Journal of Diabetes Science and Technology, vol. 4, issue 2 (2010) pp. 263-283
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.
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