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. 2010 Mar 1;4(2):263-83.
doi: 10.1177/193229681000400207.

A hazard analysis for a generic insulin infusion pump

Yi Zhang  1 , Paul L Jones, Raoul Jetley
Affiliations

A hazard analysis for a generic insulin infusion pump

Yi Zhang et al. J Diabetes Sci Technol. .

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.

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Figures

Figure 1.
Figure 1.
System architecture of generic insulin infusion pump.
See this image and copyright information in PMC

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