CRCST · Sterilization Process · 7 min read
Load Records, Lot Numbers and Traceability
- Explain the components, purpose, and proper application of load control numbers on packaged medical devices.
- Identify the required documentation elements for sterilization load logs, physical monitors, and process indicators across different modalities.
- Describe the protocols for implant quarantine, early release documentation, two-way traceability, and product recall procedures.
Load Control Numbers and Package Labeling
In the sterile processing department, every item prepared for patient care must be identifiable and linked to the equipment that sterilized it. A load control number, often referred to as a lot number, identifies the specific sterilizer used, the cycle run number, and the date of sterilization. Each sterilized package or container must carry a load control number or other identifier linking it directly to its sterilization record. The primary purpose of a load control number is to enable the recall and retrieval of items if a sterilization failure occurs, allowing a specific sterile package to be linked directly to its sterilization cycle and physical monitor records.
When constructing lot numbers, facilities often use Julian dates to represent the day of processing. Julian dates represent the consecutive day of the calendar year, from 001 to 365, or 366 in a leap year. For example, rather than writing a traditional month, day, and year, a facility might use day 032 to identify the first day of February. Load control information may be applied using approved labels, barcode printers, or other methods specified by facility policy. Before sterilization begins, the technician must apply this load identification to the outside of each package or container tag using an application method compatible with the packaging and sterilization process.
Technicians must handle package marking with extreme care to maintain package integrity. When marking a peel pouch, write only on the plastic side outside the seal area, and never on the porous paper or across the seal itself. Writing directly on the porous paper of a peel pouch can compromise the microbial barrier and contaminate the sterile contents with ink. Furthermore, only non-toxic, indelible markers approved for sterilization processes may be used to mark packages. In addition to the load control number, labels on wrapped packages should clearly identify the set name to eliminate unnecessary package opening before surgery.
Common mistakes
- Writing on the porous paper backing or across the heat seal of a peel pouch instead of on the plastic film outside the seal area.
- Releasing an implantable device before the biological indicator result is known without completing the documented emergency-release procedure.
- Assuming an intact package remains usable past an explicit manufacturer-assigned expiration date under event-related sterility practices.
- Returning recalled reusable items directly to clean storage or use without segregating and reprocessing them according to their instructions for use.
Key points
- Load control numbers identify the sterilizer used, cycle run number, and date of sterilization (often formatted as a Julian date from 001 to 365 or 366).
- Marking on peel pouches must be performed on the plastic side outside the seal area using approved non-toxic, indelible markers to avoid barrier damage and ink contamination.
- Sterilization load records are legal documents that must record cycle parameters, sterilizer ID, operator ID, cycle type, detailed contents, and physical monitor reviews in real time.
- Loads containing implantable devices must be monitored with a biological indicator process challenge device and quarantined until a negative result is verified, unless an emergency-release procedure is documented.
- Two-way traceability connects a medical device from decontamination, assembly, and sterilization directly to the patient's clinical record using manual logs or electronic tracking systems.
- A positive biological indicator requires halting sterilizer operation, supervisor notification, and using load records to recall items potentially back to the last satisfactory biological indicator.
- Recalled items must be segregated and completely reprocessed according to manufacturer instructions for use and facility policy rather than being returned to service.
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