JMIR Publications

ABSTRACT

There are over 8 million central venous access devices (CVAD) inserted each year, many of which in patients with chronic conditions who rely on central access for life-preserving therapies. CVAD-related complications can be life-threatening and add tens of billions of dollars to healthcare costs, while their incidence is most likely grossly mis- or under-reported by medical institutions. In this communication, we review the challenges that impair retention, exchange, and analysis of data necessary for meaningful understanding of critical events and outcomes in this clinical domain. The difficulty is not with data extraction from electronic health records, national surveillance systems, or other health information repositories where data might be stored. The problem is that reliable and appropriate data is not recorded, or falsely recorded, at least in part because policy, payment, penalties, and workflow burden discourage completeness and accuracy. We provide a roadmap for development of healthcare information systems and infrastructure that address these challenges, framed within the context of research studies that build a framework of standardized terminology, decision support, data capture, and information exchange necessary for the task. This roadmap is embedded in a broader Coordinated Registry Network Learning Community, and facilitated by the Medical Device Epidemiology Network, a Public-Private Partnership sponsored by the U.S. Food and Drug Administration, with the scope of advancing methods, national and international infrastructure, and partnerships needed for the evaluation of medical devices throughout their total lifecycle.