Saturday, September 23, 2023

Common Mistakes in Medical Device Labeling and How to Avoid Them

LabelingCommon Mistakes in Medical Device Labeling and How to Avoid Them

In the realm of medical device labeling, avoiding common mistakes is paramount to ensuring safety, compliance, and effective communication.

The global medical device labeling market analysis predicts steady growth from 2022 to 2029, with an expected CAGR of around 6.86%. It is valued at US$ 856.70 Mn in 2021 and is projected to reach US$ 1456.63 Mn by 2029.

The medical device industry plays a crucial role in modern healthcare. It produces many of the varied devices used to treat patients and save lives worldwide. These products are vital to medical professionals and their patients, from dialysis machines to medical waste containment systems.

These devices ‘ proper usage, storage, and transportation are crucial, so medical devices require accurate, consistent, and highly durable labeling.

Importance of Labeling in the Medical Device Industry

Medical Waste presents an ideal introduction to the importance of labeling for the medical industry and the necessity for permanence. Without a truly permanent application, the crucial roles that medical labels play become irrelevant.

Medical waste can be categorized into several classifications, each having distinct requirements.

Regulated Medical Waste containers have very specific and important job descriptions. They securely store and transport biohazardous medical waste. Every year, hospitals in the United States generate an astounding 5.9 million tons of medical waste.

Regulated Medical Waste Containers

If these are not properly contained, they may pose a serious threat in the form of exposure to disease and other potentially harmful pathogens. Medical waste container labels, therefore, serve a specific and vital purpose:

Proper Instructions

Some medical devices may be unsafe if used incorrectly. It poses a threat not only to patients but also to medical personnel. Clear and informative medical labels on devices are required per OSHA 29 CFR 1910.1030. It is crucial to provide the vital safety warnings, usage, and storage instructions that users need to avoid injuries or accidents.

Keeping Users Safe

Medical devices such as medical waste containers have to be sanitized regularly. Many of these containers experience over 500 sanitation cycles. It means the labels must endure the same cleanings to warn and inform throughout their useful lifespan effectively.

Optimizing Efficiency

A durable medical device label can also aid the overall efficiency of any hospital, clinic, pharmacy, or laboratory. They provide staff with the clear and informative text they need to make quick decisions and find the appropriate devices and items they require without any wasted time or inconvenience.

The main point is this: Both the durability of the container and its labeling must not fail throughout all years of service, no matter the sanitization cycles they endure.

Common Mistakes in Medical Device Labeling

As we can see, medical device labels are important and must be able to function for the duty they serve. To do so, they must be durably permanent and safe to handle. Unfortunately, there’s one major issue that thwarts both points:

Difficulty in Labeling the Device Material

Most medical waste containers are made of high-density polyethylene plastic (HDPE). This plastic is chosen specifically for its superior performance, including puncture and chemical resistance, ease of sanitization, and long service life as a reusable product.

However, the performance properties that make HDPE such a versatile material for reusable medical waste containers also make it problematic for common “adhesion-based” warning labeling methods available today (e.g., pressure-sensitive adhesive, in-mold, hot stamp foil, heat transfer, silk screen, pad printing and more). These problematic characteristics include the following:

Non-Polar, Low Surface Energy

As one of the most “non-stick” plastics in the world today, the “stickiness” of HDPE closely resembles the characteristics of Teflon®, meaning it ultimately rejects adhesion.

Expansion and Contraction

These plastics naturally expand and contract within hot/cold environments at a rate 18x more than metals. The adhesion-based labels made of foreign material will expand and contract at a different rate than the container, so much like a band-aid applied over a knuckle, the expansion and contraction of the plastic container will cause the label to fail.


Plastics like HDPE have microscopic pores which release gas in a process called ‘outgassing.’ After molding, these plastics naturally outgas over long periods, causing labels to bubble and lose adhesion.

Harsh Environment Exposure

In addition to these natural characteristics, medical waste containers are consistently subjected to extremely harsh environments such as sanitation cycles, extreme temperatures, chemicals, and pressure washing throughout their several-year lifespans, further degrading or delaminating adhesion-based labeling.

Real-world examples prove that adhesion-based labeling methods continuously fail to inform and warn. These failed labels leave users uninformed and exposed to contents inside, and the label has also become an unintended safety risk.

Damaged label construction layers and exposed adhesives become safe-harbor sites where medical waste pathogens colonize and multiply, protected from disinfectants and sanitization practices.

What’s left?

A medical waste container without permanent, fully integrated labeling is a major threat to the safety of everyone involved.

Common Mistakes in Medical Device Labeling

Damaged or missing medical labeling fails to meet regulatory requirements, leading to containers and their contents being improperly stored, transported, or disposed of, which may even prove life-threatening. To say that permanent labeling on medical waste containers is important would be a severe understatement.

Failure to Meet Regulatory Requirements

The medical industry is highly regulated, with strict rules about label size, font size, warning color and symbol usage, layout, placement, etc. Every single label needs to be produced by guidelines, and the reason for this is that medical devices are critical items and can be so dangerous if used incorrectly.

As mentioned before, OSHA 29 CFR 1910.1030(g)(1)(i) addresses this. The problem is that if the label is not permanently durable due to the device material and can be either directly or indirectly removed, it will ultimately fail to meet these stringent regulatory requirements.

Inaccurate or Incomplete Instructions for Use

Even though “a federal requirement doesn’t regulate instructional use” labels, the informative nature of proper use is still important.

Damaged or missing labels cannot instruct or warn of potential harm. Thus, users are put at risk of potentially hazardous results.

Again, these labels must be durable and perform for the product’s lifespan regardless of the environment they are placed in.

Contaminated Surface Transmission

While the focus has always been on the sanitization of the medical container itself (The Centers for Disease Control and Prevention have made the transmission of HAIs one of their top priorities), labels have not had the same focus, and that’s an issue.

The potential for certain labels to harbor bacteria, viruses, or other HAI (Healthcare-associated Infection) causing pathogens that could potentially come into contact with users is an understatement.

Surface attached Pressure Sensitive Adhesive Labels (PSA), for example, use multi-layer constructions and adhesives that, when damaged, allow for the harbor of HAIs as they are difficult to sanitize effectively.

The Solution for Medical Device Labeling

As we can see, some serious mistakes and issues are related to most medical device labels. Fortunately, there’s a simple method to eliminate these problems while meeting regulatory demands and keeping users safe.

The Importance of Choosing the Right Labeling Technology for Medical Products

Choosing the most appropriate labeling technology for medical products manufactured from these “difficult to label” polyolefin thermoplastics is paramount. A permanent label must be “cohesive” and specifically engineered for 100% compatibility with these polymers.

Solving Medical Labeling Challenges with Polymer Fusion Technology

This is where technology like Polymer Fusion Labeling comes in.

Enhanced Compatibility: Overcoming Labeling Challenges with Polymer Fusion Technology

Polymer Fusion Labels offer a superior alternative to forcing non-compatible adhesives and ink substrates to adhere to polyolefin’s “adhesion-rejecting” nature. These labels are crafted from fully compatible polymers that fuse with the product through heat application, ensuring a lifelong bond.

Polymer Fusion Technology

After application, the heat-fused label seamlessly integrates with the part. It allows for expansion, contraction, and outgassing without compromising permanency. This ensures the label remains securely affixed and durable throughout the product’s lifespan, regardless of environmental or internal changes.

Additionally, these labels withstand sanitation cycles, extreme temperatures, chemicals, and pressure washing, just like the medical waste container. They exhibit exceptional resilience without degradation or the risk of failure.

Sustainable Solutions: Reducing Waste and Ensuring Permanent Medical Labels with Polymer Fusion Technology

Traditional labeling methods utilize potentially harmful adhesives and multi-layer constructions that can harbor microbes.

Polymer fused labels offer inherent resistance to microbes due to their complete integration into the base polymer at the surface level. This integration eliminates the possibility of bacteria accumulation, providing a hygienic labeling solution.

As a result, these labels become permanent fixtures on medical products, remaining intact throughout the product’s entire lifespan, regardless of the environment or exposure they endure. They cannot be lifted, separated, or removed, ensuring long-lasting identification and traceability.

This also means true sustainability by reducing waste in the medical industry. Another problem with traditional labeling methods that needs to be addressed is that they contribute to two types of waste.

One type of waste occurs when traceability labels become damaged, fail, or separate entirely. This leads to losing important data regarding the container and its contents, resulting in confusion and procedural waste for organizations and personnel.

Additionally, these failed labels contribute to environmental pollution as they end up littering the surroundings.

A second type of waste exists due to traditional “foreign material” labeling methods incompatible with fully recyclable polyolefins.

Fully compatible and permanent Polymer Fusion Labels possess recyclability and serve as a comprehensive medical label solution.

By integrating seamlessly with the base polymer, they eliminate separate adhesive layers and minimize the risk of label failure. This integration significantly reduces waste in the medical industry and contributes to long-term sustainability.

Why Permanent, Durable Labeling Matters

The importance of medical device labeling cannot be overstated. Failed labels pose a significant risk by jeopardizing the knowledge of handlers and potentially harboring bacteria within the adhesive layers.

Furthermore, they lead to the loss of critical data and tracking information, hampering effective inventory management and traceability. The only solution is fully compatible and truly permanent medical labeling.


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