While manufacturers are generally responsible for initiating medical device recalls, providers are usually best positioned to identify and notify affected patients and quarantine identified devices. Without an effective recall system, providers may be exposed to lawsuits and be in violation of federal Medicare billing regulations.
In "A Provider's Guide to Managing a Medical Device Recall," published in the February 2018 issue of the American Health Lawyers Association's Journal of Health & Life Sciences Law, Day Pitney's Erin Magennis Healy, Lori J. Braender and Thomas A. Zalewski offer practical tips for staying informed of FDA recalls, tracking recalled devices, and communicating with affected patients. The full article is available here.
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