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2015 | OriginalPaper | Buchkapitel

Towards Assurance for Plug & Play Medical Systems

verfasst von : Andrew L. King, Lu Feng, Sam Procter, Sanjian Chen, Oleg Sokolsky, John Hatcliff, Insup Lee

Erschienen in: Computer Safety, Reliability, and Security

Verlag: Springer International Publishing

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Abstract

Traditional safety-critical systems are designed and integrated by a systems integrator. The system integrator can asses the safety of the completed system before it is deployed. In medicine, there is a desire to transition from the traditional approach to a new model wherein a user can combine various devices post-hoc to create a new composite system that addresses a specific clinical scenario. Ensuring the safety of these systems is challenging: Safety is a property of systems that arises from the interaction of system components and it’s not possible to asses overall system safety by assessing a single component in isolation. It is unlikely that end-users will have the engineering expertise or resources to perform safety assessments each time they create a new composite system. In this paper we describe a platform-oriented approach to providing assurance for plug & play medical systems as well as an associated assurance argument pattern.

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Fußnoten
1
Through out this section we adopt a formal notation that might lead some readers to believe that when we use the term “model” we are explicitly refering to formal models (i.e., ones that could be analyzed by a model-checker). This is not the case. We are using “model” in a very general sense and a model could range from an informal “mental model” to an executable model that could be simulated to a formal model that could be analyzed by a model-checker.
 
Literatur
2.
Zurück zum Zitat Amnell, T., Fersman, E., Mokrushin, L., Pettersson, P., Yi, W.: TIMES - a tool for modelling and implementation of embedded systems. In: Katoen, J.-P., Stevens, P. (eds.) TACAS 2002. LNCS, vol. 2280, pp. 460–464. Springer, Heidelberg (2002) CrossRef Amnell, T., Fersman, E., Mokrushin, L., Pettersson, P., Yi, W.: TIMES - a tool for modelling and implementation of embedded systems. In: Katoen, J.-P., Stevens, P. (eds.) TACAS 2002. LNCS, vol. 2280, pp. 460–464. Springer, Heidelberg (2002) CrossRef
3.
Zurück zum Zitat Arney, D., Pajic, M., Goldman, J.M., Lee, I., Mangharam, R., Sokolsky, O.: Toward patient safety in closed-loop medical device systems. In: Proceedings of the 1st ACM/IEEE International Conference on Cyber-Physical Systems, pp. 139–148. ACM (2010) Arney, D., Pajic, M., Goldman, J.M., Lee, I., Mangharam, R., Sokolsky, O.: Toward patient safety in closed-loop medical device systems. In: Proceedings of the 1st ACM/IEEE International Conference on Cyber-Physical Systems, pp. 139–148. ACM (2010)
4.
Zurück zum Zitat Ayoub, A., Kim, B.G., Lee, I., Sokolsky, O.: A safety case pattern for model-based development approach. In: Goodloe, A.E., Person, S. (eds.) NFM 2012. LNCS, vol. 7226, pp. 141–146. Springer, Heidelberg (2012) CrossRef Ayoub, A., Kim, B.G., Lee, I., Sokolsky, O.: A safety case pattern for model-based development approach. In: Goodloe, A.E., Person, S. (eds.) NFM 2012. LNCS, vol. 7226, pp. 141–146. Springer, Heidelberg (2012) CrossRef
5.
Zurück zum Zitat Behrmann, G., David, A., Larsen, K.G., Hakansson, J., Petterson, P., Yi, W., Hendriks, M.: Uppaal 4.0. In: 2006 Third International Conference on Quantitative Evaluation of Systems, QEST 2006, pp. 125–126. IEEE (2006) Behrmann, G., David, A., Larsen, K.G., Hakansson, J., Petterson, P., Yi, W., Hendriks, M.: Uppaal 4.0. In: 2006 Third International Conference on Quantitative Evaluation of Systems, QEST 2006, pp. 125–126. IEEE (2006)
6.
Zurück zum Zitat Bonner, J., McClymont, W.: Respiratory arrest in an obstetric patient using remifentanil patient-controlled analgesia*. Anaesthesia 67(5), 538–540 (2012)CrossRef Bonner, J., McClymont, W.: Respiratory arrest in an obstetric patient using remifentanil patient-controlled analgesia*. Anaesthesia 67(5), 538–540 (2012)CrossRef
7.
Zurück zum Zitat Goldman, J.: Advancing the adoption of medical device plug-and-play interoperability to improve patient safety and healthcare efficiency. Medical Device “Plug-and-Play” Interoperability Program, Technical report (2000) Goldman, J.: Advancing the adoption of medical device plug-and-play interoperability to improve patient safety and healthcare efficiency. Medical Device “Plug-and-Play” Interoperability Program, Technical report (2000)
8.
Zurück zum Zitat Goldman, J.M.: Getting connected to save lives. Biomed. Instrum. Tech. 39(3), 174–174 (2005) Goldman, J.M.: Getting connected to save lives. Biomed. Instrum. Tech. 39(3), 174–174 (2005)
9.
Zurück zum Zitat Hatcliff, J., King, A., Lee, I., MacDonald, A., Fernando, A., Robkin, M., Vasserman, E., Weininger, S., Goldman, J.M.: Rationale and architecture principles for medical application platforms. In: 2012 IEEE/ACM Third International Conference on Cyber-Physical Systems (ICCPS), pp. 3–12. IEEE (2012) Hatcliff, J., King, A., Lee, I., MacDonald, A., Fernando, A., Robkin, M., Vasserman, E., Weininger, S., Goldman, J.M.: Rationale and architecture principles for medical application platforms. In: 2012 IEEE/ACM Third International Conference on Cyber-Physical Systems (ICCPS), pp. 3–12. IEEE (2012)
10.
Zurück zum Zitat Hatcliff, J., Vasserman, E., Weininger, S., Goldman, J.: An overview of regulatory and trust issues for the integrated clinical environment. In: Proceedings of HCMDSS 2011 (2011) Hatcliff, J., Vasserman, E., Weininger, S., Goldman, J.: An overview of regulatory and trust issues for the integrated clinical environment. In: Proceedings of HCMDSS 2011 (2011)
11.
Zurück zum Zitat Hicks, R.W., Sikirica, V., Nelson, W., Schein, J.R., Cousins, D.D.: Medication errors involving patient-controlled analgesia. Am. J. Health Syst. Pharm. 65(5), 429–440 (2008)CrossRef Hicks, R.W., Sikirica, V., Nelson, W., Schein, J.R., Cousins, D.D.: Medication errors involving patient-controlled analgesia. Am. J. Health Syst. Pharm. 65(5), 429–440 (2008)CrossRef
12.
Zurück zum Zitat Hilderman, V., Baghi, T.: Avionics certification: a complete guide to DO-178 (software), DO-254 (hardware). Avionics Communications (2007) Hilderman, V., Baghi, T.: Avionics certification: a complete guide to DO-178 (software), DO-254 (hardware). Avionics Communications (2007)
13.
Zurück zum Zitat Hudcova, J., McNicol, E.D., Quah, C.S., Lau, J., Carr, D.B.: Patient controlled opioid analgesia versus conventional opioid analgesia for postoperative pain. The Cochrane Library Hudcova, J., McNicol, E.D., Quah, C.S., Lau, J., Carr, D.B.: Patient controlled opioid analgesia versus conventional opioid analgesia for postoperative pain. The Cochrane Library
14.
Zurück zum Zitat Kelly, T., Weaver, R.: The goal structuring notation-a safety argument notation. In: Dependable Systems and Networks Workshop on Assurance Cases (2004) Kelly, T., Weaver, R.: The goal structuring notation-a safety argument notation. In: Dependable Systems and Networks Workshop on Assurance Cases (2004)
15.
Zurück zum Zitat Kelly, T.P.: Concepts and principles of compositional safety case construction (2001) Kelly, T.P.: Concepts and principles of compositional safety case construction (2001)
16.
Zurück zum Zitat King, A., Procter, S., Andresen, D., Hatcliff, J., Warren, S., Spees, W., Jetley, R., Jones, P., Weininger, S.: An open test bed for medical device integration and coordination. In: 31st International Conference on Software Engineering-Companion, ICSE-Companion 2009, vol. 2009, pp. 141–151.IEEE (2009) King, A., Procter, S., Andresen, D., Hatcliff, J., Warren, S., Spees, W., Jetley, R., Jones, P., Weininger, S.: An open test bed for medical device integration and coordination. In: 31st International Conference on Software Engineering-Companion, ICSE-Companion 2009, vol. 2009, pp. 141–151.IEEE (2009)
17.
Zurück zum Zitat Leveson, N.: A new accident model for engineering safer systems. Saf. Sci. 42(4), 237–270 (2004)CrossRef Leveson, N.: A new accident model for engineering safer systems. Saf. Sci. 42(4), 237–270 (2004)CrossRef
18.
Zurück zum Zitat Plourde, J., Arney, D., Goldman, J.M.: Openice: An open, interoperable platform for medical cyber-physical systems. In: 2014 ACM/IEEE International Conference on Cyber-Physical Systems (ICCPS), pp. 221–221. IEEE (2014) Plourde, J., Arney, D., Goldman, J.M.: Openice: An open, interoperable platform for medical cyber-physical systems. In: 2014 ACM/IEEE International Conference on Cyber-Physical Systems (ICCPS), pp. 221–221. IEEE (2014)
19.
Zurück zum Zitat Quigley, P.: F2761 and the integrated clinical environment. Stand. News 37(5), 20 (2009)MathSciNet Quigley, P.: F2761 and the integrated clinical environment. Stand. News 37(5), 20 (2009)MathSciNet
20.
Zurück zum Zitat Rushby, J.: Modular certification. Technical report, SRI CSL, September 2001 Rushby, J.: Modular certification. Technical report, SRI CSL, September 2001
Metadaten
Titel
Towards Assurance for Plug & Play Medical Systems
verfasst von
Andrew L. King
Lu Feng
Sam Procter
Sanjian Chen
Oleg Sokolsky
John Hatcliff
Insup Lee
Copyright-Jahr
2015
DOI
https://doi.org/10.1007/978-3-319-24255-2_17