M.

VENTURA – CHAIRMAN of CLADIMED

Association for the Classification of Medical
Devices.

maurice_ventura@yahoo.fr
 Classification
• Act or process of putting things
(medical devices) into hierarchical
groups, according to a specific goal.

CLADIMED

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 Nomenclature
• System of terms that is elaborated
according to pre-established naming rules,
for describing and identifying things (medical
devices) in an unambiguous manner.Terms
are are assigned with a unique code and a
definition.

GMDN

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 Classifications and nomenclatures

• Classifications
– CLADIMED
– e-class
– UNSPSC
– Classificazione Nazionale dei Dispositivi Medici (Italie)
• Nomenclatures
– GMDN
– UMDNS
– CPV
– EGAR
– LPPR
– EURO-PHARMAT
– AP-HP generic article list

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 CLADIMED association

• Not-for-profit organization
• Users and suppliers association
• Develop, manage and promote a 5 level
classification
– Using family of the ATC classification for drugs
(WHO).
– For medical devices

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 Board of directors

• ACL (Manufacturer association • EUROPHARMAT (hospital

pharmacist and manufacturers
for codification)
association)
• AP-HP (First hospital group in • Hospices Civils de Lyon
Europe) (Second hospital group in
• APPAMED (Manufacturer France)
association) • SNITEM (Manufacturer
• B.BRAUN association)
• BECTON DICKINSON • SNPHPU (hospital pharmacist
trade union)
• CNIHM (hospital pharmacist
• SYNPREPH (hospital
association) pharmacist trade union)
• COLOPLAST • 4 Individuals members
(hospital pharmacists)

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 CLADIMED

• Used by most of French public hospital

• Selected for e-procurement by
“University hospital Centers”
organisation, by “regional
hospitalisation agency” Rhône-Alpes -
Auvergne…

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 Classification principles (1)

• Devices are divided into different groups

– according to the organ or system on which they act
– according to their main use
– according to validated indications
• A device can only be classified in one location
• Modifications are made when new groups are
required or if the present classification is not
adapted.

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 Classification principles (2)

• Modifications are validated by the Scientific

Committee
• Modifications are submitted to manufacturers
and users for comments or objections
• Modifications are included in the classification
once a year, in December.
• A code is never reused

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 Working process

Work groups

Comments Proposals

Users & Suppliers

Family to be reviewed Final Version

Comments

Comments

Scientific committee

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 Family
A - Alimentary tract and
metabolism
B - Blood and blood forming
organs
C - Cardiovascular system
D - Not used (ATC family)
E - Hygiene – Protection (gloves,
clothes..) (New family)
F – “Care” (wounds, bandages…)
(New family)
G - Genito-urinary system
H - Not used (ATC family)
J - Not used (ATC family)
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K – Injection – Sampling -
Exploration (catheters,
syringes…) (New family)
L – Not used (ATC family)
M - Musculo-skeletal system
N - Nervous system
P - Not used (ATC family)
Q - Not used (ATC family)
R - Respiratory system
S - Sensory organs
V - Various
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 CLADIMED

• Family : 12
– Code A to V
• Sub-family : 72
– Code 50 to 99
• Range : 303
– Code A to Z
• Sub-Range : 639
– Code A to Z
• Level 5 : 1 566
– Code 1 to 99

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 Classifications and Nomenclature

• Family CLADIMED
– Sub-Family
• Range
– Sub-Range
» Level 5 e-class

Nomenclature
UNSPSC
(GMDN preferred term +
qualifiers)
Other classifications

Commercials references
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ANNEX: Overview of classifications and
nomenclature
 Hip Prosthesis
• CLADIMED
– M52CA45 – Implant hanche, insert • GMDN
– M52CA46 – Implant hanche, tête – Prosthesis, hip, internal, femoral head/neck
component
– M52CA47 – Implant hanche, cotyloïdien
– M52CA48 – Implant hanche, cupule fixe – Prosthesis, hip, internal, acetabular
component
– M52CA49 – Implant hanche, cupule
mobile – Prosthesis, hip, internal, femoral
– M52CA50 – Implant hanche, fémoral component
modulaire – Prosthesis, hip, internal, resurfacing
– M52CA51 – Implant hanche, fémoral – Prosthesis, hip, internal, total
monobloc, bipolaire
• UNSPSC
– M52CA52 – Implant hanche, fémoral
monobloc, unipolaire – 42295701 Joint replacement implant
– M52CA53 – Implant hanche, fémoral, – 42295702 Orthopedic surgical wire
re-surfaçage – 42295703 Orthopedic trauma implant
– M52CA54 – Implant hanche, fond de
cotyle
– M52CA98 – Implant hanche,
complément
– M52CA99 – Implant hanche, autre

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 e-class - 34-32 Implant
• Joint replacement (hip)
– Primary hip stem (cemented)
– Primary hip stem (cementless)
– Short stem, femoral neck prosthesis
– Surface replacement (femoral component)
– Revision stem (cemented)
– Revision stem (cementless)
– Total hip prosthesis
– Acetabular cup (cemented)
– Acetabular cup (cementless)
– Revision cup
– Acetabular roof ring or cage
– Acetabular insert
– Femoral head
– Unipolar head
– Bipolar cup
– Complete set (hip)
– Joint replacement (hip, unclassified)
– Joint replacement (hip, accessories)

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 Angiography

CLADIMED GMDN
• K51FB01 CATHETERS D'ANGIOGRAPHIE
AORTIQUE
• Catheter, angiography
• K51FB02 CATHETERS D'ANGIOGRAPHIE • Catheter, cardiac, angiography,
CORONAIRE DROITE ventricular
• K51FB03 CATHETERS D'ANGIOGRAPHIE
CORONAIRE GAUCHE UNSPC
• K51FB04 CATHETERS D'ANGIOGRAPHIE • -
PERIPHERIQUE
• K51FB05 CATHETERS D'ANGIOGRAPHIE
e-class
POLYVALENTE • Coronary angiographic catheter
• K51FB06 CATHETERS D'ANGIOGRAPHIE
PULMONAIRE • Peripheral angiographic catheter
• K51FB07 CATHETERS D'ANGIOGRAPHIE • Neurovascular angiographic
SUPRAAORTIQUE catheter
• K51FB08 CATHETERS D'ANGIOGRAPHIE
VENTRICULAIRE • Calibration catheter (angiography)
• K51FB09 CATHETERS D'ANGIOGRAPHIE • Angiographic catheter
VENTRICULAIRE/AORTIQUE
(unclassified)
• K51FB10 CATHETERS D'ANGIOGRAPHIE
VISCERAL
• K51FB11 CATHETERS D'ANGIOGRAPHIE
CEREBRAL

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 Angioplasty
CLADIMED
• C51AB01 CATHETER D'ANGIOPLASTIE
PERIPHERIQUE
• C51AC01 CATHETER D'ANGIOPLASTIE
CORONAIRECAXIAL
• C51AC02 CATHETER D'ANGIOPLASTIE
CORONAIRE GUIDE INTEGRE
• C51AC03 CATHETER D'ANGIOPLASTIE
CORONAIRE GUIDE MONORAIL
• C51AD01 CATHETER D'ANGIOPLASTIE
VALVULAIRE COAXIAL
• C51AD02 CATHETER D'ANGIOPLASTIE
VALVULAIRE GUIDE INTEGRE
• C51AD03 CATHETER D'ANGIOPLASTIE
VALVULAIREGUIDE INTEGRE DE
REPERFUSION
• C51AD04 CATHETER D'ANGIOPLASTIE
VALVULAIRE GUIDE MONORAIL
• C51AD05 CATHETER D'ANGIOPLASTIE
VALVULAIRE GUIDE OLIVE
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GMDN
• Catheter, angioplasty, atherectomy
• Catheter, angioplasty, atherectomy,
ablative
• Catheter, angioplasty, balloon dilatation
• Catheter, angioplasty, balloon dilatation,
coronary perfusing
• Catheter, angioplasty, balloon dilatation,
heated
• Catheter, angioplasty, direct laser
ablation
• Catheter, angioplasty, radio-frequency,
thermal
UNSPSC
• Angioplasty balloon catheter
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 Thank you

M.VENTURA
CLADIMED - maurice_ventura@yahoo.fr
VIDAL SA – maurice.ventura@vidal.fr