Episode #169 Endotracheal Tube Cuff Failure and Medication Safety Associated with Drug Dilution
September 26, 2023Welcome to the next installment of the Anesthesia Patient Safety podcast hosted by Alli Bechtel. This podcast will be an exciting journey towards improved anesthesia patient safety.
First up, we are talking about the Rapid Response Article published on August 18, 2023, “Unusual Cause of Endotracheal Tube Cuff Inflation Failure” by Christopher Heine and Cory Furse.
Here are the key considerations:
- The first case report revealed that only the pilot balloon was palpated during the equipment check prior to using the endotracheal tube so the failed connection between the pilot balloon and the cuff was not discovered.
- The authors highlight that it is imperative to perform a complete pre-intubation check in order to avoid the inadvertent use of a defective endotracheal tube and the possible need for multiple intubations.
Next up, we are going to turn our attention to the July 26, 2023, article, “Drug Dilution Errors in The Operating Room. Operating Room Drug Safe Labelling System Update Needed” by Gundappa Neelakanta.
Have you experienced changes in medication vial availability leading to dilution or concentration changes during anesthesia care? This is a big threat to anesthesia medication safety. We must remain vigilant for administering the correct medication at the correct time and route with the correct concentration and infusion rate.
Thank you to Medtronic and Codonics for their responses in these articles and their commitment to anesthesia patient safety.
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© 2023, The Anesthesia Patient Safety Foundation
Hello and welcome back to the Anesthesia Patient Safety Podcast. My name is Alli Bechtel, and I am your host. Thank you for joining us for another show. It is almost time for the next APSF Newsletter release in October, but there is still more great content for us to talk about today. We have a special show to cover some newly published articles between issues. Our topics today include endotracheal tube cuff inflation failure and medication safety issues with drug dilution.
Before we dive into the episode today, we’d like to recognize BD, a major corporate supporter of APSF. BD has generously provided unrestricted support to further our vision that “no one shall be harmed by anesthesia care”. Thank you, BD – we wouldn’t be able to do all that we do without you!”
First up, let’s talk about the Rapid Response Article published on August 18, 2023, “Unusual Cause of Endotracheal Tube Cuff Inflation Failure” by Christopher Heine and Cory Furse. To follow along with us, head over to APSF.org and click on the Newsletter heading. Third one down is Rapid Response to Questions from our readers. Then, scroll down until you to August 18, 2023, and our featured article today. I will include a link in the show notes as well. Remember, rapid response articles allow rapid communication of technology-related safety concerns raised by our readers followed by input and response from manufacturers and industry representatives to help improve anesthesia patient safety.
Anesthesia professionals must perform many safety checks prior to administering an anesthetic and this includes testing the integrity and function of the pilot balloon and cuff on the endotracheal tube. The authors discuss a case of a manufacturing defect in an endotracheal tube that was not detected prior to use.
Here is the case.
DEAR RAPID RESPONSE:
A 2-year-old undergoing a dental procedure was intubated orally with a Covidien Shiley Hi-Lo Oral Tracheal 4.0 cuffed endotracheal tube. After confirmation of endotracheal tube placement, we attempted to adjust the leak to 20 cmH20. Despite over-inflating the pilot balloon, a large leak remained. After confirming with video laryngoscopy that the cuff was indeed below the vocal cords, we concluded that the most likely culprit was a faulty cuff. The decision was made to re-intubate, which was done with a new 4.0 cuffed ETT without complication. Air was added to the cuff until there was a small leak at 20 cmH20.
Upon later inspection of the original ETT, we noted that regardless of volume pushed into the pilot balloon, the cuff did not inflate. Check out Figure 1 in the article for a visual representation of the over-inflated pilot balloon while the cuff remained deflated. Unsure about where the disconnect or obstruction was, we incrementally dissected the ETT to see if we could isolate the problem. In order to determine the patency of the inflation tube, we bisected the pilot balloon and passed a wire through the inflation tube, past the cuff, to the tip of the ETT which you can see in Figure 2 in the article. Since the inflation tube was patent, we then removed the cuff and discovered that the groove which should connect the inflation lumen in the wall of the ETT and the interior space of the ETT cuff was not deep enough to allow for patency. Figures 3 and 4 in the article show differences between a normal endotracheal tube groove and the one in the problematic endotracheal tube used in this care. We injected methylene blue into the inflation lumen to demonstrate the lack of an opening into the cuff space and you can see this in Figure 5.
The authors discuss the important parts of this case since air leaks are common during airway management in anesthesia. Cuffed endotracheal tubes have made it easier to protect the trachea and provide adequate oxygenation and ventilation without the need for reintubations. Cuff leaks may occur from a mal-positioned endotracheal tube or following damage from the patient’s teeth or equipment like Magill forceps. A cuff leak compromises the integrity of the endotracheal tube and the ability to provide adequate ventilation. Air leaks may be due to underinflated cuffs, cephalad head movement, and inappropriately sized endotracheal tubes. Other causes may be manufacturing defects that result in malfunctioning endotracheal tubes. Manufacturing defects may be identified prior to use if a cuff check is performed. Checking the endotracheal tube cuff is done with inflation of the cuff via the pilot balloon, disconnection of the syringe, and palpation of the pilot balloon and cuff to test that they are both inflated.
During this case, it was discovered that only the pilot balloon was palpated during the equipment check prior to using the endotracheal tube so the failed connection between the pilot balloon and the cuff were not discovered. The authors highlight that it is imperative to perform a complete pre-intubation check in order to avoid the inadvertent use of a defective endotracheal tube and the possible need for multiple intubations.
Have you ever seen this during your anesthesia practice? We hope that you are performing a pre-insertion cuff inflation procedure prior to intubation to help keep patients safe.
Let’s take a look at the response from the manufacturer, Karen Philips, Chief Medical Officer of Respiratory Interventions for Medtronic. For reported incidents, the PMV team have confirmed that Medtronic sold about 28.2 million Shiley endotracheal tubes over the past 5 years with a rate for any inflation system complaints of 3.4 complaints per million endotracheal tubes sold during that time period. The root cause discussion highlights that the authors demonstrated a lack of patency between the pilot line and the cuff. This appeared to be an error in the manufacturing process that also survived the rigid quality inspections. The manufacturers confirm that review and improvement have been instituted at the manufacturing site to capture any defective endotracheal tubes which leave the production line. This event highlights the importance of adhering to the pre-insertion cuff inflation procedure stated in the Instruction for Use of the device. Philips concludes by stating that:
“The Medtronic Mission guides us to strive without reserve for the greatest possible reliability and quality in our products. In order to achieve that outcome, we rely heavily on physicians such as Dr. Heine, and organizations such as the APSF, to ensure that we remain true to this statement. We are grateful for the efforts and thorough investigation of the defective ETT by Dr. Heine, and to the APSF for continuing to partner with us as we strive for the best in patient safety and device quality.”
Next up, we are going to turn our attention to the July 26, 2023, article, “Drug Dilution Errors in The Operating Room. Operating Room Drug Safe Labelling System Update Needed” by Neelakanta. To follow along with us, head back over to APSF.org, click on the newsletter heading, and the second one down is articles between issues. Then scroll down until you get to our featured article.
The authors discuss a recent drug dilution change resulting in difficulty programming the syringe pump infusion. Drug dilution and the use of infusion pumps have important anesthesia patient safety considerations. The author describes the change from remifentanil 2mg/ml vials to 1mg/ml vials from the pharmacy. The perioperative syringe pumps are preprogrammed for remifentanil 40mcg/ml concentration. As a result, the new remifentanil vials needed to be diluted in only 25mls rather than the standard 50 mls that were used prior to create the desired concentration of 40mcg/ml. In this case, the author describes how the standard 50mls were used to dilute the 1mg/ml remifentanil vial leading to a concentration of 20mcg/ml. This led to confusion while programming the appropriate dose on the syringe pump. There are many drugs that need to be diluted in the operating room prior to administering to the patient as either a bolus or infusion including epinephrine, phenylephrine, and ephedrine. The author uses a Safe Label System, but notes that it displays if a drug dilution is required and the diluent based on the hospital formulary, but it does not specify the volume of the diluent. Is this an opportunity to help to minimize drug dilution error in the operating room? Including a display of volume of diluent required to obtain a certain drug concentration would help to decrease manual calculation and help to prevent human error.
Now, we are going to take a look at the response from Cristy Berg the VP of Communications with Codonics. Berg highlights the APSF’s commitment to patient safety including medication safety as one of the top 10 APSF patient safety priorities. Using safe labelling systems in the operating room is an important part for improving medication safety. The Codonics Safe Label System is widely used and recognizes, displays, and prints color coded syringe labels of drugs used in the operating room with the name of the drug, concentration, preparer’s initials, date and time of expiration, and a bar code. In addition, there is audio feedback of the drug scanned in with the concentration and dilution if required. The labels used by this system comply with The Joint Commission standards and the ASA Guidelines.
If we look closer at the Safe Label System, this system uses barcode technology at the point of care to create full color, easy to read, and ready to apply Joint Commission compliant syringe labels on demand. This system also meets the ISMP Guidelines and their 2025 goals for perioperative and procedures areas as well as the APSF recommendations that anesthesia care locations have a mechanism to identify medications prior to drawing up or administering them (such as with a barcode reader.) Over the past 10 years, Codonics has received requests to provide ‘preparation instructions’ on the Safe Label System display. This feature is part of the test track database which Codonics uses to capture all customer product enhancement requests. This enhancement has not been prioritized beyond initial preliminary conceptualization of the functionality. Before it comes to market, the business justifications and understanding of the anesthesia workflow are needed. Codonics values working with clinicians and collaborating to help expand the value of the Safe Label System and the company continues to invest in development and product improvements.
The Safe Label System capabilities have expanded from providing safety and compliance in the operating room to integration with anesthesia drug carts to reduce depleted stock, with electronic medical records to improve charge capture and accountability, with testing of waste and returns to help prevent drug diversion and with interoperability with smart pumps to reduce manual steps and human error. In the future, it will provide integration with BD intelliport. Going forward, Codonics hopes to continue to work with clinicians on a solution to help minimize drug dilution errors in the operating room environment.
Have you experienced changes in medication vial availability leading to dilution or concentration changes during anesthesia care? This is a big threat to anesthesia medication safety. We must remain vigilant for administering the correct medication at the correct time and route with the correct concentration and infusion rate.
If you have any questions or comments from today’s show, please email us at [email protected]. Please keep in mind that the information in this show is provided for informational purposes only and does not constitute medical or legal advice. We hope that you will visit APSF.org for detailed information and check out the show notes for links to all the topics we discussed today.
Do you have any technology-related safety concerns related to anesthesia care? Have you thought about contributing to the ASPF Newsletter Rapid Response column. Submissions should be fewer than 1000 words with no more than 15 references. The ASPF Newsletter is published three times a year in February, June, and October and submission deadlines are November 10th, March 10th and July 10th, but you can feel free to submit a manuscript at any time for review. Who knows you might be the next author of an article between issues or featured in a future APSF Newsletter.
Until next time, stay vigilant so that no one shall be harmed by anesthesia care.
© 2023, The Anesthesia Patient Safety Foundation