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December 1, 2013 Volume 77, Number 12
Updated and New Joint Commission FAQs: Laryngoscopes and Endotracheal Tubes Ana Pujols-McKee, M.D.
Chief Medical Officer of The Joint Commission

Beverly K. Philip, M.D.
ASA Vice President for Scientific Affairs

Maureen Amos, M.S.



Based on the volume of questions received from organizations and the number of related findings identified during surveys, The Joint Commission has updated its FAQ (Frequently Asked Questions) about laryngoscope blades and expanded it to cover handles. In addition, it was determined that a new FAQ on endotracheal tubes (ETTs) was needed. Both FAQs can help organizations comply with Infection Control standard IC.02.02.01: The organization reduces the risk of infections associated with medical equipment, devices, and supplies.

 

See the “FAQ on laryngoscope blades and handles – How to clean, disinfect and store these devices” and “FAQ on endotracheal tubes – How to clean, disinfect and store this device” (www.jointcommission.org/standards_information/jcfaq.aspx) below. The Joint Commission recommends using existing evidence-based guidelines and manufacturer’s instructions for use as they pertain to cleaning, disinfection, sterilization (as indicated), and storage practices of laryngoscope blades and handles, and ETTs. Joint Commission surveyors will evaluate processes related to cleaning, disinfection, sterilization and storage of laryngoscope blades and handles, and ETTs to ensure they are safe for patient use.

 

Laryngoscope

 

FAQ on Laryngoscope Blades and Handles: How to Clean, Disinfect and Store These Devices

Devices such as laryngoscope blades and handles may be exposed to potentially infectious material during indicated use and can become contaminated through direct contact with the patient’s skin, mucous membranes, secretions and blood. To reduce the risk of infection, the importance of standardizing the reprocessing and storage of the laryngoscope’s blade and handle is emphasized (for non-disposable laryngoscopes).

 

Cleaning Laryngoscope Blades

Equipment used for intubation such as laryngoscope blades should be properly cleaned using the process for disinfection and sterilization of semicritical items as designated by the Centers for Disease Control and Prevention (CDC) as “high-level” disinfection. Please refer to the CDC’s Healthcare Infection Control Practices Advisory Committee (HICPAC) document titled Guidelines for Disinfection and Sterilization in Healthcare Facilities, 2008 (www.cdc.gov/hicpac/Disinfection_Sterilization/toc.html).

 

In addition, the CDC’s HICPAC states laryngoscope blades are “semicritical items that should be sterilized or subjected to high-level disinfection before reuse.” Read the CDC’s HICPAC document titled Guidelines for Preventing Healthcare-Associated Pneumonia, 2003 (www.cdc.gov/hicpac/pdf/guidelines/HApneu2003guidelines.pdf). The last page of the guideline lists laryngoscope blades as semicritical items. Recommendation IIIA1b (pages 57-58) states how semicritical items must be processed and packaged:

 

“Whenever possible, use steam sterilization (by autoclaving) or high-level disinfection by wet heat pasteurization at >158oF (>70oC) for 30 minutes for reprocessing semicritical equipment or devices (i.e., items that come into direct or indirect contact with mucous membranes of the lower respiratory tract) that are not sensitive to heat and moisture (see examples in Appendix). Use low-temperature sterilization methods (as approved by the Office of Device Evaluation, Center for Devices and Radiologic Health, FDA) for equipment or devices that are heat- or moisture-sensitive (307;309;310;314;315). After disinfection, proceed with appropriate rinsing, drying, and packaging, taking care not to contaminate the disinfected items in the process (308;310). CATEGORY IA.”

 

Laryngoscope

 

Cleaning Laryngoscope Handles

Laryngoscope handles are considered contaminated after use and must be processed prior to use with the next patient. Some manufacturers suggest a low-level surface disinfectant be utilized on the surface of the handle, while others may recommend high-level disinfection or sterilization. As is the case with all medical devices, the manufacturer’s indications for use (IFU) must be followed. Also check with your state for additional law or regulation; we are aware of at least one state that requires additional processing.

 

Storage

Laryngoscopes should be kept free from contamination until the time of use. Once opened, there is potential for microorganisms to settle on the equipment the longer it remains open and unused. In addition, increased handling of the opened unused blade increases the probability of contamination. Ensure that the storage area provides protection against dust, moisture, temperature and humidity extremes. Please refer to the CDC’s HICPAC document titled Guidelines for Disinfection and Sterilization in Healthcare Facilities, 2008 (www.cdc.gov/hicpac/Disinfection_Sterilization/toc.html).

 

Storing laryngoscope blades individually eliminates the potential for contaminating multiple blades if packaged together and therefore having to reprocess several unused blades as opposed to the one that was used. 

  - An option would be to contain the individual blade in a closed plastic bag, placed in a clean storage location.

  - If steam sterilized, a peel-pack may be used.

  • When testing the light source and blade, use proper hand hygiene and partially remove the blade from the package, attach to the light source, and test. Following testing, insert the blade back into the package and return to a clean storage location (manipulation of the blade onto the light source/handle can be tested without actually removing the blade from the bag or pack without touching the blade itself).
  • Institute this practice to all areas where laryngoscopes are used. Examples are: code carts, anesthesia carts, and difficult airway boxes or carts.
  •  

    Joint Commission surveyors will evaluate processes related to laryngoscope blades/handles to ensure that they are safe for use on the next patient. They will check that laryngoscope blades/handles are:

     

  • For laryngoscope blades, processed via either high-level disinfection or sterilization.
  • For laryngoscope handles, processed following manufacturer’s instructions for use for cleaning/disinfection guidance.
  • Packaged in some way. CDC and HICPAC guidelines do not specify the manner in which laryngoscope blades should be packaged.
  • Stored in a way that would prevent contamination. Examples of compliant storage include, but are not limited to, a peel-pack post-steam sterilization or containment within a closed plastic bag. Examples of noncompliant storage would include unwrapped blades in an anesthesia drawer as well as unwrapped blades on top of or within a code cart.
  • The organization demonstrates a consistent process applied to all appropriate areas as reflected by organization policy and procedure.  
  •  

    FAQ on Endotracheal Tubes: How to Clean, Disinfect and Store This Device

    Devices such as ETTs may be exposed to potentially infectious material during indicated use and can become contaminated through direct contact with the patient’s skin, mucous membranes, secretions and blood. An ETT interferes with normal patient defenses allowing pathogens direct access to the lung.

     

    To reduce the risk of infection, the importance of standardizing the process of reprocessing as indicated, with a minimum high-level disinfection or sterilization (if a single-use device is not used and manufacturer’s instructions for use is adhered to) and storage is emphasized.  

     

    Cleaning and Disinfecting

    ETTs are most commonly obtained as sterile single-use devices. As defined, single-use devices are intended for one-time use, on a single patient, during a single procedure.

     

    If an ETT is not labeled as a single-use device, it is considered a semicritical item and therefore would require using the process for disinfection and sterilization of semicritical items as designated by the Centers for Disease Control and Prevention (CDC) as “high-level” disinfection. Please refer to the CDC’s Healthcare Infection Control Practices Advisory Committee (HICPAC) document Guidelines for Disinfection and Sterilization in Healthcare Facilities, 2008 (www.cdc.gov/hicpac/Disinfection_Sterilization/toc.html).  

     

    In addition, the CDC’s HICPAC states ETTs are “semicritical” items. Refer to the CDC’s HICPAC document Guidelines for Preventing Healthcare-Associated Pneumonia, 2003 (www.cdc.gov/hicpac/pdf/guidelines/HApneu2003guidelines.pdf). The last page of the guideline lists ETTs as semicritical items (see recommendation IIIA1b above).  

     

    Storage

    ETTs should be kept free from contamination until the time of use. Once opened, there is potential for microorganisms to settle on the device the longer it remains open and unused. In addition, increased handling of the opened unused device increases the chances of contamination. Ensure that the storage area provides protection from dust, moisture, temperature and humidity extremes. Refer to the previously mentioned CDC HICPAC document Guidelines for Disinfection and Sterilization in Healthcare Facilities, 2008.  

     

    Pre-opening of Endotracheal Tubes

     

  • Currently available evidence-based guidelines do not include recommendations for or against the pre-opening of ETTs prior to use for any length of time.
  • Related scientific articles to date that address pre-opening ETTs and the risk of contamination with potentially harmful organisms while left opened for days are few in number, with several identified methodological issues that force the clinician to realize that there remains insufficient evidence to support pre-opening ETTs at this time, given the potential consequences of using contaminated equipment.
  • Until evidence exists that is supported by well-designed clinical studies, an organization may:
  • conduct a risk assessment and refer to appropriate professional organizations that address this issue in their position statements;
  • weigh the risks versus the benefits of having pre-opened ETTs given the absence of firm evidence that pre-opened ETTs are advantageous or best practice; and
  • utilize a consistent process throughout the organization based on expert clinical consensus that is documented in policy and procedure.
  •  

    Joint Commission surveyors will evaluate processes related to ETTs to ensure they are safe for patient use. They will check that ETTs are:

     

  • A single-use device, or if not a single-use device, are processed via either high-level disinfection or sterilization according to manufacturer’s instructions for use (IFUs).
  • Packaged as a sterile single-use device. If the ETT is not a single-use device, CDC and HICPAC guidelines do not specify one method in which ETTs should be packaged. An example of an acceptable packaging method would be a peel-pack post-steam sterilization.
  • Stored in a way that would prevent recontamination. Examples of noncompliant storage would include unwrapped or opened ETTs in an anesthesia drawer as well as unwrapped or opened ETTs on top of or within a code cart.
  • If the organization pre-opens ETTs (refer to the above section on pre-opening of ETTs), a consistent process is demonstrated and is reflected by policy and procedure.


  • Ana Pujols-McKee, M.D. is Executive Vice President and Chief Medical Officer, The Joint Commission, Oak Brook Terrace, Illinois.   Beverly K. Philip, M.D. is Professor of Anaesthesia, Harvard Medical School, Founding Director, Day Surgery Unit, Brigham and Women’s Hospital, Boston.   Maureen Amos, M.S. is ASA Director of Quality and Regulatory Affairs 

     

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