February 2010 Issue

Enteral Misconnections — Changes in Pipeline to Prevent Deadly Errors
By Lindsey Getz
Today’s Dietitian
Vol. 12 No. 2 P. 18

While they don’t occur very often, enteral misconnections do happen, as evidenced by the July 2009 death of an infant in Madrid, Spain. This type of tube feeding error is preventable, making education and the proposed manufacturing changes being pushed by organizations such as the American Society for Parenteral and Enteral Nutrition (ASPEN) vital.

When Errors Turn Fatal
Enteral misconnections are defined as inadvertent connections between enteral feeding systems and nonenteral systems such as intravascular lines, peritoneal dialysis catheters, tracheostomy tube cuffs, and medical gas tubing.1 In the Madrid case, the infant died when a member of the nursing staff in the neonatal care unit administered formula through an IV catheter instead of through the feeding tube in his stomach.

Unfortunately, this is not the first time an enteral misconnection has led to death. The first reported death occurred in 1973.2 Although not all cases result in death, this type of error puts a patient at serious risk. In 1971, a young man hospitalized with a duodenal ulcer exacerbation who was receiving intragastric feedings of pasteurized milk mistakenly received about 100 mL of that feeding intravenously. Caretakers discovered the error after the patient developed a hypersensitivity reaction. In this case, the patient was treated and survived.1

More recently, a 24-year-old woman who was 35 weeks pregnant and hospitalized for vomiting and dehydration lost her life due to a tube feeding error. A nurse erroneously gave the young woman tube feeding formula through her IV line. The fetus died and the mother passed away shortly thereafter.2

“This type of tube feeding error, or enteral misconnection, is preventable,” said Peggi Guenter, PhD, RN, CNSN, director of clinical practice, advocacy, and research affairs for ASPEN, in a press release. “Best practices in EN require comprehensive understanding by healthcare practitioners and changes to the clinical and organizational processes. That’s why ASPEN works every day to provide research, training, guidelines, and standards so that healthcare professionals have the knowledge they need to help prevent these deadly mistakes.” 

Guenter adds that while tube feeding errors don’t happen often, the fact that their consequences are so severe makes them of critical concern. “In at least a third of the misconnection cases we’ve seen documented, the patient died,” she says. In many of those cases, the error resulted from the use of an IV syringe to dispense, prepare, or administer an enteral medication that was mistakenly attached to the IV system instead of the feeding tube.

“If you get the wrong medication or are the victim of some sort of medical error while staying in a hospital, in most cases, it can be corrected and isn’t life threatening,” she continues. “But with enteral misconnections, that’s not the case. Once this type of error occurs, there is a fairly high probability of death.”

Steps Toward Change
In early 2006, the FDA and ASPEN developed a survey to help them better understand the issue. The FDA’s Center for Devices and Radiological Health sent the survey to hospitals in its MedSun network while ASPEN sent the survey to its members. In total, there were 182 respondents, including dietitians, nurses, physicians, and pharmacists. Approximately 16% of survey participants reported that their institution had experienced an enteral misconnection; about 58% reported no incidents; and approximately 26% said they were unsure.

It’s important to remember when looking at such cases that people don’t make these misconnections on purpose. “These are usually done by smart [healthcare workers] who are on autopilot and may be trying to multitask,” Guenter says. “The problem is that these unlike connections do fit together, allowing these errors to occur. The patients are the victims, but there are a lot of healthcare workers who are victims, too. They’re trying to do their job, but they’re understaffed and overworked and they’re working with a system [that] can be made safer. The whole process needs to be changed. There are things we can do to prevent this.”

The physical design of connectors coupled with contributing factors such as those Guenter mentioned, as well as time pressure, rotating shift work, fatigue, inadequate training, and even poor lighting, make the possibility of error more likely.

Manufacturers need to make an effort to change the connectors so that enteral connections do not fit with any other system. Guenter says developments are currently under way to create standards so connectors that shouldn’t fit together won’t. “That’s the only way to totally prevent this,” she adds. “Everyone is on board, but it has to be recognized that it’s going to cost millions for each manufacturer to retool and get new product on the market. So it’s going to happen, but the downside is that this will take time to happen.”

Guenter anticipates that a new standard will be written by the International Organization for Standardization, in cooperation with the Association for the Advancement of Medical Instrumentation (AAMI), by this year but says it could be three to five years before a transition occurs and new products are available.

Though experts are discussing design modifications, these potential changes aren’t public knowledge to many. “A lot of people don’t even realize these changes are in the works, so we’re [the AAMI is] definitely working on educational pieces right now,” she says.
Among its educational efforts, the AAMI will offer a Webinar—currently scheduled for February 24—to alert purchasing groups, hospitals, nursing groups, and others that new connectors are coming and they may need to make some changes to the way they practice. The Webinar will explain why these changes are necessary and when the new connectors will be available.

Education, Training, and Awareness
In the meantime, until new connectors are available, the solution to reducing tube feeding errors is better education, training, and awareness. According to a paper by Guenter et al published in The Joint Commission Journal on Quality and Patient Safety, educators should emphasize the risk of tubing misconnections during orientation and training. In addition, those positioned in healthcare settings where there are multiple common connectors must be constantly aware of the risk involved in mistakenly connecting the wrong lines.

It’s also important to have strategies in place that will help minimize risk. The paper provided the following suggestions2:

• Review current systems to assess practices that include the potential for misconnection, including nonstandard, rigged workarounds (eg, Luer adapters).

• Train nonclinical staff and visitors not to reconnect lines but to seek clinical assistance. Only clinicians or those who are well informed about the device should perform a reconnection.

• When making a reconnection, clinicians should trace lines back to their origin and make sure they are secure.

• Upon arriving at a new setting or as part of a handoff process, staff should recheck connections and trace all tubes.

• Package together all parts needed for enteral feeding and reduce the availability of additional adapters and connectors to minimize the availability of dissimilar tubes or catheters that could be improperly connected.

• Label or color-code feeding tubes and connectors and teach staff about the labeling or color-coding process.

• Be sure to identify and confirm the solution labels; for example, a three-in-one parenteral nutrition solution can look like an enteral nutrition formulation bag. Label the bags with statements such as “WARNING! For Enteral Use Only—NOT for IV Use.”

• Make all connections under adequate lighting conditions.

• Identify and minimize conditions and practices that may contribute to worker fatigue and take appropriate risk mitigation action.

While these solutions are not foolproof, better education and training can help reduce human error. When new connectors become available under the newly developed standards, misconnections should be made physically unlikely.

For now, in the event that a tube feeding error does occur, it’s important for the institution to report the incident. Doing so can help speed the process of change. Institutions are required to report these occurrences to their state health department and should also report to the Institute for Safe Medication Practices Medication Errors Reporting System so the reports can be analyzed and used to raise awareness. Find the reporting process at www.ismp.org/report
errors.asp.

— Lindsey Getz is a freelance writer based in Royersford, Pa.

 

References
1. Guenter P, Hicks RW, Simmons D. Enteral feeding misconnections: An update. Nutr Clin Pract. 2009;24(3):325-334.

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.