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 PCA drug delivery.
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.
To get started with the Open PCA Pump material, begin with the requirements document on the Artifacts page.
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.
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.
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.
No physicians have reviewed these simulated artifacts to determine that they are actually safe and effective for real patients. DO NOT USE THESE ARTIFACTS TO BUILD DEVICES USED ON PEOPLE. No warranty, expressed or implied, is made for these artifacts by anyone.