PURPOSE. This circular, previously issued in 1993, directs the method by which the Indian Health Service (IHS) will comply with the Safe Medical Device Act (SMDA) of 1990. The requirement that the Area Director report all incidents within the Area to the Director, IHS, is eliminated. This information is a duplication of information provided to the Food and Drug Administration (FDA) and manufacturers.
The IHS will report all deaths, serious illness, or injuries of patients, employees, or persons affiliated with the IHS that are caused or suspected to be caused by a medical device, to the FDA and/or the manufacturer; see Exhibit A, FDA Form 3500A (6/93).
POLICY. Medical personnel and other employees of the IHS who become aware of information that reasonably suggests that a medical device has contributed to a patient's death, serious injury, or serious illness while being treated in an IHS or tribal facility will report the incident as directed by this circular. All IHS and tribal facilities are required by law to comply with the reporting requirements as specified by the implementing regulations of the SMDA.
DEFINITIONS.
1. Medical Device. An instrument, apparatus, contrivance, implant, in vitro reagent, or other similar or related article, including any component, part, or accessory, which is as follows:
  1. Recognized in the official National Formulary, or in the United States Pharmacopeia, or any supplement to them.
  2. Intended for use in the diagnosis of disease or other condition, or in the cure, mitigation, treatment, or prevention of disease in humans.
  3. Intended to affect the structure or any function of the human body, but does not achieve its primary intended purposes through chemical action within or on the human body and is not dependent upon being metabolized for the achievement of any of its intended principal purposes.
  4. Intended for use in the diagnosis of medical conditions other than disease.
  5. Used for in vitro diagnosis, including those products regulated as drugs prior to 1976.
2. Device-User Facility. A hospital, ambulatory-surgical center, nursing home, outpatient treatment facility, or outpatient diagnostic facility that it is not a physician's office.
3. Device Incident Files. Those files containing documents or other information, including medical files and patient records, in the possession of user facilities related to adverse events that may have been caused by a device.
4. Medical Device Reporting (MDR) Reportable Event. The event for which a person required to report under the SMDA has received or become aware of information that reasonably suggests that a device has or may have caused or contributed to a death, serious illness, serious injury, or other significant adverse experience, as determined by the secretary by regulation to be necessary to be reported. This includes the failure of a diagnostic device if information reasonably suggests that a misdiagnosis or lack of diagnosis resulting from the failure has caused or would cause or contribute to a death, serious injury, or serious illness if the malfunction were to recur. This includes events due to user error or failure to service or maintain the device.
5. Serious Illness or Serious Injury. An injury or illness that:
  1. Is life threatening.
  2. Results in permanent impairment of a body function or permanent damage to a body structure.
  3. Necessitates medical or surgical intervention to preclude permanent impairment of a body function or permanent damage to a body structure.
6. Contact Person. An employee of the user facility designated with the responsibility for implementing and managing the facility's medical device reporting program, and with whom the FDA will conduct its correspondence relating to user facility reporting. Examples of individuals who could be designated as a Contact Person include the facility risk manager, quality assurance coordinator, or safety officer.
7. Medical Personnel. Physicians, nurses, biomedical engineers, technologists, and risk mangers employed by the facility. For the purposes of this circular, the term does not include independent contractors.
8. Working Days. Monday through Friday excluding Federal holidays.
AUTHORITY. The Safe Medical Devices Act of 1990 and the FDA regulations implementing the Act. The proposed medical device reporting (MDR) regulations were published in the Federal Register on November 29, 1991 (56FR 60024). The MDR Final Regulation is pending as of the date of this chapter.
RESPONSIBILITY.
1. Service unit.
  1. 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.
  2. The supervisor or department head must immediately report any incidents reported to them by employees to the designated Contact Person for the facility.
  3. Contact Person Responsibilities.
    1. 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.
    2. 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.
    3. 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.
    4. 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.
    5. 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.
    6. 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).
  4. 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.
  5. 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.
  6. 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
  7. 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.
2. Area Office.
  The Area Clinical Engineer.
  1. The Area Clinical Engineer shall play a key role in investigating incidents and evaluating the safety of devices. In the absence of a facility Biomedical Engineer/Engineering Technician, these responsibilities shall be assumed by the Area Clinical Engineer.
  2. The Area Clinical Engineer shall compile an Area-wide report for the Area Director on all incidents reported to the FDA. He/she shall inform other facilities if a problem with a medical device has Area-wide implications.
3. Privacy Act.
  The medical device reporting records are subject to the Privacy Act of 1974 and, as such, must be safeguarded and maintained in accordance with the IHS Privacy Act System of Records "09-17-0001 Health and Medical Records Systems, HHS/PHS/OHP."
PROCEDURES.
1. General Reporting Requirements.
  1. Any employee of an IHS facility who discovers, witnesses, or is made aware of a potential MDR Reportable Event shall immediately notify the attending physician, his/her supervisor, and the Contact Person of the facility.
    Additionally, the individual must complete an incident report form.
  2. To ensure proper followup and investigation of the incident, the person who reports the adverse medical device incident shall obtain the following information whenever possible:
    1. Patient's name
    2. Patient's health record number
    3. Patient's location at time of incident
    4. Name of attending physician notified
    5. Product name
    6. Location of the product
    7. Serial or lot number of the product
    8. Model or catalog number
    9. Name of the manufacturer, if known
    10. Brief description of the incident
    11. Condition of the patient before and after the incident
  3. Whenever possible, the person reporting the incident shall secure the device and its packaging, if any.
  4. Within 24 hours of the suspected MDR Reportable Event, the person who reported the incident shall complete an Incident Report and forward the Incident Report to the facility Contact Person. The facility Contact Person will forward a copy of the report to the Area Clinical Engineer and the facility Biomedical Engineer/Engineering Technician.
2. Investigation.
  1. The Investigation Team shall conduct an investigation of the event to determine whether a device caused or contributed to the event and how. Outside specialists may be consulted if necessary. The results of the investigation shall be reviewed by the quality assurance/risk management committee or other appropriate committee, which shall propose recommendations for corrective action.
  2. The attending physician who is informed of a medical device incident shall examine the patient, evaluate the severity of the patients illness or injury related to the incident, record the patient's physical findings, and document in the patient's progress notes the occurrence of the suspected adverse medical device incident and any actions taken based on the examination.
  3. The Area Clinical Engineer or facility Biomedical Engineer/Engineering Technician shall assist the Contact Person with collecting the device information, service and history information, and other information required. They shall also assist in conducting an investigation of the device-related incident, evaluate the safety of the device, and determine whether the device along with the relevant supplies, accessories, and packaging should be impounded, repaired, or returned to service.
  4. The Contact Person in conjunction with the Area Clinical Engineer or facility Biomedical Engineer/Engineering Technician will conduct an investigation and determine whether similar equipment should be impounded or taken out of service. The investigation must be completed within 8-9 working days.
  5. At the conclusion of the investigation, if it is determined that a device was a contributing factor in the death of, serious injury to, or illness of a patient, the Contact Person will file the required information with the FDA and/or manufacturer.
  6. Each user facility will be required to keep records concerning medical device events. These files must contain records of any event that was investigated by the facility, whether or not it was determined to be a reportable event. Each facility shall establish a device incident file and maintain a record of any information, including any written or oral communication, received by the user facility concerning an event that is subject to reporting under this part. Such information includes information that has been reviewed by the facility in the process of determining what is a reportable event, including patient records.
    A device user facility shall maintain copies of any records required by the SMDA for 2 years after the, date of submission of a report to the FDA and/or manufacturer.
3. Medical Device Reporting.
  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 regulation. The law requires the following:
  1. Patient deaths must be reported to the FDA and the manufacturer within 10 working days of becoming aware that a device caused or contributed to the incident.
  2. Serious injuries or illnesses must be reported to the medical device manufacturer (or to the FDA, if the manufacturer is unknown) within 10 working days of becoming aware that a device caused or contributed to the incident.
  3. Semi-annual summaries of reports must be submitted to the FDA by January 31, covering reports for the previous July 1 to December 31; and by July 31, covering reports for the previous January 1 to June 30. The Contact Person will be responsible for submitting the reports.
    The summary shall include the following information: the identity of the facility; the device's name, serial number, lot number, and model number; the manufacturer's name and address; and a brief description of the event. If no incidents occur, semi-annual reports are not required.
  4. Reports should be submitted to the following address:
    FDA
    Center for Devices and Radiological Health
    MDR User Report
    P.O. Box 3002
    Rockville, MD 20847-3002
  5. Semi-annual reports should have "Semi-annual Report" written on the lower left hand side of the envelope. The report should, be made by the individual who is designated as the Contact Person.
  6. Reports that require notification of the manufacturer shall be mailed to the appropriate address when known. If no address is known or the manufacturer is unknown, the report will be mailed to the FDA.
    Additionally, a copy of the report should be sent to the Area Clinical Engineer who will compile an Area-wide Report for the Area Director and to inform other facilities if a problem with a medical device has Area-wide implications.
4. Trend Analysis.
  The Contact Person in conjunction with the Safety Committee will be responsible for the trends analysis of medical device incidents, in accordance with the Joint Commission on Accreditation of Healthcare Organizations requirements. The analysis should be shared with the governing body, service unit director, directors of all departments/services, and those responsible for other monitoring activities, including risk management or quality assessment and improvement.
5. Written Procedures.
  The Contact Person will maintain written procedures for following areas:
  1. Training and education programs that focus on employee obligations, including how to identify and report events that may be subject to user facility reporting.
  2. Internal systems that provide for identification, communication, and evaluation of events that may be subject to reporting, including a standardized review procedure for determining when an event meets the criteria for reporting and mechanisms to ensure the timely transmission of completed reports.
  3. Documentation and record keeping requirements for incident information that was reviewed, all reports and information submitted to the FDA and/or manufacturers, information that facilitates the submission of semi-annual reports, and systems that ensure access to information that facilitates timely followup and inspection by the FDA.
Reporting Forms.
Reporting forms may be found at Exhibit A, FDA Form 3500A (6/93), along with instructions to report device problems to FDA and/or manufacturers. The Office of Health Programs will ensure that all Areas are provided copies of the final reporting instrument.
Supersession.
This circular supersedes IHS Circular 93-1, dated February 12, 1993.
Effective Date. This circular is effective upon date of signature by the Director, IHS.

/Michael H. Trujillo/
Michael H. Trujillo, M.D., M.P.H.
Assistant Surgeon General
Director, Indian Health Service