Resterilization

Resterilization is the process of sterilizing an item again after it has already been sterilized or reprocessed. In healthcare, it is a component of reprocessing reusable medical devices and instrument sets, performed to restore or ensure sterility between uses or after contamination during handling. The term can describe the sterilization step within a broader reprocessing cycle, which typically starts with validated cleaning and disinfection, removal of bioburden, drying, and inspection, followed by the sterilization step and post-sterilization handling.

Processes for resterilization require validated procedures, process controls, and documentation. Items are cleaned to a specified cleanliness level, dried, inspected for damage, and then packaged for sterilization. Sterility assurance is established through monitoring, including chemical indicators and biological indicators, with cycle parameters validated for the device type and material.

Common sterilization methods used in resterilization include steam sterilization (autoclave) for heat-stable devices, dry heat, and low-temperature methods such as ethylene oxide, hydrogen peroxide plasma, vaporized hydrogen peroxide, and peracetic acid systems. The choice depends on device compatibility, material tolerance, and risk of damage from multiple sterilization cycles. Regular load monitoring, equipment maintenance, and adherence to validated cycles are essential.

Not all devices are eligible for resterilization. Many items labeled as single-use are not permitted to be resterilized, and regulatory guidance often restricts or prohibits this practice. Resterilization is governed by quality management systems and regulatory oversight (for example, ISO 13485, national regulations; FDA in the United States, CE marking in the European Union) and requires traceability to ensure patient safety.