ARC Medical was founded in 1990 to provide devices for humidification and filtration for ventilator and surgery patients. They produce high performing filtration and humidification devices based on independent testing. Their manufacturing uses state of the art engineering and automated assembly to ensure consistent product performance. ARC Medical is committed to providing innovative and cost saving products to intensive care and anesthesia departments, while protecting patients and caregivers.
8. ARC Medical, Inc. was started in 1990 to
serve the humidification and filtration
needs of ventilator dependent patients and
surgery patients.
ARC Medical provides the highest performing
devices for filtration and humidification
based upon independent, 3rd party testing.
8
9. Our manufacturing utilizes state of the art
engineering with automated assembly
assuring consistently performing devices
from one day to the next.
ARC Medical is committed to provide the
Anesthesia Department and the Intensive
Care Units with innovative and cost saving
products -- while providing a protected
environment for both the patient and the
caregiver.
9
11. There is a potential risk of bacterial and viral infection
being transmitted through anaesthesia circuits.
Several studies have shown contamination of parts of
anaesthetic equipment with bacteria that colonize the
mouth and upper airway.
Among the recommendations for preventing
transmission of infection through anaesthetic circuits are
using a bacterial/viral filter for every patient or using
disposable circuits.
Assoc Physicians India (2001) 49: 454-8.
11
12. Study Objective:
Although there is no clinical evidence for using one
alternative anesthetic device over another, we have
introduced the systematic use of filters with patients
undergoing general anesthesia.
We describe the features of filters available on the
market and our protocol for their use.
12
13. Conclusion:
The ideal filter is hydrophobic and does not increase
circuit resistance over the amount specified with the
following four principles:
1.The filter forms a part of the patient, not the apparatus.
2.Proper placement of the filter is between the patient and
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14. Conclusion:
3. The main purpose of the filter is to prevent
contamination of the apparatus.
4. If a hydrophobic filter is used with each patient, the use
of a disposable respiratory circuit is not called for.
Rev Esp Anestesiol Reanim 1994 Nov-Dec; 41 (6): 322-7
14
15. It would appear that the ISO standard only
applies to dry heat and moisture exchange filters.
Anaesthesia, July 2010 Volume 65 670-673
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16. STUDY OBJECTIVE:
To investigate bacterial contamination of anaesthetic
breathing circuits and means of prevention.
CONCLUSION:
The presence of a HMEF provides protection of the
anaesthetic circuit as well as other patients, healthcare
workers and the environment.
J Hosp Infect 1992 May; 21 (1): 51-60
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19. 3M Filtration Products Division approach to air
filtration is simple: efficient particle removal
without sacrificing airflow rate.
This approach has yielded a line of highly
efficient, low-pressure drop air filtration media
and filters.
The result is a filter that demonstrates high
efficiency against difficult-to-capture sub-micron
particles.
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20. More loading surface
Highest charge/density available
Lifetime charge in fiber
Each fiber has both positive and negative charge --
bipolar charges
20
21. The most basic form of filtration, the particle is larger than the space
between two fibers, and so, cannot follow the airstream through and is
captured.
21
22. Diffusion occurs specifically with very small particles which follow
irregular patterns, in a manner similar to gases, and not necessarily
following the airstream. This irregular pattern is known as Brownian
motion and increases the particles chance of capture through contact with
the fibers.
22
23. The mechanism by which large, high density particles are captured is called
impingement. As the particulate laden air passes through the filter media,
the air tends to pass around the fibers. Inertia of the particulate causes it to
separate from the airstream to collide with the fibers to which they become
attached.
23
24. Interception occurs when a particle follows the airstream but still attaches
itself to the fiber as it passes around it. This is due to the electrostatic force
attracting the particle towards the fiber where it is retained.
24
27. circuitGuard™ filter allows the hospital to
protect the patient from contamination from
the gas machine and to protect the gas
machine from contamination from the
patient.
Our construction eliminates the possibility
of gases bypassing filter media because of the
creation of two inner walls which are created
during the manufacturing process.
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28. We have an exclusive advantage in our manufacturing
process. This process is designed so that the top and
bottom halves of the device will not fit together unless
the filter is properly seated, thus providing 100%
inspection for seal and blow by.
Other manufactures depend on glue or ultrasonic
welding to seal their halves together.
circuitGuard ™ is built without fail points -- meaning
no glue or ultrasonic welding is used, only a
compression fit.
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30. “Unitized Construction” of circuitGuard™
(the only product on the market with this type
of construction) ensures integrity of the filter
media.
We have an exclusive advantage in
manufacturing. Our engineers assemble our
devices so that the top and bottom halves of
the device will not fit together unless the filter
is properly seated.
Other manufactures depend upon glue or
ultrasonic welding to accomplish this –
possible fail points.
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31. Housing construction ensures filter media
placement and seal.
No “blow-by” of gas is possible. All of the
gas is directed to go through the
hydrophobic filter media, it can not go
around it due to its unique construction.
Bi-directional filtration at the breathing
circuit’s wye protects the patient from the
gas machine and protects the gas machine
from the patient.
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32. Many choose to reuse their anesthesia circuits
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35. It is well established that decontaminating an
SUD is economical and reduces waste.
circuitGuard™ has recently been cleared by the
FDA as an alternative to that decontamination
process.
“Indications: Protection of patients from excessive
heat and moisture loss. Protection of patients and
equipment from contamination".
35
36. “The FilterFlo™ Filter may either be used on the
patient side or on the device side of the ventilator /
anesthetic device and is used as a hygienic
measure alternatively to decontamination of the
breathing system and / or breathing gas
conveying parts of the ventilator.
The device is intended to protect patients and
equipment from contamination.”
36
37. “circuitGuardTM (Pharma Systems) has been
used in over 56,000,000+ general anesthetic
procedures in Europe, Asia, and North
America.
There has never been a cross contamination
reported to any regulatory agency in any
country or directly to Pharma Systems.”
Curt Danielsson, Managing Director, Pharma Systems
37
38. “The protocol for use with our filter was
single patient use of the filter with multiple
patient use of the anesthesia breathing
circuit.
Circuits were changed at varying intervals
according to the hospital protocol.”
Curt Danielsson, Managing Director, Pharma Systems
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40. 10 Ways to Save on Supply Costs
“If you know where to look, you can
find big money hiding out on the
shelves in your supply room”.
Otto Griffin, VP, Materials
Management, Symbion Healthcare
“Use a circuit guard on breathing
circuits. Start using a breathing circuit
protection unit. This FDA-approved
device prevents cross-contamination
and lets you reuse a breathing circuit
all day, instead of throwing it away
after each case.
It saves you between $4 and $6 per
case. It also reduces the amount of
medical waste you produce each
Day”.
May 2008
40
41. “FOR THE RECORD
Re: ’10 Ways to Save on Supply
Costs’ (May, page 42). We’ve received
several inquires for more information
about circuitGuard, an anesthesia
breathing circuit protection unit.
This FDA-approved filter device
prevents cross-contamination and lets
you reuse a circuit throughout the day.
These disposable devices cost $1.85
each for the standard model and $2.85
for a version with a HME humidifier.
They’re sold be the case of 100 by
ARC Medical, of Tucker Ga. Learn
more at www.arcmedical.com or by
calling (800) 950-2720, ext 272”.
July 2008
41
42. “ARC Medical
circuitGuardTM
(800) 950-2721
List price: $1.85 to $2.85 each, in
cases of 100
These disposable filters let you use a
single anesthesia circuit for a day’s
worth of cases. That’s a money-saving
idea.
The circuitGuard’s integrated CO2 port
seems like it would help prevent cross-
contamination. Its compact design and
low profile are suitable for both
pediatric and adult patients.”
July 2008
42
43. FDA regulations pertaining to SUD reprocessing
do not apply to SUDs that are not reprocessed
when there is protection from mucous membrane
contact.
There are no guidelines or standards for
protecting a disposable product from
contamination.
Reprocessing standards do not apply if the device
will not be sent for reprocessing.
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44. We are a filter manufacturer and can not
advocate changing the labeling on a circuit.
If you decide to use our filter to protect the
equipment and patient from cross
contamination, and a cross contamination
occurs, the circuit is not at fault.
The type of circuit used is irrelevant.
Our filter products, used as recommended,
would be responsible for the cross
contamination.
44
45. There are no reported touch contamination
incidents between the anesthesia provider
and any equipment (knobs, flat and
horizontal surfaces, CO2 lines, etc.).
45
49. Our independent cross-contamination study
shows 100% efficiency against cross
contamination.
circuitGuard ™ with HME combo circuitGuard ™ filter only
combo
49
50. Independent testing is available from:
The 3M Company
Nelson Labs
CAMR – the Center for Applied Microbiology and
Research located in Porton Down, England.
CAMR, is one of the largest independent
microbiology laboratories in the world. They are
also associated with the International Standard
Organization (ISO).
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52. Fewer anesthesia circuits are used.
Fewer ETCO2 gas sample lines used.
Eliminates the need for additional filters.
Eliminates the need for additional HMEs.
Reduces shipping and inventory costs.
Decreases OR turnover times.
Upwards of $120.00 per minute room costs
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53. Dry, filtered gas sample line protects the
ETCO2 monitor from contamination and
down time.
Dry, filtered gas sample lines reduce the
replacement of costly water traps and repair
costs due to moisture problems.
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54. Reduces environmental stress:
An estimated 12 million circuits are disposed of
each year.
54
55. Or white bag their circuits which means the
circuits are considered not contaminated.
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60. Yes, we have FDA labeling approval.
“Indications: Protection of patients from excessive heat
and moisture loss. Protection of patients and equipment
from contamination.
The FilterFlo™ Filter may either be used on the patient
side or on the device side of the ventilator / anesthetic
device and is used as a hygienic measure alternatively to
decontamination of the breathing system and / or
breathing gas conveying parts of the ventilator.
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61. circuitGuard™ is a hydrophobic, bi-directional filter.
It protects your patient from contaminating the circuit
and machine as well as protecting the patient from
contamination by the circuit and machine.
You can choose to use any circuit of your choice.
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62. We are a filter manufacturer and can not advocate
changing the labeling on a circuit. If you decide to
use our filter to protect the equipment and patient
from cross contamination, and a cross
contamination occurs, the circuit is not at fault.
The type of circuit used is irrelevant. Our filter
products, used as recommended, would be
responsible for the cross contamination.
62
63. It is not unlawful to reuse single use devices
(SUDs); however, hospitals and third parties that
reprocess single use devices must comply with the
reprocessing laws administered by the FDA.
The use of circuitGuard while choosing to reuse
anesthesia breathing circuits is not considered
reprocessing.
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64. If there is protection from patient mucous
membrane contact then the product does not need to
be reprocessed.
FDA regulations pertaining to SUD reprocessing
do not apply to SUDs that are not reprocessed when
there is protection from mucous membrane contact.
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