Chapter 5. Probes 5 - 17
Cleaning and Disinfecting the Probe
Using an inappropriate cleaning or sterilizing agent may damage the product.
WARNING
■ Always use protective eyewear and gloves when cleaning and disinfecting
probes.
■ Inspect the housing, strain relief, lens and seal for damage, and check for
any functional problem after cleaning and disinfecting the probe.
▌ Information of Detergent, Disinfectant, and Ultrasound Gel
■ Classification of Disinfectants
To maintain the performance of ultrasound probes, proper maintenance is required.
As ultrasound probes are classified into critical, semi-critical, or non-critical devices based
on the standards of FDA guidance*, proper disinfection, cleaning or sterilization methods
for that classification should be used.
Classification
Criteria
Contact Area Application Probe Level Selection
Non-critical
device
Intact skin
Convex, Linear array, and
sector transducers
Low level disinfectant
Semi-critical
device
Mucous membrane and
damaged skin
Endocavity High level disinfectant
Critical device blood, sterile tissue, etc. Intraoperative, TEE
High level disinfectant or
sterilization
*Guidance for Industry and FDA Staff - Information for Manufacturers Seeking Marketing
Clearance of Diagnostic Ultrasound Systems and Transducers - Appendix D
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