Instrument Processing and Supply Management
From dirty to sterile
The reprocessing chain is only as strong as its weakest step: point-of-use treatment, transport in closed containers, decontamination with PPE, manual and ultrasonic cleaning of lumens, hinges, and box locks, inspection, packaging with appropriate wrap or rigid container, sterilization, monitoring, and storage. Cleaning precedes sterilization because bioburden and organic soil protect organisms. Follow the device manufacturer's written instructions for use for every step - that is the regulatory standard.
Sterilization and monitoring
Common modalities include steam (gravity and prevacuum), ethylene oxide, hydrogen peroxide plasma, and dry heat. Monitoring is layered: physical (gauges, printouts), chemical indicators (external and internal, verifying that the package met process parameters), and biological indicators, the most reliable evidence of lethality. Steam and hydrogen peroxide plasma use Geobacillus stearothermophilus spores; ethylene oxide and dry heat use Bacillus atrophaeus. A positive biological indicator quarantines and recalls the entire load. Implants are not released until biological monitoring is reviewed.
Sterile storage and rules of thumb
Sterility is event-related, not time-related: an item remains sterile as long as the package is intact, dry, and properly handled and stored. Storage areas require controlled temperature and humidity, limited traffic, closed cabinets, and shelves above the floor. The Spaulding classification guides disinfection level - critical items (entering sterile tissue or vasculature) require sterilization, semicritical items (contacting mucous membranes) require high-level disinfection, and noncritical items (intact skin) require low-level disinfection. Immediate-use steam sterilization is reserved for urgent situations with full monitoring and documentation.