Bringing your medical device to market after years of development and testing is a wonderful accomplishment. But you haven’t finished yet. You must make sure that your device continues to serve the demands of patients and healthcare professionals after it is in the hands of the public. Post-market surveillance, or PMS, can help with that.
The process of continuously observing and gathering information on the functionality and safety of medical devices after they have been put on the market is known as post-market surveillance. While complaints and unfavorable events are present in this data, there may also be chances to influence patients in novel and creative ways.
A crucial component of product stewardship is PMS. We will delve into the specifics of post-market surveillance and its significance. We’ll also go over how to set up a productive PMS system and what makes a PMS strategy. Last, we’ll offer you some pointers on gathering feedback and examining the information that will come in because of your work.
Post-market surveillance: What is it?
The process of keeping an eye on the functionality and safety of medical devices after they have been put on the market is known as post-market surveillance. This entails gathering user data, evaluating that data, and acting accordingly. PMS contributes to the efficacy and safety of medical devices for patients. Medical devices undergo extensive testing and clinical investigations before to distribution; they are conducted on a restricted population. PMS aids in evaluating the safety of gadgets in the “real world,” and a procedure must be in place to gather input from a wider range of people.
Regulations governing post-market surveillance (PMS) The Food and Drug Administration (FDA) in the United States and the European Commission (EC) in the European Union oversee PMS. Regulations have changed over time to place a greater focus on PMS operations, and this trend is probably going to continue in global marketplaces.
Part 822 of 21 CFR in the United States
The PMS standards for American medical device makers are outlined in 21 CFR part 822 by the FDA. The FDA declares that post-market surveillance is necessary for some devices that pose a substantial danger to health, using Section 522 of the Federal Food, Drug, and Cosmetic Act.
PMS is necessary for class II and class III medical devices that fit any of the following criteria:
(a) there is a reasonable probability that the device’s failure will have a serious negative impact on one’s health;
(b) the device is implanted in the human body for a duration longer than a year; or
(c) the device is used to support or sustain life outside of a user facility.
EU 2017/745: MDR in the European Union
The Medical Device Regulation (MDR), which was published by the European Union in 2017, placed more emphasis on post-market surveillance. A post-market surveillance strategy and post-market surveillance procedures are two components of the post-market surveillance system that must be proportionate to the device’s hazards.
– Post-market surveillance reports, like Periodic Safety Update Reports (PSURs) and PMS reports (PMSRs)
Why is post market monitoring crucial?
PMS is significant for several reasons. First, it aids in guaranteeing the effectiveness and safety of medical products after they are marketed. Second, it enables manufacturers to get user feedback in a “real world” environment and adjust their equipment accordingly. Last, post-market surveillance assists producers in adhering to the rules established by regional authorities.
The PMS process monitors and evaluates the quality, performance, and safety of devices. Regulation observance is merely a bonus; determining a device’s long-term safety and functionality is essential. While making a profit and maintaining financial success is the goal for most medical device companies, creating a safe and effective device should be at the center of every business’s operations; PMS shows whether this objective has been met. When properly and routinely carried out, PMS offers producers a chance to connect with consumers and gather input regarding their goods.
Post-market surveillance has been helpful in discovering new applications for products. It makes it possible to enhance product design in response to user input and real-world application in clinical settings. A device that was designed to be used in one area of the body might, for instance, turn out to be useful in another.
It’s critical to understand that clinical studies and PMS are not the same. Before a product is put on the market, clinical trials are carried out to evaluate its safety and effectiveness in limited groups. After a device is introduced to the market, post-market surveillance is carried out to keep an eye on its functionality and safety for the wider consumer base.
Establishing a surveillance system after the market
After discussing PMS let’s look at how to create a productive PMS system. The purpose of your system is to gather information about the functionality and safety of your medical equipment. A PMS system can be configured in a variety of ways, but it should always have these fundamental components:
1. Planning: This entails drafting a PMS plan and putting in place a procedure that makes it possible for you to collect feedback efficiently. First, decide who will be in charge of the PMS operations (typically a member of the quality team or a manager).
2. Data collection: Create methods for gathering user data, for as through post-market research, product complaints, and consumer feedback.
3. Data analysis: After gathering, proceed with any required action. This could entail doing post-market studies, changing the labeling of products, or releasing a recall after analyzing and trending data.
4. Training: Educate the pertinent personnel on your PMS protocols to ensure that insightful input is overlooked or lost.
5. Risk management: It entails taking steps to lessen the dangers connected to your devices. This could entail putting PMS procedures or corrective actions related to field safety into practice. It’s crucial to remember that PMS activities have to be continuing and constant rather than a one-time occurrence.
How to draft a plan for PMS
When necessary, include a PMS strategy in your de novo or pre-market approval application and submit it to the FDA. A comprehensive post-market system must include a PMS plan, which delineates the entire PMS system’s operations.
The following should be included in your PMS plan, along with the dangers related to your device:
• The patient population
• The device’s intended use
• The expected length of usage; the clinical setting; known and complications
You can create a PMS plan that is specific to your device and its intended use by taking these factors into account. The post-market data collection and analysis process, the steps to be taken if safety or performance issues are discovered through post-market studies, and the frequency of planned adjustments should all be included in your strategy.
A PMS strategy ought to be viewed as a dynamic document that is updated whenever new information becomes available. For instance, you should revise your PMS plan to incorporate the new information and make sure the necessary steps are performed if you receive a post-market study report that indicates safety risks with your equipment.
Techniques to Gather PMS Information
The techniques for gathering post-market surveillance data are numerous. User surveys, product registries, post-market clinical follow-up studies, and complaint systems are the most widely used techniques. The patient group, the type of device, and the clinical setting will all influence the approach.
User surveys are an excellent method of gathering information about the functionality and safety of medical devices. They can be used to gauge user satisfaction, learn how people use the gadgets, and spot issues before they become serious. User surveys can be given via the phone, in person, or by mail.
Product registries are informational databases about medical products. They can monitor a device’s performance and safety. A product registry can assess the safety and efficacy of various devices, find any issues with a device, and learn how a gadget is being used in the “real world.”
Studies known as post-market clinical follow-ups (PMCFs) are carried out following a device’s introduction into the market. The efficacy and safety of gadgets can be evaluated with the help of these investigations. When there is little information available concerning a device’s efficacy and safety, or when there are worries about hazards connected to a device, a PMCF study might be warranted.
Systems for complaints
Databases containing information on concerns regarding medical devices are called complaint systems. They can monitor the quantity and nature of complaints as well as spot issues before they become serious. It will be easier for you to make sure that complaints are appropriately recorded, looked into, and handled if your management SOP is compliant.
Focus groups are a type of qualitative study in which a group of people are assembled to talk about a specific subject. Data about gadget performance and safety can be gathered through focus groups. They can determine user needs, detect device issues, and learn how people feel about a gadget.
Social media is a medium that requires post-market surveillance, but it’s not always a means. Keeping an eye on social media gives patients another way to criticize or express satisfaction with a technology. Sentiment analysis can help you determine where any problems can exist and how the public feels about your product in general. Make sure pertinent comments posted on social media platforms are directed into your complaint management system when needed.
Two elements are crucial in the data collection process, regardless of the approach. First and foremost, feedback must be simple for people to submit. Ensure that users can readily submit feedback and that your post-market surveillance system is simple to use. Second, make sure users realize that their feedback is confidential and urge them to be honest in their responses.
Examining PMS information
After gathering post-market surveillance data, it’s critical to examine the information to find issues or potential new applications for your gadget. A review of the data, a statistical analysis of the data to discover trends, and a search of the literature to find any prior reports of related issues should all be included in the analysis. It will go more smoothly during your analysis phase if you remember the following:
1. Have an industrious owner. A qualified person who is conversant with post-market surveillance protocols and actively reviews the data should perform the analysis. Even in the absence of issues, routinely analyze data since it will assist you in spotting issues early on.
2. Steer clear of silos. Gathering PMS data has the drawback of creating silos within a client-facing workforce, such as customer support. Thus, it’s possible that post-market data will never be thoroughly examined by the appropriate parties. Whether in support or in the field, keeping tight relationships with teams who deal with clients is essential to bringing up issues and addressing them.
3. Be aware that finding quick solutions to problems will never be easy. You can execute changes more quickly if you have SOPs and the right training. In particular, you must act quickly if you have to file a complaint with the FDA or any authority in the EEU. Constant attention to detail is necessary to maintain a PMS program, but the insights and advantages make the effort worthwhile.
Reducing risk: PMS’s objective
Following your analysis of the post-market surveillance data, act to resolve any issues that you find. The primary goal of PMS is to uncover hazards you might not be aware of, so keep that in mind when you assess complaints for feedback.
It’s crucial that you routinely and methodically review your risk management files when you gain new information from your PMS activities and update them as needed. Reducing risk could entail altering the device’s design, refining the manufacturing procedure, giving users additional instruction, or carrying out clinical follow-up research after the product is sold. Even though you may not have expected these extra tasks when you first built and launched your product, acting on post-market surveillance data ought to be considered a continuous process throughout the product lifecycle. You may extend the life of your device on the market by taking proactive steps to mitigate risk.
You can always contact our experts and check out how we can help in making a PMS system for your products.