- Any IHS employee, who witnesses, discovers, or otherwise becomes aware of information that reasonably suggests that MDR Reportable Events have occurred, shall immediately report the incidents to their supervisors or department heads or to the facility risk manager.
- The supervisor or department head must immediately report any incidents reported to them by employees to the designated Contact Person for the facility.
- Contact Person Responsibilities.
- The Contact Person shall have overall responsibility for implementing and managing the facility's medical device reporting program. This responsibility shall include establishing and maintaining a facility-wide-system for documenting medical device incidents; providing training and education on the reporting program to all medical personnel; reviewing and analyzing all reported incidents; and completing and submitting appropriate reports to outside agencies. The Contact Person shall be the contact agent for the facility.
- The Contact Person shall convene a team to investigate all incidents involving unexpected death, serious injury, or serious illness of patients to determine whether an MDR Reportable Event has occurred. The results of the investigation should be reviewed by the Risk Management or other appropriate committee, which shall adopt recommendations for corrective action.
- Investigation Team shall consist of:
- The facility risk manager or quality assurance coordinator.
- The Clinical Director (if s/he is directly involved with the incident, the Service Unit Director will designate a substitute).
- The Director of Nursing (if s/he is directly involved with the incident, the Service Unit Director will designate a substitute).
- The Area Clinical Engineer (Area Biomedical Engineer) or facility Biomedical Engineer/Engineering Technician.
- The Safety Officer.
- The Contact Person shall be responsible for submitting appropriate reports to the FDA and/or the medical device manufacturer in accordance with Federal law and regulations.
- The Contact Person shall ensure that all data collected from the facility's medical device reporting program shall be incorporated into the facility-wide incident reporting program. The information will be communicated to administration, the safety committee, Area Office, and all device users on a need-to-know basis. Patient identifiers will remain confidential.
- The Contact Person shall be responsible for the development and upkeep of a Device Incident File for SMDA reportable incidents (see Investigation 6.B.6 of this circular).
- The Attending Physician.
The attending physician shall have the responsibility of informing the patient, and/or the patient's family whether or not a medical device has contributed to the death, serious illness, serious injury, or other significant adverse experience of the patient. The timing and manner of the notification is left to the discretion of the attending physician.
- The Clinical Director.
The Clinical Director shall be responsible for the medical aspects of the investigation, i.e., determining the seriousness of the illness or injury as defined in the SMDA.
- Facility Biomedical Engineer/Engineering Technician.
The facility Biomedical Engineer/Engineering Technician shall obtain relevant information regarding previously reported hazards, recalls, and problems with respect to incident-related devices through contact with the FDA
- The Service Unit Director.
The Service Unit Director (or Public Law 93-638 Program Director) has the responsibility to ensure that his/her facility is in compliance with Federal SMDA regulations.