The goal of the Generic Infusion Pump (GIP) project is to develop a set of generic infusion pump (safety) models and reference specifications that can be used as a reference standard to verify safety properties in different classes of infusion pumps. The figure below depicts an infusion pump class diagram with the GIP representing the "base" class.

The purpose of this website is to: a) provide a repository of medical device artifacts for use in projects that advance the science and practice of developing high-confidence medical devices, software, and systems, and b) establish infusion pump safety reference models.

As a first step towards accomplishing this purpose, the project provides a preliminary hazard analysis and (safety) reference specifications for a generic PCA (Patient Controlled Analgesic) infusion pump. The archive file contains Simulink® and Stateflow® representations of the PCA pump. This information can be used by researchers and developers interested in the modeling, analysis, implementation, and testing of an infusion pump. We encourage researchers to share corrections, extensions, and research discoveries via this website.

Device manufacturers may find this information helpful in terms of verifying aspects of their pump design against the reference model before submitting their product for regulatory review. Manufacturers are particularly encouraged to contribute their knowledge to this effort.

We encourage research to extend the GIP into different pump classes as depicted above; for example - volumetric, enteral, and insulin pumps.

This information is the result of collaborations between the FDA, UPenn, and Fraunhofer CESE. We encourage others to participate. If interested, please contact us at gipump@seas.upenn.edu.

People:

• David Arney (UPenn)
• BaekGyu Kim (UPenn)
• Raoul Jetley (FDA)
• Paul Jones (FDA)
• Insup Lee (Leader, UPenn)
• Arnab Ray (Fraunhofer CESE)
• Oleg Sokolsky (UPenn)
• Yi Zhang (FDA)

Generic PCA

The following files contain a hazard analysis, safety requirements, and specifications for a generic PCA pump. These files are a work in progress.

Reference Design

• Hazard Analysis for the Generic PCA Pump
• Safety Requirements for the Generic PCA Pump

Specification

We started with a state machine written as a series of transitions in an Excel file. Each line of the file corresponds to a single transition, and columns contain start states, destination states, guards, and actions. There are two files; the first one has the main component and the second includes the alarm component and several smaller components.

The Excel files were translated into the extended finite state machine (EFSM) format. The file here contains all of the state machines as a single communicating EFSM system.

The EFSM was then in turn translated into an input file for the UPPAAL model checker. UPPAAL allows us to check properties of the system and simulate its behavior.

• Excel file 1 and file 2 with state machine specification
• CSV file with state machine specification
• EFSM format state machine
• UPPAAL model of specification

Generic PCA model

• Model documentation
• Model files (tgz archive)

The revisions are in progress and updated versions will be posted as they become available.

We are currently developing a reference implementation of GPCA.

The information provided on this web page is for academic research purposes only. We make no claims as to the completeness or correctness of this information.

We encourage academics and others to experiment with this work and report their results to this web page so that everyone involved may benefit from the work.

Any FDA regulated party using any of this information in their work is responsible for verifying and validating their product as specified in the governing regulations.

This project is supported in part by NSF CNS-0610297, "Applying Formal Methods to Improve the Quality of Software in Medical Devices" and NSF CNS-0834524, "Robust Composition and Interoperability of CPS Components".