Attachment 13. Clean and Disinfection Validation Report

Attachment 13 Clean and Disinfection Validation ReportCleaning and Disinfection Validation Report 1. Test PurposeThis testing is prepared to determine effectiveness of clean and disinfection process for reprocessing reusable medical device - AGE Automatic Wrist Blood Pressure Monitor, including models BW-601, BW-602, BW-603, BW-605, BW-606, BW-611, BW-612, and BW-613. AGE Automatic Wrist Blood Pressure Monitor is for use by medical professionals or at home and is a non-invasive blood pressure measurement system intended to measure the diastolic and systolic blood pressures and pulse rate of an adult.2. Reference StandardASTM E 1837 96 (Reapproved 2002), Standard Test Method to Determine Efficacy of Disinfection Processes for Reusable Medical Devices (Simulated Use Test)3. Quality Assurance Statement This testing meets the technical requirement of the applied standard. The testing lab is “Microbiological and Biomedical Safety Testing Laboratory” and meets with the requirements of the “Good Laboratory Practice Regulations”.4. Testing Bacteria and Fungi The testing is conducted on the following three bacteria or fungi.1) C.albicans 2) Pseudomonas aeruginosa3) Staphylococcus aureus5. Sample RequirementsThere are 8 models BW-601, BW-602, BW-603, BW-605, BW-606, BW-611, BW-612, and BW-613 for the test. At least 3 samples are needed to test for each model.6. Test Protocol6.1 This test method is performed by contamination of accessible and exterior surfaces of devices intending to reach the sites.6.2 The number of microorganisms contaminating the test devices prior to processing is determined by contamination and elution of at least two control unprocessed units (representing a large complex instrument). More control units of smaller devices may be used. Contamination with an inoculum with high numbers of microorganisms to achieve at least 106 cfu/instrument, recoverable is required.6.3 After inoculation, the test devices are processed according to the manufacturers instructions for use of the reprocessing cycle, the disinfectant, or disinfector. Either the disinfectant, disinfector cycle alone, or the disinfectant (disinfector) cycle plus any cleaning, rinsing, or other contributory steps in the directions for use, may be tested.6.4 Following processing, the test instruments are sampled using specified elution and culture techniques to determine the number of surviving bacteria in colony forming units (cfu).7. Test Procedure7.1 Testing Bacteria and Fungi PreparationThe testing bacteria and fungi are incubated until they reach at least 1 X 108 cfu/mL.Please refer to Part 8 for Media Reagents description in detail.7.2 Inoculation of Devices1) Use pre-cleaned and pre-disinfected AGE Automatic Wrist Blood Pressure Monitor.2) Inoculate the cuff, enclosure and key of AGE Automatic Wrist Blood Pressure Monitor with testing bacteria and fungi.7.3 Quantity of Inoculum and Surviving OrganismsQuantity of inoculum and surviving organisms is considered on patient contracting part of device (Cuff - Nylon, Enclosure - ABS plastic). After the incubation period, the number of colonies recovered from each device is determined by counting appropriate sets of triplicate plates. In order for the test to be valid, an average of 106 cfu/device must be recovered.7.4 Cleaning and DisinfectionClean and disinfection of the device is used the method described in the manual.Part of deviceCleaning and disinfection methodNylon Cuff1. Wipe it with a moist cloth2. Wipe it clean with a sterilizing cloth moistened with a neutral detergent3. Wipe it again with a sterilizing cloth moistened with 75% Ethanol for 60s4. Wipe it with a dry clothABS Plastic Enclosure and Key 1. Wipe it clean with a sterilizing cloth moistened with a neutral detergent2. Wipe it again with a sterilizing cloth moistened with 75% Ethanol for 60s3. Wipe it with a dry cloth7.5 Comparative Quantitative DataThe effectiveness of the disinfectant cycle can be evaluated by the number of organisms surviving on the test device. 8. Media Reagents1) Sterile buffered elution fluid containing 0.1 % Triton X-100 prepared in Type III or better ASTM water. 2) Soybean-Casein Digest Broth, USP, with and without appropriate neutralizers for the specific test disinfectant chemical.3) Soybean-Casein Digest Agar, USP, with and without appropriate neutralizers in 10 to 50-mL tubes or bottles tempered to 50 10C.4) Middlebrook 7H9 Broth, with and without appropriate neutralizers in 10 to 50-mL tubes or 250 to 500-mL flask (for mycobacteria).5) Middlebrook 7H11 Agar, with and without appropriate neutralizers in 10 to 500-mL tubes or bottles tempered to 50 1C (for mycobacteria).6) Mycophil or Potato Dextrose Agar, with and without appropriate neutralizers in 10 to 500-mL tubes or bottles tempered to 50 1C (for fungi). Soybean-Casein Digest Broth or agar, or both, may be used for many fungi.7) Bacteria-Free Water (when a water rinse step is part of the reprocessing procedures).9. Test EquipmentThe key test equipments of this testing are listed as below:1) Syringes, 10 to 50 mL, sterile.2) Sterile Cotton, dacron or other swabs.3) Sterile Petri Dishes.4) Sterile Tubes, to hold 10 mL.5) Sterile Bottles, to hold 50 mL and sterile flasks to hold 250 to 500 mL.6) Steam, or other type of sterilizer.7) Water Bath, to maintain temperatures from 20 to 50 2C.8) Incubator(s), to maintain 35 2C.9) Membrane Filters and Filter Supports, for membrane filters.10) Colony Counter.11) Disposable Plastic Pipettes, various sizes.12) Vortex Mixer or Sonicator, or Both.10. Acceptable CriteriaThe number of organisms surviving on the test device after clean and disinfection shall be 0-3 cfu/device. 11. Test Record and Result11.1 Test Sample InformationModelBatch NoNumberBW-601201208013 piecesBW-602201208023 piecesBW-603201208033 piecesBW-605201208043 piecesBW-606201208053 piecesBW-611201208063 piecesBW-612201208073 piecesBW-613201208083 pieces11.2 Test ResultModelBatch NoNumberInoculation with bacteria and fungiQuantitation of Inoculum(cfu/device)Surviving organisms(cfu/device)BW-601201208013 pieces#1, C.albicans 1 X 106 0#2, Pseudomonas aeruginosa1 X 106 0#3, Staphylococcus aureus1 X 106 0BW-602201208023 pieces#4, C.albicans 1 X 106 0#5, Pseudomonas aeruginosa1 X 106 0#6, Staphylococcus aureus1 X 106 0BW-603201208033 pieces#7, C.albicans 1 X 106 0#8, Pseudomonas aeruginosa1 X 106 0#9, Staphylococcus aureus1 X 106 0BW-605201208043 pieces#10, C.albicans 1 X 106 0#11, Pseudomonas aeruginosa1 X 106 0#12, Staphylococcus aureus1 X 106 0BW-606201208053 pieces#13, C.albicans 1 X 106 0#14, Pseudomonas aeruginosa1 X 106 0#15, Staphylococcus aureus1 X 106 0BW-611201208063 pieces#16, C.albicans 1 X 106 0#17, Pseudomonas aerugi