Even after releasing a medical device onto the market, a manufacturer must monitor the performance of the device to ensure a high standard of product quality and safety as well as to satisfy regulatory requirements. In major markets like the United States and Europe, postmarket surveillance is a regulatory requirement for medical device companies.
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Postmarket surveillance consists of processes and activities for monitoring the performance of a medical device. Utilizing assessments of products throughout their lifecycle, these activities are designed to generate information regarding use of the device to track performance and identify areas in need of improvement or modification.
Manufacturers generate a lot of information from multiple sources throughout the lifecycle of a medical device. The proliferation of data and accessibility to data sources have afforded significant opportunities to manufacturers that can proactively collect, analyze and act on device performance. For manufacturers that are more reactive, however, the same elements have also made it more challenging to both filter through the greater volume of information and determine which data is truly valuable.
Despite having access to an abundance of data, many companies fail to take full advantage of that data to improve product safety and drive better health outcomes. Those that do through automation stand to gain substantial business and operational benefits.
Postmarket surveillance generally occurs in three phases – data collection, data analysis and data routing – each of which brings improvement opportunities through automation.
Data collection – Important sources of postmarket feedback include clinical studies, electronic health records, internal quality data like nonconformances, patient-generated information and more. As a regulatory requirement, however, manufacturers are expected to gather, review and evaluate complaints. Every product complaint, received from any source, must be appropriately investigated and, when necessary, corrected. If a complaint indicates a risk of serious injury or death, it constitutes a reportable event that must be submitted through medical device reporting (MDR).
MasterControl Customer Complaints software helps organizations gather, investigate and process complaints, and helps them in the MDR process. Automating all complaint-related tasks with the robust customer complaint management software creates a unified, closed-loop management system for tracking complaints across processes, departments and locations. Ultimately, the solution helps boost product quality and safety, increase customer satisfaction and ensure regulatory compliance.
Data analysis – After it has been collected, postmarket surveillance data must be analyzed. Corrective and preventive action (CAPA) and risk analysis are key components of the data-analysis phase. If a complaint or nonconformance is determined to be a systemic issue, the CAPA process must be employed, a root-cause investigation conducted and a risk analysis performed. The data collected during these processes must be trended. Done manually, data aggregation and trend analysis can be tedious and time-consuming.
MasterControl’s CAPA and Risk solutions help manufacturers track and trend critical quality events and risk-related information. Replacing a paper-based CAPA system with MasterControl CAPA automates the delivery, escalation and approval of CAPAs and other quality-related documentation, while the robust risk management system enables organizations to evaluate critical events more thoroughly and appropriately assess the success of corrective measures.
Data routing – After the postmarket intelligence has been collected and analyzed, the results must be put to use. To act on the investigation and analysis of data, it is important to effectively and efficiently deliver the collected information to personnel who can use the results to improve processes and products. The key is to systematically route the information to the “points of use” where it can be utilized to create knowledge bases, in addition to conducting the baseline MDR required by regulators.
With an efficient electronic solution, adverse events can be reported quickly and consistently, and all MDR event files can be documented and maintained in a centralized repository. MasterControl eMDR streamlines reporting and submission of MDR data to the FDA, maintains a summary log of the types of events that have and haven’t been reported, and provides the information to the proper channels so that all MDR decision makers are connected and informed.
To learn more about how to use automation in postmarket surveillance successfully, view the webinar above or contact contact a MasterControl representative.