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Validation of The Cleaning Processes of Robotic Instruments: T. Miorini, Austria

The document discusses validation of cleaning processes for robotic instruments. It outlines challenges with cleaning complex instruments with thin wires and limited inspection. An Austrian guideline recommends validating manual cleaning with protein tests and using automated cleaning to further reduce residuals before sterilization.

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Mauren Lopez
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83 views15 pages

Validation of The Cleaning Processes of Robotic Instruments: T. Miorini, Austria

The document discusses validation of cleaning processes for robotic instruments. It outlines challenges with cleaning complex instruments with thin wires and limited inspection. An Austrian guideline recommends validating manual cleaning with protein tests and using automated cleaning to further reduce residuals before sterilization.

Uploaded by

Mauren Lopez
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PPTX, PDF, TXT or read online on Scribd

Validation of the cleaning processes

of Robotic Instruments

T. Miorini, Austria
ÖGSV
The Da Vinci System:
The Problem:

We are talking about


Endowrist® Instruments (Intuitive Surgical)
The Problem:

• Extremely complex instruments


• Thin wires running over small reels
• Narrow lumens
• Limited possibility of visual inspection
• Extensive manual cleaning steps
• BCA protein test not applicable
(cross reaction with Wolfram wires) Positive BCA-reaction due to Wolfram
ÖGSV-Guideline

• In Austria manual processes are not able to be validated due


to lacking reproducibility and documentation

• The Expert Committee of the ÖGSV (Austrian Society for


Hospital Sterile Supply) compiled a “Guideline for the
Reprocessing of Robotic Instruments” including
recommendations for the validation of the cleaning process
ÖGSV-Guideline

The key points of the guideline are:


• Due to the complexity of the instruments the drying phase
should be kept as short as possible
• Especially the distal tips of the instruments are of
importance
• It is crucial that the instruments are kept moist until the
beginning of reprocessing. This can be managed by tools
available from different companies
ÖGSV-Guideline

• After the manual cleaning according to the manufacturer´s


instructions the protein residual of every single instrument
(distal tip) has to be evaluated before the automated
cleaning in the WD
• Acceptance criteria after manual cleaning:
50 µg/ distal tip
• In case of exceedance of the threshold value: Rinsing of the
distal tip and repetition of the manual cleaning
ÖGSV-Guideline

• In case of compliance with the Acceptance criteria:


Immediate cleaning in a WD with specific load carrier for
robotic instruments
• Acceptance criteria after automated cleaning (before
sterilization):
20 µg/ distal tip (to be checked at random on a weekly basis)
ÖGSV-Guideline
• There is positive experience with the Brillant Blue Distal Check
(Medisafe) which is approved by Intuitive Surgical
Protein Tests after manual cleaning
First manual cleaning Second manual cleaning

>50 >50 >50 >50 <50 <50


Programme specifications

Programme 3
Da Vinci TD

Dosing
Phase H 2O + H2O (L) DT °C min
ml/L
(°C)
Prerinse 1 AD 0 0,8 40 45 20
Prerinse 2 - - - - - -
Cleaning 1 AD 0 0,8 40 55 10
Cleaning 2 - - - - - -
Rinsing 1 AD 0 - - 11 2
Rinsing 2 AD 0 - - 11 10
Disinfection AD -3 - - 93 5
Drying 100 15
Protein Test after automated cleaning

<50 <50 <50 <50 <50


Conclusion

• Validation of cleaning processes of robotic


instruments is demanding but possible
• Protein tests after manual cleaning are reasonable
and compulsory in Austria
• Automated cleaning after manual cleaning is essential
THANK YOU 7-10 oct. 2015

FOR YOUR ATTENTION!

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