The FDA often requires some sort of post-market surveillance for medical devices to determine the long-term safety and effectiveness of products. In the past, FDA predominantly required passive surveillance that is reliant on self-reported adverse events, but due to the difficulty in collecting this information from providers and patients who have to voluntarily submit the data, they are moving towards active surveillance that utilizes healthcare data to detect and verify safety signals. A Congressional report found that active surveillance “may decrease the burden on regulated entities, provide information in real time, and provide more complete information about a device’s overall safety and effectiveness.”
Real-world data (RWD) from sources such as medical claims, electronic medical records (EMRs) and hospital chargemasters offer an avenue for active surveillance, however, this is not without its challenges. The Congressional report stated that, “data on medical devices comes from ‘disparate data sources with variable data elements, data definitions, data quality and frequently from only limited subsets of patient exposures.” Most importantly, it can be difficult to determine what type of device a patient received using RWD.
While ICD-10 codes indicate the procedure a patient underwent, the brand of the device used is not recorded in claims data or EMRs. Hospital chargemaster data does have text fields where device information, such as SKU, DeID, model or serial numbers may be recorded, but with the inconsistencies in how this data is reported, it can be difficult to decipher which product was used.
With the nation’s largest, fully interoperable healthcare data ecosystem, consisting of over 200 billion de-identified transactions for more than 330 million patients, HealthVerity is able to overcome these challenges, offering research-ready, privacy-protected healthcare data in a common data model. Because our vast data ecosystem is completely interoperable, using unparalleled identity management to accurately resolve patient identity across the entire ecosystem, any of the more than 75 data sources can be seamlessly synchronized with each other or a client’s proprietary data to provide a comprehensive view of the patient journey. Additionally, the relationships we’ve built with each of the leading data owners in the ecosystem, enables us to offer complete transparency and data provenance so that you know the quality of the data and how it was obtained. Key to monitoring medical devices, our RWD experts have the knowledge and abilities to efficiently sift through the data points and discover patients receiving particular products.
A global leader in patient-focused medical interventions for heart disease wanted to better understand the long-term outcomes for patients receiving their heart valve product during a Bentall procedure compared to other similar products used to repair or replace the aortic valve when there is damage. To conduct this research, the client needed to discover patients who underwent a Bentall procedure, as well as which aortic valve product they received.
The RWD experts at HealthVerity were able to use text string searches to discover patients receiving the nine aortic valve products of interest to the client, including their own, during a Bentall procedure within hospital chargemaster data and seamlessly synchronize that data to medical claims data for a comprehensive view of the patient journey.
HealthVerity discovered RWD for 18,000 patients undergoing a Bentall procedure, providing the client with data on 2,000 patients meeting their criteria of receiving their aortic valve or one of eight different competitor products.
Previously, the client had been unable to determine if patients received their aortic valve or a competitors. With the expertise and vast healthcare data ecosystem provided by HealthVerity, this client was able to gather new insights that allowed them to determine the long-term safety and efficacy of their product compared to others on the market.
To learn how HealthVerity can help you power active medical device surveillance: