Abstract and Introduction
Abstract
Background: Intrapulmonary placements of feeding tubes inserted with use of an electromagnetic placement device (EMPD) continue to occur.
Objective: To describe circumstances and outcomes associated with intrapulmonary feeding tube placements during use of an EMPD.
Methods: A retrospective review of reports to the US Food and Drug Administration's Manufacturer and User Facility Device Experience (MAUDE) database of intrapulmonary feeding tube placements during use of an EMPD from 2019 through 2021. Complications, outcomes, operator training, interference from anatomical variations and medical devices, and the use and accuracy of radiographs in identifying pulmonary placements were recorded.
Results: Sixty-two cases of intrapulmonary tube placement were identified; 10 were associated with a fatal outcome. Pneumothorax occurred in 35 cases and feedings were delivered into the lung in 11 cases. User error was cited in 6 cases and was implicit in most others. Little information was provided about operator training. Four intra pulmonary placements were associated with anatomical variations and 1 with a left ventricular assist device. Radiographic follow-up was described in 28 cases and correctly identified 23 of the intrapulmonary placements.
Conclusions: User error was a significant factor, which highlights the need for empirical data to clarify the amount of training needed to safely credential EMPD operators. Clearer information is needed about anatomical variations that may contraindicate use of an EMPD, as well as medical devices that may interfere with an EMPD. Use of follow-up radiographs, interpreted by qualified personnel, is supported to increase the probability of identifying intrapulmonary tube placements.
Introduction
Risk for intrapulmonary placement of feeding tubes is a major concern, especially during blind insertions. For this reason, some institutions elect to use an electromagnetic placement device (EMPD) to track and display the path of a feeding tube during its insertion. The EMPD discussed in this article is the Cortrak* 2 Enteral Access System from Avanos Medical, Inc.
An adequately trained operator using an EMPD properly can recognize when a tube deviates into a proximal airway before a lung placement occurs.[1] However, despite multiple reports in which EMPD operators successfully avoided intrapulmonary tube placements,[1–3] undetected misplacements continue to be reported to the US Food and Drug Administration's (FDA's) Manufacturer and User Facility Device Experience (MAUDE) database.[4–7]
A number of factors can contribute to failure to detect intrapulmonary tube placements during use of an EMPD; however, given the complexity of interpreting EMPD tracings, the most likely cause is inadequate operator training. Other factors may include variations in gastrointestinal anatomy and electromagnetic interference from other electrical equipment used in close proximity to the EMPD. The extent to which these factors affect undetected intrapulmonary placements with EMPDs is unclear.
Despite reports that highly trained EMPD operators can avoid intra pulmonary tube placements, undetected misplacements continue to be reported to the MAUDE database.
The FDA recommends that use of an EMPD be limited to clinical staff who have received the prerequisite training developed by the manufacturer and who are credentialed within their institution to place an enteral feeding tube.[8] The FDA also recommends that determination of final tube location be made according to policies at the institution where the EMPD is used.[8] Thus, some facilities may require radiographic follow-up after all EMPD-guided tube insertions, whereas others may use radiographic follow-up only sporadically.
The objective of this study was to describe circumstances associated with undetected intrapulmonary feeding tube placements during use of the Cortrak* 2 Enteral Access System (referred to as an EMPD) reported in the MAUDE database during a 3-year period (2019–2021).
Am J Crit Care. 2023;32(2):101-108. © 2023 American Association of Critical-Care Nurses