Abstract
The safety and clinical effectiveness of medical devices depend on their use in specific clinical treatments. Due to the variability in physiology and genetics, different people react differently to exactly the same treatment. High-intensity focused ultrasound systems and radiation therapy machines are examples of systems where this needs to be taken into account. If we use a conventional monolithic assurance case for such systems, the inherent complexity affects our ability to construct an argument so that manufacturers and regulators are sufficiently confident that the device is safe and effective for a given treatment. We propose separating the assurance of these types of systems into two linked assurance cases. The first assurance case demonstrates the safety of the medical system independent of its clinical effect. The second demonstrates the safety and clinical effectiveness of the system when it is used within specific clinical treatments. Based on our experience in the ongoing development of a high-intensity focused ultrasound system, we introduce these separate assurance cases, and show how to structure them. We present definitions that are useful in determining boundaries, interfaces and dependencies between the two assurance cases, and include observations related to the effectiveness of this approach.
Partially supported by the Natural Sciences and Engineering Research Council of Canada.
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References
Medical Devices - Application of Risk Management to Medical Devices (ISO 14971:2019). Standard, International Organization for Standardization, Geneva, CH, December 2019
Medical Device Software - Software Life Cycle Processes (IEC 62304:2006). Standard, International Electrotechnical Commission, Geneva, CH, May 2006
GSN Community Standard (Version 1). Standard, Origin Consulting (York) Limited, York, GB, November 2011
Medical Device Safety Assurance Case Guidance (AAMI TIR38:2019). Standard, Association for the Advancement of Medical Instrumentation, Arlington, VA, USA, January 2019
Design control guidance for medical device manufacturers: Guidance document. Food and Drug Administration, Silver Spring, MD, USA, March 1997
Althammer, E., Schoitsch, E., Sonneck, G., Eriksson, H., Vinter, J.: Modular certification support - the DECOS concept of generic safety cases. In: 6th IEEE International Conference on Industrial Informatics, pp. 258–263, August 2008
Bloomfield, R., Bishop, P.: Safety and assurance cases: past, present and possible future - an Adelard perspective. In: Dale, C., Anderson, T. (eds.) Making Systems Safer, SSS 2010, pp. 51–67. Springer, London (2010). https://doi.org/10.1007/978-1-84996-086-1_4
Bradley, W.G., Jr.: MR-guided focused ultrasound: a potentially disruptive technology. J. Am. Coll. Radiol. 6(7), 510–513 (2009)
Despotou, G., Kelly, T.: Investigating the use of argument modularity to optimise through-life system safety assurance. In: Proceedings of the 3rd IET International Conference on System Safety, November 2008
Gleirscher, M., Johnson, N., Karachristou, P., Calinescu, R., Law, J., Clark, J.: Challenges in the safety-security co-assurance of collaborative industrial robots. In: Aldinhas Ferreira, M.I., Fletcher, S.R. (eds.) The 21st Century Industrial Robot: When Tools Become Collaborators. ISCASE, vol. 81, pp. 191–214. Springer, Cham (2022). https://doi.org/10.1007/978-3-030-78513-0_11
Gordon, W.J., Stern, A.D.: Challenges and opportunities in software-driven medical devices. Nat. Biomed. Eng. 3(7), 493–497 (2019)
Hatcliff, J., Wassyng, A., Kelly, T., Comar, C., Jones, P.: Certifiably safe software-dependent systems: challenges and directions. In: Future of Software Engineering Proceedings. FOSE 2014, pp. 182–200. Association for Computing Machinery, New York, NY, USA, May 2014
Jaradat, O., Sljivo, I., Hawkins, R., Habli, I.: Modular safety cases for the assurance of industry 4.0. In: Proceedings of Safety-Critical Systems Symposium, pp. 105–124 (2020)
Johnson, N., Kelly, T.: Devil’s in the detail: through-life safety and security co-assurance using SSAF. In: Romanovsky, A., Troubitsyna, E., Bitsch, F. (eds.) SAFECOMP 2019. LNCS, vol. 11698, pp. 299–314. Springer, Cham (2019). https://doi.org/10.1007/978-3-030-26601-1_21
Kelly, T.: Using software architecture techniques to support the modular certification of safety-critical systems. In: Proceedings of the 11th Australian Workshop on Safety Critical Systems and Software. SCS 2006, vol. 69, pp. 53–65. Australian Computer Society Inc, Sydney, AU, May 2007
Lee, I., et al.: High-confidence medical device software and systems. Computer 39(4), 33–38 (2006)
McGowan, R., Stevens, A., Chapman, R.: Food and drug administration review of safety assurance cases for medical devices. J. Clin. Eng. 39(2), 96–98 (2014)
Warg, F., Skoglund, M.: Argument patterns for multi-concern assurance of connected automated driving systems. In: Asplund, M., Paulitsch, M. (eds.) 4th International Workshop on Security and Dependability of Critical Embedded Real-Time Systems (CERTS 2019). OpenAccess Series in Informatics (OASIcs), vol. 73, pp. 3:1–3:13. Schloss Dagstuhl-Leibniz-Zentrum fuer Informatik, Dagstuhl, Germany, July 2019
Wassyng, A., Joannou, P., Lawford, M., Maibaum, T., Singh, N.K.: New standards for trustworthy cyber-physical systems. In: Trustworthy Cyber-Physical Systems Engineering, pp. 337–368 (2016)
Wassyng, A., et al.: Can product-specific assurance case templates be used as medical device standards? IEEE Des. Test 32(5), 45–55 (2015)
Weinstock, C., Goodenough, J.: Towards an assurance case practice for medical devices. Technical report CMU/SEI-2009-TN-018, Software Engineering Institute, Carnegie Mellon University, Pittsburgh, PA, USA, October 2009
Yamamoto, S., Matsuno, Y.: An evaluation of argument patterns to reduce pitfalls of applying assurance case. In: 2013 1st International Workshop on Assurance Cases for Software-Intensive Systems (ASSURE), pp. 12–17. IEEE, May 2013
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Deevy, S., de Moraes Machado, T., Modhafar, A., O’Beirne, W., Paige, R.F., Wassyng, A. (2023). Redesigning Medical Device Assurance: Separating Technological and Clinical Assurance Cases. In: Guiochet, J., Tonetta, S., Bitsch, F. (eds) Computer Safety, Reliability, and Security. SAFECOMP 2023. Lecture Notes in Computer Science, vol 14181. Springer, Cham. https://doi.org/10.1007/978-3-031-40923-3_3
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