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.
