Echocardiogram Examination

Current Use of Ultrasound Transmission Gel for Transesophageal

s: A Survey of CardiothoracicAnesthesiology Fellowship Directors

Michael O’Rourke, MD, Pierre Levan, MD, and Tayyab Khan, MD

Objective: Ultrasound transmission gel (USTG) is used

routinely to enhance the image quality during transesopha-

geal echocardiogram examinations. Ultrasound gel is man-

ufactured in both sterile and non-sterile preparations, and

both preparations have been used during transesophageal

echocardiograms in the United States. The United States

Food and Drug Administration (FDA) currently recommends

that all transesophageal echocardiogram (TEE) examina-

tions be performed using sterile ultrasound gel. The authors

sought to identify if anesthesiology departments with car-

diothoracic fellowship programs follow current FDA recom-

mendations of using sterile ultrasound gel during TEE

examination.

Design: Survey.

Setting: Survey of cardiothoracic fellowship directors. The

majority of fellowship directors practice in academic hospi-

tals although the practice site was not addressed in the

survey.

From the Department of Anesthesiology, Loyola University MedicalCenter, Maywood, IL.

Address reprint requests to Michael O’Rourke, MD, Loyola Uni-versity Medical Center, Department of Anesthesiology, 2160 South 1stAvenue, Maywood, IL 60153. E-mail: miorourke@lumc.edu© 2014 Elsevier Inc. All rights reserved.1053-0770/2601-0001$36.00/0http://dx.doi.org/10.1053/j.jvca.2014.02.001

1208 Journal of Cardiothoracic

Participants: Fellowship directors volunteered to partici-

pate in the study.

Interventions: None.

Measurements and Main Results: Survey responses were

tallied using the website, www.surveymonkey.com, and

56% of respondents do not currently follow the current

FDA recommendations.

Conclusions: A majority of cardiothoracic program direc-

tor respondents to the authors’ survey do not utilize single-

use sterile packets of USTG for TEE examinations. While the

infectious risk of USTG used for TEE examinations from

multiple-use containers versus single-use sterile containers

has not been established clearly, a change in practice to

follow the current FDA recommendations may be advised.

& 2014 Elsevier Inc. All rights reserved.

KEY WORDS: transesophageal, echocardiogram, ultrasound,gel, infection, safety

ULTRASOUND TRANSMISSION GEL (USTG) is usedroutinely during intraoperative transesophageal echocar-

diogram (TEE) examinations to enhance the quality of theimages obtained. In 2012, 16 patients developed colonizationor infection with the bacteria Pseudomonas aeruginosa afterTEE examination that utilized non-sterile ultrasound gel con-taminated with Pseudomonas aeruginosa and Klebsiella oxy-toca.1 These were the first reported instances of patientinfection from ultrasound transmission gel used during a TEEexamination. However, ultrasound transmission gel contami-nated with bacteria has been shown to be a source of infectionin patients in the past.2–7

A recent commentary article highlighted that ultrasoundtransmission gel currently is available in the United States froma variety of manufacturers and comes in a variety of form-ulations.8 The gel previously had been considered bacteriostaticalthough a study has demonstrated that ultrasound transmissiongel can function as a medium for bacterial growth and, in fact,has no antimicrobial properties.9

The FDA currently recommends the use of sterile ultrasoundgel for procedures with mucosal contact in which biopsy is notplanned but any possible added bioburden would be undesirableor mucosal trauma is likely.1 This recommendation for use ofsterile ultrasound transmission gel specifically includes TEEexaminations. The FDA specifies that the only ultrasoundtransmission gel that can be considered sterile is ultrasound

gel that is in unopened containers or packets labeled as sterile.Hence, multiple-use bottles of ultrasound transmission gelspecially are defined as non-sterile. Individualuse packets maybe sterile or non-sterile depending on the preparation.

METHODS

An introductory e-mail message detailing the subject and aims ofthe study as well as a link to the online survey was sent to the 58program directors of ACGME-accredited cardiothoracic anesthesiologyfellowship programs in May of 2013. The project received approvalfrom the institutional IRB to gather anonymous survey data. The surveyconsisted of 6 Yes-or-No questions and a free-response section(Table 1). Survey questions pertained to the respondent’s awarenessof infection concerns with USTG to the existence of institutionalpolicies regarding the use of ultrasound gel.

RESULTS

Of a total of 58 program directors to whom the survey waselectronically sent, 23 replied (response rate of 40%). Therewas a 100% response rate for questions 1, 3, 4, and 5. Question2 had a 69.5% response rate (n ¼ 16 of 23 respondents); whilequestion 6 had a 95.6% response rate (n ¼ 22 of 23respondents). Responses were analyzed for each individualquestion.

When asked about the use of single-use packets or multiple-use bottles for ultrasound gel, 56.52% of respondents indicatedthat they utilize multiple-use bottles of USTG for TEEexaminations; while 43.48% use single-use packets (Fig 1).The number of respondents who said their respective depart-ment/institutions did not have a policy for tracking the time amultiple-use gel bottle is used for TEE was 87.50% ofrespondents (n ¼ 14 of 16 respondents). About half(52.17%) of respondents were aware of concerns regardingan increased infection risk from the use of multiple-use gelbottles. No respondent (n ¼ 0 of 23) had ever been concernedthat a patient was infected from such a source. However, of the

and Vascular Anesthesia, Vol 28, No 5 (October), 2014: pp 1208–1210

Table 1. Survey Questions

1. When performing transesophageal ultrasound, do you use probe

gel from single-use packets or multi-use bottles?

2. If you use multi-use bottles, does your institution/department track

the time the bottle is in use?

3. Are you aware of concerns regarding multi-use gel bottles serving

as a nidus for bacterial and/or fungal growth?

4. Do you believe that there is a risk to the patient from multi-use gel

bottles as compared to single-use packets?

5. Have you ever suspected a patient infection to be from ultrasound

gel?

6. Does your institution currently have policies regarding the use of

ultrasound gel?

7. Please use the space below for any comments you have.Fig 2. Does your institution currently have policies regarding the

use of ultrasound gel?

USE OF ULTRASOUND GEL FOR TEE 1209

23 respondents, 14 (60.87%) agreed that there is an increasedrisk of infection to the patient from the use of multiple-use gelbottles in TEE. Despite this opinion, few respondents indicated(13.64%, n ¼ 3 of 23) that their respective institutions hadpolicies regarding the use of ultrasound gel (Fig 2).

DISCUSSION

The FDA currently recommends that all TEE examinationsbe performed with sterile USTG. Despite this, a majority ofrespondents to the authors’ study indicated they utilize multi-use and, hence, non-sterile bottles of ultrasound gel for intra-operative TEE. It is unclear if the surveyed practitioners arecurrently aware of the FDA recommendations. If practitionersare unaware, it would call into question the way in which theserecommendations are disseminated to practicing physicians, inthis case cardiothoracic anesthesiologists who routinely per-form intraoperative TEE.

The actual infectious risks of the use of multi-use bottles isnot specifically known. The 16 patients who developedcolonization or infection with the bacteria Pseudomonasaeruginosa after TEE examination in 2012 were exposed toUSTG that arrived at the institution already contaminated withbacteria. The events led to the recall of several lots of USTGproduced by a specific manufacturer. It is unclear, however, ifthe routine use of multi-dose USTG containers poses aninfectious risk to patients if the container received from themanufacturer is not contaminated with bacteria. As the 16

Fig 1. When performing intraoperative TEE, do you use probe gel

from single-use packets or multiple-use bottles?

patients from 2012 are the only documented cases of infectionfrom USTG used during TEE, the cardiothoracic anesthesiol-ogists in the authors’ survey may feel the weight of evidencedoes not warrant the use of single-use sterile containers ofUSTG for all TEE examinations.

The authors chose to survey cardiothoracic anesthesiologyfellowship program directors for their study. Hence, their studymost likely reflects practice at academic medical centers in theUnited States. Cardiothoracic anesthesiology fellowship direc-tors were chosen for this survey as they have a leadershiprole in accredited fellowship programs. Thus, they likely wereaware of current standards within their institutions for USTGuse during TEE examinations. These individuals also have adirect impact upon the standards used during the training offuture cardiothoracic anesthesiologists.

Limitations of the study occur due to its small size. Theauthors chose to focus primarily on an academic setting bysurveying cardiothoracic fellowship program directors. Theutilization of single-use sterile USTG containers for TEEexamination may be different in non-academic settings andwas not explored in this study. The cost of single-use sterilecontainers versus multi-use containers of USTG also was notexplored in the authors’ survey. The response rate for theirsurvey was 40%, and, hence, results may not be generalizableto all practicing anesthesiologists who perform TEE examina-tions. Further areas of study could include whether cardio-thoracic anesthesiology fellowship directors or anesthe-siologists who routinely perform TEE examinations are awareof the FDA recommendations. The reasoning behind whypracticing anesthesiologists choose to follow or not followFDA recommendations also could be studied. However, thepurpose of the authors’ limited study was simply to identify ifcurrent FDA recommendations are being followed by cardio-thoracic anesthesiology fellowship directors at their respectiveinstitutions.

CONCLUSIONS

A majority of cardiothoracic program directors in theauthors’ survey do not utilize single-use sterile packets ofUSTG for TEE examinations. While the infectious risk ofUSTG used for TEE examinations from multiple-use containersversus single-use sterile containers has not been establishedclearly, a change in practice to follow the current FDArecommendations may be advised.

O’ROURKE, LEVAN, AND KHAN1210

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