Approach to Traceability of
Endoscopic Devices
GS1 Healthcare conference, TokyoOctober 29 2008
Olympus Medical Systems Corp.
Naomi Sekino
Endoscopy & Laparoscopic Surgery
2
Endoscopic Treatment Less Invasive Surgery
Utilizing a small incision
Flexible Endoscope for Gastroenterology
Video scope
EndoTherapy Accessories
3Video system
scope
Electro surgery unit
Endoscope reprocessing device
Surgical Endoscopy Equipment
4Video scope
Urology Instrumentation
Ultrasonic Surgical System
Electro surgery unitLaparoscopic Surgery
System Integration of Endoscopy
Improve the workflow for endoscopic treatment & surgery
5
Endoscopic Lab Operating Room
One touch control for equipment
Endoscope Network System
Issues & problems: control of medical instruments
� Article control– Prevention of missing or lost instruments
– Identifying loan instruments
� Control of infection history– Identifying infection route at the occurrence of secondary
infection
6
infection
– Sterilization and history control of instruments used for a Creutzfeldt-Jakob disease patient
� Regular maintenance check– Implementing regular check-ups of instruments according
to the use
� Economical efficiency– Providing required minimum goods, in a timely manner
Surgical instruments cycle in a hospital
OR Cleaning/Disinfection
7
OR Cleaning/Disinfection
Instruments checkSterilization
StorageDry
Problems for medical instruments
Manual checking of
Risk of human error
8
Manual checking of instruments by hand
� Which instrument?
� Where is the Lab or OR?
� Who is the Doctor?
� Who’s the patient ?
� When is the surgery?
� What type of surgery?
� How long is the surgery?
Missing
6W1H
Importance of Traceability for Endoscopic Instruments
9
-Attach data carriers for ID control to endoscopic instruments to connect the “Items” and “Data”-Centralized control of use history
“Items” “Data”
GS1 HealthcareRegulation((((Japanese MHLW,
FDA))))
Approach for traceability of endoscopesGlobal Global StandardStandard
ApplicationApplicationStudyStudy
10
Laser Marking
Labeling
RF-ID
In collaboration
with Osaka University TechnologyTechnology
StudyStudy
In collaboration with Osaka University� Verification of usefulness for traceability
utilized direct marking or RF-ID on surgical
endoscopes and instruments
11
Dr.Nakada,
Director of the Surgery CenterNumber of beds = 1,076
Number of operations/year ≒≒≒≒ 7,984
TUR-P Transurethral Resection of Prostate
Light GuideHF Cable
Bladder
Electrode
⇒⇒⇒⇒ ⇒⇒⇒⇒
12
Suction
Bladder
Electrode
Resect Scope
Prostate Irrigation
Resection
Prostate
Experiments utilizing resectscope system
Application of resectscope system for TUR to trial study
13
Why was the resectscope for Traceability?
Approximately 30
parts per container
�The instruments contain many parts in various shapes and sizes
⇒⇒⇒⇒Preparation and maintenance is quite troublesome
14
↑Autoclavable items
Camera Head EOG or Plasma sterilization →
Coding on package
�GS1-128
�Supply chain management
�Assignment for direct part marking
15
�Assignment for direct part marking
Direct marking adopted for pilot study
�Prerequisite conditions– Standard code recommended by GS1
– Durable against cleaning, disinfection and sterilization
– Size which can be marked on endoscopic instruments
Adopted conditions
16
�Adopted conditions– Data carrier:Data matrix or QRcode
– Data contents : 25 digits(GTIN+S/N)、16digits(S/N in hospital)
– Minimum size:1.44×1.44mm(25digits)
Direct marking on the metal parts
Flat stainless 1.44mm x 1.44mm□, 25Byte
18
Curvestainless
Φ4
.5(m
m)
1.2mm x 2.6mm, 16Byte
Results~Clinical trial~Previous type Impossible to read 5 per 16(Durability avg. 4 case)
Improved type Impossible to read 0 per 5(Durability avg.12 case)Previous marking Improved marking
Before use After 12 casesAfter 4cases
19
Loop 30°
Loop 12°
RF-ID
ID informationSerial No.
Olympus system server
Applied study utilizing RF-ID
20
PDAwith scanner
Scope ID tag
RF-ID
Software
system server
Surgical scope
Objects for traceability
A. Surgical Endoscopes 24pcs
B. Work Stations/ 9sets. Equipments containing 87 separate parts
C. LCD Monitor/ 6sets
21A B C
10BASEcategory5 Special Network for OR
CEroom10BASEhub
System Chart
Cleaning room Clean hall
22
Server PC
PDA1-3
Wireless LAN
Accesspoint
Reading OR data by USB memory PDA
1-1PDA2-1
PC端末
Label printer
PDA2-1
Drawing data by USB memory
PDA2-2
(for check)
PDA2:Bar code+RFID scanning modelPDA1:Barcode+2D code scanning model
Accesspoint Access
pointAccesspoint
Wireless LAN Wireless
LAN
RFID tagSizeφ36mm×7mm
Individual recognition by RF-ID & 2D code
2D code
23
Sizeφ36mm×7mm
Weight:9g
Identification No.: Adoption of GS1 code
(01)04953170201165(21)XXXXXXX(241)6001
GTIN No. S/N S/N used by hospital
RecordingCleaning
Room
PDA
After cleaning
OR Information
Stock Room
OR
InputInputInputInputEndoscope
Work Station
Store
Set
ScanScanScanScan
ScanScanScanScan
24
Label Printer
Clean Hall
OR Information
InputInputInputInput
Container
Label
Pack
Attach
Send
PrintSterile
Storage
ScanScanScanScan
ScanScanScanScan
Result(HD EndoEye Video scope)� Rigid Video scope
– A50011A: O.D.φ10mm, 0° 2 pcs.
– A50013A: O.D.φ10mm, 30° 8 pcs.
– A50021A: O.D.φ5.4mm, 0° 2 pcs.
– A50023A: O.D.φ5.4mm, 30° 2 pcs.
26
� Bending Videoscope (Flexible)
– LTF Type VH: O.D.φ10mm 8 pcs.
– LTF Type VP: O.D.φ5.4mm 2 pcs.
Period :2007/8/20~2008/7/1Total numbers of surgery performed :7800 cases(laparoscopic or endoscopic surgery):1300 cases
A record of an scope Rigid scope 10mm30°IDNo.2006
Date OR No. Course Method Doctor Start End Time
2007/8/21 7082138 ThoracoThoracoscopic ***
Dr.S 9:40 13:15 215
Laparoscopic Dr.Y 9:40 17:25 465
When Where WhoWhich How long
What
27
2007/8/27 7082714 GSLaparoscopic ***
Dr.Y 9:40 17:25 465
2007/9/5 7090520 GSLaparoscopic ***
Dr.N 13:40 17:50 250
2007/9/12 7091211 GSLaparoscopic ***
Dr.S 14:40 18:30 230
・・・・・・
・・・・・・
・・・・・・
・・・・・・
150
200
250
300
350
Usage number
Usage frequency by type
(2007/8/20~2008/7/18)Rigid 10mm 0°Rigid 10mm 30°
Rigid 5mm 30°Flexible 10mm
Rigid 5mm 0°
Flexible 5mm
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0
50
100
150
A50011A (硬性 10mm, 0°) A50013A (硬性 10mm,
30°) A50021A (硬性 5mm, 0°) A50023A (硬性 5mm,
30°) LTF VH (フレキシブル10mm) LTF VP (フレキシブル 5mm)
Kinds of endoscope
Usage number
Rig
id
10m
m 0°° °°
Rig
id
10m
m 3
0°° °°
Rig
id
5m
m 0°° °°
Rig
id
5m
m 3
0°° °°
Fle
xib
le
10
mm
Fle
xib
le
5m
m
30
35
40
45
50
Usage number
Usage frequencies by individuals
Re
pa
ir
(( ((2
mo
nth)) ))
Re
pa
ir
(( ((5
mo
nth)) ))
Re
pa
ir
(( ((5
mo
nth)) ))
Rigid 10mm 0°Rigid 10mm 30°
Rigid 5mm 30°Flexible 10mm
Rigid 5mm 0°
Flexible 5mm
29
0
5
10
15
20
25
1001
1002
2001
2002
2003
2004
2005
2006
2007
2008
4001
4002
5001
5002
3001
3002
3003
3004
3005
3006
3007
3008
6001
6002
ID of endoscope
Usage number
Re
pa
ir
(( (( Re
pa
ir
(( ((R
es
erv
e
Re
se
rve
Usage frequency by departments
150
200
250
300
Usage Number
Rigid 10mm 0°Rigid 10mm 30°
Rigid 5mm 30°Flexible 10mm
Rigid 5mm 0°
Flexible 5mm
30
G/S
Th
ora
co
Uro
Pe
dia
tric
s
OB
/Ge
ne
Ort
ho
pe
dic
s
EN
T
Oth
er
Oth
er
0
50
100
消化器
外科
呼吸器
外科
泌尿
器科
小児
外科
産婦
人科
眼科
整形
外科
形成
外科
耳鼻咽
喉科
心臓
外科
救命救
急センター
Departm ents
Usage Number
Flexible 5mm
G/S
Th
ora
co
Uro
log
y
Pe
dia
tric
s
OB
/Gyn
e
Op
hthththth
alm
olo
gy
Ort
ho
pe
dic
s
Pla
sti
c
EN
T
Ca
rdia
c
ER
Conclusion
�We can build a traceability system that shows when, where and to whom the surgical instruments are used.
�This system will allow Osaka University
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�This system will allow Osaka University Hospital to visualize their use of devices and instruments based on the history of use and lead to improvement of efficiency and patient safety.