PEDIATRICS Vol. 121 No. 5 May 2008, pp. e1133-e1138 (doi:10.1542/peds.2007-1707)
ARTICLE |
Adolescent Use of Insulin and Patient-Controlled Analgesia Pump Technology: A 10-Year Food and Drug Administration Retrospective Study of Adverse Events
a Division of Postmarket Surveillance, Office of Surveillance and Biometrics
b Division of Anesthesiology, General Hospital, Infection Control and Dental Devices, Office of Device Evaluation, Center for Devices and Radiological Health, Food and Drug Administration, Rockville, Maryland
OBJECTIVES. From January 1, 2005, through December 31, 2005, the Food and Drug Administration received 5 adolescent death reports associated with the use of insulin pumps, raising concerns about use of this device in this age group. To understand better the types of infusion pump–related problems in adolescents, we performed a comprehensive evaluation of insulin and patient-controlled analgesic pump–related adverse events reported for adolescents that were received by the Food and Drug Administration from 1996 to 2005.
METHODS. A search for medical device adverse event reports from January 1, 1996 through December 31, 2005, involving insulin pumps or patient-controlled analgesic pumps used by patients who were aged 12 to 21 years was conducted in the Food and Drug Administration's Manufacturer and User Facility Device Experience Database. Reports were reviewed for demographic characteristics, type of adverse event, and patient morbidity, and potential contributory factors were classified from narratives in the reports.
RESULTS. A total of 1674 reports were identified: 1594 for insulin pumps and 53 for patient-controlled analgesic pumps. In reports of insulin pump events, there were 13 reported deaths, 2 reports that indicated possible suicide attempts, and several additional reports indicating severe hypoglycemic or hyperglycemic events that seemed to be device-related. A total of 102 (6.4%) insulin-pump reports highlighted factors that may have contributed to the adverse event, including problems associated with compliance, education, sports-related activities, and dropping or damaging the pump. Eighty-two percent of cases involving the insulin pump resulted in hospitalization. Half of the reports involving patient-controlled analgesic pumps indicated that the patient received an excess of medication; tampering and noncompliance were evident in some cases.
CONCLUSIONS. Adolescents are a special population who deserve careful consideration of risk and benefit for use of device technology. Studies need to further identify safety problems in this age group.
Key Words: medical devices • adolescent • infusion pump • diabetes • analgesia • adverse events • postmarket surveillance
Abbreviations: PCA—patient-controlled analgesia • FDA—Food and Drug Administration • PMA—premarket approval • DKA—diabetic ketoacidosis • MAUDE—Manufacturer and User Facility Device Experience
Accepted Oct 1, 2007.
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