High-Level Disinfection

+ Disinfecting Transducers + Disinfecting TEE Transducers
+ Disinfecting TEE Transducers with an Automated Disinfector+ Disinfecting Endocavity and Intraoperative Transducers 

 

Disinfecting Transducers by Immersion


This section provides information about using the immersion method to disinfect transducers. TEE, endocavity, and intraoperative transducers require unique methods for disinfection by immersion. For details, see Disinfecting TEE Transducers by Immersion and Disinfecting Endocavity and Intraoperative Transducers by Immersion.

WARNING: If a premixed disinfectant is used, be sure to observe the expiration date.

 

Cautions:

  • Using non-recommended disinfectants, incorrect solution strengths, or immersing a transducer deeper or for a longer contact time can damage or discolor the transducer and will void the transducer warranty.
  • Do not immerse transducers longer than the minimum time needed for your level of disinfection. For information on the levels of disinfection requirements, see Choosing a Disinfectant.

To disinfect transducers by using the immersion method

1. Clean the transducer according to the General Cleaning Procedures for All Transducers.

2. Mix the disinfection solution compatible with your transducer (use the Find Compatible Disinfectants search tool to find compatible disinfection solutions) according to label instructions for solution strength. A disinfectant listed in the search results with the footnote "FDA 510(k) cleared" is recommended in the U.S.

3. Immerse the transducer into the appropriate disinfectant for your transducer as shown (see figure 1). Follow the instructions on the disinfectant label for the duration of transducer immersion. Do not immerse transducers longer than the minimum time needed for your level of disinfection.

 

Disinfecting Transducers by Immersion

Figure 1: Immersion point.

 

4. Using the instructions on the disinfectant label, rinse the transducer up to the point of immersion, and then air dry or towel dry with a sterile cloth.

5. Examine the transducer for damage, such as cracks, splitting, fluid leaks, or sharp edges or projections. If damage is evident, discontinue use of the transducer and contact your Philips Ultrasound representative.

 

 

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Disinfecting TEE Transducers by Immersion


Disinfection by immersion is the accepted method of infection control for TEE transducers. Philips recommends that a protective transducer cover be used during examinations.

 

Upon receiving your new transducer, disinfect it before performing the first exam. Clean and disinfect the transducer immediately after each use to protect patients and personnel from a variety of pathogens. Establish and clearly post a cleaning procedure that includes the following steps.

WARNING: If you use Cidex OPA Solution, residual solution may remain on your transducers, if you do not carefully follow the manufacturer's instructions. Residual Cidex OPA on TEE transducers may cause temporary staining of the mouth and lip area and irritation or chemical burns of the mouth, throat, esophagus, and stomach.

To minimize the effects from residual Cidex OPA, or any other disinfectant, Philips recommends the following:

 

  • Follow the disinfectant manufacturer's instructions very carefully. For example, the manufacturer of Cidex OPA recommends soaking transducers three times in fresh water.
  • Use a protective transducer cover during endocavity and TEE exams.
  • Use a sterile protective transducer cover with sterile ultrasound transmission gel during intraoperative and biopsy examinations.
  • Limit the time that transducers are soaked in the disinfectant solution to the minimum time recommended by the disinfectant manufacturer (for example, the manufacturer of Cidex OPA recommends a minimum of 12 minutes).
  • Check for the required level of disinfection. The level of disinfection required for a device is dictated by the type of tissue it will contact during use. Ensure the solution strength and duration of contact are appropriate for the intended clinical use of the transducer. For information on the levels of disinfection requirements, see 6. Choosing a Disinfectant. Also, see the disinfectant label instructions and the recommendations of the Association for Professionals in Infection Control, the U.S. Food and Drug Administration, and the U.S. Centers for Disease Control.

 

To disinfect a TEE transducer by immersion

Before you begin, disconnect the transducer from the system.

Cautions:

  • Do not rinse or immerse the control housing, cable, or connector.
  • Do not bend the shaft into a circle with a diameter of less than 0.30 m (1 ft).

  • Do not use bleach on any TEE transducer.
  • Do not use strong solvents such as isopropyl alcohol, acetone, freon, and other industrial cleaners on transducers.
  • Do not soak the transducer for extended periods of time. Limit the time that transducers are soaked in disinfectant solution to the minimum time recommended by the disinfectant manufacturer.
  • Do not rinse or immerse the connector or the portion of the cable near the connector.
  • Do not immerse or rinse the steering mechanism.

Use the following procedure to remove all organic matter and other residue:

 

1. Soak gauze pads in mild, soapy water. Do not use iodine-based soaps.

2. Do either of the following:

  • Wipe the distal tip and flexible shaft up to the control housing (steering mechanism) with the gauze pads.
  • Use an enzymatic cleaner to assist in removing protein residuals. Enzymatic cleaners should have a pH of 6.0 to 8.0. These cleaners are further diluted during use. Follow the manufacturer's instructions for dilution.

 

3. Use water to rinse the distal tip and flexible shaft thoroughly.

4. Disinfect the distal tip and flexible shaft by placing them in the appropriate disinfectant, as listed in the results of the compatible disinfection solution search.

Note: Follow the recommendations of the disinfectant manufacturer.

5. Remove the tip and shaft from the disinfectant and thoroughly rinse with water according to the instructions for use from the disinfectant manufacturer.

6. Check the transducer for any residual organic material. If any is present, remove it and disinfect the transducer again.

7. Dry the distal tip and flexible shaft with a sterile cloth or pad, or allow it to air dry.

8. Lightly wipe the steering mechanism of the handle only, with a pad moistened with rubbing alcohol (70% isopropyl alcohol).

9. Hang the transducer on a wall-mounted rack and let it air dry.

 

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Disinfecting TEE Transducers with an Automated Disinfector


The TD-100 is an automated disinfector available from PCI medical. Further information about this product can be found at www.pcimedical.com. Use this disinfector only for those transducers listed as compatible in the results of a compatible-solution search.

 

To clean and high-level disinfect a TEE transducer in the TD-100 Automated TEE Disinfector

Before you begin, disconnect the transducer from the system.

Cautions: Do not rinse or immerse the control housing, cable, or connector.

Use the following procedure to remove all organic matter and other residue:
1. Soak gauze pads in mild, soapy water. Do not use iodine-based soaps.
2. Do either of the following:

  • Wipe the distal tip and flexible shaft up to the control housing (steering mechanism) with the gauze pads.
  • Use an enzymatic cleaner to assist in removing protein residuals. Enzymatic cleaners should have a pH of 6.0 to 8.0. These cleaners are further diluted during use. Follow the manufacturer’s instructions for dilution.

 

3. Use water to rinse the distal tip and flexible shaft thoroughly.

4. Disinfect the distal tip and flexible shaft by placing them in the appropriate disinfectant, as listed in the results of the compatible disinfection solution search.

Note: Follow the recommendations of the disinfectant manufacturer.

5. Check the transducer for any residual organic material. If any is present, remove it and disinfect the transducer again.

6. Dry the distal tip and flexible shaft with a sterile cloth or pad, or allow it to air dry.

7. Lightly wipe the steering mechanism of the handle only, with a pad moistened with rubbing alcohol (70% isopropyl alcohol).

8. Hang the transducer on a wall-mounted rack and let it air dry.

Cautions:

  • The transducer steering mechanism is not sealed. If disinfectant or other fluid enters the steering mechanism, it will corrode the gears and electrical connections. Avoidable transducer damage is not covered by the warranty or service contract.
  • Never sterilize the transducer with autoclave, ultraviolet, gamma radiation, gas, steam, or heat sterilization techniques. Severe damage will result. Avoidable transducer damage is not covered by the warranty or service contract.

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Disinfecting Endocavity and Intraoperative Transducers by Immersion


For transducers used in endocavity and intraoperative procedures, high-level disinfection by immersion and the use of a sterile transducer cover and sterile ultrasound transmission gel is an accepted method of infection control.

WARNING: Intraoperative transducers used in animal studies should not be used on humans. Transducer disinfection procedures for cross-usage between animals and humans have not been validated.

To disinfect endocavity and intraoperative transducers by immersion

1. Clean the transducer according to the General Cleaning Procedures for All Transducers.

2. Mix the disinfection solution compatible with your transducer (use the Find Compatible Disinfectants search tool to find compatible disinfection solutions) according to label instructions for solution strength. A disinfectant listed in the search results with the footnote "FDA 510(k) cleared" is recommended in the U.S.

3. Immerse the transducer into the appropriate disinfectant for your transducer as shown in (see figure 2). Follow the instructions on the disinfectant label for the duration of transducer immersion. Do not immerse transducers longer than the minimum time needed for your level of disinfection. For information on the levels of disinfection requirements, see Choosing a Disinfectant.

 

Disinfecting Endocavity and Intraoperative Transducers by Immersion 

Figure 2: Proper immersion.

 

4. Using the instructions on the disinfectant label, rinse the transducer up to the point of immersion, and then air dry or towel dry with a sterile cloth.

5. Examine the transducer for damage, such as cracks, splitting, fluid leaks, or sharp edges or projections. If damage is evident, discontinue use of the transducer and contact your Philips Ultrasound representative.

 

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