New Sentinel Event Alert targets tubing misconnections
Phase-in begins now, but don’t let your guard down
It is easy to understand why someone thought that all tubes used in a particular setting should be interchangeable: It would be cheaper to manufacture and easier for someone getting a necessary piece of equipment to grab what was needed and not have to worry whether the male part would fit the female. But it is also easy to understand why, in a medical world where a patient can have as many as a dozen intravenous tubes, getting them mixed up could be catastrophic.
Indeed, Bruce Hansel, PhD, CCE, the executive director of forensic services at ECRI Institute in Plymouth Meeting, PA, can’t forget one of the first cases he investigated about 30 years ago, when he first began his career at ECRI. "It was a project on enteral feeding pumps. There was this World War II vet. He was paralyzed. He had developed Guillain-Barré syndrome and had lost all movement he had retained except for the ability to blink. They believed he would recover. At one point, the nurses moved him into the hall to clean his room. He had a tracheostomy tube, which has a little white pilot tube on the end. The enteral feeding tube had a white pilot with the same blue cap. The feeding bag had run out, so someone came in and plugged in another. But they plugged it into his trach cuff. That man suffocated in the hall. He could not wave or wiggle or say anything. He could just blink. I kept thinking of that war hero in the hall, suffocating as people walked by until someone happened to notice that he looked blue."
That tragic incident made Hansel a passionate investigator of this kind of error, and also a proponent of changes that have been crafted over the last 30 years. All the enteral feeding pumps at that time had begun converting to what the people in the industry call a Christmas tree connector, rather than a luer connector. That year, Hansel says he investigated about a dozen enteral feeding pumps and none of them had luer connectors, so that was obviously not the issue in those cases.
In 1993, new standards were proposed that would ensure enteral feeding sets could not be connected to luers. The standards did not require that the tubing have a specifically designed connection for its particular use, he says. "They could look any way they wanted, they just were not allowed to fit into a female luer." They were adopted in 1996, "putting into code what people were already doing," he says, although they also eliminated the practice of packaging the Christmas tree fittings with adapters so that people could have a work-around ready at hand should they want one.
That standard, ID 53, made things safer, Hansel says, but it wasn’t enough. He thinks having an entire enteral system will make a great deal of difference. "We talked about having a total connector at the time, but it was about balance — how much safer would it be versus how much more it would cost. At the time, we felt that ID 53 would eliminate the vast majority of IV misconnections. And manufacturers were worried about the cost. So we stopped. Think about the costs of development, manufacturing, and training in the hospitals. It was too far to go all at once."
The standards were reaffirmed in 2005, but over the last several years, the idea to make a complete connector system has arisen again.
At one large hospital system, a misconnection by a temporary nurse allowed an enteral bag to be spiked with an IV set, Hansel says. He worked on the case. Enteral formula entered the IV line. The hospital system asked Hansel to evaluate policies and procedures across all its facilities with an eye to unifying them. They also unified all the technology used so that they were purchasing the same pumps and sets at each facility. Mistakes like that, highly publicized, are what led to calls for further change, he notes.
By the time the new ISO 80369 standards are all in place, there will be different tubing systems for each kind of use, each requiring new molds, new processes, and probably the need for transition products in some cases, Hansel says. "It will cost hundreds of millions if not billions of dollars to make these changes, but we have come to the point where the safety is worth that expense."
In the ideal world, having 12 different IV lines, none of which can marry to something it should not, would be enough to prevent mistakes, but Hansel warns against that kind of complacence. "Mechanical lockout is ideal," he says, noting that the ISO 80369 standards include specific requirements about the amount of force it would take to mash one of the male parts into a female receptor that it is not meant to be married to. "But you still have to make sure that nurses trace all their lines."
Hansel says that all hospitals should take this opportunity to evaluate their policies and procedures, as well as to take a look at what they buy. "Make sure that the products you buy are conforming to the new standards," he notes. Work with your procurement department to review and remove old inventory from stock and update your computer purchasing program to include only new products that comply with the new updated standards.
Look for specific devices that deliver gas that still have luer fittings on them, Hansel says. "If you can’t use something else, that connector needs to be labeled as not for IV, very prominently at the user end. You should still look for replacement products for those, but it may take more time for some products, like insufflators, to meet the new standards."
The place with the greatest risk is the neonatal intensive care unit, Hansel notes. In most cases, enteral syringes and sets are used, but some places may still be using luer syringes and luer sets. "To prevent misconnections, your best bet is to segregate IV and enteral products from each other. Put them in different bins, of course, but on different sides of the room, or at the very least in different cabinets."
ECRI has developed an acronym that he thinks is useful for nurses, too: TRACER — Trace, Read, Affix a label if necessary, Connect, Examine the connection, then Retrace. The accompanying slogan — Be a Tracer not a Racer — adorns a poster that he welcomes people to download and use: https://www.ecri.org/Documents/Miscellaneous/TRACER(Poster).pdf.
"As long as there are people, there will be ingenuity and people will try to work around things," he says. "Just because there are specific connectors does not mean mistakes can’t be made. Always trace the lines."
In a busy environment, sometimes with low light, it can be easy to let that simple step slide, particularly when new products are supposed to obviate the need — at least in theory. Do not let it, he repeats. "Patients can have so many lines. You really have to be very careful."
Colleen Elliott, PMP, the director of standards at the Association for Advancement of Medical Instrumentation (AAMI) in Arlington, VA, says that many nurses make as many as 400 connections every single day. Multiply that by the number of nurses in a hospital and the number of days in a year and the total number gets large. The error rate, on the other hand, seems pretty small: just .02%, says Elliott. But it is only small as long as it is not you, or one of your loved ones. "That is a very serious number for real people."
AAMI worked on a toolkit released in the spring to help organizations deal with the interim period between the approval of the ISO standards and their implementation. (See story on luer connector toolkit in the March issue of HPR.)
She says the best way forward now is to start preparing for the change by educating staff about it, even if you haven’t changed products yet. She specifically mentions the Stay Connected project by the Global Enteral Device Supplier Association (GEDSA — www.gedsa.org) for its good advice and tools. And if you haven’t started researching new product lines, you should, she says, noting that "manufacturers have been preparing for this for a while, and they will have new items available within the next few months" if they don’t already. The timeline calls for enteral tubing supplies to be first out of the gate. The total list includes: intravascular or hypodermic, limb cuff inflation, enteral, neuraxial and breathing systems, and pressurized gases applications.
While misconnections will be much harder to make with the new products — "you’d have to really be trying," Elliott says — they will probably still occur, particularly with the types of connectors that are used least frequently and may be last on your re-order list. For such products, make sure your training is clear: If someone is using a luer adapter or some sort of work-around, then they may be making a connection between two parts that are not meant to go together, she says. Training should include the message to stop and think when using adapters, and make sure that the connection being made is correct from start to finish.
The Joint Commission Sentinel Event Alert on the tubing issue can be found at http://www.jointcommission.org/assets/1/6/SEA_53_Connectors_8_19_14_final.pdf. It contains a resource list as well as suggestions for moving forward. Further information on the Stay Connected project, including checklists, webinars, and brochures, is available at http://www.stayconnected2014.org/index.html.
And a 2006 paper on tubing misconnections from ECRI is available at https://www.ecri.org/Documents/Patient_Safety_Center/Preventing_Misconnections_of_Lines_and_Cables.pdf.
For more information on this topic, contact:
• Bruce Hansel, Ph.D., CCE, Executive Director for Forensic Services, ECRI Institute, Plymouth Meeting, PA. Telephone: (610) 825-6000.
• Colleen Elliott, PMP, Director, Standards, Association for Advancement of Medical Instrumentation, Arlington, Va. Telephone: (703) 525-4890.
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