title: The Importance of State and Context in Safe Interoperable Medical Systems.
abstract: 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.
authors.affiliation: Office of Science and Engineering Laboratories, FDA/CDRH Silver Spring MD 20993 USA.
authors.forename: Sandy
authors.initials: S
authors.lastname: Weininger
authors.affiliation: MDPnP Program Department of Anesthesia Massachusetts General Hospital Boston MA 02114 USA.
authors.forename: Michael B
authors.initials: MB
authors.lastname: Jaffe
authors.affiliation: Anakena Solutions, Inc. Woodland Hills CA 91367 USA.
authors.forename: Michael
authors.initials: M
authors.lastname: Robkin
authors.affiliation: DocBox, Inc. Newton MA 02460 USA.
authors.forename: Tracy
authors.initials: T
authors.lastname: Rausch
authors.affiliation: MDPnP Program Department of Anesthesia Massachusetts General Hospital Boston MA 02114 USA.
authors.forename: David
authors.initials: D
authors.lastname: Arney
authors.affiliation: MDPnP Program Department of Anesthesia Massachusetts General Hospital Boston MA 02114 USA.
authors.forename: Julian M
authors.initials: JM
authors.lastname: Goldman
keywords: Safety; context; interoperability; state