AIUM MECHANICAL BIOEFFECTS CONFERENCE

描述(改编自申请人摘要)： 诊断超声提供了令人难以置信的丰富的知识 医药。很少有人愿意否认这种方式所产生的影响 关于病人护理，特别是妇女和儿童。数以百万计的 每年进行超声波检查，超声波仍然是 发展最快的成像设备。这一增长是由于其较低的 成本、实时图像显示，在更大程度上也是显而易见的 缺乏生物效应。控制声音输出的调节过程 超声波医疗设备的发展在很大程度上取决于食品 和药品管理局(FDA)，由国会法案授权。直到 最近，FDA将超声波设备的最大输出调整为 通过市场审批流程的谓词级别，这需要 设备在效率和产量上与生产的设备相同 1976年之前。诊断超声技术现在允许 对细微细节的分辨和提高的诊断灵敏度 伴随而来的是声学输出的大幅增加。美国食品和药物管理局 现在为制造商提供了获得市场批准的选项 可以大幅提高声学性能的医用超声设备 超过以前允许的水平的输出，前提是输出显示 被纳入到设备设计中。根据这些更改， 声学输出调节和潜在生物学的最新证据 超声在临床输出水平上的作用，美国研究所 医学超声学会(AIUM)正在主办一次会议，以评估 与机械效应有关的科学证据 超声波，如空化。在这之前的几个月里 会议将制定一份文件，以提供超声波 社区与科学信息的概述，摘要 声明和有关诊断安全性的任何建议 超声波对机械效应的影响。AIUM有一项记录是 为超声波社区提供这项服务，以确保安全 并在医疗实践中有效地使用超声波。投保范围广 传播这一重要信息，请求提供帮助 将生成的文档的发布成本作为 在医学超声杂志上的补充问题。

DESCRIPTION (Adapted from Applicant's Abstract): Diagnostic ultrasound has provided an incredible wealth of knowledge in medicine. Few would be willing to deny the impact this modality has had on patient care, particularly women and children. With millions of ultrasound examinations performed each year, ultrasound remains one of the fastest growing imaging modalities. This growth is due to its low cost, real-time image display, and, to no lesser extent, its apparent lack of bioeffects. The regulatory process that controls acoustic output from ultrasound medical devices has been largely dictated by the Food and Drug Administration (FDA), empowered by an act of Congress. Until recently, the FDA regulated the maximum output of ultrasound devices to a predicate level through a marketing approval process which requires that devices be equivalent in efficacy and output to those produced prior to 1976. Diagnostic ultrasound technology now allows discrimination of fine detail and improved diagnostic sensitivity has been accompanied by substantial increases in acoustic output. The FDA now provides an option for manufacturers to obtain market approval for medical ultrasound devices that can substantially increase the acoustic output over previously allowable levels, provided that an output display is incorporated into the equipment design. Based on these changes in acoustic output regulation and recent evidence of potential biological effects of ultrasound at clinical output levels, the American Institute of Ultrasound in Medicine (AIUM) is sponsoring a conference to assess the scientific evidence associated with the mechanical effects of ultrasound, such as cavitation. In the months leading up to this conference a document will be developed to provide the ultrasound community with an overview of the scientific information, summary statements, and any recommendations concerning the safety of diagnostic ultrasound with respect to mechanical effects. AIUM has a record of providing this service to the ultrasound community to insure the safe and effective use of ultrasound in medical practice. To insure wide dissemination of this important information, request is made to help undersrite the publication cost of the resulting document as a supplemental issue in the Journal of Ultrasound in Medicine.