Qualification of Washer/Disinfectors. Dr. Winfried Michels

Transcription

1 Qualification of Washer/Disinfectors Dr. Winfried Michels

2 In EN ISO it is stated to be only a guideline for practice. Due to its unpraticable extend a german guideline was compiled jointly by: AKI Instrument Reprocessing Working Group DGKH German Society for Health-Care Hygiene DGSV German Sterile Supplies Society

3 Guideline issued by DGKH, DGSV and AKI on validation and routine monitoring of machine-based washing and disinfection processes for thermally stable medical products and principles of machine selection Part 1: Validation of washing and disinfection processes Part 2: Routine monitoring of washing and disinfection processes Part 3: Procurement of washing and disinfection apparatus

4 Validity (excerpts) Part 1 of the guideline applies to the validation and reassessment of the performance of thermal disinfection reprocessing methods in washerdisinfectors on thermally stable medical products in compliance with EN ISO Parts 1 and 2. This does not included reprocessing flexible endoscopes. This guideline refers to compliant and non-compliant washer-disinfectors applies to all hospitals, health-care practices and outpatient departments.

5 Validation of disinfection processes in compliant washerdisinfectors. Installation qualification Operation qualification Performance qualification

6 Installation qualification Installation qualification is performed to ensure the following: Washer and peripheral units are properly delivered and installed Machine supply and utility connections are properly installed

7 Example: Checklist re (Enclosure 10.4) Excerpt from IQ checklist Machine (Designation/No.) Location Overall qualification responsibility Further IQ test personnel Date of test Type of machine: Manufacturer: Model: Installation qualification Scope of order Art. designation 1) Protocol Type/Title Art. no. Series-produced unit Mach. no.: Build year: Yes No Documentation of items ordered and delivered Scope of delivery Damaged 2) Qty. Qty. Received Yes/No List of technical documents for washer-disinfector and peripheral units Complete Document no./ Storage location Yes/No Mat. no. Installation plan I (machine) Installation plan II (floor tray) Installation plan III (miscellaneous) Wiring diagrams Operating instructions (machine) Operating instructions (miscellaneous) Operation and programming manual Machine ledger as per MPBetreibV

8 Validation of disinfection processes in compliant washer-disinfectors. Installation qualification Operation qualification Performance qualification

9 Operation qualification Operation qualification is performed to ensure the following: Washer-disinfector, supplies and utilities comply with manufacturers' specifications and EN ISO (type test)

10 Excerpt from EN ISO Annex A

11 Exerpt from the guideline

12 Qualification of washer-disinfectors in use and not type tested- Minimum requirements An assessment must be made for washer-disinfectors already in operation. The following assessment criteria apply: Automatic/electronic programme controls Automatic error messages (water quantity, dispensing) All measurements must be calibratable Temperature indicator Separate sensors for monitoring and verification Automatic dispensing and verification Pressure monitoring etc. This assessment provides a guide to whether a washer-disinfector in use can produce a validated washing and disinfection process without unnecessary effort and expense.

13 Qualification of washer-disinfectors in operation (without homologation approval according to EN ISO 15883) The same performance criteria as for washer- disinfectors with homologation approval apply to cleaning and process validation. Compromises are only made in respect to technical equipment which is assessed and inspected more regularly (routine monitoring) or improved through upgrades!

14 Qualification of washer-disinfectors in use - Risk analysis A risk analysis enables the extent of tests (performance qualification) and other measures such as the extent of routine tests to be determined. The same tests as for non-compliant units apply. Additional tests may also be necessary.

15 Exerpt from the guideline Matrix for additional routine monitoring

16 WD s with mechanical/electronic control can not be qualified

17 WDs with an electronic control can be qualified but routine test may be necessary

18 g Dr yi n Fin al r ins e e ri n diat In te r me N eu t r al i satio i on fek t Dis in Cle a nin g n se RKI (BGA) program can not be validated due to poor reproducibility of cleaning

19 SITA Foam Tester R-2000 Quick-action agitator lock Agitator drive Sample container Needle-bed sensor Drain valve Temperature-controllable sample glass Water inlet valve Agitator GT/MP - R. Giljohann

20 Video clip: Measurement of foam formation (Tenside cleaner, 25 C

21 Foaming with blood/detergent solutions foam volume [ml] 23 C foam volume [ml] 50 C DI water + 0.1% blood DI water +0.5 % blood alk. det.1 0.3% alk. det % blood alk. det.2 0.5% alk. det.2 +1% blood Note: foam volume of 3 fillings with 5 measurements after 30 sec. stirring at 1000 rpm 21

22 Routine Monitoring Temperature- and/or pressure measurements

23 Use of powder detergent is accepted in EN ISO Dispending of powder detergent (volume/weight) has to be layed down in the SOPs. The correct dosage is verifyed by the use of a suitable measuring cup with graduation for the specific bulk density. The correct function of the dispender flat has to be checked regularly.

24 Volumetric testing of the volume admitted

25 Testing the volume admitted after a defined numer of cycles and the known reduction of reservoirs level

26 Gravimetric routine check gravimetrisch of volume admitted using a balance

27 Routine check of appropriate water volume For WD having not a volume controlled water intake it has regularly to be tested (weekly) that the conditions are kept. This is necessary, because the micro sieve in the supply line with time may be obstructed. The water intake may deviate from estimated volume if the supply water pressure fluctuates significantly and drops down below 1,5 bar.

28 Routine check of water level (example) Two minutes of start of Vario TD cycle the programme is interrupted, lower basket pulled out and the water level measured by use of a ruler or foot rule. Distance from screwing of the sieve in the bottom to for G 7782 up to level should be 148 mm +/8 mm.

29