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Oxygen W Webinar ar Part 3 3 Durable M Medical E Equipment S - - PowerPoint PPT Presentation

Oxygen W Webinar ar Part 3 3 Durable M Medical E Equipment S Suppliers February 27, 2020 www.uscopdcoalition.org Mission The mission of the U.S. COPD Coalition is to improve awareness and care of patients with COPD while supporting


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Oxygen W Webinar ar – Part 3 3 Durable M Medical E Equipment S Suppliers

www.uscopdcoalition.org

February 27, 2020

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SLIDE 2

Mission

The mission of the U.S. COPD Coalition is to improve awareness and care of patients with COPD while supporting the search for a cure.

Vision Statement

A COPD-free United States.

Goals of USCC

Promote better care for patients with COPD; Raise awareness of COPD; Promote COPD research and the search for a cure; Foster communication and networking.

The Focuses of the U.S. COPD Coalition

Awareness ; Advocacy; Collaboration and Continued Growth www.uscopdcoalition.org

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SLIDE 3

Webinar Participants

Angela King, BS, RPFT, RRT-NPS - Owner/CEO and VP of Clinical Services ~ Mobile Medical Homecare, Fort Wayne, IN

Joseph Lewarski, MHA, RRT, FAARC - Senior VP/General Manager, Global

Business-Clinical Care & North American Manufacturing Operations ~ Drive DeVilbiss Healthcare

Tangita Daramola – Competitive Acquisition Ombudsman ~ US Department of Health & Human Services, Centers for Medicare & Medicaid Services www.uscopdcoalition.org

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SLIDE 4

AGENDA

Opening Remarks

Keith Siegel, MBA, RRT, CPFT, FAARC Executive Director, US COPD Coalition

Chairman’s Welcome

Sam Giordano, MBA, RRT, FAARC Chair, US COPD Coalition

Featured Presentation:

Angela King, BS, RPFT, RRT-NPS Joseph Lewarski, MHA, RRT, FAARC Tangita Darimola Q & A Keith Siegel, MBA, RRT, CPFT, FAARC Wrap Up Sam Giordano, MBA, RRT, FAARC

www.uscopdcoalition.org

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Par artner ering W g With Your DME ME P Provider

Angela King, BS, RPFT, RRT-NPS Mobile Medical Home Care

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Spot the Safety Issues

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1 2 3 4 5

6 7

8 9 10 11 & 12

Spot the Safety Issues

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Partnering with Your DME Provider: Communicate Your Basic Information

If you are thinking about moving If you are thinking about changing your insurance If you change your phone number If you change your secondary contact person or if they change their phone number

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Partnering with Your DME Provider: Communicate Your Health Information

If you change physicians If you are admitted to the hospital If any physician changes your oxygen prescription Please remember, you need to visit the doctor who prescribed your oxygen at least every year!

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Partnering with your DME Provider: Delivery Tips

Clearly visible house numbers Snow /ice removal (if possible!) Establish a safe storage space for cylinders Plan ahead! Please order in advance! Be home for your scheduled delivery Ask about drive-up pick-ups

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Partnering with Your DME Provider: Using Your Oxygen Therapy

Be sure to use your oxygen as the doctor ordered! If you find that you are using your oxygen differently than was

  • rdered– please talk to your DME Provider or Physician!
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Partnering with Your DME Provider: Troubleshooting Your Oxygen Therapy

Please maintain your equipment as you were instructed. Keep in mind that excessive tubing length can cause serious problems. Please review any instructional materials your DME Provider gave you before you request a service call. Be willing to work with us on the telephone to try to trouble-shoot any problems. Make sure you know how to use your back-up

  • xygen (if applicable).
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Partnering with Your DME Provider: Consider Conserving Technology

If you think your oxygen system is preventing you from being mobile, speak with your DME Provider and/or your Physician! There are several types of equipment designed to help you be more mobile and/or less burdened.

  • Keep an open mind! Remember that very small

systems you have seen on T.V. or while out and about may not be the best system for your particular needs.

  • Keep in mind that all medical oxygen devices

require a prescription from your doctor!

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General Methods to Increase Patient Mobility or Reduce Burden

  • 1. Make the liquid oxygen portable last longer
  • 2. Make each oxygen cylinder last longer.
  • 3. Provide a system that permits the patient to fill their own

cylinders at home

  • 4. Provide a portable oxygen concentrator that makes its own
  • xygen
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Simplistic Diagram of Oxygen Flow

(continuous flow and pulse flow)

INHALE EXHALE Flow speed in Flow speed out Continuous oxygen flow

Pulse

Time

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Partnering with Your DME Provider: Consider Conserving Technology

Be mindful of your oxygen therapy goals:

  • Do you want to avoid having to be home for oxygen fills or deliveries?
  • Do you want to go on overnight trips away from home?
  • Do you want to travel by airplane?
  • What is the highest oxygen liter flow that you might reasonably need?

Establish a positive dialogue with your DME Provider and physician. Discuss your oxygen therapy goals so they can help you choose the best

  • ption to meet those goals!
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Potential Concerns with Pulse-Dose Technology

  • 1. Is the “pulse” sound bothersome?
  • 2. Does the pulse flow system maintain the patient’s oxygen

level as effectively as the continuous flow system?

  • 3. Is the patient consistently able to trigger the pulse of
  • xygen?
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SLIDE 18

Partnering with Your DME Provider: Pulse Oximetry Testing

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Partnering with Your DME Provider: Trialing a New System

Ask to be instructed on the proposed system Ask for a trial of the proposed system Ask to keep your current system in place while you trial the proposed system Ask your physician if you should use pulse oximetry during the trial to ensure the new system works for you

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Summary

Oxygen safety is important There are several types of home oxygen systems. Each system has pros and cons Some form of pulse-dose technology may help you be more mobile and/or less burdened by your oxygen system Pulse oximetry is a helpful tool to ensure that your oxygen system is working well for you Partnering with your DME Provider can be a benefit to your health

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Home Oxygen Therapy

Joseph Lewarski, MHA, RRT, FAARC SVP/GM Global Clinical Care Drive DeVilbiss Healthcare February 2020

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Oxyg ygen

O2

  • Elemental oxygen: atomic

number 8 and symbol “O”

  • Oxygen as we think of it

is really Di-oxygen

  • The earth’s atmosphere

is 20.9% O2

  • 78.1% Nitrogen
  • 0.9% Argon
  • 0.04% Carbon Dioxide
  • Trace amounts of
  • Neon
  • Helium
  • Methane
  • Krypton
  • Hydrogen

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Outl tline

  • Liquid oxygen systems
  • Stationary & portable
  • Concentrator oxygen systems
  • Stationary & portable
  • Compressed oxygen cylinder systems
  • Home cylinder filling systems
  • Oxygen conserving technologies
  • Matching the product to the user
  • Future home oxygen technology

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Hospital B Bulk Liquid O Oxy xygen S System

  • Liquid oxygen is produced through the

process of air liquefaction – super cooling air to separate the different gases

  • Liquid O2 separates and is stored at -

297° F

  • One liter of liquid oxygen is equivalent

to approximately 860 liters of gaseous

  • xygen
  • A typical home stationary oxygen unit is

filled with approximately 40 liters of liquid oxygen

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Early Home Liquid Stationary & Portable

  • First home liquid

transfillable systems became available from the Linde Corp. in 1965

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Liquid Stationary & Portable - E0439 & E0434

  • Liquid oxygen is produced through the process of

air liquefaction – super cooling air to separate the different gases

  • Liquid O2 separates and is stored at -297° F
  • Produces 99.6% O2
  • One liter of liquid oxygen is equivalent to

approximately 860 liters of gaseous oxygen

  • Allows for portable devices to weigh less and provide

longer use

  • A typical home stationary oxygen unit is filled with

approximately 40 liters of liquid oxygen

  • The weight (full) of a typical home liquid stationary ranges

from 135-185 pounds

  • Oxygen is supplied to the user based on physics
  • O2 warms and returns to gaseous state
  • Gas expands, exerting more pressure within the vessel
  • Gaseous O2 is under higher pressure and wants to escape
  • Pressurized O2 provides the flow for user
  • The warming/evaporation occurs even when the

device is not being used

  • The combination of the flow used for the patient and

the evaporation determine how often the vessel needs to be refilled

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Liquid Oxygen Value Chain & Economics

  • Liquid oxygen is

advantageous in bulk applications but often considered very costly and inefficient in smaller applications

  • Cost of the finished good is

modest compared to the cost

  • f the process
  • Even on a very large scale,

there is little cost advantage to the provider

  • Very difficult to create any

economy of scale

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Oxygen Concentrators

  • Introduced in the 1970’s
  • Produce O2 via a process

knows as Pressure-Swing- Adsorption (PSA)

  • All modern concentrators

still produce oxygen using PSA

  • PSA separates the room air,

filtering out the nitrogen

  • Chemical sieve bed serves

as the filter

  • Captures & releases the

nitrogen

  • Oxygen passes through
  • Produce O2 up to 96%
  • Common flow ranges from

0 to 10 LPM

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Design & Performance

  • Concentrator & POC

Design Considerations

  • Cost
  • Size
  • Weight
  • Noise
  • Oxygen production &
  • utput
  • Energy

consumption/power duration

  • Power supply

ENERGY CONSUMPTION NOISE O2 PRODUCTION SIZE & WT COST

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5 Liter Stationary Oxygen Concentrators-E1390

  • FDA Class II
  • Rx required to dispense
  • Electromechanical
  • AC Power only
  • Pressure-Swing

Adsorption (PSA)

  • < 40 lbs
  • <48 dBA
  • Flow 0 – 5 LPM
  • Most commonly used

stationary O2 delivery device

  • Same technology is used

all over the world

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High Flow Oxygen 10 Liter Concentrators-E1390

  • FDA Class II
  • Electromechanical
  • AC Power only
  • PSA technology
  • < 60 lbs
  • <60 dBA
  • Flow 1 – 10 LPM
  • Used for patients with

O2 Rx needs >5 LPM

  • Larger, heavier than 5

liter devices

  • Larger compressors

require more energy

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Oxygen Cylinders-Gaseous Portable-E0431

  • High pressure –

compressed gas cylinders

  • Steel
  • Aluminum alloy
  • Weight
  • Varies by size and

material

  • Filled to 2,000-2,200

psi

  • Must be filled in a

controlled, FDA regulated facility

  • Gas to gas or LOX to

gas transfill systems

  • Transport of gases

(compressed & liquid) is regulated by the DOT

  • Placarded vehicles
  • CDL drivers

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Modern Compressed Oxygen Cylinders

  • Standard sizes and O2

capacity at 2,000 psi

  • Multiple configurations

weighing <5 lbs.

  • Still the most commonly

used portable O2 system

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Home Trans-filling System (OGPE)-K0738

  • FDA Class II
  • Electromechanical

compressor systems designed to fill small, compressed gas cylinders from oxygen provided from an oxygen concentrator

  • Fill custom cylinders to

2,000 psi

  • Fill times vary by device &

cylinder size

  • O2 Users/Caregivers can refill

cylinders in their home

  • More freedom around

portable system use & availability

  • Promote & improve

ambulatory activities

  • Most often used with a

conserving device

  • The concept of delivering

the cow instead of the bottle of milk

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Home Liquefier Technology

  • None of these devices are commercially available today
  • Technologically challenging; very complex devices
  • Very expensive to produce and operate
  • Long fill times
  • Liquified gases equal to the concentrator gas
  • Liquifies O2 & Argon – purity same as the concentrator

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Lightweight Pulse-Dose Only POCs – E1392

  • FDA Class II
  • Rx required to dispense
  • Electromechanical
  • AC/DC power
  • Lithium ion battery
  • PSA technology
  • ≤5 lbs.
  • ~40 dBA
  • Pulse Dose O2 Delivery
  • O2 production from

600 ml to 1200 ml

  • Pulse dose settings
  • 1 to 3
  • 1 to 5
  • 1 to 6
  • O2 per breath
  • Varies by device

Design trade-offs define the device specifications

ENERGY CONSUMPTION NOISE O2 PRODUCTION SIZE & WT COST

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Continuous Flow POC-E1392

  • FDA Class II
  • Rx required to dispense
  • Sometimes referred to as

“transportable”

  • Electromechanical
  • AC/DC
  • Lithium ion battery
  • Pressure-Swing Adsorption (PSA)
  • < 25lbs
  • <45 dBA
  • Flow & Pulse Dose Delivery
  • Continuous Flow
  • 0 to 2 LPM
  • 0 to 3 LPM
  • Pulse Dose
  • 1 to 6
  • O2 per breath
  • Varies by device

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Oxygen Conserving Devices-E1399

  • FDA Class II
  • Rx required to dispense
  • Oxygen Conserving Devices

(OCD) are intended to increase the duration of use for fixed/limited volume

  • xygen systems
  • Compressed cylinders
  • Liquid portable units
  • Portable oxygen

concentrators

  • Technology
  • Mechanical / Pneumatic
  • Electromechanical
  • Reservoir system

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Pulse Dosing Technology Mechanics & Theory

Wasted Gas

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Transtracheal Oxygen Catheter-A4608

  • Transtracheal oxygen

therapy (TTOT) is a method and device designed to deliver O2 directly into the airway (trachea)

  • A plastic catheter is

surgically placed in the trachea)

  • TTOT is a form of
  • xygen conserving

device

  • It may reduce O2

flow need up to 55% at rest and 30% during exercise.

  • This varies by

patient and prescribed liter flow

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Matching the Device to the User

  • There is no single, “perfect” home oxygen system
  • Stationary device
  • Portable device
  • Pulse-dose use/device
  • The goal is to match the oxygen system best fit the user
  • Clinical need
  • Liter flow
  • Tolerance of pulse-dosing device
  • There is no evidence-based recommendation for ideal home oxygen "titration" or device selection

process

  • Lifestyle needs & desires
  • Highly active outside of the home, away from stationary
  • Work
  • Volunteer
  • Outpatient care
  • Travel
  • Barriers
  • Geographic-Remote locations, low population markets
  • Insurance payment
  • Oxygen is considered “modality neutral” so there is very limited payment difference for the various

devices

  • User tolerance of desired devices
  • Not all devices work effectively on all users

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Future Home O2 Technology

  • Continued focus on ambulatory oxygen
  • Limited R&D into new O2 production methods
  • PSA remains the most technical and cost effective & efficient method of remotely

producing medical oxygen

  • Other methods have not demonstrated practical and cost effectiveness &

efficiency of PSA

  • Fuel cell/electrochemical systems that produce Oxygen vs Hydrogen
  • Ceramic membrane technology
  • Other chemical or electrochemical reactions
  • Continued advances in the molecular sieve materials
  • New generation ceramic zeolite lithium sieve
  • Continued improvements in compressor technologies
  • Micro-compressors with high flow/pressure capabilities
  • Continued improvement in pulse-dose methods & systems
  • Growth in telemedicine applications
  • Remote monitoring – Smartphone Apps, Bluetooth, Wi-Fi, etc.
  • User feedback
  • Smarter devices – device performance / predictive analytics
  • Biometric feedback & closed loop algorithms

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SLIDE 43

Appendix & References

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Important Pulse-Dose References

  • American Thoracic Society (ATS) Standards for the diagnosis and care of patients with

chronic obstructive pulmonary disease. Am J Respir Crit Care Med 1995 152(5): S77- S121

  • Bower, J, Brook, C, Zimmer K, Davis, D. “Performance of a demand oxygen saver

system during rest, exercise and sleep in hypoxemic patients.” CHEST 1988 Vol. 94: 77-80

  • Braun SR, Spratt G, et al. Comparison of Six Oxygen Delivery Systems for COPD

Patients at Rest and during Exercise. Chest 1992; 102: 694-698

  • Case, R, Hausmann R. “Use of a portable oxygen concentrator with a fixed minute

volume oxygen conserving device to deliver oxygen to exercising pulmonary rehabilitation patients.” Abstract. Respir Care November 2005;50(11):1510.

  • Chatburn, R, Lewarski J, McCoy R. “Nocturnal oxygenation using a pulsed dose oxygen

conserving device compared to continuous flow oxygen.” Respir Care March 2006;51(3): 252-256

  • Cuvelier A, Muir J, Czernichow P, et al. “Nocturnal efficiency and tolerance of a

demand oxygen delivery System in COPD patients with nocturnal hypoxemia.” CHEST 1999 Vol. 116(1): 22-29.

  • Cuvelier, A, Nuir, J, Chakroun, N, et al. “Refillable oxygen cylinders may be an

alternative for ambulatory oxygen therapy in COPD.” CHEST 2002 Vol. 122 (2):451- 456

  • Fuhrman C, Chouaid C, Herigault R, Housset B, Adnot S. Comparison of four demand
  • xygen delivery systems at rest and during exercise for chronic obstructive

pulmonary disease. Respir Med 2004;98(10):938-944.

  • Gay, PC. “Chronic Obstructive Pulmonary Disease and Sleep.” Respir Care Jan

2004;49(1):39-51

  • Garrod R, Bestall JC, Paul E, Wedzicha JA. Evaluation of pulsed dosed oxygen delivery

during exercise in patients with severe COPD. Thorax March 1999;54(8): 750

  • Kerby, G, O’Donahue W, Romberger D, et al. “Clinical efficacy and cost benefit of

pulse flow oxygen in hospitalized patients.” CHEST 1990 Vol. 97: 369-372

  • Langenhof S, Ficther J. Comparison of Two Demand Delivery Devices for

Administration of Oxygen in COPD. Chest 2005; 128: 2082-2087

  • Lewarski JS, Messenger R, Williams TJ. More on novel oxygen concentrator based

equipment (editorial). Respir Care 2006;51(5):1-5.

  • Lewarski, J, Mikus, G, Andrews, G, Chatburn, R. “A clinical comparison of portable
  • xygen system: Continuous flow compressed gas vs. oxygen concentrator gas

delivered with an oxygen conserving device.” Abstract. Respir Care 2003 Vol. 48(11); 1115

  • Lewis, D. “Sleep in patients with asthma and chronic obstructive pulmonary

disease.” Curr Opin Pulm Med 2001;7:105-112

  • Palwai A, Skowronski M, Coreno A, et al. Critical Comparisons of the Clinical

Performance of Oxygen-Conserving Devices. Am J Respir Crit Care Med 2010;181: 1061-1071

  • Plywaczewski R, et al. Behavior of arterial blood gas saturation at night in patients

with obstructive ling diseases qualifying for home oxygen therapy. Pneumonol Alergol Pol 1997;65(7-8): 494-499

  • Plywaczewski R, et al. Incidence of nocturnal desaturation while breathing oxygen

in COPD patients undergoing long-term oxygen therapy. CHEST 2000; 117(3): 679- 83

  • Senn S, Wagner J, et al. Efficacy of a Pulsed Oxygen Delivery Device during

Exercise in Patients with Chronic Respiratory Disease. Chest 1989;96: 467-472

  • Sliwinski P, et al. The adequacy of oxygenation in COPD patients undergoing long-

term oxygen therapy assessed by pulse oximetry at home. Eur Respir J 1994;7(2): 274-278

  • Stegmaier JP. Chatburn RL, Lewarski JS. “Determination of an Appropriate

Nocturnal Setting for a Portable Oxygen Concentrator with Pulsed-Dosed Delivery.” Abstract. Respir Care November 2006;51(11): 1305

  • Stegmaier J, Lewarski J, Frate-Mikus G. Oxygen Conservation Devices Improve

Portability and Reduce the Cost of Care for Ambulatory Home Oxygen Therapy

  • Patients. Respir Care Oct 1999;44(10): 1223
  • Stegmaier, J. “Mobility, remote activity & power supply utilization among oxygen

dependent patients using a lightweight portable oxygen concentrator system.”

  • Abstract. Respir Care November 2005;50(11):1507
  • Strickland SL, Hogan MT, et al. A Randomized Multi-Arm Repeated Measures

Prospective Study of Several Modalities of Portable Oxygen Delivery During Assessment of Functional Exercise Capacity. Respir Care 2009;54(3): 344-349

  • Tarrega J, et al. Are daytime arterial blood gases a good reflection of nighttime

gas exchange in patients on long-term oxygen therapy? Respir Care 2002; 47(8): 882-6

  • Tiep BL, Barnett J, Schiffman G, Sanchez O, Carter R. Maintaining oxygenation via

demand oxygen delivery during rest and exercise. Respir Care 2002;47(8):887- 892.

  • Tiep, BL, Christopher KL, et al. Pulsed Nasal and Transtracheal Oxygen Delivery.

Chest 1990;97: 364-368

  • Tiep BL, Lewis MI. Oxygen conservation and oxygen-conserving devices in chronic

lung disease: a review. Chest 1987;92(2):263-272.

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Clinical Evidence- Nocturnal Use of PDOD

  • Cuvelier A, Muir J, Czernichow P, et al. “Nocturnal efficiency and

tolerance of a demand oxygen delivery System in COPD patients with nocturnal hypoxemia.” CHEST 1999

  • Kerby, G, O’Donahue W, Romberger D, et al. “Clinical efficacy and cost

benefit of pulse flow oxygen in hospitalized patients.” CHEST 1990

  • Bower, J, Brook, C, Zimmer K, Davis, D. “Performance of a demand
  • xygen saver system during rest, exercise and sleep in hypoxemic

patients.” CHEST 1988

  • Stegmaier J, Chatburn R, Lewarski J. “Determination of an appropriate

nocturnal setting for a portable oxygen concentrator with pulse-dosed delivery.” Respir Care 2006

  • Chatburn, R, Lewarski J, McCoy R. “Nocturnal oxygenation using a

pulsed dose oxygen conserving device compared to continuous flow

  • xygen.” Respir Care 2006

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SLIDE 46

Oxygen en T Ther erapy

  • In healthy persons, the 20.9% O2 in the atmosphere provide

more than enough O2 to keep normal levels of oxygen in the blood

  • When chronic diseases or conditions, such as COPD

(emphysema & chronic bronchitis), cystic fibrosis, and pulmonary hypertension progress, the lung performance can be degraded

  • This is measured through arterial blood tests that examine the

PaO2 or SpO2.

  • The lung tissue and the airways leading to the lungs become

damaged and ineffective. This results in inefficient transfers

  • f the oxygen from the lungs into the bloodstream and the
  • xygen level in the blood drops
  • This condition is referred to as hypoxemia
  • To correct this, we increase the amount of oxygen inspired to

then increase the % of oxygen in the lungs

  • This is referred to as oxygen therapy or oxygen delivery
  • The goal is to return the blood oxygen levels to the normal range

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Low Flow O2 Delivery 101

  • Low flow O2 systems were never intended to deliver

a specific and accurate FIO2

  • By design a low accuracy, high variability O2 delivery

method

  • Flow delivery of typically 1-6 L/min vs. inspiratory flow

demands of ≈ 35-40 L/min

  • Majority of inspired volume supplied from ambient gas

source (VT vs VO2)

  • Numerous patient variables affect FIO2
  • VT, VD, RR, I:E, inspiratory flowrate

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SLIDE 48

Constant Flow – Theory of Operation

  • Interaction between inspiratory flow and cannula

flow determines oxygen delivery

inspiratory time expiratory time

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SLIDE 49

Breathing Mechanics & O2 Delivery

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Inspired O2 Calculation

  • O2 purity changes via nasal cannula have very little impact on FIO2
  • Compare the effect that 85%, 93% and 99.6%source gas would have
  • n delivered FIO2 given a tidal volume of 500mL, a 1-second

inspiratory time and a flow of 2 L/min (33.3 ml/sec)

  • This is in great part why the FDA states oxygen ≥ 85% is medical

grade and clinically equal to 99.6% in low flow applications

99.6% Oxygen 0.21 (500 – 33.3) + (0.996 (33.3)) = 26.2% 500 85% Oxygen 0.21 (500 – 33.3) + (0.85 (33.3)) = 25.3% 500 93% Oxygen 0.21 (500 – 33.3) + (0.93 (33.3)) = 25.8% 500

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SLIDE 51

US COPD Coalition Meeting

Tangit ita D a Dar aramola, la, Competitive A e Acquisition Ombudsman

Department of Health and Human Services Centers for Medicare & Medicaid Services

Thursday, F February 27, 27, 2020 2020

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SLIDE 52

Discussion Topics

  • Role of the Competitive Acquisition Ombudsman (CAO)
  • Stakeholder engagement
  • Inquiries and complaints
  • Report to Congress

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SLIDE 53

Who do I call if I am having issues getting the service that I need?

Beneficiaries who have questions about claims and/or coverage of equipment can call:

  • 1-800-Medicare (800-633-4227)
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SLIDE 54

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Questions?

www.uscopdcoalition.org

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SLIDE 55

The US C COPD C Coalition t thanks o

  • ur panelists, a

and g grate tefully acknowledges t the g generous s support o

  • f the

Amer erican an R Respir iratory C Car are F e Fou

  • undatio

ion

https://www.arcfoundation.org/

www.uscopdcoalition.org

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