Inventory of Health Care Information Standards. IEEE 1073, Standard for Medical Device Communications

01/01/1997

A family of documents that defines the entire seven layer communications requirements for the "Medical Information Bus" (MIB). This is a robust, reliable communication service designed for Intensive Care Unit, Operating Room, and Emergency Room bedside devices.

Approved Standards:

1) IEEE 1073.3.1 - Standard for Medical Device Communications, Transport Profile - Connection Mode: This document defines the services and requirements for a bedside subnetwork. It defines services similar to those defined in Ethernet and TCP/IP. Combined

with 1073.4.1, it defines the hardware required to offer hospitals to ensure ease of use for clinician initiated automatic data capture from bedside devices. An approved ANSI Standard since August, 1995.

2) IEEE 1073.4.1 - Standard for Medical Device Communications, Physical Layer, Cable Connected: This document defines the cables, connectors, data rates, and bit level encoding for the MIB. It is coupled with IEEE 1073.3.1 to complete the "lower layers" for 1073. An approved ANSI Standard since August, 1995.

3) IEEE 1073 - Standard for Medical Device Communications, Overview and Framework:

This document serves as an overview of the 1073 family of standards and a roadmap of which

documents, present and planned, contain information on different facets of communication. It defines the underlying philosophy in the 1073 family of standards. Approved by the IEEE Standards Board in March, 1996.

On-going Standards Work:

  • IEEE 1073.1 - Standard for Medical Device Communications, Medical Device Data Language (MDDL) Overview and Framework: This document defines the ISO Standards and conventions for using Object-Oriented Technology to define communications services for bedside medical devices. This is expected to go to ballot in late 1996.
  • IEEE 1073.1.1 - Standard for Medical Device Communications, MDDL Common Definitions: This document defines the common definitions for the object oriented communications services for medical devices.
  • IEEE 1073.1.2 - Standard for Medical Device Communications, MDDL Virtual Medical Device, Generalized: This document defines the general features of all virtual medical devices, in an object oriented environment. This is highly harmonized with CEN TC251, PT021 First Working Draft "Vital Signs Representations".
  • IEEE 1073.1.3 - Standard for Medical Device Communications, MDDL Virtual Medical Device, Specialized: This document defines the general features of specialized virtual medical devices for specific device categories. This is highly harmonized with CEN TC251, PT021 First Working Draft "Vital Signs Representation".
  • IEEE 1073.1.3.1 - Standard for Medical Device Communications, MDDL Virtual Medical Device, Specialized, Infusion Device: Defines the specific object oriented communications services for infusion devices. This project should have a first draft by the end of 1996.
  • IEEE 1073.1.3.2 - Standard for Medical Device Communications, MDDL Virtual Medical Device, Specialized, Vital Signs Monitor: Defines the specific object oriented communications services for vital signs monitors.
  • IEEE 1073.1.3.1 - Standard for Medical Device Communications, MDDL Virtual Medical Device, Specialized, Ventilator: Defines the specific object oriented communications services for ventilators. This project was started in April, 1996.
  • IEEE 1073.2 - Standard for Medical Device Communications, Application Profile, Overview and Framework: Describes the common theory and rules for all application profiles to be defined for the 1073 family. This was approved by the ballot group in late 1995, but is in editing stage. Should be approved by IEEE Standards Board in September, 1996.
  • IEEE 1073.2.0 - Standard for Medical Device Communications, Application Profile, Medical Device Encoding Rules: An optimization of ISO Basic Encoding Rules made for bedside medical devices. This should go to ballot in late 1996.
  • IEEE 1073.2.1 - Standard for Medical Device Communications, Application Profile, Minimum Set: Defines the minimum application profile for bedside medical devices. The service provided allows for one way capture of device data. This should go to ballot in late 1996.
  • IEEE 1073.2.2 - Standard for Medical Device Communications, Application Profile, Basic Capabilities: Defines the basic set of communications services for an application profile for bedside medical devices. The services provided allow for two way getting and setting of attribute values, and for creating and deleting of objects.

Contact For More Information:

Bob Kennelly

Chair, IEEE 1073 General Committee

LinkTech

30 Orville Drive

Bohemia, NY 11716

(P) 516-567-5656, ext. 7482

(F) 516-563-2819

(E) bobk@linktech.ilcddc.com

Description of Standard:

The IEEE 1073 Family of Standards serves to achieve the following: Objectives: To standardize data communications for patient connected bedside devices, optimized for the acute care setting, to allow clinicians to set up device communications in a "plug and play" fashion.

Functions:

The function of this family of standards is to permit real time,

continuous, and comprehensive capture of device data from patient connected bedside devices. This data includes physiological parameter measurements and device settings.

User Environment:

This family of standards is used in any setting containing patient connected bedside devices, but was optimized in its design for acute care settings such as intensive care, operating rooms, and emergency rooms.

Systems Environment:

IEEE 1073 defines a bedside sub-network where devices communicate with a bedside communications controller. The standard is strongly based on ISO Open Systems Interconnect, and as such is able to be compatible with most computer industry standard implementations. Prototype implementations have been done with DOS, Windows, Windows NT, TCP/IP and Ethernet.

Application Function/Domain Completeness:

The lower layers, or hardware, for this standard is completed as an IEEE and ANSI Standard. Drafts exist for many of the upper layer pieces required to do prototyping. Several documents are going to ballot in 1997.

In what way(s) is this standard superior to other standards in this category/classification?

The IEEE 1073 is the first attempt to standardize device interfaces. The previous data interfaces provided by device manufacturers were based on RS-232, in which only the very basic voltage levels and data rates are defined. Each device manufacturer needed to invent heir own language for device communications. Device manufacturers frequently changed this language in large and small ways across product lines and product revisions. The result was an entirely impossible quagmire of differing device interfaces for devices that tend to be portable and able to plug into multiple ports, each requiring a specific device driver to talk. It is similar to needed a different phone plug for each area code you want to call.

Readiness of Standard:

A) The IEEE 1073 family of standards are design standards that must be implemented during device design, or in after market converters. The implementation of 1073 allows for comprehensive, automatic collection of device data, which will affect clinician practice.

B)IEEE 1073 is presently implementable, and is in the process of being done at McKay-Dee Hospital in Ogden, Utah. The lower layers standards are supported by commercially available silicon and boards. The upper layers exist as drafts, using available object oriented models. To implement 1073 in 1996, a hospital must know its device type population, and design tables in their HIS to interpret the specific message structure, format, and content from their medical devices. The delivery of this message is standardized today.

C)The IEEE 1073 Standards are available from IEEE by calling 908-562-3800.

D)There is presently no implementation guide for the IEEE 1073 Standards.

E)There is presently no implementation guide for the IEEE 1073 Standards.

F)A conformance test plan and method is intended future work of the IEEE 1073 General Committee.

G)There are no conformance test tools available for IEEE 1073.

H)There are no conformance test tools available for IEEE 1073.

I)The lower layers of the standard are completed and implementable today. The lower layers are analogous to using ethernet and TCP/IP. The upper layers are still being developed, with several documents expected to be approved in 1997.

J)There are no extensions being developed, since the scope for this standard includes all communication layers for bedside medical devices.

AA) Ballot groups for 5 upper layer documents are being formed and will be closed by the end of 1996. Balloting for these documents will occur in the second quarter of 1997, with approval by the IEEE Standards Board in September or December 1997.

BB) Upon approval of the documents in 1997, a full implementation of IEEE 1073 will be achievable. Prototype implementations will be done in the first half of 1997.

Indicator of Market Acceptance:

A)As of January 1996, approximately 400 copies of the approved standards had been sold by IEEE.

B)IEEE 1073 is in the early adopter stage in the market. There are people at LDS Hospital, Univ. of West Virginia, Univ. Texas Houston Medical School, Texas Children's Hospital, and Naval Hospital San Diego doing prototyping work. One medical device vendor, Siemens, is shipping product in Europe with IEEE 1073 embedded.

C)There is prototype and evaluation work on IEEE 1073 being done in UK, Germany, Spain, Norway, and Japan.

D)There is growing demand for 1073 from US Hospitals, which is being recognized by US device vendors, and being considered for their new product designs. Also, the Hewlet-Packard led Andover Working Group has stated their intent to do prototype implementations of 1073 in 1997.

Level of Specificity:

Notes:

A) IEEE 1073 is a family of standards that describe in specific detail what needs to be implemented to be compliant.

B)The lower layers of 1073 are very specifically defined and are supported by a commercially available integrated circuit product. The upper layer drafts define very specific message contents and structure for specific types of bedside medical devices.

C)IEEE 1073 references many ISO communications standards to define the communications protocol. These include ISO Standards for RS-485, HDLC, Basic Encoding Rules, ASN.1, and the Guide to Developing Managed Objects.

D)There is a defined nomenclature within IEEE 1073 that defines the parameter name and a code structure for physiologic parameters and device settings.

E)The code set is a subset of the Medical Device Data Language (MDDL), and is listed as the MDDL Nomenclature, IEEE 1073.1.1

F)IEEE 1073.1.1 is a draft available from IEEE. It has also been submitted to LOINC for inclusion in that work.

G)There is presently no users' guide for the code set. However, one of the vendor members of the general committee has developed a tool in-house that may be released for public use in 1997.

H)The IEEE 1073 nomenclature is not presently being used in any commercial application.

I)IEEE 1073.1.1 should be balloted in 1997.

Relationships With Other Standards:

A)IEEE 1073 is a bedside subnetwork that collects device data. In any application that requires this data, 1073 has a relationship with that standard. The relationship will most likely be expressed through application gateways. Such examples may include: conversion of device data to HL7 format for inclusion of device parameters in an HL7 based clinical data depository; conversion of device data into an X12 message for inclusion in billing applications; use of device data by an electronic medical record standardized any other SDO.

B)IEEE 1073 has been having its meeting in conjunction with the HL7 working group meetings to ensure rapid convergence of ideas.

C)The most important aspect of our coordination efforts is elimination of workscope overlap. For example, at the last HL7 meeting we received a presentation on LOINC that resulted in formal submittal of our work to LOINC.

D)The only assumed condition we have is that our work will be viewed as valuable and taken as a contribution.

IEEE 1073 is entirely based on the ISO Open System Interconnect model and multiple ISO communications standards such as HDLC, BER, ASN.1, MOSI, GDMO.

E)The remaining gaps are mainly in areas of implementations to ensure that the goals of standardization are achievable in actual practice.

F)The nearest term efforts on implementations will be done in the Andover Working Group.

Identifiable Costs:

  • Please indicate the cost or your best estimate for the following:
  • Cost of licensure: There is no licensure cost for IEEE 1073.
  • Cost of acquisition : Medical device with embedded IEEE 1073 interfaces should have minimal cost difference from present purchase prices. The hospital infrastructure to support
  • bedside data capture will likely be similar to the costs of putting PC's at bedsides.
  • Cost/timeframes for education and training: Unknown
  • Cost/timeframes for implementation: Unknown

Please note any other cost considerations: The probable investment in IEEE 1073 infrastructure for hospitals will be small compared to the benefits from being able to have comprehensive data on the conditions of the most gravely ill, and costly, patients.