This document summarizes a presentation on future compliance requirements related to medical devices. It discusses changes coming in how medical devices are named (GMDN), tracked (UDI), and have data captured (AIDC/GS1 coding). The Global Medical Device Nomenclature (GMDN) will standardize device names. Unique Device Identification (UDI) will assign each device a unique identifier tracked in a public database. Automatic identification like GS1 coding will help interface equipment and data. Hospitals should prepare by understanding these changes to integrate new identification standards.

1. Paul A Blackett
Medical Engineering Operations Manager
Lancashire Teaching Hospitals NHS
Foundation Trust
Preparing forPreparing for
futurefuture
compliancecompliance
requirementsrequirements

2. 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
AIDC UDI

3. Paul A Blackett: SBK Compliance Conference
2013

4. Paul A Blackett: SBK Compliance Conference
2013
C arm
Mobile Image Intensifier
Screening Unit
Mobile x-ray machine
Intensifier, Mobile

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2013
Introducing GMDNIntroducing GMDN
The Global Medical Device NomenclatureThe Global Medical Device Nomenclature
(GMDN) is a system of internationally(GMDN) is a system of internationally
agreed descriptors used to identifyagreed descriptors used to identify
medical device products.medical device products. [1][1]
““
””

6. Paul A Blackett: SBK Compliance Conference
2013
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

7. Paul A Blackett: SBK Compliance Conference
2013
GMDN Data

8. Paul A Blackett: SBK Compliance Conference
2013
GMDN Data
The device category is the broadest level of the GMDN data. It divides the
entire medical device product market into highest-level groups based on
device application, technology, or other common characteristics. The
standard (ISO 15225) allocates codes for 20 categories. These are:
Category Description
01 Active implantable devices
02 Anaesthetic and respiratory devices
03 Dental devices
04 Electro mechanical medical devices
05 Hospital hardware
06 In vitro diagnostic devices
07 Non-active implantable devices
08 Ophthalmic and optical devices
09 Reusable devices
10 Single use devices
11 Assistive products for persons with disability
12 Diagnostic and therapeutic radiation devices
13 Complementary therapy devices
14 Biological-derived devices
15 Healthcare facility products and adaptations
16 Laboratory equipment
17 Vacant
18 Vacant
19 Vacant
20 Vacant

9. Paul A Blackett: SBK Compliance Conference
2013
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.

10. Paul A Blackett: SBK Compliance Conference
2013
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.

11. Paul A Blackett: SBK Compliance Conference
2013
GMDN Data
Sample data…

12. Paul A Blackett: SBK Compliance Conference
2013
GMDN Data
What it looks like in real life…
•Longer Device Type names!
•Use the Term ID as the Equipment Code?

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2013
GMDN Data
•Integration with SNOMED CT
'Systematized Nomenclature of Medicine Clinical Terms'
The Integration of
GMDNS into Clinical
Terminology and
health records. [3]

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2013
Unique
Device
Identification

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2013
Unique Device Identification [4][5]
A unique code combination that
identifies the attributes of an
individual medical device.
“
”

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2013
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

17. Paul A Blackett: SBK Compliance Conference
2013
Unique Device Identification
Made up of 2 parts
The Production Identifier
The Device Identifier
(possible location in use…)

18. Paul A Blackett: SBK Compliance Conference
2013
Unique Device Identification
The Production Identifier
This code specifies the particular production unit.
•Serial Number
•Expiry Date and/or Lot Number

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2013
Unique Device Identification
The Device Identifier
This code identifies a specific product (model
variant) and acts as a key to access the Unique
Device Identifier Database (UDID)

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2013
Unique Device Identification
+ = UDI
The Production Identifier The Device Identifier
Already stored
on our databases
Something new
to store!

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2013
UDI Database

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2013
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.

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2013
Device IdentifierDevice Identifier
CodeCode

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2013
Unlocking the UDI

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2013
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…

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2013
Unlocking the UDI
• Sterile or non-sterile
• Contains latex or not
• Size and unit of
measure (if relevant)
• Packing quantity

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2013
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

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2013
[6]

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2013
Automatic
Identification and
Data Capture

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2013
Formats
• UDI should be readable in human and digital form
• Any digital formats can be used that conform to an
ISO format

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2013
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]

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2013
GS1 Coding
• Patient wrist band identification
• Drugs
• Medical Equipment
• Staff

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2013
[F1]8004505521790000023672
GIAI
Global Individual Asset Identifier Site code
Local number
GS1 identifier
Format and coding in practice

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2013
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.

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2013
Time to get
Prepared!
10
10

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2013
1 Register with the GMDN Agency
Look 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

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2013

38. Paul A Blackett: SBK Compliance Conference
2013
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 Paul.Blackett@lthtr.nhs.uk