Sensitive medical devices and those that may pose high risk to patients, such as Class II to Class III under FDA regulations and Class IIb to Class III under European guidelines, require extra considerations for packaging performance. Considerations can range from preserving certain atmospheric conditions for drug eluting devices to ensuring the physical and functional integrity of the medical devices and products.

A research paper in the Journal of Orthopaedic surgery and research studied recalls from 2016 to 2021 for osteosynthesis implants and joint replacement implants, and found that the most common causes of recalls were packaging process control and nonconforming materials or components.

The packaging challenge for orthopaedic implants

If damaged or contaminated, orthopaedic implants pose a high risk to patient safety. Orthopaedic implants are made from robust materials and may have rough surfaces abrading the packaging. This abrasion can result in particulate breaches in the sterility, medical device imperfections, and immunoreactions or contamination once implanted. Packaging solutions must minimize the risk of oxidation, puncture and abrasion throughout the supply chain and ensure that sterility barriers are not damaged.

Among all medical devices, implants are especially complex: they often include mobile parts and multiple components assembled during the surgical procedure. Many of these components are protected using foams and liners within the holding tray which, while helping reduce abrasion, make packing the device more complex. This complexity increases device manufacturers' total costs, and most importantly makes use in the surgical theatre more complex as well.

To solve this challenge, understanding the medical device manufacturing and packing process, as well as the use-flow of the specific device, is critical. Amcor has developed a material that provides the required product integrity yet reduces the abrasion risk by combining the benefits of trays, foams and liners into one single solution. This provides all the necessary benefits with none of the extra costs.

A thermoformed solution for Class III medical devices

Amcor HealthCare™ OrthoSecure® Thermoformed Trays are a simplified solution to these challenges.

Specially designed with extra protection for devices such as femoral heads, stems and knee components; Amcor is the only packaging company that offers this type of packaging solution for orthopaedic implants and medical devices.

Amcor HealthCare™ OrthoSecure™ Thermoformed Trays offer many benefits:

1. Reduces infection risk for the patients by eliminating the need for foam, sleeves, and liners, decreasing the risk of particle contamination.

2. Offers better device protection due to an excellent cut and crack resistance, and abrasion-resistance equivalent to polyurethane liners.

3. Ensures enhanced formability, allowing for more complex geometries and improved device safety.

4. Improves the total cost for medical device manufacturers by reducing the number of required packaging components, as well as reducing weight, assembly time and complexity.

5. Delivers a better sustainability profile through the elimination of foams, sleeves, and liners, and simplification of the overall pack system. This lowers the carbon footprint of the packaging compared to standard solutions.

Beyond orthopaedics, these benefits can be tailored to many other medical devices. Amcor HealthCare™ OrthoSecure® Thermoformed Trays are available globally and produced at our Mankato facility for North America and at our new Sligo, Ireland facility for Europe.

You can read about our latest healthcare packaging investment in Sligo here.

Visit our product page to find out more. Or book a meeting with the team to start your packaging design journey today. You can also find further information on Amcor’s packaging solutions for healthcare on our website.