Can I pass accreditation
when using circuitGuard?
Facilities with proper documentation, which can
be provided, have passed accreditation from all
agencies in the USA.
What documentation do I need
to use circuitGuard and
multiple patient use of the circuit?
We provide a sample Policy and Procedure docu-
ment that can be personalized for your facility.
Generally, this is all that has been requested by
inspectors. If additional information such as our
FDA clearance, technical studies, etc. can be pro-
vided.
Is it legal to use circuitGuard and
multiple patient use of the circuit?
Yes, use of the circuitGuard and multiple patient
use of the anesthesia circuit is covered under the
Practice of Medicine exemption for the FDA (21
U.S.C. § 396). The POM exemption must meet 4
criteria and circuitGuard use meets all these crite-
ria.
Is circuitGuard cleared by the FDA?
The FDA 510(k) number is K090738.
circuitGuard's FDA clearance is to protect patients
and equipment from contamination.
Does circuitGuard™ prevent
cross-contamination?
circuitGuard uses 3M Filtrete hydrophobic filter
media that is bi-directional and enclosed in a
unitized construction housing. The housing has
no failure points. circuitGuard protects the patient
from the equipment and the equipment from the
patient.
Does circuitGuard protect against TB?
We are one of only two companies that have spe-
cific testing against TB. Our efficiency is 99.998%
in one direction. Cross contamination would
require the organism to pass through two filters
on different patients. Recently an undiagnosed TB
patient was operated on and circuitGuard was
used to protect the patient and the equipment.
Because of the TB efficiency, the equipment did
not need to be sterilized nor subsequent patients
notified of potential exposure.
Is use of the circuitGuard
less expensive than our current system?
Of course, otherwise, we would not be doing this.
We are generally less than 50% of the current
cost of an anesthesia circuit and associated costs
involved. Acquisition cost are less and waste
expenses are significantly less.
Does circuitGuard reduce
turnover time between cases?
Absolutely, the only devices that need to be
changed are the circuitGuard and the face mask –
can be held in the hand instead of changing a
bulky anesthesia circuit and CO
2
sample lines.
Does circuitGuard reduce
storage space needed?
In a box containing 30 anesthesia circuits, we can
ship 800 circuitGuards. Our box takes up less
space. Shipping uses fossil fuels so there is an
environmental benefit also.
Is there an environmental benefit
to using circuitGuard?
Reducing the amount of plastics in our waste is
important. Using circuitGuard reduces the num-
ber of circuits used per OR per day by up to 80%
and significantly impacts the volume of waste
generated daily. Reduced shipping costs reduces
environmental stress as fewer fossil fuels are
needed.
H
al Norris, Founder and President of ARC Medical, Inc. was European Sales Manager for a large anesthesia circuit company in the 1980s. He saw the
use of a patient filter and multiple patient use of the circuit was standard of care in all European countries then, and still today. ARC Medical has
worked diligently to provide the documentation necessary to bring this cost effective and environmentally favorable protocol to the USA.
VM: (800) 950-2720 Ext 272
Email: arcinfo@arcmedical.com
Web: tinyurl.com/jj55ccv
A D V E R T O R I A L