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【medical-news】CT扫描可能导致医疗装置故障
"We are continuing to investigate this issue while working with device manufacturers and raising awareness in the healthcare community," according to the FDA. "To date, no patient deaths have been reported from CT scanning of implanted or externally worn electronic medical devices."
Although most patients undergo CT with no adverse effects, a small number of patients have reported interference with devices such as pacemakers, defibrillators, neurostimulators, and implanted or externally worn drug infusion pumps.
Adverse events have included unintended "shocks" from neurostimulators, insulin pump malfunctions, and transient changes in pacemaker output pulse rate. Although CT interference with cochlear and retinal implants is theoretically possible, no cases have yet been reported.
The reported malfunctions differ from those caused by the strong electric and magnetic fields in magnetic resonance imaging (MRI), the FDA said. The increased number of cases may be due to an increased frequency of CT scanning, the higher dose-rate capability of newer machines, an increased prevalence of device use, and better reporting systems.
In the interim, CT operators should use scout views to determine whether implanted or externally worn electronic medical devices are present. Devices in or immediately adjacent to the programmed scan range should be identified and moved if possible; neurostimulators should be turned off while the scan is being performed.
Technicians should minimize device exposure to X-rays by using the lowest possible X-ray tube consistent with required picture quality and ensure that the X-ray beam does not linger over the device for more than a few seconds.
The FDA notification emphasizes, "For CT procedures that require scanning over the medical device continuously for more than a few seconds, as with CT perfusion or interventional exams, attending staff should be ready to take emergency measures to treat adverse reactions if they occur."
Once the CT is completed, devices should be checked for proper functioning, even if they were turned off for the procedure. Patients with concerns regarding their device should be advised to contact their healthcare provider.
http://www.medscape.com/viewarticle/577556 认领翻译
July 15, 2008 — Direct X-ray exposure from computed tomography (CT) may cause some implanted and external electronic medical devices to malfunction, the US Food and Drug Administration (FDA) warned yesterday in a preliminary public health notification.
2008年7月15日－美国食品药品监督局(FDA)昨天在一份基础公共卫生报告中警告说：直接暴露在计算机断层(CT) 的X线下，可能导致植入和体外医疗电子装置功能失常。
"We are continuing to investigate this issue while working with device manufacturers and raising awareness in the healthcare community," according to the FDA. "To date, no patient deaths have been reported from CT scanning of implanted or externally worn electronic medical devices."
“我们将继续与设备制造商研究这一问题，并提请医疗社团的注意，”FDA介绍说。“到目前为止，还没有植入和体外医疗电子设备因为CT扫描导致死亡的报道”
Although most patients undergo CT with no adverse effects, a small number of patients have reported interference with devices such as pacemakers, defibrillators, neurostimulators, and implanted or externally worn drug infusion pumps.
对于使用心脏起搏器、除颤器、神经刺激器，以及植入型或者外携型药物注射泵等电子装置的患者来说，虽然大多数在CT扫描时没有出现不良反应，但是其中一小部分报道出现了干扰。
Adverse events have included unintended "shocks" from neurostimulators, insulin pump malfunctions, and transient changes in pacemaker output pulse rate. Although CT interference with cochlear and retinal implants is theoretically possible, no cases have yet been reported.
这些有害事件包括神经刺激器出现意外“震荡”，胰岛素泵功能失常，心脏起搏器输出脉率的短暂改变等。虽然耳蜗和视网膜植入体理论上也存在着被CT干扰的可能性，但是还没有此类事件的报道。
The reported malfunctions differ from those caused by the strong electric and magnetic fields in magnetic resonance imaging (MRI), the FDA said. The increased number of cases may be due to an increased frequency of CT scanning, the higher dose-rate capability of newer machines, an increased prevalence of device use, and better reporting systems.
FDA说，这些报道的装置功能失常有别于磁共振成像(MRI)中因强电、磁场引起的功能失常。此类案例数量增长的原因可能是由于CT扫描使用频率增加、新CT设备剂量率提高、设备使用更普遍、以及报告体系的改善。
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作者:admin@医学,生命科学 2011-01-09 05:14
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