STIP | www.infectiepreventieopleidingen.nl 1 Disclosure slide (potentiële) belangenverstrengeling Geen Voor bijeenkomst mogelijk relevante relaties Boston Scientific met bedrijven • Sponsoring of onderzoeksgeld • geen • Honorarium of andere (financiële) • geen vergoeding • • geen Aandeelhouder • Andere relatie, namelijk … • geen STIP | www.infectiepreventieopleidingen.nl 1
Salim Essakali, MS, MBA Sr. Product Manager, EMEA, Therapeutic Imaging Platforms Endoscopie gezien vanuit een infectie preventie perspectief – verleden, heden en potentiële toekomst
Data sources • Spurr C. (2018) History of the Instruments and Techniques of Gastrointestinal Endoscopy. Slide 4 • Sivak MV, Gastrointestinal endoscopy: past and future, Gut 2006;55:1061-1064. Slide 5 • Rauwers et. Al: Endoscope-associated infections: A brief summary of the current state and views toward the future Slide 7 • Rubin et. Al: Safely reprocessing duodenoscopes: current evidence and future directions Slide 8 • Harvard Med School: Scientists film bacteria’s maneuvers as they become impervious to drugs Slide 9 • Rubin et. Al: Safely reprocessing duodenoscopes: current evidence and future directions Slide 11 • Rauwers et. Al: High prevalence rate of digestive tract bacteria in duodenoscopes: a nationwide study. Slide 12-14 • Rauwers et. Al: Independent root-cause analysis of contributing factors, including dismantling of 2 duodenoscopes, to investigate an outbreak of multidrug-resistant Klebsiella pneumoniae. Slide 15 • Kurniawan, N., & Keuchel, M. (2017). Flexible Gastro-intestinal Endoscopy - Clinical Challenges and Technical Achievements. Computational and structural biotechnology Slide 17 • Rubin et. Al: Safely reprocessing duodenoscopes: current evidence and future directions Slide 18 • https://www.ambu.com/Admin/Public/DWSDownload.aspx?File=Files%2fFiles%2fAmbu%2fPresentations%2f20172018%2fQ2+presentation+2017_18.pdf Slide 19 • https://www.olympus-global.com/ir/data/pdf/investor_day_2018e_03.pdf 3
AGENDA Korte endoscopie geschiedenis en ontwikkelingen Endoscopie Huidige prestaties en opkomende uitdagingen Toekomstperspectief 4
Een beknopte Endoscopy geschiedenis* Era of Rigid Endoscopy Schindler Era Fiberoptic Era Modern Era 1940, Cameron-Schindler, US 1805, Bozzini, “Lichtleiter” • 1st gastroscope prod. in US • Developed in Mainz, Germany • Later formed EDER Instrument Co. • First Endoscope • Schindler formed AGC (precursor of ASGE) • Urethra, bladder, vagina, rectum 2001, Yamamoto, JP 1979, Ponsky • 1950, Olympus, JP Double-balloon small • First PEG 1922, Schindler, Germany • Gastrocamera bowel enteroscope • First really usuable str. gastroscope • Rubber tip tube • Air outlet to clear lens • Inner canula incl. Optics and light 1950 79 AD 1881 1949 1932 1964 1983 2013 1940 1805 1922 1979 2001 1932, Schindler, Germany • Semi-flexible Gastroscope 2013, FUSE • 32° tip deflection via m. lenses • Omnidirectional Endoscopy 1950, Hirshowitz, US 1983, Videoendoscope • ACMI 4990 fiberscope 79 AD, crude speculum • … • Found in ashes from Pompeii 1949, Eder-Hufford, US 1964, Olympus, JP • Rigid Esophagoscope • Fiberoptic gastroscope 1881, Mikulicz (surgeon), Vienna • Collab. with Vienna Instrument Maker Josef Leiter • First truly functional gastroscope 2001, Capsule Endo • … • Later version with „mignon“ light bulb 5 Spurr C. (2018) History of the Instruments and Techniques of Gastrointestinal Endoscopy.
Highlights from the “golden era” (1968 -1990) Sivak MV, Gastrointestinal endoscopy: past and future, Gut 2006;55:1061-1064. 6
AGENDA Korte endoscopy geschiedenis en ontwikkelingen Huidige prestaties en opkomende uitdagingen Toekomstperspectief 7
Opkomende uitdagingen die bijdragen aan contaminatie Complex design Insufficient process controle Rise of drug resistant pathogens ◼ Complex and fragile design ◼ Unknown sensitivity of culturing ◼ Collapsing development pipeline ◼ Challenging to sterilize ◼ Unknown sensitivity of ATP for Antibiotics testing ◼ Increasingly complicated ◼ Increasing prevalence of multi- reprocessing ◼ Biofilm formation drug-resistant (MDR) infections ◼ Constant maintenance ◼ Human factor also in Endoscopy ◼ Allowing for biofilm formation Contamination and Infection Risks Rauwers et. Al: Endoscope-associated infections: A brief summary of the current state and views toward the future 8
Voor en nadelen van corrigerende acties Rubin et. Al: Safely reprocessing duodenoscopes: current evidence and future directions 9
Uitdaging: opkomst van drugresistente pathogenen Harvard Med School: Scientists film bacteria’s maneuvers as they become impervious to drugs 10
Top 10 Gezondheidstechnische bedreigingen ECRI raises awareness about the risks in Healthcare to improve patient care #1 #2 Endoscope Risk #2 reprocessing Risk risk #4 failures continue to Risk #6 expose patients to Risk #8 infection risk Risk 2013 2014 2015 2016 2017 2018 Boston Scientific Confidential -- For Internal Use Only. Do Not Copy, Display or Distribute Externally Boston Scientific Confidential -- For Internal Use Only. Do Not Copy, Display or Distribute Externally 11 11
Opkomende uitdagingen die bijdragen aan contaminatie Rubin et. Al: Safely reprocessing duodenoscopes: current evidence and future directions 12
Landelijke studie toont 15% contaminatie Volgens een uitgebreide landelijke studie die is uitgevoerd in Nederland in 2016 en 2017, liggen duodenoscope contaminatie percentages eigenlijk hoger dan in eerste instantie gerapporteerd. 4 tot 6 70+ 150+ 15% delen van de deelnemende van de patient-klare duodenoscopes duodenoscope ERCP centrums zijn getest duodenoscopes zijn gesampeld en waren vervuild centraal gekweekt Rauwers et. Al: High prevalence rate of digestive tract bacteria in duodenoscopes: a nationwide study. 13
Contaminatie kansen bij Duodenoscope type Rauwers et. Al: High prevalence rate of digestive tract bacteria in duodenoscopes: a nationwide study. 14
Contaminatie kansen bij sampel onderdeel Rauwers et. Al: High prevalence rate of digestive tract bacteria in duodenoscopes: a nationwide study. 15
Study assessing attack rate • Duodenoscope A: – Vector from start of the outbreak – Attack rate 35%; 17/49 patients – Flush suction & biopsy channel MRKP contaminated • Duodenoscope B: – Vector after six months – Attack rate 29%; 7/24 patients – Flush biopsy channel MRKP contaminated • Drie patienten zijn mogelijk de link tussen de beide duodenoscopes. * Attack rate: aantal geïnfecteerde of gekoloniseerde casussen / aantal blootgestelde personen Rauwers et. Al: Independent root-cause analysis of contributing factors, including dismantling of 2 duodenoscopes, to investigate an outbreak of multidrug-resistant Klebsiella pneumoniae. 16
AGENDA Korte endoscopie geschiedenis en ontwikkelingen Huidige prestaties en opkomende uitdagingen Toekomstperspectief 17
Diverse uitdagingen, incl. Infectie Preventie Kurniawan, N., & Keuchel, M. (2017). Flexible Gastro-intestinal Endoscopy - Clinical Challenges and Technical Achievements. Computational and structural biotechnology 18
Mogelijke toekomstige strategieën • Reprocessing and quality assurance – Automation of manual cleaning steps – Video auditing of manual cleaning steps with feedback – Borescope video inspection of instrument channel – Autofluorescence or fluorescent stain-aided inspection for biomaterial – Point-of-care testing with higher sensitivity for contamination – Ozone-based low-temperature sterilisation • Duodenoscope/endoscope redesign: – Disposable tip and elevator assembly – Redesign of elevator channel – Replace the elevator assembly with alternative mechanism to direct accessories – Heat-stable devices to allow high-temperature sterilization – Disposable, sterile, single-use-devices Rubin et. Al: Safely reprocessing duodenoscopes: current evidence and future directions 19
Single Use Endo Technologies Single Use Endoscopes sold per year 1.000.000 aScope Broncho 500.000 SpyGlass & Lithovue 2012 2013 2014 2015 2016 2017 2018 2019 2020 AMBU: https://www.ambu.com/Admin/Public/DWSDownload.aspx?File=Files%2fFiles%2fAmbu%2fPresentations%2f20172018%2fQ2+presentation+2017_18.pdf 20 OLYMPUS: https://www.olympus-global.com/ir/data/pdf/investor_day_2018e_03.pdf
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