Disinfection Validation

START 5 Disinfection Validation

1. Turnaround time: to be determined upon study parameters
2. Sample Requirements: at least 7 samples

AAMI TIR12 & ANSI/AAMI ST58 & ISO 15883
& ISO 17664 & FDA guidance

Disinfection validations are used to validate device manufacturer’s IFU (instructions for use). Methodology involves inoculating the medical device with an appropriate microorganism. The contaminated device is subjected to the manufacturer’s IFU and the presence and quantity of surviving organisms is determined. Validations may be performed to support 3 levels (high, intermediate, low) of disinfection process depending on the intended use of the medical device. This study is specifically needed when a device can’t be sterilized using temperature (steam/heat sterilization), or is not compatible with irradiation or EO sterilization methods.

There are 3 disinfection levels with individual acceptance criteria:

  • High Level —> 6 log10 reduction of Mycobacterium spp
  • Intermediate Level —> 6 log10 reduction of Klebsiella pneumonia, Pseudomonas aeruginosa, Staphylococcus aureus, and Escherichia coli as well as a 3 log10 reduction of Mycobacterium spp
  • Low Level —> 6 log10 reduction of Klebsiella pneumonia, Pseudomonas aeruginosa, Staphylococcus aureus, and Escherichia
FDA GUIDANCE