Where would I find the results of the post market surveillance study that the FDA requiried for positive displacement needless connectors? I have looked at the FDA website and have not found the results of the data collection that I believe ended in July 2013.
Thank you for you response
Here is the site.
http://www.fda.gov/medicaldevices/safety/alertsandnotices/ucm220459.htm
Valorie
Valorie Dunn,BSN, RN, CRNI, PLNC
This was not a requirement for a single study. It was a requirement to each manufacturer of positive displacement needleless connectors to submit a plan to the FDA about addressing the 2 questions in the letter, which would probably be a study for each one. So following this letter I know there were some companies that responded with more information to the FDA and some that voluntarily removed their product from the market. Many positive connectors are no longer on the market. I would go to the manufacturers of the remaining positive devices and ask them for their study. Lynn
Lynn Hadaway, M.Ed., RN, BC, CRNI
Lynn Hadaway Associates, Inc.
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