In accordance with the US Food & Drug Administration (FDA), oxygen concentrators are considered a Class II Medical Device. This means that you must have a valid prescription from a board-certified doctor in order to purchase one.
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The FDA seeks to ensure that oxygen supplies, including oxygen concentrators, are being properly distributed to patients with genuine medical need. Patients who receive prescriptions include those with asthma, pneumonia, respiratory distress syndrome or chronic obstructive pulmonary disease (COPD).
Talk to your doctor if you think you may need a prescription for an oxygen concentrator. If necessary, your doctor will perform tests to evaluate your blood oxygen levels. Your doctor may even test to see if blood oxygen levels change during exercise or sleep.
One of the most common tests is called an ABG test, or arterial blood gas. This requires the physician to draw blood and test blood gases.
With the results of these tests, your doctor will write a prescription defining your oxygen level needs. These needs include the dosage of oxygen, often written in liters per minute (LPM). Some physicians will include the type of concentrator they feel is best a portable oxygen concentrator or a home/stationary unit. They will also indicate how often you require oxygen therapy (daily, during exercise, while sleeping, etc.).
Along with your primary care physician, a pulmonologist may also write a prescription for oxygen therapy.
Your prescription will make it easier to select the best oxygen concentrator for your needs. Here is an explanation of the guidelines provided in your prescription.
There are two types of oxygen delivery when it comes to oxygen concentrators: continuous flow and pulse dose. Continuous flow means that you require a constant, steady supply of oxygen and will most likely need a home/stationary oxygen concentrator. If your prescription calls for pulse dose oxygen, your needs are likely less severe. Pulse dose oxygen is delivered in short bursts, triggered by a patients inhalation. Portable oxygen concentrators are best suited for pulse dose oxygen needs.
Your prescription will also define specific oxygen level needs. If you are prescribed a continuous flow oxygen concentrator, your prescription will assign how much oxygen per minute you will need. Be sure the machine you select has the capacity your prescription requires.
The same applies for a pulse flow oxygen concentrator. Look for a machine that has the capacity of the pulse setting prescribed. It is important to note that a prescription of 2 LPM is not the same as a prescription for a pulse setting of 2. Consult with your doctor to determine what pulse setting best matches your continuous flow setting. Do not change settings without first talking to your doctor.
The Oxygen Concentrator Supplies Shop has a wide variety of both home and portable oxygen concentrators to choose from. Simply upload your prescription online or it to one of our customer care representatives. For additional questions or assistance selecting the best oxygen concentrator to match your prescription, give us a call at 888-941- or us at .
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By Isabella Hornick
Fact checked by Kristen Dowd
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For patients who need ambulatory oxygen, over-the-counter portable oxygen concentrators sold online that do not require a prescription may not be helpful, according to study results published in Respiratory Care.
My colleagues at the COPD Foundation and I were concerned that patients with COPD who require ambulatory oxygen might purchase OTC (not requiring a prescription) oxygen concentrators, believing that these devices would be appropriate for their use, Richard Casaburi, PhD, MD, associate chief for research in the division of respiratory and critical care physiology and medicine at Harbor-UCLA Medical Center and professor of medicine at David Geffen School of Medicine at UCLA, told Healio. However, only one of three of the OTC portable concentrators we tested was potentially of use by patients requiring ambulatory oxygen.
In this study, Casaburi and colleagues evaluated three OTC portable oxygen concentrators not cleared by the FDA to see if they might be appropriate for patients with hypoxemia.
By using a metabolic simulator that mimics metabolic rates and minute ventilations that might be seen in patients with COPD, researchers assessed oxygen supplementation on alveolar oxygen partial pressure from these devices compared with one FDA-cleared portable oxygen concentrator and a compressed oxygen tank.
Each of the three devices had varying oxygen flow settings. For example, OTC1 had continuous flow from 1 L to 7 L per minute in 1 L per minute increments, whereas OTC2 had single flow of3 L per minute and OTC3 had pulse-dose flow settings that ranged from 1 to 5.
In comparison, the FDA-cleared device had continuous flow at 1 L or 2 L per minute and pulse-dose flow settings that ranged from 1 to 6. Meanwhile the compressed oxygen tank had continuous flow at 1 L to 5 L per minute.
Researchers simulated three different metabolic rates to stimulate progressively higher exertion levels for each device with their specific settings. To mimic minimal exertion, the rate was 350 mL per minute; for moderate exercise, the rate was 850 mL per minute; and for heavy exercise, the rate was 1,200 mL per minute.
During these simulations, researchers evaluated end-tidal partial pressure of oxygen (PETO2) for each device to assess them against one another and clarify usefulness.
Through observation of each device, raising the metabolic rate generally meant decreasing PETO2, according to researchers.
Results from the simulation showed that when flow from the compressed oxygen gas tank went up, so did PETO2. Researchers found comparable increases in PETO2 to those observed in the compressed oxygen tank with the FDA cleared device using continuous flow at device settings of 1 L and 2 L per minute, but they noted somewhat smaller elevations when using the pulsatile-flow settings.
In terms of the OTC devices, researchers observed that only one (OTC3) may be suitable for patients since it demonstrated meaningful and steady rises in PETO2 as flow setting increased. Importantly, these elevations did not reach the same level as the FDA-cleared device at a given flow setting.
There was a modest increase in PETO2 with the OTC1 device, but this did not increase further when researchers raised the flow setting. Additionally, researchers found only very small rises in PETO2 with the OTC2 device.
Physicians and respiratory care professionals should inform patients requiring portable oxygen that OTC devices may not meet their oxygenation requirements, Casaburi told Healio.
This study by Casaburi and colleagues speaks to the growing issue of non-prescribed portable oxygen concentrators being sold online and encourages patients to be cautious when making a purchase, according to an accompanying editorial by Richard D. Branson, MSc, RRT, FAARC, professor in the department of surgery at the University of Cincinnati College of Medicine.
How common are OTC portable oxygen concentrators? A quick search on Amazon.com yielded 823 results for the search term oxygen concentrator, Branson wrote. Many of the results included accessories including cannulas, backpacks, humidifiers, etc, but dozens of portable oxygen concentrators. The price of devices ranged from $200 [to] $700. Of note, a number of devices used model numbers identical to model numbers used by manufacturers of FDA-cleared devices. These are clearly deceptive advertising practices.
For patients with lung disease requiring long-term oxygen therapy, caveat emptor let the buyer beware, he added. Warning patients, however, is insufficient. We should attempt to prevent the sale of these devices to vulnerable patients.
Richard Casaburi, PhD, MD, can be reached at .
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