A Consortium Position Statement – Enteral Feeding Misconnections
Authors: Peggi Guenther (American Society for Parenteral and Enteral Nutrition), Rodney Hicks (United States Pharmacopeia), Debora Simmons (MD Anderson Cancer Center), Jay Crowley (Food and Drug Administration), Richard Croteau (The Joint Commission), Cathie Gosnell (Safety Institute, Premier Inc) and Timothy Vanderveen (Cardinal Health)
Association for the Advancement of Medical Instrumentation (AAMI)
- AAMI small-bore connectors website
American Society for Parenteral and Enteral Nutrition (ASPEN)
Centers for Medicare and Medicaid (CMS)
- CMS in their October 4, 2018 Medicare Learning Network newsletter reminded clinicians about the risk of serious injuries and deaths from luer misconnections and the availability of new products that meet industry standards to reduce patient harm. It refers to the March 2013 memorandum for surveyors.
- A March, 2013 memorandum advises surveyors to be alert to the possibility of a Luer or tubing misconnection when investigating adverse events involving delivery of an incorrect substance or utilization of an incorrect delivery route. Examples given of actions that can be taken include changing to devices already on the market with alternative connector designs which reduce the likelihood of misconnections of incompatible lines;
This guidance article from ECRI (March 2017) recommends transitioning to the new 80369-3 compliant ENFit connector enteral feeding products and offers strategies for implementation.
Food and Drug Administration (FDA)
- The FDA Encourages Use of Enteral Device Connectors that Reduce Risk of Misconnection and Patient Injury September 7, 2018
- FDA encourages transition to enteral devices that meet the ISO 80369-3 compliant connectors (tradename ENFit®) and provides guidance for manufacturers, healthcare professionals, hospital purchasing departments and distributors to support the transition to these devices
- FDA Letter to Enteral Feeding Tube Manufacturers July 2010
- FDA Medical Device Connector website
Global Enteral Device Supplier Association (GEDSA)
GEDSA is a nonprofit trade association formed to establish a voice for addressing issues that face enteral device manufacturers, suppliers, and distributors, and to help introduce international standards for healthcare tubing connectors. Comprised of manufacturers, distributors, and suppliers worldwide. GEDSA developed and executed a communications plan to help organizations, clinicians, administrators, supply chain, and others transition to new ISO standard connectors. This initiative is called Stay Connected. The Premier Safety Institute has joined leading experts from the following organizations to provide support for this initiative: AAMI, The Joint Commission, American Society of Parenteral and Enteral Nutrition (ASPEN), Feeding Tube Awareness Foundation, The Institute for Safe Medication Practices (ISMP) and Novation.
The Stay Connected initiative for using safer connectors is a three-phase program. Through the Aware, Prepare, and Adopt phases, GEDSA will help facilitate a successful transition to safer connectors.
- GEDSA position statement position statement on the FDA’s 9/7/18 Letter to healthcare providers.
Institute for Safe Medication Practices (ISMP)
- Medication Safety Alert, April 9, 2015 This article discusses important safety considerations for hospitals when implementing ENFit enteral devices.
- Tubing Misconnections Self Assessment for Healthcare Facilities
This assessment tool developed by the Institute for Safe Medication Practices (ISMP) and Baxter Healthcare’s Clinical Center of Excellence assists healthcare facilities in identifying products and practices that pose a risk of inadvertent tubing misconnections and mitigating potentially known risks. The tool provides users with step by step instructions to perform a modified risk assessment designed to evaluate current delivery systems and mating devices, rate ease of connection and potential for patient harm, and assign a risk priority score.
- Article: Ongoing Risk: Misconnections of Tracheostomy Pilot Balloon Ports with IV Infusions Can Result in Fatal Outcomes, September 2018
The Joint Commission
- Sentinel Event Alert, August 2014 Issue 53, “Managing risk during transition to new ISO tubing connector standards.”
- Sentinel Event Alert, April, 2006 Issue 36, Tubing misconnections: A persistent and potentially deadly occurrence
Joint Commission and World Health Organization (WHO) WHO Collaborating Centre for Patient Safety Tubing Misconnections
National Health Service, Great Britain
- Promoting safer measurement and administration of liquid medicines via oral and other enteral routes: Patient safety alert from the National Patient Safety Agency
Stay Connected is a program designed to facilitate the transition from medical device applications that allow connection between unrelated delivery systems to new, safer connectors that ensure compatibility and consistency while reducing the likelihood of tubing misconnections. Stay Connected is organized by the Global Enteral Device Supplier Association (GEDSA) in partnership with leading industry organizations. GEDSA invites everyone to stay connected as the tubing connectors are introduced through a three-phase communications program – Aware, Prepare, and Adopt – to ensure a successful transition to safer connectors. Resources include design standards, transition checklists, products, frequently asked questions, case studies, and training videos
- Visit StayConnected.org.