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STIP | www.infectiepreventieopleidingen.nl 1 Disclosure slide (potentile) belangenverstrengeling Geen Voor bijeenkomst mogelijk relevante relaties Boston Scientific met bedrijven Sponsoring of onderzoeksgeld geen Honorarium

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SLIDE 1

1

Disclosure slide

STIP | www.infectiepreventieopleidingen.nl 1

(potentiële) belangenverstrengeling Geen Voor bijeenkomst mogelijk relevante relaties met bedrijven Boston Scientific

  • Sponsoring of onderzoeksgeld
  • Honorarium of andere (financiële)

vergoeding

  • Aandeelhouder
  • Andere relatie, namelijk …
  • geen
  • geen
  • geen
  • geen

STIP | www.infectiepreventieopleidingen.nl

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SLIDE 2

Endoscopie gezien vanuit een infectie preventie perspectief – verleden, heden en potentiële toekomst

Salim Essakali, MS, MBA

  • Sr. Product Manager, EMEA,

Therapeutic Imaging Platforms

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SLIDE 3

3 Slide 4 Slide 5 Slide 7 Slide 8 Slide 9 Slide 11 Slide 12-14 Slide 15 Slide 17 Slide 18 Slide 19

Data sources

  • Spurr C. (2018) History of the Instruments and Techniques of Gastrointestinal Endoscopy.
  • Sivak MV, Gastrointestinal endoscopy: past and future, Gut 2006;55:1061-1064.
  • Rauwers et. Al: Endoscope-associated infections: A brief summary of the current state and views toward the future
  • Rubin et. Al: Safely reprocessing duodenoscopes: current evidence and future directions
  • Harvard Med School: Scientists film bacteria’s maneuvers as they become impervious to drugs
  • Rubin et. Al: Safely reprocessing duodenoscopes: current evidence and future directions
  • Rauwers et. Al: High prevalence rate of digestive tract bacteria in duodenoscopes: a nationwide study.
  • Rauwers et. Al: Independent root-cause analysis of contributing factors, including dismantling of 2 duodenoscopes, to investigate an outbreak of multidrug-resistant Klebsiella pneumoniae.
  • Kurniawan, N., & Keuchel, M. (2017). Flexible Gastro-intestinal Endoscopy - Clinical Challenges and Technical Achievements. Computational and structural biotechnology
  • Rubin et. Al: Safely reprocessing duodenoscopes: current evidence and future directions
  • https://www.ambu.com/Admin/Public/DWSDownload.aspx?File=Files%2fFiles%2fAmbu%2fPresentations%2f20172018%2fQ2+presentation+2017_18.pdf
  • https://www.olympus-global.com/ir/data/pdf/investor_day_2018e_03.pdf
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SLIDE 4

4

AGENDA

Korte endoscopie geschiedenis en ontwikkelingen Endoscopie Huidige prestaties en opkomende uitdagingen Toekomstperspectief

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SLIDE 5

5

Een beknopte Endoscopy geschiedenis*

79 AD, crude speculum

  • Found in ashes from Pompeii

1805, Bozzini, “Lichtleiter”

  • Developed in Mainz, Germany
  • First Endoscope
  • Urethra, bladder, vagina, rectum

1881, Mikulicz (surgeon), Vienna

  • Collab. with Vienna Instrument Maker Josef Leiter
  • First truly functional gastroscope
  • Later version with „mignon“ light bulb

79 AD 1805 1881 1922, Schindler, Germany

  • First really usuable str. gastroscope
  • Rubber tip tube
  • Air outlet to clear lens
  • Inner canula incl. Optics and light

1922 1932, Schindler, Germany

  • Semi-flexible Gastroscope
  • 32° tip deflection via m. lenses

1932 1940 1940, Cameron-Schindler, US

  • 1st gastroscope prod. in US
  • Later formed EDER Instrument Co.
  • Schindler formed AGC (precursor of ASGE)

1949, Eder-Hufford, US

  • Rigid Esophagoscope

1949 1950, Hirshowitz, US

  • ACMI 4990 fiberscope

1950 1950, Olympus, JP

  • Gastrocamera

1964, Olympus, JP

  • Fiberoptic gastroscope

1964 1983 1983, Videoendoscope

  • …

1979, Ponsky

  • First PEG

1979 2001, Yamamoto, JP

  • Double-balloon small

bowel enteroscope 2001 2001, Capsule Endo

  • …

2013 2013, FUSE

  • Omnidirectional

Endoscopy

Era of Rigid Endoscopy Schindler Era Fiberoptic Era Modern Era

Spurr C. (2018) History of the Instruments and Techniques of Gastrointestinal Endoscopy.

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SLIDE 6

6

Highlights from the “golden era” (1968-1990)

Sivak MV, Gastrointestinal endoscopy: past and future, Gut 2006;55:1061-1064.

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SLIDE 7

7

AGENDA

Korte endoscopy geschiedenis en ontwikkelingen Huidige prestaties en opkomende uitdagingen Toekomstperspectief

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SLIDE 8

8

Opkomende uitdagingen die bijdragen aan contaminatie

Contamination and Infection Risks Complex design

◼ Complex and fragile design ◼ Challenging to sterilize ◼ Increasingly complicated

reprocessing

◼ Constant maintenance ◼ Allowing for biofilm formation

Insufficient process controle

◼ Unknown sensitivity of culturing ◼ Unknown sensitivity of ATP

testing

◼ Biofilm formation ◼ Human factor

Rise of drug resistant pathogens

◼ Collapsing development pipeline

for Antibiotics

◼ Increasing prevalence of multi-

drug-resistant (MDR) infections also in Endoscopy

Rauwers et. Al: Endoscope-associated infections: A brief summary of the current state and views toward the future

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SLIDE 9

9

Voor en nadelen van corrigerende acties

Rubin et. Al: Safely reprocessing duodenoscopes: current evidence and future directions

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SLIDE 10

10

Uitdaging: opkomst van drugresistente pathogenen

Harvard Med School: Scientists film bacteria’s maneuvers as they become impervious to drugs

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SLIDE 11

11

Boston Scientific Confidential -- For Internal Use Only. Do Not Copy, Display or Distribute Externally

11

Boston Scientific Confidential -- For Internal Use Only. Do Not Copy, Display or Distribute Externally

#8

Risk

#6

Risk

#4

Risk

#1

Risk

#2

Risk

#2

risk

2013 2014 2015 2016 2017 2018

ECRI raises awareness about the risks in Healthcare to improve patient care Endoscope reprocessing failures continue to expose patients to infection risk

Top 10 Gezondheidstechnische bedreigingen

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SLIDE 12

12

Opkomende uitdagingen die bijdragen aan contaminatie

Rubin et. Al: Safely reprocessing duodenoscopes: current evidence and future directions

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SLIDE 13

13

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.

70+

deelnemende ERCP centrums

150+

duodenoscopes zijn getest

15%

van de patient-klare duodenoscopes waren vervuild

4 tot 6

delen van de duodenoscope zijn gesampeld en centraal gekweekt

Rauwers et. Al: High prevalence rate of digestive tract bacteria in duodenoscopes: a nationwide study.

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SLIDE 14

14

Contaminatie kansen bij Duodenoscope type

Rauwers et. Al: High prevalence rate of digestive tract bacteria in duodenoscopes: a nationwide study.

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SLIDE 15

15

Contaminatie kansen bij sampel onderdeel

Rauwers et. Al: High prevalence rate of digestive tract bacteria in duodenoscopes: a nationwide study.

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SLIDE 16

16

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.

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SLIDE 17

17

AGENDA

Korte endoscopie geschiedenis en ontwikkelingen Huidige prestaties en opkomende uitdagingen Toekomstperspectief

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SLIDE 18

18

Diverse uitdagingen, incl. Infectie Preventie

Kurniawan, N., & Keuchel, M. (2017). Flexible Gastro-intestinal Endoscopy - Clinical Challenges and Technical Achievements. Computational and structural biotechnology

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SLIDE 19

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Mogelijke toekomstige strategieën

Rubin et. Al: Safely reprocessing duodenoscopes: current evidence and future directions

  • 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

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20

Single Use Endo Technologies

2012 2013 2014 2015 2016 2017 2018 2019 2020

aScope Broncho

500.000 1.000.000

SpyGlass & Lithovue

Single Use Endoscopes sold per year

AMBU: https://www.ambu.com/Admin/Public/DWSDownload.aspx?File=Files%2fFiles%2fAmbu%2fPresentations%2f20172018%2fQ2+presentation+2017_18.pdf OLYMPUS: https://www.olympus-global.com/ir/data/pdf/investor_day_2018e_03.pdf