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policy 0165 : Medical Device Failures and Safe Medical Devices Act Reporting

In the event of a medical device malfunction or failure, health care providers shall use their best clinical judgment to immediately address patient needs and, in emergent situations, support the patient manually or employ alternative equipment. The Safe Medical Devices Act mandates that incidents in which a Medical Device has or may have caused or contributed to a patient's death, serious illness or injury be reported to the FDA and/or to the manufacturers of the devices. This law also requires that healthcare facilities track information on certain implantable and life-support devices and report this information to medical device manufacturers.

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view  |  PDF document icon 0165 Medical Device Failures and Safe Medical Devices Act Reporting.pdf — PDF document, 233 KB (239175 bytes)


  1. effective date:

    March 1, 2020
  2. signature(s):

    Chief of Quality and Performance Improvement