Hi Carl,
This seems to fit very well with the eDevice
modelling structure ;-)
I am back from Denmark on Friday and will dig more
into it.
Can we Skype on Friday ?
Best regards
Hans
----- Original Message -----
Sent: Wednesday, July 11, 2012 4:17
PM
Subject: [bcm] Proposed rule : Unique
Identifier for Device
BCM Folk:
Please review contents of proposed USA FDA rule to have Unique
Identifier for medical Device. . and consider whether or not the TC should
provide Comments
on the proposed rule being accepted until Nov. 7, after which the FDA
will draft a final version of the rule.
................
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:
[eDevice identifier]
based on ANSI/CEA-721/844
[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.
thanks
Carl Mattocks -- CEO CheckMi President BTUSAR
Dive Team Producer Shore Adventure Cell (usa) (732) 497-CARL
{2275} CarlMattocks@CheckMi.com Information Risk Checks > Secure
Continuous Service
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