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什么是医疗器械互操作性?

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发表于 2023-11-21 06:21:27 | 显示全部楼层 |阅读模式

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本帖最后由 RA小编辑 于 2023-11-21 06:22 编辑

本文来源自FDA指南:
Design-Considerations-and-Pre-market-Submission-Recommendations-for-Interoperable-Medical-Devices---Guidance-for-Industry-and-Food-and-Drug-Administration-Staff.pdf

医疗器械互操作性的英文描述为Medical Device Interoperability,那么医疗器械互操作性指的是什么呢?
FDA对其定义如下:
Medical device interoperability is the ability to safely, securely, and effectively exchange and use information among one or more devices, products, technologies, or systems. This exchanged information can be used in a variety of ways including display, store, interpret, analyze, and automatically act on or control another product.
医疗设备互操作性是指在一个或多个设备、产品、技术或系统之间安全、可靠和有效地交换和使用信息的能力。这种交换的信息可以体现为各种方式,包括显示、存储、解释、分析和自动对其他产品采取行动或控制其他产品。

Medical device interoperability is not limited to unidirectional patient data but includes more complex interactions, such as exerting command and control over a medical device(s). Establishing and implementing appropriate functional, performance, and interface requirements for devices with such interactions is important. One way to achieve this is through use of standardized architectures and communication protocols. Another way is to specify non-standard interface requirements and characteristics in labeling.
医疗器械互操作性不仅限于单向的患者数据,还包括更复杂的交互,例如对医疗器械进行命令和控制。为具有这种交互的器械建立和实现适当的功能、性能和接口需求是很重要的。实现这一目标的一种方法是使用标准化的体系结构和通信协议。另一种方法是在标签(这里通常指的是说明书)中指定非标准的接口要求和特性。


医疗器械的互操作性设计要考虑哪些方面?
Manufacturers can choose from many design solutions to create interoperable medical devices. The information model (data attributes), the functional model (role played within the interoperable system), and the architectural model (how the device is connected within the system) should be considered during the design and development of an interoperable medical device. Design inputs should include the desired functional and performance characteristics of the electronic interface.
制造商可以从许多设计解决方案中选择,以创建可互操作的医疗器械。在设计和开发可互操作的医疗器械时,应该考虑信息模型(数据属性)、功能模型(在互操作系统中扮演的角色)和体系结构模型(器械如何在系统中连接)。设计输入应包括所需的功能和性能特征的电子接口。

As a general matter, one action manufacturers can take to reduce risk and facilitate safe and effective interoperability is to clearly set forth in device labeling the functional and performance requirements of their electronic interface. Providing these characteristics along with limitations of the interface or use of the device in an interoperable system can minimize the risks associated with failure to exchange and use data as intended.
一般而言,制造商可采取的一项措施,是在器械标签(这里通常指的是说明书)上明确列出其电子接口的功能和性能要求,以减少风险和促进安全有效的互操作性。提供这些特性以及接口或器械在可互操作系统中的使用限制,可以最大限度地降低与无法按照预期交换和使用数据相关的风险。


The following considerations should be appropriately tailored to the selected interface technology, and the intended use and use environments for the medical device.
以下考虑应根据所选的接口技术以及医疗器械的预期用途和使用环境进行适当调整。

1. Purpose of the Electronic Interface: Device manufacturers should consider the purpose for each of the electronic interfaces. This should include the types of data exchanges taking place (e.g., sending, receiving, issue command and control).
1. 电子接口的目的:器械制造商应该考虑每个电子接口的目的。这应该包括发生的数据交换的类型(例如,发送、接收、发出命令和控制)。

2. The Anticipated Users: Manufacturers should determine the anticipated user(s) for each of the electronic interfaces. Examples of users include: clinical user, biomedical engineers, home healthcare user, IT (information technology) professional, system integrator, system designers, patients, researchers, and medical device designers.
2. 预期用户: 制造商应确定每个电子接口的预期用户。用户的例子包括:临床用户、生物医学工程师、家庭医疗保健用户、IT(信息技术)专业人员、系统集成商、系统设计师、患者、研究人员和医疗器械设计师。

3. Risk Management: Manufacturers should consider ways to mitigate risks identified in the risk analysis. This includes risks that arise from others connecting to the electronic interface.
3.风险管理: 制造商应考虑降低风险分析中确定的风险的方法。这包括连接到电子接口的其他设备所产生的风险。

4.Verification and Validation: Manufacturers should establish, maintain, and implement appropriate verification and validation to ensure that their devices with electronic interfaces work correctly prior to delivery, during the integration process, continue to work while in use, and through maintenance and release of software updates.

4.验证和确认:制造商应建立、维护和实施适当的验证和确认,以确保具有电子接口的器械在交付前、集成过程中、在使用中,以及维护和发布软件更新后继续工作。

5.Labeling Considerations: Manufacturers should include information that users may need to connect predictably and safely to the interface for its intended purpose.


5.标签的考虑: 制造商应该包括用户可能需要预期和安全连接到其预期目的的接口的信息。

6.Use of Consensus Standards: Manufacturers should consider the use of consensus standards related to medical device interoperability.
6.使用共识标准: 制造商应考虑使用与医疗器械互操作性相关的共识标准。

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