Table 1. Decontamination and Sterilization Measures and Test Criteria.
| Area | Measure | Measurement Tool | Criteria for “Pass” and “Fail” |
|---|---|---|---|
| Decontamination | ATP | ATP Bioluminescence Device | A swab touches the medical instruments’ surface and is inserted into a tube that in turn is inserted into the ATP device. ATP device reads relative light units. Readings at or below 45 (“Pass”) indicate the surface is considered clean for surgical instruments. Readings greater than 45 (“Fail”) indicate the surface is considered dirty.a |
| Sterilization | Temperature inside the sterilizer and Time of run | Temperature Gauge on Sterilizer and Electronic Timer | Proper exposure to steam, pressure, and time is known to kill microorganisms. The recommended minimum exposure period for steam sterilization of wrapped healthcare supplies is 30 minutes at 121°C.b Per our protocol, “Pass” is maintaining 121C for a minimum of 35 minutes. “Fail” is the failure to maintain 121°C for 35 minutes. |
| Sterilization | Sterilization external to packaged instruments | Sterilizer Tape | Black stripes appear if the tape has been properly exposed to steam during a sterilization run. “Pass” is when the black stripes appear. “Fail” is when the black stripes do not appear.c |
| Sterilization | Sterilization internal to packaged instruments | Indicator Strip | Strip has a “Fail” and “Pass” reading. After a sterilization run, “Pass” is equivalent to a biological kill. “Fail” is not equivalent to a biological kill.d |
| Sterilization | Sterilization inside the sterilizer | Biological Indicator Tube | After the sterilization run is completed, tube is incubated for a minimum of 10 hours. Post incubation, “Pass” means the tube is purple in color, indicating that the biological agents have been killed. “Fail” means the tube is yellow in color, indicating that the biological agents have not been killed.e |
a. ATP is adenosine triphosphate, an energy-carrying molecule found in the cells of bacteria, yeast, and mold cells. Measurement of ATP documents and provides quantitative measurement to indicate the level of cleanliness and hygiene of high touch surfaces and medical instruments. See Centers for Disease Control and Prevention, Healthcare-Associated Infections, http://www.cdc.gov/hai/toolkits/Appendices-Evaluating-Environ-Cleaning.html. See also Getinge, USA. Available: http://www.getingeusa.com/life-science/consumables/contamination-monitoring-system/getinge-assure-safestep-monitoring-system/.
b. Rutala WA, Weber DJ, HICPAC. Guideline for disinfection and sterilization in healthcare facilities. Centers for Disease Control, 2008. Available: http://www.cdc.gov/hicpac/pdf/guidelines/Disinfection_Nov_2008.pdf. Temperature gauge is a geared steam gauge #72S Available: http://www.allamerican-chefsdesign.com/admin/fileuploads/product_43.pdf. Timer was electronic ‘stop watch’ on mobile telephone.