Medical device reprocessing — the cleaning, disinfection, and sterilization of reusable devices between patient uses — is one of the most regulated and critically important infection control domains in healthcare. Lapses in sterile processing have caused documented transmission of hepatitis B, hepatitis C, and bacterial pathogens in endoscopy units, surgery centers, and dental offices. The Spaulding classification system — developed in 1968 and still the regulatory and clinical foundation — categorizes devices by risk of infection transmission.
Spaulding Classification: Critical, Semi-Critical, Non-Critical
Critical devices (enter sterile tissue or vascular system): surgical instruments, implants, cardiac catheters, needles — require sterilization (sterility assurance level 10⁻⁶). Any alternative is not acceptable — single-use critical devices should never be reprocessed unless FDA-cleared for reprocessing. Semi-critical devices (contact mucous membranes or non-intact skin): endoscopes, laryngoscopes, vaginal probes, respiratory therapy equipment — require high-level disinfection (HLD). HLD kills vegetative bacteria, mycobacteria, most fungi, and viruses but may not destroy all bacterial endospores. Minimum HLD agents: glutaraldehyde ≥2%, OPA ≥0.55%, hydrogen peroxide ≥7.35%, peracetic acid-based systems. Non-critical devices (contact intact skin): blood pressure cuffs, stethoscopes, bedpans — require low-to-intermediate level disinfection with EPA-registered hospital disinfectant.
Sterilization Methods
Steam autoclave (gravity and pre-vacuum): gold standard for heat-stable, moisture-tolerant devices. 132°C for 4 minutes (pre-vacuum) is the standard cycle. EtO (ethylene oxide): required for heat- or moisture-sensitive devices (flexible endoscopes, electronics, plastic components). Long aeration time (12–48 hours) needed due to residue toxicity. Hydrogen peroxide gas plasma (Sterrad): heat and moisture-free, 30–55 minute cycles — increasingly preferred for delicate devices. Peracetic acid liquid sterilization (Steris system): for immediate-use steam sterilization (IUSS/flash sterilization) reduction and endoscope sterilization. For healthcare facilities managing sterile processing, our OR & Surgery catalog includes sterilization wrapping, indicator tape, and surgical supply products, and our medical gloves section includes sterile surgical gloves for sterile field maintenance.
