A collection of tools and resources for the MDEpiNet community.
Cardiology
- Integrating the Healthcare Enterprise (IHE) Cardiology Profiles
- National Cardiovascular Data Registry® (NCDR) Implantable Cardioverter Defibrillator (ICD) Registry™ V2.1 Coder’s Data Dictionary
- ACC/AHA/SCAI 2014 Health Policy Statement on Structured Reporting for the Cardiac Catheterization Laboratory: A Report of the American College of Cardiology Clinical Quality Committee
- ACCF/AHA 2011 Key Data Elements and Definitions of a Base Cardiovascular Vocabulary for Electronic Health Records: A Report of the American College of Cardiology Foundation/American Heart Association Task Force on Clinical Data Standards
- Most Frequent Operating Room Procedures Performed in U.S. Hospitals, 2003-2012
Informatics
- Integrating the Healthcare Enterprise (IHE) Quality, Research, and Public Health Technical Framework Supplement: Structured Data Capture (SDC)
- Office of the National Coordinator (ONC) Structured Data Capture (SDC) Initiative
- Clinical Data Interchange Standards Consortium, Inc. (CDISC) Healthcare Link Profiles
Orthopedic
UDI
- AccessGUDID
- Global Unique Device Identification Database
- Advancement of Innovative Methodologies and Medical Device Specific Infrastructure for Evidence-Based Regulatory Science and Public Health Surveillance: Implementation of Unique Device Identification Demonstration Projects Lessons Learned
- Mercy SUDID Data
- Unique Device Identifiers (UDIs): A Roadmap for effective implementation
- Premier Research Institute – Unique Device Identifier: Implementation Guide
- Learning UDI Community
Device Data Capture Efforts
- Promoting the capture of unique device identification in health care data sources
- Using automated methods and electronic systems for capturing detailed information on medical devices through the Unique Device Identifier
- Acquiring and analyzing data collected and stored within medical devices.
- Developing and implementing databases of clinical attributes for a deeper understanding of medical device design characteristics
- Communicating lessons learned/best practices to inform National Medical Device Evaluation System
Other
Evidence Synthesis
- Evaluating selected medical devices based on public health importance/need and availability of existing data sources
- Obtaining safety and effectiveness estimates throughout the total product life cycle
- Developing and applying modeling techniques to enhance understanding and context of medical device benefit/risk balance
- Translating the results of modeling for regulators, physicians and patients and disseminate the results
- Communicating lessons learned/best practices to inform National Medical Device Evaluation System
Comparative Effectiveness/Safety
- Adapting existing patient centered total product life cycle framework to evaluate selected medical devices
- Accounting for comparator selection, device characteristics, operator characteristics, procedure/intervention characteristics, intervention setting characteristics, patient characteristics and appropriate outcome measures selection
- Communicating lessons learned/best practices to inform National Medical Device Evaluation System
Analytical Methodologies
- Developing scientifically valid analytical methods for evaluating medical device exposure and clinical outcome characteristics across multiple data sets across different types of data systems
- Utilizing appropriate statistical techniques to compare performance and clinical outcomes between comparator or exposure groups and translate the modeling results for regulators, physicians and patients and publicize the results
- Evaluating existing gaps in approaches to medical device studies of approved medical devices by developing innovative methodologies using existing data sources and infrastructure
- Identifying and describing unique challenges and gaps in studying various classes of medical devices
- Identifying sustainable data and methods for evaluation of selected classes of medical devices
- Validating endpoints/outcomes using variety of data sources
- Communicating lessons learned/best practices to inform National Medical Device Evaluation System