Validation Strategy for an Automated Endoscope Reprocessor

Size: px
Start display at page:

Download "Validation Strategy for an Automated Endoscope Reprocessor"

Transcription

1 Validation Strategy for an Automated Endoscope Reprocessor November 16, 2010 Bradley Catalone AER Validation Strategy System Approach page 1

2 AER Validation Strategy AER Scope-specific connectors Requires prior manual cleaning User High turnover Resource and time constraints Endoscope Complex, multiple designs, new models consistently introduced Process Multiple steps Manual cleaning Device-specific adapters Validation Objectives Reduce manual steps Eliminate scope-specific adapters during manual cleaning Eliminate manual channel flushing Improve other cumbersome or unnecessary steps (eliminate bedside flush with detergent, reduce manual flush volumes, etc.) Reduces variability Less user dependent Improves compliance with instructions page 2

3 Modified Cleaning AER automates channel flushing External surface cleaning and channel brushing required Reduces manual steps Reduces labor Improves efficiency Improves compliance Improves consistency AER Validation Design page 3

4 AER Validation Strategy Simulated Use Testing Worst case for identified variables related to process efficacy Specific user-dependent steps not performed for testing In Use (Clinical) Testing Validate efficacy in clinical environment according to AER IFUs Repeat validation eliminating specific user-dependent steps page 4

5 Elevator-Wire Channel Partially Occluded Channel Small Channels Flow Resistance Long Channels Flow Resistance Large Channels Flow Velocity Multiple Channels Efficacy Elevator-Wire Channel Partially Occluded Channel Small Channels Flow Resistance Long Channels Flow Resistance Large Channels Flow Velocity Multiple Channels Efficacy page 5

6 Overall Performance AC Line Voltage(108 V) Detergent Action Manually Inject Minimum Amount Channel Purging Restrictor in Air Compressor Line Ultrasonic Cleaning Power to US Transducers Channel Flushing Pump Voltage to Simulate 2,500 Cycles of Use page 6

7 Overall Performance AC Line Voltage (108 V) Detergent Action Manually Inject Minimum Amount Channel Purging Restrictor in Air Compressor Line Ultrasonic Cleaning Power to US Transducers Channel Flushing Pump Voltage to Simulate 2,500 Cycles of Use page 7

8 Artificial Soil High Levels of Protein, Hemoglobin, Carbohydrate & Bioburden Inoculation Challenge Every Channel Completely Filled Delayed Reprocessing Wait 1 Hour Pre-Cleaning No Detergent Reduced Flush Volume Manual Cleaning Totally Eliminated No Channel Brushing Companion Scope Fully Contaminated Used Model with Largest Effect on Test Scope Artificial Soil High Levels of Protein, Hemoglobin, Carbohydrate & Bioburden Inoculation Challenge Every Channel Completely Filled Delayed Reprocessing Wait 1 Hour Pre-Cleaning No Detergent Reduced Flush Volume Manual Cleaning Totally Eliminated No Channel Brushing Companion Scope Fully Contaminated Used Model with Largest Effect on Test Scope page 8

9 Test Endoscopes Condition of the AER Process Conditions Test Endoscopes Condition of the AER Process Conditions page 9

10 Soil Simulated Use Simulated Use Clinical Use Clinical Use ATS ATS Patient Patient Pre-Clean Manual Clean Clean Rinse AER HLD Rinse Alcohol Simulated Use Cleaning IT - Insertion Tube IS - Instrument/Suction Channel AW - Air/Water Channels AUX - Auxiliary Water Channel EW - Elevator Wire Channel page 10

11 Simulated Use Cleaning 6.4 μg/cm 2 <LOD IT - Insertion Tube IS - Instrument/Suction Channel AW - Air/Water Channels AUX - Auxiliary Water Channel EW - Elevator Wire Channel Simulated Use Cleaning Test Devices <LOD IT - Insertion Tube IS - Instrument/Suction Channel AW - Air/Water Channels AUX - Auxiliary Water Channel EW - Elevator Wire Channel page 11

12 In Use - Cleaning Endpoints o Protein: < 6.4 μg/cm 2 o Bioburden: < 4 Log 10 CFU/cm 2 15 Endoscopes, 65 Samples Bronchoscope, Colonoscopes, Duodenoscopes Results Protein (µg/cm 2 ) Bioburden (Log 10 CFU/cm 2 ) Bronchoscopes <LOD Colonoscopes <LOD LOD Duodenoscopes = Limit of Detection <LOD In Use - Cleaning Endpoints o Protein: < 6.4 μg/cm 2 o Hemoglobin: < 1.8 μg/cm 2 14 endoscopes, 62 samples Bronchoscope, Colonoscopes, Duodenoscopes Results Protein (µg/cm 2 ) Hemoglobin (µg/cm 2 ) Bronchoscopes <LOD 1.39 <LOD Colonoscopes <LOD 4.33 <LOD LOD = Limit of Detection Duodenoscopes <LOD 0.88 <LOD page 12

13 Simulated Use Full Cycle Testing Endpoints o Protein: < 6.4 μg/cm 2 o Bioburden: 6 Log 10 reduction in M. terrae 13 endoscopes, 65 samples Gastroscope, Colonoscope, Duodenoscope and Ultrasound Endoscope Results o All samples < 6.4 μg/cm 2 residual protein o 62 of 65 samples 6 Log 10 reduction in M. terrae o 3 samples > 5.9 Log 10 reduction sample volume limitation Summary Covers all Olympus endoscopes Reduced dependence on scope-specific adapters Reduced burden on user Simplified instructions Effective endoscope reprocessing page 13

14 page 14

BIOTECH-GERMANDE ENDOSCOPE REPROCESSING WITH BRUSHLESS CLEANING PROCESS CONDITIONS. Lionel PINEAU PhD

BIOTECH-GERMANDE ENDOSCOPE REPROCESSING WITH BRUSHLESS CLEANING PROCESS CONDITIONS. Lionel PINEAU PhD ENDOSCOPE REPROCESSING WITH BRUSHLESS CLEANING PROCESS CONDITIONS Lionel PINEAU PhD CONTENT General considerations Endoscope reprocessing, channel brushing, cleaning claims Description of the 2013 study

More information

Monitoring Flexible Endoscope Channels to Assure Cleaning

Monitoring Flexible Endoscope Channels to Assure Cleaning Monitoring Flexible Endoscope Channels to Assure Cleaning Dr. Michelle J. Alfa, Ph.D., FCCM Medical Director, Clinical Microbiology, Diagnostic Services of Manitoba, Winnipeg, Canada Disclaimers: Dr. M.

More information

Flexible Endoscopes: The A,B,C s of Monitoring Manual Cleaning Efficacy!

Flexible Endoscopes: The A,B,C s of Monitoring Manual Cleaning Efficacy! Flexible Endoscopes: The A,B,C s of Monitoring Manual Cleaning Efficacy! Dr. Michelle J. Alfa, Ph.D., FCCM Medical Director, Clinical Microbiology, Diagnostic Services of Manitoba, Winnipeg, Canada Disclaimers:

More information

Testing the Endoscope Journey vs the Decontamination Process. Wayne Spencer

Testing the Endoscope Journey vs the Decontamination Process. Wayne Spencer Testing the Endoscope Journey vs the Decontamination Process Wayne Spencer Historically Validation has focused on the process with only sporadic testing of the device used on the patient Probably with

More information

Standards of Infection Prevention in Reprocessing Flexible Gastrointestinal Endoscopes Webinar FAQ

Standards of Infection Prevention in Reprocessing Flexible Gastrointestinal Endoscopes Webinar FAQ Standards of Infection Prevention in Reprocessing Flexible Gastrointestinal Endoscopes Webinar FAQ Disclaimer: The Society of Gastroenterology Nurses and Associates, Inc. assume no responsibility for the

More information

Safety, Efficacy & Microbiological Consideration

Safety, Efficacy & Microbiological Consideration Safety, Efficacy & Microbiological Consideration Endoscope Cleaning and Disinfection System (With optional cleaning cycle that eliminates manual cleaning) 1 MEDIVATORS, INTERCEPT, RAPICIDE and ADVANTAGE,

More information

Safety, Efficacy & Microbiological Consideration

Safety, Efficacy & Microbiological Consideration Safety, Efficacy & Microbiological Consideration Endoscope Cleaning and Disinfection System (With Optional Cleaning Cycle that Eliminates Manual Cleaning) 1 Medivators is a registered trademark of Minntech

More information

The purpose of this DOPs form is to provide a universal training and assessment tool for continuity when training in manual cleaning processes.

The purpose of this DOPs form is to provide a universal training and assessment tool for continuity when training in manual cleaning processes. 1 Formative DOPS Assessment Form Manual Cleaning of Gastrointestinal Endoscopes Hospital: Trainee s name (print): Job title: Date of assessment: Review date: Manufacturer: Equipment Models: (list endoscopes

More information

Is contamination of bronchoscopes really a problem?

Is contamination of bronchoscopes really a problem? Is contamination of bronchoscopes really a problem? 1 Is contamination of bronchoscopes really a problem? High Level Disinfection does not methodically clean bronchoscopes What we know 210 More than 210

More information

Endoscopy What s New Up There? Frank Myers, MA, CIC, FAPIC

Endoscopy What s New Up There? Frank Myers, MA, CIC, FAPIC Endoscopy What s New Up There? Frank Myers, MA, CIC, FAPIC Disclosures Frank Myers is a member of ASP J&J scientific advisory committee for the development of new high level disinfection or sterilization

More information

ANSI/AAMI ST91: 2015

ANSI/AAMI ST91: 2015 ANSI/AAMI ST91: 2015 Flexible Endoscope Reprocessing and the Importance of AAMI ST91 April 21, 2017 Fred Alston, CSPDT Director of Clinical Sales and Services Healthmark Industries Objectives Discuss the

More information

ENDOSCOPE REPROCESSING AND INFECTION CONTROL FOR ENDOSCOPY

ENDOSCOPE REPROCESSING AND INFECTION CONTROL FOR ENDOSCOPY ENDOSCOPE REPROCESSING AND INFECTION CONTROL FOR ENDOSCOPY Assist. Prof. Pochamana Phisalprapa, M.D., M.Sc. Department of Medicine, Faculty of Medicine Siriraj Hospital, Mahidol University GI ENDOSCOPY

More information

SUBJECT: Detection of residual organic soils inside various channels of lumened items.

SUBJECT: Detection of residual organic soils inside various channels of lumened items. ------------------------------------------------------------------------------------------------------------ NOTE: This document is an example policy that may be instituted in a health-care facility for

More information

Best Practices for Reprocessing Endoscopes

Best Practices for Reprocessing Endoscopes Best Practices for Reprocessing Endoscopes Reprocessing of Endoscopes Reprocessing Room Standards The resources referenced include: Canadian Standards Association Provincial Infectious Disease Advisory

More information

Ethicon, Inc All rights reserved. EVOTECH and the EVOTECH logo are registered trademarks owned by Advanced Sterilization Products.

Ethicon, Inc All rights reserved. EVOTECH and the EVOTECH logo are registered trademarks owned by Advanced Sterilization Products. Ethicon, Inc. 2009. All rights reserved. EVOTECH and the EVOTECH logo are registered trademarks owned by Advanced Sterilization Products. Consistent Cleaning with No Brushing. Now, the labor-intensive

More information

EVOTECH endoscope cleaner and reprocessor (ECR) simulated-use and clinical-use evaluation of cleaning efficacy

EVOTECH endoscope cleaner and reprocessor (ECR) simulated-use and clinical-use evaluation of cleaning efficacy RESEARCH ARTICLE Open Access Research article EVOTECH endoscope cleaner and reprocessor (ECR) simulated-use and clinical-use evaluation of cleaning efficacy Michelle J Alfa* 1,2,3, Pat DeGagne 2, Nancy

More information

SUBJECT: Detection of Blood (hemoglobin) residue inside the biopsy channel of an endoendoscope

SUBJECT: Detection of Blood (hemoglobin) residue inside the biopsy channel of an endoendoscope SUBJECT: Detection of Blood (hemoglobin) residue inside the biopsy channel of an endoendoscope DEPARTMENT: Central Service/ Endoscopy APPROVED BY: EFFECTIVE: REVISED: 6/2016 PURPOSE: To test for detection

More information

AUTOMATED ENDOSCOPE REPROCESSOR. OER-Pro Easy. Fast. Reliable.

AUTOMATED ENDOSCOPE REPROCESSOR. OER-Pro Easy. Fast. Reliable. AUTOMATED ENDOSCOPE REPROCESSOR OER-Pro Easy. Fast. Reliable. Olympus Endoscope Reprocessor The only reprocessor designed by an endoscope manufacturer. The OER-Pro provides high-level disinfection of Olympus

More information

MDRAO Importance of Bedside & Manual Precleaning CONMED.CA

MDRAO Importance of Bedside & Manual Precleaning CONMED.CA MDRAO Importance of Bedside & Manual Precleaning CONMED.CA AGENDA Role of MDRD Hazards related to reprocessing Importance of Adequate Reprocessing Standards Bedside PreClean Manual PreClean Solutions

More information

Dissecting Outbreaks of Multi-resistant Bacteria in Gastrointestinal Endoscopy

Dissecting Outbreaks of Multi-resistant Bacteria in Gastrointestinal Endoscopy Dissecting Outbreaks of Multi-resistant Bacteria in Gastrointestinal Endoscopy Dr. Michelle J. Alfa, Ph.D., FCCM Professor, Dept of Medical Microbiology, University of Manitoba, Winnipeg, Canada St Boniface

More information

FREQUENTLY ASKED QUESTIONS FOR THE ADVANTAGE

FREQUENTLY ASKED QUESTIONS FOR THE ADVANTAGE FREQUENTLY ASKED QUESTIONS FOR THE ADVANTAGE What is an Automated Endoscope Reprocessor? An Automated Endoscopes Reprocessor (AER) performs all the cycle steps (fresh water preflush, rinsing, disinfection,

More information

Transmissi (ERCP) visit. by multiple. sites. it. perform the to this safety. time to help. provided by a. Interim. b. Interim. Method: c.

Transmissi (ERCP) visit. by multiple. sites. it. perform the to this safety. time to help. provided by a. Interim. b. Interim. Method: c. Transmissi on of CRE bacteria through Endoscopicc Retrograde Cholangiopancreatography (ERCP) Interim Guidance NOTE: This document was distributed on 3/17/2015. It iss subject to change and may be updated

More information

Manner of Assessment Code (check all that apply) & Surveyor Notes. Yes N/A. Yes. Yes N/A N/A. Yes N/A. N/A Yes N/A

Manner of Assessment Code (check all that apply) & Surveyor Notes. Yes N/A. Yes. Yes N/A N/A. Yes N/A. N/A Yes N/A Section 4. L Reprocessing of Semi-Critical Equipment Elements to be assessed Manner of Assessment Code (check all that apply) & Surveyor Notes Manner of Assessment Code (check all that apply) & Surveyor

More information

HIGH-LEVEL DISINFECTANT RAPICIDE. Safety, Efficacy, and Microbiological Considerations

HIGH-LEVEL DISINFECTANT RAPICIDE. Safety, Efficacy, and Microbiological Considerations HIGH-LEVEL DISINFECTANT RAPICIDE PA Safety, Efficacy, and Microbiological Considerations 1 50096-959 Rev D 2011, MEDIVATORS, A Minntech Corporation Business Group All rights reserved. This publication

More information

House Keeping. Introduction to ANSI/AAMI ST91:2015: Flexible and Semi-Rigid Endoscope Processing in Health Care Facilities. Welcome!

House Keeping. Introduction to ANSI/AAMI ST91:2015: Flexible and Semi-Rigid Endoscope Processing in Health Care Facilities. Welcome! Introduction to ANSI/AAMI ST91:2015: Flexible and Semi-Rigid Endoscope Processing in Health Care Facilities Today s meeting times: 9:00 a.m. and 1:00 p.m. Central Standard Time July 16, 2015 Welcome! Topic:

More information

TOTAL SOLUTION FOR ENDOSCOPE REPROCESSING

TOTAL SOLUTION FOR ENDOSCOPE REPROCESSING TOTAL SOLUTION FOR ENDOSCOPE REPROCESSING A NEED FOR A COMPLETE PROCESS Lionel PINEAU PhD France PATHOGEN TRANSMISSION RELATED TO ENDOSCOPE WHAT IS THE CONTAMINATION RISK? Rates of bacteremia and infectious

More information

American Journal of Infection Control

American Journal of Infection Control American Journal of Infection Control xxx (2012) 1-5 Contents lists available at ScienceDirect American Journal of Infection Control American Journal of Infection Control journal homepage: www.ajicjournal.org

More information

Technical Data Monograph. Reliance EPS Endoscope Processing System

Technical Data Monograph. Reliance EPS Endoscope Processing System Technical Data Monograph Reliance EPS Endoscope Processing System TABLE OF CONTENTS Introduction...1. Reliance EPS Processor: Principles of Operation...2 Control Handle Boots...3 Consumables...4 Reliance

More information

Safety, Efficacy, and Microbiological Considerations. * For use with RAPICIDE PA outside of the USA, Canada and Australia

Safety, Efficacy, and Microbiological Considerations. * For use with RAPICIDE PA outside of the USA, Canada and Australia Safety, Efficacy, and Microbiological Considerations * For use with RAPICIDE PA outside of the USA, Canada and Australia 1 RAPICIDE, MEDIVATORS, ADVANTAGE PLUS and DSD EDGE are registered trademarks of

More information

HIGH-LEVEL DISINFECTANT AND STERILANT

HIGH-LEVEL DISINFECTANT AND STERILANT HIGH-LEVEL DISINFECTANT AND STERILANT RAPICIDE PA Safety, Efficacy, and Microbiological Considerations * For use with Rapicide PA outside of the USA, Canada and Australia Endoscope reprocessing the way

More information

Endoscopy Reprocessing: Manual versus Automated

Endoscopy Reprocessing: Manual versus Automated Endoscopy Reprocessing: Manual versus Automated 7th GCC Conference on Infection Prevention and Control December 2, 2013 Kuwait City, Kuwait William R. Jarvis, M.D. Jason and Jarvis Associates, LLC www.jasonandjarvis.com

More information

Overview: High Level Disinfection

Overview: High Level Disinfection High Level Disinfection Who you gonna call?. Bug Busters! Dr. Michelle J. Alfa, FCCM St. Boniface General Hospital, Winnipeg, MB Disclaimers: Dr. M. Alfa - Sponsored to give invited presentations at various

More information

CISA Reprocessing Systems

CISA Reprocessing Systems CISA Reprocessing Systems ERS Endoscope Reprocessing and Storage System Feel the innovation 0123 ERS/ESS An innovative approach to the treatment, reprocessing, and aseptic storage of endoscopes and other

More information

This policy has been adopted by UNC Health Care for its use in infection control. It is provided to you as information only.

This policy has been adopted by UNC Health Care for its use in infection control. It is provided to you as information only. This policy has been adopted by UNC Health Care for its use in infection control. It is provided to you as information only. Current Status: Active PolicyStat ID: 5158317 I. Description Origination: 08/2004

More information

Amanda Billings, MPH, CLS, CIC

Amanda Billings, MPH, CLS, CIC Amanda Billings, MPH, CLS, CIC I have nothing to disclose Discuss current infection prevention standards in endoscopy suite Discuss current endoscope reprocessing guidelines and standards List the decontamination

More information

St Boniface Research Centre Winnipeg, Manitoba Canada

St Boniface Research Centre Winnipeg, Manitoba Canada Medical Device Reprocessing: Can we Ban the Biofilm?! St Boniface Research Centre Winnipeg, Manitoba Canada Nancy Olson & Michelle Alfa Dr. Michelle J. Alfa, Ph.D., FCCM Professor, University of Manitoba,

More information

Endoscope Decontamination. A Tube in a Hole??

Endoscope Decontamination. A Tube in a Hole?? Endoscope Decontamination A Tube in a Hole?? John Prendergast AE(D) MIHEEM Senior Decontamination Engineer (Wales) May 2016 Note This presentation is my personal interpretation and not NHS Wales policy.

More information

Workshop on Medical Device Cleanliness: How Clean is Clean Enough? Sponsored by ASTM Committee F04 on Medical and Surgical Materials and Devices

Workshop on Medical Device Cleanliness: How Clean is Clean Enough? Sponsored by ASTM Committee F04 on Medical and Surgical Materials and Devices Breaking the Myth Case Medical Page 1 Our Position Caustic cleaners are unnecessary for instrument processing and present significant hazards to health and safety Properly formulated ph neutral instrument

More information

National Endoscopy Programme. Decontamination Standards for Flexible Endoscopes

National Endoscopy Programme. Decontamination Standards for Flexible Endoscopes National Endoscopy Programme Decontamination Standards for Flexible Endoscopes Updated March 2008 Introduction Providing an effective endoscope decontamination service within a safe environment is an essential

More information

Improper Scope Reprocessing is Dangerous and has caused Patient Infections. 1-6

Improper Scope Reprocessing is Dangerous and has caused Patient Infections. 1-6 ! Prevention Improper Scope Reprocessing is Dangerous and has caused Patient Infections. 1-6 Meeting the standards of ASGE, SGNA and AAMI, CONMED has a portfolio of products designed to help ensure your

More information

Standards of Infection Prevention in Reprocessing Flexible Gastrointestinal Endoscopes

Standards of Infection Prevention in Reprocessing Flexible Gastrointestinal Endoscopes Standards of Infection Prevention in Reprocessing Flexible Gastrointestinal Endoscopes Acknowledgements Copyright 2018 (SGNA). First published in 1996, revised 2000, 2005, 2007, 2008, 2011, 2012, 2015

More information

Understanding ANSI/AAMI ST 91. Flexible and Semi-Rigid Endoscope Reprocessing in Healthcare Facilities

Understanding ANSI/AAMI ST 91. Flexible and Semi-Rigid Endoscope Reprocessing in Healthcare Facilities Understanding ANSI/AAMI ST 91 Flexible and Semi-Rigid Endoscope Reprocessing in Healthcare Facilities Continuing Education Contact Hours Participants must complete the entire presentation/seminar to achieve

More information

OLYMPUS AUG -1 A9 :02

OLYMPUS AUG -1 A9 :02 OLYMPUS 4718 11 AUG -1 A9 :02 Division of Dockets Management (HFA-305) Food and Drug Administration 5630 Fishers Lane, Rm 1061 Rockville, MD 20852 RE: s on Draft Guidance for Industry and FDA Staff " Processing/Reprocessing

More information

Instructions for Use: Duodenoscope Sampling Kit

Instructions for Use: Duodenoscope Sampling Kit Instructions for Use: Duodenoscope Sampling Kit Brand Name of Product Generic Name of Product Product Code Number(s) Intended Use Duodenoscope Sampling Kit Endoscope sampling and culturing kit CK-250,

More information

ENDOSCOPY PRACTICE Manual cleaning and Disinfection of flexible endoscopes

ENDOSCOPY PRACTICE Manual cleaning and Disinfection of flexible endoscopes 1.0 Purpose Every patient undergoing endoscopy should be examined with clean, disinfected equipment. All endoscopic equipment will be cleaned and disinfected / sterilized according to current recommended

More information

High-Level Disinfectant and Sterilant. Rapicide SAFETY, EFFICACY AND MICROBIOLOGICAL CONSIDERATIONS

High-Level Disinfectant and Sterilant. Rapicide SAFETY, EFFICACY AND MICROBIOLOGICAL CONSIDERATIONS High-Level Disinfectant and Sterilant Rapicide SAFETY, EFFICACY AND MICROBIOLOGICAL CONSIDERATIONS Contents Product Description... 3 Intended Use... 3 Safety... 4 Storage, Use and Disposal... 4 Efficacy

More information

Comparison of ANSI/AAMI ST-91 Standards, SGNA Standards and AORN Guidelines on Processing Endoscopes March 9, 2017

Comparison of ANSI/AAMI ST-91 Standards, SGNA Standards and AORN Guidelines on Processing Endoscopes March 9, 2017 New guidelines for processing endoscopes, published May 2015 Precleaning AORN 2017 Endoscopy Guideline N/A Review N/A 1. Precleaning; 2. Leak testing; 3. Manual cleaning; 4. Rinse after cleaning; 5. Visual

More information

SUBJECT: Detection of Blood residue inside the biopsy channel of a scope

SUBJECT: Detection of Blood residue inside the biopsy channel of a scope SUBJECT: Detection of Blood residue inside the biopsy channel of a scope DEPARTMENT: Central Service/ Endoscopy APPROVED BY: EFFECTIVE: REVISED: 2/2012 PURPOSE: To test for detection of blood residue inside

More information

Summary of Proposed Legislative Provisions

Summary of Proposed Legislative Provisions Summary of Proposed Legislative Provisions The evidence obtained by the Committee on Oversight and Government Reform during its investigation of duodenoscope-related patient infections identified significant

More information

Rapicide High-Level Disinfectant and Sterilant. Safety, Efficacy, and Microbiological Considerations

Rapicide High-Level Disinfectant and Sterilant. Safety, Efficacy, and Microbiological Considerations Rapicide High-Level Disinfectant and Sterilant Safety, Efficacy, and Microbiological Considerations CONTENTS Product Description.......... 1 Safety...................... 3 Efficacy Summary............

More information

OLYMPUS Investor Day 2018 Enhancement of Infection Prevention Activities

OLYMPUS Investor Day 2018 Enhancement of Infection Prevention Activities OLYMPUS Investor Day 2018 Enhancement of Infection Prevention Activities Yoshio Tashiro Executive Officer, Medical Reprocessing Strategy Olympus Corporation September 5, 2018 Disclaimers The financial

More information

3/26/2015. This quote sums up the activity going on right now with flexible scopes

3/26/2015. This quote sums up the activity going on right now with flexible scopes This quote sums up the activity going on right now with flexible scopes Flexible Endoscope Cleaning If you want to truly understand something try to change it Kurt Lewis Objectives To understand and make

More information

ENDOSCOPE DECONTAMINATION- EDUCATION AND TRAINING COMPETENCY FRAMEWORK

ENDOSCOPE DECONTAMINATION- EDUCATION AND TRAINING COMPETENCY FRAMEWORK ENDOSCOPE DECONTAMINATION- EDUCATION AND TRAINING COMPETENCY FRAMEWORK Standardising the manual cleaning and decontamination process of flexible endoscopes throughout Lothian. C:\Users\Scott\Documents\Endoscopy\website

More information

Validation of cleaning and sterilization of reusable medical devices

Validation of cleaning and sterilization of reusable medical devices Synergy makes sence Validation of cleaning and sterilization of reusable medical devices MG-FSI72-119 Last revision: June 2012 Aurélien BIGNON 5, Chemin du Catupolan - 69120 Vaulx en Velin - France - Tel.

More information

What does ECRI consider the #1 safety issue in Healthcare for 2010? Increasing Scrutiny on Endoscopes

What does ECRI consider the #1 safety issue in Healthcare for 2010? Increasing Scrutiny on Endoscopes How can you tell your Flexible Scope is Clean? By: Stephen M. Kovach, B.S. Director of Education Healthmark Industries Objectives Background information on scopes and cleaning them Review present guidelines

More information

Best Practices for Reprocessing Robotic Instruments

Best Practices for Reprocessing Robotic Instruments Best Practices for Reprocessing Robotic Instruments Nupur Jain Manager, Validation Engineering Services Intuitive Surgical, US Agenda 1. Background on robotic instruments 2. Reprocessing procedure for

More information

CDWA3 / CDWA4 CDWAH. Page 4. BASKET ZONE: water pressure, spray system performance, detergent chemistry and concentration, temperature.

CDWA3 / CDWA4 CDWAH. Page 4. BASKET ZONE: water pressure, spray system performance, detergent chemistry and concentration, temperature. Rev. 2 March 2017 Control of cleaning and washing processes of medical instruments and materials is highly important since its outcome affects the success of subsequent disinfection and/or sterilization

More information

Endoscopy and OR Solutions SYSTEM 1 TM. Express STERILE PROCESSING SYSTEM SAFETY, ASSURANCE AND EFFICIENCY. One Integrated Approach to Healthcare

Endoscopy and OR Solutions SYSTEM 1 TM. Express STERILE PROCESSING SYSTEM SAFETY, ASSURANCE AND EFFICIENCY. One Integrated Approach to Healthcare Endoscopy and OR Solutions SYSTEM 1 TM Express STERILE PROCESSING SYSTEM SAFETY, ASSURANCE AND EFFICIENCY One Integrated Approach to Healthcare Pioneer in liquid chemical sterilization Filtration System

More information

THE TERMS VALIDATION AND VERIFICATION ARE FREQUENTLY

THE TERMS VALIDATION AND VERIFICATION ARE FREQUENTLY Lesson No. CRCST 162 (Technical Continuing Education - TCE) Sponsored by: by Susan Klacik, BS, CRCST, ACE, CIS, FCS IAHCSMM Clinical Educator Validation and Verification LEARNING OBJECTIVES 1. Describe

More information

Case 6. Fight Against Nosocomial Infections

Case 6. Fight Against Nosocomial Infections Case 6 Fight Against Nosocomial Infections Decontamination and microbiological surveillance of endoscopes Prof. dr. Isabel Leroux-Roels Laboratory of Medical Microbiology & Infection Control Team UZ Gent

More information

John van Bergen Henegouw. Monitoring the Performance of your Automated Endoscope Reprocessor. Validation

John van Bergen Henegouw. Monitoring the Performance of your Automated Endoscope Reprocessor. Validation John van Bergen Henegouw Monitoring the Performance of your Automated Endoscope Reprocessor Validation Contents: Validation of AERs 1. History of validation in the Haga Hospital 2. Guidelines 3. Annual

More information

How is Sterilization Validation Performed by the Medical Device Manufacturer?

How is Sterilization Validation Performed by the Medical Device Manufacturer? How is Sterilization Validation Performed by the Medical Device Manufacturer? Rod Parker, Ph.D. Sr. Principal Scientist Stryker Instruments Division May 9, 2016 DISCLOSURE I am an employee of Stryker Corporation.

More information

The Future of Endoscopy. STARTS NOW Sterile Sing le-use Endoscopy

The Future of Endoscopy. STARTS NOW Sterile Sing le-use Endoscopy The Future of Endoscopy STARTS NOW Sterile Sing le-use Endoscopy We want to simplify endoscopy The single most important question in healthcare today is how to improve patient outcomes with the resources

More information

Clean Collaboration: Putting the pieces of the puzzle together on difficult to clean medical devices a Collaboration approach. Jahan Azizi BS, CBET

Clean Collaboration: Putting the pieces of the puzzle together on difficult to clean medical devices a Collaboration approach. Jahan Azizi BS, CBET Clean Collaboration: Putting the pieces of the puzzle together on difficult to clean medical devices a Collaboration approach. Jahan Azizi BS, CBET Ongoing Safety Review of Arthroscopic Shavers The FDA

More information

Slide 1. Slide 2. Slide 3

Slide 1. Slide 2. Slide 3 Slide 1 1 Contact Hour CNE Presentation MK-234 Rev. a Slide 2 Successful completion: Participants must attend the entire program, including any resulting Q & A, and submit required documentation. Conflict

More information

The Reusable Surgical Instrument Cycle

The Reusable Surgical Instrument Cycle Daily and Periodic Tests for Washer-Disinfectors and Sterilizers: Regulations, Technical and Operational Characteristics, and Updates on Electronic Bowie Dick Tests Richard Bancroft, B.Sc (Hons), FRSB

More information

Endoscope Washer Disinfector Cleaning Process Challenge Devices Research & Validation

Endoscope Washer Disinfector Cleaning Process Challenge Devices Research & Validation Endoscope Washer Disinfector Cleaning Process Challenge Devices Research & Validation Richard Bancroft, B.Sc (Hons), FRSB Science & Technical Director STERIS Corporation Registered Authorising Engineer

More information

Endoscope Reprocessing: The Need to Shift from HLD to Sterilization

Endoscope Reprocessing: The Need to Shift from HLD to Sterilization Endoscope Reprocessing: The Need to Shift from HLD to Sterilization William A. Rutala, Ph.D., M.P.H., C.I.C. Director, Statewide Program for Infection Control and Epidemiology and Research Professor of

More information

A GLIMPSE AT THE TRUE COST OF REPROCESSING ENDOSCOPES:

A GLIMPSE AT THE TRUE COST OF REPROCESSING ENDOSCOPES: by Cori L. Ofstead, MSPH; Mariah R. Quick, MPH; John E. Eiland, MS, RN; Steven J. Adams, RN, CRCST A GLIMPSE AT THE TRUE COST OF REPROCESSING ENDOSCOPES: RESULTS OF A PILOT PROJECT INTRODUCTION AND METHODS

More information

Lindy Forte 1* and Cynthia Shum 2. Abstract

Lindy Forte 1* and Cynthia Shum 2. Abstract RESEARCH ARTICLE Open Access Comparative cost-efficiency of the EVOTECH endoscope cleaner and reprocessor versus manual cleaning plus automated endoscope reprocessing in a real-world Canadian hospital

More information

Endoscope reprocessing: Update on controversial issues

Endoscope reprocessing: Update on controversial issues Endoscope reprocessing: Update on controversial issues Hyun Ho Choi and Young-Seok Cho Department of Internal Medicine, College of Medicine, The Catholic University of Korea, Seoul, Korea Correspondence:

More information

Steelco Academy Training for success

Steelco Academy Training for success Steelco Academy Training for success For the Environmentally conscious Because you deserve... world class training in world class facilities from a leader in Infection Control Steelco is a leading infection

More information

TITLE: Sterilization Equipment and Requirements for Endoscopy Equipment: A Review of the Clinical Evidence and Guidelines

TITLE: Sterilization Equipment and Requirements for Endoscopy Equipment: A Review of the Clinical Evidence and Guidelines TITLE: Sterilization Equipment and Requirements for Endoscopy Equipment: A Review of the Clinical Evidence and Guidelines DATE: 19 January 2012 CONTEXT AND POLICY ISSUES Endoscopies are performed frequently

More information

Low Temperature Processing. An Update on Guidelines, Standards and Requirements

Low Temperature Processing. An Update on Guidelines, Standards and Requirements Low Temperature Processing An Update on Guidelines, Standards and Requirements Continuing Education Contact Hours Participants must complete the entire presentation/seminar to achieve successful completion

More information

Endoscope Reprocessing and Infection Prevention

Endoscope Reprocessing and Infection Prevention Endoscope Reprocessing and Infection Prevention 2015 Spring IP Boot Camp Louisville, KY Trina VanGuilder, RN, BSN, CGRN, CFER Clinical Education Consultant Objectives Identify standards relevant to processing

More information

MDRAO ONLINE COURSE FOURTH EDITION 2018

MDRAO ONLINE COURSE FOURTH EDITION 2018 MDRAO ONLINE COURSE FOURTH EDITION 2018 Introduction MDRD Function and Structure Virtual tour of MDRD Standardized workflow Organizational Structure Chapter 1: Quality Systems Creating a Culture of quality

More information

Compatibility of Olympus and Gyrus ACMI Flexible Endoscopes and Ancillary Products with Aldahol 1.8% High-level Disinfectant/Sterilant

Compatibility of Olympus and Gyrus ACMI Flexible Endoscopes and Ancillary Products with Aldahol 1.8% High-level Disinfectant/Sterilant May 1, 2013 RE: Compatibility of Olympus and Gyrus ACMI Flexible Endoscopes and Ancillary Products with Aldahol 1.8% High-level Disinfectant/Sterilant Dear Health Care Professional: The purpose of this

More information

Hygiene Management Guide for Flexible Endoscopes

Hygiene Management Guide for Flexible Endoscopes Hygiene Management Guide for Flexible Endoscopes 3M Clean-Trace Hygiene Management System 2 Contents Aim 3 Introduction 3 ATP bioluminescent monitoring technology 5 What is Adenosine Triphosphate? 5 The

More information

Parameters exerting Influence on Cleaning of flexible Endoscops

Parameters exerting Influence on Cleaning of flexible Endoscops Parameters exerting Influence on Cleaning of flexible Endoscops Heike Martiny Technische Hygiene Campus Benjamin Franklin Charité Universitätsmedizin Berlin ÖGSV Jahrestagung und wfhss-kongress 03. - 05.

More information

5 Updates to Flexible Endoscope Reprocessing

5 Updates to Flexible Endoscope Reprocessing 5 Updates to Flexible Endoscope Reprocessing AORN presents and explains what it means for hospitals. Presented by: Sponsored by: Background Background Real-time video and small cameras led to the development

More information

Contains Nonbinding Recommendations

Contains Nonbinding Recommendations Mitigating the Risk of Cross- Contamination from Valves and Accessories Used for Irrigation Through Flexible Gastrointestinal Endoscopes Guidance for Industry and Food and Drug Administration Staff Document

More information

A TAILORED SOLUTION... for endoscopic irrigation and insufflation tubing

A TAILORED SOLUTION... for endoscopic irrigation and insufflation tubing A TAILORED SOLUTION... for endoscopic irrigation and insufflation tubing...covering YOUR REQUIREMENTS A division of Nissha Medical Technologies PROVIDING A TAILORED SOLUTION FUNCTIONALITY Designed for

More information

Controversies in Reprocessing Flexible Endoscopes: High Level Disinfection or Terminal Sterilization????

Controversies in Reprocessing Flexible Endoscopes: High Level Disinfection or Terminal Sterilization???? Controversies in Reprocessing Flexible Endoscopes: High Level Disinfection or Terminal Sterilization???? HONG KONG HOSPITAL AUTHORITY - ADVANCED COURSE FOR INFECTION CONTROL NURSES NOVEMBER 2017 1 Learning

More information

DEFENDO. Sterile Single-use Valves. Procedure

DEFENDO. Sterile Single-use Valves. Procedure DEFENDO Sterile Single-use Valves Procedure YOUR PARTNER IN THE FIGHT AGAINST HEALTHCARE-ASSOCIATED INFECTIONS (HAIs) Reducing the risk of infections for endoscopy patients is critically important. More

More information

Hoe steriel moet het zijn? Prof Dr Margreet C.Vos MD PhD

Hoe steriel moet het zijn? Prof Dr Margreet C.Vos MD PhD Hoe steriel moet het zijn? Prof Dr Margreet C.Vos MD PhD m.vos@erasmusmc.nl Disclosure slide for speakers Disclosure of speaker s interests (Potential) conflict of interest Potentially relevant company

More information

STERILIZATION VALIDATION IN THIS SECTION REPROCESSING VALIDATIONS FOR REUSABLE MEDICAL DEVICES. Radiation Sterilization Validation

STERILIZATION VALIDATION IN THIS SECTION REPROCESSING VALIDATIONS FOR REUSABLE MEDICAL DEVICES. Radiation Sterilization Validation STERILIZATION VALIDATION All sterilization processes require validation of the efficacy and reproducibility of the process. Depending on the type of sterilization, this may be accomplished by partial,

More information

In use test of a Washer-disinfector reprocessing of flexible endoscopes

In use test of a Washer-disinfector reprocessing of flexible endoscopes of a Washer-disinfector reprocessing of flexible endoscopes BHT INNOVA E4 Clean Endoscope Copenhagen Hospital Corporation Denmark of INNOVA E4 Washer Disinfector from BHT, Germany. An aldehyde free thermo-chemical

More information

OBJECTIVES. Most Relative to SPD 10/22/ Top Ten Health Technology Hazards. Keeping Your Patients Safe And Your Hospital Out of The Headlines

OBJECTIVES. Most Relative to SPD 10/22/ Top Ten Health Technology Hazards. Keeping Your Patients Safe And Your Hospital Out of The Headlines 10 th Annual Northeast Regional Meeting Long Island Association for Central Service Mid Atlantic Central Service Association Atlantic City November 18-19 2018 Keeping Your Patients Safe And Your Hospital

More information

ADVANTAGE PLUS Pass-Thru

ADVANTAGE PLUS Pass-Thru ADVANTAGE PLUS Pass-Thru AUTOMATED ENDOSCOPE REPROCESSOR REPROCESSING Reprocessing Reimagined Cantel is your partner in the fight against healthcareassociated infections. Healthcare-associated infections

More information

Processing of Medical Devices: Risk Management and Plausibility Control

Processing of Medical Devices: Risk Management and Plausibility Control Processing of Medical Devices: Risk Management and Plausibility Control 50 years Decontamination Sciences 27-29th of November 2017 15.00-15.45 Hotel Hilton Blackpool UK Dr. med. Dipl.-Ing Thomas W. Fengler

More information

Residual bioburden in reprocessed side-view endoscopes used for endoscopic retrograde cholangiopancreatography (ERCP)

Residual bioburden in reprocessed side-view endoscopes used for endoscopic retrograde cholangiopancreatography (ERCP) E12 Residual bioburden in reprocessed side-view endoscopes used for endoscopic retrograde cholangiopancreatography (ERCP) Authors D. L. N. L. Ubhayawardana 1, J. Kottahachchi 1, M. M. Weerasekera 1, I.

More information

Prevention of Transmission of the Superbug Carbapenem-Resistant Enterobacteriaceae (CRE) during Gastrointestinal Endoscopy

Prevention of Transmission of the Superbug Carbapenem-Resistant Enterobacteriaceae (CRE) during Gastrointestinal Endoscopy Prevention of Transmission of the Superbug Carbapenem-Resistant Enterobacteriaceae (CRE) during Gastrointestinal Endoscopy Sponsored by: Presentation by: Lawrence F. Muscarella, Ph.D. President LFM Healthcare

More information

Research, Design and Validation of a Cognitive Aid to Support the Reprocessing. of Flexible Endoscopes. Jonathan D. Jolly

Research, Design and Validation of a Cognitive Aid to Support the Reprocessing. of Flexible Endoscopes. Jonathan D. Jolly Research, Design and Validation of a Cognitive Aid to Support the Reprocessing of Flexible Endoscopes by Jonathan D. Jolly A Thesis Presented in Partial Fulfillment of the Requirements for the Degree Master

More information

Elevator (Scope Issues) Going Up! Frank Myers, MA, CIC Infection Prevention Clinical Epidemiology UCSD Health

Elevator (Scope Issues) Going Up! Frank Myers, MA, CIC Infection Prevention Clinical Epidemiology UCSD Health Elevator (Scope Issues) Going Up! Frank Myers, MA, CIC Infection Prevention Clinical Epidemiology UCSD Health Objectives Identify two reasons why elevator scopes have a higher risk than other scopes of

More information

Instructions for Use: Flexible Endoscope Sampling Kit

Instructions for Use: Flexible Endoscope Sampling Kit Instructions for Use: Flexible Endoscope Sampling Kit Brand Name of Product Generic Name of Product Product Code Number(s) Intended Use Flexible Endoscope Sampling Kit Endoscope Culture Sample Kit CK-250,

More information

QUALITY ASSURANCE IN ENDOSCOPY

QUALITY ASSURANCE IN ENDOSCOPY QUALITY ASSURANCE IN ENDOSCOPY Frank Edward Myers III, MA, CIC Kim Delahanty, BSN, MBA/HCM,CIC WHY DO QC ON SCOPES?? The scopes are clean no problem OBJECTIVES Describe the 2 advantages of a testing based

More information

American Journal of Infection Control

American Journal of Infection Control Reprinted from American Journal of Infection Control APPLIED EPIDEMIOLOGY IN HEALTH CARE SETTINGS AND THE COMMUNITY The Effectiveness of Sterilization for Flexible Ureteroscopes: A Realworld Study visit

More information

Recommended Procedure for Sampling Gastrointestinal Flexible Endoscopes

Recommended Procedure for Sampling Gastrointestinal Flexible Endoscopes SAMPLING GUIDE* Recommended Procedure for Sampling Gastrointestinal Flexible Endoscopes This document provides the recommended procedure for obtaining acceptable samples from a flexible endoscope without

More information

Administrative Policies and Procedures. Cross Reference: Date Issued: 2/14 Date Reviewed: 9/14 Date: Revised: 12/14 Attachment: None Page of 1 of 6

Administrative Policies and Procedures. Cross Reference: Date Issued: 2/14 Date Reviewed: 9/14 Date: Revised: 12/14 Attachment: None Page of 1 of 6 Administrative Policies and Procedures Originating Venue: Infection Control Policy No.: IC 2306 Title: Cystoscope Reprocessing Policy & Procedure Cross Reference: Date Issued: 2/14 Date Reviewed: 9/14

More information

To Create and Deliver the New Standard of Care in Sterile Reprocessing. Investor Presentation 22 February

To Create and Deliver the New Standard of Care in Sterile Reprocessing. Investor Presentation 22 February To Create and Deliver the New Standard of Care in Sterile Reprocessing Investor Presentation 22 February 2018 1 Important Cautions Regarding Forward Looking Statements and Other Disclosures The statements

More information