Resterilized

Resterilized refers to an item that has undergone sterilization a second or subsequent time after an initial sterilization or after a potential contamination event. In healthcare and laboratory settings, resterilization is commonly discussed in the context of reprocessing equipment and supplies that were originally intended for single use or for items that have already been sterilized.

In medical contexts, resterilization is part of broader reprocessing programs for single-use devices (SUDs) where allowed by law and by the device manufacturer’s labeling. Reprocessing typically involves cleaning to remove soils, disinfection, inspection and functional testing, sterilization, and resealing in sterile packaging with traceable lot identification. Many devices are labeled “single-use” and are not approved for resterilization; others may be approved for multiple uses under validated protocols. Regulatory status for resterilization varies by jurisdiction and device.

Common sterilization methods used for resterilization include steam autoclaving, dry heat, ethylene oxide gas, hydrogen peroxide plasma, and other low-temperature methods. The choice depends on material compatibility, device design, and prior exposure history. Repeated sterilization cycles can affect material properties, lubricants, seals, and lumens, potentially impacting performance or increasing the risk of residual contaminants.

Standards and regulation emphasize validated processes, sterility assurance levels, and traceability. Agencies and standards bodies (for example, in some regions the FDA, EU medical device regulations, ISO 13485 for quality management, and specific sterilization standards) govern how resterilization is conducted and documented. The decision to resterilize balances cost, environmental considerations, and patient safety, with many contexts favoring new disposable devices. See also sterilization, reprocessing, single-use device, and sterilization validation.