OLYMPUS Investor Day 2018

Enhancement of Infection Prevention Activities
Yoshio Tashiro
Executive Officer, Medical Reprocessing Strategy
Olympus Corporation
September 5, 2018

Disclaimers
The financial forecasts and other material in this document are based on judgements and assumptions
derived from currently available information. Actual results may differ significantly from targets, being
subject to change due to factors such as the uncertainties implicit in these judgements and assumptions anddue to future changes in business operations and circumstances inside and outside the company.

Furthermore, this information is subject to change without notice. Accordingly, use of this information andthis document should be at the discretion of the user and done with reference to information obtained byother means.

This document contains information about products that have not yet been approved in some countries
including Japan (including products under development). This information is not intended for promotional or
medical advice use. Rather, it is provided to give examples of technology development by Olympus and noguarantees are made about the future sale of such products.

2Olympus accepts no responsibility for any losses that arise from use of the information in this document.

2018/9/5

No data copy / No data transfer permitted

Medical Device “Reprocessing”
Reprocessing
Complete processes for cleaning, disinfection and/or sterilizationin order to utilize a medical device again
Procedure in patient

Storage

Cleaning
Disinfection

Sterilization“Reprocessing”
3

2018/9/5

No data copy / No data transfer permitted

Environmental Changes at Endoscope Industries
Warning fromgovernment

Multi-drug resistantbacteria (CRE*1)

Reusable Flexible
EndoscopeSingle-use flexible
endoscopes

Complexity in regulatorycomplianceFurther needs tosecure safety

Increasing options forreprocessing methods

Will show our intensive activities to adjust environmental changes*1 CRE, which stands for carbapenem-resistant Enterobacteriaceae, are a family of germs that are difficult to treat because they have high levels of resistance to antibiotics. Healthypeople usually do not get CRE infections – they usually happen to patients in hospitals, nursing homes, and other healthcare settings. Patients whose care requires devices likeventilators (breathing machines), urinary (bladder) catheters, or intravenous (vein) catheters, and patients who are taking long courses of certain antibiotics are most at risk for CRE
infections. (CDC, https://www.cdc.gov/hai/organisms/cre/index.html)
4

2018/9/5

No data copy / No data transfer permitted

Waning from Regulatory Authorities regarding
Infection risks with Duodenoscope The FDA has issued safety communications about the risk of multidrug-resistant bacteriatransmission via endoscopes.
 In Japan, the Ministry of Health, Labor and Welfare has issued a notice based on the casesin the USA.

USA
‣FDA, February 19, 2015

Design of Endoscopic Retrograde Cholangiopancratography (ERCP) Duodenoscopes May
Impede Effective Cleaning : FDA safety communication 」

JAPAN‣MHLW, March 6, 2015

Potential outbreak of multi-drug resistantHospitals need to comply guidelines from the medical societies and instruction manuals

5

2018/9/5

No data copy / No data transfer permitted

Duodenoscope
Pay attention on reprocessing process for the endoscopewith elevator function•••

Duodenoscope was developed for conducting ERCP procedure efficiently.
Duodenoscope has a side viewing which is different from regular GI endoscope
Elevator function lift elevator with endotherapy devices such as biopsy forceps
commonbile duct
duodenum

Duodenoscope(Side View）

Elevator

CannulaDuodenoscope

6

2018/9/5

No data copy / No data transfer permitted

Objective lens GI endoscope（Straight view
Biopsy forceps）

Move devices with elevator
functionOur Approaches to Improve Safety
1. Provide comprehensive solution covering all reprocessing processes
 Develop/procure more effective/efficient endoscopy and reprocessing products Develop/improve reprocessing methods to make a process easier to reduce mistakes

2. Enhancement of training program for the HCPs and guide tools Reinforce external/internal thorough training for cleaning and disinfection technicians Strict adherence to cleaning procedures and methods as dictated by tablets
 Revise Reprocessing Manual for better understanding

3. Establish testing capabilities to validate reprocessing efficacy, efficiency andworkability
 Reprocessing efficacy with a validation test using organic microorganisms or artificial soils
 Compatibility/durability of the medical devices with chemicals or reprocessing machines
4. Enhance proactive communication with appropriate stakeholders
 Expand the audience for relevant new product and solution launches Facilitate and participate in stakeholder discussions
 Set a new organization taking a leadership to handle global reprocessing issues
８

2018/9/5

No data copy / No data transfer permitted

1. Provide Comprehensive Solutions
 Secure safety for all patients or HCPs who might have a potential infection risks
 Plan to deliver multiple solutions that addressing issues comprehensively at all
reprocessing processes
Process
management

Easier cleaning
devicesDrying/Storage
tool
Reprocess efficacy
evaluation tool
Improved cleaning
adaptor/machine９

2018/9/5

No data copy / No data transfer permitted

Process guide tool

Improved training
programDevelop Easier Handling Endoscopes/Cleaning Adaptors

Detachable Disposable Distal Cap

New Cleaning Adaptor

 Provide devices, endoscope or cleaning adaptor, with easier
handling/cleaning structures

New additional functions on
cleaning/disinfection machine

Cleaning/Disinfection
10

2018/9/5

 Provide more efficient automatedendoscope preprocessor

No data copy / No data transfer permitted

Product Development for New Duodenoscope
Features New duodenoscope is a side-viewing scope characterized byhigh-resolution imaging and narrow band imaging (NBI)
capabilities.
 Post-procedure, reprocessing is performed by detaching thedisposable distal cap and cleaning and disinfecting the tip ofthe scope.
 In addition, we have developed a new adaptor that can be
attached to the tip of the duodenoscope to inject a cleaning
solution, meant to improve cleaning efficiency.

Tear open the cap along the cut

Detach the cap completely from the distal end of theendoscope11

2018/9/5

No data copy / No data transfer permitted

Items for Reprocessing Efficacy Evaluation and Drying/Storage
Cleaning Efficacy Evaluation Device

 Provide a quick evaluation tool for cleaning efficacy

Sampling & Culturing Kit

 Provide supporting tools to evaluate reprocessing
efficacy

Storage Cabinet with Drying Function
Evaluation/Drying-Storage
12

2018/9/5

 Provide an item to keep the endoscope clean and dry
until next procedure

No data copy / No data transfer permittedReprocessing Process Management (Software base system)

Processmanagement

13

2018/9/5

No data copy / No data transfer permitted

Reprocessing Documentation, Workflow and Asset Management System
With Unifia connecting and collecting data from reprocessing and storage devices
has never been easier. Unifia’s wireless scanner technology puts the ability tocapture data from virtually all automated endoscope reprocessors, storage
cabinets, leak testers and bio burden test kits in the palm of your hand. OER-Pro
users can gain greater insight into their reprocessing times, scope serial numbersand HLD temperatures.

3. Supporting Tools and Training Program Enhancement

Enhanced training programs

 Develop and continue reprocessing training program for HCPs toprovide an opportunity to be trained.

Tablet for guiding processes

 Provide guiding tools to make reprocessing process more
visible/ institutive and improve efficiency
 Revise Reprocessing Manual for better understanding
14

2018/9/5

No data copy / No data transfer permitted

３．Enhancement of Reprocessing Tests Capabilities
4.0 billion Japanese Yen was invested to enhance functionCompatibility tests with detergent, disinfectant, reprocessing/sterilization machines
 Validation tests for reprocessing, cleaning, disinfection or sterilization, efficacy

Working on establishment of the testing capability to meet various regulatory requirements
15

2018/9/5

No data copy / No data transfer permitted

4. Enhance Communication with Stakeholders
 Patients/HCPs safety first

Prioritize safety for patients or HCPs by reducing potential
infection risks.

 Collaborations with stakeholders

With the best efforts by Medical device manufacturers, it isimportant to collaborate closely with HCPs, government ormedical societies.

Government

Medicaldevice
manufacturers

 Balancing between risks and benefits

Risks of using medical devices can’t be eliminatedcompletely. HCPs may decide whether a medical device canbe used by weighing potential risks and benefits. However
manufacturers need to continue their best effort to reduceor mitigate risks.

 Risk management

Evaluate potential risks by hazard analysis method andimplement risk mitigation actions. Collaborate with HCPs toaddress potential risks and take actions for risk mitigation.
17

2018/9/5

No data copy / No data transfer permitted

Medicalservice
providerEndoscope
medicalsocieties

Infection
controlsocieties

ReduceInfection
RiskHCPsEnhancement of Organization
Enhancement of internal collaborative structure
Businessstrategy

R&D

LegalRegulatory

Evaluation
TechReprocessing
Strategy OfficeMarketing

Quality
PR/IRServiceRegions

EuropesatelliteUSsatellite
HQ(Tokyo)

Executive Officer, Medical Reprocessing Strategy:
Yoshio Tashiro
18

2018/9/5

No data copy / No data transfer permitted

Enhancement of
global team structureSummary When developing, manufacturing or distributing medical devices, our firstpriority must be safety for patients and HCPs.
 The medical use of endoscopy is well established and continues to expand
to better diagnose and treat patients. Drug-resistant bacteria are anemerging threat to patients. We are analyzing all reprocessing processes
to address this issue.
 Need to review all processes including storage, transportation and others
beyond “cleaning” or “disinfection” until a device is delivered to the next
patient. All potential risk factors need to be reviewed and comprehensive
solution must be considered.
 In order to secure safety of medical device, medical device manufactures
will make a best effort to provide HCPs with safe and dependable devices.
And then, they will collaborate with stakeholders like HCPs, government or
medical societies together in order to enhance infection control programs.
192018/9/5

No data copy / No data transfer permitted