A Look at MedSun’s Enteral Feeding Misconnections Survey
MedSun: Newsletter #17, September 2007

Jill Marion, Biomedical Engineer, MedSun Project Manager
Jay Crowley, Senior Advisor for Patient Safety
Food and Drug Administration


Background
Many types of tubing misconnections can occur with a variety of medical devices in the clinical setting. Since misconnections involve direct routes into the body, they often result in serious injury or death. One common mode of misconnection is with Luer locks, connectors and fittings, which are commonly used components that can easily be connected, and also mistakenly misconnected, to many different medical devices.1,2,3

One frequent misconnection of Luer fittings occurs with enteral feeding systems. Because these misconnections are thought to be grossly underreported, the actual number of enteral feeding system misconnections that occur nationwide is unknown.1,4

The enteral feeding system is the entire apparatus, including the enteral nutrition formula container, the delivery tubing, and the enteral tube itself, along with any connectors, pumps, or syringes that may connect with the system. Three types of connectors commonly used in the enteral feeding system are the enteral connector (sometimes called the Christmas tree connector), the Luer slip connector, and the Luer lock connector.

Medical misconnections are a well-known issue, with enteral misconnections cited in the literature as far back as 1972, in a report of inadvertent intravenous (IV) administration of breast milk.6 The Food and Drug Administration (FDA) has received adverse event reports documenting many different types of enteral misconnections, including the mistaken misconnection of enteral feeding tubes to IV lines and tracheal tube pilot balloons.2 In addition, other health organizations have received reports of misconnections of enteral feeding systems to device components such as central venous lines, peripheral catheters, PICC lines, hemodialysis lines, parenteral lines, oxygen cannulas, and inflation ports of the tracheal cuff.5

Examples of Reported Misconnections

•A confused patient inadvertently connected his enteral set to a needle-free injection site.
•A patient’s enteral nutrition line was misconnected to a central venous line.
•Pediatric enteral feeding solution was infused into the patient’s peripheral venous catheter.
•Rather than a dedicated enteral pump, IV tubing and an IV pump were used to administer enteral feedings, with subsequent enteral feeding administered through a central venous device.

Survey Methodology
In an effort to collect information on the frequency of medical device misconnections and to understand the severity of such events, the FDA and the American Society of Parenteral and Enteral Nutrition (ASPEN) worked collaboratively to develop a survey for distribution in 2006 to FDA’s Medical Product Safety Network (MedSun) participant hospitals. The survey was sent to 150 MedSun facilities that fit the original criteria of 200 beds or more. The survey comprised approximately 10 questions regarding use of enteral systems and detected misconnections experienced. The survey questions aimed to determine the following:

•Misconnections experienced at the hospital
•Potential for misconnections in the hospital
•Internal hospital procedures to decrease the potential for misconnections to occur.
(Survey cleared through the Office of Management and Budget [OMB] under the generic Rapid Response Survey Clearance: OMB No. 0910-0500)

Survey Results
Of the 150 facilities contacted, 111 (74 percent) of them responded with 135 surveys. Note that not all survey respondents answered every question, and some facilities submitted more than one completed survey.

The survey questions and responses follow.
•What type of connectors on enteral feeding sets is used in your practice?
Connector Type: Enteral; Responses: 97
Connector Type: Luer; Responses: 19
Other; Responses: 19
Total Responses 135

•Do you use extension sets to attach the enteral feeding set to the feeding tube?
Use of Extension Set:
Yes; Responses: 25
No; Responses: 91
Sometimes; Responses: 15
Don't Know; Responses: 4
Total Responses: 135

•If you use extension sets to attach the enteral feeding set to the feeding tube, do the extension sets have different fittings?
Different Fittings on Extension Sets:
Yes; Responses: 13
No; Responses: 16
Sometimes; Responses: 11
Don't Know; Responses: 10
Total Responses: 50

•Does the use of connector type vary by location/environment, e.g., in the ICU?
Use of Variable Connector Type:
Yes; Responses: 13
No; Responses: 101
Don't Know; Responses: 21
Total Responses: 135

•If yes, how and why?
The following are representative samples of responses regarding determination of the type of connector used:

-Depends on what type of feeding tube is being used or who placed it. Pediatric patients that graduated to the adult floor usually have a different type of G-tube [gastrostomy tube] that has a unique connection. People from other hospitals have different brands of G-tubes and J-tubes [jejuneostomy tubes]. GI [gastrointestinal] procedures place different types of tubes for enteral feeding that sometimes require different connections to fit the enteral feed bags.
-Each department orders [its] own supplies, so there is no standard connector used.
-Depends on the age/type of patient. For babies, a syringe pump is used since the feeding volume is so small.
-Depends on the experience of the nurse.

•If you currently use Luer fittings for enteral feeding, what barriers or concerns do you think your organization or practitioners would have switching to the use of the enteral connectors?
The following are representative of responses received:

-Concerned with locking ability of enteral connectors.
-Enteral connectors not available for purchase from all distributors.
-It is too hard to standardize all of the parts to enteral connectors, since the clinicians are so accustomed to using Luer connectors.
-Concerned with finding an enteral connector that would accommodate the oral syringes used for infants.
-Enteral connectors tend to “stretch” the opening of the tube over time and thus the adaptor slips out of the tube.
-The PSI [pound-force per square inch] of the pump and small size of the feeding tube cause the enteral fitting to “pop off.”
-Babies can easily pull off the enteral connectors, but they can’t pull apart a Luer lock connector.
-Low-volume continuous infusion feeding pumps are currently not available in the U.S. Therefore, low-volume feedings must be delivered utilizing a medication syringe pump and medication syringe. Medication pumps are currently not calibrated for use with oral syringes. Enteral connectors split the hubs or pop off the hubs of many of the currently available gastric feeding tubes for neonates. Using oral-only feeding tubes, with oral-only extension sets, and oral-only syringes is not currently an option for low-volume infusions (especially breast milk) because of the infusion device limitation.
-Not enough devices are compatible with enteral connections.
-The cost of enteral connections is too high.

•Do you currently use any type of label or coding to differentiate feeding tubes or sets from other systems with Luer fittings?
Use of Coding to Differentiate Sets:
Yes; Responses: 56
No; Responses: 58
Don't Know; Responses: 21
Total Responses: 135

•Has your organization ever experienced a misconnection between an enteral system and another system?
Organizational Experience with Misconnections:
Yes; Responses: 19
No; Responses: 69
Don't Know; Responses: 47
Total Responses: 135

•What actions has your institution taken to address potential misconnections between incompatible systems?

The following are summaries of the responses received. (Note that these are suggestions received from MedSun hospitals and are not necessarily supported or promoted by the FDA.)

–Labeled the tubes (i.e., NOT FOR IV USE on feeding tube or ENTERAL FEEDINGS ONLY on enteral tubes).
–Color coded the tubes.
–Implemented user education/ RN inservicing/discussing JCAHO [Joint Commission] Sentinel Alerts/ Discussing ISMP [Institute for Safe Medication Practices] newsletters.
–Switched to all enteral connections.
–Devised a system to require user to trace tube back to its origin.
–Switched to using only oral syringes since they aren’t compatible with IV lines [although adapters can be used on the IV lines that would allow for oral syringe compatibility].
–Made sure products are incompatible if not used for the purpose [for which] they are purchased.
–Switched to a neonatal feeding system that doesn’t allow for IV misconnections.

•About what percentage of your patients across all clinical specialty areas have both a vascular access device (i.e., catheter) and an enteral feeding tube?
Percentage of Patients With Vascular Access Device and Enteral Feeding Tube (%):
0–20%; Responses: 43
21–40%; Responses: 15
41–60%; Responses: 18
61–80%; Responses: 10
81–100%; Responses: 17
Total Responses = 103

•Does this percentage vary by unit, e.g., ICU, Med-Surg?
Variation of Multiple Connection Devices by Unit:
Yes; Responses: 77
No; Responses: 14
Don’t know; Responses: 43
Total Responses: 134

•Do you send patients home with enteral feeding?
Patients Are Sent Home With Enteral Feeding:
Yes; Responses: 96
No; Responses: 20
Don’t know; Responses: 19
Total Responses: 135

•If yes, what connectors are used?
Type of Connectors Used at Home:
Luer; Responses: 9
Enteral; Responses: 79
Don't know; Responses: 17
Total Responses: 105

The survey results indicate that enteral misconnections continue to occur, and that there is a large potential for these misconnections to occur in various parts of hospitals. Several hospitals have taken internal steps to prevent misconnections, and many health organizations are currently working together to take action to prevent misconnections and keep patients safe.

Preventing Misconnections
Many health organizations have taken steps to raise awareness of medical misconnections.

The FDA wrote an article with a list of precautions, published in Nursing 2005, that can be taken by clinical staff in order to promote the prevention of misconnections.3

•Educate all clinical staff who use Luer devices about the hazards of misconnecting tubing and devices.

•Teach clinical staff to first carefully inspect and then follow the proper connector sequence when connecting tubing and device components.

•Read and follow the equipment manufacturers’ recommendations and precautions, especially regarding compatibility with other devices.

•Don’t modify IV or feeding devices because doing so may compromise the safety features built into their design.

•Tell patients they must ask clinical staff for help when they need to disconnect and reconnect equipment. A patient or family member could easily connect the wrong devices.

•Report known or suspected misconnections to the appropriate person in your facility and to the FDA through its MedWatch reporting program.

•At your facility, join committees that are responsible for choosing products. Then encourage these committees to choose safety-designed devices to eliminate or reduce the risk of misconnections.3

Additionally, FDA wrote an article on the topic of Luer misconnections that was published in Safe Practices in Patient Care. Free Continuing Education credits are offered after reading this article. The article can be accessed at www.safe-practices.org.7

The Association for the Advancement of Medical Instrumentation (AAMI) developed a standard in 1996 (ANSI/AAMI ID54:1996/(R) 2001 “Enteral feeding set adapters and connectors”)2,8 that called for the elimination of adapters and connectors that are compatible with female Luer lock rigid connectors. A positive result from the creation of this AAMI standard was the adoption by some device manufacturers of a unique enteral connector at the end of the enteral feeding sets. In addition, a human factors engineering guidance (HE-74, Human factors design process for medical devices) has been published by AAMI. This document can be used to test connectivity and misconnection potential between devices in a clinical setting.8

A multifaceted workgroup was formed in 2006 to address the problem of enteral feeding system misconnections. Participants include members from FDA, ASPEN, the Joint Commission on Accreditation of Healthcare Organizations (JCAHO), ISMP, ECRI Institute, the American Nurses Association (ANA), the American Hospital Association (AHA), United States Pharmacopeia (USP), and the U.S. Department of Veterans Affairs, as well as various clinical and industrial representatives. In addition, the International Standards Organization (ISO) has formed a joint workgroup to consider problems with medical device misconnections.

Premier Safety Inc., the purchasing alliance of many hospitals nationwide, continues to educate device manufacturers to encourage the design of enteral systems that do not allow for Luer misconnections.

MedSun contracted with the Beaumont Services Company’s Clinical Engineering Department and William Beaumont Hospital's Pediatric Intensive Care Unit to develop several educational tools to help hospitals deal with the complex issues of Luer misconnections, and to increase health care professionals’ awareness of misconnections and their impact on patient safety. These tools were distributed to MedSun facilities and will be made available on the soon to be released public MedSun site.

The reported misconnection examples listed in this article, as well as the results of the MedSun survey, show the many different ways misconnections can occur. The FDA is working closely with many health organizations to increase awareness of misconnections as well as to promote the prevention of misconnections. As FDA gains information about the progress these health organizations are making regarding the prevention of misconnections, the information will be made publicly available in order to achieve the common goal of ensuring patient safety.

References
1. Joint Commission Sentinel Event Alert. Tubing Misconnections—A Persistent and Potentially Deadly Occurrence, Issue 36, April 3, 2006, http://www.jointcommission.org/SentinelEvents/SentinelEventAlert/sea_36.htm; accessed on April 14, 2007.
2. ISMP Medication Safety Alert. Problems Persist With Life-Threatening Tubing Misconnections, June 17, 2004, http://www.ismp.org/newsletters/acutecare/articles/20040617.asp; accessed on April 22, 2007.
3. Eakle, Melissa, R.N., M.B.A., M.S.N., Gallauresi, Beverly Albrecht, R.N., B.S., M.P.H., Morrison, Audrey, R.N. Luer-lock Misconnects Can Be Deadly, Nursing 2005, 35 (9), Sep 2005, p. 73.
4. FDA Patient Safety News. Show #31, Sep 2004; Show #20, Oct 2003; Show #46, Dec 2005.
5. Crowley, Jay. The Risks of Misconnections Luer Fittings and Enteral Feedings; presented May 16, 2006 to U.S. Pharmacopeia’s Safe Medication Use Expert Committee.
6. Wallace, J.R., Payne, R.W., Mack, A.J. Inadvertent Intravenous Breast Milk, Lancet 1972 Jun 10:1(7763): 1264-6.
7. Gallauresi, Beverly, R.N., B.S., M.P.H., Eakle, Melissa, R.N., M.B.A., M.S.N., Morrison, Audrey, R.N., Misconnections Between Medical Devices With Luer Connectors: Under-recognized but Potentially Fatal Events in Clinical Practice, Safe Practices in Patient Care, July 2007, Vol. 3, No. 2.
8. Association for the Advancement of Medical Instrumentation, http://www.aami.org/; accessed on July 16, 2007.

Additional Information:

Tubing Misconnections—A Persistent and Potentially Deadly Occurrence
http://www.jointcommission.org/SentinelEvents/SentinelEventAlert/sea_36.htm

ISMP Medication Safety Alert. Problems Persist With Life-Threatening Tubing Misconnections
http://www.ismp.org/newsletters/acutecare/articles/20040617.asp

Association for the Advancement of Medical Instrumentation
http://www.aami.org/


MedSun Newsletters are available at www.fda.gov/cdrh/medsun