CDWA3 / CDWA4 CDWAH. Page 4. BASKET ZONE: water pressure, spray system performance, detergent chemistry and concentration, temperature.

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1 Rev. 2 March 2017

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4 Control of cleaning and washing processes of medical instruments and materials is highly important since its outcome affects the success of subsequent disinfection and/or sterilization processes. CDWA3 / CDWA4 Cleaning Indicators for thermodisinfection machines consist of a synthetic support of 70 x 30 mm, which is stable at disinfection temperatures. Each indicator contains a mixture of specially combined colored organic components. Chemdye CDWA indicators formulation allows detection of all factors that affect the cleaning process outcome. CDWA indicators can be used for routine monitoring of cleaning processes in automatic machines with different washing and thermodisinfection configurations. CDWA cleaning system offers two different levels of cleaning with different wash-off characteristics, thus allowing different challenge levels to test cleaning efficiency. CDWA indicators are validated according to testing samples described in ISO/TS part 5. CDWAH Chemdye CDWAH has been designed to hold Chemdye CDWA Cleaning Indicators, used for cleaning process routine control and monitoring of automatic washing machines effectiveness as well as monitoring ultrasonic washers. The holder can be fixed on the tray, which allows reproducible location of the cleaning indicator in the washer-disinfector. When a CDWA cleaning indicator is placed within the holder, half of the test soil is covered, thus simulating the joint of a surgical instrument, with water stream hitting it indirectly. The other half of the test soil is covered by a mesh, thus posing a challenge for water to reach it, emulating shadowed or occluded surfaces. BASKET ZONE: water pressure, spray system performance, detergent chemistry and concentration, temperature. COVERED ZONE: detergent chemistry and concentration, water quality, temperature, cycle duration, etc. Page 4

5 Results reference guide ( OK / FAIL) Visual results Location inside washer Water pressure Mechanical functions (detergent injection pump, spray arms, etc) Temperature Exposure time Detergent (type, dose) Water quality Processed and correct Code Sample color Challenge level CDWA3 CDWA4 Blue Fuchsia High Very High Advantages Provides constant cleaning characteristics compared to the use of assays based on natural samples, whose adhesive properties and polarity can change during storage time. Non toxic. High level of trust and reliability to reveal deficiencies in the cleaning process. Long shelf-life based on organic formulation. Unprocessed Page 5

6 IKW4 Chemink IKW4 Cleaning Indicator Ink contains 10 ml of a mixture of colored components (proteins, sugars and colored fatty acids) specially designed to monitor the cleaning efficiency in thermal disinfection washing machines. IKW4 poses a high challenge to the cleaning process and can be removed from metallic surfaces. Cleanliness depends on the presence, type and concentration of detergent; temperature and pressure of the washing solution and cycle time. The IKW4 ink could also be used for validating cleaning processes in ultrasonic washing machines operating at frequencies equal to or greater than 35 khz, between 20 C and 65 C, in synergy with detergents suitable for this process. Page 6

7 After cleaning, surgical instruments must be disinfected to ensure safe subsequent handling and processing. Thermal disinfection with moist heat is the most common method for disinfection of medical devices in the hospital setting. Disinfection effects can be defined by the A 0 value, a physical parameter specified in ISO , which denotes the inactivation of microorganisms. A particular A 0 value can be achieved with the most diverse temperature/ time combinations, moreover, monitoring of these conditions is paramount to ensure the effectiveness of the disinfection. Integron indicators for thermodisinfection processes have been developed to monitor a wide range of cycles so as to cater for your needs when processing surgical instruments. IT27W-1 / IT27W-5 / IT27W-10 Integron Indicators have been designed to react in moist heat disinfection processes in washer-disinfectors, providing an accurate, convenient method of routine control, and assuring disinfection efficiency. The green indicating ink was developed to turn to purple when the following temperature and time conditions are met: IT27W-1: 90 C, 1 minute, A 0 =600 IT27W-5: 90 C, 5 minutes, A 0 =3000 IT27W-10: 93 C, 10 minutes, BGA/RKI/Epidemic program Page 7

8 Control of cleaning and washing processes of medical instruments and materials is highly important, since its outcome affects the success of subsequent disinfection and/or sterilization processes. Ultrasonic washers are used to remove soil from joints, crevices, lumens and other difficult to access locations. Cleaning takes place through a process called cavitation, a phenomenon generated by special transducers within the ultrasonic washing machine. If any of these transducers is not functioning, the washer can have cold spots, areas within the washer tank where there is no cavitation and, as a consequence, ultrasonic cleaning becomes incomplete. Also, cavitation can be influenced by the presence of dissolved air on the tank water, temperature and hardness of tank water, use of cleaning solutions or detergents, among others, making a routine test of ultrasonic cleaning effectiveness indispensable. CDWU Chemdye CDWU indicator consists of a transparent vial, with a blue-colored reactive solution and glass beads immersed in it. The formulation of the solution contained in the vial allows the monitoring of cavitation capacity of the ultrasonic washer. When cavitation functions properly, vibration of the glass pearls triggers a color change in the solution, from blue to yellow, through a range of green color intermediates. The CDWU indicator can be used for routine monitoring of ultrasonic cleaning washing machines with different ultrasonic washing configurations. It should be noticed that the CDWU indicator was developed to monitor the cavitation performance of the ultrasonic washing machine with an empty tank, that is, without any load. Page 8

9 Advantages High stability compared to similar products on the market, which ensures correct long-term performance of the medium, thereby guaranteeing a reliable result in the routine control of the ultrasonic washer. High confidence and high reliability to reveal deficiencies in the ultrasonic cleaning performance. Chemdye CDWU cleaning indicators are manufactured under ISO and ISO 9001 Quality Management System standards. Unprocessed Low cavitation capacity High cavitation capacity Page 9

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12 BT400 The envelope containing Bionova BT400 Spore Strips has been designed for monitoring High Level Disinfection of endoscopes in automatic washer-disinfectors that use Peracetic Acid. The strips contain a population of 10 6 highly resistant Geobacillus stearothermophilus spores, which are completely eliminated only when the high level disinfection process takes place. After exposure to the disinfectant agent, strips are aseptically transferred to the culture medium tube and a color change is evaluated after incubation of 24 hours at 60 ºC. If the process was effective, spores are eliminated and therefore the medium remains purple. On the other hand, a failure during the disinfection process turns the culture medium to yellow as a consequence of bacterial growth. Advantages Allows safe release of reprocessed endoscopes, as it directly monitors the elimination of microorganisms potentially present in the endoscope. The exclusive envelope design avoids spore washing by the immersion process, preventing a false negative result and guaranteeing a reliable microbiological result. Easy interpretation of results thanks to a noticeable color change in the culture medium. Low cost. Page 12

13 IT400 Integron IT400 Chemical Indicators allow to confirm if adequate temperature, time and concentration of disinfectant agent conditions have been achieved during endoscope reprocessing cycles in automatic washer disinfectors that use Peracetic Acid (PAA) as disinfectant agent. IT400 indicator s ink has been specially developed for processes working at temperatures between ºC and turns to pink when integration conditions reach the stated values of the quality certificate. IT400 color change indicates that High-Level Disinfection conditions have been reached. Advantages Easy interpretation of results thanks to the accuracy in the indicator s color change. Exclusive envelope design avoids ink washing during the immersion process, therefore guaranteeing an adequate color change of the indicator s ink. Immediate results. Very low cost. Page 13

14 IT401 Integron IT401 Chemical Indicators allow to confirm if adequate temperature, time and concentration of disinfectant agent conditions have been achieved during endoscope reprocessing cycles in automatic washer-disinfectors that use Peracetic Acid (PAA) as disinfectant agent. IT401 indicator s ink has been specially developed for processes working at temperatures between ºC and turns to blue when integration conditions reach the stated values of the quality certificate. IT401 color change indicates that High-Level Disinfection conditions have been reached. Advantages Easy interpretation of results thanks to the accuracy in the indicator s color change. Exclusive envelope design avoids ink washing during the immersion process, therefore guaranteeing an adequate color change of the indicator s ink. Immediate results. Very low cost. Page 14

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18 Cleaning and disinfection are two essential steps in the healthcare industry. Sterile processing in the healthcare setting involves the proper and thorough cleaning, decontamination, disinfection and sterilization of surgical instrumentation and medical devices to remove bioburden that can cause healthcare-acquired infections. Removal of body fluids, tissue, residual organic matter and biofilm is critical to ensure proper cleaning and subsequent high-level disinfection. Poor cleaning can lead to proteinaceous residues attached to the instruments surfaces. The importance of this type of residues has been recently stressed, due to prion risk transmission. Prions are unfolded infectious proteins and they are the causative agent of iatrogenic spongiform encephalopathies such as the variant Creutzfeldt-Jakob disease (vcjd). It is necessary to use protein detection methods to check for the efficient removal of protein from surgical instruments after processing, since the total protein level is used as an indication of the amount of prion protein contamination. Recent standard revisions indicate that the upper limit of acceptable protein contamination after processing is 5μg BSA equivalent per instrument side, and that is necessary to establish a lower level for neurosurgical instruments. Page 18

19 PRO1 MICRO The PRO1 MICRO Hygiene Monitoring System has been designed to detect proteins and to reduce iatrogenic agents on surgical instruments after their cleaning, in real time. The system has a high absorption swab that allows collection of samples from different surfaces with high efficiency. A visual readout of a color change indicates the presence of detectable levels of protein. Chemdye PRO1 MICRO system has been designed to detect proteins, allergens and reducing agents on surfaces after the cleaning process and in areas of difficult access. Advantages of Chemdye PRO1 MICRO System Easy to use and interpret due to accurate color change, originated by a colorimetric reaction. The more soil detected, the quicker and darker the color changes. Low cost and easy to use. High sensitivity. Rapid test results in less than 20 minutes. Provides qualitative data. Comparison of the final color against a color pattern included within the device allows estimation of cleanliness. It does not require handling dangerous chemical substances in specialized laboratories. Quick results that allow taking immediate remedial action and avoiding healthcare-acquired infections. Manufactured under ISO standard and follow recommendations set in the HTM and HTM guidelines. Our reading devices provide quantitative data. Traceability Software results according to the HTM guidelines. Page 19

20 The first step in properly cleaning surgical instruments is to rinse off all blood, bodily fluids and tissue immediately after use. If cleaning is not carried out adequately, it may render the disinfection stage ineffective, causing patients to be exposed to body fluids and tissue contaminants from prior patients, which can result in the transmission of pathogens affecting large numbers of people. KPRO2-E69 / KPRO2-E250 Chemdye KPRO2-E69 and KPRO2-E250 Hygiene Monitoring Systems have been designed to test cleanliness of surgical equipment by detecting protein residues left behind following improper cleaning. The systems have a high absorption swab, allowing the collection of samples from different surfaces with the same efficiency. These are compatible with cleaning verification of endoscopes and other reusable instruments with hard-to-reach internal channels or cannulated instruments.they can be used on washer-disinfectors, ultrasonic cleaners, surgical instruments and endoscopes. Page 20

21 Advantages No incubation required: no special equipment needed Fast results: it only takes 15 seconds High sensitivity: it detects as little as 1 μg of protein Easy to use Definite color change Minimal training needed Detects blood derived proteins Page 21

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24 Flexible endoscopes are very complex reusable medical devices. They get in contact with human mucous membranes and tissues, consequently, high-level cleaning and disinfection is required after its use, in order to avoid pathogen dissemination. Automated Endoscope Reprocessors (AERs) are the preferred method for endoscopes washing and disinfection given that they provide a standardized method with minimal human intervention. Washing efficiency is influenced by water pressure, chemical agents concentration, temperature and cycle duration. Monitoring the efficacy of the cleaning processes is crucial to ensure compliance with the standards of cleanliness. Page 24

25 CCDER1 / CCDER2 Chemdye CCDER1 and CCDER2 devices consist of a perforated plastic capsule able to hold the CDWE cleaning indicator, which contains a mixture of specially combined colored components. The capsule is connected to a high resistance plastic tube of 2 meters long and 1 mm (CCDER1) or 2 mm (CCDER2) internal diameter. In addition, the tube has a luer-lock connector, which enables the connection to Automatic Endoscope Reprocessors terminals. One Iuer-lock male and female terminal is included. You may choose the most appropriate terminal for your AER. CCDER122 Chemdye CCDER122 device consists of three perforated plastic capsules, which are able to hold the CDWE cleaning indicator and are connected to 2-meter long high resistance plastic tubes. One of the tubes has 1 mm of internal diameter and the other two have 2 mm of internal diameter. Furthermore, each tube has a luer-lock connector that enables the connection to Automatic Endoscope Reprocessor terminals. One luer-lock male and female terminal is included for each tube. You can choose the most appropriate terminal for your AER. CDWE Chemdye CDWE Cleaning Indicator consists of a 38 mm x 6 mm synthetic, adhesive and temperature-stable support printed with indicating colored ink. Chemdye CDWE allows detection of failures of all factors affecting the outcome of the cleaning process of endoscopes in Automatic Endoscope Reprocessors. The indicator ink is non-toxic. Page 25

26 KCCDER1 / KCCDER2 / KCCDER122 Chemdye KCCDER have been designed to control the flexible endoscope washing process efficiency in automatic washer-disinfectors. The KCCDER1 and KCCDER2 simulates 1 and 2 mm inner diameter endoscope channels whilst the KCCDER122 possesses three parallel channels (a 1 mm inner diameter channel and two 2 mm inner diameter channels), thereby representing an endoscope in a realistic mode. Both devices are capable of holding the CDWE cleaning indicator strips, which have been specially designed to control the efficacy of the mentioned process in automatic washer-disinfectors. Complete removal of the indicator confirms an adequate cleaning efficacy. If indicator ink is observed after the washing cycle, the endoscope cannot be considered clean. Advantages Direct information on the effectiveness of the cycle in question. Challenge devices are directly connected to the washer and are processed simultaneously with the flexible endoscope. Easy interpretation of results. Adhesive on the back of the cleaning indicator strips facilitates results record keeping. Low cost due to the fact that these devices are manufactured with highly resistant and durable plastic. Page 26

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