Nonprescribed oxygen supply can pose serious risk to users: PFF

Patients urged to use only FDA-approved devices to avoid serious health risks

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by Mary Chapman |

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The Pulmonary Fibrosis Foundation (PFF) is urging patients to use only federally approved oxygen delivery devices, as nonprescription supplemental oxygen may be unreliable and cause serious health problems.

In a position statement, the organization said that those living with pulmonary fibrosis (PF) and related disorders should stick to prescribed oxygen delivery services approved by the U.S. Food and Drug Administration (FDA), despite the online availability of unapproved portable oxygen concentrators. Some 250,000 U.S. residents are thought to have PF or other forms of interstitial lung disease, with more than 50,000 new cases diagnosed annually.

“The PFF recommends that patients should only use FDA approved oxygen delivery devices as prescribed by their doctor and should not purchase an oxygen supply device without a prescription. Non-FDA approved oxygen delivery systems may not reliably deliver oxygen,” the foundation wrote in its statement.

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“Prescribed by a health care provider such as a physician, oxygen delivery devices include stationary and portable oxygen concentrators, compressed gas tanks, and compressed liquid tanks. Portability is an important aspect of oxygen delivery for [patients], and many prefer to use portable oxygen concentrators (POC) when outside the home for this reason,” the organization wrote.

The statement acknowledges that existing POCs have relatively short battery lives, can be overly heavy for some patients, and are inadequate for patients who need high-flow oxygen — those requiring more than three liters per minute continuously.

Recent years, however, have seen a proliferation of unapproved devices sold by online medical supply sites and retailers, with no prescription required.

“Sellers claim these devices are lightweight, high flow, with long battery life, and priced far lower than FDA-approved POCs,” the statement continues.

Study tests portable oxygen concentrators sold online vs. FDA-approved devices

The organization cited a recent study, published in the peer-reviewed journal Respiratory Care, that found POCs did not reliably provide oxygen comparable to that supplied by an FDA-approved device or compressed oxygen tank. The foundation also noted the FDA has warned against the use of over-the-counter oxygen devices or any nonprescribed oxygen supply.

“Supplemental oxygen therapy is necessary and beneficial to many people living with PF,” Amy Hajari Case, MD, PFF’s senior medical advisor for education and awareness, said in a press release.

“Oxygen users often prefer portable oxygen concentrators … so they can remain active and mobile. Unfortunately, existing POCs have limitations such as short battery life and inadequate oxygen flow,” she said. “However, non-FDA approved portable oxygen concentrators available online are not the solution. Patients should always speak with their healthcare provider before any out-of-pocket purchase of a portable oxygen concentrator.”

The foundation has joined with 23 other patient, professional, and industry groups to promote legislative changes for supplemental oxygen supply and reimbursement and continues to advocate for improved access to oxygen.