Release date: 2008-08-11
FDA warns CT to cause medical device failure
The US Food and Drug Administration issued a warning on July 14 that X-rays used in CT examinations may cause malfunctions in certain implanted or in vitro electronic medical devices.
The warning was announced in a letter by Dr. Daniel Schultz, director of the Center for Medical Devices and Radiation Health at the FDA. He said: The FDA has received several CT scans to interfere with pacemakers, defibrillators, neurostimulators, implants. Or case reports of in vitro drug infusion pumps, cochlear implants, and retinal implants. But the letter also clarifies that CT scans have no side effects for most patients with electronic medical devices.
Adverse events that have been reported include:
External shock caused by a nerve stimulator;
Insulin pump failure;
The pacemaker output pulse frequency changes.
Problems with CT scan interference that may cause electronic medical devices include:
Error signals, including cardiac defibrillation pulses;
Misinterpreting the X-ray generated signal as a true physiological signal;
Leak detection of true physiological signals;
Change or reset the settings of the instrument
Why are these cases discovered in the near future? The FDA believes this is due to the following reasons: CT is used more frequently, new CT devices have higher dose rates, more efficient case reporting systems, and more patients using electronic medical devices.
To avoid adverse events, the radiographer should know if the patient is implanted or wearing an electronic medical device before scanning, and if so, the distance from the field to the field. If the instrument is within or near the scanning range, the technician should dispose of it depending on the type of device: try to keep the extracorporeal device away from the field; scan the patient for a period of time during the scan of the patient who is wearing the neurostimulator. Under the premise of ensuring image quality, use the lowest X-ray tube current as much as possible, and ensure that the X-ray beam is irradiated on these instruments as short as possible.
If the CT procedure requires that a long-term scan (such as a CT perfusion or an interventional examination) has to be performed on the area in which the instrument is placed, first aid preparation is required for potential adverse reactions.
After the end of the examination, the patient must restart the device and check whether the function is normal. If the device is working abnormally, contact the doctor concerned as soon as possible.
——Shanghai Medical Device Industry Association
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