Autoclaving uses pressurized saturated steam to achieve sterilization, eliminating all microbial life from medical devices and instruments in healthcare and laboratory settings. Meticulous labeling of every package is a required step that establishes an unbroken chain of evidence for sterility assurance. The physical label serves as the interface between the sterilized item and quality assurance records, supporting inventory management and regulatory compliance.
Required Information for Traceability
The label applied to a sterilized package must contain specific data points to ensure the item can be traced back to its sterilization cycle in the event of a recall. A clear description of the package’s contents, such as “Dental Mirror Set” or “Surgical Tray 3,” is the most important piece of data and must be written onto the package before sterilization begins.
Every label must visibly display the Date of Sterilization (Month/Day/Year), which dictates the item’s shelf-life and inventory rotation. A unique Load or Cycle Number must be recorded, linking the item to the official sterilization logbook and mechanical data of the run. The initials or identification number of the Operator must also be present to establish accountability for the preparation and labeling procedure.
Proper Application and Labeling Materials
The physical act of labeling is governed by rules designed to preserve the sterile barrier of the packaging material. When using paper-plastic peel pouches, information must be written only on the plastic side or applied to the sealing tape. Writing on the paper side can compromise the sterile barrier by driving ink through the material or blocking steam penetration during the cycle.
Only non-toxic, indelible markers or specialized pre-printed adhesive labels designed for sterilization use should be employed. Standard pens are prohibited because their inks can run, fade, or contain toxic substances that compromise sterility or legibility. The adhesive on pre-printed labels must be heat-resistant and validated to remain securely attached without leaving residue or distorting during the steam cycle.
Sterilization tape functions as a Type 1 chemical indicator, changing color upon exposure to steam and heat. This tape is often used to seal wraps and provides a surface for the required written information. While it confirms the package has been exposed to the process, it does not confirm the contents are sterile. Placement must ensure the information is legible and does not obscure any internal or external chemical indicators.
Connecting Package Labels to Sterilization Logs
The Load or Cycle Number connects the physical item to its electronic or paper record in the facility’s sterilization logbook. This logbook is the official quality assurance document, detailing whether the time, temperature, and pressure parameters were successfully met for that specific run. Without this documented proof, the item’s sterility cannot be confirmed, regardless of the package’s appearance or the external indicator’s color change.
For every cycle, the logbook must contain the date and time, exposure parameters, the operator’s initials, and the results of all monitoring, including chemical and biological indicators. If a biological indicator test fails, the Load Number allows staff to immediately isolate and recall every other package from that specific cycle. Regulatory bodies require these detailed logs to be maintained securely for a minimum of three years to ensure long-term clinical traceability.
This comprehensive record-keeping system allows a facility to quickly trace a potentially compromised instrument from the point of use back to the exact sterilization cycle. Ultimately, the label provides a fast visual check for staff, while the corresponding log offers the necessary scientific evidence of safety.