“But,” you say upon reading the title of this blog, “I’m an anesthesiologist, and I know way more than The Joint Commission inspectors about laryngoscopes and endotracheal tubes.” This might be your reaction to this blog post's title and is undoubtedly true on a scientific and practical level, but we probably don't know the smallest minutiae about sterilization procedures for these items. If you don’t know what The Joint Commission (TJC) is looking for when their inspectors arrive, you may unhappily find your facility to be out of compliance.
Reportedly TJC inspectors had previously found open, dusty ETTs lying around, more so in code carts than anesthesia environments.
Also of concern were laryngoscope blades, which TJC infection control personnel wanted to be sterilized, despite the fact these are like silverware once entering the oropharynx.
“ASA has received reports from members who were cited by The Joint Commission (TJC) for opening single use endotracheal tubes or laryngoscope blades in preparation for use during surgical procedures. In response to these concerns, ASA engaged in collaborative discussions with TJC to clarify standards and interpretation of the requirements. As a result of these discussions, TJC has developed two new Standards FAQs for Hospital, Ambulatory Health Care and Office-Based Surgery accreditation, which delineate more simplified processes and encourage development of facility policy and procedure to manage these devices. The new Standards FAQs were released by TJC on October 11, 2013."
FAQ Documents on Laryngoscopes and Endotracheal Tubes Released by The Joint Commission
Here are the five key points you need to know.
Make sure your facility has a written policy and process for each of the following items. (And it goes without saying … but make sure they are being followed.)
Laryngoscope blades and handles
1. Sterilizing laryngoscope blades.
“Laryngoscope blades (italics added) are “semicritical” items, which should be sterilized or subjected to high-level disinfection before reuse.”
“Whenever possible, use steam sterilization (by autoclaving) or high-level disinfection by wet heat pasteurization at >158oF (>70oC) for 30 minutes for reprocessing semi-critical 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…After disinfection, proceed with appropriate rinsing, drying, and packaging, taking care not to contaminate the disinfected items in the process.”
These follow long-standing CDC recommendations found in
Guidelines for Preventing Healthcare-Associated Pneumonia, 2003.
2. Cleaning laryngoscope handles: Laryngoscope handles may not require sterilization, but, as always, any process must follow the manufacturers’ recommendations.
“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.”
3. Storing laryngoscope handles and blades: Once disinfected and/or sterilized, TJC is very concerned about proper storage of these items, so that blades do not become contaminated before use. Keep clean blades and handles stored in their packaging in the appropriate area until ready for use.
“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.”
A new, specifically acceptable option for storage of laryngoscope blades is now offered – sterilization and a peel pack are NOT required.
“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, 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).”
Laryngoscope blades and handles should be “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.”
This requirement is likely the one that will test our ability as anesthesiologists to comply with TJC policy. It is good practice not to handle the "business end" of the blade before it goes into the patient’s mouth. Make sure laryngoscope blades and handles remain within their packages until they are just about to be used, even while laying on top of the anesthesia cart in preparation for a procedure (see the italicized statements above). Your institution’s policy may also require a statement about how long these packaged laryngoscope blades and handles left out in open packaging may be used, but this is not specifically addressed in TJC's FAQs.
Laryngoscopes – Blades and Handles – How to clean, disinfect and store these devices
Most endotracheal tubes (ETTs) used in the U.S. are single-use items. However, TJC FAQ on this devotes a large amount of space to the possibility of endotracheal tube reprocessing, something I will not address here.
4. Storage of ETTs: Apply the same regulations as those regarding storage of laryngoscopes.
“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.
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.”
5. Pre-Opening and handling of ETTs: TJC devotes a lot of space to the pre-opening of ETTs, largely because there is limited to no data regarding the length of time it is considered safe to leave ETTs opened without risking contamination. As such, TJC’s basic instruction is that a written policy and procedure that is consistently followed within an organization should exist to address this issue.
“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 risk versus the benefits of having pre-opened ETTs given the absence of firm evidence that pre-opened ETTs are advantageous or best practice,
utilize a consistent process throughout their organization based on expert clinical consensus that is documented in policy and procedure.”
“Joint Commission surveyors will evaluate processes related to ETTs to ensure that they are safe for patient use. They will check that ETTs are:
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 …a consistent process is demonstrated and is reflected by policy and procedure.”
Endotracheal Tubes – How to clean, disinfect and store this device
It is a significant advance that TJC will let US decide what is appropriate in the absence of clear evidence. All we have to do is make a policy and follow it. Consult with your own facilities’ administrative compliance specialists as to what these revised regulations imply and how they are to be interpreted within your own local context.
This way you may ensure you and your facility are ready for the expectations of your next TJC visit, so you can focus on patient care and continued excellence, as the true expert on laryngoscopes and endotracheal tubes.
Thanks to Drs. Beverly Philip and Donald Arnold for review and comment on this article.