Hors-Sens


 

The FDA Needs To

Regulate POC Settings!

Portable Oxygen Concentrator(poc) settings are arbitrary numbers with no relationship to LPM(Liters Per Minute).  LPM are used on prescriptions for supplemental oxygen, and a prescription is required to buy a portable oxygen concentrator, so why does the FDA allow poc manufacturers to use meaningless setting numbers instead of LPM?  I am on supplemental oxygen 24-7 and need to know if my prescription is being filled just as I do with the rest of my prescriptions.

The chart below compare’s Inogen One and Eclipse 5 portable oxygen concentrators settings and continuous flow oxygen LPM.  The  Eclipse 5 is not really a poc, it is a luggable oxygen concentrator that can produce 3 LPM continuous flow and is why it is capable of delivering more oxygen per setting than continuous flow, up to 6 LPM and over 22 BPM.   

Continuous flow does not have a flow rate that is easily compared to a pulse mode flow rate.  We inhale about one third of the time so I am dividing the LPM by 3 to get the flow rate for continuous flow.

Inogen’s bolus sizes are considerable smaller than Eclipse 5’s and the difference grows as the BPM and the need for oxygen goes up.  Inogen’s flow rate and bolus sizes are 63% smaller than CF(continuous flow oxygen) and that is before taking into account pocs produce 87% to 95% pure oxygen while prefilled tanks and liquid oxygen are 99.5% pure oxygen.  

On the chart an Inogen 6 setting is about equal to 4 LPM continuous flow(CF).  The Inogen 5 setting is about equal to 3 LPM CF.  The Inogen 3 setting is about equal to 2 LPM CF.   The difference matters!  Three LPM while at rest will keep my blood oxygen level between 92% to 95%.  The Inogen 3 setting between 86% to 90%.

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The Following is taken from an Inogen webpage @ https://www.inogen.com/resources/what-to-know-about-oxygen-concentrator-liter-flow/

PORTABLE OXYGEN CONCENTRATOR LITER FLOWS

Generally speaking, portable oxygen concentrators typically offer liter flows from 1-6 LPM. Inogen Portable Oxygen Concentrators are able to offer these same portable oxygen concentrator liter flows, along with a variety of other features to improve your life on oxygen. Wondering “What is LPM availability with an Inogen One Portable Oxygen Concentrator?” Take a look.

Inogen One Model  :  Available LPM Flow Rates

Inogen One G3  :  Pulse Dose: 1-5 Settings

Inogen One G4  :  Pulse Dose: 1-3 Settings

Inogen One G5  :  Pulse Dose: 1-6 Settings

Your prescription will dictate how many flow settings you will need.

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Why does the FDA allow small poc manufacturers to make these blatantly false statements?  It adds  confusion , not only to those on supplemental oxygen, but also to their caregivers, nurses, physicians, respiratory therapists and I would be willing to bet some pulmonologists!

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From the Eclipse 5 Manual

Table

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I use an Eclipse 5 and know their settings are close to an equivalent of LPM.   When I get on a treadmill using the Eclipse 5 plugged into a wall socket on a 6 setting and raise the speed until my blood oxygen level drops to 89% and holds for 10 minutes then switch to 6 LPM liquid oxygen my blood oxygen level will rise to 90% - 91%.  If I switch back to the Eclipse 5 my blood oxygen level will drop back to 89%.  I have tested an Inogen One G3(with 4 settings) the same way and believe the 4 setting is about equal to 2.6 LPM continuous flow(CF). 

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Your lungs and exercise

If you have a long-term lung condition, the thought of becoming quickly out of breath can be daunting and you may not feel motivated to exercise. It can be tempting to avoid exercise because you think it will make you breathless, but with less activity you become less fit and daily activities will become harder.

From - https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4818249/pdf/EDU-ELF121.pdf

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I can shop with a 6 setting on the Eclipse 5 or 6 LPM continuous flow.  With a 6 setting on an Inogen One G5 I really struggle and am less active.

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Regular physical activity reduces hospital admission and mortality in chronic obstructive pulmonary disease: a population based cohort study

Conclusions

Subjects with COPD who perform some level of regular physical activity have a lower risk of both COPD admissions and mortality. The recommendation that COPD patients be encouraged to maintain or increase their levels of regular physical activity should be considered in future COPD guidelines, since it is likely to result in a relevant public health benefit.

From - https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2117100/

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An article on the American Thoracic Society website, “Portable Oxygen Concentrators (POCs) by Chris Garvey FNP, MSN, MPA, MAACVPR.”  It is a short read and offers good insights into pocs.

https://www.thoracic.org/patients/patient-resources/resources/portable-concentrators-garvey.pdf

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Portable oxygen concentrator manufacturers can easily change the setting numbers they use making a 3 setting the equivalent of 3 LPM on all new pocs.  They could have a chart on their website to show what LPM a 3 setting would be on a poc already sold would be.  Then anyone with a prescription could look at the new settings on a poc and know if it could fill their prescription.  Physicians, respiratory therapists, family members and all concerned could look at the prescription and know if a particular poc could fill it.

It will cost portable oxygen concentrator manufacturers, but mainly from lost sales because the poc won’t fill a prescription.  But it will save Medicare, insurance companies and people with a prescription from buying a poc that won’t fill the prescription.  Some are now using a poc, like I did, that doesn’t fill their prescription and it causes health issues and raises their medical costs, often paid by Medicare or other insurances.

Making poc setting equivalent to LPM will result in relevant public health benefits!

Ask medical professionals, your durable medical equipment supplier, or any one you are comfortable asking to contact their representatives in Congress and tell them about the need for the FDA to regulate pocs so settings are equivalent to LPM.  Having the FDA regulate poc settings will raise the quality of life for those on supplemental oxygen and save Medicare money!


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