Registry-Based Prospective, Active Surveillance of Medical-Device Safety

Abstract

Background Assuring the safety of medical devices is challenged by reliance on voluntary reporting of adverse events. We evaluated a strategy of prospective, active surveillance of a national clinical registry to monitor the safety of a vascular closure device suspected as potentially associated with increased adverse events. Methods We used an integrated clinical-data-surveillance system to conduct a prospective, propensity-matched analysis of the safety of the Mynx vascular closure device, as compared with alternative approved vascular closure devices, using the National Cardiovascular Data Repository CathPCI Registry. Outcomes were vascular complications including the composite of access-site bleeding, access-site hematoma, retroperitoneal bleeding, any vascular complication requiring intervention or blood transfusion. Results Between 1/1/2011 and 9/30/2013, 73,124 patients receiving Mynx devices used following femoral percutaneous coronary intervention (PCI) procedures were analyzed. When compared with alternative vascular closure devices, the Mynx device was associated with an increased risk of vascular complications (absolute risk [AR]: 1.21% vs. 0.76%; relative risk [RR]: 1.59; 95% CI: 1.42-1.78), access-site bleeding (AR: 0.38% vs. 0.28%; RR: 1.34; 95% CI: 1.10-1.62) and transfusion (AR: 1.82% vs. 1.48%; RR: 1.23; 95% CI: 1.13-1.34). The initial alerts occurred within the first 12 months of monitoring. Relative risks were greater for three prespecified high-risk subsets (diabetics, elderly patients and women). These safety signals were confirmed in an independent sample of 48,992 cases between 4/1/14 and 9/30/15. Conclusions A strategy of prospective, active surveillance of a clinical registry was capable of rapidly identifying potential safety signals following use of an implantable medical device.

Quantifying the utilization of medical devices necessary to detect postmarket safety differences: A case study of implantable cardioverter defibrillators

“…Surveillance methods that mirror automated systems have been developed for medical device surveillance that leverage medical product registry data, and FDA recently supported planning of the National Evaluation System for health Technology and proposed development of the National Medical Evidence Generation Collaborative . Key questions remain as to the potential effectiveness of a real‐time active surveillance system to detect safety differences among medical products.…”

“…1 While the Sentinel Initiative has been successful in performing analyses to investigate drug safety, a real-time system that proactively monitors all approved drugs and devices has not been developed, but remains an aspiration. 2,3 Surveillance methods that mirror automated systems have been developed for medical device surveillance that leverage medical product registry data, [4][5][6][7][8] and FDA recently supported planning of the National Evaluation System for health Technology 9 and proposed development of the National Medical Evidence Generation Collaborative. 10 Key questions remain as to the potential effectiveness of a real-time active surveillance system to detect safety differences among medical products.…”

Can machine learning complement traditional medical device surveillance? A case-study of dual-chamber implantable cardioverter–defibrillators

“… 8 Current medical device surveillance efforts to address these issues include mandatory reporting of certain device-related adverse events and miscellaneous product problems to the US Food and Drug Administration (FDA) Manufacturer and User Facility Device Experience program, the hospital-based Medical Product Safety Network, and required postmarket surveillance studies. Although each has well-described limitations, 9 – 12 data from these sources have contributed unique insights that have helped to inform patient and physician decision-making and improve quality of care. In particular, required studies and registries offer an opportunity to collect detailed information about patients, procedures, and devices not routinely collected by electronic health records or administrative claims data.…”

Trust and transparency in medical device regulation

“…These include greater reliance on medical device registries to capture key procedural, comorbidity, and outcome data, introduction of “unique device identifiers” to streamline tracking of devices,8 and development of statistical methods to identify safety signals 9…”