The following sections provide the information and instructions for cleaning, disinfecting, and sterilizing transducers, cables, and connectors.
Choosing a Disinfectant
To choose an appropriate disinfectant, you first must determine the required level of disinfection, based on the device classification (see table 1).
Table 1: Levels of Disinfection Requirements
| Classification | Definition | Level of Disinfection |
| Critical | Device enters otherwise sterile tissue (for example, intraoperative applications) | Sterilization1 |
| Semi-critical | Device contacts mucous membranes (for example, endocavity applications) | High |
| Noncritical | Device contacts intact skin | Intermediate or low |
1High-level disinfection and the use of a sterile gel and a transducer cover, as described in the instructions provided with the transducer cover, is an accepted method of infection control for ultrasound transducers. See the FDA Guidance document "Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers," September 30, 1997, at the following Web site: 
www.fda.gov/cdrh/ode/ulstran.pdf.
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General Cleaning Procedures for All Transducers
These general cleaning instructions are indicated for all transducers. It is important that you clean the transducer and cable according to the following procedures.
Caution:
- Transducers must be cleaned after each use. Cleaning the transducer is an essential step before effective disinfection or sterilization. Be sure to follow the manufacturer's instructions when using disinfectants.
- Do not allow sharp objects, such as scalpels or cauterizing knives, to touch transducers or cables.
- When handling a transducer, do not bump the transducer on hard surfaces.
- Do not use a surgeon's brush when cleaning transducers. The use of even soft brushes can damage transducers.
- During cleaning, disinfection, and sterilization, orient the parts of the transducer that must remain dry higher than the wet parts until all parts are dry. This will help keep liquid from entering permeable areas of the transducer.
To clean a transducer
1. After every patient exam, wipe the ultrasound transmission gel off of the transducer.
2. Disconnect the transducer from the system and remove any transducer covers, biopsy guides, or tip guards.
3. Use a soft cloth lightly dampened in a mild soap or an enzymatic cleaner (in accordance with the manufacturer's instructions) to remove any particulate matter or body fluids that remain on the transducer or cable.
4. To remove remaining particulate and cleaning residue, rinse thoroughly with water up to the immersion point shown in figure 1.
5. Wipe with a dry cloth.
Figure 1: Immersion Point
Note: Enzymatic cleaners should have a pH of 6.0 to 8.0. These cleaners are further diluted during use. For a list of approved enzymatic cleaners, use the Find Compatible Disinfectants search tool.
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