gmdns, udi, barcodes and more

Paul A BlackettMedical Engineering Operations Manager

Lancashire Teaching Hospitals NHS Foundation Trust

Preparing for Preparing for future future

compliance compliance requirementsrequirements

Paul A Blackett: SBK Compliance Conference 2013

What’s Changin

g?

What we call our medical devices!

Where we get

our data from...

How medical devices

are tracked

GMDN

AIDCUDI


C arm

Mobile Image Intensifier

Screening Unit

Mobile x-ray machine

Intensifier, Mobile


Introducing GMDNIntroducing GMDN

The Global Medical Device Nomenclature The Global Medical Device Nomenclature (GMDN) is a system of internationally (GMDN) is a system of internationally agreed descriptors used to identify agreed descriptors used to identify medical device products. medical device products. [1][1]

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Introducing GMDN

Brings together 6 previous nomenclatures [2]

From ISO 15225:2010 (part of Global Harmonization)

Used by Manufacturers and EUDAMED (European Database on Medical Devices)

Maintained by GMDN Agency [1]

Accessible at a low cost to pay for administration Device type = Preferred Term

http://www.gmdnagency.com/Default.aspx


GMDN Data


GMDN DataThe device category is the broadest level of the GMDN data. It divides theentire medical device product market into highest-level groups based ondevice application, technology, or other common characteristics. The standard (ISO 15225) allocates codes for 20 categories. These are:

Category Description01 Active implantable devices02 Anaesthetic and respiratory devices03 Dental devices04 Electro mechanical medical devices05 Hospital hardware06 In vitro diagnostic devices07 Non-active implantable devices08 Ophthalmic and optical devices09 Reusable devices10 Single use devices11 Assistive products for persons with disability12 Diagnostic and therapeutic radiation devices13 Complementary therapy devices14 Biological-derived devices15 Healthcare facility products and adaptations16 Laboratory equipment17 Vacant18 Vacant19 Vacant20 Vacant


GMDN Data

Collective terms are high-level device terms used to aggregate medical device groups that have common features within the GMDN. Collective terms may be device names (e.g., Stents, Catheters, Pacemakers) or device attributes (e.g., Electrophysiology, Absorbable, Home-use); the device name collective terms are especially used to create hierarchical constructs in the GMDN.


GMDN Data

Preferred terms with their unique 5 digit codes are the only terms available for product identification. The preferred term is the optimal name selected to represent a group of devices (a collection of device types) that have the same or similar intended use or commonality of technology allowing them to be grouped in a generic manner, typically without reflecting specialized characteristics such as brand or trade names.

Other Terms exist such as Template, which is used as a root for more specific terms and Synonym which is used as a navigational toot to find the Preferred Term.


GMDN DataSample data…


GMDN DataWhat it looks like in real life…

•Longer Device Type names!•Use the Term ID as the Equipment Code?


GMDN Data

•Integration with SNOMED CT

'Systematized Nomenclature of Medicine Clinical Terms'

The Integration of GMDNS into Clinical Terminology and health records. [3]


Unique Device Identification


Unique Device Identification [4][5]

A unique code combination that identifies the attributes of an individual medical device.

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Unique Device Identification• Been around for 20+ years• GHTF Proposal in 2010• The FDA progressing in US• Reusable and single use • Permanent markings

New guidance due 14 Nov 13



Made up of 2 parts

The Production Identifier

The Device Identifier

(possible location in use…)



The Production Identifier

This code specifies the particular production unit.•Serial Number•Expiry Date and/or Lot Number



The Device Identifier

This code identifies a specific product (model variant) and acts as a key to access the Unique Device Identifier Database (UDID)



+ = UDI

The Production Identifier The Device Identifier

Already stored on our databases

Something new to store!


UDI Database


UDI Database

•Data submitted by Manufacturers

•Single database or possibly a network of national ones that update each other.

•Publicly and internationally accessible - free of charge.


Device IdentifierDevice IdentifierCodeCode


Unlocking the UDI


Unlocking the UDI• Manufacturers name• Manufacturers address• Contact name (if different)

• GMDN code• Any Trade or Brand name • Device Model number• Controlled by…

(serial/batch/lot)

• and…


Unlocking the UDI• Sterile or non-sterile• Contains latex or not• Size and unit of

measure (if relevant)• Packing quantity


Practical Uses of the UDI

• Tracking and tracing

• MHRA alerts

• Adverse Incident reports

• Recalls of implants

• Counterfeit control

• Populating databases with correct data

• Procurement improvements


[6]


AutomaticIdentification and Data Capture


Formats• UDI should be readable in human and digital form

• Any digital formats can be used that conform to an ISO format


Coding

• DH encouraging common data structures - Coding for Success in 2007 [7] – GS1 coding for patient and equipment use– Register with GS1uk (300+ trusts reg’d)

– Recommended by the NAO [8] and Lord Hunt [9]

• Considered by Parliament – DH to progress implementation [10]


GS1 Coding

• Patient wrist band identification

• Drugs

• Medical Equipment

• Staff


[F1]8004505521790000023672

GIAIGlobal Individual Asset Identifier Site code

Local number

GS1 identifier

Format and coding in practice


In Summary…

• GMDN – FDA will adopt as part of UDI

– Some UK hospitals already registered

• UDI Mentioned in EU Medical Devices Regulations revision [11]

• UDI-US adopting this year

• UDI-MHRA acknowledged [12]

• GS1 – Already here.


Time to getPrepared!

10 10


1 Register with the GMDN AgencyLook into changing to GMDN

2 Contact your database support and ask if they are ready for UDI

3 If your Trust hasn’t already done so, register with GS1uk and think

about labelling integration


References and suggestions for further study[1] http://www.gmdnagency.com/[2] http://www.gmdnagency.org/Downloads/GMDN_Agency_User_Guide_v120810.pdf[3] http://www.ihtsdo.org/news/article/article/ihtsdo-and-gmdna-signs-cooperation-agreement/[4] GHTF 2010 Unique Device Information for Medical Devices

http://www.ghtf.org/documents/ahwg/AHWG-PD2-N2R2.pdf no longer available see instead:http://www.imdrf.org/docs/imdrf/final/work-items/imdrf-wi-120923-presentation-udi.pdf#search="revised udi guidance“

[5] http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm310505.htm[6] http://www.udiconference.com[7] DH 2007 Coding for Success.

http://www.dh.gov.uk/en/Publicationsandstatistics/Publications/PublicationsPolicyAndGuidance/DH_066082[8] GS1-uk 2010 http://www.gs1uk.org/news/Pages/GS1UKNewsDetails.aspx?NewsID=445 [9] http://www.connectingforhealth.nhs.uk/systemsandservices/aidc/background[10] http://www.publications.parliament.uk/pa/cm200809/cmselect/cmhealth/151/15110.htm[11] Revision of Medical Device Directive

http://www.mhra.gov.uk/Publications/Consultations/Deviceconsultations/CON205361 page 20 #15.4

[12] MHRA Draft 2013-2018 corporate plan http://www.mhra.gov.uk/home/groups/comms-ic/documents/publication/con216948.pdf see page9 for UDI information

Thank you for your attention [email protected]

http://www.gmdnagency.com/

http://www.gmdnagency.org/Downloads/GMDN_Agency_User_Guide_v120810.pdf

http://www.ihtsdo.org/news/article/article/ihtsdo-and-gmdna-signs-cooperation-agreement/

http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm310505.htm

http://www.udiconference.com/

http://www.gs1uk.org/news/Pages/GS1UKNewsDetails.aspx?NewsID=445

gmdns, udi, barcodes and more

Health & Medicine

device names

medical device products

medical device groups

device attributes

individual medical device

highlevel device terms

administration device

collection of device