ISO 80369-3 syringe designs
Male Syringe (RightFit)
Products in development
Female Syringe (ENFit)
Products available
missing, providers will find work-arounds to meet
the urgent needs of patients. And work-arounds
increase the risk of error.
The Instructions for Use indicate that the syringe
should be flicked to clear the moat of excess drug.
Flicking disperses the excess drug into the air. If
you are delivering an oral hazardous drug, flicking
may lead to hazardous drug exposure for healthcare
providers, and for parents/carers.
The male ISO syringe design
An ISO 80369-3 compliant enteral system with a male
syringe to be known as RightFit is being developed
by Becton, Dickinson & Company (BD), that is also
compliant with ISO7886-1 as it maintains the traditional
male to female orientation. This design is available to
all manufacturers; it is one of the two options within
ISO 80369-3. To prevent misconnections, the syringe has
a collar and threading that differs from a luer lock, so
it cannot be misconnected to physically incompatible
systems. The inner tip protrudes from the collar and
prevents any excess medication in the collar from being
administered.
Dose accuracy
The RightFit syringe is compliant with ISO 7886-1,
which assures consistent performance. Although
a hypodermic syringe standard by name, ISO 7886-
1 is the standard that male oral/enteral syringe
manufacturers, including BD, have used for years
and clinicians have accepted as a standard of care.
Panellists suggested that the male design may be safer
for patients because dose inaccuracy is not a risk.
Simplicity NOT complexity
The RightFit enteral syringe can be used
for nutrition, oral, and enteral medication
administration, across all patient groups/ages, and
dosage ranges. It is anticipated that this design will
require none or fewer additional parts than the
female design to connect to a feeding tube, which
reduces preparation time and costs. There is no need
to procure and store multiple syringes and parts.
Workflow integration
This design maintains the traditional orientation
of the overall system, and is similar to traditional
male syringes in design, function, and performance.
Therefore, minimal additional training will be
required. The design itself is engineered to guard
against misconnections, validated by the ISO
80369-3. The panel noted that there is a feeling
of familiarity with the male syringe system in the
way the connection is set up, with the male/female
elements in the traditional orientation.
The future
The panellists acknowledged the value of
an improved system to reduce the risk of
misconnections. For both systems, they made
specific recommendations for further device
refinements that are presented in this report. After
handling both systems, panellists expressed safety
concerns about the female ENFit ® design.
A key recommendation was the need for
additional studies for both female and male systems,
such as testing on small volumes and diverse liquids.
The panel stressed the importance of publications
to provide evidence on the safety of the devices in
different settings and patient subgroups. The panel
proposed that a workshop with key stakeholders
under the banner of major EU body would raise
awareness of the major issues related to the ISO-
80369-3 standard for enteral systems.
Learn more about
ISO-compliant enteral
systems and safety at
BD.com/enteralsafety
*ENFit ® is a registered
trademark of the Global
Enteral Device Suppliers
Association (GEDSA)
34 | Issue 91 | 2019 | hospitalpharmacyeurope.com