本文摘译自FDA 2020年6月25日

以下为详文

持续呼吸机是一种通过在呼吸气体中输送预定百分比的氧气来机械控制或协助患者呼吸的装置。FDA曾经发布EUA，助力增进呼吸机和呼吸机附件的可用性，这是COVID-19大流行期间治疗严重呼吸窘迫患者所不可或缺的。

FDA网站截图

关于呼吸机和呼吸机配件的《伞式EUA》

2020年3月24日，FDA发文《伞式EUA》，以应对COVID-19大流行期间FDA批准的用于医疗机构治疗患者时的呼吸机在供应性和可用性方面的不足。该《EUA》紧急授权某些呼吸机、气体麻醉机改装的呼吸机、正压呼吸装置改装的呼吸机、呼吸机管连接器和呼吸机附件，并确定了这些设备在符合安全、性能和标签方面的特定标准。按照《EUA》，符合入选资格的设备是那些目前没有在美国销售的产品，或是那些目前在美国销售但又对设备进行了改装的产品，正如FDA《呼吸机强制实施政策》中所讨论的，要求制造商向FDA提交新的上市前通知（510（k））。

呼吸机参考版权图

本授权的范围仅限于呼吸机、呼吸机管连接器和呼吸机附件的使用，列表见附录B：COVID-19流行期间供患者在医疗环境中使用的已授权的呼吸机、呼吸机管连接器和呼吸机附件。

■EUA授权书---呼吸机、气体麻醉机改装的呼吸机、正压呼吸装置改装的呼吸机（统称为“呼吸机”）、呼吸机管连接器和呼吸机附件

■医疗保健提供者的资料表

■患者的资料表

■附录A：安全、性能和标签的标准

■附录B：已授权的呼吸机、呼吸机管连接器和呼吸机附件

呼吸机EUA：根据呼吸机EUA的规定，用于向FDA提供信息的交互审查模板支持纳入合格产品：《呼吸机EUA交互审查模板》（2020年4月21日更新版）。

下表列出了在《伞式EUA》中授权的呼吸机、呼吸机管连接器和呼吸机附件。

附录B：授权的呼吸机、呼吸机管接头和呼吸机配件（更新日期：2020年6月29日）

下表是COVID-19突发公共卫生事件期间根据《伞式EUA》中的授权产品清单所列出的包含授权呼吸机、呼吸机管接头和呼吸机附件在内的一份清单。

■授权呼吸机

■授权呼吸机管连接器

■授权呼吸机附件

原文：

Ventilators and Ventilator Accessories EUAs

June 25, 2020 By FDA

A continuous ventilator is a device intended to mechanically control or assist patient breathing by delivering a predetermined percentage of oxygen in the breathing gas. FDA has issued EUAs to help increase the availability of ventilators and ventilator accessories, which are integral to treat patients with severe respiratory distress during the COVID-19 pandemic.

Umbrella EUA for Ventilators and Ventilator Accessories

On March 24, 2020, FDA issued an umbrella EUA in response to concerns about the insufficient supply and availability of FDA-cleared ventilators for use in health care settings to treat patients during the COVID-19 pandemic. This EUA authorizes the emergency use of certain ventilators, anesthesia gas machines modified for use as ventilators, positive pressure breathing devices modified for use as ventilators, ventilator tubing connectors, and ventilator accessories that the FDA determines meet specified criteria for safety, performance, and labeling. The devices that are eligible for inclusion under the EUA are those that are not currently marketed in the U.S., or those that are currently marketed in the U.S. but a modification is made to the device that would trigger the requirement that a manufacturer submit a new premarket notification (510(k)) to the FDA, as discussed in the agency's Ventilator Enforcement Policy.

The scope of this authorization is limited to the use of ventilators, ventilator tubing connectors, and ventilator accessories listed below in Appendix B: Authorized Ventilators, Ventilator Tubing Connectors, and Ventilator Accessories for use in healthcare settings by patients during the COVID-19 pandemic.

EUA Letter of Authorization - Ventilators, anesthesia gas machines modified for use as ventilators, and positive pressure breathing devices modified for use as ventilators (collectively referred to as "ventilators"), ventilator tubing connectors, and ventilator accessories

Facts Sheets for Healthcare Providers

Facts Sheets for Patients

Appendix A: Criteria for Safety, Performance and Labeling

Appendix B: Authorized Ventilators, Ventilator Tubing Connectors, and Ventilator Accessories

For Ventilator EUA: The interactive review template, which can be used to provide information to FDA, to support inclusion of an eligible product under the Ventilator EUA is available: Ventilator EUA Interactive Review Template (Updated April 21, 2020)

The tables below lists the ventilators, ventilator tubing connectors, and ventilator accessories authorized in this umbrella EUA.

Appendix B: Authorized Ventilators, Ventilator Tubing Connectors, and Ventilator Accessories (Updated June 25, 2020)

The table below includes a list of authorized ventilator, ventilator tubing connector, and ventilator accessory to the list of authorized products in this Umbrella EUA during the COVID-19 public health emergency.

Authorized Ventilators

Authorized Ventilator Tubing Connectors

Authorized Ventilator Accessories