Optimizing packaging for sterile medical devices
The design of packaging for sterilized medical devices represents a critical challenge for stakeholders in the medical packaging industry. This process, both complex and decisive, must ensure a perfect interaction between the medical device and its packaging system to guarantee efficiency, safety, and performance until used by healthcare professionals.
The vital role of packaging in the medical industry
Packaging for medical devices is essential because it enables sterilization and ensures product protection. It maintains the sterility of the device until its use and allows for aseptic presentation. Key elements such as the specificity of the medical product, the sterilization methods employed, intended use, as well as durability, transportation, and storage conditions are fundamental in the design of suitable medical packaging.
Current data and impact on patient safety
According to data from the National Agency for the Safety of Medicines (ANSM), nearly 5% of medical device recalls are attributed to packaging failures (ANSM, 2022). These packaging errors can have serious repercussions, including post-operative infections and sometimes fatal consequences, highlighting the importance of reliable medical packaging.
Experience feedback and product recalls
The recall of cardiac devices in 2019 due to stent contamination caused by packaging failure (FDA, 2019) illustrates the importance of rigorous monitoring and continuous improvement in the design of packaging for medical devices.
Compliance with standards and testing protocols
Compliance with ISO 11607 is proven through various standardized tests and procedures, including:
- ASTM F1980: Protocol for accelerated aging of medical packaging.
- ASTM D4332: Conditioning for packaging testing.
- ASTM F1929: Method for detecting leaks in porous medical packaging.
- ASTM F2096: Bubble test for detecting major leaks.
- EN 868-5: Specifications for sealable pouches and reels.
- ASTM D4169: Performance testing for packaging transport systems.
- ASTM F 2338: Non-destructive tests for leak detection.
- ASTM F2054: Evaluation of the resistance of flexible package seals.
- ASTM D3078: Determination of leaks in flexible packaging.
- ISO 4180 : General performance tests for packaging.
Regulatory evolution and ISO standards updates
The revision of ISO 11607 in 2020 introduced additional criteria for the validation of medical packaging designs, with a focus on environmental impacts and risk management, marking a step towards enhanced patient safety and increased ecological responsibility.
Packaging design for sterilized medical devices is essential to ensure the effectiveness, safety, and performance of the product until its use. It provides physical protection and maintains the sterility of the medical device.