FDA Moves to Mitigate ‘Continued Reports of Misconnections’ Linked to Enteral Devices
Posted 10 September 2018 | By
Manufacturers of enteral feeding tube devices were directed to adopt recommendations outlined in a new US Food and Drug Administration (FDA) letter to reduce the risk of misconnections.
The letter to manufacturers of these devices, designed for the delivery of liquid nutrients or medicine to the stomach or patients’ intestines, was issued by FDA’s Center for Devices and Radiological Health (CDRH) on Friday in light of “continued reports of misconnections.”
Reports analyzed as part of an effort to mitigate misconnections include two patient deaths, 24 serious injuries and 32 device malfunctions since 2011. Yet the agency is also concerned over potentially many misconnections that may go unreported or misreported as medication errors.
The set of four recommendations for manufacturers in the letter support a transition to meeting standards developed by the International Organization for Standardization (ISO)—80369-1 or ISO 80369-3. These include actions suggested in 2014 by the Joint Commission, evaluating patient needs, as well as implementing design changes to meet the specified ISO standards and a strategy to eventually remove legacy devices that present a higher risk for misconnection.
Misconnections between enteral and non-enteral devices “may occur when one type of medical device is mistakenly attached to another type of medical device that performs a different function,” said
William Maisel, director of CDRH’s Office of Device Evaluation. “Because the connectors on these devices are easy to use and may be compatible with different medical devices, users can mistakenly connect unrelated systems to one another.”
The letter points to FDA final guidance
from 2015 on considerations for the design and testing of enteral connectors aimed reducing the chance or misconnection to non-enteral devices, such as tracheostomy tubes. It also highlights a 2010 letter
, alerting over the associated adverse events and FDA’s suspicion that these misconnections are wrongfully reported as medication errors.
In January, the agency sent a letter
to health care providers to notify of the 51 medical device reports received from January 2012 through July 2017 describing pneumothorax events linked to the use of three devices that obtained FDA clearance for use as enteral access systems.