Fischer Robert
Food and Drug Administration, Center for Devices and Radiological Health, Office of Surveillance and Biometrics, Division of Postmarket Surveillance, Rockville, Maryland, USA.
AANA J. 2008 Feb;76(1):37-40.
During the past 3 years, the US Food and Drug Administration (FDA) has received a growing number of adverse event reports on the breakage or fracturing and retention of anesthetic conduction device tips with associated complications. Serious injuries and other problems such as spinal stenosis, nerve root compression, and subcutaneous effusion can result. Several case reports demonstrate how the problems occur; some illustrate the severity of the problem. All cases are from adverse event reports in the FDA Center for Devices and Radiological Health (CDRH) Manufacturer and User Facility Device Experience database. Frequently, in the interest of not causing patient harm, a device fragment might not be removed as long as the patient is not neurologically compromised or at risk for infection or there is little potential for migration of the fragmented piece. On many occasions, the fragments remain in patients without their knowledge. The FDA wants to raise awareness of the problem and its potential impact in creating complications, encourage the practice of informing patients of the fragmented device, and promote reporting of such incidents to CDRH via the MedWatch reporting system. Based on a search of the current literature, recommendations for prevention are suggested.
在过去3年里，美国食品药品监督管理局（FDA）收到了越来越多关于麻醉传导装置尖端破裂、断裂及残留并伴有相关并发症的不良事件报告。这可能导致严重伤害以及其他问题，如椎管狭窄、神经根受压和皮下积液。几例病例报告展示了这些问题是如何发生的；有些则说明了问题的严重性。所有病例均来自FDA器械与放射健康中心（CDRH）制造商和用户设施器械经验数据库中的不良事件报告。通常，为了不伤害患者，只要患者没有神经功能受损、没有感染风险或碎片迁移的可能性很小，就可能不会取出器械碎片。很多时候，碎片在患者不知情的情况下留在体内。FDA希望提高人们对该问题及其引发并发症的潜在影响的认识，鼓励告知患者器械碎片的做法，并通过MedWatch报告系统促进此类事件向CDRH报告。基于对当前文献的检索，提出了预防建议。
