FDA Surveillance Project

Optimizing Medical Device Post-Market Surveillance for Public Value

Overview

The surveillance of medical devices is intended to provide critical information to all relevant stakeholders about device safety, long-term product performance, and effectiveness in improving patient outcomes. However, we are far from this ideal system. Instead, we rely largely upon voluntary reporting systems from providers, health care facility networks, industry, and claims-based or other health care practice databases to characterize risks and benefits of devices in the post-approval environment. There are many shortcomings of these current surveillance systems, and there are no common methods to define the safety signals or the underlying relationships between device, or machine, failure and clinical events. Moreover, single registry efforts are inefficient and not scalable. Electronic health record or claims-based systems currently do not contain the detail needed for longitudinal device evaluation and patient follow-up with outcome assessment.

The prospective registry format, with attention to epidemiological study principles of cohort assembly, data collection, and appropriate analysis and inference, has the potential to remedy some of the problems facing medical device surveillance in the United States. A prospective registry network, leveraging data collection and analysis processes capable of monitoring several devices across health care facilities, may be the most effective and efficient surveillance model given our current level of system integration. For such a registry surveillance network model to achieve its promise of accurate, timely and useful dissemination of product performance to the public, many critical issues need to be addressed. To ensure the best research methods, objective data collection, prioritization of which devices to survey under resource constraints, as well as generation of the credibility and trustworthiness to ensure that no single entity is setting standards alone, we need a collaborative surveillance registry network, forging a partnership between industry, academic institutions, patient groups, government agencies, and other stakeholders to overcome surveillance system challenges.

Aims of the Surveillance Project

Yale University, in partnership with Medtronic, Inc., has been selected to receive a five-year cooperative agreement from the U.S. Food and Drug Administration (FDA). The focus of this collaborative is to develop methods and facilitate best practices for medical device surveillance. The cooperative agreement is designed to address the following specific aims:

  • Produce a generalizable surveillance framework, policies, and procedures to guide collaboration among private industry, regulators, and academic partners.
  • Develop strategies to promote transparency and maintain integrity through sharing of device, clinical and quality data among clinical investigators and other stakeholders.
  • Develop novel research methodological approaches to data collection (including device follow-up and Unique Device Identification (UDI) compliance), signal detection, and data analysis that address the current deficiencies that undermine existing medical device surveillance systems.
  • Seek efficiencies in the application of the new systems so that they can be pursued as inexpensively as possible.
  • Interact with the Medtronic Post Approval Network (PAN) Advisory Board, investigators and Medtronic business units to explore collaboration models and stakeholder concerns, both within PAN and external to PAN, and test collaboration processes, acceptance, and willingness to develop a stakeholder-based system of medical device surveillance.