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Overview :
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.
Definitions used by the FDA:
(1) medical
device: instrument, apparatus, implant, in vitro agent or other similar or
related article or component used in the prevention, diagnosis, treatment
and/or care of disease.
(2) device
failure: if a device fails to perform as required or if it does not function
within its specifications
(3) device
related incident: if the incident results from the device being operated in an
incorrect manner. This includes power failure or operator error.
(4) patient
adverse reaction: when the patient has an adverse reaction and the device is
being properly used.
Reportable incidents:
(1) All events
involving patient injury or death if the probability exists that the event was
caused or contributed to by a medical device or drug interaction.
(2) Patient adverse reactions do not need to be reported to
the FDA.
All healthcare personnel have the responsibility for
reporting an incident, even if not personally involved.
Actions to be taken:
(1) The device
must be removed from use immediately.
(2) The device
is to be sent for evaluation to the biomedical engineering department or other
qualified facility, with all pertinent device documentation.
(3) A complete
event report is to be completed, documenting all relevant details of the
occurrence including patient specifics.
(4) The
completed report need to be sent to the appropriate action office within 48
hours of the incident.
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