Safety by Design:
Reducing User Errors
in Fluid Handling Systems
By Jim Brown, Medical Business Unit
Fluid-based systems dominate thermal management in to- day’s medical devices. Liquids
maintain consistent temperatures in
systems that require precise temperature control. In cooling applications,
liquids draw away heat more quickly
and cost-effectively than fans. Used in
acute care, rehabilitation and home
settings, cooling and warming devices
regulate body temperature and contribute to comfort and healing after
injury or procedures.
Though thermal management devices using liquids vary in design and
purpose, they all depend on a small
but critical component to function
optimally: the connector. Reliable,
intuitive and leak-free connectors are
vital to the successful operation of
a range of fluid-based systems from
simple at-home devices to complex,
expensive equipment used in hospitals.
During the design process, consider
three key areas in selecting the right
connectors for your products and the
people who use them.
1. Broaden the Definition of User
The U.S. healthcare system continues
to look for ways to reduce expendi-
tures. Surgical procedures increasing-
ly occur in lower-cost freestanding
surgery centers instead of traditional
hospitals. Long-term care and rehabil-
itation facilities rely on a lower skilled,
less expensive workforce. Patients
experience earlier discharges and
assume greater post-procedure care
responsibilities as they recuperate at
home. As a result, device makers must
accommodate a wide range of care
settings and user skills and experience,
from novices to highly trained health
While functionality and ease of use
are important connector attributes for
all users, health care professionals may
rank durability and quick operation
as top priorities. In contrast, patients
using a device at home may simply
want clear cues that help confirm
secure tubing attachment or identify
the correct button to activate.
Choosing connectors which meet
all these criteria will help insure that
a therapeutic device works well in a
wide range of real-world conditions
while minimizing the risk of leaks,
spills and misconnections that affect
overall product safety and satisfaction.
In addition, choosing fluid-handling
components with widely applicable
performance characteristics up front
saves time and development costs.
2. Design Out Complexity - But
There is no question that ease of
use is a critical design factor, but
simplicity does not trump all. Consider the luer. It is simple, functional,
inexpensive, and widely available.
Unfortunately, its design also creates a
potential safety issue — misconnection.
Figure1: Application-specific connectors, such as this new coupling used with blood
pressure monitors, help avoid misconnections—a goal of ISO 80369 standards.