FDA阻止奥林巴斯设备进入美国-动脉网

FDA stops Olympus devices from entering the US

HealthcareDive 等信源发布 2025-06-30 23:44



可切换为仅中文







First published on

首次出版于

Listen to the article

听取文章

2 min

2分钟

This audio is auto-generated. Please let us know if you have

此音频是自动生成的。如果您有任何问题，请告诉我们。

feedback

反馈

。

Dive Brief:

概要：

The Food and Drug Administration

食品药品监督管理局

has blocked

已阻止

certain Olympus Medical devices from entering the U.S. because of quality system failings at a site in Japan.

由于日本一处设施的质量系统问题，某些奥林巴斯医疗设备被禁止进入美国。

FDA officials issued the import alerts Tuesday to prevent 58 models of Olympus devices used in urinary, respiratory, abdominal and pelvic procedures from reaching customers in the U.S.

FDA官员在周二发布了进口警报，以阻止奥林巴斯用于泌尿、呼吸、腹部和骨盆手术的58款设备进入美国市场。

The import alerts are the latest in a series of regulatory actions by the FDA, which

这些进口警告是 FDA 采取的一系列监管行动中的最新举措，

accused Olympus

指控奥林巴斯

in 2023 of having “a troubling disregard for patient safety.”

在2023年，表现出“对患者安全的严重漠视”。

Dive Insight:

深入洞察：

The FDA sent three warning letters to Olympus from November 2022 to March 2023 as part of its work to reduce the risk of infection associated with reprocessed endoscopes. Inspectors found the company was noncompliant with current best practices in manufacturing requirements. Olympus is yet to fix the problems..

从2022年11月到2023年3月，FDA向奥林巴斯发出了三封警告信，作为其减少与再处理内窥镜相关感染风险的工作的一部分。检查员发现该公司不符合现行的制造要求最佳实践。奥林巴斯尚未解决这些问题。

“Despite extensive and ongoing efforts to address compliance issues, FDA continues to have concerns related to outstanding Quality System regulation violations by Olympus,” the FDA said in a statement.

“尽管为解决合规问题做出了广泛且持续的努力，FDA仍然对奥林巴斯未解决的质量体系违规行为表示担忧，”FDA在一份声明中表示。

The import alerts cover ureterorenoscopes, bronchoscopes, laparoscopes and automated endoscope reprocessors. While imports will be refused entry to the U.S., healthcare providers can continue to use devices they already own that are working as intended. The FDA has asked users to follow the labeling and reprocessing instructions and advised against using damaged devices or those that fail a leak test..

进口警报涵盖了输尿管肾镜、支气管镜、腹腔镜和自动内窥镜再处理设备。虽然这些设备的进口将被拒绝进入美国，但医疗服务提供者可以继续使用他们已拥有的、功能正常的设备。FDA 已要求用户遵循标签和再处理说明，并建议不要使用损坏的设备或未通过泄漏测试的设备。

Olympus has been working to resolve the quality issues identified by the FDA. In a May earnings call, Yasuo Takeuchi, who

奥林巴斯一直在努力解决FDA指出的质量问题。在5月的财报电话会议上，竹内康雄（Yasuo Takeuchi）表示

stepped down

辞职

as CEO on June 1,

作为首席执行官，6月1日

said the company

公司表示

expected to complete its commitments to the FDA by the end of its 2026 fiscal year. Olympus’ fiscal year ends March 31. Olympus spent 11 billion yen on its regulatory transformation project in fiscal 2025.

预计将在2026财年结束前完成对FDA的承诺。奥林巴斯的财年于3月31日结束。奥林巴斯在2025财年为其监管转型项目花费了1100亿日元。

The FDA said it is continuing to work with Olympus “to accelerate corrective actions related to ongoing violations and minimize risk to patients.”

美国食品和药物管理局表示，它将继续与奥林巴斯合作，“以加快与持续违规相关的纠正措施，并尽量减少对患者的风险。”