The Open Patient Controlled Analgesic (PCA) Pump project provides open source design artifacts
for a realistic a PCA Pump.

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 experts 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.

A broader goal of the project is to facilitate knowledge transfer between academia,
industry, and regulators.

• Academics can study and use the work products of a realistic medical device development and assurance effort. They can also use the artifacts to illustrate their research on advanced specification, development, and verification techniques in a realistic context.
• Industry can use these artifacts to better understand the potential benefits of high-assurance development techniques developed in academia. They can also make use of this non-proprietary material in standards development and technical committees to interesting aspects of medical device development and assurance (including development and assurance of interoperability features).
• Regulators can use these artifacts to explore how development and assurance research results may be used to support regulatory submissions.

This is a joint research effort between Kansas State University researchers, US Food and Drug Administration (FDA) engineers, and industry experts at Adventium Labs.

The development of the original Open PCA Pump artifacts was sponsored by the US National Science Foundation FDA Scholar-in-Residence Program, which has the goals of (a) improving regulatory science by transitioning academic research results in quality processes and rigorous development, verification, and assurance techniques, (b) informing the academic community of regulatory, safety, and security challenges.

The Open PCA Pump artifacts are being used by the Intrinsically Secure, Open, and Safe Cyber-physically Enabled, Life-critical Essential Services (ISOSCELES) project sponsored by the US Department of Homeland Security Cyber-Physical System Security (CPSSec) research program led by Adventium Labs. The DHS CPSSec project supports research to improve the security of critical infrastructure technologies.

The ISOSCELES project is developing an open-source software platform, running on generic hardware, to provide both safety and security features for networked, interoperable medical devices to be used by (small) manufacturers more knowledgeable about medical function than computer security. The original Open PCA Pump requirements and architecture currently presented on this web site are being extended to show how the general ISOSCELES platform can be specialized for a particular medical function.

When referencing this work in scientific publications, please cite the following paper:

"The Open PCA Pump Project: An Exemplar Open Source Medical Device as a Community Resource",
John Hatcliff, Brian Larson, Todd Carpenter, Paul Jones, Yi Zhang, Joseph Jorgens. Proceedings of the 2018 Medical Cyber-Physical Systems (MedCPS) Workshop. (download .pdf)

Getting Started

To get started with the Open PCA Pump material, read the overview paper above, and then begin with the concept of operations and 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.

This work is sponsored in part by US National Science Foundation Food and Drug Administration Scholar-in-Residence program (CNS 1238431,1355778,1446544,1565544), the Department of Homeland Security (DHS) Science and Technology Directorate, Homeland Security Advanced Research Projects Agency (HSARPA), Cyber Security Division (DHS S\&T/HSARPA/CDS) BAA HSHQDC- 14-R-B0005, the Government of Israel and the National Cyber Bureau in the Government of Israel via contract number D16PC00057. Earlier work on this material was supported 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.