FDA Class 1 recall of over 2 million breathing devices driving demand for ISO 18562医疗器械测试

Over 2 million breathing devices were subject to a class 1 recall 医疗设备s (MDR) after facing several observations from the US FDA. 此次召回涉及各种类型的机械呼吸机, 包括双水平气道压力(BiPAP)和, 持续气道正压通气.

1类召回纠正措施

In response to the FDA-483 report delivered to the plants head of quality in November 2021, 公司已经实施了一系列的纠正措施. These actions include the establishment of an internal team of subject matter experts (SMEs) within Respironics, 重点关注FDA对生物相容性的关注, 清洁和消毒, 和毒理学. The company will also be adding personnel to assess risk and implement changes to ensure compliance with FDA regulations.

ISO 18562测试的重要性

这一召回进一步突出了适当的重要性 ISO 18562医疗器械测试 & 生物相容性 新的和现有的监管文件的信息. ISO 18562 is a standard focused on the 生物相容性 evaluation of breathing 气体 pathways in healthcare applications. 与呼吸机等医疗设备相关, 麻醉工作站, 呼吸回路. It helps to ensure that any materials used in the breathing 气体 or 气体 pathway do not pose a risk to human safety due to compounds that inevitably migrate from materials such as plastics and rubbers.

510(k)上市前通知程序

在美国.S.在美国，FDA负责监管医疗器械. The 510(k) Premarket Notification program is the most common type of 医疗设备 premarket review conducted by the FDA. 除了关于设备描述的信息, 相同的设备, 软件, 以及性能测试, the 510(k) submission must include data on the 生物相容性 of any materials that come into direct or indirect contact with the patient.

避免延迟上市时间

不幸的是, many regulatory submissions lack adequate 生物相容性 information, which can result in additional information requests and slow down the review process. 尽量减少延误，优化上市时间, completing the necessary testing and exposure assessments in advance is crucial.

The ISO 18562 standard for 生物相容性 evaluation of breathing 气体 pathways in healthcare applications was published in 2017 and serves as the reference for testing the 生物相容性 of breathing components by addressing three key associated hazards. 颗粒物排放(PM2).5 & PM10), volatile organic compounds in a 气体 stream (VOC) and leachables in condensate.

im体育APP如何提供帮助? 

im体育APP has a long history of expertise in testing breathing 气体 pathways against the ISO 18562 standard, boasting a global network of laboratories and established test methods.

ISO 18562 has four main components which are supported by im体育APP Materials 技术:

• ISO 18562-1: Evaluation and testing within a risk management process
• ISO 18562-2:颗粒物质排放试验
• ISO 18562-3:挥发性有机化合物排放试验
• ISO 18564 -4:冷凝水中浸出物的测试

Additional toxicological assessments and interrelated ISO10993 testing services are also available.

拥有超过二十年的材料分析专业知识 可提取和可浸出, im体育APP曼彻斯特 offers a wide selection of analytical and sample preparation tools to its customers. 多年来, the company has conducted numerous tests on various products and materials, providing trace analytical identification and quantification services to its clients.

If you have further questions about ISO 18562医疗器械测试 or would like to discuss potential requirements with a technical expert at im体育APP, 请联系 im体育APP曼彻斯特.