20/30 Labs is one of the few laboratories globally approved by Intuitive Surgical to validate and verify Washer Disinfectors and EndoWrist Instruments. Our accreditation attests to our commitment to meeting Intuitive Surgical’s rigorous policies and procedures, in full compliance with ISO 15883:5 standards.
At 20/30 Labs, we recognise the significance of staying ahead in an ever-evolving decontamination industry. That’s why our dedicated team underwent comprehensive specialist training at Intuitive’s renowned headquarters in California. This training equipped us with the latest knowledge and expertise necessary to uphold the highest standards of cleaning efficacy.
As part of our rigorous certification process, an Intuitive representative reviewed our state-of-the-art facility, examined our SOPs, and conducted method witnessing. As a result, we have been certified to qualify Washer Disinfectors for the reprocessing of Da Vinci EndoWrist Instruments. Additionally, we are authorised to conduct periodic process qualification (PQ) tests on EndoWrist Instruments, ensuring their optimal performance and safety.
Periodic Routine (PQ) Testing
We are approved to conduct Routine PQ Testing of Da Vinci EndoWrist Instruments, as outlined by Intuitive Surgical to ensure effective implementation of decontamination instructions.
Compliance to manufacturer’s reprocessing instructions and a demonstration of effective cleaning is paramount to the safety of all surgical devices, including the instruments of the Da Vinci system which proscribe a specialised reprocessing method.
Routine protein analysis using the PQ test for da Vinci EndoWrist Instruments is an effective measure of cleaning efficacy and can replace Bioburden testing which is currently performed quarterly on general surgical instruments.
We are approved to validate the cleaning efficacy of the washer-disinfector for reprocessing Intuitive EndoWrist instruments according to protocols required by Intuitive in following circumstances:
- Before commissioning of the Washer Disinfector
- When adding Intuitive Instrument’s reprocessing function as a process
- When changes are made to validated cleaning and disinfection cycles