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

In the event of medical device failure, health care providers shall use their best clinical judgement to facilitate continued care of the patient. 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 0165Medical Device Failures and SafeMedicalDevicesActReporting.pdf — PDF document, 64 KB (65924 bytes)


  1. effective date:

    April 1, 2017
  2. signature(s):

    Pamela M. Sutton-Wallace, CEO, UVA Medical Center