Alerts

New Safety Information for CT Scanning

The Food and Drug Administration (FDA) has issued a preliminary public health notification regarding the malfunction of electronic medical devices caused by computed tomography (CT) scanning. http://www.fda.gov/cdrh/safety/071408-ctscanning.html

The FDA has received a small number of reports of adverse events in which CT scans may have interfered with electronic medical devices, including pacemakers, defibrillators, neurostimulators, and implanted or externally worn drug infusion pumps.

In the reports received by the FDA, the following adverse events were likely to have been caused by x-rays from CT scans:

• Unintended “shocks” (i.e., stimuli) from neurostimulators
• Malfunctions of insulin infusion pumps
• Transient changes in pacemaker output pulse rate

Requirements when performing CT scans for research purposes only:

1. The consent form should include the following risk language for research related CT scanning:
   
   “Rare: Malfunction of worn or implanted electronic medical devices.*
   
   *If you wear or have electronic medical devices implanted such as a pacemaker or a drug pump, please make sure you tell your study doctors and research staff. It was recently reported by the FDA that the CT scan may cause a malfunction of electronic medical devices.”
   

2. The protocol or study related documents should include a description of how the investigator and research staff will comply with the recommendations set forth in the FDA Preliminary Public Health Notification for CT scans.

3. Prior to performing a research related CT scan, the research participant should be notified of the new risk information to determine whether or not they wish to continue participating in the study. This notification should be documented in the research file. Re-consent should occur once the consent form has been revised.

Implementation of new requirements:

1. For new study submissions, the consent language and protocol information is required if performing research related CT scans.
   
2. For current studies performing research related CT scans:
   
   1. You may immediately file a modification (Form 5) to revise your consent and protocol/study related documents to comply with the above mentioned requirements; or
      
   2. The consent and protocol information can be included with the next submission to HRPO, such as a renewal or modification.

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Last updated: 8/29/08