The Importance of State and Context in Safe Interoperable Medical Systems.

This paper describes why "device state" and "patient context" information are necessary components of device models for safe interoperability. This paper includes a discussion of the importance of describing the roles of devices with respect to interactions (including human user workflows involving devices, and device to device communication) within a system, particularly those intended for use at the point-of-care, and how this role information is communicated. In addition, it describes the importance of clinical scenarios in creating device models for interoperable devices.

Capturing Essential Information to Achieve Safe Interoperability.

In this article, we describe the role of "clinical scenario" information to assure the safety of interoperable systems, as well as the system's ability to deliver the requisite clinical functionality to improve clinical care. Described are methods and rationale for capturing the clinical needs, workflow, hazards, and device interactions in the clinical environment. Key user (clinician and clinical engineer) needs and system requirements can be derived from this information, therefore, improving the communication from clinicians to medical device and information technology system developers.

Design of an x-ray / ventilator synchronization system in an integrated clinical environment.

Patients in an ICU may receive daily chest x-rays. These x-rays are taken manually and may be at different phases of respiration, which limits their clinical usefulness. We examine design issues around automatically synchronizing an x-ray and ventilator in an interoperable manner, including requirements on the individual devices and new safety hazards introduced by connecting them into a system.

The development of an interoperable roadmap for medical devices.

It is believed that interoperability between medical devices and electronic medical records (EMR) is one key to developing a system of higher quality, safer, and efficient healthcare delivery. Interoperability speaks to either wireless or hard-wired streaming of two-way patient and related data between devices and EMRs. An analysis of a large integrated delivery system's medical devices and EMR was conducted to demonstrate this potential.