Presterile

Presterile is a term used for medical devices, supplies, or components that have been sterilized and packaged in a sterile state by the manufacturer or a third-party sterilizer, and are intended to be used directly in a sterile environment without additional sterilization steps at the point of use. Presterile items are typically designed for single use, though some devices may be suitable for limited reprocessing according to the manufacturer’s instructions and local regulations.

Packaging and indicators: Presterile items are placed in sterile barrier packaging designed to maintain sterility until the package is opened. Packaging often includes a sterilization indicator that confirms the sterilization process was carried out and a lot or batch number for traceability. Common sterilization methods include steam (autoclave), ethylene oxide (ETO), radiation (gamma or electron beam), and dry heat.

Regulatory scope and standards: The sterility claim is supported by validated processes and testing, with guidelines provided by regulatory and standards bodies such as ISO, ANSI/AAMI, and, in some regions, the FDA. Sterility assurance levels and packaging integrity testing underpin quality control. Items may carry an expiration date indicating the period during which sterility is guaranteed if the packaging remains intact.

Handling and storage: Presterile items should be stored according to the manufacturer’s conditions, protected from moisture, heat, and damage to packaging. Before use, inspect packaging for integrity and verify the expiration date and lot information. Do not use items with compromised packaging or past their expiration. While presterile, these items should still be handled within aseptic practices to preserve sterility.