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Review FDA recommendations for CT scanners


March 1, 2010

Review FDA recommendations for CT scanners

Patients allegedly received excess radiation from equipment

Safety committee members should read through the FDA’s new interim recommendations on CT scans, given reports that hundreds of patients were allegedly subjected to excess radiation during these procedures.

“While we do not know yet the full scope of the concern, facilities should take reasonable steps to double-check their approach to CT perfusion studies and take special care with these imaging tests,” Jeffrey Shuren, MD, acting director of the FDA’s Center for Devices and Radiological Health, said in a media release.

An initial safety notification was issued by the FDA in October 2009 after learning of 206 patients who had been exposed to excess radiation at Cedars-Sinai Medical Center in Los Angeles over a period of 18 months. Since then, the FDA has identified at least 50 additional patients who were exposed to excess radiation of up to eight times the expected level during their CT perfusion scans.

These cases so far involve more than one manufacturer of CT scanners. The FDA has also received reports of possible excess radiation from other states. Some of these patients reported hair loss or skin redness following their scans.

Based on its investigation, the FDA issued interim recommendations for imaging facilities, radiologists, and radiologic technologists to help prevent additional cases of excess exposure. These recommendations apply to all CT perfusion images, including brain and heart.

The FDA recommends that facilities with CT services take the following actions:

  • Assess whether patients who underwent CT perfusion scans received excess radiation
  • Review radiation dosing protocols for all CT perfusion studies to ensure that the correct dosing is planned for each study
  • Implement quality controls to ensure that dosing protocols are followed every time and the planned amount of radiation is administered
  • Check CT scanner displays to ensure the appropriate radiation level for the patient
  • Ensure that if more than one study is performed on a patient in one imaging session, the radiation dose is adjusted to an appropriate level for each study

Go to http://tinyurl.com/yfcxcxx to read the full FDA alert.

Settings of machines may be culprits

The settings on Cedars-Sinai’s three CT scanners were changed, causing “immediate jeopardy” in a case that the hospital says involved 206 patients who underwent stroke imaging between February 2008 and September 2009, according to a report released in November by California health officials.

The report stated that in February 2008, the scanning parameters of three CT scanners were changed from the manufacturer’s recommended output of 80 kv (the amount of voltage delivered) and 200 mA (milliampere, the duration of the exposure) to 120 kv and “automatic,” meaning the machine determined mA duration, usually in the 500 mA range.

Government asks for manufacturers’ review

The FDA is also working with manufacturers, professional organizations, and state and local public health authorities to investigate the scope of these excess exposures.

The agency has asked manufacturers to review training for users and information provided to healthcare facilities and put into place new surveillance systems to identify problems quickly.

Cedars-Sinai said it has already implemented many of the FDA’s recommendations following an investigation at the medical center.

“The FDA’s recommendations are similar to the policy and procedure changes that Cedars-Sinai implemented in September after it identified that brain perfusion CT scans were unexpectedly producing higher than expected levels of x-ray radiation,” the medical center said in a media release.

California’s Department of Public Health accepted Cedars-Sinai’s policy changes as the medical center’s plan of correction in response to the state’s investigation.

Blame is swirling on errors

It is still not clear who is to blame for the mishap at Cedars-Sinai. Hospital officials previously said they did not want to shift responsibility for the incident to the CT scanner’s manufacturer, GE.

But in its statement, Cedars-Sinai officials said the incident “has raised considerable questions about why the manufacturer-set ‘auto’ mA setting for the brain perfusion CT scan delivered a higher than expected level of x-ray radiation, since ‘auto’ mA settings in CT and other imaging scanners are generally designed to provide the lowest appropriate level of x-ray radiation.”

Cedars-Sinai said that nearby Glendale Adventist Medical Center also “reported a similar problem with GE brain perfusion CT scan equipment where patients received higher than expected levels of x-ray radiation.”

GE has denied culpability in the alleged overexposures, saying, “Due to pending litigation, we cannot comment on that, but again, there were no malfunctions or defects in any of the GE Healthcare equipment involved in the Cedars incident.”

The state’s classification of the event as one involving “immediate jeopardy” means that Cedars-Sinai may be subjected to fines of $25,000–$50,000. Hospital officials have said that about 40% of the 206 patients who received excess doses of radiation either had patches of hair fall out or redness of skin.

Medical center officials also have said that the additional radiation exposure may have made patients more susceptible to cataracts. The hospital has volunteered to pay for any medical expenses caused by conditions related to their overexposures.

Editor’s note: The original version of this article first appeared on HCPro’s HealthLeaders Media Web site. Please go to www.healthleadersmedia.com to read the latest healthcare headlines.

EC standards tie into FDA alert

Regarding the FDA’s new interim recommendations on CT scans, several Joint Commission standards may apply:

  • EC.02.01.01, element of performance (EP) 11, which requires hospitals to respond to recalls and safety notices
  • EC.02.02.01, EP 7, which requires hospitals to minimize risks of using hazardous energy sources, including radiation and x-ray equipment
  • EC.02.04.01, EP 3, which requires hospitals to identify activities for inspecting, testing, and maintaining medical equipment
  • EC.02.04.01, EP 5, which requires hospitals to report incidents in which medical equipment causes serious injury or illness

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