美国FDA通过医疗器械清洁确认报告

1、Cleaning Validation reportDevice name: XXXXXModel: XXXXXTest parts: XXXXXXXNO.NamePositionSpeciality1RA Engineer/team memberMajor: Biotechnology, Understand cleaningstandard and regulation2Mechanical Engineer/team memberFamiliar with XXXXX products3Quality manager/team memberProfession in Quality Ma

2、nagement4ManagementRepresentative/test directorProvide the resource supportPrepared by:Title: Management Representative1. General informationReport No.: XXXXXFDA-01Audited by:Title: RA EngineerPage: 2 of 7Sponsor:XXXXX Limited.Add: XXXXX.Study personal : XXXXXTest objective: Validate the efficacy of

3、 cleaning method (manual cleaning) provided in user manual for XXXXX.Test sample:XXXXTest Lab:XXXXXDate:The cleaning validation date: Nov. 11,2021Reference:AAMI TIR12:2021 Designing, Testing, and Labeling Reusable Medical Devices for Reprocessing in Health CareFacilities. A Guide for Device Manufact

4、urers 1st ed.AAMI TIR30:2021 A Compendium of Processes, Materials, Test Methods, and Acceptance Criteria for CleaningReusable Medical Devices.Alfa MJ, Degagne P, Olson N. Worst-case soiling levels for patient used flexible endoscopes before and after cleaning.Am J Infect Control 1999;27:392-401.ASTM

5、 D7225-13 Standard Guide for Blood Cleaning Efficiency of Detergents and Washer-disinfectors ReprocessingMedical Devices in Health Care Settings: Validation Methods and Labeling Guidance for Industry and Food and DrugAdministration Staff. March 17, 2021 User manual2. IntroductionCleaning: This repor

6、t details the methods to validate the effectiveness of a manual cleaning procedure for the XXXXX(include part XXX 2, XXX 1 and XXX 3), which was inoculated with an artificial test soil in various areas including thoseconsidered to be most challenging to clean and most likely to be soiled during actu

7、al use. The handpiece then was processed inaccordance with the cleaning procedure delineated in section 5. The device was assayed and any residual blood was recoveredto determine if adequate cleaning was achieved. This testing was repeated for a total of three test cycles.3. JUSTIFICATION5 CleaningP

8、age: 3 of 7Cleaning test method was based on methods outlined in AAMI TIR 30:2021 and ASTM D7225-13. cleaning instructions forreusable medical devices required validation in order to assure proper and safe reprocessing of devices by health care facilities.It is well known that a device which has not

9、 been cleaned properly may inhibit the ability of the sterilization process to achievethe proper sterility assurance level. This cleaning procedure must be able to remove gross amounts of soil from the test devicein order for it to be determined clean and safe for further processing. This study veri

10、fied that gross amounts of soil can beremoved from the device following the recommended cleaning procedure.The artificial test soil used to inoculate the device simulated worst case contaminants (blood and saliva) that may come incontact with the device and remain on the device after clinical use. T

11、he device was soiled using the artificial test soil andinoculated in the most difficult to clean locations and areas most likely to be soiled during actual use,the least effective (lowest)cleaning temperatures (according to the using temperature) within recommendations etc. These procedures provided

12、 worstcase soiling conditions for the cleaning validation.Acceptance criteria is no obvious stain under visual Observation, and will be based on study data of residual blood levels ofproperly cleaned medical instruments which indicate that the level of blood after cleaning is less than 0.1 g/dqvice.

13、 A bloodlevel of less than 0.1 g/device aft er performing the recommended cleaning procedure will indicate adequate cleaning anddemonstrate that the cleaning method is efficacious in removing soil.4. EQUIPMENT AND MATERIALS1)XXXXX: include part XXX2)Detergent: 75% alcohol: LOT#XXX3)Rabbit blood, Hem

14、ostat:LOT#XXX4)Fresh Human saliva5)Physiological saline:LOT#XXX6)Solution 1-0.1%Tetramethylbenzidine (TMB) in 5% acetic acid: LOT#XXX solution 2-3% hydrogen peroxidesolution: LOT#XXX7)Swab: LOT#XXX8)Timer:Equipment#XXX9)Thermometer#XXX10) Soft cloth5.1 Preparation of artificial test soilThe artifici

15、al test soil contained the following components to mimic blood and saliva:2.5 ml rabbit blood2.5 ml physiological saline5 ml human saliva5.2 Cleaning validation Procedure1)The devices listed in Table 1 were obtained. See table 2 for testing sample sizes.Page: 4 of 72)Prior to testing, all devices we

16、re pre-cleaned following steps 5).3)The test samples were inoculated in the most difficult to clean locations and areas most likely to be soiled during actualuse with the prepared artificial test soil. See Figure 1 for the device inoculation description.4)The inoculated test samples were allowed to

17、dry at room temperature for a minimum of two (2) hours to simulate worstcase conditions. See Figure 3 for visual clarification of soiling procedure.5)Each test sample and the negative control were disassemble (see Figure 2) and rinsed under running cold tap water andhand washed the full surface of t

18、he device until no obvious dirty, wiped the product with cloth moistened with water,then wiped clean with alcohol-immersed cotton , ensuring contact with difficult to clean areas such as chuckholes,crevices etc.6)The test samples and negative control were visually inspected. no visible soil was obse

19、rved on the test samples.7)Steps 3) through 6) were repeated three additional times for a total of four repetitive inoculation and cleaning cycles tosimulate soil accumulation that might occur during actual use.8)Steps 3) and 4) were repeated for the positive control.9)Sampled the whole handpiece wi

20、th swab, especially the areas difficult to clean, such as chuck holes,crevices etc. (Cleancotton swab that do not react with the test solution were used . If surfaces were dry, moistened swab with a drop of water.If the surface was wet, the swab needed not be pre-moistened)10) Activated 1 ml of solu

21、tion1 with 100 l of solution 2 and dropped the swab in the liquid. Observed and record the colorchange. (Visible color change will occur at 0.1 g or greater.) Repeated the step 9) through 10) until get all results of thesesamples.11) Recorded all the above results, See Table 3Disassembled device (fo

22、r cleaning):Page: 5 of 7Table 1 Bill of materialsAccessoriesNameLot number ProcessingvalidationSample sizePhotoXXXXXXCleaningTotal: 10PCSTest sample: 6PCS (3PCS areintended to contact with XXX1, others for XXX 2); Positivecontrol: 2PCS (1PCS isintended to contact with XXX1, another for XXX 2);Negati

23、ve control : 2PCS(1PCS is intended to contactwith XXX 1, another for XXX2)XXXXXXCleaningTotal: 5PCSTest sample: 3PCS;Positive control: 1PCS;Negative control: 1PCSXXXXXXCleaningTotal: 5PCSTest sample: 3PCS;Positive control: 1PCS;Negative control: 1PCSTest Sample SizesTestcycleTest samplePositive cont

24、rolNegative controlXXX 2+XXX3XXX 1+ XXX 3XXX 2+XXX 3XXX 1 +XXX 3XXX 2+XXX 3XXX1+XXX313 set3set1set1set1set1set23 set3set33set3setTable 2Device soiling descriptions:Figure 1The motor should be connect to XXX 2 or XXX 1 during clinical use, respectively connected the motor toXXX 1 and XXX 2, Using gloved hands soiled with artificial test soil, handled the surface of the device, ensuring contactedwith difficult clean areas such as chuck hole,crevicesPage: 6 of 7Figure 2For XXX 2+XXX 3, disassembled the motor and straight handpiece according t