Reusing anesthesia circuits

1. The circuitGuard System
September 2014 1

2. ARC Medical
September 2014 2

4. How do you know your filter filters?

5. Company Background
ARC Medical, Inc. was started in 1990 to serve the
filtration and humidification needs of all types of
patients.
ARC Medical provides the highest performing
devices for filtration and humidification based
upon independent, 3rd party testing.
Our manufacturing utilizes state of the art
engineering with automated assembly assuring
consistently performing devices from one day to
the next.
September 2014 5

6. Company Background
ARC Medical is committed to provide Surgery
Centers and the Anesthesia Department with
innovative and cost saving products, while
providing a safe environment for both the
patient and the caregiver.
“Always do right. This will gratify some people
and astonish the rest.” -- Mark Twain
September 2014 6

7. ARC Medical has five Region Managers
and 53 sales reps covering all 50 states

8. Drager Healthcare Fabius GS Operator’s Manual - page 110
Recommendations for Typical Cleaning and Disinfection After Use
(After each patient)
Breathing bag and hose and Y-piece, Diaphragm, Breathing system,
Valve discs, Expiratory port, Absorber and insert, AGS housing,
AGS buffer vol. container, AGS transfer hose, etc
When was the last time your
anesthesia machine was
“CLEANED”?
Cleaned Between Patients??
September 2014 8

9. Studies have shown that few if any anesthesia
machines are cleaned between patients!
circuitGuard protects the patient from the anesthesia machine
and protects the anesthesia machine from the patient.
September 2014 9

10. But I have a
filter on my
circuit now?
A question for
you…
How do you
know your
filter filters?
10 September 2014

11. But I have a
filter on my
circuit now?
circuitGuard has
a story to tell-why
it works!
11 September 2014

12. circuitGuard
• On August 10th, 2000, the FDA issued a new ruling
on the re-use of single patient devices. “It is not
unlawful to reuse single patient devices.”
• Manufacturers, preprocessor and hospitals that
choose to reprocess single patient devices must
follow GMP – Good Manufacturing Practices.
• Using circuitGuard is not considered to be
reprocessing.
September 2014 12

13. circuitGuard
• In July 2009, the FDA issued ARC Medical an
additional Indication of Use known as a 510k.
“circuitGuard is used as a hygienic measure
alternatively to decontamination of the breathing
system and / or breathing gas conveying parts of
the ventilator.”
• Simply stated ……
“Decontamination and subsequent reprocessing
of disposable breathing circuits can be avoided by
using circuitGuard.”
September 2014 13

14. circuitGuard
• Protects the patient from the machine and the
machine from the patient, giving the Surgery Center
the choice of re-using the anesthesia breathing
circuit of preference.
• Is a highly effective, hydrophobic filter with
>99.99+% efficiency – with independent cross-contamination
studies showing 100% efficiency
against cross-contamination.
• “Unitized Construction” of circuitGuard (the only
product with this type of construction) ensures the
integrity of the filter media within the housing.
September 2014 14

15. circuitGuard
Independent testing data is available from:
• The 3M Company
• Nelson Labs
• CAMR – the Center for Applied Microbiology and
Research located in Porton Down, England
• One of the large independent microbiology
laboratories in the world.
• They are also associated with the International
Standard Organization (ISO).
September 2014 15

16. “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.”
September 2014 16

17. circuitGuard Components
Patient Elbow HCH Media ETCO2
Ridge & Lip Construction Circuit Connection
17
September 2014

18. And circuitGuard…
18
September 2014

19. 3M Filtrete Fibers
September 2014 19

20. 3M Filtrete Fibers
September 2014 20

21. Incorporating a Hydrophobic Barrier
September 2014 21

22. Unitized Construction
We have an exclusive advantage in our manufacturing
process.
This process is designed so the top and bottom halves
of the device will not fit together unless the filter is
properly seated, providing 100% inspection for seal
and blow by.
Other manufactures depend on glue or ultrasonic
welding to seal their halves together.
22
September 2014

23. Unitized Construction
• Pressure testing of other devices only assures that
the top and bottom are sealed -- not that their filter
media is in it’s correct place.
• Fail points may allow for the passage of gas
through the device without filtration.
• Our construction eliminates the possibility of gases
bypassing the filter media because circuitGuard
has no fail points which ensures filtration
efficiencies.
September 2014 23

24. Unitized Construction
circuitGuard is constructed without fail
points -- meaning no glue or ultrasonic
welding is used, only a compression fit.
24
September 2014

25. circuitGuard
Our independent cross-contamination study
shows 100% efficiency against cross
contamination.
circuitGuard with filter/HME combo circuitGuard filter only combo
September 2014 25

26. Better Patient Care
Bottom line, the circuitGuard filter system
filters unlike any filter on the market.
Se2p6tember 2014

27. Prevention of Cross-Contamination
Patient to Anesthesia Apparatus to Patient
Using Filters Study
• 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.
September 2014 27

28. Prevention of Cross-Contamination
Patient to Anesthesia Apparatus to Patient
Using Filters Study
Conclusion:
• The ideal filter is hydrophobic and does not
increase circuit resistance over the amount
specified with the following principles:
1. The filter forms a part of the patient, not the
apparatus.
2. Proper placement of the filter is between the
patient and the circuits wye piece.
Assoc Physicians India (2001) 49: 454-8
September 2014 28

29. There are no reported touch contamination incidents
between the anesthesia provider
and equipment or patient.
September 2014 29

30. Lowers Associated Costs
Reduces environmental stress –
An estimated 12 million circuits are disposed of
each year.
REDUCE--
RED BAG WASTE !
September 2014 30

31. Value Added Services
Reduces inventory and storage costs
ARC has large
shipping units per
case – less freight
charges.
One dABC box will
hold 800
circuitGuards.
ARC currently sells
over 450 facilities on
a monthly basis.
Since 1990, we have
had NO back orders.
September 2014 31

32. Value Added Services
• Fewer anesthesia circuits are used
• Fewer ETCO2 gas sample lines used
• Eliminates the need for additional filters
• Eliminates the need for additional HMEs
• Reduces red bag disposal costs
• Reduces shipping costs
September 2014 32

33. Value Added Services
• Decreases OR turnover times
• Dry, filtered gas sample line protects the
ETCO2 monitor from contamination.
• Dry, filtered gas sample lines reduces ETCO2
monitors down time.
• Dry, filtered gas sample lines reduce the
replacement of costly water traps and repair
costs due to moisture problems.
September 2014 33

34. Value Added Services
• ARC has large shipping units for our customers
with case quantities of 100 or 300 for larger
volume accounts.
• This packaging was established for freight
savings considerations.
• Visa and Master Card accepted.
• ARC has not had a back order since 1990.
September 2014 34

35. Environmental Footprint
• Over 65+ million anesthesia general cases
have been performed using circuitGuard…
• Meaning at least 32+ million circuits have been
used on multiple patients while using
circuitGuard…
• Without a single case of cross-contamination
reported to any healthcare monitoring agency
in the U.S. or Europe.
September 2014 35

36. Environmental Footprint
Meaning at least 32+ million circuits have been
been saved from adding to the environment
footprint.
(5,280 feet per mile; 24,901 miles around the earth)
5’ (average length of circuit) times 32,000,000 =
160,000,000’ saved = 30,303 miles
1.22 times around the earth saved
September 2014 36

37. Member of Practice Greenhealth
Go Green & Reduce Landfill Waste
September 2014 37

38. Manufactured in Sweden
September 2014 38

39. Questions - Comments
“Directions For Use”
(next 5 slides if
requested)

40. Directions for Use

41. The circuitGuard is not reusable. It must be
changed between patients
• Securely attach the circuitGuard to the patient wye on
the breathing circuit.
• Follow the directions for use of the circuitGuard.
• Be sure the elbow is securely attached to the
circuitGuard.
• Test the completed breathing circuit assembly prior to
use, as directed in breathing circuit directions for use.
• Medicine cannot be delivered through the gas sample
port.

42. The circuitGuard is not reusable. It must be
changed between patients
• Remove circuitGuard from the flow and use an adapter
• Place circuitGuard back in place after the medicine has
been delivered.
• The patient will receive a clean mask and circuitGuard™
at the beginning of each case, but the circuit and bag can
be effectively decontaminated in the same manner as
other OR equipment surfaces between cases.
• The patient should be monitored continuously while using
the circuitGuard system.

43. The circuitGuard is not reusable. It must be
changed between patients
• Ventilator alarms should be in use at all times.
• Do not soak, rinse, wash, gas or steam sterilize
circuitGuard. Doing so may result in harmful residual
gases, dangerously increased resistance, blocked filters
or dangerously weaken components.
• The circuit must be discarded if the integrity of the patient-side
breathing filter has been breached at any time during
use.
• An increase in resistance to flow is one indication that the
filter has been breached.

44. The circuitGuard is not reusable. It must be
changed between patients
• If there is an increase in resistance, check the
circuitGuard to determine if there is an excess of
secretions.
• The circuitGuard must not be used with heated
humidifiers - active humidification.
• The circuitGuard is not intended for use on patients who
produce large amounts of secretions or froth. If a patient
produces exudates or blood, which enter the filter, the
filter must be removed.

45. The circuitGuard is not reusable. It must be
changed between patients
• This accessory device should always be used in
accordance with safe hospital policy and sound medical
judgment.
• Discard used circuitGuard according to hospital policy.

46. Questions - Comments
The End