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Medical Device Standards

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Presentation on theme: "Medical Device Standards"— Presentation transcript:

1 Medical Device Standards
Organization Description Link Systematized Nomenclature of Medicine--Clinical Terms (SNOMED-CT®) International Health Terminology Standards Development Organisation (IHTSDO) Comprehensive clinical terminology Logical Observation Identifiers Names and Codes (LOINC®) Regenstrief Laboratory and clinical observations Rosetta Terminology Mapping (RTM) IHE Patient Care Devices Working group Medical Device Terminology Mapping that relates proprietary device codes to ISO IEEE , LOINC, SNOMED-CT. Universal Medical Device Nomenclature System™ (UMDNS) ECRI Institute Standard international nomenclature and computer coding system for medical devices. It is used to as a taxonomy of devices for inventory, management, and acquisition. https://www.ecri.org/Products/Pages/UMDNS.aspx?sub=Management%20Tools,%20Guidelines,%20Standards,%20and%20Nomenclature IHE Patient Care Devices Technical Framework – Integration Profiles (Volume 1) Integrating the Healthcare Enterprise (IHE) Specification of detailed workflow and information exchange to support Device to Enterprise Communication, Implantable Device Communication, Infusion Pumps, and Rosetta Terminology Mapping. IHE Patient Care Devices (PCD) Technical Framework – Transactions (Volume 2) IHE Technical specification consisting of set of HL7 Version transaction profiles to support the integration profiles in Volume 1 The lines identify the relationships between standards initiatives. We also highlight that HL7 Version 2 is used/constrained. HL7 Version 2

2 Medical Device Standards
Organization Description Link IHE PCD Technical Framework – Semantic Content (Volume 3) IHE Specifies use-case-specific content profiles that constrain the structure and content (including standards-based interoperability). It is intended to encourage the reuse of structural/semantic specification referenced in Volume 2 of the framework. Terminology such as ISO IEEE , LOINC, SNOMED-CT are used to specify constraints. Supplement to IHE PCD framework: Alarm Communication Management (ACM) Published to support alarm communication and management – including notifying clinicians of specific alarm events Supplement to IHE PCD framework: Infusion Pump Event Communication (PEC) Published ; the CP-PCD (IPEC Trigger Event) was published to support the communication of pump workflow events. Subscribe to Patient data (SPD) Published (Reissued for on ) to support patient demographics lookup.

3 Medical Device Standards
Organization Description Link The Continua Version 2011 Design Guidelines Continua Health Alliance The Continua Health Alliance's Design Guidelines contains references to the standards and specifications that Continua selected for ensuring interoperability of devices. It also contains additional Design Guidelines for interoperability that further clarify these standards and specifications by reducing options in the underlying standard or specification or by adding a feature missing in the underlying standard or specification. These guidelines focus on the following interfaces: PAN-IF - Interface to Personal Area Network health devices. xHRN-IF - Interface between Disease Management Services (DMS) WAN devices (xHR Senders) and Electronic Health Record (EHR) devices (xHR Receivers). These guidelines were specifically written for device manufacturers that intend to go through the Continua Certification process with their devices, companies that integrate Continua devices in systems and subsystems, and test labs that certify compliance to Continua specifications. Continua offers verification and certification of vendor products. This aspect is very attractive from a contracting stand-point. The contract language could also require that a product passes Continua certification testing.

4 Medical Device Standards
Organization Description Link ISO IEEE , Health informatics – Point-of-care medical device communication – Nomenclature ISO IEEE Within the context of the ISO/IEEE 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.


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