18aMedical Device Safety Untuk WSKPIKPRS PERSI(Dr. BAMBANG

7/18/2019 18aMedical Device Safety Untuk WSKPIKPRS PERSI(Dr. BAMBANG

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Medical Device

dal

Keselama

Dr BAMBANG T

ORKSHOP KESELAMATAN PASIE

DI RUM

e

s / Instruments

am

an Pasien

TUKO SpAn KIC

N DAN MANAJEMEN RISIKO KLINI

H SAKIT



What

Why

Which

Who

When

Whom

How



SAFETY

AT KESEHATAN dengan

DEVICE

ISIKO TERKECIL beraki











lcohol Swab

lat Suntik

arung Tangan

ressing”

otol Infus / Infusion Set

atheter / NGT

empat Tidur

ermometer

CG

mbulans

SG / Rontgen / CT-Scan / MRI dll…

f t D i



fety DevicesMed

De

Therapy

Diagnostic

Medical

Data/Image

Capturety

ces

EC

MRI,

ICU

Care

Related

Non-Care Relat

Non-Medical Food,

ication

livery

yr nges

Non

Syringes Ca

N

Ca

pecimen

Capture

Bloo

dNon-Blood

Va

T

CL

Sy

Other TUBEs

or Devices

, USG,

CT-Scan

Monitor

ed

Waste

Mngmnt.

Linen, Gas, Ambulance etc.

Building

Medic

Wa

ShaWa



he RIGHT P•The RIGH

Safe

OCEDURE f PATIENT

ty in



SAFETY BAHAN

ntuk PASIEN

tuk PETUGAS

k ANGGARAN

KONSEPTU

EKNO PROSES

LOGI

TEK

L / Strategis



unt

Saf

AMuntuk

Kelangsungan

Bisnis

u

ty

Nuntuk



selamatan

Kerja

Na-Kes

Kese

Pasi

Orang

Alat AlatSistem Kerja

lamatan

n

Kesela

Instit

Rumah



1:AMAN un

ISIKO TERKECIL(HAI/BSI, Drug

ATROGENIC DAMA

Sa

MIS-DIA

t uk PASIE

untuk KTD & KN Reactions, and

E dan terutama,

ety

NOSIS )



Infus set - mencegah emboli udara





s of Infections

Japan

Europe

.6 5.96.3

6.9

6.4

U.S.

02 2005 2009 2010 2015

Stop Press MRSE sud

• Hampir 6 juta HAIs pe

di USA, Eropa, Jepang • ,

per tahun di USA; 50,0

Eropa• Umumnya terkait dg

resistant bacteria : MR

VRE (UP 2,5x since 20• Beban biaya sangat ti

bagi pelayanan kesehat

h HADIR di Indonesia!



MORBIDITAS

= Urinary Tract Infecti= urg ca e n ec

= Pneumonia/Lung In

= Blood-Stream Infect

DIM

• 1,96 % = High Risk

• , = e - a

• 24,55 % = ICUs (all

• 74,55 % = Outside I

USA : Klevens, Edwards, Richards, e

ns

MORTALIT

• 11,1 %ns

ections

ions

• ,

• 36,3 %

• 30,9 %

NA?

Nurseries

urser es

atients)

Us (all patients)

al. Pub Health Rep 2007;122:160-6



RI SI KO

ntuk NSI & B

Sa

memu a an

ERKECI L

ood Splatter,

ety

saa



USA 1993-2001, 87 instit

Laboratory (4%)Technicians (5%)

ry Therapists (2%)

r assistants (4%)

Phlebotomists (5%)

Others (8%)

Source: International Health Care W

Nurs

utions; 25,577 incidents

OR Nurses (5%)

Students (2%)

Staff physicians (6%)

Residents (9%)

House keeping & laundry

rker Safety Center, Univ. of Virginia, USA

s ( 55%)

APAN KTD L k k/NSI t j di



APAN KTD Luka

saat/sesudah menyuntik/

t memasang kembali (re-

at gerak pasien tidak terkt pemindahan cairan tubu

gumpul lain untuk pemeri

a cipratan darah ( Blood

ter atau dari sampah me

usuk/NSI terjadi

emasang IV-Cathether (

ap) penutup jarum suntik

ontrol (Paediatri & Psikiatri h ke dalam alat suntik ata

saan Laboratorium

platter ) dari ujung jarum

is yang tidak ter-AMAN-k







USA 1993-2001 - 87 insti

(

ng Tindakan (5%)

aboratory (3%)

osal area (2%)

Clinic (1%)

Others (9%)

OK (2

Source: International Health Care W

tutions - 25,577 incidents

4%)

Diluar kamar pasien

beres-beres (2%)

Emergency Room (8%)

%)

rker Safety Center, Univ. of Virginia, USA



lobal Distribution of

HIV/AIDS, 1999Source: UNAIDS/WHO

ers Sub-Saharan

Africa70%

26%

u -

ica/ Western Europe

4%

Global Distribution of

Infections, 1984-19

Source: Ippolito, et.al.

North

Wester

Others 90%6%

4%

a aran

Africa



ban risiko terkena infek

), HepC (3%) + 20 infean arus segera per

ban Di-bebastugas-kan

beban biaya langsung a tidak langsung/indir

k

-elamatan Kerja).

l biaya sekitar Rp 9,67

si HIV AIDs (0.3%), HepB

si lain sa a erap

ari merawat pasien

direct cost terkait korbact cost) akibat lanjut KT

,000/orang/KTD



: AMAN un

beri TOTAL VA enurunkan TOTA

Sa

uk NGGAR

UE yang TING COST of CAR

ety



a as e aya



a =

uasan Pelanggan

euangan

as e aya

(Pasien & Kelua

e ap e a





Fisik Specim

CONTINUUG

DIAGN

TER

Medikasi(Medicine

Delivery)

Farmasi

n

Data &

Images

of CAREO

S

STIK

PI

NursingTindakan

(Inter-

vention)

ee e e



ee e e ,

K



TEKNIS

Infeksi(HAI/BSI/CRBSI)

NSI

Mis-Dx & Mis-Tx

Pasie

tal Cost of Care” NAIK

Total Value TURUN

STRATEGIS

“Tuntutan”Image

Sustainability

& RS

“Total Business Co

TINGGI



MORBIDITAS

= Urinary Tract Infecti

= Pneumonia/Lung In

= Blood-Stream Infect

DIM

1,96 % = High Risk N

, -

24,55 % = ICU (semua

74,55 % = Di luar ICU (

USA : Klevens, Edwards, Richards, e

ns

MORTALIT

• 11,1 %

ections

ions

,

• 36,3 %

• 30,9 %

NA?

rseries (PICU/NICU)

pasien)

semua pasien)

al. Pub Health Rep 2007;122:160-6



INDO

feksi di RS tertin i :

feksi Aliran Darah (IAD

erikutnya:feksi Saluran Kemih (IS

feksi Saluran Napas (IS

feksi Luka O erasi ILO jadian Dekubitus.

ESIA

BSI) kejadian Plebit

K)

dan VAP)

.



SAFETY

BAHAN : MedicaTEKNOLOGI : Mutakhir

DEVICES

l / Surgical Gradeg Error Margin 3% - 5%

y

y



y

TaperedPlunger

ated

mb

s

ring

Flanges

MINI Reflu

y

arka Jelas

Luer TiLatex - Free

Stopper

arre

BENIN

BAHAN

Polyprophylene

Medical Grade

UMxdan

iteria ALAT S

NTIK yang bai



iteria ALAT S

an polyprophyleneing kaca

umst a in less st eel su r g

ead space m i n im um (

arka jelas (

bo ld sca le

unger su t epas saat

nger ada lekuk an (

t a p

ngkal Barrel bersaya

NTIK yang bai

edical grade Barr

i ca l g r ade & double be

less than 0.01 )

m a r k i n g

)

asp ras (

posi t i ve st o

er ed p l unger r od

)

lebar

(

w ide f lange

)

as cs or a e er



han k ateter : Biomater

as cs or

stainless steel

andrin

am an untuk Ntter

=

n k a teter m er upakan penye

an Biomater ia l mengu

gu r ang i ker usakan u juRCE : Gaukroger, P.B. et al, Infusion Thrombophl

ial

a e er

I/ luk a tusuk & Blood

ab u tam a t h r om boph leb it i s

angi ph lebi t is s/ d 4 6%

g ka teter s/ d 50% bitis: A prospective comparison, Anaesth Intens

B h

F l l C t t



Bahan :

Pack ing : Ful l alum in

in ing

di bagian luar dahan akt if : Isopropyl

Alcohol +

sics for

Electr

r i l m n n

Micro-voltage

Clear d i rect ion f or m

50,000

Ful l Cot ton

m f oi l dg heat-resist

n d iproses secara vak lcohol / Acohol + Iodi

hlorhexidine

nic Diagnost ic

T n r l R H

Ful l Insulat ion

in tenance & cali br at io

ours LCD



RISIKO TIN(1) Infeksi , (2) Imag

(3) Tuntutan

TINGGI dal• Pemakaian Alat

• e an er a,

• Capital Investme

GIe,

m

t.



ARUS (“Segera”) :. .

. Laboratorium (Klinik/

6. Bangsal Bedah 7.

ebaiknya juga sege

*.

aru kemudian….emua Ban sal Unit Pel

.

ikro/Rad.) 5. Poliklinik

angsal Paediatri

ra…

.

anan



MEMILAH d n MEMILIH?



kaherkaitalatan?CA)

YA! KTD krn Alat?

an RCA encari

AK

KTD krnCara Pakai?

dasarD!

LAKUKAN Laporan

RCA, FMEA, Risk G

PeralatanSUDAH

Safety?

MONI(HAI/B

anREVI

YA!

SEGERA LAKUKAN

BELUM FOKUS PADAHIGH RISK

InfectionImage, Le

HIGH inUsage/ConsuProduction PreCapital Invest

KTD/NSI,

ading dll



alat habis pakai/co

s, Gloves, IV Catheter,

,

pada unit-unit RS denure, high infection-ris

OK, ICU, UGD, Lab, P

IP

: Biaya langsung 6 KTD Luka Tusuk = 2

sumables (Syringes, Al

dll) & alat high Capital

, ,

an high production

dan high image-&-le

li, Bangsal Paediatri, B

0,000 safety syringe / 4,000 safety IV Ca



sence o qu

:

India :

Nep

Ban ladesSrilangka :

Indone(IAPB Works

men a n enan

Moderate

l : High

: Moderate oderate –Low

ia : High op Report, 2008)

s c gu ance on sa e y n ca ra on c ec s



s c gu ance on sa e y n ca ra on c ec s

Risk assessment before first use



Risk assessmen

• Some products should bEquipment requiring risk

t before first use

risk assessed before first us ssessment before first use

CORRECT ROCEDURE



CORRECTStaff handling used medical eq

contaminated and take precau.

equipment/clothing should be

Medical devices should be dec

accordance with legislative anappropriate decontamination s

dedicated facilities, for exampl

• endoscopes – endoscopy s

• surgical instruments – steril

• home loans – home loans d

There should be a local politransport of medical equipm

ROCEDURE uipment should assume that it is

ions to reduce the risk to

onsidered.

ontaminated and stored in

best practice requirements. Wh ould always be carried out in

:

ite

services

contamination facility.

y for the management andent from the point of use to the

with the deconta ination of medical



with the deconta

devi

• Senior mana ers and th

ination of medical

ces

board should monitor and







ININ

PEMANFAATANPEMANFAATAN

ORMATION TECHNOLOORMATION TECHNOLO

(IT)(IT)

ERRORS ANDERRORS AND E USINGE USING ITIT



ERRORS ANDERRORS AND

OLS TOOLS TO IMPROVEIMPROVE

KINGKING KNOWLEDGKNOWLEDGCCESSIBLECCESSIBLE

SISTING WITHSISTING WITH CACA

RFORMING CHECRFORMING CHEC

SSISTING WITHSSISTING WITH

OVIDINGOVIDING DECISIODECISIO

Es USINGEs USING ITIT

COMMUNICATIONCOMMUNICATION

EE MORE READILYMORE READILY

CULATIONSCULATIONS

S IN REAL TIMES IN REAL TIME

ONITORINGONITORING

N SUPPORTN SUPPORT



TIENT SAFETY INFTIENT SAFETY INF

VERSE EVENT RVERSE EVENT R

((AERS AERS))

GH RISK RESULTGH RISK RESULT

EDICATION SAFETEDICATION SAFET

RGICAL SAFETYRGICAL SAFETY

ORMATION SYSTEORMATION SYSTE

PORTING SYSTEPORTING SYSTE

((HRRHRR)) DETECTIODETECTIO

SYSTEMSYSTEM

YSTEMYSTEM



ROVINGROVING ACCESS ACCESS

VIDING DECISIOVIDING DECISIO

-- ALERTS & REMI ALERTS & REMI

-- MEDICATION PRMEDICATION PR

-- AND MONITORI AND MONITORI

-- ADVERSE EVEN ADVERSE EVEN

O INFORMATIONO INFORMATION

SUPPORT:SUPPORT:

DERSDERS

ESCRIBINGESCRIBING

GG

DETECTIONDETECTION

U i T h l tU i T h l t d M di tid M di ti



Using Technology toUsing Technology to

Computerized PhysicComputerized Physic

POE is effective in r POE is effective in r

edication errors.edication errors.

involves entering minvolves entering m

stem rather than onstem rather than on

rbally.rbally.

educe Medication erroeduce Medication erro

an Order Entry (CPOE):an Order Entry (CPOE):

ducingducing

dicationdication

paper or paper or

a ons m n s ra on

rocess



ian enters CPOE

uterized Physician Order

ts CPOE

Nurse alertedto administer

patient medicati

1

gets medication from Smart

t; Unit dose medication is

ded; Dispensed medication

to patient ID; and theorder is sent.

Nurse administers medication

n

and eMAR (Electronic Medication

Administration Record updated)

4

Nurse goes to patient r

and scans medication;

Medication checked ag

Patient ID and time; Docalculations generated

o d e t e c h n o l o g y w i t h eo d e t e c h n o l o g y w i t h ed i t i f i ld i t i f i l

e c t r o n ic p a t i e n te c t r o n ic p a t i e n t



e d i c a t i o n p r o f i l e s .e d i c a t i o n p r o f i l e s .

h e s y s t em i s d e s i g n e dh e s y s t em i s d e s i g n e d

i g h t i g h t p a t i e n t p a t i e n t

i g h t i g h t d r u g d r u g

i g h t i g h t d o s e d o s e

i g h t i g h t t i m e t i m e

i g h t i g h t r o u t e o f adm in i s t r r o u t e o f adm in i s t r

t o a c h i e v e t h e t o a c h i e v e t h e

a t i o n a t i o n







$25

atient should under

$250

delivered

o sur er without u



Documents

18aMedical Device Safety Untuk WSKPIKPRS PERSI(Dr. BAMBANG