Press Release

German Federal public health authority clarification: wipes cannot be validated on site for disinfection of semi-critical devices

The RKI Institute has released a clarification that disinfection with manual wipes cannot be validated on site. On site validation is a requirement for the final disinfection step of semi-critical devices such as endocavitary ultrasound probes.

Highlights:

  • The RKI states ”we see the ability to validate the final wipe disinfection of semi-critical medical devices is currently not given
  • On site validation is required as part of the mandatory validation requirements for reprocessing semi-critical devices under German law
  • Taken together, this information clarifies that wipes cannot be used as the final disinfection step for semi-critical devices, including endocavitary ultrasound probes.

The Robert Koch Institute released a technical explanation on November 20, 2020 that resolves a long standing open question on the use of wipes for final disinfection step of semi-critical devices.1 According to German Federal requirements §8 Clause 1 MPBetreibV & the KRINKO-BfArM Recommendation 2012, on site validation is required as part of the mandatory validation requirements for reprocessing semi-critical devices. 

The RKI clarifies there is currently no method for on site validation of wipes.

The RKI are not aware of any guideline or standard that could serve as an appropriate basis for ensuring:

  • sufficient application of the disinfecting agent to all surfaces to be disinfected
  • sufficient “manual mechanical force application
  •  “the different geometries of the medical devices and any crevicesare taken into account
  • the manual wipe disinfection is “reproducibly documented by each person carrying out the reprocessing of the specifically present medical devices in the respective facility

Automated, validated disinfection with trophon®2 is the answer

Given the RKI’s position that wipes cannot be suitably validated for disinfection of semi-critical devices, users should look to options that can be adequately validated. Immersion disinfection is difficult to integrate into everyday clinical practice due to the time required and the necessary workplace protection. trophon®2 is the optimal solution for automated, validated and digitally documentable disinfection.  Remove user to user variability from disinfection of semi-critical ultrasound probes by delivering the global standard of care for every single patient in your care.

Contact us now and find out more about trophon2

Learn more:

https://www.nanosonics.co.uk/trophon/trophon-2/

Contact us directly for more information:

T: +44 (0) 1484 860 581

E: [email protected]


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