医疗器械上市后监督

Post-market surveillance or post-marketing surveillance (PMS) is a regulatory requirement for manufacturers of medical devices that need to collect and evaluate the experience obtained from the devices placed in a particular market.

上市后监督（PMS）是对需要收集和评估特定市场上设备使用经验的医疗器械制造商的法规要求。

For example, as a manufacturer of a closed-loop artificial pancreas system, your goal is to ensure that the medical device is safe and efficacious for your customers. However, a situation may arise wherein the device causes a major adverse event. In such a case, you need to find out what happened so that this adverse event does not repeat.

例如，作为闭环人工胰腺系统的制造商，您的目标是确保医疗器械对客户安全有效。然而，可能会出现设备引发重大不良事件的情况。在这种情况下，您需要找出发生了什么，以防止这种不良事件再次发生。

How do you achieve this?

您如何实现这一目标？

There is a system of reporting to generate feedback on medical devices on the market. This is called post-market surveillance.

有一种报告系统可以生成关于市场上医疗器械的反馈。这就是所谓的上市后监督。

What is Post Market Surveillance? 什么是上市后监督？

The US FDA defines post-market surveillance as:

美国 FDA 将上市后监督定义为：

“The active, systematic, scientifically valid collection, analysis, and interpretation of data or other information about a marketed device.”

“对市场上设备的数据或其他信息进行积极、系统、科学有效的收集、分析和解释。”

Thus, if you are bringing a particular medical device into the market, you must ensure that your product is risk-free. It is possible that certain risks can manifest over time, with the regular use by end-users. This is where post-market surveillance comes into play.

因此，如果您将特定的医疗设备引入市场，您必须确保您的产品是无风险的。有可能某些风险会随着最终用户的常规使用而显现。这就是上市后监督发挥作用的地方。

Thus, post-market surveillance denotes the monitoring of a medical device on the market for safety. It is a part of pharmacovigilance, i.e. drug and device safety.

因此，上市后监督意味着对市场上的医疗设备进行安全监测。它是药物和设备安全的一部分，即药物警戒和设备安全。

Purpose of Post Market Surveillance 上市后监督的目的

Post-market surveillance is crucial for a medical device’s lifecycle. When your medical device is used by a larger population, as compared to clinical trial participants, a lot more data and information becomes available.

上市后监督对医疗设备的生命周期至关重要。与临床试验参与者相比，当您的医疗设备被更多人群使用时，会有更多的数据和信息可用。

As a result, you will get real-world evidence that provides a holistic picture of the safety and efficacy of your medical device.

因此，您将获得真实世界的证据，提供了您的医疗设备安全性和有效性的整体画面。

Post-market surveillance aims at the following:

上市后监督的目标如下：

  • Monitoring safety and efficacy of a medical device in the projected patient population. 监测医疗设备在预计患者群体中的安全性和有效性
  • Finding of adverse events. 发现不良事件
  • Compliance with regulatory requirements. 符合监管要求
  • Evaluation of a new device’s performance with current standards of care. 评估新设备在当前护理标准下的性能

Let us look at, for example, your closed-loop artificial pancreas system that is now available on the market. Its intended use is to facilitate patients with type 1 diabetes to adjust their blood glucose levels in an automated manner. During clinical trials, your device worked perfectly. However, on the market patients detect certain flaws that reduce their safety and efficacy.

例如，您现在市场上可用的闭环人工胰腺系统。它的预期用途是以自动化方式帮助 1 型糖尿病患者调节血糖水平。在临床试验中，您的设备运行完美。然而，在市场上，患者发现了一些降低安全性和有效性的缺陷。

Since you have a post-market surveillance plan in place, you can identify these flaws and make the necessary corrections.

由于您已经制定了上市后监督计划，您可以识别这些缺陷并进行必要的修正。

Let us now look at the steps involved.

现在让我们来看看所涉及的步骤。

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	dme([Develop medical device 开发医疗器械]) --> pice([Perform initial clinical evaluation 进行初步临床评估])
	pice --> pmdom([Place the medical device on the market 将医疗器械投放市场])
	pmdom --> csmdom([Continuous surveillance of your medical device on the market 对市场上的医疗器械进行持续监测])
	csmdom --> dae([Detection of adverse events 检测不良事件])
	dae --> ucerm([Update clinical evaluation and risk management 更新临床评估和风险管理])
	ucerm --> doma([Decide on measures/action 决定措施/行动])
	doma --> ar(["Action required? 是否需要采取行动？"])
	ar -- No --> ucerm
	ar -- Yes --> paip([Perform actions and improve the product 执行行动并改进产品])
	paip --> pimdom([Place the improved medical device on the market 将改进的医疗器械投放市场])
	pimdom --> csmdom
  • Develop medical device: The R&D team in your company has improved on existing closed-loop artificial pancreas systems currently available. 开发医疗设备：贵公司的研发团队改进了目前已有的闭环人工胰腺系统。
  • Perform initial clinical evaluation: The medical device now undergoes all mandated evaluations to prove its safety and efficacy in a target population. 进行初步临床评估：该医疗设备现在经历了所有必要的评估，以证明其在目标人群中的安全性和有效性。
  • Place the improved medical device on the market: The closed-loop artificial pancreas system is now made available on the market. 将改进后的医疗设备投放市场：闭环人工胰腺系统现在已在市场上提供。
  • Continuous surveillance of your medical device on the market: The new medical device is constantly surveilled for any safety issues. 对市场上的医疗设备进行持续监测：新的医疗设备将不断受到监测，以发现任何安全问题。
  • Detection of adverse events: You get reports that end-users are facing certain safety and efficacy issues with your medical device. 检测不良事件：您收到报告，最终用户在使用您的医疗设备时遇到了某些安全性和有效性问题
  • Update clinical evaluation and risk management: These adverse events are used to update the medical device’s clinical evaluation and risk management data. 更新临床评估和风险管理：这些不良事件用于更新医疗器械的临床评估和风险管理数据。
  • Decide on measures/action: You will now need to decide on what measures or actions your company must take. 决定措施/行动：现在您需要决定公司必须采取的措施或行动。
  • Action required?: Is any action or measure required in the first place? 是否需要采取行动？首先是否需要采取任何行动或措施？
  • Perform actions and improve the product if necessary: The medical device now needs to be fine-tuned to remove the flaws. 执行必要的行动并改进产品：现在需要对医疗器械进行微调以消除缺陷。
  • Place the improved medical device on the market: The improved medical device is now ready to be sold on the market. 将改进后的医疗器械投放市场：改进后的医疗器械现在已经准备好在市场上销售。

Value of Post Market Surveillance 市场监测的价值

There are different stakeholders for the medical device that you have placed on the market, these include:

对于您在市场上推出的医疗设备，有不同的利益相关者，包括：

  • You (the manufacturer) 您（制造商）
  • Clinicians 临床医生
  • Provider organizations 提供者组织
  • Regulatory agencies 监管机构

Let us look at the importance of post-market surveillance for each stakeholder.

让我们来看看对每个利益相关者来说，上市后监督的重要性。

You (the Manufacturer) 您（制造商）

Post-market surveillance gives you extra information on the disease in question. In the example cited, it is type 1 diabetes. You will also be able to compare your device with similar marketed devices.

上市后监督为您提供有关所讨论疾病的额外信息。在所引用的例子中，这是 1 型糖尿病。您还将能够将您的设备与类似的市场设备进行比较。

The information that you get will help you to fine-tune your strategies concerning pricing, marketing, and clinical features of your product. You can consequently develop an upgraded product.

您获得的信息将帮助您调整有关定价、营销和产品临床特征的策略。因此，您可以开发升级产品。

Clinicians and Provider Organizations 临床医生和提供者组织

Post-market surveillance will provide clinicians and provider organizations with information about real-world patient populations. Such populations are often different from clinical trial participants.

上市后监督将为临床医生和提供者组织提供有关真实世界患者群体的信息。这些群体通常与临床试验参与者不同。

With the information obtained, clinicians can make informed treatment choices.

通过获得的信息，临床医生可以做出明智的治疗选择。

Recommended Reading: Clinical Quality Management System [Role of an eQMS]

推荐阅读：临床质量管理系统[电子质量管理系统的角色]

Regulatory Agencies 监管机构

Information obtained from post-market surveillance of any given medical device helps regulatory agencies decide which products are the safest, most efficacious, and cost-effective.

从对任何给定医疗设备的上市后监督中获得的信息有助于监管机构决定哪些产品是最安全、最有效和最具成本效益的。

Post Market Surveillance Requirements 市场监测要求

The main regulatory requirements for post-market surveillance are:

市场监测的主要监管要求有：

  • US FDA 21 CFR Part 822: This details the post-market surveillance requirements in the USA. 美国 FDA 21 CFR 第 822 部分：详细说明了美国的市场监测要求。
  • MedWatch: This is the FDA’s medical product safety reporting program for healthcare professionals, patients, and consumers. MedWatch：这是 FDA 的医疗产品安全报告计划，面向医疗专业人员、患者和消费者。
  • EU MDR: The EU requirements for post-market surveillance. 欧盟 MDR：欧盟对市场监测的要求。

How to Conduct Post-Market Surveillance in an eQMS 如何在电子质量管理系统中进行上市后监督

As a manufacturer of medical devices, you could take the following steps to conduct post-market surveillance using digital post-market surveillance solutions:

作为医疗器械制造商，您可以采取以下步骤，使用数字化上市后监督解决方案进行上市后监督：

1. Create a Post-Market Surveillance Plan 创建一份上市后监测计划

You must continuously collect and monitor data generated for your medical device. This PMS plan is part of the medical device technical file.

您必须持续收集和监测您的医疗设备生成的数据。这个 PMS 计划是医疗设备技术文件的一部分。

The post-market surveillance plan lists out the requirements needed for your post-market surveillance. The following details are addressed in the PMS plan:

上市后监督计划列出了上市后监督所需的要求。以下细节在 PMS 计划中得到了解决：

  • Information about serious adverse events and corrective actions. 严重不良事件和纠正措施的信息
  • Facts on non-serious incidents and undesirable side effects, if any 非严重事件和不良副作用的事实，如果有的话
  • Technical information, databases, and registers. 技术信息、数据库和注册表
  • Feedback and complaints, CAPAs, Non-Conformances, etc., given by end-users, distributors. 最终用户、经销商提供的反馈和投诉、CAPA、不符合等信息
  • Information on similar medical devices. 类似医疗设备的信息

With an electronic quality management system (eQMS), you will be able to cover all processes related to the PMS plan, such as CAPAs, complaints, and others which will help you save time and make regulatory compliance much easier.

通过电子质量管理系统（eQMS），您将能够涵盖与 PMS 计划相关的所有流程，如 CAPAs、投诉等，这将帮助您节省时间并使法规合规更加容易。

Recommended Reading

推荐阅读

2. Implement the Plan 实施计划

Now that you have generated the PMS plan, you need to implement it.

既然您已经生成了 PMS 计划，您需要实施它。

Efficient QMS software will help you streamline and automate processes reoccurring processes like data collection, routing, approvals, follow-ups, reminders, email notifications, and more.

高效的 QMS 软件将帮助您简化和自动化重复出现的流程，如数据收集、路由、批准、跟进、提醒、电子邮件通知等。

Moreover, QMS software for medical devices like SimplerQMS allows you to record NCs, audit findings, complaints, deviations, and other issues, link, and process any number of CAPAs, based on the severity.

此外，像 SimplerQMS 这样的医疗设备 QMS 软件还允许您记录 NCs、审计结果、投诉、偏差和其他问题，根据严重程度链接和处理任意数量的 CAPAs。

3. Generate a PMS Report Based on the Findings 根据调查结果生成 PMS 报告

A variety of documents are generated during the PMS processes.

在 PMS 过程中会生成各种文件。

Post-market surveillance reporting should contain a summary of all the outcomes and decisions that were derived when the PMS data has been collected and analyzed.

售上市后监督报告应包含在收集和分析 PMS 数据时得出的所有结果和决策的摘要。

It will also describe the corrective and preventive actions (CAPAs) taken by your company. Another important piece of documentation is the Periodic Safety Update Report (PSUR). The latter summarizes the results and conclusions obtained when the PMS, PMCF, and vigilance data have been analyzed.

它还将描述贵公司采取的纠正和预防措施（CAPAs）。另一个重要的文件是定期安全更新报告（PSUR）。后者总结了在分析 PMS、PMCF 和警戒数据时获得的结果和结论。

With QMS software all the documents generated throughout your PMS activities are well organized, hyperlinked, and stored in a single, highly secure, cloud-based system. Solutions, like SimplerQMS, allow you to get an overview of NC-, Complaint-, CAPA-trending thanks to automated KPI reporting capabilities.

使用 QMS 软件，您在整个 PMS 活动中生成的所有文件都得到了良好的组织，超链接，并存储在一个高度安全的基于云的系统中。像 SimplerQMS 这样的解决方案，通过自动化的 KPI 报告功能，使您能够获得 NC-、投诉-、CAPA 趋势的概览。

Vigilance is beneficial for planning post-market clinical data information when the technical documentation of the device is done.

当设备的技术文件完成时，警惕对于规划市场后临床数据信息是有益的。

With a vigilance system in place, you can enable the uncovering of unknown adverse events, which will help prevent any future occurrence of such incidents.

有了一个警惕系统，您可以揭示未知的不良事件，从而帮助防止类似事件的再次发生。

Using eQMS reporting capabilities, you can analyze data, identify patterns, and better understand the root cause behind every complaint, non-conformance, deviation, or any other issue. This allows you to trace different quality events back to their root cause as well as correct areas of concern before they come to reality.

利用 eQMS 的报告功能，您可以分析数据，识别模式，并更好地了解每个投诉、不符合、偏差或其他问题背后的根本原因。这使您能够追溯不同的质量事件到其根本原因，并在其成为现实之前纠正关注的领域。

5. Use Pre-Configured Forms for CAPAs, Complaints, NCs, Etc. 使用预配置的表单进行 CAPAs、投诉、NC 等

With so many documents being generated during the PMS, you must have a proper form management process for distributing, processing, completing, and managing forms in place. This will allow you to get better data, streamline complaince and become more efficient.

在 PMS 期间生成如此多的文档，您必须有一个适当的表单管理流程来分发、处理、完成和管理表单。这将使您能够获得更好的数据，简化合规性并提高效率。

When you have efficient eQMS software, like SimplerQMS, you are enabled with a powerful form and template management module that includes – pre-configured forms for generating CAPAs, NCs, registering complaints, etc., automated workflows, automatic data collection, and more.

当您拥有高效的 eQMS 软件，例如 SimplerQMS 时，您将获得一个强大的表单和模板管理模块，其中包括-用于生成 CAPAs、NCs、注册投诉等的预配置表单、自动化工作流程、自动数据收集等。

Leveraging Technology for Effective Post Market Surveillance 利用技术进行有效的上市后监督

As a manufacturer of medical devices, you will likely invest in efficient eQMS, to facilitate and automate your PMS processes.

作为医疗设备制造商，您可能会投资于高效的电子质量管理系统（eQMS），以便促进和自动化您的 PMS 流程。

The Quality Management Software by SimplerQMS allows the seamless recording of audit findings, NCs, deviations, complaints, etc., along with automated linking and processing of CAPAs.

SimplerQMS 的质量管理软件可以无缝记录审计结果、NCs、偏差、投诉等，并自动链接和处理 CAPAs。

With the SimplerQMS QMS software solution, you can create hyperlinks to all your products, equipment, components, suppliers, customers with relation to any post-market surveillance issue. Moreover, you can upload any file, document, record, email, etc., and associate it with any CAPA, audit, or risk. The built-in dashboards and automated KPI reports allow you to overview the status of NCs, complaints, or CAPAs, helping you achieve a more proactive approach to quality management.

通过 SimplerQMS QMS 软件解决方案，您可以创建与任何上市后监督问题相关的产品、设备、组件、供应商、客户的超链接。此外，您可以上传任何文件、文档、记录、电子邮件等，并将其与任何 CAPA、审计或风险关联起来。内置的仪表板和自动化 KPI 报告使您能够概览 NCs、投诉或 CAPAs 的状态，帮助您实现更加积极的质量管理方法。

Frequently Asked Questions About Post-Market Surveillance 关于上市后监督的常见问题

Below are the answers to some of the common questions about post-market surveillance.

以下是关于上市后监督的一些常见问题的答案。

What Is Meant by Post-market Surveillance? 什么是上市后监督的意思？

Post-market surveillance (PMS) is a regulatory requirement for all manufacturers of medical devices. It is necessary to collect and evaluate the experiences obtained after the medical device has been placed in a given market.

上市后监督（PMS）是对所有医疗器械制造商的法规要求。在医疗器械投放市场后，收集和评估所获得的经验是必要的。

What Is the Purpose of Post-market Surveillance? 什么是上市后监督的目的？

Post-market surveillance is essential for the lifecycle of a medical device. When your medical device is used by a larger patient population versus clinical trial participants, much more data and information is generated. The real-world evidence thus generated provides a holistic picture of the safety and efficacy of the medical device.

上市后监督对医疗设备的生命周期至关重要。当您的医疗设备被更多的患者群体使用，相比临床试验参与者，会产生更多的数据和信息。因此产生的真实世界证据提供了医疗设备安全性和疗效的整体画面。

Difference Between Vigilance and Post-market Surveillance? 警戒系统和上市后监督之间的区别是什么？

Vigilance is one component of the post-market surveillance system. It deals with reporting serious adverse events to the relevant authorities. On the other hand, post-market surveillance is carried out systematically by the manufacturer to review the experience obtained from their devices on the market.

警戒系统是上市后监控系统的一个组成部分。它涉及向相关机构报告严重不良事件。另一方面，市场后监控是制造商系统地对其产品在市场上的经验进行审查。

Difference Between PMS and PMCF? PMS 和 PMCF 之间的区别？

The post-market clinical follow-up (PMCF) is an important part of post-market surveillance (PMS) for medical devices. The PMCF is an element of PMS that constantly verifies the benefits of your medical device and to detects previously unknown risks.

市场后临床跟踪（PMCF）是医疗器械市场后监控（PMS）的重要组成部分。PMCF 是 PMS 的一个元素，不断验证您的医疗器械的益处，并检测以前未知的风险。

Conclusion 总结

Post-market surveillance is a regulatory requirement for manufacturers of all medical devices. It is critical to a medical device’s lifecycle.

市场后监管是所有医疗器械制造商的法规要求。这对于医疗器械的生命周期至关重要。

With the information that is gathered from a large patient population that uses your medical device, you will get real-world experience that will provide an all-inclusive picture of the safety and efficacy of your medical device.

通过从使用您的医疗器械的大量患者群体中收集的信息，您将获得真实世界的经验，这将提供您的医疗器械安全性和功效的全面画面。

SimplerQMS solution is built specifically for Life Science industries and is aligned with relevant regulations and standards. If you are interested in facilitating and automating your PMS processes, we recommend you schedule a demo to see SimplerQMS in action and talk to our experts.

SimplerQMS 解决方案专为生命科学行业而建，并与相关法规和标准保持一致。如果您有兴趣促进和自动化您的 PMS 流程，我们建议您安排一个演示，以了解 SimplerQMS 的运作，并与我们的专家交谈。

References 参考文献