Oxygen360

Oxygen360 Logo

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

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.


Oxygen360: Oxygen Basics

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

Word Cloud from COPD360social | Oxygen

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:

  1. A "Target Product Profile" describing ideal features of an oxygen delivery system (or systems), based on feedback from the patient/caregiver community.
  2. Clinical education solutions to give health care professionals the tools they need to appropriately prescribe and monitor oxygen therapy.
  3. 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

Michael W. Hess MPH, RRT, RPFT


Michael W. Hess is the Senior Director of Public Outreach and Education and leads the Oxygen360 project for the Foundation. The goal of the project is to facilitate oxygen equipment innovation and research, promote policy improvements surrounding oxygen reimbursement, and enhance clinician education on the appropriate use of this critical therapy. The Foundation aims to redesign the oxygen infrastructure into a robust, resilient system that works for all stakeholders, from manufacturers to equipment distributors to the patients at the heart of our mission.

Prior to joining the Foundation, Mike served in a unique position at WMed Health in Kalamazoo, Michigan. As Chronic Lung Disease Coordinator, he provided patient education, diagnostic testing, care coordination, and other respiratory care services as part of a primary care clinic while also designing and implementing community outreach programs to enhance respiratory health.

Mike is a registered respiratory therapist and has a Master of Public Health degree from Western Michigan University. In 2019 he received the Ambulatory and Post-Acute Care Specialty Practitioner of the Year from the American Association for Respiratory Care.


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Ruth Tal-Singer, PhD


Ruth Tal-Singer, PhD, President & Chief Scientific Officer at the COPD Foundation (consultant) is internationally recognized as an innovative, patient-focused and highly analytical health care leader and clinical scientist with extensive Research and Development experience. She has a proven history of successfully leading international public and private partnerships and non-profit organizations through critical advancements and progress of clinical trials and large observational cohorts. She is adept at building and maintaining partnerships between Pharma, patients, academia and governments. Her wide-ranging technical and scientific knowledge comprises molecular biology, immunology, application of digital technology and in vivo disease models (pre-clinical and clinical). Ruth led the initial clinical development of GSK’s inhaled anti-muscarinic portfolio, currently available to patients as umeclidinium bromide. She has authored 160+ peer-reviewed articles including highly-cited scientific publications (h-index 58). Ruth was the Industry Co-Chair of the COPD Biomarker Qualification Consortium (CBQC) from its inception in 2010 and up to her retirement from GSK in October 2019.

As President & Chief Scientific Officer at the COPD Foundation, Ruth is focused on working with the leadership team, our many partners and the Board on aligning the COPD Foundation strategy with its mission of Research, Community Support, Education and Advocacy.


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John Linnell, BA


John is a COPD patient diagnosed in 2005. His career was in retail as a district manager and troubleshooter and then as a marketing director. He left the workforce in 2011. After engaging in an educational COPD internet film project and being asked to share his story at a pharmaceutical conference, John decided his experiences and efforts would be best spent in advocacy work for the COPD community.

He now sits on the board of directors of multiple organizations, including the US COPD Coalition, EFFORTS (an international support group for the COPD community) and Right2Breathe (a unique advocacy group that promotes lung health education and screening events at automotive and sporting events). For the COPD Foundation, John serves as an advocacy captain for the state of Wisconsin and on the governing board for the Patient-Powered Research Network. In addition, he is a patient reviewer for the Department of Defense’s Peer Review Medical Research Programs, and is a member of the American Lung Association Patient Advocacy Group.

His involvement in social media and interacting with other patients and caregivers led to a position of Research Associate with the Breathe Chicago Center at University of Illinois/Chicago. John is also a Co-investigator for a Patient-Centered Outcomes Research Institute-funded study at Johns Hopkins: Impact of a Peer Support Program Amongst COPD Patients and Their Caregivers.


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Ana Maria Garcia, BS, MBA

Ana Maria (Annie) is a charismatic leader who at every opportunity attempts to add value and enhance the lives of others. She is an experienced senior executive with notable positions in both the United States and Europe with industry leaders including AT&T, Bank of America, Verizon, American Express, VISA International, and Johnson & Johnson.

One of her most treasured legacies is having built an award-winning Call Center for Customers with Disabilities, with both 911 service for the Northeastern United States, as well as a Relay Call Service (711) for New England. Relay is administered by the Federal Communication Commission for individuals who are deaf, hard of hearing, deaf/blind, or speech disabled.

Annie has been a valuable and successful corporate union contract negotiator with the unions of Communications Workers of America & International Brotherhood of Electrical Workers, negotiating for thousands of representatives. Upon her retirement from the corporate world due to alpha-1 antitrypsin deficiency and COPD diagnoses in 2002, she experimented with proprietorship of a nationally well-known franchise, Edible Arrangements.

Annie holds a BS degree in Business Administration from Florida International University and an MBA from Nova Southeastern University. She is fluent in English, Spanish, and French.


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Louise-Hobden

Louise retired as a legal secretary in 2009. She was awarded Outstanding Young Woman of America as well as volunteer of the year for Breathe New Hampshire in 2018 and elected to their Board of Directors in 2020. Louise also volunteers on the editing committee for the Center for Information and Study on Clinical Research Participation (CISCRP).

As a State Captain in New Hampshire for the COPD Foundation, and as someone passionate about patient self-advocacy through education, Louise uses this platform to educate herself so that she may help educate others.

Louise was diagnosed at the age of 55; however the full impact of her COPD began at age 61. While the last ten years have been very challenging, she is so proud of her family; her husband is a wonderful caregiver and has been her rock, and all four of her children are involved in their communities as volunteers. She has nine grandchildren ranging in age from 2 to 24 years, describing them as each a joy in his or her own way. Louise and her husband love to travel when they can, and love to play competitive trivia, which she says is very fun especially when you win!


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Bill Clark

Bill Clark is the Foundation’s Vice President of Patient Experience. Recruited by Foundation founder John W. Walsh and with the Foundation since its inception, Bill serves as Community Manager of COPD360social, a social network for patients, caregivers, and professionals. Bill leads Foundation staff in monitoring members’ posts, answering questions, finding resources, and bringing in medical experts, as necessary, to ensure that members of the network have the most accurate and current information available. As a COPD patient himself, Bill is uniquely qualified to ensure that COPD360social members feel supported, comforted, and heard by the larger COPD community. He was instrumental in COPD360social recently reaching an impressive milestone of having 50,000 registered members.

Bill also contributes to many of the Foundation’s educational publications, has been extensively interviewed by national media outlets, and is involved in numerous research initiatives.

Prior to joining the Foundation in 2004, Bill was a retired special education teacher in Ohio for 28 years. Bill has a Bachelor of Science in education degree from Western Illinois University.


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Want to get involved?

Contact Mike Hess, Senior Director of Public Outreach and Education – mhess@copdfoundation.org

Want to support Oxygen360? Donate here!


  1. 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
  2. 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