Understanding post-market surveillance for medical devices
After spending years developing and testing your medical device, getting it to market is an exciting achievement. But your job isn't done yet. Once your device is in the hands of the public, you need to ensure that it continues to meet the needs of patients and healthcare providers. That's where post-market surveillance (PMS) comes in.
Post-market surveillance is a continuous process of monitoring and collecting data on the safety and performance of medical devices after they've been released to the market. Yes, this data contains complaints and adverse events, but it also may reveal opportunities to impact patients in new and innovative ways.
PMS is an important part of product stewardship. We'll dive into the details about what post-market surveillance is and why it's important. We'll also review setting up a successful PMS system and cover the elements of a PMS plan. Finally, we'll give you tips for collecting feedback and analyzing the data that will flow in from your efforts.
What is post-market surveillance?
Post-market surveillance is the process of monitoring the safety and performance of medical devices after they've been released to the market. This includes collecting data from users, analyzing that data, and taking action if necessary. PMS helps ensure that medical devices are safe and effective for patients. Before release, medical devices go through stringent testing and clinical studies, however, this is done using a limited number of people. PMS helps assess the safety of devices in the 'real world,' and it's necessary to have a process in place to capture feedback from the larger population.
Post-market surveillance regulations
PMS is a regulated activity in the United States by the Food and Drug Administration (FDA) and in the European Union (EU) by the European Commission (EC). Over the years, regulations have shifted to more emphasis on PMS activities and this is likely to continue in markets across the world.
21 CFR part 822 in the United States
The FDA's 21 CFR part 822 outlines the PMS requirements for medical device manufacturers in the U.S. Referencing Section 522 of the Federal Food, Drug, and Cosmetic Act, the FDA states that post-market surveillance is required for certain devices that present a potential for serious risk to health.
PMS is required for class II and class III medical devices that meet any of the following criteria:
(a) Failure of the device would be reasonably likely to have serious adverse health consequences;
(b) The device is intended to be implanted in the human body for more than 1 year; or
(c) The device is intended to be used outside a user facility to support or sustain life.
MDR in the European Union (EU 2017/745)
In 2017, the European Union released the Medical Device Regulation (MDR), which featured an increased focus on post-market surveillance. The post-market surveillance system must be commensurate with the risks associated with the device and include:
- A post-market surveillance plan
- Post-market surveillance procedures
- Post market surveillance reporting such as PMS reports (PMSRs) or Periodic Safety Update Report (PSURs)
Why is post-market surveillance important?
PMS is important for a number of reasons. First, it helps ensure the safety and efficacy of medical devices post-market. Second, it allows manufacturers to collect feedback from users in the 'real world' setting and make necessary improvements to their devices. Finally, post-market surveillance helps manufacturers meet the regulatory requirements set out by their local governing bodies.
PMS is a process that monitors and assesses device safety, performance, and quality. Compliance with regulations is simply a bonus; identifying the long-term safety and performance of devices is critical. While most medical device companies hope to turn a profit and find ongoing financial success, developing an effective and safe device should be core to every medical device company—PMS reveals if that ultimate goal has been achieved. When consistently and thoroughly conducted, PMS provides an opportunity for manufacturers to build relationships with customers and get feedback about their products.
As mentioned, post-market surveillance can also help identify new uses for devices. It also allows for the opportunity to improve product design based on user feedback and actual use in clinical settings. For example, a device that was originally intended for use in one area of the body may be found to be effective in another area.
It's important to note that PMS is not the same as clinical trials. Clinical trials are conducted before a device is released to the market, and they are used to test, in small populations, the safety and efficacy of a device. Post-market surveillance is conducted after a device is released to the market, and it's used to monitor the safety and performance of a device for the general market.
Creating a post-market surveillance system
Now that we've reviewed PMS in general, let's take a look at how you can build an effective PMS system. Your system's goal is to collect data on the safety and performance of your medical device. There are many different ways to set up a PMS system, but all systems should include some basic elements:
- Planning: This includes creating a PMS plan and setting up a process that enables your feedback gathering to be effective. Begin with identifying who will be responsible for PMS activities (this is usually a quality manager or quality team member).
- Data collection: Establish channels for collecting data from users, such as customer feedback, product complaints, and post-market studies.
- Data analysis: After collection, take action if necessary. After reviewing and trending data, this might involve conducting post-market studies, modifying product labeling, or issuing a recall.
- Training: Train the relevant staff on your PMS procedures, so valuable feedback isn't lost or ignored.
- Risk management: This includes taking action to reduce the risks associated with your device. This might involve implementing PMS procedures or field safety corrective actions. It's important to note that PMS activities should be ongoing and continuous, not just a one-time event.
How to create a PMS plan
When required, a PMS plan should be submitted to the FDA as part of your premarket approval application or de novo submission. A PMS plan is a necessary component of a complete post-market system and outlines the activities of the larger PMS system.
Your PMS plan should be commensurate with the risks associated with your device and take into account the following:
- The intended use of the device
- The patient population
- The clinical environment
- The expected duration of use
- Known and potential complications
These considerations will help you develop a PMS plan that's tailored to your device and its intended use. Your plan should include how you intend to collect post-market data, how you will analyze that data, what actions you will take if post-market studies reveal safety or performance concerns, and the frequency of planned revisions.
You should consider a PMS plan to be a living document that should be updated as new information becomes available. For example, if you receive a post-market study report that reveals safety concerns with your device, you should update your PMS plan to reflect the new information and ensure that appropriate actions are taken.
Methods for collecting PMS data
There are many different methods for collecting post-market surveillance data. The most common methods are user surveys, product registries, post-market clinical follow-up studies, and complaint systems. The method will depend on the type of device, the patient population, and the clinical environment.
User surveys are a great way to collect data on the safety and performance of medical devices. They can be used to assess user satisfaction, understand how users are using the devices, and identify problems early on. User surveys can be conducted by mail, phone, or in person.
Product registries are databases of information on medical devices. They can be used to track the safety and performance of devices over time. A product registry can be used to identify potential problems with a device, understand how a device is being used in the 'real world', and compare the safety and effectiveness of different devices.
Post-market clinical follow-up studies (PMCF)
PMCF studies are studies that are conducted after a device has been released to the market. These studies can be used to assess the safety and effectiveness of devices. A PMCF study may make sense when there is limited data on the safety and effectiveness of a device or when there are concerns about potential risks associated with a device.
Complaint systems are databases of information on complaints about medical devices. They can be used to track the number and types of complaints, and to identify problems early on. A compliant management SOP will help you to ensure that complaints are properly documented, investigated, and addressed.
Focus groups are a form of qualitative research that involves bringing together a group of people to discuss a particular topic. Focus groups can be used to collect data on the safety and performance of devices. They can be used to understand how users feel about a device, identify problems with a device, and understand user needs.
While not necessarily a method, social media is a channel that needs post market surveillance. Monitoring social media is an additional outlet for patients to voice complaints or satisfaction with a device. Analyzing sentiment can give you an idea of how the general public is feeling about your product, as well as where there may be potential issues. When necessary, ensure relevant feedback delivered via social media channels is funneled into your complaint management system.
Regardless of the method, 2 things are paramount in the data collection process. First, it must be easy for users to provide feedback. Make sure that your post-market surveillance system is easy to use and that users can easily provide feedback. Second, encourage users to be honest in their feedback, and make sure that they understand that their feedback is confidential.
Analyzing PMS data
Once you've collected post-market surveillance data, it's important to analyze the data to identify problems or new uses for your device. The analysis should include a review of the data, a statistical analysis of the data to reveal trends, and a review of the literature to identify any previous reports of similar problems. Your analysis phase will run more smoothly if you keep the following in mind:
- Have a proactive owner. Analysis should be conducted by a qualified individual who is familiar with post-market surveillance procedures and proactively reviews the data. Analyze data regularly, even if there are no problems—this will help you identify problems early on.
- Avoid silos. A pitfall of collecting PMS data is that it becomes siloed with a customer-facing team like customer support. As a result, post-market data may never be properly investigated by the right parties. Whether it's a support or field, maintaining close ties with groups that interact with customers is key to surfacing complaints and taking action.
- Know that resolving issues in a timely manner will be a constant challenge. SOPs and proper training will help you implement changes faster. Speed is especially important if you are required to report a complaint to the FDA. Maintaining a PMS program will require constant vigilance, but the benefits and insights are worth the effort.
Mitigating risk: The purpose of PMS
Once you've analyzed the post-market surveillance data, it's important to take action to address any problems that have been identified. While you're evaluating complaints for feedback, it's important to remember that the primary purpose of PMS is to identify risks you may not know about.
As you gain new information from your PMS activities, it's critical that you frequently and systematically revisit your risk management files and make updates when necessary. Risk mitigation may involve changing the design of the device, changing the manufacturing process, providing more training to users, or conducting post-market clinical follow-up studies. You may have not planned for these additional activities when you originally designed and released your device, but taking action from post-market surveillance should be seen as an ongoing part of the product lifecycle. By being proactive and constantly mitigating risk, you can ultimately keep your device on the market longer.
Looking for an eQMS to help you launch and scale your medical device company? Let's talk about Qualio.