Post-Surgical Contamination of Rigid Endoscopic Instruments
Conditions
Brief summary
This study is a prospective, comparative trial designed to evaluate the cleaning effectiveness of a novel pulsed vacuum cleaning and disinfection device against a conventional vacuum ultrasonic cleaner for rigid endoscopic instruments. Key outcomes measured include cleaning time, cleaning quality (via visual, light source, and ATP inspection), protein residue levels, and instrument damage rate.
Detailed description
Rigid endoscopic instruments, due to their complex structure, pose significant challenges for cleaning and sterilization, which is critical for preventing hospital-acquired infections. Traditional methods like ultrasonic and spray cleaning have limitations in efficiency and thoroughness. This study was conducted to assess a newer technology, the pulsed vacuum cleaning and disinfection device, which integrates cleaning, rinsing, disinfection, and drying. A total of 800 rigid endoscopic instruments were divided into two groups: one cleaned with the pulsed vacuum device (Observation Group) and the other with a conventional vacuum ultrasonic cleaner (Control Group). The study aims to provide evidence-based insights into the efficiency, efficacy, and safety of the pulsed vacuum device for clinical application in sterilization supply centers.
Interventions
DEVICEPulsed Vacuum Cleaning and Disinfection Device
After manual pre-treatment, instruments were placed into the pulsed vacuum cleaning and disinfection machine (Shandong Xinhua Medical, Model PC-150L). The automated program included pulsed vacuum cleaning, rinsing, thermal disinfection (93°C for 2.5 minutes), and vacuum drying.
DEVICEVacuum Ultrasonic Cleaner
After manual pre-treatment, instruments were cleaned in a vacuum ultrasonic cleaner (Shandong Xinhua Medical, Model super-6000) with a multi-enzyme solution for a minimum of 5 minutes. This was followed by a separate process in a spray cleaning and disinfection machine for rinsing and drying.
Sponsors
Xue Wang
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Rigid endoscopic instruments scheduled for post-operative cleaning. * Types of instruments included: laparoscopes, hysteroscopes, arthroscopes, nephroscopes, prostate resection scopes, and thoracoscopes.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Protein Residue Detection | Assessed once per instrument, immediately following the completion of the single cleaning procedure (Day 0) | The level of residual protein on the instrument surface was measured using the biuret method. Outcomes were categorized as clean, mild, moderate, or severe contamination. The rate of clean instruments was compared between groups. |
| Cleaning Qualification Rate | Assessed once per instrument, immediately following the completion of the single cleaning procedure (Day 0) | The cleaning effect was evaluated based on the Hospital Sterilization Supply Center Part 3: Cleaning, Disinfection, and Sterilization Effect Monitoring Standards. Qualification was determined by a composite of three methods: * Visual Inspection: No visible contaminants. * Magnifying Light Source Observation: No visible stains or residues under magnification. * ATP Fluorescence Detection: Relative Light Unit (RLU) value ≤2000. The percentage of instruments passing all three checks was calculated. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cleaning Time | Assessed during a single time point event (the cleaning procedure on Day 0). The duration of the measurement is approximately 60 to 90 minutes. | Total time required to process all 400 instruments in each group, from the start of manual pre-treatment to the completion of the final drying step. Unit: Minutes. |
| Instrument Damage Rate | Assessed at a single time point: immediately after the completion of the single cleaning procedure on Day 0. | The number and percentage of instruments found to be damaged (e.g., deformation, breakage) after the complete cleaning and drying cycle in each group. |
Countries
China
Outcome results
None listed