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Medical Devices

7/19/2008
Paul Napoli
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FDA Warning: CT Scans May Cause Medical Device Malfunction

CT scans, also known as computer tomography, is a medical imagining method used to used to generate a three-dimensional image of the inside of an object from a large series of two-dimensional X-ray images taken around a single axis of rotation. However, recently the FDA warned CT scan administrators that the use of a CT scan could cause peacemakers, defibrillators, and other electronic medical devices to malfunction. This is causing a big stir in the medical industry because the use of CT scans are very prevalent in testing for different conditions using tying to people who currently use these types of medical devices. Some of the malfunctions that the medical devices incurred include unintended shocks from neurostimulators, malfunctions of insulin infusion pumps, and transient changes in pacemaker output pulse rate.
    After issuing this warning, reports came into the FDA saying that there were no deaths attributed to possibly CT scans causing malfunctions to persons currently using these medical devices. "It is possible that this interference is being reported more frequently now because of the increased utilization of CT, the higher dose-rate capability of newer CT machines, an increase in the number of patients with implanted and externally worn electronic medical devices, and better reporting systems," the FDA said. It is important to get this information out to the public about medical devices that are malfunctioning because it is a big risk to have these types of occurrences happening everyday. Medical devices that are defective could cause devastating affects to the user, ending in further complications and fatalities.
    Some devices that could be affected by the CT scanner include: retinal implants, cochlear implants, cardiac pacemakers, implantable cardiac defibrillators, neurostimulators, and drug infusion pumps. What the FDA is planning to do to get this information out is to issue a public health notice making sure that the public is aware of the reports on the matter. When putting CT scanner in use, the FDA recommends "the operator should use CT scout views to determine if implanted or externally worn electronic medical devices are present and if so, their location relative to the programmed scans range." Other operations musts include: getting rid of external devices out of the rang of the scanner, questioning the patients and asking them if it is possible to temporarily turn off their medical devices, and to minimize exposure to the ct scan by using a low frequency.
    Patients currently using one of the devices affected by the CT scan, and needs a scan should be very observant of the rules and make sure pay attention to all of the precautions. Product liability and medial device malfunction go hand in hand. Therefore it pays to have a lawyer experienced in both arenas. At Napoli Bern Ripka, there is over 40 years of combined experience in dealing with cases regarding faulty medical devices. They have experience in dealing with large corporations and insurance companies that seem to intimidate others. Contact Napoli Bern Ripka so they can help you gain the compensation that you deserve, not what is offered.

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