1. OF INSUFFLATORS - AUGUST/2009
ENDOSCOPY SURGERY?
BY: CHARLES E. MEISCH
ENDOSCOPIC CONSULTANT
NBS GROUP SUPPLY
257 LIVINGSTON AVENUE, NEW BRUNSWICK, NJ 08901, USA
1-732-610-2042
As the U.S. and Europe continue to see the
breakthrough use of Endoscopic Surgery
versus conventional surgery in all areas, it
appears the procedures increasing most
rapidly are cholecystectomies, female
sterilization, lap bariatric, bowel resection,
hernia repair, hysterectomy, appendectomy,
anti-reflux, and nephrectomy, most of which
require the use of an insufflator. Usually
electronic in design, insufflators are
differentiated by flow rates, ranging from 9.9
LPM to 45LPM at 1 PSI or lower. They are
also pressure-limited gas flow regulators used
In January of 1996, the Medical Devices
to produce a pneumoperitoneum.
Agency released a Safety Notice stating that
patient fluid contamination continues to be
found in the internal gas circuits of
laparoscopic insufflators and that practitioners
According to AORN's 1995 Standards and should, "ensure that any bacterial filter/liquid
Recommended Practices, "Insufflator trap assembly provided and recommended by
equipment should include a disposable the manufacturer of the insufflator be used
hydrophobic (liquid blocking) filter." Over the and disposed of appropriately." In May of
past few years, health care providers in the 1992, The Emergency Care Research Institute
United States have come to the consensus (ECRI) released a statement which warned,
that filter devices are a necessary part of all "blood was being delivered to a patient via an
laparoscopic procedures that employ insufflator." This blood apparently came from
insufflation. The need for filters for the a prior patient. Manufacturers and various
retention of particulates such as hospital clinic engineers confirm this is a
inorganic debris, rust, metal filings and common occurrence. The right hydrophobic
Teflon has been recognized by the filter (liquid trap) stops the reflux (backflow)
majority of practitioners. However, it is of blood and other body fluids as well as
important to choose a filter which also particulates, preventing contamination of the
prevents body fluids from entering insufflators and cross contamination between
insufflators. For this purpose, the filter patients.
must be hydrophobic.

2. N OF INSUFFLATORS - AUGUST/2009
IN ENDOSCOPY SURGERY?
Because of this dual hazard, it is important to
specify both the particle retention rating and
the level of hydrophobicity required when
selecting a filter for use with insufflation. NBS
Group Supply recommends that an insufflation
filter be rated at 99.99% (particle retention),
0.1 micron, and should have a hydrophobicity
rating of 50mm Hg. NBS Group Supply offers
a wide range of media and connectors to
address the specific needs of your application.
These specifications ensure not only the
retention of particulate, but under operating
conditions, the retention of aqueous fluids as
well.
PARTICULATE RETENTION
The particle retention specification of a filter
designates what percentage of particulate of a
certain size or greater will be trapped by that
filter.
HOW MUCH HYDROPHOBICITY IS
ENOUGH?
Recently the Canadian Government issued a
warning in their alert to all hospital
administrators basically stating that once the
internal gas circuit of an insufflator is
contaminated with liquids or gases from the
patient cavity, a potential hazard of cross
contamination is usually created. In one of
the incidents reported, a filter had been used,
but it failed to provide protection against
liquid backflow. Subsequent discussions with
the manufacturer revealed that the filter was
not recommended for the purpose of backflow
preventions.

3. THE CONTAMINATION OF INSUFFLATORS
THE NEXT MAJOR PROBLEM IN ENDOSCOPY SURGER
Hydrophobicity is only a relative characteristic
and must be accompanied by a specific
pressure and time designation to be valid.
For example, the claim "this filter is
hydrophobic" would be more valid if it read
"this filter has a hydrophobicity rating of
50mm Hg pressure."
CUSTOMIZATION
NBS Group Supply offers a wide range of
options to ensure the correct performance of
an insufflator. The filter specification,
retention rating, level of hydrophobicity,
sterile or non-sterile, labeling, tube length,
connectors, and packaging are all calculated
to be used with most insulators. It is
important to remember insufflation tubing in
the U.S. falls under a Class I status. This
means that any company can take a common
Hydrophobicity is the characteristic of a filter
medical gas filter, assemble it to tubing, and
media, which allows it to repel water, or
call it an insufflation tubing set. All that is
water based substances such as body fluids.
required is to register with the FDA and
To provide protection against reflux during
comply with the FDA's cGMP's, but not
insufflation, a filter must have a
necessarily submit for premarket approval.
hydrophobicity rating above the pressure
Under these criteria, the set may or may not
that can be exerted in a reverse direction.
work with your insufflator. NBS Group Supply
For insufflation, that rating is 50mm Hg for
specifically tests filters so that they meet all
10 minutes. In the above example, the
necessary medical and FDA criteria. Unlike
filter being discussed was considered to be
other companies, our tubing sets go beyond
"hydrophobic", but it did not carry a
hydrophobic rating strong enough to retain what is required by the FDA and have been
submitted to the FDA for premarket approval
body fluids under these conditions.
as Class II devices. This means not only the
Every hydrophobic filter media has a product, but the packaging, the method of
pressure level at which aqueous liquids can sterilization and the labeling are all carefully
be forced through the pores. This level is reviewed. The FDA has reviewed our
the "water breakthrough" pressure. application and has approved it for the
Water breakthrough is also affected by the intended use thereby removing any doubt that
length of time the pressure is applied. While our sets are truly manufactured as insufflation
many filters are hydrophobic, this statement tubing sets and not just gas filtering systems.
does not mean that the filter will be We feel this is important for you to know. For
hydrophobic at all pressures, or that it is a copy of the approval, please contact our
hydrophobic enough for a particular corporate office in New Brunswick, NJ.
application.