Misconnected IV, drug, and feeding tubes are expected to be less likely when new tubing connector standards, now in development, are in widespread use, The Joint Commission says.
With at least 21 hospital patient deaths and nearly 100 other adverse events occurring because plastic tubing intended to deliver food instead went into an IV, a Joint Commission Sentinel Event Alert urges healthcare providers to be extra diligent to avoid such mistakes.
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In addition to the 2006 death of a pregnant woman whose feeding tube was placed into her bloodstream in a Kansas hospital, the commission said, this week, "116 other case studies [involved] misconnections directing enteral feeding solutions into IV lines" over the last decade.
What's more, the commission said, "tubing misconnections are underreported," and the adverse events that often result are "sometimes not reported, especially when the mistake does not result in harm to the patient." Or they're reported under another category, such as a medication error.
New tubing connector standards are now in development, to make such misconnections less likely. The first set of standards have already been adopted, the agency said in its alert.
"Small-bore (less than 8.5 mm inner diameter) connectors will be engineered to make it nearly impossible to connect one delivery system to another delivery system that serves a completely different function," the commission said.
The standards are being developed through a collaboration between the International Organization for Standardization (ISO), the Association for the Advancement of Medical Instrumentation (AAMI), clinicians, manufacturers, and regulators such as the U.S. Food and Drug Administration.
New connectors will reach the market by this fall, followed by "a slow, deliberate and careful transition to each new connector." The period of transition will "introduce new risks into the healthcare environment," the commission cautioned.
Enteral connectors will come first, and for patients with old catheters in place, there will be a temporary adapter to allow continued use.
Some of the documented misconnections include a limb cuff inflation device mistakenly connected to an IV, which resulted in the death of a 71-year-old woman from an air embolism, and epidural solutions connected to a peripheral or central IV catheter.
Causes Cited
The Joint Commission referenced a number of causes of these mishaps, including the fact that the problematic connections are often done as "work-arounds," when appropriate adapters, tubes, or catheters are not available.
Providers make "connection errors after going into 'automatic' mode due to stress, fatigue, or distractions," the agency said. Poor lighting is also to blame.
The commission made a special note of the so-called "spaghetti syndrome," in which providers position functionally dissimilar tubing in close proximity. Failure to recheck or trace tubing connections to make sure they begin and end at the appropriate locations is a failure often occurring during the handoff process or during times when patients are transferred or transitioned from one care setting to another.
"Less-than-optimal reporting of adverse events and near misses as part of efforts to educate and raise awareness" thwarts improvement, the agency said. "There is still a fear of repercussions and legal action."
Recommendations
The commission suggests that hospitals take the following actions to prepare for the new ISO connector standards.
1. Create an interdisciplinary task force to identify potential misconnection hazards and develop strategies to mitigate them. Also conduct acceptance testing for performance, safety and usability on new tubing and catheter purchases.
2. Prepare for ISO connector changes by increasing awareness for clinicians, administrators, supply chain, healthcare technology management and support staff.
3. Assess existing systems, processes and protocols to carefully transition to the new connectors. Find out what each supplier will do to help the transition. Train clinicians and supply chain management on transition plans, including the use of temporary adapters.
4. Purchase only equipment that will conform to the new standards and avoid buying equipment with luer lock connectors for limb cuff inflation, neuraxial, enteral, breathing systems, and pressurized gasses applications. Luer connectors will continue to be used for intravascular or hypodermic applications.
5. Trace tubing or catheters from the patient to the point of origin before connecting or reconnecting, at any transition, and as part of the hand-off process.
6. Route tubes and catheters having different purposes in different, standardized directions, especially in neonates.
7. Use labels. When there are different access sites or several bags are hanging, tubing should be labeled to reduce chance of misconnection, especially when multiple IV lines are in use.
8. Ensure implementation of safe practices for administration of high-alert meds. For high-risk medications delivered via an epidural, intrathecal, or arterial route, label the catheter and do not use tubing or catheters that have injection ports.
9. Use tubing and related equipment only as intended.
10. Take inventory and store carefully. Package all parts needed for initial enteral feeding together to minimize the chance of using dissimilar tubes or catheters.
11. Educate the staff appropriately.
12. Make sure non-clinical staff, patients and visitors that they must get help from clinicians whenever there is a real or perceived need to connect or disconnect devices or infusions. They should not attempt to disconnect or connect these devices themselves.
13. Identify and improve unsafe working conditions, especially fatigue, inadequate staffing, and interruptions.
14. Report adverse and serious events to the Joint Commission's Sentinel Event program and/or the U.S. Food and Drug Administration's MedWatch program.