Safe

Medical Devices / Instruments

dalam
Keselamatan Pasien
Dr BAMBANG TUTUKO SpAn KIC

WORKSHOP KESELAMATAN PASIEN DAN MANAJEMEN RISIKO KLINIS

DI RUMAH SAKIT
What When
Why Whom
Which How
Who
 SAFETY DEVICE

LAT KESEHATAN dengan RISIKO TERKECIL berakib

Alcohol Swab
Alat Suntik
Sarung Tangan
V Catheter
Dressing
Botol Infus / Infusion Set
Catheter / NGT
Tempat Tidur
Termometer
Tensimeter
ECG
Ambulans
USG / Rontgen / CT-ScanScan / MRI dll
 Syringes ADS
afety Devices
Medication Non
Cat
Delivery Syringes
Therapy No
Cat
Intervention Safety Tools
Medical
Specimen Bloo
Capture d Vac
Diagnostic Non-Blood
TU
CL
Sys
ECG, USG,
ety Data/Image Other TUBEs
MRI, CT-Scan
CT
Capture ICU Monitor or Devices
ices
Waste Medica
Care Mngmnt. Was
Related
Non-Medical Food, Linen, Gas, Ambulance etc.
Shar
Was
Non-Care
Care Related Building
PRINSIP SAFETY DEVICE
1
The RIGHT DEVICE for
The RIGHT PROCEDURE fo
The RIGHT PATIENT
2
Safety in
KRITERIA SAFETY DEVICE

SAFETY BAHAN TEKNO PROSES

LOGI
Untuk PASIEN
TEKN
ntuk PETUGAS
uk ANGGARAN

KONSEPTUAL / Strategis
 untuk

Safety
untuk AMAN
untuk
Kelangsungan
Bisnis Petugas
ENYATAAN.

eselamatan Keselam
Keselamatan
Kerja Institu
Na-Kes Pasien
Rumah

Orang
Alat
Sistem Kerja
#1:AMAN untuk PASIEN
RISIKO TERKECIL untuk KTD & KNC
(HAI/BSI, Drug Reactions, and
IATROGENIC DAMAGE dan terutama,
MIS-DIAGNOSIS
DIAGNOSIS )

Safety
Infus set - mencegah emboli udara
AIs: Masalah Pelayanan Kesehatan Duni

Hampir 6 juta HAIs per

ns of Infections
di USA, Eropa, Jepang
6.9 90,000 kematian akiba
per tahun di USA; 50,00
6.3 6.4
.6 5.9

Eropa
Umumnya terkait dg d
Japan
resistant bacteria : MRS
Europe VRE (UP 2,5x since 200
U.S.
Beban biaya sangat tin
002 2005 2009 2010 2015
bagi pelayanan kesehata

Stop Press MRSE sudah HADIR di Indonesia!

AIs: Masalah Pelayanan Kesehatan Dunia

MORBIDITAS MORTALITA
% = Urinary Tract Infections 11,1 %
% = Surgical Site Infections 8,2 %
% = Pneumonia/Lung Infections 36,3 %
% = Blood-Stream
Stream Infections 30,9 %
DIMANA?
1,96 % = High Risk Nurseries
1,12 % = Well-Baby
Baby Nurseries
24,55 % = ICUs (all patients)
74,55 % = Outside ICUs (all patients)
USA : Klevens, Edwards, Richards, et al. Pub Health Rep 2007;122:160-6
2: AMAN untuk PETUGA

RISIKO TERKECIL
untuk NSI & Blood Splatter,
Splatter
DAK memudahkan ERROR saat DIPAK

Safety
 SIAPA : Profil
Profil Korban NSI
NSI
USA 1993-2001,
2001, 87 institutions; 25,577 incidents

OR Nurses (5%)
Technicians (5%)
Students (2%)
Laboratory (4%)
Residents (9%)
Others (8%)
House keeping & laundry
Phlebotomists (5%)
er assistants (4%) Staff physicians (6%)
ory Therapists (2%)

Nurses ( 55%)

Source: International Health Care Worker Safety Center, Univ. of Virginia, USA
KAPAN KTD Luka Tusuk/NSI terjadi?
saat/sesudah menyuntik/memasang IV-Cathether
IV (B
atter!)
at memasang kembali (re-cap)
cap) penutup jarum suntik
bat gerak pasien tidak terkontrol (Paediatri & Psikiatri
at pemindahan cairan tubuh ke dalam alat suntik atau
ngumpul lain untuk pemeriksaan Laboratorium
mbuangan alat suntik bekas yg tidak sesuai aturan
na cipratan darah (Blood
Blood Splatter)
Splatter dari ujung jarum a
eter atau dari sampah medis yang tidak ter-AMAN-ka
ter
DIMANA KTD Luka Tusuk terjadi?
USA 1993-2001 - 87 institutions - 25,577 incidents

Kamar Pasien
Others (9%) (34%)
Clinic (1%) Diluar kamar pasien,
posal area (2%) beres-beres (2%)
Laboratory (3%)
Emergency Room (8%)
ang Tindakan (5%)

%) Outpatient Clinics ICU (7%)

OK (23%)

Source: International Health Care Worker Safety Center, Univ. of Virginia, USA
lobal Distribution of Global Distribution of H
HIV/AIDS, 1999 Infections, 1984-199
Source: UNAIDS/WHO Source: Ippolito, et.al.

North A
Western

hers Sub-Saharan
26% Africa Others 90%
70% 6%
4%
Sub--Saharan
Africa
4%

ica/ Western Europe

rban risiko terkena infeksi HIV AIDs (0.3%), HepB
%), HepC (3%) + 20 infeksi lain
rban harus segera diperiksa lab & diterapi/PEP
rban Di-bebastugas-kankan dari merawat pasien
a beban biaya langsung/direct
/direct cost terkait korban
ya tidak langsung/indirect
/indirect cost) akibat lanjut KTD
uk
ya-biaya ini HARUS ditanggung Institusi (ref:
elamatan Kerja).
al biaya sekitar Rp 9,670,000/orang/KTD
9,670,000
3: AMAN untuk ANGGARA
(Kelangsungan Bisnis)
mberi TOTAL VALUE yang TINGG
enurunkan TOTAL COST of CARE

Safety
tal VALUE = Hasil Pelayan

asil Klinis Terbaik Yang Dapat Dicap

+
puasan Pelanggan (Pasien & Keluar
+
Keuangan RS tetap Sehat
fety Devices dalam Pelayanan Kesehat
Data &
Fisik Specimen
Images

DIAGNOSTIK

NG OR
t CONTINUUM of CARE SE

TERAPI

Medikasi Tindakan
(Medicine Farmasi Nursing (Inter-
Delivery) vention)
wiss Cheese Diagram (Reason, 199

KT
 KENYATAAN

TEKNIS STRATEGIS

Infeksi Tuntutan
(HAI/BSI/CRBSI) Image
NSI Sustainability
Mis-Dx & Mis-Tx

otal Cost of Care NAIK Total Business Cos

Total Value TURUN TINGGI

Pasien & RS
AIs: Masalah Pelayanan Kesehatan Dunia

MORBIDITAS MORTALITA
% = Urinary Tract Infections 11,1 %
% = Surgical Site Infections 8,2 %
% = Pneumonia/Lung Infections 36,3 %
% = Blood-Stream
Stream Infections 30,9 %
DIMANA?
1,96 % = High Risk Nurseries (PICU/NICU)
1,12 % = Well-Baby
Baby Nurseries
24,55 % = ICU (semua pasien)
74,55 % = Di luar ICU (semua pasien)
USA : Klevens, Edwards, Richards, et al. Pub Health Rep 2007;122:160-6
 SAMPLE Data SURVEILANS di
INDONESIA
nfeksi di RS tertinggi :
nfeksi Aliran Darah (IAD/BSI) kejadian Plebit
Berikutnya:
nfeksi Saluran Kemih (ISK)
nfeksi Saluran Napas (ISN dan VAP)
nfeksi Luka Operasi (ILO).
ejadian Dekubitus.
 KRITERIA TEKNIS
SAFETY DEVICES

BAHAN : Medical / Surgical Grade

TEKNOLOGI : Mutakhir dg Error Margin 3% - 5%
asics for Hypodermic Syring
Tapered Marka Jelas
Plunger
Positive Stop retaining
retaining Barrel
ring BENING

Luer Tip
ated Latex - Free
umb Stopper
ss Sayap lebar
Flanges BAHAN
Polyprophylene
Medical Grade

MINIMUM
Reflux
Reflux dan
riteria ALAT SUNTIK yang bai

han polyprophylene medical grade

grade Barre
ning kaca
um stainless steel surgical grade & double be
Dead space minimum (less than 0.01)
Marka jelas (bold scale marking)
Plunger sulit lepas saat aspirasi (positive stop
unger ada lekukan (tapered plunger rod)
angkal Barrel bersayap
bersayap lebar
lebar (wide flange)
 Basics for IV Catheter
han kateter : Biomaterial
Biomaterial
han bagian lain : polypropylene medical grade
n stainless steel
andrin aman untuk NSI/luka tusuk & Blood
atter

bitis = Komplikasi IV Catheter yg paling sering

an kateter merupakan penyebab utama thrombophlebitis
han Biomaterial mengurangi phlebitis s/d 46% D
ngurangi kerusakan ujung kateter s/d 50%
URCE : Gaukroger, P.B. et al, Infusion Thrombophlebitis: A prospective comparison, Anaesth Intens c
 Bahan : Full
Full Cotton
Cotton
Packing : Full foil dg heat-resista
Full aluminum foil
lining di bagian luar dan diproses secara vak
Bahan aktif : Isopropyl alcohol / Acohol + Iodin
Alcohol + Chlorhexidine

asics for Electronic

Electronic Diagnostics
ndustrial Component NOT General OR Househ
voltage & Full Insulation
Micro-voltage
Clear direction for maintenance & calibration
50,000 hours LCD
RISIKO TINGGI
(1) Infeksi , (2) Image,
(3) Tuntutan

TINGGI dalam
Pemakaian Alat,
Beban Kerja,
Capital Investment.
MANA & KAPAN Safety Device

HARUS (Segera) :
1. UGD 2. ICU 3. OK
4. Laboratorium (Klinik/Mikro/Rad.) 5. Poliklinik
6. Bangsal Bedah 7. Bangsal Paediatri

Sebaiknya juga segera

1. VIP Unit* 2. Bagian Gizi

Baru kemudian.
Semua Bangsal/Unit Pelayanan
MEMILAH dan MEMILIH?
Tindak Lanjut?
akah MONIT
Peralatan
Terkait YA! KTD krn YA! (HAI/BS
SUDAH
ralatan? Alat? and
Safety?
RCA) REVIE

KTD krn
Cara Pakai?
DAK BELUM FOKUS PADA
HIGH RISKS
kan RCA SEGERA Infections
mencari LAKUKAN Image, Leg
yebab HIGH in
DVA! Usage/Consum
dasar
Production Pres
TD!
Capital Investm
LAKUKAN Laporan KTD/NSI,
RCA, FMEA, Risk Grading dll
 s alat habis pakai/consumables (Syringes, Al
bs, Gloves, IV Catheter, dll) & alat high Capital
stment (Diagnostik, Transport, Infrastructure, dll

unit RS dengan high production

s pada unit-unit
sure, high infection-risk
risk dan high image-&-leg
(OK,
OK, ICU, UGD, Lab, Poli, Bangsal Paediatri, Be
VIP)

T : Biaya langsung 6 KTD Luka Tusuk = 20,000 safety syringe / 4,000 safety IV Ca
Absence of Equipment Maintenanc
:
India : Moderate
Nepal : High
Bangladesh : Moderate
Srilangka : Moderate Low
Indonesia : High
(IAPB Workshop Report, 2008)
asic guidance on safety and calibration checks
Risk assessment before first use
Some products should be risk assessed before first use

Equipment requiring risk assessment before first use

 DECONTAMINATION
CORRECT PROCEDURE
Staff handling used medical equipment should assume that it is
contaminated and take precautions to reduce the risk to
themselves and others. The use of personal protective
equipment/clothing should be considered.

Medical devices should be decontaminated and stored in

accordance with legislative and best practice requirements. Whe
appropriate decontamination should always be carried out in
dedicated facilities, for example:

endoscopes endoscopy suite

surgical instruments sterile services

home loans home loans decontamination facility.

There should be a local policy for the management and
transport of medical equipment from the point of use to the
with the decontamination of medical
devices

Senior managers and the board should monitor and

 PEMANFAATAN
INFORMATION TECHNOLOG
(IT)
DALAM PATIENT SAFETY
MAIN STRATEGIES FOR PREVENTING
ERRORS AND AEs USING IT
IT

OOLS TO IMPROVE COMMUNICATION

AKING KNOWLEDGE MORE READILY
ACCESSIBLE
SSISTING WITH CALCULATIONS
ERFORMING CHECKS IN REAL TIME
ASSISTING WITH MONITORING
ROVIDING DECISION SUPPORT
ATIENT SAFETY INFORMATION SYSTEM

DVERSE EVENT REPORTING SYSTEM

(AERS)
AERS)
IGH RISK RESULTS (HRR)
HRR) DETECTION
SYSTEM
EDICATION SAFETY SYSTEM
URGICAL SAFETY SYSTEM
IT EFFECTS ON PATIENT SAFETY
IT

PROVING ACCESS TO INFORMATION

OVIDING DECISION SUPPORT:

- ALERTS & REMINDERS
- MEDICATION PRESCRIBING
- MEDICATION APPROPRIATENESS
AND MONITORING
- ADVERSE EVENT DETECTION
 Using Technology to Reduce Medication error
Computerized Physician Order Entry (CPOE):

CPOE is effective in reducing

medication errors.
involves entering medication
rders directly into a computer
ystem rather than on paper or
erbally.
cations Administration Process
cian enters CPOE
puterized Physician Order
)
Nurse administers medication
and eMAR (Electronic Medication
1 Administration Record updated)

Nurse alerted 4
to administer
patient medication
ets CPOE

2 3
gets medication from Smart Nurse goes to patient ro
et; Unit dose medication is and scans medication;
ded; Dispensed medication Medication checked aga
to patient ID; and the Patient ID and time; Do
k order is sent. calculations generated
 eMap), helps prevent errors by linking the bar
eMap)
code technology with electronic patient
medication profiles.

The system is designed to achieve the

five rights
rights:

Right patient

Right drug

Right dose

Right time

Right route of administration

 $25 $250
delivered

patient should undergo surgery without pul