60 microbiological sampling series over an 11-month investigation period
• No detection of Pseudomonas aeruginosa during the study period

• Legionella remained below the technical detection limit throughout the investigation

• One Mycobacterium chimaera finding was associated with the sampling outlet and was not detected again after technical modification

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Source: Foltan M, Nikisch A, Dembianny J, et al. A solution for global hygienic challenges regarding the application of heater-cooler systems in cardiac surgery. Perfusion. 2021. DOI: 10.1177/02676591211033483.

Institute for Hygiene, Medical University of Graz
• Under the stated test conditions, all selected test organisms were reduced to below the detection limit after 2.5 minutes

• Selected test organisms included Pseudomonas aeruginosa, a staphylococcal species, and Bacillus subtilis

• Testing was performed under defined laboratory conditions in duplicate

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Source: Mascher F. Test Report: Inactivation of selected test bacteria in water by treatment with a pro aqua diamond electrode. Institute for Hygiene, Medical University of Graz. 09.02.2017.

SEM Surface Analysis and Long-Term Material Assessment
• Oxygenators from two manufacturers were exposed to treated water for 36 hours

• No perforations or micro-ruptures were observed on the examined surfaces

• After 11 months of constant application, no degradation marks were found on the cooling heat exchanger or heating coil

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Source: Foltan M, Nikisch A, Dembianny J, et al. A solution for global hygienic challenges regarding the application of heater-cooler systems in cardiac surgery. Perfusion. 2021. DOI: 10.1177/02676591211033483.

Administrative decision issued on 27 November 2023, valid across Europe.
• BASG determined that WCD2 is not a medical device within the meaning of Regulation (EU) 2017/745

• BASG also determined that WCD2 is not an accessory to a medical device under Regulation (EU) 2017/745

• The decision is based on the stated intended purpose of WCD2 as a system for cleaning and disinfecting process water in hypothermia devices, not the medical device itself

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Source: Austrian Federal Office for Safety in Health Care (BASG). Administrative Decision - Demarcation “WCD2 - Water Cleaning & Disinfection Device”. Reference number GZ: 102523930 / 3569224-008. 27.11.2023.

TÜV SÜD decision issued on 8 October 2024
• Confirms the decision of the Austrian Federal Office for Safety in Health Care (BASG).

• TÜV SÜD expressly states that it agrees with the BASG decision of 27 November 2023.

• The notice confirms that WCD2 is not a medical device and not an accessory to a medical device under the MDR.​

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Source: TÜV SÜD Product Service GmbH. Refusal of Application Due to Regulation. Project number 713342194-AR. 08.10.2024.

Test Report 01/23 - Classification of WCD2 under MDR
• The stated intended purpose of WCD2 is the automatic disinfection of water in the water circuits of hypothermia devices

• The report clearly distinguishes between disinfection of process water and disinfection of the medical device itself

• Based on the stated intended purpose, the report concludes that WCD2 is not a medical device within the meaning of MDR 2017/745

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Source: Graz University of Technology. Test Report 01/23 - Classification of WCD2 under MDR 2017/745. 22.02.2023.