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Why Sterile Packaging Is Crucial for Medical Devices

February 8, 2024|BY: Rob Helmke

The Impact of Sterilization on Medical Device Packaging
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Patients who need medical treatment often fear being exposed to harmful germs and unsanitary instruments. Just the thought of a healthcare provider using an unsterilized surgical device or needle is enough to make people feel queasy. As a result, patients find it reassuring to watch a clinician remove healthcare devices from sterile packaging before starting a procedure. 

Sterile packaging refers to non-reusable plastic shells, wrappings, and other packing materials that have been terminally sterilized by ethylene oxide (EO), gamma, or autoclave sterilization. Manufacturers use this packaging to ensure that medical devices, instruments, and other healthcare products stay germ-free. Sterile packaging has many advantages for healthcare providers, manufacturers, and patients. 

Read on to learn more about the importance of sterile packaging for medical devices and the specific sterilization methods used for them.

The Importance of Sterile Packaging for Medical Devices

The rising demand for medical care has led to a boom in packaging for healthcare products. Experts predict that the global consumption of medical device packaging will increase by 7.4% annually between 2021 and 2031. 

In response to this rapid growth, manufacturers have developed innovative ways to produce sterile packaging. The healthcare industry relies on this technology to protect medical devices and products from contamination. Sterile packaging also ensures that facilities and medical device manufacturers comply with industry regulations. Let’s take a closer look at the benefits of sterile packaging in healthcare settings. 

Preventing the Spread or Exacerbation of Diseases

Protecting patients from disease is the primary purpose of sterile packaging. Packaging like blister packs and pouches help prevent the spread of harmful germs that can make patients ill or exacerbate their symptoms. 

According to the World Health Organization, about 7% of patients in acute-care hospitals contract a healthcare-associated infection (HAI) while receiving treatment. HAIs are most likely to affect vulnerable populations like newborns and people receiving intensive care.

Many HAIs are related to medical instruments like catheters and IVs that have been improperly sterilized and become contaminated before use. The Centers for Disease Control and Prevention have identified these common types of medical device-associated HAIs

  • Catheter-associated urinary tract infections
  • Central line-associated bloodstream infections
  • Surgical site infection 
  • Ventilator-associated pneumonia 

Also, improperly sanitized medical devices can spread bacteria and viruses between patients and providers. For example, patients who receive central venous catheters may develop Candida auris, a yeast that can spread through the bloodstream. Similarly, medical devices like IV catheters and ventilators can increase patients’ risk of developing carbapenem-resistant enterobacterales such as E. coli

HAIs spread by medical devices can have serious consequences, including: 

  • Sepsis: An estimated 25% of hospital-treated sepsis cases are caused by HAIs.
  • Death: Approximately 10% of patients who develop HAIs will die. 
  • Increased Costs: Patients who contract HAIs often have a longer recovery time and require more specialized medical treatment. As a result, these infections lead to higher costs for patients, healthcare facilities, and insurance companies. The CDC estimates that these infections cost $28.4 billion yearly

Medical device sterile packaging plays an essential role in preventing HAIs. Research shows the use of disposable medical devices by healthcare facilities reduces the spread of disease. The medical professional removes the device from its sterilized packaging, uses it once, and discards it. 

Meeting Industry Requirements and Standards for Sterile Packages

Sterile packaging ensures that medical devices comply with industry standards. Device creators should search for an expert packaging manufacturer that’s intimately familiar with the specific requirements of the healthcare sector. 

FDA Requirements

The U.S. Food and Drug Administration (FDA) oversees the manufacturing of sterilized medical devices and their packaging. The FDA defines sterile packaging as a container-closure system with a microbial barrier. A container-closure system consists of packaging components like containers, stoppers or screwtops, administration ports, closure liners, and inner seals. These components work together to shield the medical device from germs. 

Packaging manufacturers must perform sterility tests to demonstrate that their containers will maintain package integrity and protect products for their whole shelf life. These tests can take several forms, such as: 

  • Bubble tests
  • Dye penetration tests
  • Immersion tests
  • Microbial challenge tests
  • Trace gas leak tests

If you’re in the market for a packaging manufacturer for medical devices, search for a company with a track record of receiving FDA approval for its packaging systems.  

ISO Standards

The International Organization for Standardization (ISO) also regulates the medical devices industry. Manufacturers who follow the ISO’s stringent quality control standards can receive ISO 13485 certification. Companies must demonstrate their excellence in five areas: 

  • Quality management system 
  • Management responsibility
  • Resource management
  • Product realization
  • Measurement, analysis, and improvement

Plastic Ingenuity has received ISO 13485 certification and designs all of its thermoformed plastic packages to conform to industry standards. 

The Sterilization Process for Medical Packaging Materials

Developing sterilized medical packaging is a multi-step process. First, the manufacturer works with the medical device creator to select the best packaging for its product. Popular packaging materials include: 

  • PETG: Many manufacturers use this plastic to create sterile barrier trays. 
  • HIPS: This impact-resistant material is often used to make sterile medical trays. 
  • HDPE: Manufacturers use this tough, versatile plastic to produce medicine bottles and plastic bags. 
  • PC: This light but durable plastic can be used to create housing for diagnostic tools and pharmaceutical packaging. 
  • PP: Manufacturers use this low-density, solid polymer packaging to create medical trays, pill bottles, syringes, and other devices. 
  • Tritan: This heat-resistant material can be used to package products with a long self life, such as surgical kits. 

Next, the manufacturer uses one of several techniques for sterilization, such as: 

  • Ethylene oxide (EO): This method uses EO, a colorless gas, to sterilize products. The manufacturer warms the products to 45° Celsius and places them in a sealed chamber filled with EO gas. Over 50% of medical devices have been sterilized with EO. Manufacturers typically use this technique with porous packaging materials that allow the gas to escape after sterilization. 
  • Ionizing radiation: This approach is also known as electron beam or gamma radiation sterilization. During this process, the packaged medical devices are placed on a conveyor belt and exposed to radiation until sterilized.  
  • Steam sterilization: The manufacturer places the packaged product in a sealed chamber and fills the space with steam. Companies frequently use this technique with porous packaging materials like paper and woven containers.

A thermoforming manufacturer can help you determine the most appropriate and cost-effective sterilization method for your medical device. 

Trust an Industry Leader in Thermoform Sterile Packaging

Thermoform sterile packaging ensures that your medical devices will reach patients safely. Plus, a stylish but functional package brands your product and helps it stand out from competitors. Plastic Ingenuity has four decades of sterile packaging knowledge. Our expert team can offer guidance on every step of the medical packaging process, including design, production, and distribution. Contact us today to get started.