For performing the HTM 01-05 Cleaning Efficacy Test and Manufacturer Soil Tests.
Supplied as a starter kit or separate test strips.
How this product helps you comply with HTM 01-05 (2013 Edition)
- HTM 01-05 has cleaning efficacy test as a Daily and Quarterly requirement, however there is a difference in how they are performed. Daily cleaning efficacy is a visual check that requires the use of inspection magnification lamp. Quarterly cleaning efficacy requires a test soil such as the product listed on this page. (HTM 01-05 2013 edition.
- Section 13.3 Washer Disinfector. Section 14.3 Ultrasonic Cleaners) Some manufacturer’s recommend the quarterly test method, with use of a test soil, is carried out more frequently.
- Please seek manufacturer’s advice on the quarterly cleaning efficacy test, or download for FREE a validation test schedule (VTS) on the Isopharm website.
1. Prepare the machine as normal for processing instruments.
Add the normal detergent dosage.
|2. If the test is being performed in an ultrasonic cleaner, a degas cycle should be carried out prior to testing.|
|3. Place a single Load CEI Test Strip into the PCD Holder.|
4. Place the test into the machine.
No instruments should be present when testing an ultrasonic cleaner as the test will heavily soil the solution.
When performing the test for a washer disinfector, instruments can be present as the cycle will flush the test soil away.
5. Start a machine cycle as normal for cleaning your instruments.
6. When the cycle has completed, remove the test strip from the holder and inspect.
The test strip should be visually free of all red staining to pass the test.
7. If any red staining remains, the test should be determined as a fail result.
8. Record the test information and result in the machine log book.
9. The test strip should also be attached to the log book as further evidence of test.
Reasons Why the Test May Fail
Should the test fail a re-test should be performed. If the test fails a second time, a diagnosis of both the method of cleaning and method of testing is required.
The compliance team at Isopharm is also available to discuss the test and test method.
Possible fail reasons for a Cleaning Efficacy or Soil Test are:
Diagnosing the Method of Cleaning
- Changing detergent may present a false result, especially if this has been changed from the manufacturers recommended product. A fail may also be caused when the detergent used has been changed but the level of dosing has not.
- In some cases it may be that the machine under test is not working correctly and an engineer may be required to diagnose further.
Diagnosing the Method of Test
- Check that the test product used is within the expiry date provided.
- Check that the correct test soil is being used. There are several products available and the manufacturer should recommend the correct test to use to validate their machine. Using the wrong test soil will present misleading results.
PCD Holder & CEI Test Strips
£63.40 – £70.80excl VAT
12 / Holder / Kit
Used to verify the cleaning efficacy of a surgical instrument ultrasonic cleaner or washer disinfector.
PCD Holder & CEI Test Strips are:
- Easy to use – Can be performed with minimal training.
- Pre-applied and dried test soil - No mess for the User.
- Simple - Visual reading of soil removal and interpretation of results.
Make sure that this test soil is recommended by the machine manufacturer for use in validating their machine.