543330
research-article2014
NCPXXX10.1177/0884533614543330Nutrition in Clinical PracticeGuenter
Invited Review
New Enteral Connectors: Raising Awareness Peggi Guenter, PhD, RN1
Nutrition in Clinical Practice Volume 29 Number 5 October 2014 612–614 © 2014 American Society for Parenteral and Enteral Nutrition DOI: 10.1177/0884533614543330 ncp.sagepub.com hosted at online.sagepub.com
Abstract Small-bore connectors, in the past, have enabled misconnections between therapeutic systems that should not connect. Many enteral misconnections have been reported with subsequent frequent fatal outcomes. New enteral connectors have been designed via an International Organization of Standardization (ISO) standards development process. The new patient access connectors will be in the marketplace soon for the purpose of improving patient safety. Becoming aware of the changes and planning for them within your facility or agency will ease the transition to these new devices while continuing enteral nutrition support. Clinicians should look for education and information from appropriate resources and work with their suppliers to see when these changes will come to their institution or agency. (Nutr Clin Pract. 2014;29:612-614)
Keywords enteral nutrition; feeding tubes; connectors; safety; nutritional support
Ever since the first reported accidental infusion of enteral nutrition (EN) into an intravenous (IV) line in 1972, clinicians have been concerned about misconnections.1 An enteral misconnection is defined as an inadvertent connection between an enteral feeding system and a nonenteral system such as an intravascular line, peritoneal dialysis catheter, tracheostomy tube cuff, medical gas tubing, and other medical devices. In each case, serious patient harm, including death, can occur if fluids, medications, or nutrition formulas intended for administration into the gastrointestinal tract are administered via the wrong route.2
number of instances, resulted in deadly consequences. That sentinel event alert called for design changes in small-bore connectors. Product manufacturers were urged to implement “incompatibility by design” features. The Joint Commission stated that “forcing function” design changes would make incorrect connections impossible, a physical barrier is the most effective preventive tool when inappropriate connections are attempted, and the entire line of connections must be unique to prevent mistakes in connection.3
Incidence of Enteral Misconnections
Small-Bore Connectors A small-bore connector is a connector with an inner diameter of less than 8.5 mm that is used to link or join medical devices, components, and accessories for the purpose of delivering fluids or gases. The Luer connector has been a classic type of a small-bore connector used commonly in the healthcare setting as a universal connector. The use of the Luer connector in a variety of medical devices for different uses has led to misconnections between many types of therapeutic applications such as respiratory, IV, enteral, neuraxial, inflation devices such as blood pressure cuffs, and urinary devices. Despite warnings from safety and regulatory agencies, misconnections continue in many healthcare settings. The Joint Commission issued a sentinel event alert in April 2006 regarding tubing misconnections.3 This alert stated that multiple reports to patient safety organizations, including The Joint Commission, ECRI Institute, U.S. Food and Drug Administration (FDA), the Institute for Safe Medical Practices (ISMP), and U.S. Pharmacopeia (USP), demonstrate that these misconnection errors continue to occur with significant frequency and, in a
One published literature review found more than 116 reported cases of enteral misconnections.4 Published reports consistently substantiate the severity of this type of error, which too frequently resulted in the death of the patient because of ensuing embolus or sepsis. As with other voluntary adverse event reporting systems, enteral misconnections may be greatly underreported compared with the number of actual cases. One series of misconnections reported an overall 33% sentinel event rate, with sentinel events meaning actual or risk of permanent patient harm or death. From the 1American Society for Parenteral and Enteral Nutrition, Silver Spring, Maryland. Financial disclosure: None declared. This article originally appeared online on August 19, 2014. Corresponding Author: Peggi Guenter, PhD, RN, Senior Director for Clinical Practice, Quality, and Advocacy, American Society for Parenteral and Enteral Nutrition (A.S.P.E.N.), 8630 Fenton St, Suite 412, Silver Spring, MD 20910, USA. Email: [email protected]
Downloaded from ncp.sagepub.com at ANADOLU UNIV on December 25, 2014
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Figure 2. Patient access enteral connector. Reprinted with permission from the Global Enteral Device Supply Association (GEDSA).
Figure 1. Nutrition end connector. Reprinted with permission from the Global Enteral Device Supply Association (GEDSA).
EN Delivery System The EN delivery system for adults and older children often has an administration set, which can be connected to a formula bag. The connector between that administration set spike and the nutrition source has been one place where misconnections occurred due to a universal spike, which was often confused with IV administration tubing. In recent years, the EN manufacturers have, for the most part, switched to a different type of cross-spike unique to EN, referred to as the nutrition source connector, and can be seen in Figure 1. Another area of misconnections has occurred downstream, toward the patient, where the administration set, syringes, extension tubing, or other delivery devices connect to the patient’s feeding tube. This connection is referred to as the “patient access connector,” and this is the connector that is being redesigned.
Patient Access Connector Design Changes In 2008, the International Organization of Standardization (ISO) convened a working group to develop standards for the redesign of small-bore connectors. ISO standards are recognized by many countries, organizations, and other entities as the resource to drive conformity. As such, ISO sets voluntary global standards to which various governments, purchasing organizations, manufacturers, and users subscribe. The first step in this process was developing a master standard for small-bore connectors that contained certain requirements to which all small-bore connectors must adhere. That standard is
ISO 80369-1 and is called Small Bore Connectors for Liquids and Gases in Healthcare Applications—Part 1: General Requirements.5 These general requirements include the following: (1) not connectable to others in the series, (2) made of rigid or semi-rigid material, (3) passing a misconnection test, and (4) not connectable with Luer or needleless connector ports. This master standard set the stage for redesigned connectors to be used in respiratory, enteral, noninvasive blood pressure monitoring, neuraxial, urology, and intravascular systems. The patient access enteral connector can be seen in Figure 2. The new connector, once approved by the FDA, will be made available on enteral administration sets, enteral syringes, and enteral feeding tubes. Beginning with the administration sets, devices with these connectors are projected to be available in the market around October to December 2014. To transition from the current connector to the new connector, a transition set is planned to assist with making sure patients receive their nutrition formula, hydration, and medications. Figure 3 illustrates the plans for this type of transition set. The enteral syringe launch is expected January to March 2015, and the new feeding tubes with this connector are planned for spring 2015. Communication about these changes will come from many sources, including the American Society for Parenteral and Enteral Nutrition6 and the Global Enteral Device Supply Association (GEDSA), which has launched a campaign for the introduction of new small-bore connectors called StayConnected (www.StayConnected2014.org).7
What Can You Do Now? The following is a checklist of action items for your facility or agency to begin to become aware and prepare for this change.
Downloaded from ncp.sagepub.com at ANADOLU UNIV on December 25, 2014
614
Nutrition in Clinical Practice 29(5) •• Review feeding tube placement, EN, and medication delivery protocols for any needed revisions based on this connector change. •• Revise patient education materials and reach out to patients and caregivers and inform them about these changes and how they may be affected.
Summary New enteral connectors will be in the marketplace soon for the purpose of improving patient safety. Becoming aware of the changes and planning within your facility will ease the transition to new devices while continuing EN support to patients. Look for education and information from appropriate resources and work with your supplier to see when these changes will come to your institution, facility, or agency.
References
Figure 3. Patient access transition set. Reprinted with permission from the Global Enteral Device Supply Association (GEDSA).
•• Look for education opportunities through the information sources above. •• Identify a champion or leader within the organization to actively stay informed as plans progress and timely communicate updates to others in the organization early and often. •• Make sure all stakeholders are aware and involved, including your supply chain personnel, and all clinicians and administrators involved in the EN delivery process. •• Consider all areas where patients with a feeding tube may present, such as clinics and emergency departments.
1. Wallace JR, Payne RW, Mack AJ. Inadvertent intravenous breast milk. Lancet. 1972;1(7763):1264-1266. 2. Guenter P, Hicks RW, Simmons D, et al. Enteral feeding misconnections: a consortium position statement. Jt Comm J Qual Patient Saf. 2008;34(5):285-292. 3. The Joint Commission Sentinel Event Alert. Tubing Misconnections—A Persistent and Potentially Deadly Occurrence. 2006. http://www.jointcommission.org/sentinel_event_alert_issue_36_tubing_misconnections—a_persistent_and_potentially_deadly_occurrence/. Accessed April 4, 2014. 4. Simmons D, Symes L, Guenter P, Graves K. Tubing misconnections: normalization of deviance. Nutr Clin Pract. 2011;26:286-293. 5. ISO Small Bore Connectors Working Group. ANSI/AAMI/ISO 803691:2010. Small Bore Connectors for Liquids and Gases in Healthcare Applications—Part 1: General Requirements. Arlington, VA: Association for the Advancement of Medical Instrumentation; 2011. 6. American Society for Parenteral and Enteral Nutrition. Enteral Nutrition Toolkit. March 2014. www.nutritioncare.org/ENToolkit. Accessed April 7, 2014. 7. Global Enteral Device Supply Association (GEDSA). Stay Connected 2014. January 2014. www.StayConnected2014.org. Accessed April 7, 2014.
Downloaded from ncp.sagepub.com at ANADOLU UNIV on December 25, 2014
research-article2014
NCPXXX10.1177/0884533614543330Nutrition in Clinical PracticeGuenter
Invited Review
New Enteral Connectors: Raising Awareness Peggi Guenter, PhD, RN1
Nutrition in Clinical Practice Volume 29 Number 5 October 2014 612–614 © 2014 American Society for Parenteral and Enteral Nutrition DOI: 10.1177/0884533614543330 ncp.sagepub.com hosted at online.sagepub.com
Abstract Small-bore connectors, in the past, have enabled misconnections between therapeutic systems that should not connect. Many enteral misconnections have been reported with subsequent frequent fatal outcomes. New enteral connectors have been designed via an International Organization of Standardization (ISO) standards development process. The new patient access connectors will be in the marketplace soon for the purpose of improving patient safety. Becoming aware of the changes and planning for them within your facility or agency will ease the transition to these new devices while continuing enteral nutrition support. Clinicians should look for education and information from appropriate resources and work with their suppliers to see when these changes will come to their institution or agency. (Nutr Clin Pract. 2014;29:612-614)
Keywords enteral nutrition; feeding tubes; connectors; safety; nutritional support
Ever since the first reported accidental infusion of enteral nutrition (EN) into an intravenous (IV) line in 1972, clinicians have been concerned about misconnections.1 An enteral misconnection is defined as an inadvertent connection between an enteral feeding system and a nonenteral system such as an intravascular line, peritoneal dialysis catheter, tracheostomy tube cuff, medical gas tubing, and other medical devices. In each case, serious patient harm, including death, can occur if fluids, medications, or nutrition formulas intended for administration into the gastrointestinal tract are administered via the wrong route.2
number of instances, resulted in deadly consequences. That sentinel event alert called for design changes in small-bore connectors. Product manufacturers were urged to implement “incompatibility by design” features. The Joint Commission stated that “forcing function” design changes would make incorrect connections impossible, a physical barrier is the most effective preventive tool when inappropriate connections are attempted, and the entire line of connections must be unique to prevent mistakes in connection.3
Incidence of Enteral Misconnections
Small-Bore Connectors A small-bore connector is a connector with an inner diameter of less than 8.5 mm that is used to link or join medical devices, components, and accessories for the purpose of delivering fluids or gases. The Luer connector has been a classic type of a small-bore connector used commonly in the healthcare setting as a universal connector. The use of the Luer connector in a variety of medical devices for different uses has led to misconnections between many types of therapeutic applications such as respiratory, IV, enteral, neuraxial, inflation devices such as blood pressure cuffs, and urinary devices. Despite warnings from safety and regulatory agencies, misconnections continue in many healthcare settings. The Joint Commission issued a sentinel event alert in April 2006 regarding tubing misconnections.3 This alert stated that multiple reports to patient safety organizations, including The Joint Commission, ECRI Institute, U.S. Food and Drug Administration (FDA), the Institute for Safe Medical Practices (ISMP), and U.S. Pharmacopeia (USP), demonstrate that these misconnection errors continue to occur with significant frequency and, in a
One published literature review found more than 116 reported cases of enteral misconnections.4 Published reports consistently substantiate the severity of this type of error, which too frequently resulted in the death of the patient because of ensuing embolus or sepsis. As with other voluntary adverse event reporting systems, enteral misconnections may be greatly underreported compared with the number of actual cases. One series of misconnections reported an overall 33% sentinel event rate, with sentinel events meaning actual or risk of permanent patient harm or death. From the 1American Society for Parenteral and Enteral Nutrition, Silver Spring, Maryland. Financial disclosure: None declared. This article originally appeared online on August 19, 2014. Corresponding Author: Peggi Guenter, PhD, RN, Senior Director for Clinical Practice, Quality, and Advocacy, American Society for Parenteral and Enteral Nutrition (A.S.P.E.N.), 8630 Fenton St, Suite 412, Silver Spring, MD 20910, USA. Email: [email protected]
Downloaded from ncp.sagepub.com at ANADOLU UNIV on December 25, 2014
Guenter
613
Figure 2. Patient access enteral connector. Reprinted with permission from the Global Enteral Device Supply Association (GEDSA).
Figure 1. Nutrition end connector. Reprinted with permission from the Global Enteral Device Supply Association (GEDSA).
EN Delivery System The EN delivery system for adults and older children often has an administration set, which can be connected to a formula bag. The connector between that administration set spike and the nutrition source has been one place where misconnections occurred due to a universal spike, which was often confused with IV administration tubing. In recent years, the EN manufacturers have, for the most part, switched to a different type of cross-spike unique to EN, referred to as the nutrition source connector, and can be seen in Figure 1. Another area of misconnections has occurred downstream, toward the patient, where the administration set, syringes, extension tubing, or other delivery devices connect to the patient’s feeding tube. This connection is referred to as the “patient access connector,” and this is the connector that is being redesigned.
Patient Access Connector Design Changes In 2008, the International Organization of Standardization (ISO) convened a working group to develop standards for the redesign of small-bore connectors. ISO standards are recognized by many countries, organizations, and other entities as the resource to drive conformity. As such, ISO sets voluntary global standards to which various governments, purchasing organizations, manufacturers, and users subscribe. The first step in this process was developing a master standard for small-bore connectors that contained certain requirements to which all small-bore connectors must adhere. That standard is
ISO 80369-1 and is called Small Bore Connectors for Liquids and Gases in Healthcare Applications—Part 1: General Requirements.5 These general requirements include the following: (1) not connectable to others in the series, (2) made of rigid or semi-rigid material, (3) passing a misconnection test, and (4) not connectable with Luer or needleless connector ports. This master standard set the stage for redesigned connectors to be used in respiratory, enteral, noninvasive blood pressure monitoring, neuraxial, urology, and intravascular systems. The patient access enteral connector can be seen in Figure 2. The new connector, once approved by the FDA, will be made available on enteral administration sets, enteral syringes, and enteral feeding tubes. Beginning with the administration sets, devices with these connectors are projected to be available in the market around October to December 2014. To transition from the current connector to the new connector, a transition set is planned to assist with making sure patients receive their nutrition formula, hydration, and medications. Figure 3 illustrates the plans for this type of transition set. The enteral syringe launch is expected January to March 2015, and the new feeding tubes with this connector are planned for spring 2015. Communication about these changes will come from many sources, including the American Society for Parenteral and Enteral Nutrition6 and the Global Enteral Device Supply Association (GEDSA), which has launched a campaign for the introduction of new small-bore connectors called StayConnected (www.StayConnected2014.org).7
What Can You Do Now? The following is a checklist of action items for your facility or agency to begin to become aware and prepare for this change.
Downloaded from ncp.sagepub.com at ANADOLU UNIV on December 25, 2014
614
Nutrition in Clinical Practice 29(5) •• Review feeding tube placement, EN, and medication delivery protocols for any needed revisions based on this connector change. •• Revise patient education materials and reach out to patients and caregivers and inform them about these changes and how they may be affected.
Summary New enteral connectors will be in the marketplace soon for the purpose of improving patient safety. Becoming aware of the changes and planning within your facility will ease the transition to new devices while continuing EN support to patients. Look for education and information from appropriate resources and work with your supplier to see when these changes will come to your institution, facility, or agency.
References
Figure 3. Patient access transition set. Reprinted with permission from the Global Enteral Device Supply Association (GEDSA).
•• Look for education opportunities through the information sources above. •• Identify a champion or leader within the organization to actively stay informed as plans progress and timely communicate updates to others in the organization early and often. •• Make sure all stakeholders are aware and involved, including your supply chain personnel, and all clinicians and administrators involved in the EN delivery process. •• Consider all areas where patients with a feeding tube may present, such as clinics and emergency departments.
1. Wallace JR, Payne RW, Mack AJ. Inadvertent intravenous breast milk. Lancet. 1972;1(7763):1264-1266. 2. Guenter P, Hicks RW, Simmons D, et al. Enteral feeding misconnections: a consortium position statement. Jt Comm J Qual Patient Saf. 2008;34(5):285-292. 3. The Joint Commission Sentinel Event Alert. Tubing Misconnections—A Persistent and Potentially Deadly Occurrence. 2006. http://www.jointcommission.org/sentinel_event_alert_issue_36_tubing_misconnections—a_persistent_and_potentially_deadly_occurrence/. Accessed April 4, 2014. 4. Simmons D, Symes L, Guenter P, Graves K. Tubing misconnections: normalization of deviance. Nutr Clin Pract. 2011;26:286-293. 5. ISO Small Bore Connectors Working Group. ANSI/AAMI/ISO 803691:2010. Small Bore Connectors for Liquids and Gases in Healthcare Applications—Part 1: General Requirements. Arlington, VA: Association for the Advancement of Medical Instrumentation; 2011. 6. American Society for Parenteral and Enteral Nutrition. Enteral Nutrition Toolkit. March 2014. www.nutritioncare.org/ENToolkit. Accessed April 7, 2014. 7. Global Enteral Device Supply Association (GEDSA). Stay Connected 2014. January 2014. www.StayConnected2014.org. Accessed April 7, 2014.
Downloaded from ncp.sagepub.com at ANADOLU UNIV on December 25, 2014
