Trick - Scelta del needlefree connector oggi

INS SOP #34

The Primary Purpose

Needleless Connectors

‘To protect health care personnel by

eliminating needles and subsequent

needlestick injuries when attaching

Needle Free Connectors

What is ‘Best’?

Least Amount Patient Risk

Reliable

Performance Performance Sustainable Performance Repeatable

Substantial 3rd _{Party Clinical Evidence}

Reduce Needle Stick Injuries to HCP

Generations of Needle Free

Technology

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•  All provide an access point

All have varying degrees of risk and benefits

associated with protocols for use in various clinical settings

NFC Design & Fluid Dynamics

Negative Displacement NC. Allows blood reflux into vascular access device (VAD) lumen upon disconnection due to movement of valve mechanism or removal of

syringe/set

Positive Displacement NC. Allows a small amount of fluid to be held in the device; upon set or syringe disconnection, this fluid is pushed through the catheter lumen to clear any blood that refluxed into the lumen

Neutral NC. Contains an internal mechanism designed to prevent blood reflux into the catheter lumen upon connection or disconnection

Anti-Reflux NC. Contains a pressure-sensitive internal mechanism designed to prevent blood reflux into the catheter lumen when the flow of infusion solution has stopped

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NFC Features that Increase Risk Infection

surface HCW’s may not adequately clean the intricate surface details, leading to fluid path contamination.

Gap around plunger

•  FDA concerned about the safety of positive pressure needle free connectors after receiving three reports of death associated with bloodstream infections and positive displacement needleless

connectors

•  The FDA cited multiple clinical reports showing an association between multi-branded, positive displacement needless

connectors and bloodstream infections and a subsequent reduction

in bloodstream infections when facilities switched to another type of needleless connector

2010 FDA Post Marketing Surveillance

Mandate

2010 FDA 522 Mandate

9 Manufacturers

Post-marketing surveillance required

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In-Vitro Study Completed

Analysis of studies reporting CLABSIs in patients when using a positive displacement needle free connector (study NFC) compared with

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“ USA Hospital Compare Analysis”

The advantages of using publicly reported outcome data such as used in this study include:

•  There was no sampling bias, because all eligible hospitals were

included

•  There was no potential conflict of interest compared to data

collected by manufacturers themselves

•  It was the most current with minimal time lag

In order to satisfy an FDA post-market surveillance request

(known as a ‘522’), CareFusion undertook the largest

analysis known to-date for needleless connectors.

Used 2013 Center for Medicare and Medicaid Services

Hospital Compare data

•  3,074 hospitals

•  Nearly 11,000 recorded events

•  Nearly 10 million catheter days

•  Merged with Manufacturer’s client database

‘Hospital Compare Results’

Final Thoughts

Preferred Design & Extended Usage