Transcript Unique Device Identification (UDI) System for Medical Devices http://www.ghtf.org/ahwg/ahwg-proposed.html Dr Larry Kelly Therapeutic Goods Administration Australia WHO Informal Consultation on Nomenclatures for Medical Devices – Geneva.

Unique Device Identification (UDI) System
for Medical Devices
http://www.ghtf.org/ahwg/ahwg-proposed.html
Dr Larry Kelly
Therapeutic Goods Administration
Australia
WHO Informal Consultation on Nomenclatures for Medical Devices – Geneva – 23-24 March 2011
The objective of a UDI is to enhance patient
safety by:
• Facilitating traceability of devices by providing a single globally
accepted source for identification of medical devices through
distribution and use.
• Improving the identification of devices involved in adverse events
leading to more rapid resolution of problems.
• Facilitating field service corrective actions.
It is anticipated that a UDI System may facilitate the reduction of
medical errors by simplifying integration of information on device
use into medical records.
WHO Informal Consultation on Nomenclatures for Medical Devices – Geneva – 23-24 March 2011
Implementation issues of a global UDI
The true benefit, in terms of patient safety , will only be achieved if all
stakeholders (from manufacturer through to healthcare providers) use
the globally harmonized UDI systems.
Local deviations (regional or country) will have a negative impact on
the main objective of enhancing patient safety. The risk that the
entire UDI concept would become inconsistent and unmanageable is
very high. Therefore the GHTF strongly recommends avoiding such
deviations.
WHO Informal Consultation on Nomenclatures for Medical Devices – Geneva – 23-24 March 2011
The GHTF guidance aims to avoid prescriptive countryspecific requirements regarding the core elements of the
UDI System by developing common guidance to:
– Create, use and maintain a unique “Device Identifier”
– Develop and apply a “UDI Carrier”
– Describe a ‘UDI Database” with a defined list of Data
Elements.
WHO Informal Consultation on Nomenclatures for Medical Devices – Geneva – 23-24 March 2011
UDI
The UDI is a series of numeric or alphanumeric characters
that is created through a coding system. It allows the
unambiguous identification of a specific product on the
market and represents the “access key” to device related
information stored in the UDI Database. The UDI
comprises the Device Identifier and Production Identifier.
Note: The word “Unique” does not imply serialisation of
every single device, e.g. those devices marketed in lots
and batches.
WHO Informal Consultation on Nomenclatures for Medical Devices – Geneva – 23-24 March 2011
Explanation of Terms
UDI System
The framework for the production of a Unique Device Identifier (UDI), the application of
the UDI on the label or directly on product, and the storage of the UDI and additional
device related information in a UDI Database.
UDI – Device Identifier (static)
Is a unique numeric or alphanumeric code specific to a medical device and that is also
used as the “access key” to information stored in a UDI Database.
UDI – Production Identifier (dynamic)
Is a numeric or alphanumeric code providing information reflecting how the device is
controlled. The different types of Production Identifier(s) can include any combination of
serial number, lot/batch number, manufacturing or expiration date.
UDI Carrier
UDI Carrier is the means to convey the UDI by using automatic identification and data
capture (AIDC) and if applicable human readable information (HRI).
UDI Database (UDID)
The UDID is an organized collection of information associated with medical device
identification and labelling.
WHO Informal Consultation on Nomenclatures for Medical Devices – Geneva – 23-24 March 2011
Guidance for the UDI System
•
A UDI System for medical devices shall consist of a unique identification code
using a globally accepted standard format. In order to accommodate most
methods of labelling, marking, and identifying products, UDI Carrier should be
technology neutral. National or regional regulatory requirements shall not
restrict methods of AIDC as this will hinder the establishment of a global UDI
System.
•
Internationally accepted coding systems such as GS1 and HIBCC, meet the
criteria of the UDI and manufacturers shall be permitted to choose which
system to use.
WHO Informal Consultation on Nomenclatures for Medical Devices – Geneva – 23-24 March 2011
Guidance for the UDI System
•
The manufacturer shall be responsible for creating and maintaining the
uniqueness of its medical device UDI throughout all jurisdictions world-wide.
All along the supply chain the UDI created by manufacturer shall not be
altered.
•
The UDI Carrier shall be on the label of the device or on the device itself.
•
The manufacturer is responsible for maintaining the accessibility of their UDI
and the related information (UDI Database)
•
The National/Regional regulation for UDI System shall include a robust
process for evaluation and adjudicating applications for UDI exemptions.
WHO Informal Consultation on Nomenclatures for Medical Devices – Geneva – 23-24 March 2011
Guidance for the UDI System
•
The assignment of a UDI to a device shall follow international medical device
identification standards allocation rules. A significant change to device
characteristics requires that a new UDI must be allocated to the product.
•
Reprocessors of single use devices (SUD) shall create a new UDI. All
requirements shall apply to the reprocessed SUD. The processor is
responsible for ensuring that the reprocessed device cannot be confused with
the original SUD.
•
Remanufacturers shall create a new UDI. All requirements shall apply to the
remanufactured device. In addition the remanufacturer shall retain a record of
the original manufacturer’s UDI.
WHO Informal Consultation on Nomenclatures for Medical Devices – Geneva – 23-24 March 2011
Guidance for the UDI System
•
The Device Identifier and the Production Identifier must be individually
identifiable.
•
The UDI should be human readable and encoded in an AIDC format.
•
If there are significant space constraints limiting the use of both forms on the
label, the AIDC format shall be favoured. However, certain environments or
use situations, such as home care, may warrant the use of human readable
over AIDC.
•
In case of RFID, human readable information and bar code shall also be
provided.
WHO Informal Consultation on Nomenclatures for Medical Devices – Geneva – 23-24 March 2011
Device Identifier
•
Manufacturer information
•
Device information
•
Special characteristics (sterile) and properties (latex),
•
Production information.
WHO Informal Consultation on Nomenclatures for Medical Devices – Geneva – 23-24 March 2011
Production Identifier
•
The Production Identifier specifies the particular production unit i.e. Serial
number, and/or batch, or lot number. If the label has an expiry date, it shall be
part of the UDI Production Identifier. If the device does not have a serial
and/or batch or lot number, the manufacture date shall be used.
•
The different types of Production Identifiers included in the UDI will depend on
the risks associated with the distribution and use of the device. Based on this
risk assessment certain devices do not require Production Identifiers as part
of the UDI.
WHO Informal Consultation on Nomenclatures for Medical Devices – Geneva – 23-24 March 2011
UDI Database
The wording UDI Database (UDID) refers to a global conceptual Database
which in practice may consist of a single internationally accessible database
or a network of Regional UDI Databases which should be able to
communicate with each other.
The manufacturer shall be responsible for submitting and maintaining the
identifying information and other device data elements in the UDID.
All UDID data elements are required, unless indicated otherwise. “If
applicable” means the information shall be in the UDID when it appears on the
label.
WHO Informal Consultation on Nomenclatures for Medical Devices – Geneva – 23-24 March 2011
Acknowledgements:
GHTF Ad Hoc Working Group
L Selles (Chair)
C Tarrajat
J Crowley
L Tao
M Kreuzer
T Werthwi
Y Liang
C Rose
J Elkin
J Secunda
M Neumann
R Munoz
V Zeinar
H Ishikawa
http://www.ghtf.org/ahwg/ahwg-proposed.html
WHO Informal Consultation on Nomenclatures for Medical Devices – Geneva – 23-24 March 2011