Replacing a draft guidance issued in February 2016, FDA recently finalized its guidance on the use of human factors engineering (HFE) in the development of combination medical devices with a drug or biological product. The Application of Human Factors Engineering Principles for Combination Products document, released in a Q&A format, pertains to combination products submitted to the Center for Biologics Evaluation and Research, the Center for Devices and Radiological Health, or the Center for Drug Evaluation and Research.

FDA取代2016年2月发布的指导草案，最近最终确定了使用人为因素工程（HFE）开发与药物或生物制品组合医疗器械的指导。以问答格式发布的人因工程原理在组合产品中的应用文件涉及提交给生物制品评估和研究中心，器械和放射卫生中心或药物评估和研究中心的组合产品。

The agency recommends the guidance be read in conjunction with Applying Human Factors and Usability Engineering to Medical Devices and Safety Considerations for Product Design to Minimize Medication Errors..

该机构建议结合将人为因素和可用性工程应用于医疗设备以及产品设计的安全考虑因素来阅读指南，以最大限度地减少用药错误。。

HFE uses the knowledge of human behavior, and an individual’s abilities, and limitations to design products better able to be used safely and effectively. Additionally, intended user population characteristics must be considered as specific limitations could impact use of the product.

HFE利用人类行为知识和个人能力以及局限性来设计能够更好地安全有效地使用的产品。此外，必须考虑预期的用户群体特征，因为特定的限制可能会影响产品的使用。

“For example, for a digital health combination product intended for use in a geriatric patient population, common characteristics or limitations may include decreased vision/hearing, varying literacy levels, and cognitive decline,” according to the guidance document. “Furthermore, the design of the combination product should take into account, among other things, the use environment(s), including any limitations (e.g., limited internet /cellular phone service).”.

根据指导文件，“例如，对于旨在用于老年患者群体的数字健康组合产品，共同特征或限制可能包括视力/听力下降，识字水平不同和认知能力下降”。“此外，组合产品的设计应考虑到使用环境等因素，包括任何限制（例如，有限的互联网/手机服务）。

Adding to the guidance on the general principles of human factors, including information found in Applying Human Factors and Usability Engineering to Medical Devices, the FDA document specifies two unique definitions in HFE directed towards combination products — the final finished combination product and combination product critical task.

除了关于人为因素的一般原则的指导之外，包括将人为因素和可用性工程应用于医疗器械的信息，FDA文件还规定了针对组合产品的HFE中的两个独特定义-最终成品组合产品和组合产品关键任务。

A final finished combination product is the final form of a product intended for market and to be submitted in regulatory applications. The term includes the user interface for the product, like the proposed packaging, labels and labeling, as well as training if applicable..

最终成品组合产品是打算上市并在监管申请中提交的产品的最终形式。该术语包括产品的用户界面，如建议的包装，标签和标签，以及适用时的培训。。

A combination product critical task is a user task which, if performed wrong or not at all, would or could cause harm to the user themselves or the patient. FDA defines harm to include compromised medical care. While this definition is similar to that used in a standalone device, it differs in the level of harm.

组合产品关键任务是用户任务，如果执行错误或根本不执行，将或可能对用户本身或患者造成伤害。FDA将危害定义为包括受损的医疗护理。虽然此定义类似于独立设备中使用的定义，但其危害程度不同。

While a critical task in a standalone device only has the device itself to contend with, a combination product critical task is associated with risks in a combination product as a whole that don’t exist for the device alone or the drug alone..

虽然独立设备中的关键任务仅与设备本身相抗衡，但组合产品关键任务与组合产品整体中的风险相关联，而单独设备或单独药物不存在这些风险。。

“Therefore, combination product critical tasks reflect the use-related risks resulting from both the drug and device constituent parts used together as a combination product,” according to FDA. “For a combination product critical task, compromised medical care includes consideration of medication errors.”.

FDA表示：“因此，组合产品的关键任务反映了药物和设备组成部件作为组合产品一起使用所带来的与使用相关的风险。“对于组合产品关键任务，妥协的医疗护理包括考虑用药错误。”。

A comprehensive use-related risk analysis (URRA) can help determine combination product critical tasks. These analyses should include a systematic evaluation of all the tasks involved in using the combination product — based on a task analysis and should reflect on the use errors that may occur if the tasks are not completed — task failures.

全面的使用相关风险分析（URRA）可以帮助确定组合产品关键任务。这些分析应包括对使用组合产品所涉及的所有任务的系统评估-基于任务分析，并应反映任务未完成时可能发生的使用错误-任务失败。

Additionally, combination devices must be studied for intended use, use environment, user interface, and the users..

此外，必须研究组合设备的预期用途，使用环境，用户界面和用户。。

In the guidance document, FDA noted that it is particularly interested in the assessment of tasks that directly impact dosing (overdosing, underdose, or missed dose), administration of the product (wrong site of administration, improper preparation of drug/biologic before administration), and the potential result in harm (physical injury, adverse events, events that ma need patient monitoring to confirm no harm, or events leading to hospitalization)..

FDA在指导文件中指出，特别感兴趣的是评估直接影响剂量（过量，剂量不足或错过剂量），产品给药（给药部位错误，给药前药物/生物制剂制备不当）的任务，以及可能造成伤害（身体伤害，不良事件，需要患者监测以确认没有伤害的事件或导致住院的事件）。。

FDA highlighted specific examples of what would and wouldn’t be considered critical tasks. “Consider an autoinjector for repeat use that includes a task to remove the cap. If a user cannot initially remove the cap, then the user is initially delayed in the sequence of tasks. However, there is no sense of urgency associated with completion of tasks for this hypothetical combination product and the user ultimately removes the cap.

FDA强调了哪些将被视为和不会被视为关键任务的具体例子。“考虑重复使用自动注射器，其中包括移除帽子的任务。如果用户最初无法移除帽子，则用户最初会按任务顺序延迟。但是，完成任务没有紧迫感。这个假设的组合产品的任务和用户最终移除帽子。

In cases where the timeliness of the injection is not linked to physical injury, it’s unlikely that FDA would consider this task to be a combination product critical task.”.

如果注射的及时性与身体伤害无关，FDA不太可能将此任务视为组合产品关键任务“。

The document continued, writing, “Consider an autoinjector for a non-urgent, repeat use where the user must complete the task of pushing the needle end against the skin to activate the injection sequence and administer the dose. In this example, a user does not complete the task of pushing to activate the full injection sequence because the user did not know s/he needed to push the needle all the way down, and thus fails to administer the dose.

文件继续，写作， “考虑使用自动注射器进行非紧急重复使用，用户必须完成将针头推到皮肤上的任务，以激活注射顺序并施用剂量。在这个例子中，用户没有完成推动任务激活完整的注射序列，因为用户不知道他/她需要一直向下推针头，因此无法广告部长剂量。

The omission of a single dose is a medication error that may not result in an immediate change in clinical signs or symptoms; however, it is reasonable to consider the potential for repeated dose omission medication errors over the course of treatment. The treatment for that patient may be compromised and could result in harm to the patient.

省略单剂量是药物错误，可能不会导致临床症状或体征立即改变；然而，考虑在治疗过程中重复剂量遗漏药物错误的可能性是合理的。该患者的治疗可能会受到影响，并可能对患者造成伤害。

Thus, the task of pushing the needle end against the skin to activate the full injection sequence would be considered a combination product critical task.”.

因此，将针端推到皮肤上以激活完整注射顺序的任务将被视为组合产品关键任务“。

Other topics in the guidance included the differences between URRA to support the user interface compared to of types of risk analysis, writing, “the URRA is a subset of the full engineering risk analysis for the device constituent part and combination product as a whole (including the drug constituent part).

指南中的其他主题包括支持用户界面的URRA与风险分析类型，写作类型之间的差异，“URRA是设备组成部分和组合产品整体完整工程风险分析的子集（包括药物成分部分）。

For the purposes of this guidance, the URRA is the systematic use of available information to identify use-related hazards and to estimate the use-related risk.”.

就本指南而言，URRA是系统地使用可用信息来识别与使用相关的危害并估计与使用相关的风险“。

In another question related to how the agency evaluates human factor validation studies, FDA recognized the impossibility of designing a completely error-proof or risk-free user interface, noting that “some residual use-related risk may remain. The HF validation study results should be considered within the overall benefit-risk assessment of the combination product.”.

在另一个与该机构如何评估人为因素验证研究有关的问题中，FDA认识到不可能设计完全防错或无风险的用户界面，并指出“可能存在一些与剩余使用相关的风险.HF验证研究结果应该是在组合产品的整体效益风险评估中考虑“。