Luer Activated Access Site

7-Day Microbial Challenge Summary

Sponsored by: Halkey-Roberts Corporation

Executed by: Apptec Laboratory Services

Scope: 

20 devices accessed 20 times per day for 7 days. Study included 2 positive controls; 2 negative controls and 3 sterility controls. 

Bacteria Inoculum:

1.0 x 103 CFU per 0.01mL Staphylococcus aureus.

Procedure:

a. Swab seal of access site with 70% IPA. Allow to dry for 1 minute.

b. Place 0.01mL of inoculum directly on seal. Let rest for 30 minutes.

omit step "b" for negative control

c. Swab seal of access site with 70% IPA. Allow to dry for 1 minute.

d. Fill sterile syringe with with 10mL of sterile saline and connect to access site.

e. Flush access site with sterile saline and through 0.45-micron membrane filter.

f. Place filter on TSA (tryptic soy agar) and incubate for 48hrs @ 2-8 degrees Celcius.

g. Enumerate CFU after incubation.

h. Repeat for duration of 7 days for total of 140 actuations

Results:

No growth was observed on any of the test samples.

No growth was observed on the the negative controls.

Positive controls exhibited typical growth of the challenge organism.

Sterilized units were placed in tyrptic soy broth for sterility control. No growth was observed after 7 days of incubation. 

Conclusion:

The luer-activated access site, when used in accordance with operating instructions, maintains microbial barrier properties after 7 days and 140 actuations.

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