Update on effectiveness of an electromagnetic feeding tube-placement device in detecting respiratory placements

Background Radiography is the accepted gold standard for testing feeding tube placement; however, an electromagnetic tube-placement device (ETPD) is sometimes used in lieu of radiography for this purpose. High success rates have been reported when the device was used by well-trained individuals. However, authors previously described 20 cases that occurred between 2007 and 2012 in which clinicians voluntarily reported inability to detect inadvertent tube insertions in the respiratory tract while using an ETPD. Objective To describe case reports to the US Food and Drug Administration's Manufacturer and User Facility Device Experience (MAUDE) database between 2013 and 2015 regarding inadvertent respiratory placement of feeding tubes by operators using an ETPD. Methods The MAUDE database was searched for cases dated from January 1, 2013, through December 31, 2015, along with selected brand names. A total of 34 cases (25 after removal of duplicates) were located in which a feeding tube was inserted into the respiratory tract during insertions assisted by an ETPD. Results Sites of the malpositioned tubes included the right lung (n = 13), left lung (n = 6), unspecified lung (n = 4), and bronchus (n = 2). A pneumothorax occurred in 17 of the 25 misplacements; feedings were administered in 6 cases. Conclusions Many case reports involved clinicians failing to recognize tube misplacements in the respiratory tract while using an ETPD. These reports provide evidence that not all clinicians can use the device effectively to detect malpositioned tubes. Thus, one must continue to question the wisdom of eliminating radiographic confirmation of tube position before starting feedings.