asatt – american society of anesthesia technologist and technicians

The Daily Route of an Anesthesia Tech

Region 4 Spring Conference

Presentation By:Steve Koontz

ARC Medical. Inc.

Midwest Region ManagerNational Sales Trainer

Region 4 Spring Conference

Topics:Providing Airway Moisture

Retaining Moisture and Heat

Reusing Anesthesia Circuits

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.

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.

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

Just Another Day At The Office

The respiratory system is a balanced mechanismdependent upon humidity.

Respiratory Humidification

Humidity

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.

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.

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.

Mucociliary Clearance

Powdered Water, What To Mix To Create Liquid

Maybe You Can Help?

All “Noses” Are Not Alike!

16

The Artificial Nose

17

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.



• 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.



• 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 lungsvessels, coating the nasal and oral mucous membrane called mucosa. (2)

• This moisture may also wet the filter media causing a decrease in filtration effeciencies.



• 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.



• 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 thebreathing 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.

Georgia Institute of Technology Heat Recovery Report

Warming blankets on the outside.

What is conserving the heat from the inside?

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.

All “Noses” Are Not Alike!

25

Examples of Humidification Media

26

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

Absorption: Incorporation of moisture.The moisture is held by the humidification media

Adsorption: Adhesion of moisture to a surfaceThe moisture is not held by the media

28

Both Are Considered to be Hygroscopic

Tip of the Day

Don’t be Fooled, The 3Cs

30

32

Holding Moisture?

Collecting Water Vapor -- Function of design?

34

gas in gas in

gas out

How do you know your filter,

filters?How Do You Know Your Filter Filters?

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?


• 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?


• Is the filter media hydrophobic?

• Is it possible for gas flow to go around the filter media due to construction?

circuitGuardHydrophobic filter media

circuitGuardBypassing the filter media is

not possible due to construction

???

Construction Of circuitGuardTM

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

circuitGuardtmConnections

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.


circuitGuardÔ from the flow and use an adapter.

· Place circuitGuard back in place after the medicine has been delivered.



· The patient should be monitored continuously while using the circuitGuardÔ system.


circuitGuardÔ. Doing so may result in harmful residual gases, dangerously increased resistance, blocked filters or dangerously weaken components.



breached. If there is an increase in resistance, check the circuitGuardÔ to determine if there is


· 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.


sound medical judgment. Discard used circuitGuardÔ according to hospital policy.

Patient Connection

Gas Sample Line Connection

Circuit 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.


circuitGuardÔ from the flow and use an adapter.

· Place circuitGuard back in place after the medicine has been delivered.



· The patient should be monitored continuously while using the circuitGuardÔ system.


circuitGuardÔ. Doing so may result in harmful residual gases, dangerously increased resistance,

blocked filters or dangerously weaken components.



breached. If there is an increase in resistance, check the circuitGuardÔ to determine if there is


· 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.


sound medical judgment. Discard used circuitGuardÔ according to hospital policy.

Breathing Circuit Connection

Gas Sample Line Connection

Patient Connection

Independent Documentation of Effectiveness

42

Sent Down To The Minors


44

“Another report of obstruction of a heat and moisture exchange filter.”

• The breathing circuit was then tested, and the - - - -HMEFwas found to be occluded.

• The HMEF was changed and resolution of all obstructionoccurred. The HMEF was examined.

• It was not obviously contaminated, but some regions of the HMEF were a faint yellow colour. (5)


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 exchange filter 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.

Coffee Pour Test

46

Coffee Pour Test

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Is It Legal To Re-use Anesthesia Breathing Circuits?

Three Companies Currently Selling Breathing Filters

In The Reuse of anesthesia Circuits

ARC Medical, Inc.Intersurgical

Pall Corporation

U.S. Food and Drug Administration

Protecting and Promoting Your Health

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.

Legal Interpretations And Conclusions


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.


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.

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.?

Does The Device Have FDA Clearance?

ARC Medical’s, circuitGuardTM

is cleared by the FDA.

Independent Testing?

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


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


• - - - - 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 of 3M Filtrete Air Filter Media in HME Filters

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.

circuitGuard Angle (With Built-In Elbow)

Questions?

References

Wilkes, A. R. (2011), Heat and moisture exchangers and breathing system filters: their use in anaesthesia andintensive 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.

References

(3) British Standards Institution. Anaesthetic and Respiratory Equipment – Heat and MoistureExchangers (HMEs) for Humidifying Respired Gases in Humans - Part 1: HMEs for Use withMinimum Tidal Volumes of 250 ml (BS EN ISO 9360-1:2009). London: British StandardsInstitution, 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)

References

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

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

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