Category Archives: Patient & Staff Safety

The STIC Intra-Compartmental Pressure Monitor System by C2Dx

by Rob Salter, Internal Product Specialist, C2Dx, Inc.

C2Dx is the exclusive manufacturer of the STIC Intra-Compartmental Pressure Monitor System previously supplied by Stryker. The company is led by a team of medical device industry veterans with years of experience providing superior products and service to customers around the globe. Our company is privately held and dedicated to providing world class products and service to healthcare professionals, while driving costs out of the healthcare continuum.

Compartment syndrome is one of the few true orthopedic emergencies and the consequences can be dire. A delay in diagnosis often leads to delayed treatment, causing irreversible muscle damage after 8 hours and irreversible nerve damage after 6 hours. The leading causes of malpractice claims filed against orthopaedic surgeons is missed compartment syndrome. These suits involve 87% delays in diagnosis and 37% delays in treatment, with 65% of total suits won by the plaintiff.

As described, time to diagnosis is one of the most prognostic factors, yet the ambiguity of the clinical signs may lead to delay. Many clinical exam findings are lagging indicators while pain out of proportion is the only leading indicator. Pain has low sensitivity, is considered subjective and on its own, inconclusive. Individual signs have only 13 – 54% sensitivity and 3+ signs are required for 98% sensitivity.

Recognized as the Gold Standard for over 30 years, the STIC Intra-Compartmental Pressure Monitor provides quick and continuous measurements, which adds valuable data to your clinical assessment for a prompt and more informed decision. Results show 94% sensitivity, 98% specificity, and 99% negative predictive value (Duckworth and McQueen, 2019).

Additional benefits of the STIC Monitor System include:

  • Sterile disposables for a simple, rapid set-up
  • Proven accuracy and reliability with strong clinical evidence
  • Hand-held with convenient pre-filled syringe for easy transport
  • Cost effective with a dedicated CPT reimbursement code

Click here to learn more about the STIC Intracompartmental Pressure Monitor System.

Examples of Who and Why Healthcare Institutions are Transitioning to Reusable Isolation Gowns

by Michael Benko

This year has been tough one for everyone including the professionals in charge of safety supplies, PPE and materials management. The struggle to keep healthcare employees safe during a pandemic is harder than it sounds. Covid-19 hit the world like a runaway train and unfortunately, it still hasn’t found its brake lever. The need for quality PPE, including isolation gowns is at an all-time high, but the supply remains elusive at best.

Prior to Covid-19, disposable isolation gowns were considered the typical answer to most Purchasing Directors’ question of “What type of isolation gown does my facility need?”. The disposable isolation gown was readily available from many overseas manufacturers, at a price that satisfied the bottom line. The number of gowns needed on any given day was low enough that any facility could order what they needed in advance and keep an ample supply level. My goodness, how things have changed.

Due to the increase in the need, and the decrease in availability, many hospitals and healthcare facilities have transitioned to reusable isolation gowns. This is not a new, or novel, idea. In fact, prior to the access to cheap plastic and polymer type materials over the last few decades, reusable items, including isolation gowns, were utilized at much higher rate than they are today. It wasn’t until the healthcare community was slapped in the face with a pandemic, and a need to change antiquated habits, that the idea and popularity of reusable isolation gowns came back into vogue. But the question that continues to come up is “Who has transitioned to, or who is already using reusable isolation gowns, and how have they done it?” The purpose of this article is to shed light on these questions.

Some proactive institutions that have led the way on this front. In some cases, due to the need that the H1N1 pandemic a few years ago revealed the lack of preparedness that the overall healthcare community was facing. In some cases, it was due to the massive amounts of waste and overuse of single use items. In other cases, it was due to the huge costs involved with having to purchase so many disposable items. Regardless of the reasons, the outcomes have been documented, and the benefits should be plastered everywhere.

Following is an excerpt from that was published back in December, 2015, following the impact of H1N1. The link to the article is here:

“Ronald Reagan UCLA Medical Center, located in West Los Angeles, began a reusable isolation gown pilot project in May 2012, starting with a liver transplant unit that was using 1,000 disposable isolation gowns per day. During a collaborative six-month trial period, the reusable isolation gown design was finalized and rolled out. The reusable gowns offer more comfort and better protection than their disposable counterparts, and can be laundered and reused 75-100 times. More than 3.3 million reusable gowns have been used at both hospitals since the implementation, representing a financial savings of over $1.1 million, on purchase alone. Since 2012, a total of 297 tons of waste has been diverted from landfills as a direct result of the reusable gown program.”

The savings in cost, and reduction in waste, were realized after only three years. We can only speculate the cost savings and waste reductions, since then, and since the current, arguably the worst, pandemic in modern history, Covid-19, wreaked havoc on the medical world. It goes on to say,

“Isolation gowns are used by practitioners, housekeepers, and visitors when entering the room of a patient on precaution. These gowns are single-use disposables. At Ronald Reagan UCLA Medical Center, on average approximately 6,000 gowns were being used per day (2.2 million gowns per year). In order to reduce the waste associated with isolation gowns, the academic and healthcare sides of UCLA came together in 2012 to pilot the use of reusable isolation gowns.”

It is easy to see that the benefits were plenty, and on many fronts. Although not all healthcare facilities were as forward thinking as UCLA prior to Covid-19, many have since made the transition to reusable isolation gowns since, due to the caring need that they were confronted with.

In a more recent article written by Will Maddox, published in Healthcare Business in May, 2020, and posted on (, the following statements were made:

“Alan Bonds is the general manager of the North Texas Health Care Laundry, which is a nonprofit cooperative owned by Baylor Scott & White Health, Texas Health Resources, and Methodist Health that launders linens, scrubs, and gowns for 50 hospitals and 500 clinics in North Texas. The nonprofit employs 300 people and processes about 1 million pounds of hospital laundry a week. When the pandemic began to grow, he placed orders for more reusable gowns and scrubs to be ready for what he thought was coming. 

 As more hospitals move to reusable PPE to avoid shortages, there may be economic and environmental benefits, but making sure hospitals are prepared for a second wave is reason enough to plan ahead. “The supply chains worldwide were caught off guard, who knew this was going to happen?” Bonds says. “Everyone is trying to be prepared so that next time this happens we are not caught off guard.” “

The article goes on to state the following with multiple quotes from Dr. Cohen:

“As the pandemic took hold, PPE was suddenly in high demand and price gouging became an issue. Manufacturers of disposable equipment are based largely in China and India, which were dealing with their own economic and health issues. By early spring, supply lines were cut off. Suddenly, reusable PPE became the alternative protection gear. “Studies show that reusable items are better for the environment, reduce solid waste generation, energy, water use and cut greenhouse gas emissions,” writes Dr. Murray Cohen, a now retired infectious disease epidemiologist.”

 “Reusable personal protective equipment, scrubs, patient gowns and other reusable healthcare garments have already proven safe and effective and more sustainable than disposable products,” writes Cohen, who notes that this equipment can be used 80 to 100 times rather than just once. “The utilization of reusable PPEs, once the industry standard, needs to be greatly expanded to prevent the types of shortages being experienced now at hospitals nationwide.”

The demand for reusable isolation gowns has grown exponentially and will continue to transform the norm, from disposable to reusable, for years to come. In a recent publication, even household names in the garment industry have begun to produce reusable isolation gowns. The following is an article regarding Hanes Brands, which is now producing reusable isolation gowns to be used by FEMA:

“The long-sleeve medical gowns are made from fabric designed to be splash resistant and can be washed and reused. They will be distributed by FEMA to hospitals nationwide and temporary treatment facilities.”

Green Leaf Medical Solutions, LLC was created to deliver the best-in-class, most comfortable, reusable, Level 2 Isolation gown to whoever needs it. To deliver it to them in the shortest time frame possible by utilizing a 100% American workforce and proudly claiming Made in the USA. But even reusable isolation gowns will eventually have to be discarded, and the idea of just reducing waste was not enough for Green Leaf Medical Solutions.

Thus, we created a closed loop system, that allows for the retired gowns to be returned to a repurposing facility, that will break down the used 100% polyester fabric and create new, usable polyester fabric. This is the closest thing the industry has to a zero-waste system, period.

EZ-USE Reusable Isolation Gowns allow for up to 50 washes before having to be retired. Once you have an order of them in rotation at your facility, you will always be only one laundry day away from a fresh, clean batch of isolation gowns. Compare that to the number of disposable gowns that you have to go through on a weekly, monthly, or annual basis. EZ-USE, Level 2 reusable isolation gowns give you the confidence that you will never run out of critical isolation gowns again.

Nevertheless, many facilities and healthcare organizations have NOT made the change to reusable isolation gowns. Many times, it is simply because of uncertainties, namely the cost and process of laundering.

First, what about the cost? We would be foolish to create a product that no one can afford. Yes, the cost to produce in the USA is more expensive than overseas production. Yes, the usage of premium materials has its price as well. That’s where the beauty of mathematics comes in.  You can reuse the EZ-USE reusable isolation gown up to 50 times vs. a disposable isolation gown only being able to lawfully be used once. When you divide the cost per gown, by the number of uses, and add in the cost to launder, the cost per use is around $0.83 cents. The current cost of disposable isolation gowns is still elevated from pre-COVID pricing and can be as high a $4.00 per gown. Even at pre- COVID pricing for disposable isolation gowns, the EZ-USE Reusable Isolation Gown is a BARGAIN!

Second, the process to launder reusable isolation gowns was clearly laid out by both the CDC and Joint Commission. The process is simple, fast and the laundering process is no more arduous than washing other materials. Highlights of the procedure to launder reusable isolation gowns is as follows:

– Do not shake dirty laundry; wear PPE when handling.

– Follow manufacturer’s instructions- warmest water setting for the item and dry completely.

-Dirty laundry that has been in contact with COVID-19 patient can be washed with general laundry.

– Clean and disinfect laundry room surfaces, washers, hampers or other carts for transporting laundry according to guidance for hard or soft surfaces.

− If using reusable gowns, notify laundry services.

This is why so many healthcare organizations, hospitals, clinics, and even the US government have started making the transition to reusable isolation gowns. If you are on the fence about how to protect your healthcare employees, doctors, nurses, and staff, and would like to discuss how Green Leaf Medical Solutions, LLC may be able to show you that our gowns are GREENER on the other side, feel free to reach out to me anytime.

Thanks for taking the time to read.  I look forward to helping you find a SOLUTION!

Michael Benko, Green Leaf Medical Solutions, LLC


To learn more about EZ-USE, Reusable, Isolation Gowns, please click here.

Why Recreate the Isolation Gown?

by Michael Benko, Owner, Green Leaf Medical Solutions, LLC

Green Leaf Medical Solutions, LLC was created to solve the problems that we saw in the Healthcare community when the world was introduced to the pandemic know as Covid-19. Prior to Covid-19 disposable isolation gowns were the norm. They were cheap, readily available, and the demand was low enough, that no one thought about the use of disposable isolation gowns as a primary focus point. Materials management, Supplies Directors, Purchasing Executives and the like, went about their daily tasks of ordering what they needed, when they needed it. Status quo worked. Why rock the boat if there isn’t a need?

Then Covid came along and shocked the healthcare community to the core. Hospitals were overrun. Demand skyrocketed for all PPE, including disposable isolation gowns, and so did the prices. The entire world was in a battle to source effective, compliant PPE. In addition to the need for more supply, political tensions heated up and international sourcing became even more difficult, time consuming, and expensive. The available supply of all PPE equipment dried up almost overnight, as the need continued to climb along with the positive cases of Covid-19. This is when, what we call, ’Crisis-Mode” occurred.

Nurses, doctors, hospital staff members, and HCPs were using whatever they could find to act as PPE. HCPs tried desperately to find new ways to protect themselves and their patients with limited supplies of isolation gowns, face masks, head covers and almost all other types of disposable PPE equipment. The FDA and Joint Commission even started to allow healthcare workers to reuse disposable PPE equipment and coined it “Conservation Methods”. Something that has never been done in the past, due to the risk involved. On August 14, 2020, that statement has since been retracted and facilities must now use 1 gown/patient/visit. Increasing, once again, the number of disposable isolation gowns that will be needed. Something had to be done. This is why Green Leaf Medical Solutions, LLC was created.

Green Leaf Medical Solutions, LLC didn’t invent the reusable isolation gown, but we did RE-INVENT the reusable isolation gown. In fact, we like to think that Green Leaf Medical Solutions, LLC PERFECTED the reusable isolation gown.

Most isolation gown users do not like utilizing a reusable isolation gown for multiple reasons. One being due to the inefficiency of donning and doffing, having to untie the gown in 2 separate places in hard to reach locations, often times after being ‘contaminated’. Another reason is comfort. Most reusable isolation gowns are created with the least expensive material the manufacturer can find. They are heavy, hot and stiff. Many times the fit is less than optimal as well. Leading to an increase in non-compliance and possible accidental contamination.

The patent pending EZ-USE design of the Green Leaf Medical Solutions Level 2 (ANSI/AAMI PB70), reusable isolation gown solves these issues, and more. The design of the EZ-USE Isolation Gown allows for SAFE, single person donning and doffing, and is as easy as tearing off a cheap, less effective disposable isolation gown. The 100% polyester material is the best in the business and has a tight weave, that gives the EZ-USE Isolation Gown, a soft, cool, comfortable feel. It’s presentation is professional and end users love to wear it. Green Leaf Medical Solutions designed a novel and unique thumb hole that is unparalleled in the isolation gown market. This unique thumb hole design allows for easy access to insert the thumb while donning the gown. As an added level of professionalism, any healthcare facility, hospital, workforce, or company can add their logo to the EZ-USE Level 2 Reusable Isolation Gowns at no extra charge. This adds a level of professionalism and uniformity to all who see it.

While attempting to solve the availability issues that Covid-19 brought to the healthcare community, Green Leaf Medical Solutions had to do something that very few companies are willing to do, MADE IN THE USA. We decided that every single part and piece, from the fabric weaving, to the cut and sew operations, had to be done in our own backyard. The fabric is produced in the state of North Carolina, and the manufacturing of the EZ-USE isolation gown is done in Georgia. Both within a stone’s throw from our headquarters in the great state of South Carolina. We are truly MADE IN THE USA, and we are very proud of that fact. This allows the ‘lead time’ to be very short. In most situations we can deliver up to

10,000 brand new, premium, EZ-USE level 2 reusable isolation gowns per week, with a lead time of only 2 weeks.

EZ-USE Reusable isolation gowns allow for up to 50 washes before having to be retired. Once you have an order of them in rotation at your facility, you will always be only one laundry day away from a fresh, clean batch of isolation gowns. Compare that to the number of disposable gowns that you have to go through on a weekly, monthly, or annual basis. EZ-USE level 2 reusable isolation gowns give you the confidence that you will never run out of critical isolation gowns again.

But what about the cost? We would be foolish to create a product that no one can afford. Yes, the cost to produce in the USA is more expensive than overseas production. Yes, the usage of premium materials has its price as well. That’s where the beauty of mathematics comes in…

With the EZ-USE reusable isolation gown, you are able to reuse it up to 50 times vs. a disposable isolation gown only being able to lawfully be used once. When you divide the cost per gown, by the number of uses, and add in the cost to launder, the cost per use is around $0.83 cents. The current cost of disposable isolation gowns is still elevated from pre-Covid pricing and can be as high a $4.00 per gown. Even at pre-Covid pricing for disposable isolation gowns, the EZ-USE Reusable Isolation Gown is a BARGAIN!

Lastly, and in our mind, the most important part, is the environment. The healthcare system in North America alone disposed of an estimated 5 million tons of single use plastic/polymer items into our landfills last year. That’s 10 BILLION pounds. That’s right, Billion… with a B! Green Leaf Medical Solutions, LLC is partnering with a 3rd party organization to take back all EZ-USE isolation gowns after they are retired. They will then repurpose the entire gown and reuse the created fabric. This is as close to a ZERO- WASTE closed loop cycle as possible. We may not be able to single handedly alter the course of the environment, but together, we can be part of the SOLUTION, instead of being part of the problem. As an added incentive to facilities choosing the path less traveled… the GREEN path, we offer 10% discounts on all future orders once the majority of the total EZ-USE gowns originally purchased are return to the repurposing facility.

That is the story of Green Leaf Medical Solutions, LLC. This is why we do what we do. Our goal is to help the healthcare community… Be safe, be prepared, look professional, feel good, be confident, save money, and do their part to help save this amazing planet…EARTH!

Please click here to learn more about the EZ-USE, Disposable, Isolation Gown.


Cost-per-Use Analysis and Reasons to use the EZ-USE Isolation Gowns

Why Choose EZ-USE reusable isolation gowns?

  1. The EASE-OF-USE of the patent pending “EZ-USE” design makes donning and doffing:

    a. Faster and easier, completely eliminating ties.
    b. Able to be doffed one handed, safely by a single user, without secondary assistance. c. More efficient, saving time and money.
    d. Safer, reducing the risk of cross contamination.
    e. More comfortable to the staff, potentially increasing compliance.
    f. Eliminates the need for additional staff members to don and doff for others.

  2. It is 100% Made in the USA and Berry Compliant:

    a. Green Leaf Medical Solutions, LLC is headquartered in Summerville, SC.
    b. The premium ANSI/AAMI PB70 Level 2 fabric is produced in North Carolina. c. The EZ-USE gown is manufactured in Swainsboro, GA.

    1. This allows for fast turnaround time; from P.O. to delivery in as little as 2 weeks.
    2. Decreases the risk of delayed shipments from international manufacturing.
    3. Increases availability vs. international manufacturing.
    4. Allows for constant and complete oversight of production; less risk of delays and

      receipt of faulty product.

    1. With reusable isolation gowns, you will always have a fresh supply of gowns each day.
    2. Covid-19 taught us that the availability of important PPE equipment can disappear faster than than we can reorder it, without any warning, putting you in a crisis situation.

    c. Using “Conservation Methods” was a bandaid on a bullet hole, which lead to some getting unnecessarily sick, and is no longer permissible according to Joint Commission.

    1. Reusable isolation gown utilization allows for constant availability of supply, no matter the situation.
    2. Decreases the stress and hassle of having to constantly reorder sub-par, inferior gowns, over and over again, saving your time for more important things.
  4. COST, plain and simple.
    1. With up to 50 uses per reusable isolation gown, the cost per use is about the
      same as pre-covid pricing pricing for disposable gowns, even with the cost to launder included.
    2. The average cost of the EZ-USE gown is $26.50/gown (depending on volume).

    c. Divide $26.50 by 50 uses and the cost per use is $0.53 cents per use.

    1. Due to recent shortages and price gouging in the PPE marketplace, the cost of

      disposable gowns has skyrocketed to prices in excess of $5.00+ per gown. In this

      current situation, the cost for the EZ-USE gown is significantly LESS EXPENSIVE.

    2. Regardless of the cost of single use disposable gowns, over the life of the EZ-USE

      Reusable Isolation Gown, including cost to launder (see below), it saves you money.

  5. But what about the cost to launder?

    a. The average cost to launder reusable gowns is $0.35 (cents/pound). The EZ-USE gowns weighs 13.9oz. Thats 87% of 1 pound equating to circa $0.30 per washing.

    b. Once you add the $0.53 cents/use/gown to the $0.30 cents/wash/gown, the total cost of the EZ-USE gown is approximately $0.83 cent/per use.

    c. That is only $0.83 cents per use vs. as high as $5.00 per disposable.
    d. Even pre-Covid pricing would have a hard time competing with that, plus the quality of

    product, ease of use, comfort, convenience, availability, and overall appearance, is worth so much more!

Michael Benko: 843.934.8700

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Disposable Gowns








$0.86(includes laundry costs)






Example Scenario #1:

If your facility uses 1000 isolation gowns/week:

Cost per Unit:
Number Needed/week: Cost to Purchase: Number of uses per gown: Time to Reorder:
Cost to Launder:
Total cost per use:
Total cost/50 weeks:

Savings every 50 weeks:

Example Scenario #2:


If your facility uses 10,000 isolation gowns/week:

Disposable: $4.00

1000 $4,000 1 Weekly $0



EZ-USE: $28.00

500 $14,000

50 Weeks

$0.30 $0.86


Disposable: $4.00

10,000 $40,000 1

Weekly $0 $4.00


EZ-USE: $28.00 5,000 $140,000

50 Weeks

$0.30 $0.86


Cost per Unit:
Number Needed/week: Cost to Purchase: Number of uses per gown: Time to Reorder:
Cost to Launder:
Total cost per use:
Total cost/50 weeks:

Savings every 50 weeks:
Disclaimer: Prices given in example scenarios are averages. Some prices may be subject to change

$1.78 Million



PATRAN® Slide Sheets, an Inexpensive and Efficient Way to Safely Move Patients

By Stefanie Scott

Repositioning and transferring patients are among the most common tasks that lead to healthcare worker injuries, the U.S. Occupational Safety and Health Administration reports. A low-tech, low-cost slide sheet can assist in most of these patient-handling tasks, reducing the risk of injury to caregivers while increasing patient comfort.

With no installation or accessories required, PATRAN® slide sheets (sometimes referred to as friction-reducing devices, slips, glide sheets or lateral transfer devices) allow healthcare organizations to start a safe patient handling and mobility program with little financial investment and quickly prevent some of the most frequent and debilitating musculoskeletal injuries incurred by healthcare professionals.

Slide sheets are designed to slide, not lift a patient, so there is no weight limit to who can be moved with a PATRAN slide sheet. However, larger patients may require using a larger size or multiple slide sheets so the entire body fits.

PATRAN single-patient, multiple-use slide sheets can be used in just about every area of a hospital or health care setting. With the full-body size, log-rolling a patient is not required to insert the PATRAN under a patient, which can prevent pain, dislocation or further injury in orthopedic patients. From pre-hospital emergency response to radiology, surgery and orthopedic medical floors, slide sheets have a number of patient handling and mobility uses.

The following are just a few reasons why PATRAN slide sheets are the industry leader:

PATRAN slide sheets can be used 30+ times with the same patient before they lose their slip, which is generally more than sufficient for an acute care patient.

PATRAN moves in all directions, so one tube-shaped sheet can be used 20+ ways, including lateral transfer, repositioning/boosting in bed, getting slings on patients and even putting on compression hose.

PATRAN is inexpensive, especially based on its size. The original PATRAN at 72×36 fits most patients’ entire body. Smaller slide sheets, many at a higher price point, require additional caregivers to hold the head and feet of the patient or the body parts hanging off the slide sheet increase the friction and skin shear.

PATRAN helps prevent cross-infection. Patients get their PATRAN upon entering a healthcare facility and it stays with them throughout their stay. Then it’s disposed of upon discharge. It can be used in just about every area of a hospital. PATRAN is radio-translucent, is latex-free and contains an anti-stat.

PATRAN comes in more styles than any other single-patient-use (sometimes called disposable) slide sheet brand. In addition to the original PATRAN, smaller and larger (bariatric), as well as individually wrapped versions are available.

PATRAN doesn’t require log-rolling to get it under a patient. The size, flexibility and slipperiness give caregivers options about how to insert it and methods of use that allow them to take the patient’s medical condition into consideration.

Click on PATRAN SLIDE SHEET to see the PATRAN listing on

Stefanie Scott is President of Jamar Health Products, Inc., manufacturer of PATRAN® slide sheets. She is a Certified Safe Patient Handling Associate through the Association of Safe Patient Handling Professionals.

Accepting the Risks in Medical Education and Medical Practice

by Douglas Dirschl, MD

In a March 17, 2009 article in the New York Times, Dr. Richard Friedman, a professor of psychiatry at Weill Cornell Medical College, discusses the nearly universal preference patients have for a seasoned physicians over residents or physicians just out of training.  The strong perception is that physicians learn from experience, implying that the “practice” of medicine is just that – a process of continual learning and improvement.

How does one learn in medicine? Clearly, one large component has been intensive exposure to medical practice within the supervision of residency training programs.  Dr. Friedman points out to us, however, that there may be an inherent conflict at the heart of medical training: “what may be best for making a skilled, independent-thinking doctor may not always be best for patient comfort or safety”. We want our young physicians to be competent, knowledgeable, and confident, yet we also have a responsibility (and increasing scrutiny from regulatory and legal agencies) in protecting patients from the medical errors that could result from a physician’s inexperience.

All residents, at some point, leave the relative security of training and go out on their own. Some experts are now questioning whether medical training programs are striking the right balance between education and training and patient safety to produce physicians who can function optimally. Dr. Friedman argues that restrictions imposed by resident duty hour limitations, decreasing amounts of resident autonomy due to concerns of patient safety, and regulatory groups mandating that some medical complications should never occur, have combined to create a generation of young physicians who lack confidence in their ability to make judgments about patient care. In the pursuit of patient safety, we now deliberately prevent residents from acting independently on their own judgment in situations where a patient poses a theoretical risk.

It is said that 90% of orthopaedic residents currently go on to do fellowship training after residency. Is this because orthopaedics has become so highly complex that 5 years is not sufficient time to master it all, is it that residents completing programs today have less self confidence in their own abilities than the generation of physicians before them, or is it that society expectations have increased and it now expects ‘perfection’ of every physician, no matter how experienced. The answer is probably “yes, yes, and yes”.

To date, there are no reliable national data that regulatory changes in resident work hours, patient safety initiatives, or ‘never events’ (for example, CMS has determined that no patient should have a DVT after an orthopaedic procedure, and won’t pay for it if a patient does), have had a significant impact on preventable medical error or patient mortality rates. There is a cost to the development of professional identity of young doctors, arguing that it is hard to feel confident and independent unless you are given ample opportunity to stand on your own — and risk making a mistake.

There is no doubt that all physicians in training – and those in practice as well – pose an inherent risk to patients.  We should do everything we can to minimize this risk but recognize that doing so will probably impair physicians’ self-confidence.  We may end up with a generation of physicians who, by virtue of the environment in which they have trained, are more hesitant, more uncertain, and less self-confident that the American public might like.

Click here to read the full text of Dr. Friedman’s article.

Dr. Douglas R. Dirschl is Frank C. Wilson Distinguished Professor and Chair of Orthopaedics at UNC School of Medicine. He also serves on the Own the BoneSteering Committee and chairs the Critical Issues Committee for the American Orthopaedic Association.

Patient Warming: The Inside Story

by Scott D. Augustine MD, Augustine Temperature Management

October 15, 2015

 Almost 30 years ago, I invented a forced-air warming system for surgical patients and introduced it to the medical world.  Now, I am proclaiming that forced-air warming, in certain circumstances, is a danger to patients.  Given the irony, I thought some people might be interested in the full story.

 I was a new anesthesia resident at the Naval Hospital in San Diego when I first encountered perioperative hypothermia. Nearly all patients were clinically hypothermic on admission to the recovery room in 1981, and no one thought twice about it.  Despite using all available patient warming equipment (i.e. water mattresses, airway heaters, and fluid warmers) hypothermia was ubiquitous and considered an accepted part of surgery.

I started asking postoperative patients and found that “freezing to death” was the most memorable aspect of surgery.  My interest was piqued.

What was clear from the literature is that under anesthesia, general or conduction anesthesia, we all become poikilothermic.  Just like the reptiles, we gain or lose heat depending on the environmental temperature.  The challenge was obvious: how to produce a warm environment around a patient without requiring the whole room to be warm, as was the common practice in pediatric surgery.

During my spare time as a resident, I started working on an inflatable air blanket that would wrap around the patient and circulate warm air. The first prototypes were very crude and made of plastic sheets that were heat-sealed together using a clothes iron. The first blower was a hairdryer. It took a lot of prototyping and refining, but by 1988 forced-air warming (FAW) was launched in recovery rooms across America.

It was a good product that solved a need.  The “need” morphed from simply providing thermal comfort to avoiding the many recently documented negative physiological effects of hypothermia.  Hundreds of published studies demonstrated that mild hypothermia had an adverse effect on nearly everything that we studied: increased soft tissue wound infections, increased bleeding, increased adverse cardiac events, increased mortality, and increased hospital stays among other things.

FAW changed surgical practice and measurably improved the outcomes of hundreds of millions of surgical patients over the past 25 years.

I left Augustine Medical (renamed Arizant) at the end of 2002. Arizant was subsequently sold to a private equity firm and later to 3M.  After sitting out my two-year non-compete, I formed a product development company with no intention of getting back into patient warming. We were working on reliably producing a bubble of HEPA-clean air over a pillow for allergy and asthma reduction when we stumbled on the FAW waste heat rising phenomena.

Forced-air systems produce 1000 watts of heat at 40 ft/m3. Convective heat transfer is not particularly efficient, so only about 50 watts of the heated air gets transferred to the patient. We learned that there is a significant unintended consequence of that waste heat. The remaining 950 watts of waste hot air vents near the floor, heats the contaminated air resident near the floor, and then rises alongside the table into the sterile surgical field carrying contaminants with it.

For 18 months we studied the rising waste heat from every angle.  Bottom line–the waste heat rises 100% of the time, which is not surprising since it is a basic principle of physics.

Even though I had been gone from the Company for six years, I was feeling terribly responsible for the unintended consequences of my invention.  Digging into the research, we found that while soft tissue infections require contamination of over 1 million bacteria, the biofilm that can form on implanted material allows a single airborne bacterium to cause a devastating periprosthetic joint infection.  Clearly implant patients, especially orthopedic implant patients, were the “at-risk” group.

The fact that a problem turned up with forced air warming after 20 years on the market is certainly not unheard of in the medical device or pharmaceutical industries.  For example, Cox-2 NSAIDs—after many years on the market–now carry a “black box” warning to not use if you have coronary artery disease.  They are still very good drugs, just don’t use them if you’ve got heart problems.  Similarly, I believe that forced-air warming should have a “black box” warning: “do not use in implant surgery, especially orthopedic implant surgery.”

I became a doctor to help patients, not hurt them. I have the same motivation as an inventor, so I invented a safe alternative to FAW:  air-free HotDog® patient warming. It’s the only warming system that can warm from above and below the patient simultaneously, which is far more effective than either above or below individually. HotDog® uses conductive fabric to deliver safe, even warmth—no blowing air or water—resulting is a uniquely versatile, more effective warming solution.

Over the next short while, six independent studies were published corroborating our research showing that the rising waste forced air heat contaminates the sterile surgical field with contaminants from the floor.  One study by Legg et al showed 2000 times more contaminating particles in the air above the surgical site with FAW than with HotDog® warming.  McGovern et al published their study showing that their deep joint infection rates dropped 74% (1437 patients, 2.5 years, p=0.028) when they discontinued FAW in orthopedics. They switched to HotDog® for safely maintaining normothermia.

I let the manufacturer know about the problem with FAW, urging them to take action, offering business collaborations.   Their response was massively negative. The more research that was published showing contamination and infection risk, the more adamant their denials.  They have no credible research to refute the published waste heat studies—zero studies. With no research to promote, they instead decided to start a personal smear campaign against me and the HotDog® product, as if that could possibly solve their problem.

A company can obfuscate, confuse and mislead for awhile, but eventually their customers and plaintiffs lawyers catch on.  About two years ago, a law firm out of Houston filed two product liability lawsuits against that FAW manufacturer alleging that their clients’ devastating knee infections were caused by the waste heat from FAW. By August 2015, a Google search of “FAW infections” revealed over 100 law firms advertising for injured joint implant patients.  Many of these firms are also advertising on TV.  These mass tort lawyers are well funded and seem to be very well organized.  They have already filed for Multidistrict Litigation (MDL) certification in Federal Court. It is reasonable to assume that there could be tens of thousands of plaintiffs.

We at ATM are just 3rd party bystanders watching the litigation show.  While I feel terrible that my invention is causing catastrophic infections, I also feel that I’ve done everything that I could reasonably do to warn both the FAW manufacturer and the medical community.  FAW remains a useful tool, just not in ultra-clean surgeries like orthopedics. That is where air-free warming is the safer alternative.

Dr. Augustine is a retired Anesthesiologist and inventor of the HotDog® Warming System.