Posted on March 12, 2023 |
The United States Food and Drug Administration (FDA) has issued a medical device correction for all Baxter International’s Life2000 Ventilation Systems. There is potential for the user’s oxygen saturation to fall to dangerous levels during use while the equipment is attached to an oxygen source. As mentioned in an earlier communication from the FDA, users can continue to use their machines, but they should perform careful daily inspections of the tubing and the equipment in use – both the Life2000 Ventilation System and the oxygen source. Routine cleaning procedures should be performed as described in the Life2000 user manuals.
A device correction is different from a recall because the device may still be used if the user takes the precautions listed on the FDA website. Baxter intends to communicate with the patients using this equipment, but for anyone with further questions, you may call Baxter’s Clinical Support Team at 800-397-9071.
For the full FDA statement and information on how to report adverse events related to this device correction, please visit the FDA website.
Posted on February 10, 2023 |
February 9, 2023 - The US Food and Drug Administration (FDA) issued a statement today related to the Philips Respironics recall of respiratory assist devices such as CPAP, BiPAP, and Trilogy machines. All device manufacturers are required to file medical device reports (MDRs) when they become aware that their devices have caused injury or death. To learn more about the MDRs filed by Philips Respironics, please visit the FDA website.
Patients and health care professionals can file voluntary reports for adverse reactions with the FDA through their respective links.
Posted on February 07, 2023 |
This article was written by Michael W. Hess, MPH, RRT, RPFT
In 2021, our Oxygen360 team noticed that online retailers were selling machines listed as “portable oxygen concentrators (POCs).” Many POCs are a good way for many people to stay mobile and active. However, they are not a good fit for everyone. They use a type of oxygen delivery called pulse dosing to conserve oxygen. This is different than the continuous flow from a regular concentrator. They are not able to provide high liter flow rates for people who need lots of oxygen during exercise or activity. Medicare and other insurance companies are not always willing to pay for them. That means they can be very expensive to get. Finally, they should always be prescribed by a licensed health care provider.
The machines available online were different. They only cost a few hundred dollars, a fraction of what the standard models cost. They claimed that they could provide five, six, even seven liters a minute of continuous flow, far more than any other on the market. Best of all, they could be ordered without a prescription, lowering the number of paperwork hoops someone had to jump through. Their advertising was slick and professional. People in white coats were seen alongside people wearing nasal cannulas. Those with cannulas were seen living their best lives thanks to the freedom these machines seemed to provide. It seemed almost too good to be true. Looking at the fine print, there were some disclaimers that the statements had not been evaluated by the Food and Drug Administration (much like one might see on the label of a nutritional supplement). Those disclaimers meant that the machines themselves had not gone through any kind of FDA testing for safety or effectiveness. Far from being medical devices like true POCs, these machines seemed to be no more than fancy air compressors. But these were buried far down in the descriptions, easy to overlook.
The COPD Foundation immediately took action against these “noncentrators,” writing a position statement against the sale of these machines. We also created a petition so the community could also ask these retailers to stop selling them. But we also knew that to make our case more strongly, we would need evidence. We started looking at ways we could prove that these machines were making false claims and that they could be putting people at risk.
Posted on January 23, 2023 |
This post was authored by Kristen Szymonik, BS, RRT, AE-C
When you are diagnosed with a new health condition, you are often left with many questions, thoughts, and feelings. Even if you ask questions when you are first diagnosed, you may end up with more questions days or even weeks later. We're here to help answer those questions for you.
Here at the COPD Foundation, we have many free educational materials designed specifically for those who are new to COPD. The best place to start is with the Basics of COPD and Understanding COPD booklets. In these booklets, you will find information about what COPD is, how it is diagnosed, what treatment options are available, how to live well and stay active, and much more. As you read through both booklets, make notes about topics that you would like to discuss with your health care provider at your next appointment.
Another helpful tool is the My COPD Action Plan. Print out a copy of the My COPD Action Plan and fill it out with your health care provider. Don't forget to post it in a place in your home where you will see it every day. Follow your My COPD Action Plan on good days and bad, and be sure to follow the Tips for Living Well with COPD found on the back side of the flyer. These easy tips can help you to stay well and avoid COPD flare-ups (exacerbations).
This post was written by Michael W. Hess, MPH, RRT, RPFT with guest authors Jean Rommes, PhD and David Reynolds, RRT, EMT.
Inside the hospital, oxygen therapy can seem pretty easy. There is an endless stream that comes out of the wall, or as many tanks as you need to move around. Outside the hospital, it gets more complicated. This is especially true when it comes to trying to figure out what portable oxygen system fits your needs best. To help cut through some of the confusion, we asked a couple of experts to share their thoughts on how to choose the best portable oxygen system for your lifestyle. Jean Rommes is an oxygen therapy user and longtime patient advocate. Dave Reynolds is a respiratory therapist and emergency medical technician with over 25 years of experience as a durable medical equipment (DME) supplier. Together, we hope to help answer some of the most common questions about oxygen therapy.
GETTING OXYGEN THERAPY
The first thing to figure out is if oxygen therapy can help you. Dave points out that to qualify, either your pulmonologist or primary care provider (PCP) must order a test that measures the oxygen level in your blood. This is sometimes done with a special lab test called an arterial blood gas sample, or ABG. Most commonly this is done by using a device called a pulse oximeter on your finger or ear. If your oxygen level is below a certain level (usually 88%), oxygen therapy might help. Jean points out that it is important that you do things like what you do in your daily routine when you are being tested. You will be tested while you are at rest, but your oxygen level should also be checked with low activity (as Jean describes it, “strolling through the mall”), harder exercise (“walking at a good steady clip”), and then your maximum level, like climbing stairs. You may need to change your oxygen settings depending on how hard you are working.
OXYGEN ON THE GO
Those settings may also affect the kind of portable oxygen system you need. The two main kinds of portable oxygen equipment are compressed gas cylinders (often called tanks) and portable oxygen concentrators (POCs). Both types have pros and cons. For example, many POCs use what is called “pulse dose” delivery. Instead of a constant flow of oxygen, a puff of oxygen is delivered as you start to inhale. That may not be enough for you, especially if you are exercising hard. Jean has used both but prefers using a tank while exercising for exactly that reason. “If the POC won't meet your O2 needs, then anything that will is better,” she says. Dave reminds us that POCs are also electronic devices that can fail unexpectedly. Oxygen tanks can be quite heavy, so you may need a backpack or a small cart to move them around. It is important to work with your care team and your oxygen equipment supplier to review the options. You may be able to do a “test drive” with different equipment to see what works best for your lifestyle.
Certain Trilogy ventilators that were repaired due to the earlier recalls are being recalled again due to two new potential problems. One issue is the reworked machines may have trace amounts of polyester-based polyurethane (PE-PUR) foam or other particles in the air delivery portions of the device. The other issue is that the sound abatement foam used to correct issues from the earlier recall, may come loose and block the air inlet. This blockage could cause a Low Inspiratory Pressure alarm.
If you have one of these restored devices, please visit the U.S. Food and Drug Administration (FDA) website for more information, and consult with your physician. If you are a health care professional who assists patients with these devices, you can report any problems with them here: https://www.accessdata.fda.gov/scripts/medwatch/index.cfm?action=reporting.home
Posted on November 15, 2022 |
This article was written by Michael W. Hess, MPH, RRT, RPFT
The Global Initiative for Chronic Obstructive Lung Disease (GOLD) is a strong voice in the COPD world. They create a yearly report with all the latest COPD research and treatment recommendations. Many members of the GOLD Science Committee are also part of the COPD Foundation’s Medical and Scientific Advisory Committee. Today, we will take a closer look at GOLD and the impact they have on everyone affected by COPD.
THE EARLY DAYS
Believe it or not, expert panels have been meeting to discuss COPD since the late 1950s. At the time, words like “emphysema,” “chronic bronchitis,” and even “asthma” were used by health care professionals (HCPs) with little consistency or even formal definitions. In 1959, a group of respiratory experts got together to create formal definitions for these problems and suggest future research directions.1
Unfortunately, not much came of the symposium, and the real burden of COPD was still not very well understood. Because of that, there was little urgency to try and lower that burden. Worse, medical science did not fully grasp all the changes inside the body that lead to COPD. Much of the technology we rely upon today for diagnosis, like spirometers, was not yet common. Some of the diagnostic tools, like CT scanners, had not even been invented yet.
The COPD epidemic continued to grow under the radar for the next four decades. By the late 1990s, COPD was still not top of mind for many in health care, but a new generation of lung health experts knew it was time to act. They encouraged the United States National Institutes of Health (NIH) and the World Health Organization (WHO) to work together and create a new global initiative dedicated to preventing and treating COPD.2 That initiative was GOLD.
Posted on November 10, 2022 |
This article was written by Jessica Burke
Everyone has something they are passionate about – whether it’s running, baking, gardening, music, fashion, or volunteer work to support a cause. These COPD Foundation community members have found some incredible ways to combine their unique interests with their passion for helping people with chronic lung diseases. Learn about these COPD Foundation advocates and their Do It Yourself (DIY) fundraisers, what they learned, and how you can host a meaningful and successful fundraising event – and have a blast doing it!
Russell Winwood, a COPD Foundation advocate, shared that a stroke followed by a stage 4 COPD diagnosis at the age of 45 led him to make a powerful choice: to take charge of his lung health and live his life as a COPD advocate.
“I decided I didn’t want to just go lay in a corner and let the disease take over my life,” Russell said. “I wanted to still enjoy a quality of life.” That’s when he began participating in Ironman competitions, then marathons. With only 30% lung capacity, Russell has since completed the New York marathon, the Boston marathon, the Gold Coast marathon, and the London marathon – all to encourage living well with COPD, and to honor the millions of people it impacts, while raising money for chronic lung disease research, education, and treatment.
In October 2022, Russell, who is widely known as “The COPD Athlete,” completed the Chicago marathon as a DIY fundraiser for the COPD Foundation. The marathon was a huge physical and logistical undertaking for him, but he emphasized it was worth the effort to support the Foundation, meet other COPD patients, and build awareness and community.
“The COPD Foundation has the biggest network of patients, so it’s a really big and positive community,” he said. “The best part of the event is that I get to meet people through the fundraising, and every race I’ve run I’ve gotten to connect with other patients on the course.” Russell shared that anyone who believes strongly in their cause and commits to relentlessly promoting their fundraiser can have a successful and meaningful event.
Posted on October 11, 2022 |
This post was written by: Amanda Atkinson, MSN, RN.
When you hear the word COPD, what do you think of first? There are several common beliefs surrounding COPD. Some are true but many are not. Today, we are going to uncover what is myth and what is fact.
Myth #1 COPD is only a smoker's disease
Fact: Some people think that if they never smoked, they are not at risk for COPD. While smoking of any kind and vaping are primary risk factors for developing COPD, approximately 25% of individuals diagnosed with COPD have never smoked.1 Did you know that many things can influence the development of COPD? These can include certain genetic mutations, childhood asthma, premature birth, secondhand smoke exposure, and environmental or occupational factors.2 Anyone can get COPD!
Myth #2 COPD cannot be passed down in families
Fact: Genetic forms of COPD, such as alpha-1 antitrypsin deficiency, can be passed down in families. Unfortunately, only about 10% of those with Genetic COPD are diagnosed. Screening ALL patients with COPD and their family members is vitally important to properly diagnose or rule out Genetic COPD.3
Myth #3 COPD only impacts older adults or those over 65
Fact: Symptoms of COPD can develop at virtually any age. This is especially true for genetic forms such as alpha-1 antitrypsin deficiency. Adults as young as 20 can experience early symptoms of COPD, 2,4,5 Early identification of risk factors and early diagnosis and treatment may help reduce or reverse lung damage.2,5
Posted on September 29, 2022 |
This article was written by Stephanie Williams, BS, RRT.
So often, people visit our website and find that the COPD Foundation is involved in more than just providing education or promoting research. We also have a program dedicated to connecting with elected officials and others who can help make a positive difference in the lives of those with COPD, called IMPACT. Recently, Linda Walsh, Chief Community Engagement Officer, took some time to answer a few questions about the advocacy work we do.
What is your favorite part about working with advocacy?
Many people initially shy away from the idea of advocacy. They think it's difficult, time-consuming, or feel their story might not be impactful. I've learned from many years of advocating that every minute spent supporting important causes matters. And every voice counts.
Our elected officials want to hear from us - the voters - and it's their job to represent our interests. Meeting (in-person or virtually) with Congress has given me the platform to keep COPD top of mind with those directly responsible for supporting change. It's empowering when speaking to representatives or their staff, as they ask questions and engage in our passion and urgency to advocate for people with COPD and other chronic lung diseases.
You can sense that many of them really care and often share their own stories or insight about how they are connected to COPD. This fosters relationship-building to affect real change.
Posted on August 29, 2022 |
This article was written by Jamie Sullivan, MPH, and COPD Advocate.
By now, you have likely heard about a new law called the Inflation Reduction Act (IRA). The IRA is a wide-ranging bill that touches on many policy areas outside of health care. This blog will cover a few aspects of the IRA that may help you afford your medications in the coming years.
Medicare Provisions in the IRA
Due to reconciliation rules, which is the strategy used to pass the IRA, only federal health insurance reforms are included, focused mainly on Medicare Part D plans. Here are a few fundamental changes you should know and the timeline for when the changes take effect.
1) Eliminates patient cost-sharing in the catastrophic phase of Medicare Part D coverage beginning in 2024:
Medicare considers you to be in the 'catastrophic phase' once annual drug spending reaches $7,050, including the amount you have paid and the amount your insurance company has paid. Once you enter this phase, you are responsible for 5 percent of the drug's cost for the remainder of the year. While this may seem like a small percentage of the total cost, it can still be a large sum of money every month, especially for those requiring multiple drugs and those using drugs without a generic option.
The IRA will eliminate the 5 percent out-of-pocket obligations starting in 2024. This change ensures that when you reach the $7,050 annual spend threshold, you will no longer have any out-of-pocket expenses for Medicare Part D drugs in that calendar year.
Posted on August 25, 2022 |
This article was written by Cathy Gray Carlomagno, BS
Articles recently published in Volume 9, Issue 3 of the Foundation's peer-reviewed medical journal, Chronic Obstructive Pulmonary Diseases: Journal of the COPD Foundation, have corresponding plain language summaries.
The summaries are short and written in simple, non-technical language with the goal of providing a helpful overview of the published original research, review, or perspective articles. These articles (and their short summaries) cover a variety of COPD-related research topics including predicting disease progression, links between lung cancer and COPD, exacerbations and quality of life and more.
Plain language summaries are available for each of the following articles:
Exacerbations and Quality of Life
In the article, "Short-Term Impact of the Frequency of COPD Exacerbations on Quality of Life" researchers present their study of individuals with moderate-severe COPD, recruited from two large clinical trials.
For the complete plain language summary, click here
Bacteria, Fungi, Viruses, and COPD
A microbiome is a community of microorganisms—bacteria, fungi, and viruses—that live or co-exist as a group in different parts of the body—such as the lungs or nasal passage. In the article, "Differences of the Nasal Microbiome and Mycobiome by Clinical Characteristics of COPD Patients" researchers discuss their study to determine the relationship between specific COPD clinical characteristics and the microbiome of the nasal passages.
For the complete plain language summary, click here