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How Medical Packaging Protects Patients

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Medical packaging is more than just a pouch, tray or lid; it’s a critical component in the protection of patients. Effective packaging systems are designed to perform three essential functions: enable sterilization, maintain sterility, and allow for aseptic presentation. Each of these functions plays a vital role in protecting patients and ensuring the safety of medical devices. 

1

Enabling Sterilization

Before a medical device reaches a patient, it must be sterilized to eliminate all microbial life. Medical packaging must be compatible with various sterilization methods such as steam, ethylene oxide, or gamma radiation. Some forms of sterilization, like steam and ethylene oxide, need materials that are breathable to allow sterilizing agents to penetrate and effectively sterilize the contents. Other sterilization methods, like radiation, can go through unbreathable substrates. This is why it is important to know your method of sterilization when selecting your packaging material. You can learn more about sterilization methods and their effects on sterile barrier packaging in this blog article. 
2

Maintaining Sterility

Once sterilized, the packaging must function as a sterile barrier system, ensuring that sterility is preserved throughout storage and transportation. The materials used in this packaging are essential to maintaining that sterile barrier. Differences in, for example, puncture resistance can make a difference. A sharper or heavier device might need a material with a higher puncture resistance. Also, to maintain the sterile barrier it is important to carefully select the correct material. Because even minor breaches in the packaging can compromise the barrier, allowing contaminants to enter and posing serious risks to patient safety. 
3

Aseptic Presentation

Finally, packaging must allow healthcare professionals to open and present the healthcare device without contaminating it. This is especially critical in operating rooms, where maintaining a sterile field is paramount. Packaging designs must support intuitive, clean opening techniques that minimize the risk of touch contamination.  

To ensure these functions are met, manufacturers follow the ISO 11607 standard, which outlines requirements for materials, design, and validation testing of packaging for sterilized medical devices.  

By fulfilling these three roles, medical packaging significantly reduces the risk of Hospital Acquired Infections (HAI’s). That is why it is very important to think about the way you design your packaging and which materials you are going to use. In the end, they are protecting the patients.    
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