Post-Market Active Surveillance and Health Economic Evaluation of Cerebrovascular Diagnostic and Therapeutic Devices

Overview

The research focuses on "post-market active surveillance and health economic evaluation of non-pharmacological therapies and innovative cerebrovascular diagnostic and therapeutic devices". Partnering with top-tier domestic institutions including the National Medical Administration Center, Regional Drug Evaluation Center, Beijing Tiantan Hospital, Capital Medical University, The First Affiliated Hospital of Naval Medical University, The First Affiliated Hospital of Harbin Medical University, and the School of Public Health, Fudan University, the project intends to: Establish standards for post-market active surveillance of cerebrovascular diagnostic and therapeutic devices and develop an intelligent surveillance system; Build a nationwide collaborative network covering multi-level medical institutions, and conduct serial cohort studies on cerebrovascular diseases based on the surveillance platform; Carry out safety, effectiveness and health economic evaluations for cerebrovascular diagnostic and therapeutic devices using data collected from the network and platform, so as to provide scientific evidence for the full-life-cycle regulation of such devices.

Cerebrovascular disease is the leading cause of disability and adult mortality in China,with a high overall incidence. The rapid advancement and widespread application of neurointerventional techniques have driven an annual increase in the volume of cerebrovascular interventional procedures. Consequently, various cerebrovascular diagnostic and therapeutic devices-including multiple domestically developed innovative devices-have gained market approval following pre-market clinical trials,thereby expanding clinical treatment options. However, pre-market studies are often limited by small sample sizes, restricted population representativeness, short observation periods, and highly controlled clinical environments, making it difficult to fully evaluate device performance in real-world clinical settings. Therefore, strengthening post-market device regulation and establishing a comprehensive post-market active surveillance system are critical. These measures are essential for the timely detection and management of clinical risks,ensuring patient safety, accumulating real-world data (RWD), and supporting the optimization of health policies and healthcare reimbursement decisions. China has long prioritized the post-market surveillance of medical devices. Since initiating a pilot program for medical device adverse event (MDAE) monitoring in 2002, China successively promulgated the Measures for the Monitoring and Re-evaluation of Medical Device Adverse Events (Trial) in 2008 and the revised Measures for the Monitoring and Re-evaluation of Medical Device Adverse Events in 2018 to strengthen device surveillance. Furthermore, the newly revised Regulations on the Supervision and Administration of Medical Devices (State Council Decree No.739 of the People's Republic of China), promulgated in 2021, emphasize full-lifecycle, full-process and full-chain oversight of medical devices. Throughout this progression, China has established the Medical Device Adverse Event Reporting and Management System, anchored by provincial MDAE monitoring centers. This system enables medical institutions and manufacturers that identify adverse events to submit reports, increasing the volume of adverse event submissions and improving risk monitoring and control capacity. However, it is notable that China's existing post-market regulatory framework for medical devices still faces a significant challenge: the lack of an active surveillance system. The current reporting system, which designates medical device registrants as the primary responsible entities, is voluntary rather than mandatory. This inevitably leads to inherent flaws such as low reporting rates, high misreporting rates, the inability to calculate true incidence rates, and delayed signal detection. Consequently, the real-world safety, effectiveness, and health economics of medical devices cannot be comprehensively evaluated, posing potential risks to public health safety and the efficient utilization of healthcare resources. Therefore, it is imperative to transition from a passive surveillance model to an active surveillance paradigm characterized by proactive data collection and active outcome analysis. Although active surveillance takes various forms, conducting real-world active surveillance based on healthcare data has become a prevailing trend. This is driven by the enhanced integration and application of healthcare data, alongside continuous advancements in analytical techniques. For instance, in 2012, the U.S. Food and Drug Administration (FDA) initiated the Medical Device Epidemiology Network (MDEpiNet)-a multi-stakeholder collaborative platform involving healthcare institutions, academic organizations, device manufacturers, and patient advocacy groups. This initiative aims to conduct surveillance research by sharing resources across network members and integrating RWD, including electronic health records (EHR), cohort studies, and healthcare claims data. In recent years, China has initiated pilot programs for active post-market surveillance of medical devices (i.e., the medical device vigilance system) in regions such as Jiangsu, yielding preliminary results. Overall, however, the implementation of real-world evaluation still faces significant challenges: 1. Lack of a unified national surveillance system: Inefficient cross-hospital collaboration hinders standardized data integration and creates isolated information silos. 2. Absence of a multi-center collaborative network: The surveillance framework is solely regulator-led, leaving healthcare institutions (core data providers) with insufficient incentives for active data submission and early risk alerting. 3. Deficient long-term follow-up workflows: Incomplete longitudinal follow-up data limits the availability of health economic evidence to support healthcare policy design. China has unique national conditions: a vast territory, large population, heterogeneous regional epidemiological profiles, and unbalanced socioeconomic and healthcare resources. Combined with the broad clinical adoption of post-market cerebrovascular devices (domestic innovative devices in particular) and the massive volume of real-world data they generate, the above challenges will be further exacerbated when rolling out nationwide active surveillance. Therefore, the successful implementation of active medical device surveillance tailored to China's context relies on several key strategies: First, coordinating inter-hospital collaboration through departments with core advantages in cross-sector coordination to construct a national system and achieve data harmonization across medical institutions.Second, empowering medical institutions as the primary executing entities of active surveillance by leveraging specialized academic influence to build collaborative networks and research-sharing mechanisms, thereby incentivizing institutional participation.Third, establishing research cohorts with standardized disease follow-up protocols to acquire robust long-term follow-up data for comprehensive longitudinal and health economic evaluations.