General Information

Olympus is continually monitoring the global developments around the COVID-19 pandemic and has set up a global task force to ensure business continuity. The health and safety of our employees, our customers and the patients they treat, and our global communities are extremely important to us. We are doing everything we can to maintain supplies while also being vigilant about the risk. We are paying special attention to partners in the health care industry who are at the center of working to address this global crisis.

The Olympus repair centers strive for high hygienic standards in order to keep not only our customers and patients but also our staff safe.
The following stages within the repair process contain a potential risk of infection:

• Registration.
• Reprocessing

Since proof that medical instruments received at Olympus repair facilities are properly cleaned, disinfected and/ or sterilized is not given in every single case, these instruments need to be treated as contaminated during the registration and reprocessing process. Regardless of the decontamination status of the received instrument, corresponding PPE must be worn by every employee who comes in close contact with the instruments and their packaging.

The standard reprocessing process already requires that any suspicious packaging such as cases or inlays are cleaned by using disinfecting wipes. Wrapping foils are disposed of in sealable waste bins for biohazardous material and any paperwork is scanned and safely disposed of as well. All instruments for which Olympus does not receive sufficient proof of disinfection are cleaned and disinfected in EndoThermo Disinfectors (ETD) before further handling. If the technical condition of an instrument does not allow the disinfection process in an ETD, the instrument must be passed through a manual cleaning and disinfection process or a gas sterilization process. With these clear steps, which are part of more than 60 mandatory hygienic standards, repair guidelines, inspection methods and quality checks, Olympus ensures a safe work environment and high OEM standards for our instruments.

<sub>Please note:
As a response to the coronavirus pandemic, Olympus implemented additional safety measures as follows:
- Implementation of all applicable governmental regulations and recommendations of public authorities like the Robert Koch Institute into clear and binding Olympus guidelines.
- Physical distancing rules and a maximum number of persons per designated area.
- Temporary physical splitting of teams by means of shift work where the distancing rules can’t always be followed.
- Mandatory usage of face shields and/or face masks in situations where the distancing rules can’t be followed.
- Continuous disinfection of frequently touched objects such as door handles, switches, handrails, etc.</sub>

In the Olympus instructions for use (IFU), state of the art processes and evidence are taken into account when describing how to reprocess the respective instrument. Therefore, the safety measures are constructed to avoid transmission of ANY pathogenic microorganism from the instrument to:

• The hospital staff (personnel safety).
• The next patient (patient safety).

Olympus reprocessing instructions assume that after each treatment your instrument is potentially contaminated with high loads of microorganism of any kind (even the most infectious and resistant ones) in organic soil. Therefore, the reprocessing requirements and instructions ensure safe reprocessing:

• Not only against SARS-CoV-2.
• Not only during a pandemic.
• After every single treatment/procedure.

In addition to our IFU, please follow specific local guidelines, recommendations and best practices as your first source of information.

International health care societies as the World Health Organization (WHO) and World Endoscopy Organization (WEO) state that no additional approach is needed for instrument reprocessing, since coronaviruses including the COVID-19 virus (SARS-CoV-2) can be inactivated by many commonly used disinfectants or in accordance with safe routine procedures.

Customers can continue using their reusable instruments safely when closely following the instructions for use and reprocessing,employing reprocessing best practices for their respective markets.

Due to its relatively large size and envelope, SARS-CoV-2 is very prone to chemical and physical attack. For its removal and also inactivation, washing hands with soap and water for about 20 seconds is regarded as a highly effective measure. Hand disinfectants, preferably based on alcohol (isopropanol and ethanol), are also highly effective as long as they are labeled as having virucidal properties*. Both soap and alcohol dissolve the fat membrane of the envelope and the virus falls apart like a house of cards and becomes inactive. Please follow the indicated contact times of the chemistry and make sure and make sure that it covers every part of the hand.

_{*Classification as “limited” and “full” virucidal disinfectants
According to EN 14476/EN 17111 or national institutes such as the German Association for the Control of Viral Diseases (DVV).}

_{Check the labeling on your disinfectant.
“Limited virucidal*” (= effective against enveloped viruses) or “full virucidal*” (= effective against enveloped and naked viruses).
Therefore even disinfectants labeled as “limited virucidal” are effective against SARS-CoV-2.}

Wearing personal protective equipment (PPE) protects you against transmission of pathogens during reprocessing. Ensure the correct use of PPE, especially to prevent mucosa in the mouth, nose and eyes from getting into contact with aerosols/droplets. For specific guidance on appropriate PPE in the case of COVID-19 as well as the correct donning and removal, please refer to national and global guidance such as that from the European Centre for Disease Prevention and Control (ECDC), World Endoscopy Organization (WEO) or European Society of Gastroenterology and Endoscopy Nurses and Associates (ESGENA).