GB/T 38497-2020 in English
VALIDEvaluation method of endoscopic disinfection effect
- Issued on:2020-03-06
- Implemented on:2020-10-01
- File Format:PDF
- Delivery:Via email within 1~3 business days
$97.00
《GB/T 38497-2020内镜消毒效果评价方法》由628（国家疾病预防控制局）归口，主管部门为国家疾病预防控制局。
Introduction
Analysis of the core content of the standard
This standard establishes a dual evaluation system including laboratory tests and simulated field tests in view of the particularity of endoscope disinfection. Among them:
| Test type | Applicable objects | Core indicators | Judgment criteria |
|---|---|---|---|
| Laboratory test | All disinfectants/machines | Kill logarithmic values of 6 types of microorganisms such as Escherichia coli | ≥5.00 (bacteria)/≥4.00 (viruses, spores) |
| Simulated field test | Self-produced disinfectant equipment | Pseudomonas aeruginosa+subtilis spores | ≥5.00+≥3.00 |
Technological breakthroughs and innovations
The standard first simulated endoscopy test device (polytetrafluoroethylene tube, total length 2000mm) has bacteria-contaminated carriers set at three locations of 50mm/1000mm/1950mm to truly simulate clinical usage scenarios. Key innovations include:
- Dynamic disinfection test: A flow rate of 0.1-0.2L/min is used to simulate the flow of liquid in the endoscope cavity
- The most difficult point to disinfect: The carrier at 1950mm represents the most difficult distal part of the endoscope to clean
- Sealing verification: A sealing film is used at the connection to ensure the accuracy of the disinfectant penetration test
Implementation points and suggestions
Application guide for medical institutions
Taking the digestive endoscopy center of a tertiary hospital as an example, the key points for implementing this standard are:
- Disinfectant selection: Prioritize products that have passed the subtilis spore killing test (≥5.00)
- Process optimization: Establish a double-check disinfection process in accordance with clause 6.2.2.3
- Effect monitoring: Conduct biological monitoring according to the indicators in 5.2.1 every month
Analysis of standard evolution
Compared with previous specifications, this standard has three major improvements:
- More comprehensive coverage: Added detection requirements for Mycobacterium chelonae (a representative of non-tuberculous mycobacteria)
- More stringent requirements: The killing value of Pseudomonas aeruginosa was increased from 3.00 to 5.00
- More scientific methods: Introduced the quantitative killing logarithm value (KL) calculation formula
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