PMS is one of the most critical tools to ensure that medical devices are safe, effective, and of quality once they enter the market.
With the enhanced complexity of healthcare delivery systems and a growing priority on patient safety issues, the use of real-world data (RWD) has become revolutionary for PMS.
RWD through electronic health records (EHR), claims databases, patient registries, and even wearable devices provides actual real-time dynamic and comprehensive knowledge on how medical products perform under everyday conditions.
A PMS system, which is a component of the manufacturer’s Quality Management System (QMS) and must be set up proportionately to the product’s risk, must be incorporated with every medical device.
Article 83 of MDR specifies the post-market surveillance systems under the new regulatory regime. Each manufacturer shall plan, establish, document, implement, maintain, and update a PMS system for every medical device.
The system is to be designed and documented in a PMS plan and then constantly updated according to a structured assessment of how well it is working and an analysis of the data it has provided.
For the PMS to verify device performance and safety or start the Corrective and Preventive Action (CAPA), the pertinent data must be gathered and examined.
PMS Plans create a systematic and proactive method to gather PMS data to describe the device’s performance and assess how well it performs in comparison to other similar devices available on the market.
The description of data collection and analysis, the synopsis of data-gathering techniques about related QMS procedures, and the analysis techniques, including quantifiable outputs, are all included in a PMS plans.
There are several sources of information that may be useful in PMS, including:
- serious incidents and field safety corrective actions.
- non-serious incidents and undesirable side effects.
- trend analysis and reporting.
- pertinent data from literature, databases, and registers.
- feedback from users, distributors, and importers.
- publicly available data about similar medical devices.
A good PMS system will monitor the safety and performance of a medical device through two complementary domains. One is Post-Market Clinical Follow-up (PMCF) which involves the design and conduct of clinical studies to proactively and continually assess device safety and performance.
Another one is vigilance systems, which monitor and react to complaints, adverse events, media reports, serious incidents, and Field Safety Corrective Action (FSCA).
PMCF generates Real World Evidence (RWE) on safety and performance by continuously collecting clinical data throughout the device’s clinical lifetime.
Clinical evidence derived from observational data on the actual use of medical devices is known as Real World Evidence (RWE). RWE relates to experience with a device in all contexts and with all types of patients/users who are typically exposed to the device, which sets it apart from data generated by formal clinical trials.
RWE studies frequently have no time restriction and continuously add new participants to the dataset.
Real-world data may include information regarding any serious incidents or adverse effects, patient registries, medical device feedback, claims, and patient-reported outcomes. Manufacturers may monitor rare adverse occurrences, validate clinical study findings, and get a comprehensive understanding of device performance by utilising this real-world data.
In addition, the PMS plan must outline what is an acceptable way to evaluate the information and data collected.
Afterward, there are to be valid indicators and threshold values for continued review of the benefit-risk balance and possible amendments to the risk management system.
The PMS plans includes indicators and thresholds that allow for constant risk management as well as for the continuous assessment of risk-benefit analysis.
Proactive post-market surveillance by manufacturers can lead to earlier discovery of trends or potential risks, lowering the chance for adverse events to occur. The PMS also generates safer, more effective medical devices while upholding compliance, combining data gathered from clinical studies, registries, and actual use.
Conclusion
The way in which devices are tracked and assessed has completely changed with the inclusion of real-world data in post-market surveillance strategies. It provides information regarding a variety of populations and long-term effects, which helps manufacturers and regulators to ensure public safety.
For the ultimate benefit of patients and the medical community, the combination of post-market surveillance and real-world evidence in a world of rapidly evolving technology will undoubtedly open the door to more resilient and flexible healthcare systems.
Advanced analytics and teamwork will enable the efficient application of real-world data, perhaps resulting in safer and more efficient medical devices and improved health outcomes for everybody.
Author: Aswathy G (Medical Device Consultant and Clinical Writer)