Unique Device Identification of Surgical Instruments · PDF fileNumber of instruments to tag...
Transcript of Unique Device Identification of Surgical Instruments · PDF fileNumber of instruments to tag...
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Unique Device Identification ofUnique Device Identification ofSurgical Instruments
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Summary
Presentation of Robert Ballanger Hospital
The evolution of the traceability of sterile medical devices
2
The project of Unique Device Identification
Our next GS1 projects
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Robert Ballanger Hospital
Intercity hospital serving a population of 400,000 persons
650 beds
450 beds in acute care (medical, chirurgical and maternity)
3
maternity)
200 psychiatry beds
Outpatient clinic and pharmacy inside Villepinte detention center
CDG airport hospital
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Traceability of Medical Devices in Robert Ballanger HospitalRobert Ballanger Hospital
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Sterilization unit
120 000 sterilized devices per year
20 000 surgery boxes per year
5
20 000 surgery boxes per year
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Repartition of the sterilisation unit activity
OTHERS27% OPERATING
THEATER39%
6
STOMATOLOGY13%
UCSA6%
EMERGENCY6%
39%
MATERNITY9%
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Traceability
Operating room Sterilization unit
Pre-cleaning Cleaning
Pharmacy
ReceptionImplantable
Medical Device
TraceabilityImplantable
Medical Device
7
Surgery intervention
PackagingSterilization
DistributionDistribution
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Traceability of Medical Devices with GS1 Standards
Pharmacy
ReceptionImplantable Medical Device
Distribution
GS1
Operating room
GS1
8
Sterilization unit
Distribution of a sterile medical device
Process
GS1
Surgery intervention
Patient traceability
Patient record
GS1
IT Prescription
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Unique Device IdentificationThe CHIRB choice
DATAMATRIXInfodotLaser
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+Easy and fast taging
Cost
-Deterioration faster than the others
+Industrial tagingEasy reading
Industrial treatment of instrument
-Time to tag Devices
GS1
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Traceability in year 2009
The Robert Ballanger Hospital choice
% Traceability of sterilisations / year
2009DATAMATRIX% Traceabilityof instruments
10
20%
Clinical services
Operating theater
INFODOT
LASER
4 000
1 000
35%
10%
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DATA MATRIX LASER
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Non conformity of surgical boxes
8.7% of No Conformity
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Quality of Instruments3.7%
Problem of packaging5 %
Can be resolved by UDI Can Not be resolved by UDI
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Number of instruments to tag
Article name N° Quantity
BOITE INOX 42X18X9 CM B120 1
MANCHE DE BISTOURI N° 4 M330 1
CISEAUX MAYO DROIT 16 CM C111 1
CISEAUX MAYO COURBE 18 CM C112 1
PINCE DISSECTION A/G 14 CM P124 1
PINCE DISSECTION S/G 14 CM P125 1
PINCES KOCHER A/G 14 CM P126 61 reference
6 Trays / reference39 instruments / tray
234 instruments
Tray 1
Tray 2
13
PINCES KOCHER A/G 14 CM P126 6
PINCES KELLY DROITES S/G 14 CM P127 6
PINCES KELLY COURBES S/G 14 CM P128 6
PINCES A CHAMPS BACKHAUSS 12 P129 4
PINCE A PANSEMENT DROITE 24 CM P130 1
PORTE-AIGUILLES MAYO-HEGAR 18 A440 1
PORTE-AIGUILLES DE DOYEN 14 CM A441 1
ECARTEUR DE FARABEUF 12 CM E550 1
ECARTEUR FARABEUF 15 CM E551 1
VALVES DE KELLY 23 CM V660 2
VALVES VAGINALES DE DOYEN 90 MM V661 2
PINCE DISSECTION S/G 20 CM D770 1
PINCE DISSECTION A/G 25 CM D771 1
CaesareanTray
1 reference 234 instruments for the reference “Caesarean Tray”
Tray 3
Tray 4
Tray 5
Tray 6
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Number of instruments to tag
63333255498725178222Number of trays
33115143253341530138Number of
references
SumOphtalmoInfantilUrologyStomatoORLObstetricVisceralOrthopa
edics
Surgical specialities
14
10 6603826727121 6739451 1071 8993 270Number of
instruments to tag
951081860260
Trays which can
not be tagged
(implants)
63333255498725178222Number of trays
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Tag resistance to sterilisation
Test on 8 different instruments :
95% inox – 5% titanium
laser datamatrix, stamping, infodot, RFID
Result : 100% lisibility on Inox laser marked instruments after 200 sterilisation cycles
Pre
Cleaning
Thermal
disinfection
Rinsing DryingWashing
Time
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Resistance of the laser tag
100
120
140
160
180
Resis
tan
ce o
f th
e laser
tag
-Y
ears
-
16
0
20
40
60
80
100
0 50 100 150 200 250 300 350
Number of references
Resis
tan
ce o
f th
e laser
tag
-Y
ears
-
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Number of instruments to tag
3 438148665 years ≤ LT < 10 years
2 54597162 years ≤ LT < 5 years
3031LT < 2 years
number of sterilisation cycles / year)
N°instruments
N° TraysN° referencesTag life time (LT) in years (based on
Life time of the tags : 200 cycles
N° tagging /
10 years
5 053
5 893
161
10 106
11 787
323
N° tagging /
20 years
17
10 660634335Total
2 24127219120 years ≤ LT
2 4061146110 years ≤ LT < 20 years
3 438148665 years ≤ LT < 10 years
3 899
5 656
5 053
20 663Number of markings if life cycle of
instruments is 10 years
Number of markings if life cycle of
instruments is 20 years28 045
2 241
3 589
10 106
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Type of Tagged Instruments
200
250
300
350
400
450
30
40
50
60Number
%
18
N=719 Instruments Tagged
0
50
100
150
Troca
r
Sca
lpel
Hook
s
Retra
ctor
Force
ps
Sci
ssor
sN
eedle
Hold
er
Var
ious
0
10
20
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Logistic data360 instruments can be tagged a week
Depending on supplier (500 a week for our French supplier)
Depending on the numbers of instruments that can be sent per week
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Percentage of code readable : >97%100 % technically readable when tested after their laser marking
Our choice : keeping speed of work by not reading very small instruments
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Conclusion – Laser Data Matrix
First results show the easiness of the logistic of tagging
Laser 2D barcodes are practically all readable
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Laser 2D barcodes are practically all readable and it is possible to tag small instruments
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Our next GS1 projects2010 - 2012April 2010
Ongoing2010 - 2012End 2009 End 2010
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Link between prescription and material flow (GS1) : a focus on drug process
Electronic
Patient
Record
Ward / Nursing unit Pharmacy
Collaborative work
Prescription -Opinion
doctor pharmacist
1. Prescribe
2.
Analysis
Proposed prescription *
Prescription+ opinions
3. Analysis opinions + exchanges
(*) : following te protocols established between pharmacists and medical practitioners
Depending on manufacturer
Ongoing
Pharmacy Computerized Stock Management
Delivery
Informations
patient
Nurse
Dispensation
Supply chain management
Collaborative work
Opinion
SupplierSemi-automated distribution robot
Central pharmacystocks
4.Preparation
5.Adminis-tration
Prescription
6. Administrative recording
Administration
Medecine
catalog
Data matrix
Nursing Unit medecine cabinet
GS1End 2010
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What are we all aiming for?
Improving patient safety
• And GS1 standards are helping us ...
Contact : [email protected]