Advocacy News
October 13, 2015



AAOS Disappointed in Release of Meaningful Use Stage 3 Final Rules

Bonefied News

Senators Introduce Legislation to Improve Electronic Health Records

What We’re Reading

Senate HIT Hearing

Legislators Introduce Loan Forgiveness Legislation for Pediatric Subspecialists

Risk Evaluation & Mitigation Strategies: Understanding and Evaluating Their Impact on the Health Care Delivery System & Patient Access

PQRS Informal Review Process

Ambulatory Surgery Center Association Meets in DC

MDEpiNet PPP Annual Meeting- October 1 -2, 2015

AAOS Orthopaedic PAC Online Contribution Center


AAOS website

AAOS Calendar

House of Representatives Legislative Activities
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MDEpiNet PPP Annual Meeting- October 1 -2, 2015

The American Joint Replacement Registry (AJRR) attended and presented at the 2015 Medical Device Epidemiology Network (MDEpiNet) PPP Annual Meeting, “Harnessing Evidence from Clinical Experience: Ecosystem-Driven Solutions to Patient-Centric, Device-Focused Information” meeting hosted by MDEpiNet.  The goal of MDEpiNet is to develop tools, data sources, scientific infrastructure, and operational best practices for the implementation of the “National Device Evaluation System.” 

On October 1, there was discussion on MDEpiNet Public Private Partnership Updates & Strategic Priorities and proposed new projects.  The topics that were discussed included “Ecosystem Approaches to Device Evaluation – Back to the Future,” “The MDEpiNet PPP: Who Are We and How We Work?,” and “The MDEpiNet Selected Projects in Motion.”  During the meeting, Mitch Krucoff, MD, shared MDEpiNet’s vision for a medical device evaluation system, stressing the need for flexible regulation, knowledge commons, a national evaluation system and appropriate reimbursement policy. Representatives from a diverse array of stakeholder groups, including Yale University, Medtronic, Inc., George Washing University, Stanford University, Harvard University, Weill Cornell Medical College, Johnson and Johnson and DePuy Synthes also shared their perspectives on a device evaluation and the goals of MDEpiNet, addressing topics such as patient-centered research and perspectives and MDEpiNet updates.

During the afternoon of October 1, there was discussion on “MDEpiNet Collaborations: Developing Strategically Coordinated Registry Networks (CRNs),” where Jeff Knezovich, AJRR Executive Director, presented on AJRR’s contribution to orthopaedic Coordinated Registry Network (CRN).  He provided information on AJRR’s accomplishments as far as collecting 90 percent of all total joint procedures, AJRR becoming a QCDR designated by CMS and their creation of a platform for public reporting.  Registries can provide information on the long-term performance of the device and the health impact on patients.  MDEpiNet is urging the development of a series of CRNs to help monitor the performance of medical devices,  especially those implanted in individuals, and to provide manufacturers, patients, clinicians, regulators and payers with better data on these products.  The last topic of the day included, “Advancing the National System through Optimal Balance between Patient Protection and Transparency:  The Common Rule, Open FDA and Beyond.”  There was a panel of stakeholders from the American College of Cardiology, Cook Group, TMJ Association and FDA that spoke on the registry perspective, industry perspective and patient perspective. 

On October 2, the topics included “Methodologies for Strategically Coordinated Registry Networks (CRNs),” “Evidence Generation and Innovation throughout the History of Medicine,” and Bridging Innovation and Evaluation Internationally.”  To improve both the quality and efficiency of medical device evaluation fundamentally requires eliminating gaps in and fragmentation of device-related data.  There was also discussion on "Building on Current Investments: Expanding Areas of MDEpiNet Programs,” and “Promoting the Inclusion of Device Identifiers and the Global Unique Device Identification Database.”  There is an emphasis on leveraging existing resources and registries, building on those successes through pilot programs, and coordinating these disparate efforts to deliver something that functions as a national system.  Overall, the meeting was well attended.  The ideas and presentations from all stakeholders will be used to improve the “National Device Evaluation System.”