✅ Quality Assurance

Documentation & traceability

Quality assurance creates an auditable record proving that each load was processed correctly. Lot control labels link a sterilized item to a specific sterilizer, cycle, and date, enabling traceability to the patient on whom it was used.

Routine monitoring program

• Run a biological indicator at least daily (and in every load containing an implant, with that load quarantined until the BI result is known).
• Perform the daily Bowie-Dick test on pre-vacuum steam sterilizers.
• Document physical printouts, chemical indicator results, and operator initials for every cycle.
• Verify sterilizer maintenance and qualification testing after installation, relocation, malfunction, or major repair (three consecutive BI-negative cycles).

Failed loads & recall

1. If a BI is positive or a monitor fails, take the sterilizer out of service immediately.
2. Quarantine and recall all items processed since the last negative result.
3. Notify the appropriate departments and document the event.
4. Identify the cause, repair/retest the sterilizer (three negative BIs), and reprocess the recalled items.

Standards & regulatory bodies

Several organizations shape SPD practice. Knowing who does what is commonly tested:

• AAMI / ANSI — publish consensus standards (e.g., ANSI/AAMI ST79 for steam sterilization).
• HSPA (formerly IAHCSMM) — certifies sterile processing technicians (CRCST).
• The Joint Commission — accredits healthcare facilities.
• OSHA — worker safety regulations; CDC — infection-control guidelines; FDA — regulates devices and sterilants.