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Reporting & Handling Medical Device Failures

Purpose:

To report to the FDA all incidents in which a medical device failure resulted in the injury, illness or death of a patient.

Specialty:

General content (available to all)

Objective:

failure handling (loss to followup, etc)

ICD-10:

Y40-Y84

Description:

The Safe Medical Device Act of 1990 and other laws give the Food and Drug Administration (FDA) authority to regulate medical devices.  Healthcare facilities must report all instances of a medical device failure causing serious illness, injury or death.

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