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research-article

The open PCA pump project: an exemplar open source medical device as a community resource

Authors:

Todd Carpenter,

Joseph JorgensAuthors Info & Claims

ACM SIGBED Review, Volume 16, Issue 2

Pages 8 - 13

https://doi.org/10.1145/3357495.3357496

Published: 16 August 2019 Publication History

Abstract

Building safe and secure interoperable medical devices with accompanying assurance artifacts is challenging. Many start-up companies have great ideas for innovation, but are not familiar with appropriate safety/security-critical engineering processes, architecture principles, risk management, and assurance techniques. Larger, more experienced, companies may face hurdles in re-engineering their devices for interoperability and greater security. In academia, researchers often have good techniques for addressing some of the issues above, but are not familiar with how a realistic medical device is developed and assured. Building a prototype medical device for a classroom project or research work to validate proposed techniques is often a huge effort.

The Open PCA Pump illustrates a full suite of realistic development artifacts including use cases, requirements, architecture models, verified source code, testing and simulation infrastructure, risk management artifacts, and assurance cases that can be used to develop shared understanding of medical device innovations across the academic, industry, and regulatory communities.1

References

[1]

Daniel Amyot. 2018. jUCMNav - Eclipse plugin for the User Requirements Notation. http://jucmnav.softwareengineering.ca/foswiki/ProjetSEG/WebHome. (2018).

[2]

David Arney, Raoul Jetley, Paul Jones, Insup Lee, and Oleg Sokolsky. 2007. Formal Methods Based Development of a PCA Infusion Pump Reference Model: Generic Infusion Pump (GIP) Project. In Proceedings of 2007 Joint Workshop on High Confidence Medical Devices, Software, and Systems and Medical Device Plug-and-Play Interoperability.

Digital Library

[3]

Todd Carpenter, John Hatcliff, and Eugene Y. Vasserman. 2017. A Reference Separation Architecture for Mixed-Criticality Medical and IoT Devices. In Proceedings of the 1st ACM Workshop on the Internet of Safe Things (SafeThings'17). ACM, New York, NY, USA, 14--19.

Digital Library

[4]

Alistar Cockburn. 2001. Writing Effective Use Cases. Addison-Wesley, Boston, MA.

Digital Library

[5]

Joint Commission. 2005. Preventing Patient-Controlled Analgesia Overdose. Joint Commission Perspectives on Patient Safety (October 2005), 11.

[6]

FDA Infusion 2010. US FDA Infusion Pump Improvement Initiative. (April 2010).

[7]

FDA Infusion Pump Guidance 2014. Total Product Life Cycle: Infusion Pump - Guidance for Industry and FDA Staff. https://www.fda.gov/downloads/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm209337.pdf. (2014).

[8]

Generic Infusion Pump {n. d.}. Generic Infusion Pump Project Homepage. http://rtg.cis.upenn.edu/gip.php3. ({n. d.}).

[9]

Michael D. Harrison, Paolo Masci, Jose Creissac Campos, and Paul Curzon. 2017. Demonstrating that Medical Devices Satisfy User Related Safety Requirements. In Software Engineering in Health Care, Michaela Huhn and Laurie Williams (Eds.). Springer International Publishing, Cham, 113--128.

[10]

John Hatcliff, Andrew King, Insup Lee, Anura Fernandez, Alaisdair McDonald, and Eugene Vasserman. 2012. Rationale and Architecture Principles for Medical Application Platforms. In Proceedings of the 2012 International Conference on Cyberphysical Systems.

Digital Library

[11]

John Hatcliff, Brian R. Larson, Jason Belt, Robby, and Yi Zhang. 2018. A Unified Approach for Modeling, Developing, and Assuring Critical Systems. In Leveraging Applications of Formal Methods, Verification and Validation. Modeling, Tiziana Margaria and Bernhard Steffen (Eds.). Springer International Publishing, Cham, 225--245.

[12]

J. Hatcliff, E. Y. Vasserman, T. Carpenter, and R. Whillock. 2018. Challenges of distributed risk management for medical application platforms. In 2018 IEEE Symposium on Product Compliance Engineering (ISPCE). 1--14.

[13]

John Hatcliff, Alan Wassyng, Tim Kelly, Cyrille Comar, and Paul L. Jones. 2014. Certifiably safe software-dependent systems: Challenges and directions. In Proceedings of the on Future of Software Engineering (ICSE FOSE). 182--200.

Digital Library

[14]

Rodney W. Hicks, Vanja Sikirica, Winnie Nelson, Jeff R. Schein, and Diane D. Cousins. 2008. Medication errors involving patient-controlled analgesia. American Journal of Health-System Pharmacy 65, 5 (March 2008), 429--440.

[15]

SAE International. 2015. SAE AS5506/1, AADL Annex E: Error Model Annex. SAE International, http://www.sae.org.

[16]

Andrew King, Dave Arney, Insup Lee, Oleg Sokolsky, John Hatcliff, and Sam Procter. 2010. Prototyping Closed Loop Physiologic Control with the Medical Device Coordination Framework. In ICSE Companion.

Digital Library

[17]

Brian Larson, Patrice Chalin, and John Hatcliff. 2013. BLESS: Formal Specification and Verification of Behaviors for Embedded Systems with Software. In Proceedings of the 2013 NASA Formal Methods Conference (Lecture Notes in Computer Science), Vol. 7871. Springer-Verlag, Berlin Heidelberg, 276--290.

[18]

Brian Larson, John Hatcliff, Kim Fowler, and Julien Delange. 2013. Illustrating the AADL Error Modeling Annex (V.2) Using a Simple Safety-critical Medical Device. In Proceedings of the 2013 ACM SIGAda Annual Conference on High Integrity Language Technology (HILT '13). ACM, New York, NY, USA, 65--84.

Digital Library

[19]

Brian R Larson. 2018. Behavior Language for Embedded Systems with Software (BLESS) website. http://bless.santoslab.org. (2018).

[20]

Brian R Larson, John Hatcliff, and Patrice Chalin. 2013. Open Source Patient-Controlled Analgesic Pump Requirements Documentation. In Proceedings of the 5th International Workshop on Software Engineering in Health Care. IEEE, Piscataway, NJ, 28--34.

Digital Library

[21]

I. Lee, O. Sokolsky, S. Chen, J. Hatcliff, E. Jee, B. Kim, A. King, M. Mullen-Fortino, S. Park, A. Roederer, and K. K. Venkatasubramanian. 2012. Challenges and Research Directions in Medical Cyber-Physical Systems. Proc. IEEE 100, 1 (Jan 2012), 75--90.

Digital Library

[22]

D. Lempia and S. Miller. 2009. Requirement Engineering Management Handbook. Technical Report DOT/FAA/AR-08/32. US Federal Aviation Administration.

[23]

Paolo Masci, Yi Zhang, Paul Jones, Paul Curzon, and Harold Thimbleby. 2014. Formal Verification of Medical Device User Interfaces Using PVS. In Proceedings of the 17th International Conference on Fundamental Approaches to Software Engineering - Volume 8411. 200--214.

Digital Library

[24]

Gdansk University of Technology. 2018. NOR-STA: Support for Achieving and Assessing Conformance to NORms and STAndards. http://www.nor-sta.eu/en. (2018).

[25]

Object Modeling Group (OMG). 2017. OMG System Modeling Language (SysML) v1.5. http://www.omg.org/spec/SysML/1.5/. (2017).

[26]

Boston Scientific. 2007. PACEMAKER System Specification. http://sqrl.mcmaster.ca/pacemaker.htm. (2007).

[27]

Sireum {n. d.}. Sireum: A high-assurance software development platform. http://sireum.org. ({n. d.}).

[28]

Kansas State University. 2018. Open PCA Pump Project. http://openpcapump.santoslab.org. (2018).

[29]

D.D. Walden, G.J. Roedler, K.J. Forsberg, R.D. Hamelin, and T.M. Shortell (Eds.). 2015. INCOSE Systems Engineering Handbook. Wiley, Hoboken, NJ.

[30]

Yi Zhang, Brian Larson, and John Hatcliff. 2018. Assurance Case Considerations for Interoperable Medical Systems. In Computer Safety, Reliability, and Security, Barbara Gallina, Amund Skavhaug, Erwin Schoitsch, and Friedemann Bitsch (Eds.). Springer International Publishing, Cham, 42--48.

Cited By

Vašíček O(2025)Early Validation of High-level Requirements on Cyber-Physical SystemsElectronic Proceedings in Theoretical Computer Science10.4204/EPTCS.416.40416(390-397)Online publication date: 13-Feb-2025
https://doi.org/10.4204/EPTCS.416.40
Hatcliff JBelt J(2024)The Isolette System: Illustrating End-to-End Artifacts for Rigorous Model-Based EngineeringThe Combined Power of Research, Education, and Dissemination10.1007/978-3-031-73887-6_9(93-117)Online publication date: 23-Oct-2024
https://doi.org/10.1007/978-3-031-73887-6_9
Hatcliff JStewart DBelt J. RSchwerdfeger A(2023)An AADL Contract Language Supporting Integrated Model- and Code-Level VerificationACM SIGAda Ada Letters10.1145/3591335.359133942:2(45-54)Online publication date: 5-Apr-2023
https://dl.acm.org/doi/10.1145/3591335.3591339
Show More Cited By

Index Terms

The open PCA pump project: an exemplar open source medical device as a community resource
1. Computer systems organization
  1. Embedded and cyber-physical systems
    1. Embedded systems
      1. Embedded software

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Information & Contributors

Information

Published In

cover image ACM SIGBED Review

ACM SIGBED Review Volume 16, Issue 2

Special Issue on Medical Cyber-Physical Systems Workshop 2018 (MCPS'18)

July 2019

53 pages

EISSN:1551-3688

DOI:10.1145/3357495

Editors:
Sergiy Bogomolov
Australian National University, Australia
,
Oleg Sokolsky
University of Pennsylvania
,
Philip Asare
Bucknell University
,
Lu Feng
University of Virginia
,
Paolo Masci
INESC-TEC and Universidade do Minho, Portugal
,
James Weimer
University of Pennsylvania

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Copyright © 2019 Authors.

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Association for Computing Machinery

New York, NY, United States

Publication History

Published: 16 August 2019

Published in SIGBED Volume 16, Issue 2

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Cited By

Vašíček O(2025)Early Validation of High-level Requirements on Cyber-Physical SystemsElectronic Proceedings in Theoretical Computer Science10.4204/EPTCS.416.40416(390-397)Online publication date: 13-Feb-2025
https://doi.org/10.4204/EPTCS.416.40
Hatcliff JBelt J(2024)The Isolette System: Illustrating End-to-End Artifacts for Rigorous Model-Based EngineeringThe Combined Power of Research, Education, and Dissemination10.1007/978-3-031-73887-6_9(93-117)Online publication date: 23-Oct-2024
https://doi.org/10.1007/978-3-031-73887-6_9
Hatcliff JStewart DBelt J. RSchwerdfeger A(2023)An AADL Contract Language Supporting Integrated Model- and Code-Level VerificationACM SIGAda Ada Letters10.1145/3591335.359133942:2(45-54)Online publication date: 5-Apr-2023
https://dl.acm.org/doi/10.1145/3591335.3591339
Hallerstede SHatcliff J(2023)A Mechanized Semantics for Component-Based Systems in the HAMR AADL RuntimeFormal Aspects of Component Software10.1007/978-3-031-52183-6_3(45-64)Online publication date: 26-Oct-2023
https://dl.acm.org/doi/10.1007/978-3-031-52183-6_3
Geoffrey Chase JZhou CKnopp JMoeller KBenyo BDesaive TWong JMalinen SNaswall KShaw GLambermont BChiew Y(2023)Digital Twins and Automation of Care in the Intensive Care UnitCyber–Physical–Human Systems10.1002/9781119857433.ch17(457-489)Online publication date: 9-Jun-2023
https://doi.org/10.1002/9781119857433.ch17
Fernandes Costa TSobrinho ÁChaves e Silva Lda Silva LPerkusich A(2022)Coloured Petri Nets-Based Modeling and Validation of Insulin Infusion Pump SystemsApplied Sciences10.3390/app1203147512:3(1475)Online publication date: 29-Jan-2022
https://doi.org/10.3390/app12031475
Bowen JWeyers BLiu B(2022)Creating Formal Models from Informal Design ArtefactsInternational Journal of Human–Computer Interaction10.1080/10447318.2022.209583339:15(3141-3158)Online publication date: 2-Aug-2022
https://doi.org/10.1080/10447318.2022.2095833
Thiagarajan HHatcliff JRobby (2021)Awas: AADL information flow and error propagation analysis frameworkInnovations in Systems and Software Engineering10.1007/s11334-021-00410-w18:4(485-504)Online publication date: 19-Jul-2021
https://doi.org/10.1007/s11334-021-00410-w
Hatcliff JBelt JRobby Carpenter T(2021)HAMR: An AADL Multi-platform Code Generation ToolsetLeveraging Applications of Formal Methods, Verification and Validation10.1007/978-3-030-89159-6_18(274-295)Online publication date: 17-Oct-2021
https://dl.acm.org/doi/10.1007/978-3-030-89159-6_18
Thiagarajan HHatcliff JRobby (2020)Awas: AADL Information Flow and Error Propagation Analysis FrameworkSoftware Architecture10.1007/978-3-030-59155-7_23(294-310)Online publication date: 7-Sep-2020
https://doi.org/10.1007/978-3-030-59155-7_23
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