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How Labeling Influences HAI's

Written By: Noël Daigle

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With the current global pandemic of COVID-19 causing mass quarantine, and business doors shuttering to slow the spread of the disease, healthcare workers all over the globe are clocking in overtime to take care of an overwhelming number of patients.

In this time of crisis, we are experiencing massive shifts in the way we think, behave, and operate. While it has produced a lot of uncertainty, it has also meant the birth of ingenuity!

For Polyfuze Graphics Corporation, this means the introduction of an antimicrobial safety product in support of healthcare associated infections (HAIs).

According to the World Health Organization, the estimated incidence rate (for HAIs) in the United States of America (USA) was 4.5% in 2002, corresponding to 9.3 infections per 10000 patient-days and 1.7 million affected patients.”1

The CDC estimate agrees with the above WHO figures, “1.7 million infections, and 99,000 associated deaths each year.”2

The manner in which HAIs occur and are transmitted has not always been known, and while in the past it was a bit of mystery or at best, guesswork, we have gained a lot of knowledge in recent years that sheds light on HAI transmissions.

Many people (and probably many reading this) have personal stories, or know of someone who’s loved one has contracted a disease or infection from a healthcare setting. These are not always minor infections, but can often be dangerous and life threatening. MRSA, Ventilator Associated Pneumonia, Surgical Site Infections (SSI), and bloodstream infections, are just some of the common healthcare associated infections that many people suffer from.

As healthcare associated infections are proving to be the cause of death for 99,000 people per year that would could have otherwise been prevented, it is time to approach this tragic problem in an innovative and preventative manner. We can develop practical, cost-saving solutions that will effect positive change in reducing those staggering statistics over time, by developing protocol and technologies that are seen as a worthy investment to fight against HAIs.

We believe it’s not only possible, but also our duty, to drastically reduce the number of people who have had to see their loved ones fighting for their health and life from an infection that could have been prevented in the first place.

What Are Some Contributors to HAIs?

According to a study conducted by Stephanie A. Boone and Charles P. Gerba2, experts have seen increasing evidence that contaminated surfaces or fomites play a prominent role in the spread of HAI viral and bacterial infections.

“Fomites” are every non-living object, (or surfaces) in the medical environment which commonly attract and therefore carry disease causing pathogens. Materials such as clothes, utensils, and furniture, doorknobs, bedding, or handrails are common fomites. These surfaces are major attractants for bacteria and viruses. When exposure or contact occurs, bacteria and virus live on that surface, and can remain infectious (and therefore be transmitted) for upwards of several hours, days, or weeks.

Considering the wide array of equipment, items, and surfaces that are located in a healthcare facility, it is strange to think that many of the things used in a medical environment that are supposed to keep healthcare workers and patients safe from infections (nurses and doctors clothing, medical or bio hazard waste containers, laundry carts, divider curtains, etc), can actually become host to those bacteria and infections, literally harboring them and providing an environment for them to actively grow, thus becoming a conduit by which HAIs are spread to new victims.

In this article, we discuss the role that Low Surface Energy (LSE) Polyolefin plastics, such as polyethylene and polypropylene, play in the healthcare environment. We’ll also discuss the role of labeling, how that labeling reacts to LSE plastics, and how they too become infected-carrying fomites throughout their life and use.

Olefin based plastic is widely utilized in the medical industry,3 and is ideal for biomedical applications for several reasons. It possesses a high level of durability, which means it can stand up to both heat and cryogenic freezing. For example, Sharps Containers must meet 600 cycles of high temp pressure washing and detergent cleaning and autoclaving. It is also chemically inert, (meaning it does not react chemically with other substances). Because plastic is chemically inert, it is easily cleansed of bacteria or virus that could cause an HAI or spread infection. Once it is wiped down with a disinfectant solution, any bacteria or virus that might’ve been on the surface of the plastic is easily killed and removed.

Biohazard or warning labels used in the medical industry are required by law 29 CFR § 1910.1030 – Bloodborne pathogens4, which states: “warning labels must be affixed to prevent loss or unintentional removal.” Warning labels permanently convey critical information to healthcare workers and patients alike. Adhesive based stickers, In Mold Labels (IMLs), Heat Transfers, Hot Stamp Foils, and Screen-printing Inks are the more common types of labels currently used in a healthcare setting.

The problem with these current, widely used medical labels might not seem obvious at first, but we need to look into the matter more deeply.

What Makes Medical Labels Fail?

Problem #1. Incompatibility.

Every label method mentioned above is attempting to adhere or bond to polyolefin plastic products permanently and therein lies the issue.

The reason these label methods fail has to do with how they’re made. Multiple layers of incompatible materials. An adhesive-based or bonding substrate followed by printing inks and finished with a protective varnish or layer coating.

When damage occurs, either by these labels inability to adhere or bond to polyolefin plastics, or due to the damaging effects of disinfectants, detergents, cryogenic freezing, autoclaving or general use, the exposed edges, underlying layers and gummy adhesives caused by scratches become the perfect environment that harbors HAI causing virus and bacteria.

The irony is that while these very labels sole purpose is to provide instruction on how to safely handle infectious waste or substances, the label has itself becomes the breeding ground for bacteria and becomes unsafe for healthcare workers or patients to encounter. With 1.7 million affected patients (from HAIs), it’s important to recognize that there are improvements we can make to help ensure healthcare environments are safer for those who work and are treated in them.

Problem #2. The Polyolefin Plastics.

The problem is not that the labels currently and widely used are not being applied correctly, it’s that Thermoplastic Olefins are not easy for labels to adhere to, for several reasons.

For one thing, Olefin based plastics are a non-polar, low surface energy material. With a dyne/cm level close to Teflon™, nothing wants to stick to them. Because of this, thermoplastic olefins resist adhesion, and over time with repeated exposures to cleaning chemicals and detergents, will eventually “reject” the adhesive label. In order for adhesives to work, they must “wet-out” over the surface of a higher surface energy substrate to create a permanent bond while maintaining that bond over it’s life use through cleaning and use cycles. Polypropylene used in the manufacture of sharps containers for example have 97% less surface energy than stainless steel and are more similar to Teflon™.

Polyolefin plastics also expand and contract up to 18 times more than metals or other materials when exposed to cryogenic freezing or high steam autoclaving.

Outgassing is another reason adhesives fail. Agents used within polyolefin plastics to make them more structural and durable also cause outgassing to the outer surface, which will cause the adhesive label to fall off or peel up on the edges.

If you can imagine the plastic as a type of “body,” the plastic body rejects the foreign material of the sticker or the label. They are not working together cohesively as a unit.

Medical Labels that fail from falling off or become so damaged during use that they no longer warn or inform, puts healthcare workers and patients at risk. For example, “Failure to Warn,”5 leads to improper use of the product and is missing information about potential health risks that may be present, such as Biohazard Waste of Pathogens. Furthermore, label failure also leads to liability issues or the manufacturer or OEM and in the event of injury or death, it will NOT fulfill the safety/warning label’s essential job function, which is to warn of any potential danger. In order to protect both healthcare workers and patients, the label must be deemed legally adequate and it it’s been damaged or removed from the product, it cannot be considered adequate.

Economically speaking, a label that fails also means additional costs. A Sharp’s container, for example, undergoes around 600 intensive sanitation cycles of high heat pressure washing with heavy duty detergents as seen here: https://www.youtube.com/watch?v=RxCajbO2040. Labels that can’t stand up to the intense cleanliness standards of a medical setting, including harsh chemicals and autoclaving, will mean the label has to be replaced multiple times over its life use. Doing a cost analysis of replacing just one failed label on one medical container for instance reveals there’s room for much needed improvement, a factor that only multiplies exponentially when factoring multiple label failures over multiple product lines over multiple years of use and the costs associated (lost time, labor, label materials, additional waste).

Failed labels not only fail to protect people, they also fail to deliver on low cost and return on investment.  They can lead to potential litigation in the event that a safety/warning label was not present during the time of injury and costs associated. But they can also add to the costs of a HAI. Not only from healthcare workers and patients’ exposures to them, but according to the US National Library of Medicine, the overall direct cost of HAIs to hospitals which ranges from $28-$45 billion.6

Just like the COVID-19 Virus, the problem is complex, and multi-faceted, and though uncertainty surrounds us, we also tread forward with confidence, knowing the possibilities of ingenuity involving new ideas, perspectives, and technologies are waiting there to prove how valuable and worthy they are to solve the complex problems we face.

While we cannot solve every single problem surrounding HAIs, we can do our part to help prevent them.

Prevention #1. Compatible Prevention

What sets Polyfuze Patented Fusion Technology apart from all other labeling methods? 100% Compatibility.

Because Polyfuze Fusion Technology Labels are made of the same polyolefin plastic, they fuse molecularly into the subsurface of and take on the same attributes of the polyolefin plastic medical products they’re fused to (non-polar, low surface energy, expanding/contracting, outgassing). This successfully eliminates medical label failures by completely eliminating the source of those failures, multiple layers of incompatible materials (such as adhesive, inks, or substrates) attempting to adhere or bond.

Once fused, Polyfuze Fusion Labels are fully flush with the medical product surface making those products easier to clean and sanitize in the healthcare environment. No peeling edges, gummy adhesives or exposed under layers to harbor virus or bacteria. They are also 100% permanent for the life use of those products meaning they can successfully endure daily abuse, autoclaving and more for the life of those products.

Prevention #2. Antimicrobial Infusion

Polyfuze and its sister company Mold In Graphic Systems (MIGS) recently created a new antimicrobial product called PREVENT. The benefit of PREVENT is that it can be incorporated into the usual warning and biohazard labels offered by both Polyfuze and MIGS while opening the door to creative “outside the box” uses such as labels for grab points on Sharps containers, lift points on waste bins, and more. While both the Polyfuze and MIGS “flush surface” labels help to keep medical and waste containers free of areas for pathogens and bacteria to be harbored, PREVENT Antimicrobial will assist by inhibiting future bacterial growth and harboring. At a 10% loading, PREVENT provides 100-200ppb silver ion efficacy right at the surface where it’s most needed and most effective.

Mold In Graphic Systems (MIGS), has been in the Fusion Labeling business for rotomolded products since 1983 when Michael Stevenson invented the first Mold In Graphic. Since then, MIGS has invented several other products that help make rotomolded products better and the job a little easier for those who rotomold them.

Just like Polyfuze labels, PREVENT can be infused into a Mold In Graphic, allowing rotomolded medical products, food service products, laundry service products and more to have antimicrobial properties right at the surface where it’s needed.

But MIGS didn’t stop there. PREVENT has also been incorporated into a surface coating technology that’s easily sprayed into rotational molds prior to charging with polyolefin resin. During the molding cycle, molecular fusion melds the antimicrobial and polyolefin matrix into the surface of the final product.

Prior to PREVENT Antimicrobial Surface Coating Technology, rotomolded products required a 1%-5% loading of antimicrobial agent to be compounded into the base resin. This creates a two-fold issue. Additives compounded into polymers can degrade structural integrity and/or diminish product performance. The minimum of 1% antimicrobial agent load (by weight) is usually inefficient as it doesn’t return an acceptable release of silver ion efficacy. Increasing the loading, although helpful to increase efficacy, typically produces degradation while adding a substantial cost increase especially when the cost per lb. ranges from $50 to over $100.

In one study for a medical pallet application, using PREVENT Antimicrobial Surface Coating Technology reduced the cost of compounding antimicrobial into the 40lb. shot weight by a significant 81% savings in the 1% loading example, and stunning 96% over the 5% example.

But using PREVENT has other benefits beyond just antimicrobial. Rotomolded products are notorious for having surface imperfections such as pin holes, pores and voids after molding which can hold, harbor and allow the migration of virus and bacteria. Finely dispersed 100% compatible polyolefin compounds within the PREVENT mixture leaves products completely smooth, porous & void-free.

PREVENT Antimicrobial Surface Coating Technology makes rotomolded products easier to clean and sanitize while mitigating the growth of bacteria or harmful pathogens.

As healthcare associated infections statistics show, it is important to work together to provide worthwhile investments in technologies that will solve the complex problems that contribute to HAI related deaths. By focusing on effective solutions, we can provide contributions that will work cohesively with other innovative technologies to accomplish the goal of drastically reducing the number of HAI related deaths through the means of eliminating the possibility for infectious diseases to exist on surfaces and fomites as much as possible. By utilizing technology that produces medical labels that are consistently anti-microbial, flat-surfaced, 100% inert polymer, we can solve multiple problems that contribute to HAIs.

We can eliminate the problem of facing the exponential costs of essential labels needing to be replaced multiple times over the lifespan of the olefinic medical waste container or device. We can ensure that users can 100% expect that the information the label imparts will permanently exist.

We can reliably eliminate the existence of bacteria, virus, pathogens, and the spread of infection, by utilizing 100% polymer anti-microbial medical labeling technology that works cohesively with the plastic part it adorns.

By investing in worthwhile technologies, we can actively reduce or eliminate unnecessary costs and we can offer a solution that will help ensure that the medical labeling we use in medical settings is not contributing to the number of HAIs. Practical solutions, protocol, and innovation will lead the way to investing in technologies with the ability to improve our health and our lives.

  1. https://www.who.int/gpsc/country_work/gpsc_ccisc_fact_sheet_en.pdf
  2. https://patientcarelink.org/improving-patient-care/healthcare-acquired-infections-hais/
  3. https://www.medicalplasticsnews.com/news/opinion/material-gains_1/
  4. https://www.law.cornell.edu/cfr/text/29/1910.1030
  5. https://www.industryweek.com/the-economy/public-policy/article/22022797/failure-to-warn-vs-failure-to-read-recent-developments-in-product-liability-litigation
  6. https://www.leapfroggroup.org/sites/default/files/Files/Leapfrog-Castlight%202018%20HAI%20Report.pdf
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