美国食品和药物管理局与外周血管中使用可扩张金属胆道支架的超适应证使用-更新。
US Food and Drug Administration and Off-Label Use of Metal Expandable Biliary Stents within the Peripheral Vasculature-Update.
机构信息
Obesity and Hepatobiliary Devices Team, Division of Health Technology 3A, Office of Health Technology 3, Center for Devices and Radiological Health, US Food and Drug Administration, 10903 New Hampshire Avenue, Building 66, Silver Spring, MD 20993-0002.
Obesity and Hepatobiliary Devices Team, Division of Health Technology 3A, Office of Health Technology 3, Center for Devices and Radiological Health, US Food and Drug Administration, 10903 New Hampshire Avenue, Building 66, Silver Spring, MD 20993-0002.
出版信息
J Vasc Interv Radiol. 2020 Apr;31(4):622-628. doi: 10.1016/j.jvir.2019.10.016. Epub 2020 Feb 21.
In the past, some medical device manufacturers were obtaining marketing clearance for metallic stents indicated for biliary use; however, these devices were being promoted and used in the peripheral vasculature, creating a patient safety problem. The US Food and Drug Administration (FDA) acted in 2006-2008 to help decrease off-label use of metal expandable biliary stents. This communication describes the early and continued efforts of the FDA to address safety concerns relating to off-label use of metal expandable biliary stents and the status of this issue. An analysis of Medical Device Reporting (MDR) data from January 1, 2005, through December 31, 2018, was conducted to determine the percentage of MDR reports associated with off-label use. The percentage was approximately 90% in 2001-2006 and decreased to < 40% a decade later. In reports associated with off-label use, these devices are still associated with death and serious injury; however, the percentage of injury MDR reports associated with off-label device use has trended down since 2007. Whereas 92%-95% of reported serious injuries were with off-label placement in 2005-2007, 43%-79% of injuries were with off-label placement in 2008-2018. Collaborative efforts among the FDA, manufacturers, and physicians appear to have made progress in addressing this issue.
过去，一些医疗器械制造商为胆道使用的金属支架获得了市场准入批准；然而，这些器械被推广并用于外周血管，造成了患者安全问题。美国食品和药物管理局（FDA）在 2006 年至 2008 年采取行动，以减少金属扩张式胆道支架的非适应证使用。本通讯描述了 FDA 为解决与金属扩张式胆道支架非适应证使用相关的安全问题而进行的早期和持续努力，以及该问题的现状。对 2005 年 1 月 1 日至 2018 年 12 月 31 日的医疗器械报告（MDR）数据进行了分析，以确定与非适应证使用相关的 MDR 报告的百分比。2001-2006 年的比例约为 90%，十年后降至<40%。在与非适应证使用相关的报告中，这些器械仍然与死亡和严重伤害有关；然而，自 2007 年以来，与非适应证器械使用相关的伤害 MDR 报告的比例呈下降趋势。2005-2007 年，报告的严重伤害中有 92%-95%是由于非适应证放置，而 2008-2018 年，这一比例为 43%-79%。FDA、制造商和医生之间的合作努力似乎在解决这一问题方面取得了进展。
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