1
ARC Medical, Inc.                7
ARC Medical, Inc. was started in 1990 to  serve the humidification and filtration  needs of ventilator dependent patients ...
Our manufacturing utilizes state of the art  engineering with automated assembly  assuring consistently performing devices...
10
   There is a potential risk of bacterial and viral infection    being transmitted through anaesthesia circuits.   Sever...
   Study Objective:     Although there is no clinical evidence for using one      alternative anesthetic device over ano...
   Conclusion:       The ideal filter is hydrophobic and does not increase        circuit resistance over the amount spe...
   Conclusion:      3. The main purpose of the filter is to prevent         contamination of the apparatus.      4. If a ...
   It would appear that the ISO standard only    applies to dry heat and moisture exchange filters.       Anaesthesia, J...
   STUDY OBJECTIVE:     To investigate bacterial contamination of anaesthetic      breathing circuits and means of preve...
17
Particulate inclusions, drawn to scale,            that may be found in a carrier gas.©2001 by American College of Chest P...
   3M Filtration Products Division approach to air    filtration is simple: efficient particle removal    without sacrifi...
   More loading surface   Highest charge/density available   Lifetime charge in fiber   Each fiber has both positive a...
The most basic form of filtration, the particle is larger than the spacebetween two fibers, and so, cannot follow the airs...
Diffusion occurs specifically with very small particles which followirregular patterns, in a manner similar to gases, and ...
The mechanism by which large, high density particles are captured is calledimpingement. As the particulate laden air passe...
Interception occurs when a particle follows the airstream but still attachesitself to the fiber as it passes around it. Th...
25
26
   circuitGuard™ filter allows the hospital to    protect the patient from contamination from    the gas machine and to p...
   We have an exclusive advantage in our manufacturing    process. This process is designed so that the top and    bottom...
29
   “Unitized Construction” of circuitGuard™    (the only product on the market with this type    of construction) ensures...
   Housing construction ensures filter media    placement and seal.   No “blow-by” of gas is possible. All of the    gas...
   Many choose to reuse their anesthesia circuits                                                     32
ARC Medical    Inc       33    Member
34
   It is well established that decontaminating an    SUD is economical and reduces waste.   circuitGuard™ has recently b...
    “The FilterFlo™ Filter may either be used on the    patient side or on the device side of the ventilator /    anesthe...
   “circuitGuardTM (Pharma Systems) has been    used in over 56,000,000+ general anesthetic    procedures in Europe, Asia...
   “The protocol for use with our filter was    single patient use of the filter with multiple    patient use of the anes...
circuitGuardTM Sales    2009 - 2012                       39
10 Ways to Save on Supply Costs           “If you know where to look, you can           find big money hiding out on the  ...
“FOR THE RECORD            Re: ’10 Ways to Save on Supply            Costs’ (May, page 42). We’ve received            sev...
“ARC Medical            circuitGuardTM            (800) 950-2721            List price: $1.85 to $2.85 each, in           ...
   FDA regulations pertaining to SUD reprocessing    do not apply to SUDs that are not reprocessed    when there is prote...
   We are a filter manufacturer and can not    advocate changing the labeling on a circuit.   If you decide to use our f...
   There are no reported touch contamination    incidents between the anesthesia provider    and any equipment (knobs, fl...
The circuitGuardTM SystemPatient Elbow              HCH Media        ETCO2 PortRidge & Lip Construction               Circ...
47
48
Our independent cross-contamination study        shows 100% efficiency against cross                 contamination.circuit...
Independent testing is available from:   The 3M Company   Nelson Labs   CAMR – the Center for Applied Microbiology and ...
   Fewer products used                          51
   Fewer anesthesia circuits are used.   Fewer ETCO2 gas sample lines used.   Eliminates the need for additional filter...
   Dry, filtered gas sample line protects the    ETCO2 monitor from contamination and    down time.   Dry, filtered gas ...
   Reduces environmental stress:      An estimated 12 million circuits are disposed of      each year.                   ...
Or white bag their circuits which means the circuits are considered not contaminated.                                     ...
Reduces inventory and storage costs                                      56
circuitGuard ™ with HME combo   circuitGuard ™ filter only combo                                                          ...
58
Discussion…              59
   Yes, we have FDA labeling approval.   “Indications: Protection of patients from excessive heat    and moisture loss. ...
   circuitGuard™ is a hydrophobic, bi-directional filter.   It protects your patient from contaminating the circuit    a...
   We are a filter manufacturer and can not advocate    changing the labeling on a circuit. If you decide to    use our f...
   It is not unlawful to reuse single use devices    (SUDs); however, hospitals and third parties that    reprocess singl...
   If there is protection from patient mucous    membrane contact then the product does not need to    be reprocessed.  ...
65
How are you protecting your general anesthesia procedure patients from contamination?
How are you protecting your general anesthesia procedure patients from contamination?
How are you protecting your general anesthesia procedure patients from contamination?
How are you protecting your general anesthesia procedure patients from contamination?
How are you protecting your general anesthesia procedure patients from contamination?
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How are you protecting your general anesthesia procedure patients from contamination?

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Steve Koontz, Director of Sales Training, ARC Medical, December 2012

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How are you protecting your general anesthesia procedure patients from contamination?

  1. 1. 1
  2. 2. ARC Medical, Inc. 7
  3. 3. 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
  4. 4. 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
  5. 5. 10
  6. 6.  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
  7. 7.  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
  8. 8.  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 13
  9. 9.  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
  10. 10.  It would appear that the ISO standard only applies to dry heat and moisture exchange filters.  Anaesthesia, July 2010 Volume 65 670-673 15
  11. 11.  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 16
  12. 12. 17
  13. 13. Particulate inclusions, drawn to scale, that may be found in a carrier gas.©2001 by American College of Chest Physicians; Demers R Chest 2001;120:1377-1389
  14. 14.  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. 19
  15. 15.  More loading surface Highest charge/density available Lifetime charge in fiber Each fiber has both positive and negative charge -- bipolar charges 20
  16. 16. The most basic form of filtration, the particle is larger than the spacebetween two fibers, and so, cannot follow the airstream through and iscaptured. 21
  17. 17. Diffusion occurs specifically with very small particles which followirregular patterns, in a manner similar to gases, and not necessarilyfollowing the airstream. This irregular pattern is known as Brownianmotion and increases the particles chance of capture through contact withthe fibers. 22
  18. 18. The mechanism by which large, high density particles are captured is calledimpingement. As the particulate laden air passes through the filter media,the air tends to pass around the fibers. Inertia of the particulate causes it toseparate from the airstream to collide with the fibers to which they becomeattached. 23
  19. 19. Interception occurs when a particle follows the airstream but still attachesitself to the fiber as it passes around it. This is due to the electrostatic forceattracting the particle towards the fiber where it is retained. 24
  20. 20. 25
  21. 21. 26
  22. 22.  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. 27
  23. 23.  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. 28
  24. 24. 29
  25. 25.  “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. 30
  26. 26.  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. 31
  27. 27.  Many choose to reuse their anesthesia circuits 32
  28. 28. ARC Medical Inc 33 Member
  29. 29. 34
  30. 30.  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
  31. 31.   “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
  32. 32.  “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
  33. 33.  “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 38
  34. 34. circuitGuardTM Sales 2009 - 2012 39
  35. 35. 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
  36. 36. “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
  37. 37. “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
  38. 38.  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. 43
  39. 39.  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
  40. 40.  There are no reported touch contamination incidents between the anesthesia provider and any equipment (knobs, flat and horizontal surfaces, CO2 lines, etc.). 45
  41. 41. The circuitGuardTM SystemPatient Elbow HCH Media ETCO2 PortRidge & Lip Construction Circuit Connection 46
  42. 42. 47
  43. 43. 48
  44. 44. Our independent cross-contamination study shows 100% efficiency against cross contamination.circuitGuard ™ with HME combo circuitGuard ™ filter only combo 49
  45. 45. 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). 50
  46. 46.  Fewer products used 51
  47. 47.  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 52
  48. 48.  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. 53
  49. 49.  Reduces environmental stress: An estimated 12 million circuits are disposed of each year. 54
  50. 50. Or white bag their circuits which means the circuits are considered not contaminated. 55
  51. 51. Reduces inventory and storage costs 56
  52. 52. circuitGuard ™ with HME combo circuitGuard ™ filter only combo 57
  53. 53. 58
  54. 54. Discussion… 59
  55. 55.  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. 60
  56. 56.  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. 61
  57. 57.  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
  58. 58.  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. 63
  59. 59.  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. 64
  60. 60. 65

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