Medical Device Interoperability and Systems Engineering
Safe(?) Interoperability
Sandy Weininger
FDA, Division of Biomedical Physics, Office of Science and Engineering Laboratories, 2024. Presentation slides
Interoperability Listening Session: Federal Vision
Sandy Weininger
FDA/CDRH Office of Science and Engineering Labs, July 17, 2019. Session PDF
A Medical Device Information Data Sheet (MDIDS) to Support the Interoperability of Externally Controllable Infusion Pumps for Tele-Critical Care
Goldman, J.M., Arney, D., Zhang, Y., Jaffe, M., Sandy Weininger Anesthesia & Analgesia, 136, 85-85, 2023.
Capturing essential information to achieve safe interoperability
Sandy Weininger, et al. Anesthesia & Analgesia, 124(1): 83-94, 2017.
The need to apply medical device informatics in developing standards for safe interoperable medical systems
Sandy Weininger, et al. Anesthesia & Analgesia, 124(1): 127-135, 2017.
The importance of state and context in safe interoperable medical systems
Sandy Weininger, et al. IEEE Journal of Translational Engineering in Health and Medicine, 4: 1-10, 2016.
Levels of conceptual interoperability model for healthcare framework for safe medical device interoperability
Robkin, M., Sandy Weininger, Preciado, B., Goldman, J. IEEE Symposium on Product Compliance Engineering (ISPCE), 1-8, 2015.
Rationale and architecture principles for medical application platforms
Hatcliff, J., King, A., Lee, I., MacDonald, A., Fernando, A., Robkin, M., Sandy Weininger, et al. IEEE/ACM Third International Conference on Cyber-Physical Systems, 3-12, 2012.
Supporting Medical Device Adverse Event Analysis in an Interoperable Clinical Environment: Design of a Data Logging and Playback System). D Arney, S Weininger, SF Whitehead, JM Goldman ICBO 833, 335-339, 2011.
Medical device interoperability-assessing the environment
Lesh, K., Sandy Weininger, Goldman, J.M., Wilson, B., Himes, G. Joint Workshop on High Confidence Medical Devices, Software, and Systems and Medical Device Plug-and-Play Interoperability, 2007.
Oximetry, Signal Processing, and Sensor Evaluation
Melanometry for objective evaluation of skin pigmentation in pulse oximetry studies
Vasudevan, S., Vogt, W.C., Sandy Weininger, Pfefer, T.J. Communications Medicine, 4(1), 138, 2024.
Development of tissue-mimicking phantoms for pulse oximetry
Bhusal, A., Vasudevan, S., Hasan, M.S., Farahmand, M., Vogt, W.C., Sandy Weininger Design and Quality for Biomedical Technologies XVII, PC128330A, 2024.
Evaluation of the robustness of cerebral oximetry to variations in skin pigmentation using a tissue-simulating phantom
Afshari, A., Saager, R.B., Burgos, D., Vogt, W.C., Wang, J., Mendoza, G., Sandy Weininger, et al. Biomedical Optics Express, 13(5), 2909-2928, 2022.
Cerebral oximetry performance testing with a 3D-printed vascular array phantom
Afshari, A., Ghassemi, P., Lin, J., Halprin, M., Wang, J., Mendoza, G., Sandy Weininger, Pfefer, T.J. Biomed. Opt. Express, 10, 3731-3746, 2019.
Skin pigmentation impact on cerebral oximetry: Development and implementation of a phantom-based test method
Afshari, A., Saager, R., Zhou, X., Ghassemi, P., Sandy Weininger, Wang, J., Durkin, A.J., Pfefer, T.J. Proc. SPIE 10870, 2019.
Optical–thermal characterization of cutaneous transilluminators
Pfefer, T.J., Mehrabi, A., James, R., Landry, R., Sandy Weininger, Chang, I. Physics in Medicine & Biology, 54(22), 6867, 2009.
Fetal pulse oximetry and cesarean delivery
Bloom, S.L., Spong, C.Y., Thom, E., Varner, M.W., Rouse, D.J., Sandy Weininger, et al. New England Journal of Medicine, 355(21), 2195-2202, 2006.
Closed-Loop Control and Computational Modeling
Evaluation of fluid resuscitation control algorithms via a hardware-in-the-loop test bed
Mirinejad, H., Parvinian, B., Ricks, M., Zhang, Y., Sandy Weininger, Hahn, J.O., et al. IEEE Transactions on Biomedical Engineering, 67(2): 471-481, 2020.
Credibility evidence for computational patient models used in the development of physiological closed-loop controlled devices for critical care medicine
Parvinian, B., Pathmanathan, P., Daluwatte, C., Yaghouby, F., Gray, R.A., Sandy Weininger, Morrison, T., Scully, C. Frontiers in Physiology, 10, 220, 2019.
Regulatory considerations for physiological closed-loop controlled medical devices used for automated critical care: Food and Drug Administration workshop discussion topics
Parvinian, B., Scully, C., Wiyor, H., Kumar, A., Sandy Weininger Anesthesia & Analgesia, 126(6), 1916-1925, 2018.
Development of a standard for physiologic closed loop controllers in medical devices
Wallroth, C., Goldman, J., Manigel, J., Osborn, D., Roellike, T., Sandy Weininger Anesthesia & Analgesia, 106, 2008.
Product Development, Standards, and Regulatory Science
Formation of a Collaborative Community (CC) to Advance Smart and Autonomous Medical Systems (SaAMS)
Goldman, J.M., Agler, H.L., Sandy Weininger Anesthesia & Analgesia, 140(4), 96-96, 2025.
An open test bed for medical device integration and coordination
King, A., Procter, S., Andresen, D., Hatcliff, J., Warren, S., Spees, W., Jetley, R., Sandy Weininger, et al. 31st International Conference on Software Engineering-Companion Volume, 2009.
Exploring medical device reliability and its relationship to safety and effectiveness
Sandy Weininger, Pecht, M. IEEE Symposium on Product Compliance Engineering, PSES 2009.
Understanding the benefits and risks inherent in medical device interoperability
Sandy Weininger, Scully, C., Robkin, M.
IAMPOV, 2012..
We use cookies to analyze website traffic and optimize your website experience. By accepting our use of cookies, your data will be aggregated with all other user data.