Validation of low-temperature steam with formaldehyde sterilization for endoscopes, using validation device

Area of Science:

• Medical Device Validation
• Sterilization Technology
• Gastrointestinal Endoscopy

Background:

• Sterilization validation is critical for medical equipment safety before clinical use.
• Adequate sterilization validation for endoscopes remains underreported due to a lack of suitable validation devices.
• The development of specialized validation tools is essential for ensuring endoscope safety.

Purpose of the Study:

• To validate the sterilization efficacy of the low-temperature steam with formaldehyde (LTSF) sterilizer for gastrointestinal (GI) endoscopes.
• To assess the performance of a novel validation device for endoscope sterilization (VDES).
• To confirm the reliability of LTSF sterilization for Olympus endoscopes.

Main Methods:

• The study utilized two types of VDES (validation device for endoscope sterilization) prototypes, designed to mimic gastroscopes and duodenoscopes.
• Each VDES contained a biological indicator within a dual-tubing system to test sterilization effectiveness.
• The VDES devices were subjected to a 60-minute LTSF sterilization cycle.

Main Results:

• Complete eradication of bacteria was confirmed by biological indicator culture after LTSF sterilization in all 10 experimental trials for both VDES types.
• The VDES effectively demonstrated the efficacy of the LTSF sterilizer in eliminating microbial contamination.
• The results indicate successful sterilization of the tested endoscope models.

Conclusions:

• The LTSF sterilizer is confirmed as an effective method for sterilizing Olympus GI endoscopes.
• The commercialization of VDES will facilitate reliable sterilization validation for endoscopes.
• VDES enables the evaluation of sterilization reliability when integrated with endoscopes in sterilization devices.