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Medical
Electronic Cable Assemblies
By John C. Colwell, Bishop & Associates
Inc.
In 2007,
medical cable assemblies accounted for approximately 35 percent of the
total value of connector factory shipments to the medical electronics
industry, or an estimated $386 million. This value is expected to grow
in excess of 11 percent, reaching $430 million in 2008. Unlike most
other industry sectors, where the ratio of the value of connectors
applied to cable assemblies vs. total connector consumption is stable,
the ratio of connectors applied to medical cable assemblies, compared to
total medical connector consumption, is on the rise. This trend is
attributable to the changing mix of cable assembly types and evolving
circumstances of use within the medical electronics industry.
There are various ways to analyze the medical cable assembly market, for
example, by form factor or type of construction, as shown below.

Looking deeper
into the applications environments of the various types of cable
assemblies, we find additional levels of characterization. Broadly
speaking, medical cable assemblies can also be classified as equipment
and sub-system interfaces, communications interfaces, and patient
interfaces.
Equipment and sub-assembly interfaces
include those cable assemblies that are installed as original equipment
and typically remain in place for the life of the equipment. Examples
would be harness assemblies found in a nuclear imaging device or, in the
consumer world, a refrigerator. Except for equipment retrofits and
upgrades, these assemblies are rarely replaced.
Communication interfaces
include industry-standard serial cable assemblies, such as EIA RS-232,
422, 423, and 485 types, modular LAN interconnects EIA/T568 A/B types
and fiber optic types. These cable assemblies are occasionally replaced
when equipment is either rearranged or relocated within the facility.
Patient interfaces,
or patient cables, include those cable assemblies that physically
connect the patient to an electro-medical instrument for diagnostic or
therapeutic purposes. As such, most patient cables are subject to
periodic replacement throughout the course of the equipment life.
Depending on the replacement frequency, the aftermarket value of patient
cables can far exceed the value of the original equipment market. For a
variety of reasons, the replacement frequency for several types of
patient cables is increasing. To examine this trend, we must look a bit
deeper into the classifications of patient cables.
Long-life/Expendable
patient interface cables are designed for long life. However, it is
generally accepted that most of these cables will be replaced several
times during the life of the equipment. Cable assemblies are
occasionally upgraded for performance reasons, or they become damaged
from use and/or abuse. Such cable assemblies include ultrasound imaging
transducer cable assemblies (shown right), ECG diagnostic and stress
test cables, EEG diagnostic patient cables, defibrillator coil cord
assemblies, MRI field coil cable assemblies, and control pendant
assemblies.
Generally, cable assemblies in this category are custom designed for
high reliability and long life. Specialty wires and cordage, designed
for flexibility and wear resistance, are commonly employed in
conjunction with well designed, bonded strain reliefs. Not only are
these assemblies designed for reliability, they are also designed for
ease of use. The optimal design is often a delicate compromise. A stiff,
one-inch diameter ultrasound transducer cable would probably withstand
being run over by the wheel of a heavy cart, but it would also make the
ultrasound technician’s job difficult, if not impossible. It is for this
reason that cable assembly manufacturers who specialize in medical
assemblies have been so successful. They understand the environment.
Limited-use
disposable
patient cables include ICU/CCU monitor cables, ECG diagnostic leads,
oxymeter cable assemblies, and similar types. Limited-use disposable
assemblies are cable assembly types that are generally exposed to wear
and tear in the application environment. For example, a 10-lead, ECG
diagnostic patient cable typically consists of an interconnection yoke
attached to a connectorized bulk cable and a set of 10 individual leads.
The leads tend to deteriorate from exposure to mechanical stresses and
cleaning solvents, resulting in faulty readings and the waste of
valuable technician time.
A scheduled replacement of such assemblies is the preferred course of
action, and also reduces labor costs and risk of failure.
Use-once
disposable
patient cables include catheters (right), electro-surgical knife
assemblies, electro-surgical (dispersive) return electrodes, external
pacing lead sets, surgical monitoring cables, fetal monitoring cables,
neural stimulator lead sets, and other similar devices. For each of the
various types of procedures performed in operating rooms, catheter labs,
and delivery rooms, it has long been the practice to provide all of the
instruments and accessories required for the procedure in a pre-packaged
sterilized kit, assembled elsewhere in a six-sigma quality environment.
That same concept is now beginning to be applied to use-once disposable
cable assemblies. The bottom line is that the labor-cost of cleaning,
sterilizing, and maintaining cable assemblies in a sterilized state for
future re-use exceeds the initial cost of the assembly.
There
is also a migration from some limited-use disposable cable assemblies to
use-once types, as illustrated by the disposable pulse oxymeter shown at
left. Instead of clipping onto a fingertip, the disposable type is more
securely applied with medical tape. The finger-clip type, while
reusable, tends to fall off the patient, resulting in false alarms at
the nursing station and the need to dispatch someone to the patient’s
location to re-apply the clip. The stay-on disposable device eliminates
these unnecessary costs and distractions.
There
are risk factors as well. Electro-surgical dispersive return electrodes
collect and safely return the RF energy to the generator, thereby
preventing hazardous leakage paths to ground. Traditionally, this was a
two-piece assembly consisting of a disposable pad and a limited-use cord
assembly. There were two points of interconnection: at the pad and at
the generator. Increasingly, today’s return pads are provided with the
return cable permanently attached, thereby eliminating the possibility
of an inadvertent disconnect during surgery.
Moreover, hospital patient deaths as a result of nosocomial infections,
specifically methicillin-resistant staphylococcus aureus (MRSA), are
rising. This is forcing the health care industry to re-evaluate many of
its cleaning and sterilization practices.
At the same time, the connector industry is beginning to focus on this
shift towards limited-use and use-once disposable assemblies. Amphenol
has introduced its Pulse-LokTM Series of limited use and
disposable circular connectors (below left). W.W. Fischer Connector has
introduced its L.U.C. TM line of disposable circular
connectors designed for patient cable and similar applications (below
right).

ODU has
introduced its MEDI-SNAP TM line of circular disposable
connectors (right). Other manufacturers of disposable medical connectors
include Positronics, Lemo, and others.

These
connectors are nonmagnetic, making them suitable for MRI applications.
The number of mating cycles varies by manufacturer, from a very limited
number of matings, to as many as 5,000 mating cycles.
Most disposable medical connector manufacturers have developed their own
efficient, in-house cable termination capabilities. This enables them to
furnish medical equipment OEMs with connectorized cord assemblies on a
highly cost-effective basis.
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John Colwell
Director, Telecom, Medical and Instrumentation, Bishop &
Associates Inc.
John
Colwell’s background includes 10 years at Nortel
Networks‑Cable Group, where he directed the U.S. premises
cable marketing effort. In addition, Colwell directed
Nortel's global product development group. Prior to joining
Nortel, Colwell held positions in engineering, business
planning and development at Amphenol Corporation.
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