Standards to Focus on Tubing
Small bore connection systems are
the most common way of attaching catheters, IV tubes, etc. They consist of
small, round "male" and "female" interlocking tubes, slightly tapered to
hold the two components together. Misconnections results in creating a high
degree of risk of a medication error occurring.
An international effort to create
standards designed to minimize the likelihood of life-threatening tubing
misconnections in healthcare facilities is under way and gaining momentum.
Advancement of Medical Instrumentation's (AAMI) working group and an
International Organization for Standardization (ISO) committee are working
together "to develop international standards that create engineering 'forcing
functions' that would physically preclude using mismatched tubing sets which
results in creating a high degree of risk of a medication error occurring.
According to Brad Noe of Becton Dickinson & Company and co-chair of AAMI , "Our
target audience is clinical users, buyers of these products, manufacturers, and
those who supply components for use in these applications. This is a globally
recognized issue with a corresponding global effort to provide appropriate,
workable, and relevant solutions."
The problems with tubing and catheter misconnections have existed for years.
However, the issue gained prominence in healthcare facilities when The Joint
Commission published an April 2006 Sentinel Event Alert (SEA) that referred to
tubing misconnections as a "persistent and potentially deadly occurrence." While
the Joint Commission identified just nine actual cases involving tubing
misconnections in its SEA, eight of which resulted in patient deaths, it noted
that the problem is underreported.
The international committee is currently developing a foundation document that
would allow for future expansion and revision as necessary, without having to
rewrite the standard.
"This approach takes into account the likelihood of continued expansion and
development of new clinical applications and related tubing sets," says Noe.
Noe also points out that "small bore connector teams are being formed to address
specific types and groupings of small bore connectors.
Small bore connection systems are the most common way of attaching catheters, IV
tubes, etc. They consist of small, round "male" and "female" interlocking tubes,
slightly tapered to hold the two components together.
"Given that we are dealing with potential medication errors and potential injury
to patients, one can never move quickly enough to create solutions to resolve
this. However, the team is extremely aware of their responsibility and is
working diligently to reach solutions that are realistic, applicable, and
economically sound, and can be implemented with minimal disruption to clinical
The initial international standard, expected to be titled Small bore connectors
for liquids and gases in healthcare applications-Part 1: General requirements,
is currently under review, with an anticipated publication date of January 2010.
Founded in 1967, AAMI is the world's leading organization dedicated to advancing
the safe and effective development and use of medical technology. AAMI's annual
conference attracts healthcare professionals from hospitals, universities,
consulting firms, independent service organizations, and manufacturing companies
around the world.
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