Wednesday, July 7, 2010

Standards for Naming Medical Devices

Medical devices are an increasingly important part of care delivery. Discussion of medical device issues has become part of the mainstream press such as last week's Boston Globe article about their security.

A year ago, I wrote about a breakthrough in medical device interoperability standards for content, vocabulary and transmission.

Important work on device interoperability continues in IEEE, IHE, and the Continua Health Alliance.

As devices increase in number and complexity, the FDA wants to ensure devices are tracked with a standardized device nomenclature facilitating recall workflow and enabling easier patient followup over the lifecycle of the device. It should be simple to identify who has what kind of device and which subcomponents have been incorporated into the device.

What are the evolving standards for naming and identifying medical devices?

There are two popular approaches.

The first is the Universal Medical Device Nomenclature System (UMDNS), which is a standard international nomenclature and computer coding system for medical devices. It contains 8,842 unique medical device concepts and definitions (preferred terms), along with an additional 15,702 entry terms to facilitate classifying of biomedical information. UMDNS contains explicit relationships among the nearly 25,000 terms, including relationships among related devices (i.e. component devices versus the overall system). The National Library of Medicine has incorporated UMDNS into the Unified Medical Language System (UMLS)

The second is the Global Medical Device Nomenclature (GMDN). Its creation was mandated by the European Commission in order to provide the necessary tools to carry out many of the obligations required by the Medical Devices Directives. Its scope includes:
1. to give a common generic description for every general term that describes characteristics of a medical device. This is to be used for identifying similar devices to those involved in an adverse incident report;
2. to identify a device, using the generic term, for having been awarded a specific design or other certificate;
3. to serve as a basis for E-commerce – to provide a generic basis for purchasing individual types of manufactured devices, by establishing a heading for comparison of products from different manufacturers.

GMDN notes that UMDNS has been given special consideration within the GMDN. When a term selected from the UMDNS has been used as the preferred choice to create a GMDN term, the exact code of the UMDNS term has been retained.

Although the two systems share a significant common core from a past version of UMDNS, I have been told that the two have drifted apart over time.

Going forward, it would be helpful to have a single nomenclature for all devices and I expect that the HIT Standards Committee will be asked to recommend a single standard to support FDA regulatory needs.

Having a consistent device nomenclature supports quality, safety, and efficiency improvements such as

* Streamlining integration of EHRs and PHRs with home monitoring devices.

* Enhancing reporting from specialist EHRs to device registries (pacemakers, hip joints etc.)
* Reporting of adverse events from the EHR to Medwatch/FDA.

I look forward to the work ahead, harmonizing device naming to enable new functionality and provide increased safety monitoring for all the medical devices we use.

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