Oxygen360
Oxygen360 is a new project aimed at modernizing every aspect of oxygen therapy services. Our focus will be promoting innovative new technology to improve the quality of life for everyone in the oxygen community. We will also work with equipment manufacturers, durable medical equipment (DME) suppliers/distributors, and payers to develop practical and sustainable solutions that work for everyone.
COPD Foundation Launching Oxygen360 at TechConnect Innovation Spotlight Summit
The COPD Foundation (COPDF) is establishing a core project responsible for facilitating innovation across the entire spectrum of oxygen therapy services. Innovation will focus on patient and caregiver needs while working with DME companies, manufacturers, engineering firms, and payer representatives to foster an environment of practicality and sustainability.
Mike Hess, MPH, RRT, Senior Director of Public Outreach and Education ay the Foundation, presented at TechConnect Innovation COVID Spotlight Summit on February 17, 2021
The Problem
For many years, supplemental oxygen has been a mainstay of therapy for not only COPD, but many other chronic respiratory conditions (like pulmonary fibrosis, interstitial lung disease, and others). In fact, supplemental oxygen is one of the relatively small number of treatments that has been clinically shown to prolong life in these conditions.1,2
However, anyone involved in the oxygen community knows that it is a land of confusion. Misunderstandings, inefficiencies, and unrealized potential are the orders of the day. People who need oxygen are often reluctant to use it as prescribed, because current devices can be bulky and cumbersome, and do not adapt to changes in breathing. Interfaces (like nasal cannulas) can be unpleasant to use and lead to painful experiences like skin breakdown. Distribution and delivery of equipment and consumables calls for an expensive, complex infrastructure, and during the COVID-19 pandemic that infrastructure has been shown to be susceptible to critical failures. Supply shortages and waiting lists have prevented people in many regions from getting the therapy they need and deserve.
The situation is not much better in the clinical and administrative areas. Confusion is also present in diagnostic and prescribing practices, leading to therapy plans that just do not work as well as they could. Complicated billing and reimbursement policies have made it difficult for DME companies to survive, let alone provide high-quality service and support to their communities. All these barriers combine to once again prevent people from accessing the right therapies for their needs.
COPD Foundation Position on Non-Clinical Retail Oxygen Concentratorsplus
Background
Supplemental oxygen therapy is a mainstay of therapy for COPD and other chronic lung conditions. As with all medical devices, oxygen concentrators intended for clinical use in the outpatient setting must undergo a rigorous approval process to demonstrate both safety and efficacy before sales and distribution are permitted. This assures that those who need supplemental oxygen therapy can be confident that their needs will be met by their equipment.
Over-The-Counter Oxygen Concentrators
Recently, a number of lower-cost devices being marketed as oxygen concentrators (as well as 'oxygen generators') have appeared on retail websites such as Amazon.com and eBay.com and Facebook. These devices are appealing to many, as they are readily accessible without a prescription and at a fraction of the retail cost of approved devices. They are also often marketed with stock images of people using standard oxygen cannulas, as well as stock images of people wearing clinical attire, implying these items are the equivalent to approved medical devices. Comments and (potentially seller-generated) reviews in the retail listings often indicate these units are safe and effective for patients requiring up to 7 liters per minute of flow, leading many to believe these units are appropriate for their needs. However, the technical specifications (which are often obfuscated or difficult to find), reveal that the purity of the oxygen delivered is as low as 30%, an unsafe level far below regulatory standards.
COPD Foundation Position
At this time the FDA has not approved the purchase of oxygen concentrators without a prescription. The COPD Foundation does not recommend the purchase or use oxygen concentrators that are not approved for use as Medical Devices for the treatment of COPD or other chronic lung condition. We advocate for these unregulated devices to be removed from the marketplace due to the high levels of risks they pose. The COPD Foundation encourages all individuals to discuss oxygen therapy with their personal clinical team and adhere to their prescribed regimen.
Getting and using oxygen can be a challenging process and we want to help make it easier for you! Join the COPD Foundation’s Mike Hess and co-host John Linnell for this informative conversation on the basics of oxygen use, as well as an introduction to our new Oxygen360 project.
Our Strategy
Our position is that the lack of progress and improvement in oxygen therapy has been influenced by two main factors: lack of input from people who use oxygen and their caregivers, and not enough communication between those groups who do have input. We will bridge those gaps first by gathering input from the community through our existing resources (like COPD360social and the US State Advocacy Captain Network), as well as new tools like surveys and focus groups. Some of the issues that our team has already identified include:
- A lack of lightweight liquid oxygen options, particularly important for those who need high oxygen flow rates.
- Inefficient, cumbersome batteries for portable concentrators
- A lack of responsive ("smart") oxygen devices (for example, devices that adjust oxygen flow based on measurements like blood oxygen saturation or pulse rate)
- Better patient interfaces with modern, skin-friendly materials
*word-cloud from COPD360social | click to view larger inmage
At the same time, we will use similar tools to get input from DME suppliers, manufacturers, and clinicians to understand the challenges they face in delivering high quality oxygen solutions, and we will consult with payers (including the Centers for Medicare and Medicaid Services) and our Medical and Scientific Advisory Committee (MASAC) to develop new and better administrative and payment practices, as well as promote research to help improve clinical practice.
Our Goals
Of course, asking questions is not enough. After completing all this information-gathering, Oxygen360 will create and distribute a series of position papers aimed at setting priorities for what can be fixed quickly and help build momentum, what will take a little more effort, and what will take a long-term investment. These will include:
- A "Target Product Profile" describing ideal features of an oxygen delivery system (or systems), based on feedback from the patient/caregiver community.
- Clinical education solutions to give health care professionals the tools they need to appropriately prescribe and monitor oxygen therapy.
- Partnership frameworks that lead to impactful innovation in oxygen delivery and access well into the future
Ultimately, we aim to create solutions that work for all stakeholders in the oxygen community, and to do so in a way that is practical, sustainable, and equitable.
Our Team
Want to get involved?
Contact Mike Hess, Senior Director of Public Outreach and Education – mhess@copdfoundation.org
Want to support Oxygen360? Donate here!
- Kvale PA, Conway WA, Coates EO. Continuous or nocturnal oxygen therapy in hypoxemicchronic obstructive lung disease. A clinical trial. Ann Intern Med. 1980;93(3):391-398. https://doi.org/10.7326/0003-4819-93-3-391
- Leggett RJ, Cooke NJ, Clancy L, Leitch AG, Kirby BJ, Flenley DC. Long-term domiciliary oxygen therapy in cor pulmonale complicating chronic bronchitis and emphysema. Thorax. 1976;31(4):414-418. https://doi.org/10.1136/thx.31.4.414