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Uni n q i u q e u e D ev e i v c i e c e I d I e d n e t n i t f i i f c i a c t a i t o i n o n of Surgical Instruments

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(1)

Unique Device Identification of

Unique Device Identification of

(2)

Summary

Presentation of Robert Ballanger Hospital

The evolution of the traceability of sterile medical

devices

The project of Unique Device Identification

Our next GS1 projects

(3)

Robert Ballanger Hospital

Intercity hospital serving a population of 400,000

persons

650 beds

450 beds in acute care (medical, chirurgical and

maternity)

maternity)

200 psychiatry beds

Outpatient clinic and pharmacy inside Villepinte

detention center

(4)

Traceability of Medical Devices in

Robert Ballanger Hospital

(5)

Sterilization unit

120 000 sterilized devices per year

20 000 surgery boxes per year

(6)

Repartition of the sterilisation

unit activity

OTHERS

27%

OPERATING

THEATER

39%

STOMATOLOGY

13%

UCSA

6%

EMERGENCY

6%

39%

MATERNITY

9%

(7)

Traceability

Operating room

Sterilization unit

Pre-cleaning Cleaning

Pharmacy

Reception Implantable Medical Device Traceability Implantable Medical Device Surgery intervention Packaging Sterilization Distribution Distribution
(8)

Traceability of Medical Devices

with GS1 Standards

Pharmacy

Reception Implantable Medical Device Distribution

GS1

Operating room

GS1

Sterilization unit

Distribution of a sterile medical device

Process

GS1

Surgery intervention

Patient

traceability

Patient record

GS1

IT Prescription

(9)

Unique Device Identification

The CHIRB choice

DATAMATRIX

Infodot

Laser

+

Easy and fast taging Cost

-Deterioration faster

+

Industrial taging Easy reading Industrial treatment of instrument

-Time to tag Devices

(10)

Traceability in year 2009

The Robert Ballanger Hospital choice

% Traceability of

sterilisations / year

2009

DATAMATRIX

% Traceability

of instruments

20%

Clinical services

Operating theater

INFODOT

LASER

4 000

1 000

35%

10%

(11)
(12)

Non conformity of surgical boxes

8.7% of No Conformity

Quality of Instruments

3.7%

Problem of packaging

5 %

(13)

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 6

1 reference

6 Trays / reference

39 instruments / tray

234 instruments

Tray 1

Tray 2

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

Caesarean

Tray

1 reference

234 instruments

for the reference

“Caesarean Tray”

Tray 3

Tray 4

(14)

Number of instruments to tag

633 33 25 54 98 72 51 78 222 Number of trays 331 15 14 32 53 34 15 30 138 Number of references Sum Ophtalmo Infantil Urology Stomato ORL Obstetric Visceral Orthopa edics

Surgical specialities

10 660

382 672 712 1 673 945 1 107 1 899 3 270 Number of instruments to tag 95 1 0 8 18 6 0 2 60

Trays which can not be tagged (implants) 633 33 25 54 98 72 51 78 222 Number of trays

(15)

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 Drying Washing

(16)

Resistance of the laser tag

100 120 140 160 180 R e s is ta n c e o f th e l a s e r ta g -Y e a rs -0 20 40 60 80 100 0 50 100 150 200 250 300 350 Number of references R e s is ta n c e o f th e l a s e r ta g -Y e a rs
(17)

-Number of instruments to tag

3 438 148 66 5 years ≤ LT < 10 years 2 545 97 16 2 years ≤ LT < 5 years 30 3 1 LT < 2 years

number of sterilisation cycles / year)

N° instruments N°Trays

N° references Tag 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 10 660 634 335 Total 2 241 272 191 20 years ≤ LT 2 406 114 61 10 years ≤ LT < 20 years 3 438 148 66 5 years ≤ LT < 10 years 3 899 5 656 5 053

20 663

Number of markings if life cycle of instruments is 10 years

Number of markings if life cycle of

instruments is 20 years

28 045

2 241 3 589 10 106

(18)

Type of Tagged Instruments

200 250 300 350 400 450 30 40 50 60 Number %

N=719 Instruments Tagged

0 50 100 150 Troc ar Sca lpel Hoo ks Ret ract or Forc eps Sciss ors Nee dle Hol der Var ious 0 10 20
(19)

Logistic data

360 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

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

(20)

Conclusion – Laser Data Matrix

First results show the easiness of the logistic

of tagging

Laser 2D barcodes are practically all readable

Laser 2D barcodes are practically all readable

and it is possible to tag small instruments

(21)

Our next GS1 projects

2010 - 2012 April 2010

(22)

Link between prescription and material flow (GS1) : a focus on drug process

Electronic Patient Record

Ward / Nursing unit Pharmacy

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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

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Supply chain management

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Supplier Semi-automated distribution robot Central pharmacy stocks 4. Preparation 5. Adminis-tration Prescription Medecine catalog Data matrix Nursing Unit medecine cabinet

GS1

End 2010
(23)

What are we all aiming for?

Improving patient safety

And GS1 standards are helping us ...

References

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