Proposed rule : Unique Identifier for Device

The system established by this rule would require the label of medical devices and device packages to include a unique device identifier (UDI), except where the rule provides for alternative placement of the UDI or provides an exception for a particular device or type of device such as devices sold over-the-counter and low risk devices. Each UDI would have to be provided in a plain-text version and in a form that uses automatic identification

and data capture (AIDC) technology

The UDI will provide a key to obtain critical information from a new database, the Global Unique Device Identification Database (GUDID), which will include information important to the identification of devices. UDIs will appear in both plain-text format and a format that can be read by a bar code scanner or some other AIDC technology. Certain devices for which the labeling requirement alone may not be sufficient would also be directly marked with a UDI, allowing accurate identification even when the device is no longer accompanied by its label or package.

The types of devices that would be subject to the direct marking require are implantable devices; devices intended to be used more than once, and which are intended to be sterilized before each use; and stand-alone software. These types of devices have physical characteristics, or characteristics of use, that significantly increases the probability that the device will become separated from its label, particularly when used over an extended period of time.

On Thu, May 3, 2012 at 12:59 PM, carl mattocks <carlmattocks@gmail.com> wrote:

Good Folk:

Before our next meeting I would like to get your comments on the following as possible (normative) Schema elements for an EPR e-Device http://www.oasis-open.org/committees/download.php/39080/EPR%20eDevice%20Standard.pdf

[eDevice identifier]
based on ANSI/CEA-721/844

http://www.eprforum.no/news.php/EPR-eDevice-copyright-transfer-from-the-CEA-721-series-and-CEA-844-to-EPR-Forum/1/29/

[identity credential]

OASIS Trust Elevation TC works to define a set of standardized protocols that service providers may use to elevate the trust in an electronic identity credential presented to them for authentication.

[personal identity]
OASIS Cross-Enterprise Security and Privacy Authorization (XSPA) Technical Committee will specify healthcare profiles of existing OASIS standards to support reliable, auditable methods of confirming personal identity, official authorization status, and role attributes. This work aligns with security specifications being developed within the U.S. Healthcare Information Technology Standards Panel (HITSP)

[UMDNS identifier]

Incorporate Universal Medical Device Nomenclature System identifiers

UMDNS consists of a unique five-digit universal medical device code (UMDC) number followed by a plain-language description in English or various other languages. .. to establish document files and computer-based data retrieval systems and to index articles, publications of hazards, recall reports, regulatory data sets, etc. UMDNS names are also used as the primary term for more detailed product classifications.

https://www.ecri.org/Products/Pages/UMDNS2009License.aspx

thanks

Carl Mattocks

bcm message