There are countless lessons learned since the pandemic began in early 2020. One of those learnings include the importance of medical devices — to both healthcare systems as well as public health in general.
Not only did shortages of personal protective equipment (PPE) cause a frenzy, but so did other essential devices such as ventilators, testing supplies, and tools necessary to conduct vaccines.
The coronavirus pandemic showed tremendous vulnerability in our supply chain, both nationally and abroad. It also exposed just how much the United States relies on devices and raw materials imported from other countries, including China.
Any hospital would agree that sterile processing departments are the artery of their facility. Without a fully functioning, efficient operation in place, the business could not effectively perform their duties, and subsequently would not generate revenue.
Because sterile processing is integral to practically every facet of healthcare delivery, when a machine malfunctions or needs some level of maintenance, it slows down the bottom line — treating patients.
At the end of 2020, Auxo Medical was procured by a regional healthcare system with 11 hospitals in the United States to replace their OEM service support. Auxo became the sole provider for preventative maintenance (PM) as well as repair support.
This healthcare system’s units had been disorganized prior to Auxo Medical’s involvement; servicing the units had been a headache and caused a cascade effect of problems whenever maintenance was necessary.
A research letter, published in the Journal of the American Medical Association (JAMA), reports that Americans are heavily relying on melatonin supplements to help them sleep.
What is Melatonin?
Our bodies naturally produce a hormone, melatonin. It is made by the pineal gland in our brains, but is also found in other areas including our eyes and gastrointestinal tract.
It is commonly referred to as the sleep hormone since it’s associated with helping people fall asleep faster. Yet, it’s important to understand that the hormone is not going to nudge you into a coma-like state. Melatonin’s role is to simply prompt your body that it’s time to unwind and fall asleep by governing your circadian rhythm.
As of February 3, 2022, accessories for non-FDA approved automated external defibrillators (AEDs) and professional defibrillators, “must no longer be supported by manufacturers,” according to the U.S. Food and Drug Administration (FDA).
The FDA informed the manufacturers, distributors, owners, users and prescribers of all AEDs and defibrillators about this update.
For a unit to be considered non-FDA approved, that means the manufacturer failed to file for a premarket approval application (PMA) prior to the modified deadline of February 3, 2022. The revised compliance policy deadline was intended to give facilities additional time, especially during the coronavirus pandemic, to acquire FDA-approved AEDs, and for manufacturers to file the necessary PMA for accessories.
In the United States, more than 95% of all confirmed COVID-19 cases are believed to be the variant known as Omicron.
According to the CDC, the accelerated rate of growth in Omicron infections is considered to be a result of multiple factors — the variant’s elevated transmissibility as well as its power to evade immunity by way of a previous infection or vaccination.
So where do all of these insights and data come from? They’re the result of invaluable efforts taking place ‘behind the scenes’ through the process of tracking information on the virus.
Collecting & Analyzing Information
Gathering data to track COVID-19 cases is a fluid, collaborative process that has evolved over the course of this global coronavirus pandemic.
One example of tracking efforts underway is between Walgreens and their lab-testing partner, Aegis Sciences. The company has developed a novel tracking tool that pin-points, in real time, the extent of existing and emerging variants. This 95% statistic of the Omicron variant mentioned above is based on data procured and monitored from the national retain chain and pharmacy, by way of positive test results among their thousands of locations.
Starting on January 1, 2022, a new law came into effect that should be a breath of fresh air for insured families all over the United States — no more surprise medical bills. This law applies to patients receiving medical care in emergency rooms as well as other health services such as nonelective emergency cases and air ambulances.
With bipartisan support, the No Surprises Act was passed by Congress last December. The law puts into motion, with federal protection, no surprise medical bills for consum-ers.
What constitutes a “surprise” medical bill?
For starters, it’s important to understand what type of medical bills are protected by this new law, how patients’ wallets are shielded, and if there are any financial implications when it comes to medical care costs and premiums.
Healthline Media interviewed policy experts to help answer these questions.
Research professor emeritus in the Health Policy Institute of Georgetown University’s School of Public Policy, Jack Hoadley, PhD, explained, “This is important because there are numerous situations that can be surprising but don’t fall into this official bucket of surprise medical bills.” Hoadley continued, “When we talk about surprise medical bills for the purposes of the No Surprises Act, it means situations where you end up using an out-of-network healthcare facility or healthcare provider, generally, through no fault of your own.”
For example, some circumstances include not realizing that your insurance coverage requires a high deductible to be met, or not knowing that particular surgeries and proce-dures are quite expensive. A recurrent situation in this type of dynamic often takes place in crisis scenarios — such as being transported to a hospital by ambulance that isn’t in your insurance plan’s network; you later receive a surprise medical bill even though you had no involvement in choosing an out of network hospital.
Another example would be if you do go to a hospital that is within your insurance plan’s network (for an emergency or elective procedure), but you are treated by a physician who isn’t considered in-network by your plan.
Hoadley clarified, “So even if you’ve done your due diligence and pick an in-network fa-cility and picked an in-network surgeon to do your procedure or an in-network obstetri-cian to deliver your baby, while you’re there, you can also be treated by an out-of-net-work anesthesiologist, or radiologist, or a cardiologist. And again, it’s not something you were told about or could control.”
The outcome of these situations can oftentimes end with an unexpected bill showing up in the mail, informing the patient there is a balance due; this is the difference owed be-tween what the insurance company covered vs. the total amount charged for the ser-vices. According to research, approximately 20% of inpatient visits to the ER can result in a surprise medical bill, ranging anywhere from $750 all the way to $2,600 depending on what healthcare services were provided.
How does this bill protect you?
Patients with private insurance are protected by the No Surprises Act by not paying more than their in-network rate, even when they’re treated at out-of-network medical in-stitutions or cared for by out-of-network medical professionals, without their signed con-sent.
As of this moment, the law does not include ambulances on the ground, however there is an advisory committee in place to formulate recommendations and help streamline the system. Their advisement covers a range of items such as full disclosure of medical service charges, to enforcement systems.
Patients have the right to receive elective procedures by medical workers outside of their insurance plan’s network, however the No Surprises Act mandates that they have to be informed beforehand and give consent.
What should you do if you receive a surprise medical bill?
Ideally, after January 1, the surprise medical bills should come to a halt, but certainly the system isn’t foolproof from day one. If you still get an unexpected payment request in the mail, there are recommendations in place on how to handle it.
Step one is to contact your health insurance company.
Hoadley said, “When you receive your explanation of benefits, it will tell you how much you’re liable to pay and how much the policy is paying, and then you can compare that with the bill you got from the medical facility, and see whether you’re getting billed for more than you should be.”
Next, utilize resources that are available for people who have questions about whether or not their medical bill constitutes as a surprise under this new law. The toll-free phone number to call is 1-800-985-3059, and the website is https://www.cms.gov/nosurprises.
As always, stay tuned for the latest in healthcare news by visiting our Auxo Medical blog.
Anticipation is high within the healthcare industry for upcoming pioneering innovations based on what transpired in 2021. Here are our top six predictions for 2022 when it comes to technologies and trends within the medical space.
Trailblazing Drug Development
Developing several effective COVID-19 vaccines in under a year may go down as one of the most notable scientific achievements in the history of mankind. The groundbreaking rollout was expedited by governing regulatory experts, as well as innovative vaccine trials. Hosting virtual clinical studies enabled the participation not to be compromised. The FDA announced new guidelines for virtual trials, which opens up the doors for the creation and exploration of new drugs down the road.
Additionally, it must be noted that pharmaceutical competitors came together in a collaborative effort, which further helped speed along the novel vaccine and drug developments. For example, pharma giants Gilead, Novartis, and WuXi AppTec have formed an alliance to explore antiviral therapies.
Telehealth 2.0
Throughout the pandemic, telehealth was the shining star. Prior to the coronavirus outbreak in 2020, approximately 24 percent of healthcare organizations had telehealth services available. After only one year, more than one billion telehealth appointments were conducted. By 2021, nearly all healthcare institutions had telehealth programs at the top of their priority lists.
Thanks to telehealth, accessibility to health care providers and mental health support has grown and will continue to grow exponentially.
Digital Assistances
Digital staples in countless households across the globe, including Alexa and Google Home, have fundamentally shifted the manner in which people live their lives. Digital assistances, so to speak, have also played a contributing role within healthcare.
Data capturing has been embedded within the medical arena for years. So, it only makes sense that natural language systems and ambient listening have found their place as it relates to capturing and processing healthcare data.
The two most prominent electronic health care records (EHR), Epic and Cerner, started to use voice-enabled virtual assistants as part of their software in 2020. We expect this technology to advance with further refinement over time.
Nanomedicine
Nanotechnology is the branch of technology that deals with dimensions and tolerances of less than 100 nanometers. Nanomedicine utilizes nanotechnology in order to work on incremental scales such as atomic, molecular, and supramolecular. In 2021, researchers navigated innovative techniques in order to reach individual cells using nanomedicine. One clever example is a biopharmaceutical company leveraging nanotechnology which can combat bacteria and viruses.
Intelligent Pacemakers
A significant advancement within the medical field is the Bluetooth-enabled pacemaker. This technology provides patients the ability to connect their pacemaker to their mobile device, which in-turn advances monitoring the health of their heart.
A pacemaker’s purpose is to transport electrical pulses throughout chambers of the patient’s heart in order to avoid heart arrhythmias. Historically, the monitoring system is too complicated for a lay person to comprehend. Now, with the ability to connect mobile devices, it gives medical providers the ability to safely track their patients’ health status from afar.
Smarter Wearables
Fitness trackers became popular years ago, and their attraction to consumers has not slowed down. In 2019, the popular fitness tracking device FitBit, shipped nearly 10 mil-lion products.
Next up in 2022 — wearables within the medical technology space will become even more specified. For example, wearable continuous glucose monitors (CGMs) are set to become the new normal for people with diabetes. These wearable monitors offer real-time blood sugar level readings, vs. the need to periodically take glucose tests. Besides the convenience factor, it also provides instant insights from food consumption and fitness activity.
We wish everyone a healthy and prosperous New Year from Auxo Medical. In 2022, you can continue to count on us for delivering relevant, timely and valuable content as it pertains to healthcare.
If you plan on traveling during the 2021 holiday season, there are several COVID-19 considerations you should take into account.
Adopting Healthy Habits
The Centers for Disease Control (CDC) published a list of healthy habits to adopt during the holiday season.
1. Wash your hands regularly to aid in preventing the spread of germs; it is flu season after all. Briskly wash your hands with soap and warm water for a minimum of 20 seconds.
2. When going outdoors, layer your clothes to ensure you stay warm and dry. Don’t forget your gloves, a hat, scarves.
3. Stress is linked to taking a toll on our immune systems. If you’re feeling overwhelmed, take a time-out. That could look like a walk outside to get some fresh air and clear your head. It also includes getting restful sleep, as well as having outlets for releasing the stress such as catching up with a friend over the phone, or practicing meditation.
4. If you’ve been putting them off — now is the time to call your providers’ offices and book routine exams and screenings.
5. Make sure you are current on all relevant vaccinations. Vaccines save lives.
6. The holidays are often spent around the dining room table enjoying home cooked meals. Remember to regularly wash your hands and disinfect surfaces to avoid cross contamination.
7. It’s perfectly normal to indulge a bit more during this time of year, but don’t aban-don clean eating entirely — consuming daily servings of fruits and vegetables will help lower your risk for certain diseases.
Vaccine Mandates
Healthline interviewed pulmonary and critical care physician at the Cleveland Clinic, Dr. Joseph Khabbaza, If you plan on traveling during the holiday season, Khabbaza suggests continually researching requirements for various forms of travel — that includes understanding vaccine requirements at your final destination. Travel can be stressful enough, so avoiding any surprises will make for a much more pleasant experience.
At this time, the only place that currently requires proof of vaccination within the United States is entry into Hawaii. The state has an online portal to upload proof of vaccination status.
If you have received the COVID-19 vaccine within the United States and its territories, you’ll steer clear of the mandatory 10-day quarantine. Of course you’ll need to prove your vaccine history in order to avoid this mandate.
If you do not want to indicate proof of your vaccination status, then you can undergo a pre-travel test, proving a negative COVID-19 test result. This process needs to be completed no more than 72 hours before the final leg of your trip to the state.
Quarantine Protocols
Look into the CDC’s latest quarantine protocols prior to solidifying your travel accommodations.
According to countless industry experts, the most reliable source to research quarantine mandates for your destination is the CDC’s website.
Keep in mind that COVID-19 statistics are constantly changing, which means that travel guidance will also regularly change. A country could require self-isolation upon arrival tomorrow, whereas today there are no quarantining protocols in place. Also, remember that vaccination status will often play a part in self-isolating requirements after entering the country.
Tropical Destinations
It goes without saying that any travel during the coronavirus pandemic, no matter the method or the destination, incurs risk. Some experts say that picking a tropical location could be slightly safer given the fact it likely means you’ll spend a lot of time outdoors with lower transmission rates.
Once again, even if a particular tropical destination boasts lower COVID-19 infection rates, you’ll still need to consider the local vaccination rates. Additionally, if a particular country isn’t very strict with their COVID-19 regulations, it would be particularly prudent of you to practice safe social distancing in those locations.
Final Thoughts
The CDC has created a helpful Travel Recommendations by Destination map. Using this resource can assist in circumventing destinations that may be considered high risk.
Please continue to visit our Auxo Medical Blog for updated, relevant healthcare infor-mation.
Meta Description: This article highlights safety considerations for travelers during the 2021 holiday season, including vaccines, quarantining, and health habits.
Last month, a Final Rule was adopted by the Library of Congress regarding access to medical device software as a means to diagnose, repair, and maintain the products; the ruling states that this accessibility is regarded as fair use under copyright law. The Librarian of Congress ruling in its entirety can be found here.
A recommendation came from the Copyright Office Registrar, advising exemption to the provision of the Digital Millennium Copyright Act (DMCA) which prohibited “circumvention of technical measures that control access to copyrighted works” according to the published document released on October 28, 2021.
Notably, the ruling exempts responsibility for medical device manufacturers accessing copyrighted software and associated data files on legally procured medical devices or systems when it’s imperative to maintaining and/or restoring a device to operate congruently with its original framework.
The ruling states that in order to, “establish the need for an exemption, proponents must show, at a minimum, (1) that uses affected by the prohibition on circumvention are or are likely to be non-infringing; and (2) that as a result of a technological measure controlling access to a copyrighted work, the prohibition is causing, or in the next three years is likely to cause, an adverse impact on those uses.”
Jay Crabtree, Auxo Medical’s President, said, “We feel that this is a great decision for both healthcare operators and independent service operators. This will give healthcare operators more choices, and will help keep cost of providing care at reasonable levels.”
A thorough overview of the rule making process, evidentiary record, as well as the Register’s analysis of proposed exemptions are available for review here.
Additionally, here are resources and links to better understand the ruling’s history and implications.
As always, stay tuned for relevant and timely healthcare content on the Auxo Medical blog. In our next post, with the pandemic in mind, we’ll review recommendations for safe travels during the 2021 holiday season.
