About the Open PCA Pump Project

The Open PCA Pump Project presents development and assurance artifacts for a mock Patient Control Analgesia (PCA) Pump. These artifacts simulate the result of domain experts working with systems engineers to define function that will be safe for patients, and effective for some medical need. For PCA, the medical need is to
provide narcotics to dull excruciating pain. Delivering medication as prescribed is what makes a PCA pump effective. Avoiding overdose, and all other harms to patients, is what makes a PCA pump safe.

These simulated artifacts are provided as a public-domain example to facilitate research and standards development for people that

  • do not have domain knowledge related to PCA,
  • need a non-propriety context in which to carry out their work, or
  • are domain expert and are interested in best practices for rigorous development of high-assurance systems.

Real development artifacts are typically highly-confidential to medical device
manufacturers, and thus detailed domain knowledge is exceedingly difficult to come by. However, since showing safety and effectiveness can be legal necessities for regulatory approval, and since university curricula and other training for engineers needs to address relevant topics in settings that are as realistic as possible, these simulated artifacts were created to fill the vacuum.

This work is carried out as part of an academic research project in the SAnToS research group at Kansas State University (KSU) funded by funded by the National Science Foundation US Food and Drug Administration Scholar-in-Residence (NSF FDA SIR) program. Thus, the emphases and content of the artifact are driven by broader mission
goals of the NSF FDA SIR program and KSU SAnToS -- specifically, the goal of providing resources primarily to the academic community (but also to industry and government agencies) that will facilitate research in safety critical systems, requirements engineering, hazard analysis and risk management, rigorous model-based development, formal specification and verification, and interoperable medical systems.

Getting Started

To get started with the Open PCA Pump material, begin with the requirements document on the Artifacts page.

The Open PCA Pump Material is being used in other courses at Kansas State -- Specifically, John Hatcliff's Safety-Critical Systems course provides lecture materials with slides and lecture videos for the FAA Requirements Engineering Management Handbook (used in the Open PCA Requirements Document), hazard analyses and risk management, the Architecture and Analysis Definition Language (AADL), and the BLESS behavioral specification language for AADL.

Licensing

This work is protected under the Creative Commons Attribution-ShareAlike license. This license lets others remix, tweak, and build upon this work even for commercial purposes, as long as they credit this document and its authors, and license their new creations under the identical terms.

Providing Feedback

The authors welcome feedback and suggestions for improving this document. To provide feedback send email to both brl 'at' ksu.edu and hatcliff 'at' ksu.edu.

Acknowlegements

This document builds off of the Generic Infusion Pump (GIP) and Generic PCA (GPCA) Pump work jointly developed by the University of Pennsylvania (U Penn) and FDA engineers Paul Jones and Raoul Jetly. Dave Arney, previously from U Penn and now from the CIMIT Medical Device Plug-and-Play (MDPnP) interoperability group, played a significant role in the GIP and GPCA efforts and provided several important forms of source material for this requirements document. FDA engineers Paul Jones and Sandy Weininger who shepherd the NSF FDA Scholars-in-Residence provided valuable feedback on earlier drafts of this document. Dr. Julian Goldman, head of the CIMIT MDPnP program also provided feedback, resources, and encouragement.

Funds for KSU SAnToS's broader work on medical device interoperability were provided by the National Science Foundation under grants #0932289,1065887,1238431,1239543 and by a subcontract from the CIMIT MDPnP group funded via an NIH/NIBIB Quantum grant.

Disclaimer

No physicians have reviewed these simulated requirements for a generic system to determine that they are actually safe and effective for real patients. DO NOT USE THESE REQUIREMENTS TO BUILD DEVICES USED ON PEOPLE. No warranty, expressed or implied, is made for these requirements by anyone.