Journal article

A hazard analysis for a generic insulin infusion pump.

Zhang Y, Jones P, Jetley R ...see all

Journal of diabetes science and technology, vol. 4, issue 2 (2010) pp. 263-83

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Abstract

BACKGROUND: 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.

METHODS: 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.

RESULTS: 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.

CONCLUSIONS: 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.

Author-supplied keywords

  • Disease Transmission
  • Electricity
  • Equipment Design
  • Equipment Failure
  • Humans
  • Infectious
  • Infectious: prevention & con
  • Insulin Infusion Systems
  • Insulin Infusion Systems: adverse effects
  • Insulin Infusion Systems: standards
  • Insulin Infusion Systems: utilization
  • Proportional Hazards Models
  • Research
  • Research: standards
  • Safety
  • Software
  • Transportation

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Authors

  • Yi Zhang

  • Paul L. Jones

  • Raoul Jetley

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