Workshop CSSD, Cleaning & Disinfectant

RS Margono Purwokerto, 7 – 8 Oktober 2016

The cycle of sterile supply
Pentingkah Pencegahan Terhadap Infeksi
Nosokomial?

 Pasien dan tenaga kesehatan

memiliki tingkat resiko yang
tinggi terhadap Infeksi
 Infeksi nosokomial
(Healthcare Associated
Infection / HAI) dapat dicegah
/ dikendalikan dengan
beberapa strategi pencegahan
infeksi
 Strategi pencegahan infeksi
adalah dekontaminasi,
pembersihan, disinfeksi dan
sterilisasi
 (Sumber : Materi Pelatihan Desinfeksi dan
Sterilisasi Instrument, Depkes RI tahun 2008)
 PENCUCIAN
MENCUCI / CLEANING

Mencuci bersih adalah :

• Proses yang menghilangkan
semua partikel yang kelihatan
dan hampir semua partikel yang
tidak kelihatan dan menyiapkan
permukaan dari semua alat-alat
agar aman untuk proses
desinfeksi dan sterilisasi.
Pencucian merupakan
aspek fundamental yang
mempengaruhi keberhasilan
proses sterilisasi
 Recommended Practices for Cleaning
Surgical Instruments
AORN (Association of periOperative Registered Nurses) Recommended
Practices Committee.
Please refer to recommendation n°5.

 Cleaning and decontamination should occur as soon as possible after

instruments and equipment are used. (PNDS:I70)

should occur as soon as possible after instruments and equipment are

used to prevent the formation of biofilm.
Faktor-faktor yang mempengaruhi
keberhasilan pencucian :
CONTOH PENGGUNAAN ENZYMATIC CLEANER
Recommended Practices for Cleaning Surgical
Instruments
Countries References Protocol

INDONESIA Pedoman Instalasi Pusat Sterilisasi ( Pencucian dan perendaman instrumen

Depkes RI 2009 ) menggunakan enzymatic cleaner

Argentina Esterilizacion Hospitalaria Volumen 2 - 2005 Pre-soaking with an enzymatic solution

USA ANSI/AAMI ST-35 Pre-soaking with an enzymatic solution

 Disinfection and Sterilization

 A proper disinfection depends on the object’s

intended use:

 Critical
 Semi Critical
 Non Critical

=> CDC guidelines 2008

(Center for Disease Control and prevention)
Critical items : objects which enter normally sterile
tissue or the vascular system

Surgical instruments, cardiac catheters, implants, arthroscopes….

Sterilization / Cold sterilant

 Semi Critical items: Object that touch mucous
membranes or skin

GI endoscopes, respiratory therapy equipement, anesthesia equipment,

thermometer….

High Level Disinfection

Non critical items: object that touch only intact skin

Object that can be expected to be contaminated with some

microorganisms….

Low Level Disinfection

Wrapped and Packed (Pengemasan)

Contoh :
 Linen

 Plastik Film
 Kertas
 Pouches (Kombinasi
plastik film dan kertas)
 Wrapped and Packed (Pengemasan)
• Kriteria Kemasan Yang Baik :

a) Tahan terhadap proses STERILISASI .

( suhu tinggi, kelembaban, tekanan & kondisi vacum )
b) Harus bisa memungkinkan terjadinya pemindahan udara dari
isi & kemasannya .
c) Harus memungkinkan terjadinya penetrasi & kontak langsung
dari agen sterilant, baik itu steam, gas EtO, dan lain-lain .
d) Pada saat akhir proses sterilisasi memungkinkan terjadinya
pengeluaran agen sterilant .
e) Memungkinkan untuk mengeluarkan isi kemasan tanpa
menimbulkan kontaminasi (aseptis ).
 STERILE BARRIER SYSTEM

 DEFINISI:
Suatu sistem pengemasan dengan konfigurasi
minimum ( sederhana ) yang dapat menjaga
sterilitas instrumen didalamnya dan
memungkinkan untuk penyajian aseptis saat akan
digunakan.
 Barrier System Method

- Berdasarkan penelitian Lous Pasteur bahwa

bakteri berjalan hanya lurus dan tidak bisa
berkelok-kelok
Teknik Membungkus Wrapping Paper
Quality checks to be performed by
the user at the CSSD

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 Requirements of ISO11607-2
for Sterile Barrier Systems
The packing material used must be suited to and defined for the
intended packing and sterilization processes

The supplier must provide conformity certificates as per

ISO11607-1
and sections of the EN868, parts 2-10
in respect of:
-microbial impermeability
-compatibility with the sterilization process

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Sterilisation compatibility
STEAM EO & FORM VH2O2
(Plasma)
Paper/film laminates
Non woven/film
laminates

Crepe paper , non

woven, paper bags

Tyvek/ilm laminates

SMS wrapping

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 Sealing seam
one line = minimum standard

three lines = higher safety factor

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 Printing requirements
In case the manufacturer has validated the manufacturing process
only ISO11607 can be printed
other printed standards are not valid

Size of product must be mentioned

Date of manufacturing to calculate the shelf life and lot number

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Printing rapport of indicators on reels shall not be more
than 155mm

Do not use if pack is damaged

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 opening direction

Single use only and brand name

Thumb cut as opening support must be provided at pouches

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 Sealing of pouches and reels
Rotary Sealers are highly recommended
The sealing process must run automatically and must be validated

Minimum 6mm sealing seam width similar at all sides of

the pack – max. 15mm
Recommended temperature for sealing 175°C-200°C
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Unprofessional bar sealer

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 The sealing seam made by the hospital must be checked
for integrity
no sealing failures like channels or holes at the sealing seam are accepted
sealing seam integrity test seal check

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No channel= sealing seam is integer channel=sealing seam is not integer
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Do not put pouches, reels or wrappings close to alcohol,soap or
desinfactents as the barrier function get distroid by it

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Wrong packed and overloaded
Sterile Barrier System

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 How to use Sterile Barrier Systems

Marking of Sterile Barrier Systems

 Marking at film side only and if you have to do on the

paper side just outside the filling area
 A steam resistant solvent free soft tip pen must be used
 Hard tip pens are not usable as they can damage the packing material

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 Sterile Barrier System Protective Packing
(double packing)

Double packaging / double

wrapping minimizes the risk of
recontamination during the
opening process and gives a
second shield against package
damages during storage and
transportation

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 Sterile Barrier System
Protective packing (double packing)
configuration of materials designed to prevent damage
to the sterile barrier system and its contents until the
point of use

Single = Sterile Barrier System double= protective packing

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 Sterile Barrier Systems
pouch loading in sterilization
Multiple packages baskets

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 Sterile Barrier Systems
Multiple
Loading in packages
sterilizer chambers

Light items on top

Heavy items at the bottom

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Sterile Barrier Systems loading in sterilizer chamber

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Sterile Barrier Systems loading in sterilizer chamber

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 STERILISASI
 Definisi :
suatu proses yang bertujuan untuk membunuh
semua bentuk mikroorganisme beserta sporanya
dengan menggunakan sterilan.
PANAS BASAH
( Autoclave)

PANAS KERING
( Oven, Dry Heat )

GAS
( Ethylen Oksida )

KIMIAWI
( Glutaraldehide)

Plasma
( H2O2 )
Proses Sterilisasi
 MONITORING STERILISASI

• Dapat berupa :
– Tabel
Mekanik – Indikator suhu/temperatur
– Indikator tekanan
• Menunjukkan : Alat sterilisasi dan
proses berjalan dengan baik

• Menandai terjadinya paparan sterilitas

(misalnya : uap panas, gas etilen oksid)
Kimia pada objek yang disterilkan.
• Diproduksi dalam berbagai bentuk: (
strip tape, kartu, vial ), sensitive
terhadap satu atau lebih parameter
sterilisasi.
• Baik diluar/didalam kemasan

• Indikator berupa sediaan yang berisi

populasi mikroorganisme spesifik
Biologi dalam bentuk spora yang bersifat
resisten terhadap parameter yang
terkontrol dan terukur dalam suatu
proses sterilisasi