FDA审批医疗器械清洁验证方案

1、Page 1 of 6Cleaning Validation ProtocolDevice name:XXXXModel: XXXXTest parts: XXXXNO.NamePositionSpeciality1RA Engineer/team memberMajor: Biotechnology, Understand cleaningrequirements2Mechanical Engineer/teammemberFamiliar with Dental XXXXs3Quality manager/team memberProfession in Quality Managemen

2、t4ManagementRepresentative/test directorProvide the resource supportPrepared by:Title: Management representative1. General informationAudited by:Title: RA EngineerPage 2 of 6Protocol No.: XXX-01Sponsor: XXXX Limited.Add: XXXX China.Test director: XXXTest personal : XXXTest objective: Validate the ef

3、ficacy of cleaning method (manual cleaning) provided in user manual for XXXX.Test sample:XXXX, see table 1Test Lab:XXXX LimitedReference:AAMI TIR12:2010 Designing, Testing, and Labeling Reusable Medical Devices for Reprocessing in Health CareFacilities. A Guide for Device Manufacturers 1st ed.AAMI T

4、IR30:2011 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 aftercleaning. Am J Infect Control 1999;27:392-401.ASTM D7225-13 Standard

5、Guide for Blood Cleaning Efficiency of Detergents and Washer-disinfectorsReprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling Guidance for Industryand Food and Drug Administration Staff. March 17, 2015User manual of XXXX2. IntroductionThis protocol details the method

6、s to be used to validate the effectiveness of a manual cleaning procedure for theXXXX.The device will be inoculated with an artificial test soil in various areas including those considered to be mostchallenging to clean and most likely to be soiled during actual use. The device then will be processe

7、d in accordancewith the cleaning procedure delineated in section 5. the device will be assayed and residual blood will be recovered todetermine if adequate cleaning was achieved.This testing will be repeated for a total of three (3) test cycles.3. JUSTIFICATIONThis test method was based on methods o

8、utlined in AAMI TIR30:2011 and ASTM D7225-13 .Cleaning instructionsfor reusable medical devices require validation in order to assure proper and safe reprocessing of the devices by healthPage 3 of 6care facilities. It is well known that a device which has not been cleaned properly may inhibit the ab

9、ility of thesterilization process to achieve the proper sterility assurance level. This cleaning procedure must be able to removegross amounts of soil from the test device in order for it to be determined clean and safe for further processing. Thisstudy will attempt to verify that gross amounts of s

10、oil can be removed from the device following the recommendedcleaning procedure.The artificial test soil used to inoculate the device will simulate worst case contaminants (blood and human saliva) thatmay come in contact with the device and remain on the device after clinical use. The device will be

11、soiled using theartificial test soil and inoculated in the most difficult to clean locations and areas most likely to be soiled during actualuse. The least effective (lowest) cleaning temperatures (according to the using temperature) within recommendationsetc. These procedures will provide worst cas

12、e soiling conditions for the cleaning validation.Acceptance criteria : no obvious stain under visual Observation, and will be based on study data of residual bloodlevels of properly cleaned medical instruments which indicate that after cleaning, the level of blood 0.1 g/deviceonthe device after perf

13、orming the recommended cleaning procedure will indicate adequate cleaning and demonstrate thatthe cleaning method is efficacious in removing soil .4. EQUIPMENT AND MATERIALS1)XXXX: XXXX2)Detergent: 75% alcohol3)Rabbit blood4)Human saliva5)Solution 1-0.1%Tetramethylbenzidine (TMB) in 5% acetic acid,

14、solution 2-3% hydrogen peroxidesolution, used for blood Analysis6)Swab7)Timer8)Thermometer9)Soft cloth10) soft brush5. Cleaning5.1 Preparation of artificial test soilThe artificial test soil will contain the following components to mimic blood and saliva:2.5 ml rabbit blood2.5 ml physiological salin

15、ePage 4 of 65 ml human saliva5.2 Cleaning validation Procedure1)The devices listed in Table 1 will be obtained. See Table 2 for testing sample sizes.2)Prior to testing, all devices will be pre-cleaned following steps 5).3)The test samples will be inoculated in the most difficult to clean locations a

16、nd areas most likely to be soiledduring actual use with the prepared artificial test soil, see Figure 1 for the device inoculation description.4)The inoculated test samples will be allowed to dry at room temperature for a minimum of two (2) hours tosimulate worst case conditions. A photo of the soil

17、ed devices will be included in the final report.5)Head cleaning (for Each test sample and negative control):a.Remove dirt and debris from the water spray outlets with a soft brush,b.Fill a cup halfway with clean water,c.Activate the XXXX and immerse into water whilst bur is rotating,d.Start and stop

18、 rotating the bur for 2 to 3 seconds 3 times whilst the head remains in the water. Remove andwipe dry with a clean soft cloth.XXXX cleaning(for Each test sample and negative control)a.Rinse the device under running cold tap water and hand wash the full surface of the device until no obviousdirty.b.W

19、ipe the device with a water soaked soft cloth.c.Wipe clean with alcohol-immersed cotton swab or cloth, ensuring contact with difficult to clean areas suchas chuck holes,crevices etc.6)The test samples and negative control will be visually inspected. If visual soil remains, steps 5) will be repeatedu

20、ntil test devices are visibly clean.7)Steps 3) through 6) will be repeated three additional times for a total of four repetitive inoculation and cleaningcycles to simulate soil accumulation that might occur during actual use.8)Steps 3) and 4) will be repeated for the positive control.9)Sample the wh

21、ole XXXX surface with swab, especially the areas difficult to clean, such as chuck holes,crevicesetc. (Use the clean cotton swab that does not react with the test solution. If surfaces are dry, swab should bemoistened with a drop of water. If the surface is wet, the swab need not be pre-moistened)10

22、) Activate 1 ml of solution1 with 100 l of solution 2 and drop the swab in the liquid. Blood residue will beindicated by a blue color reaction. Visible color change will occur at 0.1 g or greater. Repeated the step 9)through 10) until get all results of these samples.Page 5 of 611) Results, equipment, lot numbers, and other pertinent information will be record and issued in the final report.Table 1 Bill of materialsDescriptionProcessingvalidationSample sizePhotoXXXXXXXXCleaningTotal:Test sample:Positive control:Negative control:Tes