Posted on Leave a comment

Aluminum: The Hidden Danger in Blood Warmers

Posted on by Stephen Alexander

Recently, there have been growing concerns from regulatory agencies, such as the FDA, as to the safety of aluminum containing medical devices, especially those involved with the infusion of fluids into patients. Just this past year, the FDA has recalled six intravenous fluid warming products due to evidence showing increased levels of aluminum. According to the FDA, “Exposure to toxic levels of aluminum may not be easily recognized and exposure effects may cause serious adverse events including death”. Some manufacturers have provided a potential solution by using coated aluminum surfaces. While these solutions certainly show improvement, they still release detectable levels of aluminum into infused fluids. The question is, are these levels safe or not? In this article, I will unfold some information about the recent recalls, the risk in aluminum, and other safety considerations regarding blood/fluid warmer. But I would like to start by making it clear to the reader that —

I’m not an expert, just an informer. First let me say that I am no expert in the field of toxicology, therefore it is beyond me to say for certain the safety of aluminum based warmers. That job I leave to regulatory agencies such as the FDA. However, once I reviewed the evidence and recalls put out by the FDA, I felt that I needed to make sure other providers are aware of the risks and recent recalls of these products. We should trust the sophisticated and rigorous medical approval system that we have in place. Therefore, it is my viewpoint that aluminum-based heaters that are regulatory cleared must be 100% safe to use. Nonetheless, we as critical care paramedics, nurses, and physicians must, as a minimal requirement, understand the risks associated with this method of warming. We owe it to our patients to be as well informed and up to date with the risks of certain treatments we provide, especially given the growing number of recalls of aluminum based warming devices.

Peer reviewed research of the risks. Aluminum toxicity can lead to a plethora of diseases ranging from Alzheimer’s, autism, breast cancer, to pancreatitis and pneumonia just to name a few (Igbokwe, 2019). In infants, aluminum toxicity is associated with impaired neurological development (Bishop, 1997). What’s even more alarming is that aluminum can also cause decreased iron absorption and anemia. Imagine trying to infuse blood products to correct anemia, and exposing your patient to toxic aluminum that causes the problem you are trying to reverse! Recalls of blood/fluid warmers due to the potential of aluminum leaching are typically identified as Class I recalls. These are the most serious as they are for devices that may cause serious injury or death! Patients most at risk are pediatric patients, specifically neonates and infants, pregnant women, geriatric populations, and those with decreased renal function or on dialysis.

Why manufacturers like to use aluminum in fluid warmers. Aluminum is used in a wide spectrum of medical devices, and when compared to other materials, it’s easy to see why. Aluminum has a large strength-to-weight ratio. This means that aluminum compared to other materials is stronger and lighter. Aluminum is also a good thermal conductor. In addition, aluminum is very malleable, thus it can be formed to almost any specification. Aluminum is a plentiful material as well; in fact, it is the most abundant metal in earth’s crust, making it very cost effective. All these reasons are why we find aluminum, not just in medical equipment, but in our everyday lives. It’s a good, plentiful, strong material that has countless applications. However, this article seeks to explain why using aluminum may not be the best option with respect to blood/fluid warmers.

Advancements in analytical technology have changed the stance on aluminum. If aluminum is unsafe, then why did the FDA approve of its use in fluid warmers initially? The answer is basically “you don’t know what you don’t know”. Regulatory agencies such as the FDA are only as good as the technology they have available to them. In recent years, advancements in technology have enabled regulators to measure more accurately the levels of aluminum produced from blood warmers that use that material. Keep in mind that when the FDA approved aluminum containing medical devices, it was before sensitive testing instruments were used to detect the minimum allowable limits of aluminum that is set forth today. This means that there was no way of knowing if these devices were leaching aluminum or not into the infused fluids. Therefore, these devices were developed, approved, and put on the market. Only until recently are regulatory agencies capable of measuring the threshold limits produced by these products, and the results — for some of these devices — are concerning.

Increased concern over aluminum containing warmers evident by 3 FDA recalls of 6 warming devices in just 6 months. Since March of this year there have been three separate recalls on fluid warmers that contain aluminum. The FDA has warned that the aluminum used in the heating elements is leaching into the fluids and being infused into patients. In March of 2021 ThermaCor 1200 disposable sets were recalled. The customers were notified of a Toxicological Assessment that there was potential aluminum leaching into fluids. Later, Eight Medical International’s Recirculator disposables were recalled in July of this year. The most recent recall was of 4 Smith Medical’s Level 1 configurations for the same reason, leaching of aluminum. This is on top of yet another global recall of the enFlow device in 2019. With so many recalls in such a short period, it does raise concern that blood warmers containing aluminum in their heating elements pose a potential risk to patients. You can read the FDA’s Letter to Health Care Providers on the recent recalls here.

Researchers find that coated aluminum may not prevent leaching. Manufacturers of blood/fluid warmers with aluminum heaters often make a distinction between uncoated and coated aluminum heaters. The latter (i.e. coated aluminum) is expected to be safer for patients, compared with non-coated aluminum. This makes sense. However, even blood/fluid warmers that utilize coated aluminum may pose a risk to patients. In June of 2019, researchers found that aluminum was still detectable in fluids infused with devices that use coated aluminum. The study compared aluminum release of coated and uncoated fluid-warming devices. The results of the study found that while aluminum release was less in coated devices, it still was elevated above baseline. In fact, the researchers stated that “our methodology does not have the ability to differentiate between the concentrations we measured and the FDA threshold.”(Perl, 2019).

Manufacturers may be predisposed to maintain the status quo. Despite the recent recalls, the default claim of manufacturers that use aluminum heaters is that the aluminum remains below the acceptable limits set forth by regulatory agencies. However, the accuracy of this claim is debatable, and the data that is used to defend these claims is often open for contradicting interpretations. At least in one recent case, the Canadian FDA publicly refuted such a claim proposed by Smiths Medical. Without getting into the specifics of this particular case, it’s easy to understand why manufacturers may resist a change. It goes without saying that they must trust that their solution is 100% safe in order to commercialize it. However, is it possible that this high level of confidence may also be fueled by some sort of an ‘organizational predisposition’? Let me try to explain: these manufacturers assumed significant risks and invested millions of dollars to overcome the demanding regulatory barriers that stand between any medical device innovation and the marketplace. Even after commercializing the product, they had to invest significant budgets in continuous engineering and regulatory affairs. Therefore, they need to see positive returns following these huge investments, otherwise future innovation might suffer. Certainly, a very complex and delicate situation that manufacturers must contend with.

Other associated risks of blood/fluid warming. It should be noted that warming fluids does come with other risks besides aluminum leaching. Let’s review some of these other risks:

  • Hemolysis. One risk is hemolysis due to the age of blood products given. This isn’t necessarily a risk associated only with warming blood products, but just a general risk overall. As the products age, red blood cells have a higher chance of rupturing. That’s why it’s important to infuse blood products before the expiration date.
  • Excessive sheer force, turbulence, and cavitation. Hemolysis might be accelerated by suboptimal design of the fluid path of the warming element. You expect your blood/fluid line to be smooth and homogeneous, then why make exceptions for the warmer’s fluid path (or as it is often called, the cassette)? In other words, preferably the fluid path of the warmer should be designed in an ‘undisrupted’ fashion. That is, and to the extent possible, the fluid path design should avoid for example abrupt turns, connection points, and flow changes (e.g. from a wide to narrow carrier and vice versa) in order to minimize sheer force, turbulence, cavitation, and air bubble formation, to name just a few potential complications associated with high flows and elevated pressure. Why don’t you simply try to look under the hood of your chosen warmer?
  • Over/under heating. Another risk is over/under heating the fluids/blood being infused. I believe that under heating is a bigger and more common issue especially with high flows and with intermittent flow methods. If your agency requires high flows or uses an infusion device that utilizes intermittent flow, most warmers cannot keep up with the job. If the warmer can’t physically warm the fluids to body temperature at the rate being infused, you’re introducing hypothermic fluids into your patient. Even room temperature fluids are far below body temperature, especially for severely sick patients suffering from shock.
  • Aggressive heat transfer process. It seems logical that a relaxed heat transfer process from the heat exchanger to the blood/fluids is safer than an aggressive heat transfer process. Therefore, why not add this to your evaluation criteria? The most relaxed heat transfer mechanisms require a warming surface of 15-20 ml. We all love solutions with small priming volume, but we need to acknowledge that this may come at a ‘price’. And the price is a potentially aggressive heat transfer process from the heater to the blood, especially at elevated flows.
  • Unavailability. One of the most prominent risks associated with your blood/fluid warmer over the past years is that you will not be able to use it since there is a shortage of disposable sets or a recall of the device. Ask users of enFlow, Level 1, ThermaCor, Thermal Angel, and several others to understand how frustrating this can get. And if there is one thing that COVID taught us, it is that complex solutions lead to complex supply chains and therefore to many months of lead times when the unexpected strikes. Therefore, make sure that the consumable of your solution of choice is simple enough to manufacture in large quantities, fast! Make sure that there are no chips that need to be placed into this consumable, otherwise you will be at the mercy of the market availability of chips, which is currently experiencing significant shortages.

A solution. Clearly the wrong answer to prevent aluminum leaching from blood/fluid warmers is to not utilize a warmer. Myself and other colleagues have written extensively about the importance of warming fluids, especially blood products in rapid transfusions. You can read some of those articles here .One practical solution to this problem is utilizing a warmer that is aluminum free in the first place, or, if you decide to use an aluminum warming solution, then do your due diligence about the solution. There are several prehospital and hospital solutions that are aluminum free, such as the Thermal Angel, Quantum, and Ranger, to name just a few. QinFlow’s Warrior is another excellent example of an aluminum-free warmer: it has battery and AC power sources and it therefore fits both prehospital and hospital settings. It has amazing performance levels, measured in maximum delivery rates. And as importantly, its per-use price is very competitive. You can read more about the Warrior here.

Summary & Conclusion. New, more sensitive, monitoring technology has made it possible for regulatory agencies to detect trace levels of aluminum, before unknown to us. Exposure to toxic levels of aluminum, according to the FDA, “may cause serious adverse events including death”. With that information, three recalls of 6 devices have been issued within the past few months over growing concern of elevated aluminum levels in fluids infused by products containing aluminum heating elements. We’ve seen that not even coated aluminum surfaces prevent leaching into fluids. The only way to ensure that zero aluminum is leaching into your patients is most probably to utilize solutions that are aluminum free. While there are several options out there, the QinFlow’s Warrior is a good place to start. Their fluid path is 100 percent aluminum free. They are also amongst the most cost efficient solutions on the market. A true win win. QinFlow’s disposable cassettes have a comfortable and gentle priming volume of 19mL. Finally, the Warrior is rugged enough to withstand high pressures of intermittent flow and can warm near freezing blood products to body temperature within seconds, safely!

***

Bishop NJ, Morley R, Day JP, Lucas A. Aluminumneurotoxicity in preterm infants receiving intravenous-feeding solutions. New England Journal of Medicine 1997;336: 1557–61

Igbokwe, I. O., Igwenagu, E., & Igbokwe, N. A. (2019). Aluminium toxicosis: a review of toxic actions and effects. Interdisciplinary toxicology, 12(2), 45–70. https://doi.org/10.2478/intox-2019-0007

Perl, T., Kunze-Szikszay, N., Bräuer, A., Quintel, M., Röhrig, A.L., Kerpen, K. and Telgheder, U. (2019), Aluminium release by coated and uncoated fluid-warming devices. Anaesthesia, 74: 708-713. https://doi.org/10.1111/anae.14601

Stephen Alexander

Stephen Alexander is a Critical Care Paramedic residing in Little Rock Arkansas. He enjoys writing informative and educational articles about pre-hospital medicine. Stephen started his career in EMS by enlisting in the Army as a 68W Combat Medic. He then attended the U.S Army Flight Medic program through UTHSCSA and received his paramedic license through NREMT. He then went to RUSH Advanced Trauma Training Program in Chicago and attained his CCEMTP. He currently flies for the Arkansas Army National Guard MEDEVAC unit.

Full article can be found here: https://www.qinflow.com/aluminum-the-hidden-danger-in-blood-warmers/

Posted on Leave a comment

1976 – Oh what a Year!!

In 1976 Steve Jobs and Steve Wozniak started a small computer company and called it Apple Computers. The first commercial supersonic Concorde flight took place between London and New York. The film “Rocky” was released and Jimmy Carter was elected president of the USA. NASA’s Viking 1 Lander touches down on Mars and they also reveal their prototype space shuttle called “The Enterprise”. Abba, the Eagles, Queen and David Bowie helped create the sounds of 1976.

top-banner-blog.png

At the same time, Margaret Piehl was a nurse working in a small community hospital ICU in America. She noted that when patients with acute respiratory distress syndrome (ARDS) were placed in the prone position their oxygenation levels improved. Margaret described this phenomenon in a ground-breaking paper published in Critical Care Medicine in 1976. Together with physician Robert Brown she described the improvements in arterial oxygenation on 5 patients brought about by “extreme position changes”(1)

In the following years other physicians studied this observation to understand who would benefit from the technique, when it should be carried out and how long a patient should be in the prone position. It took many years of clinical trials to confirm that prone positioning improves arterial oxygenation. Finally in 2013 the PROSEVA(2) trial was published in the New England journal of Medicine. This trial showed that early intervention with the use of prone positioning in ARDS patients with the most severe hypoxemia resulted in a 17% absolute reduction in mortality. Prone positioning has the most impact on survival of ARDS patients than any other intervention. Thank you, Margaret Piehl, for your keen eye back in 1976.

For over 40 years this remarkable but simple technique has helped save the lives of many ARDS patients in ICU and the world barely noticed. Scroll forward to 2020 and Covid 19 sweeps across the globe. Images appear on our TV screens of ICU’s full of desperately ill Covid 19 patients being treated by incredible nurses and doctors. ARDS is often associated with Covid 19, resulting in many patients being proned. We see proning in action and start to take an interest in Margaret Piehl’s observation.

So, what is proning, how is it carried out and how does it prevent any patient, with ARDS, whether they have Covid 19 or not, from dying.

Proning is a manual handling procedure where a patient’s position is changed, so they are lying on their front, face down, in a “prone” position. The aim is to change the way the patient is resting, which is usually going from lying on their back to their front and back again. That sounds quite straight forward. All you have to do is move the patient from lying on their back to lying on their stomach.

But they probably have Covid 19 with associated ARDS and are sedated. They will be on a ventilator, and they may have a chest drain, cannulas and ECG leads in place.

You begin with the patient in this position with all the attached leads etc

The Intensive Care Society
The Intensive Care Society

And end up with them in a prone position

The Intensive Care Society
The Intensive Care Society

It can be quite a complicated manoeuvre that is described brilliantly in the Intensive Care Society Guidelines for Prone Positioning in Adult Critical Care(3):

  • You need at least 5 trained healthcare professionals with someone taking control at the head of the patient.
  • Staff are allocated to manage the airway and the drains etc. and are positioned along the side of the patient.
  • The patient is on a clean sheet with a slide sheet underneath.
  • Pillows are placed strategically on the patient who is then covered with another sheet leaving the head and neck free.
  • The edges of the top and bottom sheets are rolled together to tightly wrap the patient.
  • The patient is then moved to the edge of the bed and turned through 90°, so they are lying on their side.
  • The rolled-up sheet is pulled up from beneath the patient whilst the patient is carefully turned into the prone position.
  • All the leads and ETT are checked to ensure they are not kinked.
  • The patients’ arms are placed in the “swimmers” position, head turned to one side, and they are nursed at 30° in the reverse trendelenburg position.

Most hospitals maintain patients in a prone position for at least 12 hours per day, though practices vary. Throughout the time the patient is in the prone position, the head and arms are moved regularly to prevent pressure damage. This requires at least 3 healthcare professionals including an anaesthetist at the top of bed to manage the airway when changing head position. Proning sessions continue until there is a sustained improvement in oxygen levels, or if proning does not improve oxygen levels.

AP: Zhang Yuwei via Xinhua
AP: Zhang Yuwei via Xinhua

With all this extra workload in ICU, caring for seriously ill Covid 19 patients, it doesn’t surprise me when I hear that ICU staff are exhausted. This is a demanding role and ICU staff deserve the highest praise from us all.

Prone positioning can help a severely ill Covid 19 patient in many ways:

  • In the supine position, the lungs are compressed by the heart and abdominal organs. Gas exchange is reduced in areas of collapsed lung, resulting in low oxygen levels. In the prone position, lung compression is less, improving lung function.
  • The body has mechanisms to adjust blood flow to different portions of the lung. In ARDS, an imbalance between blood and air flow develops, leading to poor gas exchange. Prone positioning redistributes blood and air flow more evenly, reducing this imbalance and improving gas exchange.
  • With improved lung function in the prone position, less support from the ventilator is needed to achieve adequate oxygen levels. This may reduce risk of ventilator-induced lung injury, which occurs from overinflation and excess stretching of certain portions of the lung.
  • Prone positioning may improve heart function in some patients. In the prone position, blood return to the chambers on the right side of the heart increases and constriction of the blood vessels of the lung decreases. This may help the heart pump better, resulting in improved oxygen delivery to the body.
  • Because the mouth and nose are facing down in the prone position, secretions produced by the disease process in the lung may drain better.

The benefits of proning severely ill patients are very clear but there are risks associated with the procedure. Placing patients in this position may put them at risk for complications such as pressure injuries, airway complications, facial injuries, peripheral nerve injuries, musculoskeletal injuries, and cognitive impairment.

The Intensive Care Society Guidelines(3) recommend that there should be no direct pressure on the eyes. Unfortunately, this is not always possible and prone nursed patients may suffer direct pressure on the eyes or raised orbital/ophthalmic pressure due to gravitational effects or periocular swelling. This can cause number of complications including acute primary angle closure glaucoma, ischaemic optic neuropathy, vascular occlusion, orbital apex syndrome and corneal abrasions. In a busy ICU full of seriously ill patients taking care of the proned patients’ eyes can be missed. Eye care can contribute enormously to improved patient recovery by ensuring the eyes are not painful or swollen and vision isn’t blurred. Additionally, painful corneal abrasions and infections are avoided.

The Intensive Care Society Guidelines(3) recommend that prior to proning, the eyes are assessed, cleaned, ointment applied and then covered with eye coverings. Eye condition should be checked every 2 to 4 hours and corneal clarity checked.

It surely makes sense that the eye covering of choice in this situation should be EyePro.™ which has clear advantages over micropore tape. EyePro™ is sterile and ensures rapid, complete, and safe eyelid closure. By sealing around the eye circumferentially, all moisture is retained, thus preventing the eye from drying out.

Additionally, a clear central window allows direct observation of eyelid closure. EyePro™ was specifically designed for one purpose; to protect the eyes during general anaesthesia. In doing so, EyePro™ provides a superior level of protection against corneal abrasions.

eyepro-patient-1500px.jpg

References:

  1. Piehl MA and Brown RS. Use of extreme position changes in acute respiratory failure. Critical Care Med 1976;4(1):13-14. 
  2. PROSEVA trial: Prone positioning in severe ARDS. New Engl J Med 2013;368(23):2159-2168.
  3. The Intensive Care Society Guidelines for Prone Positioning in Adult Critical Care. Published November 2019.
niall-shannon-european-business-manager-innovgas.png

Author: Niall Shannon, European Business Manager, Innovgas

This article is based on research and opinion available in the public domain.

Interested in a Free Sample?

Free samples of NoPress, EyePro & BiteMe available upon request.
Conditions apply.

innovgas-squarespace-popup.jpg
Posted on Leave a comment

Innovative MAC anesthesia approach to reducing nausea and vomiting!

Patients experience nausea and vomiting 30-50% of surgical recoveries!  There are NO positive reviews from a patient that vomits post-surgery.  PONV is costly in many ways including slowed patient recovery, poor patient experience and in increased staffing needs.  Reducing PONV can help make hospitals and surgery centers become more productive, more pleasant and more profitable and anesthesia providers happier. 

Aromatherapy from the vanilla infused Capnomask O2/CO2 mask is a safe and effective tool for anesthesia to use to reduce PONV, provide oxygen and monitor the patients breathing to assure safe MAC anesthesia. 

The vanilla infused Capnomask offers a drug-free therapy to give anesthesia a proactive way to reduce the chance of a patient experiencing nausea and vomiting.  The Capnomask offers other advantages including:

  • Excellent patient oxygenation of over double the FiO2 of nasal oxygen canula.
  • Capnomask acts as a physical shield or barrier reducing atomization of a patient’s exhalation thus protecting nurses, surgeons and anesthesia by reducing the spread of germs including Covid19.
  • Capnomask comes preassembled with oxygen tubing and 10’ EtCO2 sample line to safely monitor a patient’s breathing to assure no hypoventilation incidents.
  • Vanilla infused scent reduces nausea and vomiting reducing PONV.
  • Low cost of Capnomask compared to cost of DIY or Do It Yourself options of converting a standard oxygen mask with IV catheter and adding an EtCO2 sample line.
  • Reduced anesthesia time to set up DIY version for MAC cases. 

Further benefits of the Capnomask:

  • Reducing Costs
    • Reduced staffing costs and resources used to administer and monitor PONV treatments
    • Reduced drug costs and side effects of nausea prevention drugs
    • Reduced involvement of pharmacy and medication costs
    • Reduced length of recovery time and improved PACU throughput
    • Improved HCAHPS scores with less PONV
  • Adding Value
    • Preventing nausea with the aromatherapy of Capnomask improves patient experience.
    • Satisfaction scores improve with the reduction in PONV
    • Less staff required for PONV intervention if prevented by proactively using Capnomask
    • Capnomask may be considered an added component of ERAS or Enhanced Recovery after Surgery
Posted on Leave a comment

No One’s Safe Until Everybody’s Safe

5.4.2021

It’s unclear who first made this comment about the Covid-19 pandemic, but it is being used by health care leaders around the world to encourage their people to get the Covid-19 vaccination. Vaccines have played an important role throughout history in keeping us well.

Evidence exists that early attempts to inoculate people against smallpox were reported in China as early as the 16th Century. Smallpox scabs could be ground up and blown into the recipient’s nostrils or scratched into their skin. The practice, known as “variolation”, came into fashion in Europe in 1721, with the endorsement of English aristocrat Lady Mary Wortley Montagu.

The next development which turned out to be much safer than variolation, originated from the observation that dairy farmers did not catch smallpox. The 18th Century English physician, Edward Jenner, hypothesised that prior infection with cowpox, which is a mild illness spread from cattle, might be responsible for the suspected protection against smallpox.

In 1796, Jenner inoculated an eight-year-old boy by taking pus from the cowpox lesions on a milkmaid’s hands and introducing the fluid into a cut he made in the boy’s arm. Six weeks later, Jenner exposed the boy to smallpox, but he did not develop the infection then, or on 20 subsequent exposures. The origin of the term comes from the Latin for cow or “vacca”.

Edward Jenner vaccinating his child against smallpox; coloured engraving.  Image: Wellcome Library, London (CC BY 4.0)
Edward Jenner vaccinating his child against smallpox; coloured engraving. Image: Wellcome Library, London (CC BY 4.0)

In 1881 French microbiologist Louis Pasteur demonstrated immunisation against anthrax by injecting sheep with a preparation containing forms of the organism that causes the disease. Four years later he developed a protective suspension against rabies. Jenner’s approach was to use a virus similar to, but safer than, smallpox to prevent disease. Pasteur on the other hand developed a weakened or attenuated form of the virus or bacteria to treat the patient.  

This was the birth of vaccinations and heralded a new era in the treatment of diseases around the world using injections containing live, weakened, or killed viruses to produce immunity against an infectious disease. In the early 20th century, we saw the development of vaccines to protect against whooping cough (1914), diphtheria (1926), tetanus (1938), influenza (1945) and mumps (1948). Later vaccines were developed for polio (1955), measles (1963) and rubella (1969) with the world being announced smallpox free in 1980.

Vaccine technology still uses the approaches developed by Jenner and Pasteur but has developed enormously in recent years with a number of new approaches. These include:

  • A subunit vaccine, which is made from proteins found on the surface of infectious agents e.g. Influenza, Hepatitis B.
  • Inactivated toxins of infectious organisms e.g., Tetanus, Diphtheria, Whooping cough.
  • Gene sequencing and editing has allowed the mass production of antigens that are used in vaccines and made the production of attenuated vaccines safer and more effective.
  • Recombinant DNA technology has also been used effectively to develop vaccines e.g., Human papillomavirus.

Today there are around 30 diseases around the world that are treated and controlled by vaccination programmes making us all healthier and allowing us to live longer.

So here we are in 2021 and vaccines will once again help us fight against another highly infectious disease, Covid-19. There are currently 10 vaccines licensed around the world that offer protection against Covid-19. Staggeringly, there are 88 vaccines in clinical development and 184 in pre-clinical development.

vaccination-5884513_1920.jpg

The speed of development of these vaccines has been nothing short of remarkable and their efficacy rates are equally impressive. However, public attitudes to vaccines appears to have shifted markedly to what it was when this type of treatment was introduced. People either trust vaccines or they don’t. Then we have the antivaxxers who believe vaccines are unsafe and infringe their human rights. Antivaxxers also use social media to actively spread misinformation to persuade people to their point of view. Antivaxxers have been pumping out misinformation for a number of years now, so it’s useful to see if they have had any success.

Claims about the Covid-19 vaccine made by the antivaxxer community include:

  • The vaccine alters your DNA.
  • The vaccine causes infertility.
  • Bill Gates is inserting microchips into people.
  • The virus is being used as a ploy to move a country to a “police state”.
  • Don’t be a guinea pig for pharmaceutical companies.

A number of surveys have been conducted assessing public reaction to having a Covid-19 vaccination. The Imperial College London YouGov Covid-19 Behaviour Tracker Data Hub gathers global insights on people’s behaviours in response to COVID-19. Data represents the share of respondents who have not received a COVID-19 vaccine and who agree with the following statement: “If a COVID-19 vaccine were made available to me this week, I would definitely get it.” Respondents were presented with a 1 to 5 scale, ranging from “Strongly agree” (1) to “Strongly disagree” (5). The following chart shows monthly data on the willingness of unvaccinated individuals to receive the COVID-19 vaccine. They asked this question in November 2020 with the following results:

imperial-college-of-london-mar-31.png

You can see that in those countries surveyed there is a wide variation in the willingness to be vaccinated ranging from 67% in the U.K. to only 40% in France. A study conducted by Ipsos on behalf of the World Economic forum found similar results.

Is this vaccine hesitancy the result of antivaxxer misinformation? There is no doubt that some of the claims made by antivaxxers will have resonated with some people. However, when you ask people objectively about vaccine hesitancy the reasons are quite straight forward. “Side effects”, “long term effects on health” and “how well the vaccine works” were the top three reasons for reporting negative sentiment towards the vaccine and this was consistent across all population groups. These concerns are not unreasonable. It is important to note that as more and more people are vaccinated, vaccine hesitancy is declining. In fact, in England 95% of the over 50’s have been vaccinated which is way higher than scientists thought could be achieved.

To ensure high rates of vaccination so that a population can gain “herd” immunity, health care leaders need to target vaccine hesitancy messaging very carefully. This is because hesitancy rates vary by population sub-group.

A survey carried out by the Office of National Statistics in the U.K. in early 2021 revealed that vaccine hesitancy was highest in:

  • 16–29 year olds.
  • Black or Black British adults.
  • Parents with child aged 0-4 years.
  • Adults living in the most deprived area.

It’s pretty clear that as vaccine programmes are rolled out around the world, governments and health care workers will have to work hard to ensure the majority of their people are vaccinated. Only then can we stop saying no one’s safe until everybody’s safe and we can start getting back to a normal life and fix some of the other issues this pandemic has caused.

  • We need to be more vigilant against infections, particularly with vulnerable hospitalised patients. That’s why sterile EyePro™ should be the only eyelid cover used to maintain eyelid closure during general anaesthesia or deep sedation.
  • As surgery returns and we start to reduce the huge backlog of patients waiting for routine surgery, hospitals must ensure they deliver a great patient experience by protecting patients’ eyes from trauma by using NoPress™, our foam and rigid plastic shield designed specifically to protect anaesthetised patient’s eyes from externally applied pressure.
  • Enhance the patient experience further, by guarding against dental damage and/or negative pressure oedema through the use of BiteMe™ our purpose designed, air-filled, soft plastic bite block.

So, no one’s safe until everybody’s safe and although vaccines will help the world recover, it’s important we do our utmost to protect patients from infection as well as non Covid-19 complications that can be easily avoided. By using our products, you will optimise your care and ensure your patients have the best experience they can possibly receive.

Author: Niall Shannon, European Business Manager, Innovgas

This article is based on research and opinion available in the public domain.

Posted on Leave a comment

Corneal Abrasion; problem what problem?

Well, it all depends on which side of the fence you are sitting on. Most medical definitions describe a corneal abrasion as a painful scrape or scratch on the surface of the clear part of the eye. This clear tissue of the eye is known as the cornea, the transparent window covering the iris, the circular coloured portion of the eye. Descriptions also state that in most cases the cornea heals in a couple of days and all symptoms pass.

A patient on the other hand would probably describe a corneal abrasion as painful to say the least. In fact, it may be extremely painful. This is because the cornea has a high concentration of nerve endings, so it is going to be really painful. Alongside the extreme pain they may feel as though there is something in their eye. The eye will look red, vision will be blurred and there will be excessive tearing. They may be sensitive to light but closing the eye may only cause the pain to intensify. There may be vision loss and headaches which will cause concern.

So, this can be an extremely uncomfortable situation for someone to be in and they need treatment immediately to relieve the pain and allow them to see clearly.

How does a corneal abrasion occur? The answer is, quite easily. Minor abrasions can be caused by:

  • Poking your eye with a fingernail, pen, or makeup brush.
  • Rubbing it too hard.
  • Wear poor-fitting or dirty contact lenses or wearing them for too long.
  • Walking into something like a branch of a tree.

More serious abrasions can occur from:

  • Getting chemicals in your eye.
  • Get dirt, sand, sawdust, ash, or some other foreign matter in your eye, especially at work and not wearing eye protection.
  • Play sports or engaging in high-risk physical activity without eye protection.

You may be surprised to learn that a corneal abrasion can occur when you are having an operation and are anaesthetised. How can that possibly happen, you are probably thinking. Again, the answer is quite easily. But before we consider how a corneal abrasion can occur in the operating theatre, we need to look at how the eye behaves when it is anaesthetised, and the steps taken to protect your eyes when you have an operation.

A general anaesthetic can have several effects on your eyes, including:

  • It can cause lagophthalmos which is a failure of the eyelids to fully close. During normal sleep, lid closure is maintained by the tonic contractions of the orbicularis muscle. Lagophthalmos only occurs in about 4% of people during normal sleep. However, under anaesthesia one study demonstrated that 59% of patients failed to have complete eyelid closure.(1)
  • Tear production and stability are significantly reduced which causes the cornea to dry out.
  • Bell’s phenomenon is a protective mechanism that turns the eyes upwards to protect the cornea. It occurs naturally during sleep, but this mechanism is also lost during general anaesthesia.

Therefore, you can see that the eyes are compromised when you are given a general anaesthetic and so must be protected from being damaged. But how common is getting a corneal abrasion in the operating theatre, what causes it and what is done to protect the eyes?

A corneal abrasion is the most frequent ocular complication of general anaesthesia.(2) The American Society of Anaesthesiologists’ closed claims analysis of ocular injuries associated with general anaesthesia, 35% were corneal abrasions, of which 16% resulted in permanent ocular damage.(3)

Because the eyes are compromised during general anaesthesia, almost anything can cause a corneal abrasion. The list is endless. A watch strap, name badge, the anaesthetist’s hands, facemasks, drapes, instruments laryngoscope, skin preparation solutions, or the direct irritant effect of inhalational anaesthetic agents. In recovery the eye may be injured by face masks, the patient’s fingers, or the bed linen. However, most corneal abrasions are caused by the failure of the eyelids to close properly leading to corneal drying.(4) I will return to this point later.

It’s clear that the eyes need some solid protection to prevent them from being damaged. So, what is done in today’s modern, high tech expensive operating theatre? They do this.

eyes-taped-shut-1500px.jpeg

Usually, a theatre technician will use some general-purpose tape that is lying on a trolley or in their pocket and your eyes will be taped shut. Prior to taping a protective ointment or gel may be applied. However, we all know that adhesiveness of tape varies and that used in the operating theatre is no different. Too little stick may not ensure or maintain complete eyelid closure, leading to moisture loss from the eye. Too much stick may cause eyelid bruising, irritation and skin tears or eyelash loss on removal. Tape used is usually opaque making it difficult to tell if the patients’ eyes are completely closed. Frequent removal and reapplication of the tape makes it less sticky and prone to falling off Additionally, the anaesthetist may need to check pupil dilation and the tape needs to be removed and reapplied whilst wearing surgical gloves. Not an easy thing to do!

So, back to our patient. Despite taping the patient’s eyes being taped during an operation, the tape was opaque, and no one spotted that the eyes opened during the operation causing the cornea to dry out. When the patient woke up, they had a really painful and sore red eye. A saline washout of the eye was tried but that didn’t work. In the end an ophthalmologist was called to examine the patient and a corneal abrasion, caused by the eye drying out was diagnosed. This required treatment including pain management, antimicrobial prophylaxis, a pressure patch, and close monitoring meaning the patient was in hospital for an extra day.

Could all this have been avoided? Could the anaesthetist have spotted that the patients’ eyes had opened during the operation and closed them? Could a corneal abrasion have been avoided and the patient not had such a painful experience? Could the hospital have avoided all those extra treatment costs such as consultant time, drugs, and bed usage?

Instead of using opaque general-purpose tape to protect the patients’ eyes, the hospital should have used EyePro™ instead.

eyepro-patient-1500px.jpg
eyepro-hero-1500px.jpg

Why should we use EyePro™ instead of tape?  EyePro™ is a unique eyelid cover designed by an anaesthetist to maintain eyelid closure during general anaesthesia.

It ensures rapid, complete, and safe eyelid closure. By sealing around the eye circumferentially, all moisture is retained, thus preventing the eye from drying out. Additionally, a clear central window allows direct observation of eyelid closure.

EyePro™ has a patented dual zone design whereby an inner transparent window allows intra-operative assessment of eyelid closure, while an outer, more rigid, opaque zone allows for easy handling and excellent conformity to the eye socket. The inner window has a gentle adhesive which helps to maintain eyelid closure and reduces eyelid trauma and/or eyelash removal. The outer zone has slightly stronger adhesive that maintains eyelid closure for extended periods. Also, non- adhesive tabs allow for easy handling, application, and removal, even while wearing gloves.

Additionally, each pair of EyePro™ comes packaged together in a sterile wrap to decrease the risk of cross contamination. In a world where we are going to have to live with Covid-19 anything that reduces the risk of infection must be a good thing. But that will be the subject of another article.

EyePro™ is more expensive than tape I hear you say. Yes, it is. That’s because it has been specifically designed for one purpose; to protect the eyes during general anaesthesia. In doing so, EyePro™ provides a superior level of protection against corneal abrasions. And don’t forget those extra treatment costs such as consultant time, drugs, and bed usage. An extra day in hospital would cost approximately $1800/day in the USA, $AUD1000/day in Australia, £400/day in the UK and €600 in the EU.

EyePro™ is a major advance in keeping the patients’ eyes safe during general anaesthesia. Remember, most corneal abrasions are caused by the failure of the eyelids to close properly leading to corneal drying. EyePro™ allows the anaesthetist to ensure the eyes remain closed, thereby reducing the risk of corneal abrasion. This leads to a better patient experience, quicker recovery time and a reduction in the use of valuable hospital resources such as drugs, bed occupancy and clinical time. Additionally, within the overall cost of treating the patient EyePro™ could also save you money. It really is a no brainer!!!

References:

  1. Batra YK & Bali IM. Corneal abrasions during general anaesthesia. Anaesthesia and Analgesia 1977; 56: 363– 5.
  2. Terry TH, Kearns TP, Grafton‐Loue J, Orwell G. Untoward ophthalmic and neurological events of anaesthesia. Surgical Clinics of North America 1965; 45: 927– 9.
  3. Gild WM, Posner KL, Caplan RA, Cheney FW. Eye injuries associated with anaesthesia. Anaesthesiology 1992; 72: 204– 8.
  4. White E, Crosse MM. The aetiology and prevention of peri‐operative corneal abrasions. Anaesthesia, 1998, 53, pages 157–161
niall-shannon-european-business-manager-innovgas.png

Author: Niall Shannon, European Business Manager, Innovgas

This article is based on research and opinion available in the public domain.

Posted on Leave a comment

Doctor There’s a Problem in the Recovery Room

The operation had been a long, but it had been a success. The patient had been taken into the recovery room and was being looked after by theatre staff as they were slowly woken up. In theatre the anaesthetist was talking with colleagues about the operation.

Suddenly, a member of staff put their head through the door of the recovery room and looking at the anaesthetist said, “doctor there’s a problem in the recovery room.”

Upon entering the recovery room, the anaesthetist found that the patient, had started to recover but was biting down on the reinforced laryngeal mask airway (LMA). The anaesthetist tried to encourage the patient to stop biting, but that didn’t work. The patient bit right through the LMA and this part was removed from his mouth. Remarkably the patient could still breathe through the bitten off end. A few minutes later the patient had recovered enough to spit the remnants of the LMA out. The photographs below clearly show the aftermath. 

lma-bitten-670px.jpg
lma-bitten-2-670px.jpg

Thankfully, that was a good outcome both for the patient and the anaesthetist and their team. But there are two other scenarios that could have occurred:

  • The patient could have broken their teeth and suffered dental damage. I wrote about this last year and pointed out the consequences both from a repair perspective and a financial one for the patient and the hospital.
  • Another more serious scenario is that the patient obstructs the lumen of the LMA or the LMA blocks the upper airway. There is a real risk of desaturation and negative pressure pulmonary oedema. This is a dangerous and potentially fatal condition. Negative pressure pulmonary oedema (NPPE) or post obstruction pulmonary oedema (POPE) is a clinical entity of great relevance in anaesthesiology and intensive care. The presentation of NPPE can be immediate or delayed, which therefore necessitates immediate recognition and treatment by anyone directly involved in the perioperative care of a patient.(1)

So, what do we know about negative pressure pulmonary oedema or Post Obstruction Pulmonary Oedema?

There are few studies in the public domain that look at the incidence of NPPE. The incidence of NPPE has been reported to be 0.05%–0.1% of all anaesthetic practices. However, it is suggested that it occurs more commonly than is generally documented. According to one estimate, NPPE develops in 11% of all patients requiring active intervention for acute upper airway obstruction (2) . In a small review of case reports where laryngeal mask is cited, 60% reported that the patient bit through the LMA and of that group ⅔ reported that the patient developed a pulmonary oedema (3) .

The review concluded, ”The vast majority of the papers found are case reports, though a single survey suggests that biting of an unguarded laryngeal mask airway (LMA) is not an uncommon event. Complications of biting include airway obstruction and the development of negative pressure pulmonary oedema, neither of which would be welcome events in the resuscitation area.”

In a U.K. national survey of the use of bite guards and critical incidents involving the laryngeal mask airway (3) a postal questionnaire was sent to 451 anaesthetists with a 42% response rate. 63% of consultants, 45% of SpRs and 43% of recovery staff never used a bite guard in conjunction with a laryngeal mask airway of any sort. However, biting of a laryngeal mask airway by a patient, resulting in airway obstruction, had been experienced by 18 users of the flexible laryngeal mask airway (7.3%) and 71 users of the standard laryngeal mask airway (18.8%).

The recovery staff reported an average of two incidents per month of laryngeal mask airway obstruction. The authors concluded that the use of a bite guard with a laryngeal mask airway is an uncommon practice but the occurrence of airway obstruction with the laryngeal mask airway is high.

An upper airway obstruction is the cause of negative pressure pulmonary oedema. A blocked or broken LMA caused by biting is one cause. Others include hanging, strangulation, upper airway tumours, foreign bodies, croup, choking, migration of Folly’s catheter balloon used to tamponade the nose in epistaxis, near drowning, goitre mononucleosis, big tonsils, hypertrophic adenoids, or a redundant uvula.

Once the upper airway is obstructed a very large, negative, intrathoracic pressure is generated by the patient’s increased effort to breathe. This causes pulmonary oedema or fluid build-up in the lungs resulting in acute respiratory failure. The onset of pulmonary oedema is usually rapid (within a few minutes after signs of upper airway obstruction). The patient will become agitated, may look frightened, will breathe rapidly, may become tachycardic, crackling sounds or rales may be heard with a stethoscope and pulmonary secretions become frothy and pink as progressive oxygen desaturation occurs.

Quick thinking and action are required to remove the blockage causing this emergency. If the blockage were caused by a broken LMA the patient would need to be rapidly re-anaesthetised and paralysed to allow the LMA to be removed. This would also allow reoxygenation to occur if the patient were desaturated. This intervention not only exposes the patient to more drugs but if desaturation carries on for long enough the situation can become an anaesthetic emergency. The Difficult Airway Society Guidelines for the management of tracheal extubation(4) recommend the following for the management of negative pressure oedema.

  1. Treat the cause: relieve the airway obstruction.
  2. Administer 100% O2 with full facial CPAP mask. In addition to relieving upper airway obstruction, CPAP may reduce oedema formation by increasing mean intrathoracic pressure and minimise alveolar collapse by increasing functional residual capacity, improving gas exchange, and reducing the work of breathing.
  3. Nurse the patient sitting upright.
  4. If there is fulminant pulmonary oedema with critical hypoxaemia, tracheal intubation and mechanical ventilation with PEEP are necessary. Less severe hypoxia responds to supplemental oxygen and ⁄ or non-invasive ventilation, or CPAP.
  5. Intravenous opioids may help reduce subjective dyspnoea.
  6. Chest radiography may exclude other complications of difficult airway management and causes of hypoxia (gastric aspiration, pre-existing infection, pneumothorax, barotrauma, pulmonary collapse).
  7. Frank haemoptysis may necessitate direct laryngoscopy and ⁄ or flexible bronchoscopy.
  8. Diuretics are often administered, but their efficacy is unproven.

The Difficult Airway Society also comment,” Post-obstructive pulmonary oedema may be prevented through use of a bite block during emergence.”

And so, let us finally consider the economics of managing a patient who develops negative pressure oedema from biting through their LMA. The first thing to say is that the patient would probably need to spend more time recovering in hospital either in the recovery room, on a ward, HDU or even ICU. Further investigations such as a chest x-ray or blood gas analysis might be needed. Interventions as described in the Difficult airway Society Guidelines may also be required.

Uncovering the daily cost of a hospital bed is not easy and the data is quite old. A stay in a hospital bed without factoring in investigations and/or interventions would cost approximately $1800/day in the USA, $AUD1000/day in Australia and £400/day in the UK. Private healthcare charges would be higher. In most health care systems around the world the daily cost of an ICU bed is in 4 figures. In the USA it is approximately $6000/day, Australia approximately $AUD4000/day and the UK approximately £2000/day. A bite block such as BiteMe™ costs $1.48 per patient and would reduce the incidence of negative pressure pulmonary oedema resulting in fewer patients needing to spend extra time in ICU.

I leave you to make your own mind up when it comes to cost effectiveness.

So, what can we determine from this article?

  • The incidence of NPPE is poorly understood and probably under reported.
  • NPPE can result in acute respiratory failure which is a dangerous and potentially fatal condition.
  • Biting through a laryngeal mask airway (LMA) is not an uncommon event.
  • Despite being recommended by the Difficult Airway Society the use of a bite block with a laryngeal mask airway is not a common practice.
  • Using a bite block in conjunction with an LMA would reduce the incidence of potentially fatal negative pressure pulmonary oedema caused by a patient biting through their LMA.
  • Using a bite block such as BiteMe™ to prevent NPPE caused by the patient biting through the LMA and the upper airway becoming blocked is a more cost-effective option than having the patient spend extra time in ICU.

By using a specifically designed bite block such as BiteMe™. Which is made of a very strong, but soft, plastic that resists the shear forces of a human bite very well reduces the risk of desaturation and/or Negative pressure pulmonary oedema if the patient’s airway device becomes obstructed.

The combination of the soft plastic surrounding a closed air-filled space means that when a patient bites down, there are two forces opposing the bite. This means BiteMe™ has a spongy recoil and therefore reduces the risk of the patient severing the LMA if they start biting during emergence.

biteme-insertion-2-900px.jpg
biteme-insertion-900px.jpg

References

  1. Bhaskar B, Fraser JF. Negative pressure pulmonary edema revisited: Pathophysiology and review of management. Saudi J Anaesth. 2011 Jul-Sep; 5(3): 308–313.
  2. Tami TA, Chu F, Wildes TO, Kaplan M. Pulmonary edema and acute upper airway obstruction. Laryngoscope. 1986;96:506–9.
  3. Heptinstall E, Heptinstall L. Should Bite Guards Be Used with Laryngeal Mask Airways In Adults? Best Evidence Topics Database (BestBETS). March 2015.
  4. Popat M (Chairman),Mitchell V, Dravid R, Patel A, Swampillai C, Higgs A. Difficult Airway Society Guidelines for the management of tracheal extubation. Anaesthesia 2012, 67, 318–340
niall-shannon-european-business-manager-innovgas.png

Author: Niall Shannon, European Business Manager, Innovgas

This article is based on research and opinion available in the public domain.

Original Post Here

Posted on Leave a comment

LifeFlow Blood and Fluid Infuser: Volume resuscitation when minutes matter!

LifeFlow offers improved resuscitation through earlier and controlled fluid delivery. LifeFlow is a hand operated rapid infuser for critically ill patients who require urgent fluid delivery. 

  • Controlled hand-operated rapid infuser
  • Easy to use, intuitive and safe
  • Four times plus faster than pressure bag delivering 500ml in less than 2 minutes
  • Reverses shock and restores tissue perfusion saving lives
  • Improves outcomes and reduces mortality
  • Easy set up and priming with set up in less than 40 seconds
  • Measured delivery with 10ml delivered with each trigger pull
  • Built in “force reducer” reducing infuser force protecting IV site from blow outs
  • Works with the QinFlow Warrior blood warmer
  • Eliminates “Pull/Push technique for pediatrics
  • Fluids can be delivered through 24 gauge catheter and blood through a 22g. 
  • 5 times faster than pressure bag
  • Great for hypotension
  • Safety system prohibits more than 200PSI pressure delivery

Click to view a short training video

Can be used with Warrior Blood and Fluid Warmer

Posted on Leave a comment

The face mask that could end the pandemic

By Keri Enriquez

Updated 10:24 AM ET, Sat January 23, 2021

 (CNN)Getting Americans masked up is a top priority for the Biden administration.

Biden, who calls wearing masks “a patriotic act,” signed an executive order Wednesday — his very first as President — to ask Americans to wear masks of their choice for the first 100 days of the new administration. The executive order also requires mask use on all federal property, though in this case, not just any old mask will do.

On Wednesday, after the inauguration, White House press secretary Jen Psaki showed off her bright white N95 mask in the press briefing room. “I wore it out, of course, here today and will continue to do that,” Psaki said after removing her medical-grade mask and before turning to questions.

CDC reports record number of daily Covid-19 vaccinations as states struggle with supply

N95 masks are considered the gold standard in personal protective equipment because they block 95% of large and small particles utilizing a unique electrostatic filter.

The filter works by trapping neutral particles like bacteria and viruses before they pass through the mask, protecting the wearer and those around them. It’s similar to how socks might get stuck to a blanket in the dryer. The N95 mask, which costs roughly $5, also fits securely to the face, eliminating most of the leakage that may occur with a loose-fitting cloth or paper mask.

Studies have shown that masks significantly decrease the chances of transmitting or contracting the coronavirus. But not all masks provide equal protection. Depending on the fabric and number of layers, homemade and simple cloth masks have a range of effectiveness that can be as low as 26%, which leaves the wearer vulnerable.

Some experts like Brigham and Women’s Hospital and Harvard Medical School physician Dr. Abraar Karan have been advocating for public use of N95 masks from the start of the pandemic. In an interview with CNN Chief Medical Correspondent Dr. Sanjay Gupta, Karan outlined why N95s are critical at this stage of the pandemic.

“If for four weeks the country essentially wore these masks in those risky settings like that indoors, what kind of difference do you think it would make?” Gupta asked.

“This would stop the epidemic,” Karan responded.

Dr. Gupta on Covid-19: This is the worst it’s ever been 05:46

The quality of protection a face mask can provide is crucial. A respiratory illness like the coronavirus is transmitted through aerosols, tiny particles that waft and hang in the air. Some virus-carrying particles are small enough to travel through or around lower-quality masks, making the wearer vulnerable to inhalation of viral particles.

“We know now that aerosols spread best when there is poor ventilation, crowding and close contact that’s prolonged,” Karan told Gupta in an interview. “So we were arguing that actually in those settings, cloth masks alone are not going to block aerosols.”

Karan is not the only expert who has been vocal in support of better quality masks for the general public. Former US Food and Drug Administration Commissioner Dr. Scott Gottlieb wrote in an op-ed in the Wall Street Journal that “encouraging Americans to wear higher-quality masks is a simple step that might make a difference.”

The biggest problem is lack of supply. This week marked a full year of the coronavirus, and the Biden administration has committed to invoking the Defense Production Act more often to boost manufacture of N95 masks and other critical supplies. Experts hope manufacturing will hit a speed to be able to sufficiently supply the population.

“An N95 that’s well-fitted clearly is the best that you can do,” National Institute of Allergy and Infectious Diseases Director Dr. Anthony Fauci told CNN Friday. “You could get production of that at a much higher rate now.”

Karan believes N95 masks could be an essential asset in reopening the economy as the vaccine rollout remains sluggish and quarantine fatigue soars.

The huge stakes of Biden’s new Covid-19 plan

“If we have better personal protection for people, they can more safely go back to work. They can more safely re-engage, especially if testing and tracing is not where we need it to be,” Karan said.

“This was going to be one way to get people back in and get the economy back up.”

Some European countries are already taking that step to prevent coronavirus spread within their borders. Earlier this week, Germany and France mandated that all citizens wear high filtration masks like the N95 in all public places.

After months of treating coronavirus patients, Karan says it’s time to invest in making sure masks people wear are even more effective. “Focus on getting better masks to as many people as possible, focus on the messaging around masks, be consistent with your messaging, make masks part of American culture to stop the epidemic.”

The key here is to always wear a mask whenever you’re in public. One study in Lancet Digital Health found that a 10% increase in mask-wearing could lead to a three-fold increase in the odds of maintaining control over virus transmission in a community. The ability to control the spread of the coronavirus is in our hands — and on our faces.

Original Article Viewed Here

Posted on Leave a comment

Novaerus Defend 1050 air purifier approved by FDA as 510(k) Class II Medical Device

Novaerus Defend 1050 cleared by FDA as 510(k) Class II Medical Device to inactivate and filter out airborne virus and bacteria for medical purposes

Defend 1050 uses patented NanoStrike® technology to damage and inactivate airborne micro-organisms.

Dublin, Ireland and Stamford, CT – Novaerus, a WellAir company that delivers clean air solutions to help prevent the spread of infectious outbreaks, announced today that the U.S. Food and Drug Administration (FDA) cleared the Novaerus Defend 1050 (NV 1050) as a 510(k) Class II Medical Device to inactivate and filter out micro-organisms, including virus and bacteria, for medical purposes. The Novaerus Defend 1050 is the first system that uses NanoStrike®, a patented plasma generating technology, to receive FDA 510(k) clearance.

The Novaerus Defend 1050 is a free-standing, portable recirculating air cleaning system designed for additional frontline protection in healthcare settings such as operating rooms, intensive care units, in vitro fertilization labs, emergency rooms, waiting and treatment areas, neonatal units, and other critical environments including those performing aerosol-generating medical procedures (AGMP).

The Defend 1050’s NanoStrike technology uses a plasma field that rapidly inactivates micro-organisms at the molecular level. Within 15 minutes, the Defend 1050 has demonstrated a 4-log (99.99%) reduction of the MS2 bacteriophage RNA virus, an accepted surrogate for SARS-CoV-2. The Defend 1050 also showed a 4-log (99.99%) reduction in Bacillus Globigii endospores (bacterial spores) within 15 minutes, which was maintained over the prolonged operation (24 hours).

The Defend 1050 is currently used in hospitals and healthcare settings worldwide. Given the rapid spread of COVID-19, WellAir moved quickly to understand how this device could potentially combat the virus while moving it through a thorough FDA medical device clearance process. Additionally, the Defend 1050 meets relevant performance criteria in the FDA Guidance, which provides non-binding recommendations that may reduce the risk of viral exposure for patients and healthcare providers during the current public health emergency.

“Our team of outstanding engineers and scientists have been focused on delivering innovative and powerful airborne infection control devices. The FDA clearance on the Defend 1050 is a critical milestone for our company, validating our work to deliver a safe and effective medical device,” said Dr Kevin Devlin, WellAir CEO. “The Defend 1050 has demonstrated tremendous efficacy in third party testing against viruses, bacteria, VOCs, and particulate matter, which makes it an ideal solution for hospitals and healthcare settings. As we continue to see an alarming rise in the number of COVID-19 cases, we have moved quickly to make the device readily available.”

Defend 1050 utilizes multiple stages to reduce airborne micro-organisms. The first stage is a general air pre-filter that captures particles between 4 and 10 microns from the input airflow. This filtered air passes through a series of NanoStrike coils (plasma generators) that damage and inactivate micro-organisms on contact, including viruses and bacteria. The resulting inactive particulates are trapped by a HEPA (High-efficiency Particulate Air) filter. In a final cleaning stage, an activated carbon filter traps VOCs in the airstream before the air is released into the environment.

The Defend 1050 system is delivered complete with all components necessary for immediate use. It can be wheeled easily by a single person to the desired point of use and plugs into standard outlets. Five airflow speed settings enable optimization to each healthcare environment. The only routine maintenance required is a calendar-based filter change schedule.

If you are a medical or healthcare facility interested in learning more about the Novaerus Defend 1050 or other Novaerus products, additional information can be found here, or please contact us

Posted on Leave a comment

Xavant Technology Announces First Dual-Sensor Neuromuscular Patient Monitor

The Stimpod NMS450X NMT monitor for Anesthesia first to feature both AMG and EMG modalities in one single, portable patient monitoring system.  

Pretoria, South Africa, October. 15, 2019 – Xavant Technology, a pioneer in neuromuscular monitoring and innovative neuromodulation modalities, announced an addition to the company’s newest generation of Stimpod neuromuscular transmission monitor – the capability of utilizing either of the two most industry prominent types of monitoring sensors, AMG and EMG. The new Stimpod system and EMG sensor accessory will be exhibited at the American Society of Anesthesia (ASA) Annual Meeting, October 19-21 in Orlando, Florida alongside the company’s entire Stimpod portfolio for anesthesia.

“We are excited to announce the EMG modality to our Stimpod line of monitors,” stated Corlius Birkill, CEO of Xavant Technology. “By offering, for the first time, anesthesiologists and clinicians a choice in using either AMG or EMG, we can give them unparalleled clinical and budgetary benefits.” Mr. Birkill continued, “We believe quantitative or objective monitoring of patients who are undergoing neuromuscular block for surgery should be the standard of care. Our goal is to provide physicians with the most optimal and efficient tools to achieve that standard.”

The latest update to the AMG-based Stimpod NMS450X monitor series will enable the use for the first time ever, a dual sensor objective neuromuscular transmission monitor that enables anesthesiologists the choice of using either acceleromyography (AMG) with a reusable sensor or electromyography (EMG) with a disposable sensor to manage patients undergoing neuromuscular block during surgery or while being cared for in the intensive care unit.

By adding an EMG sensor accessory to the Stimpod, clinician opportunities in monitoring will be maximized. Being able to choose either AMG or EMG at site of service, hospitals can perform cost-effective entire-surgery monitoring with the platform that is optimal for that specific case. While AMG is a proven, accurate and cost-effective technology, the EMG sensor will simplify how clinicians monitor patients in more restrictive surgical cases, such as robotic surgery where restricting the hands is common. The EMG accessory is pending FDA clearance.

“The Stimpod NMT monitor is simple and economical way for hospitals to drive patient safety, Operating room, PACU, and ICU efficiency, and manage their very expensive paralytic and recovery drug budgets,” stated Xavant Chairman Roche van Rensburg. “We believe the data is fairly conclusive that hospitals can enhance safety outcomes related to residual neuromuscular block by utilizing objective NMT monitoring. But also important is the power to more effectively manage the time and cost-of-care efficacy for the hospital – we believe the Stimpod system can make a tremendous positive difference on both fronts,” added Mr. van Rensburg.

About Xavant Technology

By Xavant Technology October 17, 2019