A revamped National Medical Device Postmarket Surveillance System (MDS) should function as part of the emerging health information infrastructure and incorporate patient experience as part of medical device reporting, recommends a report from the Brookings Institute. The report, commissioned by the U.S. Food and Drug Administration (FDA) and coauthored by former FDA commissioner and Centers for Medicare and Medicaid Services administrator Mark B. McClellan, outlines a seven-year rollout of the new program. During the first two years, FDA should sponsor an "incubator project" that will develop a five-year implementation plan through research and a variety of pilot projects. The plan would be executed during years three through seven, which must address challenges such as "(1) supporting a multi-pronged approach to ensure widespread adoption and use of UDIs [unique device identifiers] in electronic health care data; (2) minimizing the burden of data capture and sharing; (3) developing policies to ensure the protection of patients and their privacy; and (4) building the capabilities to provide value to a broad group of stakeholders." Additional coverage is provided in a February 24, 2015, Healthcare IT News article.

HRC Recommends: A comprehensive medical device recall and hazard management system, including appropriate medical device adverse event reporting as required by law, is a critical component of the risk management process. Working with biomedical engineering colleagues, risk managers should stay up to date with any changes proposed by FDA and prepare to comment when appropriate and ensure compliance as changes are more formally implemented.