英国医疗器械命名和分类系统的现状:聚焦于GMDN和SNOMED CT。

JRSM short reports Pub Date : 2013-06-05 Print Date: 2013-07-01 DOI:10.1177/2042533313483719
Judith White, Grace Carolan-Rees
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引用次数: 6

摘要

用于描述医疗器械的标准化术语可以实现安全和明确的信息交换。欧盟范围内医疗器械法规的拟议变更要求使用这种系统。本文回顾了英国医疗器械的两个重要分类系统。全球医疗器械命名法(GMDN)提供了一个专门针对医疗器械和诊断的分类系统,并促进了制造商和监管机构之间的数据交换。SNOMED CT是NHS用于交流、共享和存储有关患者医疗保健事件信息的首选术语。GMDN和SNOMED CT的统一将鼓励在器械的整个生命周期内使用单一术语;从监管批准到临床使用和上市后监测。制造商将被要求向欧洲设备数据库(Eudamed)注册医疗设备,并为某些设备配备唯一设备标识符;两者都是为了提高医疗设备的透明度和可追溯性。这些要素的成功实施取决于医疗器械的一致命名法。
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Current state of medical device nomenclature and taxonomy systems in the UK: spotlight on GMDN and SNOMED CT.

A standardised terminology for describing medical devices can enable safe and unambiguous exchange of information. Proposed changes to EU-wide medical devices regulations mandate the use of such a system. This article reviews two important classification systems for medical devices in the UK. The Global Medical Device Nomenclature (GMDN) provides a classification system specifically for medical devices and diagnostics, and facilitates data exchange between manufacturers and regulators. SNOMED CT is the terminology of choice in the NHS for communicating, sharing and storing information about patients' healthcare episodes. Harmonisation of GMDN and SNOMED CT will encourage use of single terminology throughout the lifetime of a device; from regulatory approval through clinical use and post-marketing surveillance. Manufacturers will be required to register medical devices with a European device database (Eudamed) and to fit certain devices with a Unique Device Identifier; both are efforts to improve transparency and traceability of medical devices. Successful implementation of these elements depends on having a consistent nomenclature for medical devices.

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