Validation and requalification of Washer disinfectors and Steam sterilizers

1. Validation and requalification of Washer disinfectors and Steam sterilizers Mr. Henrik Nilsson Medical technical engineer University Hospital of Linköping Sweden

2. Index • History • Quantity of machines and Workingarea • What is a Washer disinfectors? • What is a Steamsterilizer (Autoclave)? • What is the main reason for all this? • Organization flowchart • Validation • Requalification • Routine test

3. History • The validations and requalifications of Autoclaveswere introduced in Sweden in year 1997. • Over the past 10 years all test was preformed by external companies, mainly manufacturers. • Year 2007 the hospital management decided that the tests should be performed by the hospitals own engineers mainly because of economic reasons. • Year 2009 the validation and routine tests of washerdisinfectorsis started.

4. Quantity of machines

5. Hospital of Finspång, 50 beds Hospital of Norrköping, 450 beds Hospital of Motala, 150 beds University Hospital of Linköping, 600 beds Working area

6. What is a Washerdisinfector? It is a machine that create clean, dry and disinfected produkts. • Cleaning is performed by water and detergent at a critical time and temperature. • Drying is made out of hot air blowing with a specified temperature. • Desinfektion is reached at a very critilal combination of time and temperature created by water.

7. What is a Steamsterilizer (Autoclave)? It is a machine that create surface steril produkts. • The sterilization is performed at a very critilal combination of time, pressure and temperature created by steam. • Note that an Autoclave do not clean the produkts.

8. What is the main reason for all this? The international ISO standards: • Steam sterilizers = ISO 17665-1:2006 • Washer disinfectors = ISO 15883-1,2,3,4,5:2006 Do we complying to this standards? Yes and No. We have appointed a Standard interpretation group that provide the validation engineer with guidelines.

9. Sterilizationcenter (Problem owner) Hospital Director Standard interpretation group • Hygiene nurse • Chief of sterilizing center • Chief of engineer • Validation engineer Engineer (Problem owner) Organisation flowchart

10. Validation

11. Validation is performed: • during the installation by the manufacturer. • on all Autoclaves and critical Washer disinfectors. • according to the valid standards. IQ : Installation Qualification Verify so the installation is made correctly and the safety system is working according the specification. OQ : Operating Qualification Verify that the machine is operating according to specification. PQ : Performing Qualification Verify that the machine is performing according to specification.

12. Requalification of Autoclaves (UPQ)

13. What is a requalification? • It’s a test to prove that the machine still performing as good as it did when it was validated. • You repeat most of the part called PQ (performance qualification) from the validation. • That’s why it’s called UPQ.

14. Requalification is performed: • on all Autoclaves. • annually by the hospitals own engineers. • according to the guidelines provided by the Standard interpretation group.

15. Requalification in detail (guideline). • Calibration • Load documentation • Steam tests • Temperature measurement

16. Calibration and Internal test • Calibration and adjustment of the internal sensors • Temperature sensors at 119 oC and 137 oC • Pressure sensors at 50 mbar and 1000mbar • Test the internal test programs (Leakage test).

17. Load documentation • Document the load composition carefully with pictures and text. • Inspect and document the dryness of the wrapping system. • Perform a validation report.

18. Steam tests • Make a saturated steam condition test in the software. • Check steam penetration whit Brownes Bowie-Dick test. • Make a complete mechanical test of the steam every third year (overheating, non-condensating gas and dryness).

19. Temperature measurement • Perform a calibration of the test equipment before starting the measurement and make a confirm test of the equipment afterwards. • Verify that product has been exposed to the specified sterilization temperature whit 5-12 sensors depending to the chamber size. • Perform tests on at least 3different loadtypes.

20. Routine test of washer disinfectors

21. What is a rutine test? • It’s more or less the same as the UPQ whit an extra test regarding the cleaning efficacy. • You repeat most of the part called PQ (performance qualification) from the validation.

22. Routine test is performed: • on all critical Washer disinfectors. • annually by the hospitals own engineers and the manufacture, because of the amount of machines. • according to the guidelines provided by the Standard interpretation group.

23. Routine test in detail (guideline). • Calibration • Cleaning efficacy • Chemical dosage accuracy • Temperature measurement

24. Calibration • Calibration of the internal sensors • Temperature sensor at 50oC and 100oC

25. Cleaning efficacy • Verifying the cleaning efficacy on the load with a artificial blood (type Browne soil test). • Using a reference load of 20 scissors and 20 Peanclamps / shelf. • Perform a validation report.

26. Chemical dosage accuracy • Verify the accuracy of the chemical dosage system.

27. Temperature measurement • Measuring the disinfection temperature in the chamber and on the load with a minimum of 4 to 8 sensors depending on the amount of shelf. • Calculating the Ao-value only in the disinfection phase with starting at 75oC.

28. Equipment • E-Val Flex – Thermal Validation System by Ellab A/S • Temperature Calibration system by Ellab A/S • Pressure Calibration system by Keller • Steam Quality test system by AD-medical

29. What’s next • Validation and routine test of Washer disinfectors for flexible endoscopes • Standard ISO 15883-4

30. Question