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Understanding Medical Device Recalls

Morabito, Kenneth PhD; Marion, Jill MS, MBA

doi: 10.1097/JCE.0000000000000102
FEATURE ARTICLES
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Clinical engineers play an important part in helping hospital staff to understand medical device recalls. Thus, it is important for them to understand the nuances of the recall process and where they serve a key role. We review what constitutes a recall and several important subcategories of the recall process critical to understanding the whole process. Clinical engineers are better equipped to keep patients safe through their own involvement and awareness of medical device recalls.

Corresponding author: Kenneth Morabito, PhD, Division of Patient Safety Partnerships, Office of Surveillance and Biometrics, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Avenue, Silver Spring, MD 20993 (Kenneth.Morabito@fda.hhs.gov).

Kenneth Morabito, PhD, is a biomedical engineer with the FDA’s Division of Patient Safety Partnerships within the Office of Surveillance and Biometrics, Center for Devices and Radiological Health.

Jill Marion, MS, MBA, is a biomedical engineer and the director of FDA’s Division of Patient Safety Partnerships within the Office of Surveillance and Biometrics, Center for Devices and Radiological Health. She is also the director of FDA’s Medical Product Safety Network (MedSun). She can be reached at Jill.Marion@fda.hhs.gov.

The authors declare no conflicts of interest.

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