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What is ISO 80369
Hospitals and other healthcare facilities depend on a variety of
catheters, tubing and syringes to deliver medications and other
substances to patients through vascular, enteral, respiratory,
epidural and intrathecal delivery systems. These delivery
systems frequently employ fittings called luer connectors
to link various system components. Unfortunately, because
luer connectors are ubiquitous, easy-to-use, and compatible
between different delivery systems, end users can inadvertently
connect the incorrect systems together. These misconnections
can cause medication or other fluids to be delivered through the
wrong route, resulting in serious patient injuries and even death.
In an effort to reduce the occurrence of these misconnections,
the FDA is actively participating internationally to develop and
implement standards for the non-interconnectability of small
bore medical connectors. A joint working group established by
the International Organization for Standardization (ISO) and the
International Electrotechnical Commission (IEC) leads this effort
to develop a series of standards for incompatible connectors.
ISO 80369-1 is the first in the series of standards and establishes
the applications specified below that will have their own unique
connector geometries.
ISO 80369-2:
Breathing Systems and Driving Gases
ISO 80369-3:
Enteral and Gastric
ISO 80369-4:
Urethral and Urinary
ISO 80369-5:
Limb Cuff Inflation
ISO 80369-6:
Neuraxial
ISO 80369-7:
Intravascular (IV)
When Will it Come into Effect?
ISO 80369-1 is published and active currently. There are
several requirements that can be followed to ensure non-
interconnectability with connector sets based on criteria
outlined within the standard. We have decided not to act at
this time due to the fact that the sub-standards associated with
80369-1 will determine component geometry, and we want to
ensure a seamless transition for our customers. Determining the
exact time the 80369 sub-standards will come into effect can
be a difficult task as they are still under development. Our team
is on the front lines in the development of these standards,
allowing us great insight to when these standards will be
released. We will be updating our website regularly to when
these changes will occur as we get more information.
How Does it Impact Me?
Compliance with the ISO 80369 standard may require major
changes on the part of medical device manufacturers. In the next
few years, if these standards are approved it could mean new
designs, new parts, newmoldings and updating or replacing
millions of components. The 80369 standard series will eventually
define connector set geometries for specific applications,
meaning new connectors will be needed to replace luers in a
multitude of areas. Value Plastics has taken a very active role in the
development of these standards to help reduce the impact of this
change on our customers. At this time, a definitive solution cannot
be defined since the standards are still in a development phase,
however as we get more information on a timeline, we will be
updating our website to indicate the direction we will be taking.
How Can I Prepare?
While the standards have not yet been completely established,
the main precaution that medical device manufacturers can take
to help prevent any future problems is to stay up-to-date on
ISO 80369 news. Value Plastics is one of only a few connector
companies worldwide actively participating on ISO 80369
committees. To keep the medical device community apprised
of new developments, we have chosen to provide information
in one web location. Value Plastics has set up an online resource
to help medical device OEMs stay informed of the changes and
updates to this standard.
To read the latest updates, subscribe to alerts, and view
related resources, go to Value Plastics’ online resource at
ISO 80369 STANDARDS & UPDATES
ISO
80369
