Working on a medical device doesn’t end once it’s been introduced to the market. In fact, responsible medical device management involves recurring actions throughout its lifecycle. One critical aspect of pharmacovigilance is Post-Marketing Surveillance (PMS).
PMS is defined as an ongoing risk review and analysis throughout the lifecycle of the medical device. Post-marketing surveillance includes all activities carried out by manufacturers, government agencies, and other bodies to collect and review patient experiences with medical devices.
What are the Benefits of a Properly Executed PMS?
Medical devices, regardless of class, are approved and released based on a limited set of interactions with patients. Even the most extensive evaluations cannot include the complete set of possibilities and extenuating factors a medical device will encounter over its lifecycle, so establishing and maintaining a continual review process ensures the best possible chance that any potential problems are detected and addressed as early as possible. When these methods are incorporated into redesign efforts, medical devices can continually evolve and provide the best patient care.
An effective PMS lowers the overall risk profile of a medical device by actively and passively collecting device use information. As new data becomes available and treatment limitations are more clearly understood, manufacturers and physicians can utilize that information to identify how and when the device should be used more accurately.
Articles 85 and 86 of the European Union’s Medical Device Regulations (MDR) identify some of the primary ways data gathered under a PMS can be used, allowing manufacturers to:
- Modify or revise risk to benefit ratios and modify risk management as needed;
- Revise the design, manufacturing information, or manufacturing processes as applicable. This can include any revisions for user instructions or device labeling;
- Revise clinical evaluation and medical device performance evaluations;
- Update summary of safety and clinical performance;
- Identify and implement any corrective and preventive actions (CAPAs);
- Identify options for improvement of medical device usability, performance, and/or safety;
- Collect and establish extensive trend reporting
Although an effective PMS is a regulatory requirement, medical device manufacturers should view it as so much more than simply that. It also is an opportunity to continually review data regarding the device’s use and improve patient safety, device efficacy, and even manufacturing efficiency. Additionally, reduced risk profiles decrease the possibility of litigation.
What Governs the PMS Process?
There are different PMS requirements for both the United States and European Union, but they have similar standards. The overall process is fundamentally the same: an ongoing review of use data to drive potential improvements in device design and use.
In the United States, the Food and Drug Administration (FDA) is entrusted with overseeing the post-marketing surveillance process. Many individual tasks are required of the manufacturer; the FDA does not actively participate in most aspects of data collection but periodically audits manufacturers to ensure compliance. However, for any devices with premarket approval (PMA) or 510(k) submissions/approvals, the FDA can require manufacturers to actively conduct post-marketing studies to ensure patient safety.
It’s essential to clarify the difference between “post-marketing requirements” and “post-marketing commitments” since both are used in the PMS process.
Post-marketing requirements are those studies and surveillance activities explicitly required by the FDA. In contrast, post-marketing commitments are trials or studies that a manufacturer has promised to conduct but is not required to.
One FDA mechanism is a passive surveillance system known as MedWatch. Patients and physicians alike can voluntarily report any adverse interactions with medical devices to this database, and it’s an important source of information for manufacturers. The FDA also has two overlapping programs that govern active attempts to collect and review information on regulated devices: Total Product Life Cycle (TPLC) and Idea Development, Exploration, Assessment, and Long-term Study Framework for Devices (IDEAL-D).
In Europe, neither the European Medical Devices Directive (MDD), the Regulations for Active Implantable Medical Devices (AIMD), nor the In Vitro Diagnostic Medical Devices Directive (IVDD) formally define PMS requirements, they do recognize it as a vital aspect of medical device design and manufacturing. Its execution is assumed for every medical device. Over the past few years, pressure has mounted to define PMS requirements explicitly, and this will likely occur soon.
What Does Post-Marketing Surveillance Look Like?
PMS mechanisms can be divided into two broad categories: active and passive. In the former, manufacturers engage in actions such as customer surveys, post-market clinical trials, monitoring medical device tracking/implant registries, patient follow-ups, and conducting focus groups. Any activity where the manufacturer proactively attempts to collect information regarding device use is an active expression of PMS.
Reactive mechanisms are just as important as active attempts. These can include user/customer complaints, unsolicited user feedback (either through formal channels or via avenues such as social media), and literature reviews by medical authorities. Established routines also provide valuable information, and manufacturers can glean quite a bit of data by reviewing device service and maintenance reports. In-house testing and validation during the manufacturing process is another critical source of feedback.
Understanding the difference between surveillance and vigilance is vital. While post-marketing surveillance covers all mechanisms by which information is collected—active and passive—vigilance is a subset of passive actions. Whenever a device fails to perform to its intended standards, regulatory agencies in the US and EU require manufacturers to have a systematic process to review the data and take any identified actions in a timely manner.
When information leads manufacturers to change something, they have several tools at their disposal. Two of these include field-safety corrective actions and recalls, depending on whether the identified issue can be addressed within a manufacturing setting or elsewhere. Additionally, part of a sound PMS system is outlining corrective actions and preventive actions (CAPAs) when appropriate to address any problems permanently.
What Should a PMS Include?
Ideally, solid post-manufacturing surveillance should begin 18 to 24 months before market introduction with a quality management system (QMS). When manufacturers do this, it allows them to establish, then continuously update and improve their procedures. By the time commercialization and distribution begins, all that is necessary is continuing an established process.
Formal reviews of all available information should be conducted least annually, although best practices indicate assessments should be performed at least quarterly. For medical devices that have been recently released, manufacturers should consider increasing the frequency to monthly evaluations for the first year. These reviews should focus on answering three primary questions:
- Are changes required to the medical device design itself, including the manufacturing process?
- Are changes required to instructions regarding the clinical usability, performance, or safety?
- Has the definition of risk changed based on the new information?
These questions should be revisited at every review. As a medical device becomes more well established, PMS review frequency can decrease; however, it should continue to occur on at least an annual basis throughout the lifecycle of the medical device.
Reviewing the Overall PMS Process
Post-manufacturing surveillance is an ongoing risk review and assessment process that should begin well before the device is introduced to the market and continue throughout its lifecycle. The overarching goals include optimizing device design and use instructions based on user/customer/physician feedback, which can include everything from how the device is constructed to its labeling.
Data can and should be collected via active and passive sources, with periodic reviews occurring frequently (possibly monthly) when a new device is commercialized and at least annually until the device’s end of life. Establishing a consistent quality management system during the device design phase forms the structure for a quality PMS process.
Keep in mind that although the FDA and EU both have regulatory requirements that relate to post-manufacturing surveillance, the real value of PMS is found in how it can help manufacturers improve medical devices. A well-executed PMS process will raise patient care while decreasing the chance of medical misuse and possible litigation.
