A Hazard Analysis for a Generic Insulin Infusion Pump
- ISSN: 1932-2968
- DOI: 10.1177/193229681000400207
Background\n\nResearchers at the Food and Drug Administration (FDA)/Center for Device\nand Radiological Health/Office of Science and Engineering Laboratories\nhave been exploring the concept of model-based engineering as a means\nfor improving the quality of medical device software. Insulin pumps\nwere chosen as a research subject because their design provides the\ndesired degree of research complexity and these types of devices\npresent an ongoing regulatory challenge.\n\n\nMethods\n\nInsulin pump hazards and their contributing factors are considered\nin the context of a highly abstract generic insulin infusion pump\n(GIIP) model. Hazards were identified by consulting with manufacturers,\npump users, and clinicians; by reviewing national and international\nstandards and adverse event reports collected by the FDA; and from\nworkshops sponsored by Diabetes Technology Society. This information\nhas been consolidated in tabular form to facilitate further community\nanalysis and discussion.\n\n\nResults\n\nA generic insulin infusion pump model architecture has been established.\nA fairly comprehensive hazard analysis document, corresponding to\nthe GIIP model, is presented in this article.\n\n\nConclusions\n\nWe believe that this work represents the genesis of an insulin pump\nsafety reference standard upon which future insulin pump designs\ncan be based to help ensure a basic level of safety. More interaction\nwith the diabetes community is needed to assure the quality of this\nsafety modeling process.