The Generic Infusion Pump (GIP)

A workbench for improving safety, security and usability of medical systems

Generic Infusion Pump Research Project

Medical infusion pumps deliver medicine (e.g. drugs, food nutrients, chemicals) to patients in various physical conditions. These types of devices are ubiquitous in health care settings from hospitals, to nursing homes, to private residences. Researchers in FDA/CDRH/ Office of Science and Engineering Laboratories (OSEL) developed the notion of a Generic Infusion Pump (GIP) safety “reference” model in response to extensive evidence of safety problems in this class of medical device.

The GIP safety model project serves to identify hazards, their causes, and control measures common to all types of medical infusion pumps at a design level that is independent of any hardware or feature set.

Two safety models have been established to date – the Generic Patient Controlled Analgesic (GPCA) infusion pump and the Generic Insulin Infusion pump (GIIP). These two models are “open / public” designs, intended to be used by academia as a realistic workbench for demonstrating tools and techniques that can improve the safety, security and usability of these and other medical devices. The ultimate goal is to (a) establish safety/security/usability reference models that can be used by manufacturers early in their design process to verify safety/security/usability properties which, in turn, (b) can be used to establish safety/security/usability assurance case arguments for regulatory review processes, and (c) serve as examples demonstrating the use of state-of-the-art safety-critical design and development engineering techniques.

This website provides direct links to tools, techniques, and examples developed to date by various international research groups in collaborations with the US Food and Drug Administration. Device manufacturers may find this information helpful for the analysis of aspects of their pump design before submitting their product for regulatory review. Manufacturers are particularly encouraged to contribute their knowledge to this effort.

PennUMNKSUCHI+MEDCIMITSEIASUMcMasterU MichiganU VirginiaU Illinois/Drexel UFDA

Requirement Documents
Penn description GPCA Functional Requirements description GPCA Safety Requirements

UMN description GPCA System Requirements

KSU description Open PCA Pump Requirements

CIMIT description PCA Clinical Scenario

UMN widgets Architectural Model

CHI+MED widgets GIP User Interface Architecture (GIP-UI)

ASU widgets Architecture for safety analysis and verification for medical devices (BAND-AiDe) widgets Architecture for analysis of mobile applications under dynamic contexts

Hazard Analysis
Penn whatshot GPCA Hazard Analysis

CHI+MED whatshot Hazard Analysis for Infusion Pump User Interface Software

ASU whatshot Pulse Oximeter thermal safety analysis

Security Analysis
ASU security Physiological signal based system wide security for medical devices

Human Factors / HCI
CHI+MED people Human-Computer Interaction for Medical Devices

UVirginia people Enhanced Operator Function Model (EOFM) people A Method for the Formal Verification of Human-Interactive Systems
people Formally verifying human–automation interaction as part of a system model: limitations and tradeoffs

UIllinois/DrexelU people Evaluating Human-automation Interaction Using Task Analytic Behavior Models

Model-Based Design / Engineering
Penn developer_board GPCA Uppaal Model

UMN developer_board GPCA Behavior / Usage Model

CHI+MED developer_board Model-Based Design of User Interface Software of Infusion Pumps

ASU developer_board Using formal methods to improve home-use medical device safety

ASU devices Health-Dev medical application code generator

Penn check_box Verification of the GPCA Uppaal model

KSU check_box Open PCA Pump Verification Suite

CHI+MED check_box Verification of User Interface Software of Infusion Pumps

ASU check_box Spatio-Temporal Hybrid Automata for Model based Verification of Artificial Pancreas

Safety / Security Assurance Case
Penn library_books GPCA Assurance Case

KSU library_books Open PCA Pump Assurance Case

SEI library_books Assurance Cases for Medical Devices

Data Loggers and Forensic Analysis
CHI+MED history Analysis of Infusion Pump Logs and Forensic Analysis

CIMIT history OpenICE Data Logger

CHI+MED buildTools and Guidance for Medical Device Developers

Quality Measures
Coming soon!

Coming soon!

CHI+MED reorderCHI+MED Publications and Presentations

ASU reorderMobile medical application workshop 2014 held in conjunction with Sensys 2014
reorderMobile Medical application tutorial 2013 at FDA

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