美國食品與藥物管理局（FDA）的一名官員表示，引發加州大學洛杉磯分校醫學院里根醫療中心（Ronald Reagan UCLA Medical Center）兩名病患死亡的內窺鏡的製造商奧林巴斯（Olympus）沒有獲得FDA的醫療儀器銷售許可。
據報導，FDA對外事務副策略主任Karen Riley 表示，奧林巴斯（Olympus）在2010年開始銷售TJF-Q180V 十二指腸鏡，但是FDA直到2013年末或2014年初才注意到。
去年10月至今年1月間，7位病人在加州大學洛杉磯分校醫學院附屬里根醫療中心感染了致命的超級細菌碳青霉烯類耐藥腸桿菌（CRE）。兩人死亡。患者在進行常規的內窺鏡治療後感染了超級病菌。醫院官員相信，兩個醫療內窺鏡在按滅菌規範消毒後，依然攜帶有緻命病菌。
Riley 表示，兩家提交數據的公司不能顯示清潔度達到99.9999%。這一指標是FDA的消毒標準。
連結：Duodenoscope Model TJF-Q180V by Olympus: FDA Safety Communication – New Reprocessing Instructions Validated（美國FDA公告）
ISSUE: Olympus has issued new, validated manual reprocessing instructions for the TJF-Q180V duodenoscope to replace those provided in the original labeling. The FDA has reviewed these new reprocessing instructions and the validation data as part of its ongoing review of the 510(k), and recommends that any facilities that are using Olympus’ TJF-Q180V duodenoscope train staff on the new instructions and implement them as soon as possible.
BACKGROUND: Reprocessing is a detailed, multistep process to clean and disinfect or sterilize reusable devices. The FDA is closely monitoring the possible association between reprocessed duodenoscopes and the transmission of infectious agents, including multidrug-resistant bacterial infections caused by Carbapenem-Resistant Enterobacteriaceae (CRE) such as Klebsiella species and Escherichia coli. If not properly reprocessed, residual body fluids and organic debris may remain in microscopic crevices of the device following an attempted cleaning and high level disinfection. If these residual fluids contain microbial contamination, subsequent patients may be exposed to serious infections. The FDA’s investigation into the possible association between inadequately reprocessed duodenoscopes and patient infections, including the agency’s recommendations for health care facilities, is more fully discussed in the following recent communications: February 2015 Safety Communication and FDA’s Updated Information for Healthcare Providers Regarding Duodenoscopes issued March 4, 2015.
小編評：沒核可卻可以在醫院裡使用，真的有點扯…關於「耐碳青霉烯類腸桿菌科細菌（CRE）」大家可以看下面那一篇。