nominated as a 2010 Super Lawyer for Washington, D.C.  Ms. Bertram has 20 years of trial experience and is unique in that she was formerly the Director of Risk Management for Georgetown University Hospital so she brings a wealth of knowledge to her practice including how hospitals should be run and what doctors and nurses can do to protect patients.   She is a partner with the firm and devotes her practice to the representation of patients and families of loved ones who have been injured or lost due to medical errors.  Ms. Bertram lectures regularly to lawyers and health care providers, nationally and locally,  regarding patient safety, medical negligence and other related issues. She has also recently published a chapter in a medical textbook.   She can be reached by email at cbertram@reganfirm.com or by phone 202-822-1875 in her office in Washington, D.C.