PoCD - Point-of-Care Devices

John Rhoads

EMB/11073 - IEEE 11073 Standards Committee

Within the context of the ISO/IEEE 11073 family of standards for point-of-care (POC) medical device communication (MCD), this standard provides the nomenclature that supports both the domain information model and service model components of the standards family, as well as the semantic content exchanged with medical devices. The nomenclature is specialized for patient vital signs information representation and medical device informatics, with major areas including concepts for electrocardiograph (ECG), haemodynamics, respiration, blood gas, urine, fluid-related metrics, and neurology, as well as specialized units of measurement, general device events, alarms, and body sites. The standard defines both the architecture and major components of the nomenclature, along with extensive definitions for each conceptual area.

The scope of this standard is upper layer [i.e., the International Organization for Standardization's (ISO's) open systems interconnection (OSI) application, presentation layer, and session layer] services and protocols for information exchange under the ISO/IEEE 11073 standards for medical device communications (MDC). This standard is the base standard of the ISO/IEEE 11073-20000 medical device application profiles (MDAP), as harmonized through the Committee for European Normalization (CEN) and the ISO.

The scope of this standard is to define a nomenclature for communication of information from point-of-care medical devices. Primary emphasis is placed on acute care medical devices and patient vital signs information. The nomenclature also supports concepts in an object oriented information model that is for medical device communications.

This standard extends the base nomenclature provided in ISO/IEEE 11073-10101:20041 to support terminology for implantable cardiac devices. Devices within the scope of this nomenclature are implantable devices such as pacemakers, defibrillators, devices for cardiac resynchronization therapy, and implantable cardiac monitors. This nomenclature defines the terms necessary to convey a clinically relevant summary of the information obtained during a device interrogation. The nomenclature extensions may be used in conjunction with other IEEE 11073 standard components (e.g., ISO/IEEE 11073-10201 [B2]2) or with other standards, such as Health Level Seven International (HL7).

The scope of this project is medical device communication for dialysis medical devices, including renal intensive care devices. It will specialize definitions provided by other IEEE 11073 standards, including general data format standards, application profile standards, and transport standards. The project will define data model and semantics specifically related to dialysis devices.

Within the context of the ISO/IEEE 11073 1 family of standards for point-of-care (POC) medical device communication (MDC), this standard provides an abstract, object-oriented domain information model that specifies the structure of exchanged information, as well as the events and services that are supported by each type of object. All data structure elements are specified using abstract syntax (ASN.1) and may be applied to many different implementation technologies, transfer syntaxes, and application service models. Core subjects include medical, alert, system, patient, control, archival, communication, and extended services. Model extensibility is supported, and a conformance model and statement template is provided.

Replaced by ISO/IEEE 11073-10101-2004. Within the context of the ISO/IEEE 11073 family of standards for point-of-care (POC) medical device communication (MCD), this standard provides the nomenclature that supports both the domain information model and service model components of the standards family, as well as the semantic content exchanged with medical devices. The nomenclature is specialized for patient vital signs information representation and medical device informatics, with major areas including concepts for electrocardiograph (ECG), haemodynamics, respiration, blood gas, urine, fluid-related metrics, and neurology, as well as specialized units of measurement, general device events, alarms, and body sites. The standard defines both the architecture and major components of the nomenclature, along with extensive definitions for each conceptual area.

Within the context of the ISO/IEEE 11073 family of standards for point-of-care (POC) medical device communication (MDC), this standard provides an abstract object-oriented domain information model that specifies the structure of exchanged information, as well as the events and services that are supported by each object. All elements are specified using abstract syntax (ASN.1) and may be applied to many different implementation technologies, transfer syntaxes, and application service models. Core subjects include medical, alert, system, patient, control, archival, communication, and extended services. Model extensibility is supported, and a conformance model and statement template is provided.

The base IEEE 11073-10101 Nomenclature is extended by this standard to provide support for ECG annotation terminology. It may be used either in conjunction with other IEEE 11073 standards (e.g., ISO/IEEE 11073-10201:2001) or independently with other standards. The major subject areas addressed by the nomenclature include ECG beat annotations, wave component annotations, rhythm annotations, and noise annotations. Additional ?global? and ?per-lead? numeric observation identifiers, ECG lead systems, and additional ECG lead identifiers also are defined.

The base nomenclature provided in IEEE 11073 to support terminology for implantable cardiac devices is extended in this standard. Devices within the scope of this nomenclature are implantable devices such as pacemakers, defibrillators, devices for cardiac resynchronization therapy, and implantable cardiac monitors. The discrete terms necessary to convey a clinically relevant summary of the information obtained during a device interrogation are defined in this nomenclature. To improve workflow efficiencies, cardiology and electrophysiology practices require the management of summary interrogation information from all vendor devices and systems in a central system such as an Electronic Health Records (EHR) system or a device clinic management system. To address this requirement, the Implantable Device, Cardiac (IDC) Nomenclature defines a standard-based terminology for device data. The nomenclature facilitates the transfer of data from the vendor proprietary systems to the clinic EHR or device clinic management system. Additional files can be found at http://standards.ieee.org/downloads/11073/11073-10103-2012/ if not attached to the PDF.

Within the context of the ISO/IEEE 11073 family of standards for point-of-care (POC) medical device communication (MDC), the nomenclature defined by the base ISO/IEEE 11073-10101:2004 nomenclature standard is extended by this amendment. Significant extensions to support haemodynamics, respiration, ventilation and anesthesia monitoring, blood gas, urine, fluid-related metrics, and neurology, as well as units of measurements and measurement sites, are included. Formal definitions for observation identifiers used by the IEEE 11073 Personal Health Device standards and additional attributes for reporting their regulatory and certification status are also captured and provided. Information attributes to support alert communication and accurate medical device time synchronization and timekeeping are also defined.

Within the context of the ISO/IEEE 11073 family of standards for point-of-care (PoC) medical device communication, a communication protocol specification for a distributed system of PoC medical devices and medical IT systems that need to exchange data, or safely control networked PoC medical devices by profiling Web Service specifications, is defined by this standard. Additional Web Service specifications are part of this standard.

Within the context of the ISO/IEEE 11073 family of standards for Point-of-Care medical device communication, this standard defines an architecture for service-oriented distributed Point-of-Care medical devices and medical IT system. It defines a binding of the participant and communication model defined in IEEE 11073-10207 to the profile for transport over Web services defined in IEEE 11073-20702. Moreover, a binding to Network Time Protocol (NTP) and 5 Differentiated Services (DiffServ) is defined for time synchronization and transport quality-of-service requirements.