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CareFusion and the EnVe® name are © 2013
CareFusion Corporation; Used with permission.
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The procedure of developing any ISO standard is a very deliberate and time-consuming
process, and ISO 80369 is no different. Once
a standard is established, then implementation
will take additional time.
Federal and State Mandates
As of February 2014, there were no federal
mandates regarding small-bore connectors for
manufacturers or healthcare organizations.
Effective January 11, 2016, a California law
(HB 1867) will prohibit general acute care, acute
psychiatric, and special hospitals from using an
epidural, intravenous, or enteral feeding connector that fits into a connection port other than
the type for which it was intended. The AAMI
expects that all medical device manufacturers
and suppliers will comply with the new California law, and develop modified products that
incorporate the new connectors, while phasing
out products with old connectors.
The FDA has announced that it is considering recognizing the ISO 80369 standards. If the
FDA does recognize them, it will provide guidance to manufacturers regarding the timeline
for devices currently on the market to come
into compliance (typically three to five years).
The European Union (EU) and other
international regulatory bodies have their
own requirements for acceptance of the standards. Foreign medical device manufacturers
wishing to sell product into U.S. markets,
however, would need to comply with the
ISO 80369 standards.
The ISO 80369 committees are all engaged in
varying amounts of progress. Most have significant work to be done to finalize connectors for
their specific market.
Once the standards are approved, there
will be a transition period marked by stages.
That approach is under development and will
be communicated by manufacturers with advanced warning so that all parties can prepare
for the changes in the market.
The changes for the new standard connectors will roll out by delivery system. Manufacturers will incorporate the new connectors
into their existing offerings where applicable.
The introduction will include developing and
executing a coordinated joint communications
plan, identifying each unique connector with
a common name to be used by all suppliers of
devices for each respective delivery system.
Beginning in 2014, manufacturers of breathing systems and driving gases, enteral, limb cuff
inflation, and neuraxial and urethral devices will
need to redesign their products to accept the
new small-bore connector standards as they are
approved. Enteral feeding devices (ISO 80369-
3), intravascular or hypodermic (ISO 80369-7),
and limb cuff inflation (ISO 80369-5) are the
ones likely to be among the first to be released,
expected as early as fourth quarter 2014. The
enteral devices that will be impacted include
feeding tubes, administration sets, and syringes.
Manufacturers are prepared to launch new
connectors with minimal disruption to supply
and clinical practice. There will be a phase-in
period for product development and implementation guided by the FDA, and existing
state legislation (i.e., California). The standard
generally allows three years to manufacturers
for new product adoption of the new connector standards, and five years for adoption into
existing devices. However, these timelines are