Secondary Logo

Institutional members access full text with Ovid®

Share this article on:

Mandatory Medical Device Reporting, MedSun, and MedWatch: What Are the Differences?

Markwell, Sherry K. MM, BSN, RN, CPHRM

doi: 10.1097/JCE.0b013e31829a2ba7
FEATURE ARTICLES

You may have heard the terms Mandatory Medical Device Reporting, MedWatch, or MedSun (the Medical Product Safety Network) during your career in the medical field, but do you know what they are, and do you know the differences between them? All device reports are received and analyzed by the Food and Drug Administration’s Center for Devices and Radiological Health. However, there are some distinctions between the 3 types of reporting programs. Refer to the Table 1 below for a comparison of reporting types.

You may have heard the terms Mandatory Medical Device Reporting, MedWatch, or MedSun (the Medical Product Safety Network) during your career in the medical field, but do you know what they are, and do you know the differences between them? All device reports are received and analyzed by the Food and Drug Administration’s Center for Devices and Radiological Health.

From the Food and Drug Administration in Silver Spring, Maryland.

Corresponding author: Sherry K. Markwell, MM, BSN, RN, CPHRM, Food and Drug Administration, Silver Spring, MD (sherry.markwell@FDA.HHS.gov).

Sherry K. Markwell, MM, BSN, RN, CPHRM, is a nurse consultant at the Food and Drug Administration in Silver Spring, Maryland.

The author declare no conflicts of interest.

© 2013 Wolters Kluwer Health | Lippincott Williams & Wilkins.