Presentation ASATT Spring Region 4 Conference

1. The Daily Route of an Anesthesia Tech

2. Region 4 Spring Conference
Presentation By:
Steve Koontz
ARC Medical. Inc.
Midwest Region Manager
National Sales Trainer

3. Region 4 Spring Conference
Topics:
Providing Airway Moisture
Retaining Moisture and Heat
Reusing Anesthesia Circuits

4. ASATT Mission Statement
» The ASATT mission is to establish a professional entity for the
anesthesia technician that will positively affect health care and
standards of quality in patient care by providing a safe anesthetic
environment.
» The ASATT has the only nationally recognized certification for
technicians.

5. Employment Characteristics AT/T
» Employment characteristics
• The AT/T provides support to the anesthesia providers for routine and
complex surgical cases before, during and after anesthesia care.
• In this role, the AT/T may work in a variety of clinical settings such as
hospital operating rooms, interventional and diagnostic radiology, post
anesthesia care units, intensive care units, cardiac catheterization
laboratories, emergency rooms, endoscopies, dental suites, and
ambulatory surgery centers.

6. Occupational Description AT/T
» Occupational description
The duties of the AT/T may include equipment maintenance and
servicing such as:
• Cleaning and sterilizing
• Assembling, calibrating and testing
• Trouble shooting
• Requisitioning and recording of inspections and maintenance
• Operating a variety of mechanical, pneumatic, and electronic
equipment used to monitor the patient undergoing anesthesia

7. Just Another Day At The Office

8. Just Another Day At The Office

9. The respiratory system is a balanced mechanism
dependent upon humidity.
Respiratory Humidification

10. Humidity

11. Humidity
• Humidity is water in its vapor form which is invisible and referred to as
molecular water, sometimes molecular humidity.
• Normally inspired air is warmed to nearly body temperature and is
saturated with water vapor when it reaches the carina.
• In a healthy person, 75% of respiratory gas conditioning takes place in the
upper respiratory tract and the remaining 25% is taken over by the
trachea.
• Warming of breathing air is effected by many small blood vessels, coating
the nasal and oral mucous membrane called mucosa.

12. Benefits Of Humidification
• Humidity will help the natural defense systems in the airway.
• Humidity helps to create efficient gas exchange and ventilation.
• Increasing patient comfort reducing sore throats and tolerance to
treatment.
• Conditions requiring humidity - Administration of medical gases from a
cylinder or pipeline.

13. Mucociliary Clearance
• The mucociliary escalator is a major barrier against infection.
• Microorganisms hoping to infect the respiratory tract are caught in the
sticky mucus and moved up by the mucociliary escalator.

14. Mucociliary Clearance

15. Powdered Water, What To Mix To Create Liquid
Maybe You Can Help?

16. All “Noses” Are Not Alike!
16

17. The Artificial Nose
17

18. Heat and moisture exchangers and breathing system filters:
their use in anaesthesia.
• To humidify gases and protect the breathing system from expired infective
droplets, the device is placed between the patient and the breathing
system.
• In this position, it adds to the dead space, thus increasing rebreathing
necessitating an increase in ventilation or allowing permissible
hypercapnia, and it also adds to the resistance to gas flow, thus increasing
the work of breathing.

19. Heat and moisture exchangers and breathing system filters:
their use in anaesthesia.
• Heat and moisture exchangers (HMEs) are intended to conserve a portion
of the patient’s exhaled heat and moisture and condition inspired gas by
warming and humidifying.
• Breathing system filters are intended to reduce the transmission of
microbes and other particulate matter in breathing systems when the
patient’s upper airways have been bypassed during anaesthesia and
intensive care.
• Heat and moisture-exchanging filters (HMEFs) provide both functions.

20. Heat and moisture exchangers and breathing system filters:
their use in anaesthesia.
• Liquid can flow into HMEs and filters from either the patient (sputum or
pulmonary oedema), or from the breathing system if condensation
present. (1)
• This can cause an increase in resistance to gas flow and, in some cases,
complete occlusion, preventing adequate ventilation of the lungs
vessels, coating the nasal and oral mucous membrane called mucosa. (2)
• This moisture may also wet the filter media causing a decrease in filtration
effeciencies.

21. Heat and moisture exchangers and breathing system filters:
their use in anaesthesia.
• Blockage can also occur if liquid enters the device. Although the patient
might benefit from the addition of the device to the breathing system,
some harm might also occur.
• Guidelines have been formulated for the use of these devices for patients
with specific diseases, or on preventing patients from succumbing to
particular diseases.

22. Heat and moisture exchangers and breathing system filters:
their use in anaesthesia.
• When comparing devices, some smaller devices tend to have greater
resistance to gas flow than larger ones, especially if their media has a
tendency to capture and hold excess moisture.
• The Centers for Disease Control and Prevention made several
recommendations:
Using high-efficiency bacterial filters at various positions in the
breathing circuit (e.g. at the Y-piece or on the inspiratory and
expiratory sides of the circuit) has been advocated and shown to
decrease contamination of the circuit.

23. Georgia Institute of Technology Heat Recovery Report
Warming blankets on the
outside.
What is conserving the
heat from the inside?

24. Georgia Institute of Technology Heat Recovery Report
The ThermoFlo FilterTM is approximately 56%
more effective in recovering sensible heat than
the - - - - device.
The test results indicate the ThermoFlo FilterTM
device recovers 81% of the available sensible
thermal energy.

25. All “Noses” Are Not Alike!
25

26. Examples of Humidification Media
26

27. Hygroscopic = Buzz Word
• Hygroscopic Is the ability of a substance to attract and hold
water molecules from the surrounding environment by
enhancing the natural physical properties.
• This is achieved through either absorption or adsorption with
the humidification material becoming physically changed.
27

28. Absorption: Incorporation of moisture.
The moisture is held by the humidification media
Adsorption: Adhesion of moisture to a surface
The moisture is not held by the media
28
Both Are Considered to be Hygroscopic

29. Tip of the Day

30. Don’t be Fooled, The 3Cs
30

31. 31

32. 32
Holding Moisture?

33. 33

34. Collecting Water Vapor -- Function of design?
34
gas in gas in
gas out

35. How do you know your filter,
filters?
How Do You Know Your Filter Filters?

36. Ask! How Do You Know Your Filter Filters?

37. Ask! How Do You Know Your Filter Filters?
Summary:
Filtration expectations should not be taken for granted. Construction of the
filter device is almost never mentioned or explained. Filtration conversations
should at least include the following questions:
• Who is the filter media manufacturer?
• What type of media is used?
• Is the media hydrophobic?
• What is the resistance wet and dry?
• Will the media lose filtration efficiencies if it becomes saturated?

38. Ask! How Do You Know Your Filter Filters?
• Is independent testing available?
• How is the product constructed?
• Is the device constructed with fail points?
• Is it possible for gas to bypass the media due to fail points?
• What do the 9s mean?
• What type of quality control is used?
• Have any incident reports been reported such as resistance issues?
•
• Is a shelf life associated with the media?

39. Ask! How Do You Know Your Filter Filters?
• Is the filter media hydrophobic?
• Is it possible for gas flow to go around the filter media due to
construction?
circuitGuard
Hydrophobic filter media
circuitGuard
Bypassing the filter media is
not possible due to
construction
???

40. Construction Of circuitGuardTM

41. Filter/HME and Filter Only Variations circuitGuardTM
Securely attach the circuitGuardä to the patient wye on the breathing circuit. Follow the
directions for use of the circuitGuardä. Be sure the elbow is securely attached to the
circuitGuardä. Test the completed breathing circuit assembly prior to use, as directed in
breathing circuit directions for use.
· The circuitGuardä is not reusable. It must be changed between patients.
· Medicine cannot be delivered through the gas sample port. Remove
circuitGuardä 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 circuitGuardä system.
· Ventilator alarms should be in use at all times. Do not soak, rinse, wash, gas or steam sterilize
circuitGuardä. 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. If there is an increase in resistance, check the circuitGuardä to determine if there is
an excess of secretions.
· The circuitGuardä must not be used with heated humidifiers - active humidification.
· The circuitGuardä 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.
· This accessory device should always be used in accordance with safe hospital policy and
sound medical judgment. Discard used circuitGuardä according to hospital policy.
Patient Gas sample line Breathing circuit
circuitGuardtm
Connections
Securely attach the circuitGuardÔ to the patient wye on the breathing circuit. Follow the
directions for use of the circuitGuardÔ. Be sure the elbow is securely attached to the
circuitGuardÔ. Test the completed breathing circuit assembly prior to use, as directed in
breathing circuit directions for use.
· The circuitGuardÔ is not reusable. It must be changed between patients.
· Medicine cannot be delivered through the gas sample port. Remove
circuitGuardÔ 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 circuitGuardÔ system.
· Ventilator alarms should be in use at all times. Do not soak, rinse, wash, gas or steam sterilize
circuitGuardÔ. 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. If there is an increase in resistance, check the circuitGuardÔ to determine if there is
an excess of secretions.
· The circuitGuardÔ must not be used with heated humidifiers - active humidification.
· The circuitGuardÔ 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.
· This accessory device should always be used in accordance with safe hospital policy and
sound medical judgment. Discard used circuitGuardÔ according to hospital policy.
Patient Connection
Gas Sample Line
ConnectionCircuit Connection
ARC Medical - circuitGuard #7056 Instructions for Use
September 2014
Securely attach the circuitGuardÔ to the patient wye on the breathing circuit. Follow the
directions for use of the circuitGuardÔ. Be sure the elbow is securely attached to the
circuitGuardÔ. Test the completed breathing circuit assembly prior to use, as directed in
breathing circuit directions for use.
· The circuitGuardÔ is not reusable. It must be changed between patients.
· Medicine cannot be delivered through the gas sample port. Remove
circuitGuardÔ 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 circuitGuardÔ system.
· Ventilator alarms should be in use at all times. Do not soak, rinse, wash, gas or steam sterilize
circuitGuardÔ. 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. If there is an increase in resistance, check the circuitGuardÔ to determine if there is
an excess of secretions.
· The circuitGuardÔ must not be used with heated humidifiers - active humidification.
· The circuitGuardÔ 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.
· This accessory device should always be used in accordance with safe hospital policy and
sound medical judgment. Discard used circuitGuardÔ according to hospital policy.
Breathing Circuit
Connection
Gas Sample
Line Connection
Patient
Connection

42. Independent Documentation of Effectiveness
42

43. Independent Documentation of Effectiveness

44. Independent Documentation of Effectiveness
44
“Another report of obstruction of a heat and moisture
exchange filter.”
• The breathing circuit was then tested, and the - - - -HMEF
was found to be occluded.
• The HMEF was changed and resolution of all obstruction
occurred. The HMEF was examined.
• It was not obviously contaminated,but some regions of
the HMEF were a faint yellow colour. (5)

45. Independent Documentation of Effectiveness
45
“Rapid and complete occlusion of a - - - - heat and moisture
exchange filter by pulmonary edema (Clinical report)”
• A case of near fatal obstruction of a breathing system is
described, due to occlusion of a heat and moisture
exchangefilter in a patient with pulmonary edema.
• Previous reports have described cases of mechanical
obstruction to fresh gas flow due to an accumulation of a
bolus of fluid within the filter housing.

46. Coffee Pour Test
46

47. Coffee Pour Test
47

48. Is It Legal To Re-use Anesthesia Breathing Circuits?

49. Three Companies Currently Selling Breathing Filters
In The Reuse of anesthesia Circuits
ARC Medical, Inc.
Intersurgical
Pall Corporation

50. U.S. Food and Drug Administration
Protecting and Promoting Your Health

51. POM – The Practice Of Medicine
• The circuitGuard filter is on-label use.
• The breathing circuits and sample lines are off-label use.
• The FDA requirements of using labeled “single patient use” circuits and
sample lines -- the following files are legal interpretations and conclusions
with off label use.

52. Legal Interpretations And Conclusions

53. POM – The Practice Of Medicine
Summary:
• The practice of a healthcare practitioner using a circuit, labeled for single
patient use, on multiple patients is perfectly legal if the POM exemption
criteria are met.
• The law expressly defers circuit off-label use to the discretion of the
licensed healthcare practitioner acting within the scope of his or her
practice.
• The FD&C Act specifically provides for this exemption from FDA
regulation.

54. POM – The Practice Of Medicine
Summary:
Four criteria must be met in order for a healthcare practitioner to rely on the
POM exemption.
The four criteria are:
1. A legally marketed device is used.
2. Use is by a licensed healthcare practitioner.
3. An actual healthcare practitioner/patient relationship exists.
4. The healthcare practitioner does not solicit patients for the off-label use.

55. Does The Device Have FDA Clearance?
Does your chosen filter device…
• Have FDA Clearance?
• At least filters on the market have FDA clearance.
• Have you seen and read the copy?
• Does the FDA clearance say you can use any hospital
contractual items such as anesthesia circuits without
losing clearance?
• In order to maintain clearance, are you required to
use their patient kit and/or machine kit? E.g. - filter,
mask, circuit, reservoir bag, ETCO2 gas sampling line,
etc.?

56. Does The Device Have FDA Clearance?
ARC Medical’s, circuitGuardTM
is cleared by the FDA.

57. Independent Testing?

58. Is Independent Testing Important For Supporting Claims?
Independent Lab Report
“A value of > 99.99 is reported when no colonies are
detected on the Anderson sampler plates. The actual
experimental value is 100%.
100% against cross-contamination

59. Is Independent Testing Important For Supporting Claims?
AMTAC MEDIQA Nelson LABORATORIES, INC.
has approval of laboratory facilities in accordance with
the principles of BS EN ISO/IEC 17025, in order to
establish the laboratory's suitability to support medical
device manufactures in their compliance with Annex I
of the Medical Devices Directive 93/42/EEC for the
provision of:
• AEROBIOLOGY, MICROBIOLOGY, BIOCOMPATIBILITY,
ENVIRONMENTAL, PHYSICAL, CHEMISTRY, STERILIZATION
SERVICES

60. Is Independent Testing Important For Supporting Claims?
• - - - - Corporation recently published a report in which a
series of tests were used to evaluate a Pharma Systems
ThermoFlo FilterTM. Unfortunately, each test Pall used was
inappropriate foe evaluating this type of filter.
• The TherrmoFlo Filter is a heat and moisture that
incorporates hydrophobic (water repelling 3MTM
• These data show that HME filters incorporating Filtrete,
such as those produced by Pharma Systems, are up to to
99.9999 percent efficient when tested in a manner
appropriate for their intended use.
• 3M must reject both - - - - tests and results.
3M Technical Report – Performance

61. Performance of 3M Filtrete Air Filter Media in HME Filters
3M Filtration
Products Laboratory
3M Center
Bldg. 60-1; W-17
St. Paul, MN 55144-1000
800.648.3550
3 July 3, 2001
To Whom It May Concern:
As per your request here is the data.
There are standard methods for testing the Bacterial Filtration Efficiency - BFE and Virus
Filtration Efficiency - VFE of filter media. The test consists of challenging the filter
media using bacteria that are classified as Biosafety No. 2, and viruses that are classified
as Biosafety No. 1, meaning that there is little if any health risk associated with them.
These microbes are contained in aerosol droplets with an average size of approximately
2.8 mm. This challenge is passed through the filter media and the challenge reduction is
calculated. The filter performance reported using this test method reflects the removal of
the aerosol that contains the microorganisms not the removal of the individual microbes,
and therefore is independent of the size or shape of the virus or bacteria.
The testing was performed at Nelson Laboratories, Inc. according to Procedure No.
920693-1, Laboratory No. 48061 for BFE and Procedure No. 920694-1, Laboratory No.
48060 for VFE.
There is also information on the filtration efficiency of the media versus Tuberculosis TB.
Due to the obvious health risk of TB or any other hazardous bacteria and viruses, testing
laboratories in the United States will not test the efficiency of filters against the aerosol
transmission of these specific microorganisms.
Fortunately, there are standard methods for testing this type of bacterial filtration
efficiencies. See the above description for bacterial testing. Nelson Laboratories, Inc. did
the testing according to Procedure No. 930743-1, Laboratory No. 49838 using
Mycobacterium Smegmatis for the challenge aerosol.

62. circuitGuard Angle (With Built-In Elbow)

63. circuitGuard Angle (With Built-In Elbow)

64. Questions?

65. References
Wilkes, A. R. (2011), Heat and moisture exchangers and breathing system filters: their use in
anaesthesia and
intensive care. Part 2 – practical use, including problems, and their use with paediatric
patients. Anaesthesia,
66: 40–51. doi: 10.1111/j.1365-2044.2010.06564.x
1) Schummer W, Schummer C, Fuchs J, Voigt R. Sudden upper airway occlusion due to
invisible rain-out in the heat and moisture exchanger.
British Journal of Anaesthesia 2002; 89: 335–6.
2) Williams DJ, Stacey MRW. Rapid and complete occlusion of a heat and moisture
exchange filter by pulmonary edema (clinical report). Canadian Journal of Anesthesia 2002;
49: 126–31.

66. References
(3) British Standards Institution. Anaesthetic and Respiratory Equipment – Heat and
Moisture
Exchangers (HMEs) for Humidifying Respired Gases in Humans - Part 1: HMEs for Use with
Minimum Tidal Volumes of 250 ml (BS EN ISO 9360-1:2009). London: British Standards
Institution, 2009.
(4) Wilkes AR. Heat and moisture exchangers and breathing system filters: their use in
anaesthesia and intensive care. Part 1 – History, principles and efficiency. Anaesthesia 2011;
66: 31–39. Web of Science® Times Cited: 1 (/resolve/reference/ISI?id=000286347600008)

67. References
(5) Canadian Journal of Anesthesia 49:1001 (2002)
© Canadian Anesthesiologists’ Society, 2002
General Anesthesia Correspondence
Another report of obstruction of a heat and moisture exchange filter
Clifford J. Peady, FANZCA

68. References
(6) Rapid and complete occlusion of a heat and moisture exchange filter by pulmonary
edema (Clinical report); [Résumé clinique : occlusion rapide et totale du filtre de
l'échangeur de chaleur et d'humidité par de l' dème pulmonaire]; David J. Williams, FRCA
and Mark R.W. Stacey, FRCA; From the Department of Anaesthesia and Intensive Care,
University Hospital of Wales, Heath Park, Cardiff, United Kingdom.
Canadian Journal of Anesthesia 49:126-131 (2002); © Canadian Anesthesiologists’ Society,
2002; General Anesthesia