Shelf-life is the length of time you can expect a product to look and act as expected and to stay safe for use. This length of time varies, depending on the type of product, how it is used, and how it is stored. Medical devices containing highly sophisticated electronics that are lasting longer than before, raising the bar for safety and liability. The concept of shelf-life/expiration date was created to help consumers realize when a product should be discarded.
Expiration date of the medical device states the termination of shelf life. After expiration date medical device may no longer function as meant to. There are different parameters that must be considered to determine the shelf-life and expiration date of the medical device.
Implantable medical devices containing highly complicated electronics and they are lasting longer than before, so this is raising the bar for safety and liability. The concept of an expiration date was created to help consumers realize when a product should be discarded. Within the shelf life the product will remain safe and retain the desired sensory, chemical, physical, and microbiological characteristics. Understanding shelf life is essential in assuring the safety and quality of the product.
There are multiple parts in a medical device and the part with lowest shelf life determines the Overall shelf life of the device. Shelf life is essential in assuring the safety and quality of the product.
There are various factors that impact the shelf-life of a product, and they are specific to device:
- Sterilization and sterilizing method
- Storage conditions
There are two types of shelf-life testing.
- Real time ageing
- Accelerated ageing
Real time ageing: This testing is conducted at ambient conditions in actual real time in order to analyse the conditions of packages and/or products and the effects that time has on them. They are also performed to confirm the results of accelerated ageing on test samples.
Accelerated ageing: In accelerated stability testing product is stored at extreme stress conditions. In this case real-time testing is being done in parallel to confirm shelf-life testing results. This testing helps manufacturer to get their products to the market faster. The Accelerated Aging process is based on the relationship of temperature and reaction rate where an increase in temperature increases the reaction rate
To support US FDA 510k and CE Marking Requirements the shelf-life appropriate bench tests of real time ageing and Accelerated ageing should be submitted.