Detailed Clinical Models for Medical Devices

Project Summary

The intent of this project is to create and maintain one generic Detailed Clinical Model that defines the main concepts of using medical device related data safely and traceably in for patient care. This DCM is intended to be reused in other domains where devices play a role in assessment and treatment. In addition, several specific DCM will be developed for exemplar medical devices in order to iteratively test the generic model. Furthermore, the project will organize clinical content from and about medical devices in such a manner that it becomes reusable in different domain models, standards and technologies, thus supporting consistency of representation and semantic interoperability.

Project Team

• Anneke Goossen-Baremans
• John Rhoads
• Greg Staudenmaier
• Ioana Singureanu
• Todd Cooper
• Dr. Christof Gessner
• Jan Wittenber
• Melvin Reynolds
• Catherine Hoang
• Holly Miller
• Donna DuLong
• Luigi Sison

Meeting Information

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Template for Meeting Minutes (Detailed Clinical Models for Medical Devices)

Project Scope

The intent of this project is to create and maintain one generic Detailed Clinical Model that defines the main concepts of using medical device related data safely and traceably for patient care. This DCM is intended to be reused in other domains where devices play a role in assessment and treatment. In addition, several specific DCM will be developed for exemplar medical devices in order to iteratively test the generic model. Furthermore, the project will organize clinical content from and about medical devices in such a manner that it becomes reusable in different domain models, standards and technologies, thus supporting consistency of representation and semantic interoperability.

The overall purpose of a Detailed Clinical Model (DCM) is to enhance the semantic interoperability between different standards, systems and developments. This includes internal HL7 harmonization efforts. Patient Care WG is currently creating a top 10 of DCM which is part of HL7 project 320 on DCM. The DCM criteria and methodology is addressed by ISO NIWP 13972, approved July 2009, the methodology for HL7 Domain Analysis is documented in the HL7 Development Framework (HDF).

DCMs are created for a variety clinical domains. The core part of a DCM is the full data item specification and determination of relationships between data elements. In many types of DCM (in particular the Blood Pressure, Body Weight, O2 Saturation and others) medical device measurement are an integral component of the clinical data used by nurses and physicians.

The stakeholder requirements (use cases, mind maps) will be used by the facilitators to create models that use a formal notation (UML2) and may be published and balloted as Domain Analysis Models.

DEfinition of Medical Devices

The baseline for medical device DCM is the following definition based on the Information Document Concerning the Definition of the Term “Medical Device”. GHTF/SG1/N29R16:2005 published by the Global Harmonization Task Force, (2005):

• • Medical device means any instrument, apparatus, implement, machine, appliance,

implant, in vitro reagent or calibrator, software, material or other similar or related article: 1) intended by the manufacturer to be used, alone or in combination, for human beings for one or more of the specific purpose(s) of:

• diagnosis, prevention, monitoring, treatment or alleviation of disease,
• diagnosis, monitoring, treatment, alleviation of or compensation for an injury,
• investigation, replacement, modification, or support of the anatomy or of a physiological process,
• supporting or sustaining life,
• control of conception,
• disinfection of medical devices,
• providing information for medical or diagnostic purposes by means of in vitro examination of specimens derived from the human body;

and

2) which does not achieve its primary intended action in or on the human body by pharmacological, immunological or metabolic means, but which may be assisted in its intended function by such means.”