Medical Device Plug and Play
Each year thousands of patient injuries and near-misses are caused by improper or unsafe medical device interactions. The recently enhanced IEEE/ISO 11073 series of standards aims at providing consistent, reliable and secure medical data communication between different devices. This is an important step forward. However, better communication standards are necessary but insufficient to ensure that medical devices interoperate effectively and safely. As illustrated in Figure 1, medical systems are an important class of network controlled reconfigurable cyber physical systems with a high degree of complexity. They have both loosely coupled and tightly coupled subsystems with different degrees of safety certification and reliability, including infusion pumps, respirators, robot-assisted surgery devices, monitoring and diagnostic devices, as well as medical information systems, patients, and medical personnel. These components have different individual safety levels and different real time requirements. They must work within the context of medical procedures that have different safety and operational interlock requirements at different stages of operation. This raises many system composition challenges. For example,
- Correct interpretation of medical data and effective monitoring of patients’ conditions are context-dependent. Operational contexts may be different at different stages of a complex medical procedure. How can we obtain and distribute timely medical context information consistently and correctly? How can we use the context information and real time monitoring data to provide better decision support?
- Medical devices have different safety levels and different levels of reliability. How do we verify that a dynamically configured system is safe at each stage of a complex medical procedure and is safe during the transition from one stage to next? This is the medical workflow safety challenge.
- There are many commonly used medical device configuration patterns. How can we formally described them, verify their safety and use them as building blocks in medical procedure driven workflow architecture?
To provide a framework for addressing these challenges, a consortium of medical, industrial, academic, and government bodies have been collaborating through the safe “MD PnP” (medical device Plug and Play) research program to identify the broad requirements for the integration of medical devices in high-acuity settings. A subset of these requirements formed the framework for a proposed ISO/IEC standard for a safe Integrated Clinical Environment (ICE) (62A 580NP). The committee for this proposed standard is chaired by Co-PI Dr. Julian Goldman. However, there are many open research questions in extending the current standard to achieve the safe composition of medical devices. The purpose of this project is to use state-of-the-art tools and cross-discipline experience to develop system composition architecture for safe medical device plug-and-play. This architecture will do more than just ensure interoperability; it will make sure that the composition of medical devices and information systems with different safety levels will result in a verifiably safe system. Specifically, we have the following goals:
- Goal 1: Develop a representative set of use cases to guide the safe MDPnP Research in general and safe user interface in particular.
- Goal 2: Develop verifiably safe architecture patterns as building blocks for safe MDPnP.
- Goal 3: Develop context-sensitive MDPnP and decision support.
- Goal 4: Develop medical grade wireless networking technologies for safe MDPnP.
- Po-Liang Wu, Dhashrath Raguraman, Lui Sha, Richard Berlin, Julian Goldman 「A Treatment Validation Protocol for Cyber-Physical-Human Medical Systems」. to appear in EUROMICRO Software Engineering and Advanced Application (SEAA) 2014
- Woochul Kang, PoLiang Wu, Maryam Rahmaniheris, Lui Sha, Richard B. Berlin Jr.,Julian M. Goldman, 「Towards Organ-Centric Compositional Development of Safe Networked Supervisory Medical Systems」, The 26th IEEE International Symposium on Computer-Based Medical Systems (CBMS 2013), June, 2013 (paper, slides)
- M. Rahmaniheris, W. Kang, L. Lee, L. Sha, R. B. Berlin, and J. M. Goldman, 「Modeling and Architecture Design of an MDPnP Acute Care Monitoring Systems「, The 26th IEEE International Symposium on Computer-Based Medical Systems (CBMS 2013), June 2013 (Short paper)
- Po-Liang Wu, Woochul Kang, Abdullah Al-Nayeem, Lui Sha , Richard Berlin, Julian Goldman. 「A Low Complexity Coordination Architecture for Networked Supervisory Medical Systems」. International Conference on Cyber Physical System (ICCPS). April, 2013 (paper, slides)