Beruflich Dokumente
Kultur Dokumente
Science.
Applied to Life.
Reprocessing of instruments
and equipment
“Quality Control &
Monitoring
Sterilization"
HISSI, Surabaya
March 3,2017
23 February
© 3M 2017 . All Rights Reserved. 3M Confidential. 1
Objektif
Issue dan update
Mendiskusikan pengembangan jaminan mutu sterilisasi dan
program quality control
Mendiskripsikan proses sterilisasi
Standard dan guideline
Mengidentifikasi penggunaan control kualitas sterilisasi,
sterilisasi,
meliputi indicator fisik,
fisik, kimiawi dan biologi
APSIC COE Program
https://www.jointcommission.org/assets/1/23/Quick_Safety_Issue_Two_May_2014.pdf
23 February
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1
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http://www.lanierlawgroup.com/blog/dangerous-healthcare-settings-
23 February
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1.
1. Inadequate
Inadequate Cleaning
Cleaning of
of Flexible
Flexible Endoscopes
Endoscopes 1. Infusion Errors Can Be Deadly If Simple
1. Alarm hazards 1. Alarm Hazards: Inadequate Alarm and
and surgical
surgical instruments
instruments Safety Steps Are Overlooked.
Configuration Policies and Practices
2. Infusion pump medication errors 2. Missed Alarms Can Have Fatal 2.
2. Inadequate
Inadequate Cleaning
Cleaning of
of Complex
Complex Reusable
Reusable
2. Data Integrity: Incorrect or Missing Data Consequences Instruments
Instruments Can
Can Lead
Lead to
to Infections.
Infections
Infections
3. CT radiation exposures in pediatric
in EHRs and Other Health IT Systems
patients 3. Failure to Effectively Monitor Postoperative 3. Missed Ventilator Alarms Can Lead to Patient
3. Mix-Up of IV Lines Leading to Patients for Opioid- Harm.
4. Data integrity failures in EHRs and other
Misadministration of Drugs and Solutions 4. Inadequate Surveillance of Monitored 4. Undetected Opioid-Induced Respiratory
health IT systems
4. Inadequate Reprocessing of Endoscopes Patients in a Telemetry Setting. Depression.
5. Occupational radiation hazards in hybrid
and Surgical Instruments 5. Insufficient Training of Clinicians on 5. Infection Risks with Heater-Cooler Devices
Ors
Operating Room. Used in Cardiothoracic Surgery
5. Ventilator Disconnections Not Caught
6. Inadequate reprocessing of endoscopes
because of Mis-set or Missed Alarms 6. Errors Arise When HIT Configurations and 6. Software Management Gaps Put Patients,
and surgical instruments Facility Workflow and Patient Data, at Risk
6. Patient-Handling Device Use Errors and
7. Neglecting change management for 7. Unsafe Injection Practices Expose Patients to 7. Occupational Radiation Hazards in Hybrid
Device Failures
networked devices and systems Infectious Agents Ors.
7. “Dose Creep”: Unnoticed Variations in
8. Risks to pediatric patients from “adult” 8. Gamma Camera Mechanical Failures Can 8. Automated Dispensing Cabinet Setup and
Diagnostic Radiation Exposures
technologies Lead to Serious Injury or Death Use Errors May Cause Medication Mishaps.
8. Robotic Surgery: Complications due to 9. Failure to Appropriately Operate Intensive 9. Surgical Stapler Misuse and Malfunctions .
9. Robotic surgery complications due to
Insufficient Training. Care Ventilators .
insufficient training 10. Device Failures Caused by Cleaning
9. Cybersecurity: Insufficient Protections 10. Misuse of USB Ports Can Cause Medical Products and Practices
10. Retained devices and un retrieved
for Medical Devices and Systems Devices to Malfunction
fragments
10. Overwhelmed Recall and Safety-Alert
Management Programs
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http://edition.cnn.com/2014/03/26/health/hospital-infections/index.html
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Endoscopic Retrograde
Cholangiopancreatography
(ERCP)
http://edition.cnn.com/2015/03/04/us/superbug-endoscope-no-
permission/
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11 © 3M 2014 All Rights Reserved.
http://edition.cnn.com/2015/02/24/opinion/vox-superbug/index.html
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Definisi
Instrument kotor
Alur Proses
Pencucian,
Disinfeksi dan
Sterilisasi
Instrument bersih
Intrument Steril
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Efikasi Sterilisasi
Dipengaruhi Faktor-Faktor Berikut
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5
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Item
Penyimpanan/Distribusi
Steril /Dokumentasi
Pencucian & Item
Dekontaminasi Kotor
Quality
Proses Sterilisasi
Control
Item Bersih
Inspeksi / Assembly
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Pre Treatment
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Endoscopy Reprocessing
Leakage
Drying
testing
Thorough
Rinsing cleaning
Rinse
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Ketidak tepatan dan ketidakadekuatan penanganan di tempat pengguna meningkatkan risiko paparan
terhadap staf yang akan melakukan reprocessing, sehingga ini menjadi alasan mengapa audit sangat perlu
dilakukan pada langkah ini
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Pengemas
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Item Item
Steril Pencucian & Kotor
Penyimpanan/Distribusi
Dekontaminasi
/Dokumentasi
Quality
Proses Sterilisasi
Control Inspeksi / Assembly
Item
Bersi
h
All Rights
9
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Easy for Air Remove and Steam Difficult for Air Remove and
Penetrate Steam Penetrate
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Instrument sterile,
berfungsi optimal
Goal & Challenge Safety pasien dan
operator
International
Organization for
Standardization
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Standard/Rekomendasi
JCI
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2014!
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Monitoring Biological
Monitoring Chemical
Monitoring Physical
Sterility
Assurance
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1. Suhu
2. Lamanya Paparan
3. Qualitas Steam
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Temperature
Pressure
39
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Indikator Fisik/
Fisik/Mekanik Menunjukkan:
Menunjukkan:
Apa Yang terjadi di dalam chamber?
Apakah kondisi telah terpenuhi?
Cycle, waktu, suhu dan pressure?
Indikator Mekanik/fisik
Memonitor satu lokasi didalam chamber mesin
Tidak memonitor setiap kemasan atau tray
Tidak menjadi INDIKATOR Sterilitas telah tercapai.
Indikator fisik/
fisik/Mekanik
Recording thermometer – circle graph
Computer printouts – paper strip
Gauges – jacket and chamber pressure
Monitoring fisik
• Catat dengan benar tanggal
dan parameter sterilizator untuk
setiap muali cycle
• Baca & verifikasi dengan
memberikan tanda tangan
disetiap cycle
• Jika tidak benar, jangan
dilakukan prose sterilisasi.
Type 6 Emulating
Type Multi-variable Indicators Type 5 Integrating Indicators
Indicators
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Steam Penetration
© 3M 2010.
All Rights
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Porous BD test
everyday by hospital
• The Porous Bowie Dick test is a test that is intended to be performed daily by the
hospital
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Keuntungan
Mendeteksi kemasan yang tidak
benar
Ketidaktepatan tata letak
Malfungsi mesin sterilisasi
Mudah dalam pengaplikasian dan
intepretasi
Type 5 Vs Type 6
Type 5 Type 6 Keterangan
Kelas 5 indikator Mengintegrasikan Kelas 6 indikator Meniru adalah
adalah dirancang untuk bereaksi dirancang untuk bereaksi terhadap
terhadap semua critikel semua penting
variabel (waktu, suhu, dan variabel (waktu, suhu, dan
kehadiran steam) dan memiliki kehadiran uap) untuk
Nilai menyatakan bahwa berkorelasi ditentukan sterilisasi cycle.1 Anda
dengan mungkin mendengar Kelas 6 indikator
Indikator biologis (BI) di tiga dimaksud
hubungan waktu / suhu. sebagai indikator spesifik siklus
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Indikator Biologi
Memastikan tidak adanya
mikroorgansime instrumen/ lumen/
scopes Geobacillus Stearothermophilus
What is the definition of “sterile”?
Bebas dari semua bentuk mikroorganisme. Tapi tidak mungkin mengukur “10-6”
Dalam prakteknya tidak ada pernyataan mutlak SAL yang diperlukan dapat dicapai dengan menerapkan sebuah
seperti tentang tidak adanya Mikroorganisme proses yang akan mengurangi jumlah organisme ke nol dan
dapat dibuktikan kemudian menerapkan faktor keamanan yang akan memberikan
Didefinisikan sebagai probabilitas dari 1 dalam pengurangan 6 log ekstra
sejuta dari container yang terkontaminasi (10-6) Load Control
Ini disebut sebagai Sterility Sterilization
Assurance Level (SAL) Biological Indicators
Mikroorganisme mati dalam bentuk exponential. Terdiri dari jumlah spora yang besar
Mengintegrasikan semua critical variable pada proses
sterilisasi.
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Definisi“Sterile”
MICROBIAL INACTIVATION
-kt
Nt = No e
1200 3.50
3.00
1000
2.50
2.00
No of surviving organisms
800
1.50
1.00
600
0.50 No remaining
-0.50
200 -1.00
-1.50
0 -2.00
0 1 2 3 4 5 6 7 8 9 10
No remaining 1000 368 135 50 18 7 2 1 0 0 0
Log No remaining 3.00 2.57 2.13 1.70 1.26 0.83 0.39 -0.04 -0.47 -0.91 -1.34
Time
Definisi“Sterile”
Resistance “Perlawanan” dari suatu organisme disebut “D-value”
D-Value
Definisi“Sterile”
Contoh
Pada kondisi awal bioburden terdeteksi 102
proses sterilisasi membutuhkan kemampuan
menurunkan mikroorganisme sebesal log 8
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Biological Indicators
Bagaimana cara kerja. . .
Spora akan terekspose proses sterilisasi
Setelah proses, spora akan tercampur dengan media (
soy broad) dan diinkubasi pada suhu optimal
Spore strips ditranfer ke media melalui aspetic
tekhnike
Self-
Self-contained didesain untuk pencampuran tanpa
dilakukan proses transfer
© 3M 2008. All
Rights
Biological Indicators
•Technology Enzym base early-readout (AAMI) or
rapid-action readout (AORN) or Super rapid 30 menit - 1 jam
Action and resulth
• Super Rapid Biological Indicator dengan
pembacaan hasil 1 jam untuk mesin vaccum 1-3 jam
dan 30 menit untuk mesin gravity.
• Rapid Autoreader : Fluorescence dalam 1
sampai 3 jam
• Perubahan warna 24 jam sampai 48 jam untuk
mesin steam
•Convensional
1-3 jam
• Perubahan warna 24 sampai 96 jam
•Intruksi inkubasi mengacu terhadap instruksi
pabrik 24-48 Jam
1985-1998
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Implant
1. Monitoring Fisik – setiap load
2. Eksternal indikator kelas 1– setiap
pack
3. Internal indikator 5 – every pack Loads contain implantable devices
4. Monitoring untuk setiap load dengan should be quarantined until biological
PCD yang terdiri BI dan Kelas 5 CI. indicator results are available
5. Implant should NOT be released until
the results of the BI.
BI.
AAMI ST79:2014
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AAMI ST79:20016
Service tahunan
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Setiap hari untuk Setiap kemasan Setiap kemasan Setiap hari Setiap load
setiap mesin
Setiap hari untuk Setiap kemasan Setiap kemasan Setiap hari Setiap load
setiap mesin
Setiap hari untuk Setiap kemasan Setiap kemasan Setiap hari Setiap load
setiap mesin
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Record Keeping
“Documentation establishes accountability.”
AORN Sterilization Recommended Practice
Load Records
Tanggal dan waktu semua cycle
Lamanya paparan dan suhu
Isi cycle
Initial atau no absensi
Hasil BI, Hasil CI
Catatan perbaikan, calibrasi dan perbaikan
Bibliography
1. The ASEAN Guideline For Disinfection and Sterilization Of Instrument In Health Care
Facilities:APSIC,:2017
2. Decontamination and Reprocessing of Medical Devices for Health-care Facilities:
WHO:2016
3. Comprehensive guide to steam sterilization and sterility assurance in healthcare facilities
(ANSI/AAMI ST79). Association for the Advancement of Medical Instrumentation, 2014. 2014.
4. AORN:2013
5. Sterilization of health care products-
products-Chemical indicators-
indicators-Part 1: General requirements
(ISO/ANSI/AAMI 11140-
11140-5:2014).
6. http://www.fda.gov/cdrh/pdf7/K070461.pdf
3. Pedoman instalasi pusat sterilisasi:Depkes.RO,:2009
4. Symmetry Medical http://www.flashpak.com/hospital_products.htm
22