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New FDA Recommendations | |||||||||||||||||||||||||||||||||||||||||
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In April 2005, the FDA initiated more stringent guidance for microbial ingress testing on Needleless valves. These new recommendations are highlighted below: Static insertion of luer / syringe for more than one hourRequires repeated insertions of the luer / syringe. Valve inoculations should approximate # of daily interactions with siteMore than 5 valve inoculations per day10 - 20 microliters of inoculantStaphylococcus aureus or epidermis as inoculantsAllow inoculant to dry for > 1 minuteUse 70% IPA to disinfect |
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Please make sure to ask the manufacturer of your needleless valve whether they qualify their valve to the New FDA standards. Here at Maximus Medical, we made sure our MaxPlus featuring Tru-Swab Technology connector was tested to (and beyond) the new FDA standards at an independent lab2; the MaxPlus® produced zero failures and was clearly the clinically superior valve when tested to it’s competitors. The study can be found here. |
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1. FDA, US Department of Health and Services: "Guidance for industry and FDA Staff, Intravascular Administration Sets Pre-Market Notification Submissions (510K)", April 15,2005. 2. In vitro testing per established protocol conducted by LGGS Laboratory Services, Anaheim, CA. |
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| Take a Look at the New FDA Recommendations for Microbial Ingress Testing... | ||||||||||||||||||||||||||||||||||||||||||
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| Does your current valve's microbial study meet the above requirements? Take a Look at the New FDA Recommendations
for Microbial Ingress Testing... If not, you may want to take a closer look at one that does: the MaxPlus Tru-swabTM IV connector... |
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| *Does not advertise Microbial Challenge Study MaxPlus and Tru-Swab are trademarks of Medegen MMS |
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