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Using BGMs in a Hospital Setting: A Q&A with CAP and CMS - CD

Using BGMs in a Hospital Setting
  • Copyright: 2014

Price: $119.00

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This is a recorded version of an AACC live webinar that was held July 16, 2014. The Food and Drug Administration (FDA) released draft guidance in 2014 that outlined submission requirements for point-of-care (POC) blood glucose meters (BGMs) used in professional settings. During public discussions, questions emerged about the regulatory and accreditation requirements for using these devices in hospitals, particularly when using them for purposes or in populations that are not listed in the product labeling. During this program, representatives from the Centers for Medicare and Medicaid Services (CMS) and the College of American Pathologists (CAP) discuss how each oversees POC BGMs in hospital settings, including:

  • The current requirements associated with these devices;
  • Verifying performance when introducing new meters;
  • Validating POC BGMs for off-label uses;
  • Distinguishing between special general hospital populations and the regulatory responsibilities for each; and
  • Common errors inspectors are finding and how to address them.

A Q&A session from the live webinar is also included on the recording.