Abbreviations: (BG) blood glucose, (FDA) Food and Drug Administration, (GIIP) generic insulin infusion pump, (ISO) International Organization for Standardization, (MBE) model-based engineering, (PHA) preliminary hazard analysis Abstract Researchers at the Food and Drug Administration (FDA)/Center for Device and Radiological Health/Office of Science and Engineering Laboratories have been exploring the concept of model-based engineering as a means for improving the quality of medical device software. Insulin pumps were chosen as a research subject because their design provides the desired degree of research complexity and these types of devices present an ongoing regulatory challenge. Insulin pump hazards and their contributing factors are considered in the context of a highly abstract generic insulin infusion pump (GIIP) model. Hazards were identified by consulting with manufacturers, pump users, and clinicians; by reviewing national and international standards and adverse event reports collected by the FDA; and from workshops sponsored by Diabetes Technology Society. This information has been consolidated in tabular form to facilitate further community analysis and discussion. A generic insulin infusion pump model architecture has been established. A fairly comprehensive hazard analysis document, corresponding to the GIIP model, is presented in this article. We believe that this work represents the genesis of an insulin pump safety reference standard upon which future insulin pump designs can be based to help ensure a basic level of safety. More interaction with the diabetes community is needed to assure the quality of this safety modeling process.
The United States Food and Drug Administration (US FDA), the regulatory body for approving medical devices for market in the US, have been exploring the use of model-based approaches for evaluating properties about medical device safety REF .
A Hazard Analysis for a Generic Insulin Infusion Pump
Journal of Diabetes Science and Technology
Medicine