Debora Simmons spoke at one of the main sessions during this year’s Oley annual conference. This article is adapted from her presentation.
I do a lot of speaking in my professional life, and I am most moved by the people I see at this conference. Because honestly, at the end of the day, what health care providers try to do is take care of people who have a problem. Whether your problem is something that puts you in the hospital or something that changes your life, that’s really what any good clinical person’s life is about—taking care of people. That is what led me down the path of studying tubing misconnections.
| Multiple lines increase the possibility of a misconnection.
I’ve been doing research on tubing misconnections for over ten years. The first case I investigated was in 2002, and our first publication was in 2002. The published literature, warnings, position statements and other publications that followed are too numerous for me to start counting, but every major health-care safety organization in this country and internationally has stated this is a hazard to human life. I could talk to you today about publications and the research we did, but will this make a difference for you? I’m not sure. I hope to bring you something that will help you in the days that follow this conference.
I have no commercial or financial interests, I don’t endorse any products, and the opinions are my own. I want to recognize Bryanne Patail, who was with the VA Patient Safety Center; Peggi Guenter, from the American Society for Parenteral and Enteral Nutrition (A.S.P.E.N.); and Nancy Pratt for supporting this research. They began this many years ago when the topic was not well known.
The Ford Pinto
How many people know the story of the Ford Pinto? Briefly, this is the story of a car that had a design failure. When the car got rear-ended, it would burst into flames and people would die. Nobody really knew about it until they started researching it and found several cases. Engineers found that one piece of the car—a piece that cost $11.00—was causing them to go up in flames under certain circumstances.
When Ford CEOs sat down and looked at it, they said, this is what we know is going to happen with this piece, and it needs to be changed out in all Pintos. The piece costs $11.00. But they also reasoned there were only going to be about two thousand deaths related to this problem, and each death would only cost them about $200,000. So they decided, as noted in a well-publicized memo, they were not going to change the design because the cost of human life was less than the cost of lawsuits in the future deaths. In a blink of an eye human life had a price tag on it decided by executives in a manufacturing company.
Why do I bring this up? I bring it up because we have a Ford Pinto in health care. That Pinto is the Luer lock connector. As many of you know, we use Luer locks for everything that we connect in health care.
Incompatible with Life
It is not uncommon to see a child or adult in the hospital with a feeding tube, an arterial catheter, and a central venous catheter. All of those tubes and catheters have the same connector. That sounds kind of utilitarian and easy, because we can connect all these tubes, but there is one problem: A misconnection is physiologically incompatible with life. If you put an enteral feeding [formula] into an IV line, for example, it’s like pouring concrete into a patient’s heart.
How many systems in health care have these connectors? They are on drains into the brain; on tubing that goes into people’s lungs; on tubing for blood pressure machines. In acute care settings, it is not unusual for a patient to have ten or even twenty of these attached to them, with each one needing to be changed every twenty-four hours or less because they get infected easily, which is very critical. Every time the patient gets a new medicine or therapy we connect these to something else.
The issue of tubing misconnections is about all these different systems. I want you to consider a nurse who has a patient who has twenty of these tubes and catheters—who has two patients with this many—and who has to change the patient’s tubings every twenty-four hours or less, over and over and over again.
I’m not an expert in nutrition or in feeding tubes. I am an expert in safety. I study and teach human factors science as it applies to this type of error.
Human factors science categorizes the ways people make mistakes, with one category being “automatic mode.” You are in automatic mode all of the time. The more you do something, the less you think about it and the better you are at it. When you go to the coffee machine, you don’t say, “I’m going to put the lever up with my right hand, then put the cup underneath and so on…” You don’t, because you know how to do it. That’s how your brain works, so you don’t have to have your attention on things you do routinely.
Deb Simmons speaking at the 2016 Oley Conference
Think about when you were first learning to drive. You thought, Oh no, where’s the brake? Now when you’re driving, your foot goes directly to that brake pedal when necessary. That is automatic mode, and it is very important. Automatic mode is most often in familiar circumstances, when you know how to do something.
Here’s the important thing about an automatic mode error: it’s like your brain skips a step. You know how to do this, and all of a sudden you’ve skipped one little step. You know this; it has happened in your life. But this kind of error is not detected at the time by the person doing it. Because you do this all the time, you don’t even recognize you skipped that step.
Have you ever locked your keys in the car? Or locked yourself out of the house? I’ve locked my keys in my safe. How many times do you think, as you drive out the driveway, did I turn off the coffee pot? Turn on the porch light? Or put the dog out? We dial the wrong number. We put milk in the cabinet and cereal in the refrigerator. I left my refrigerator door open all day last week while I was at work. These are errors you don’t recognize as they are happening. And unfortunately, they are inevitable because we are humans and we cannot have perfect performance.
The particularly bad thing about one of these errors is there is no grace period. There is no time when you go, whoops, I left the refrigerator door open. There’s no warning saying don’t do it. It is inevitable because we are human; it is undetectable because this is how our brain works; and it is inescapable. You cannot escape this type of error and the more you perform this task the more likely you are to make the error. The only way to prevent it is to change the design.
Right now, when you connect tubes meant for different systems, someone is going to die. When you connect physiologically incompatible systems, it is going to cause patient harm. And it is going to happen. This is without question.
Every major safety organization is endorsing a change. The Institute for Safe Medication Practices (ISMP), the FDA, A.S.P.E.N., ECRI Institute, and the American Nurses Association all agree this design must be changed, and it has to be changed for all of the systems I have mentioned, not just for tube feeding.
If we have all these tubes and catheters sitting there with the same connectors, we’re causing a danger for whoever has those tubes. Again, inevitably someone is going to make a mistake. There’s going to be a distraction, something that draws your attention away, or some flaw in performance. It doesn’t matter how well trained you are or how careful you’re going to be, because the design allows them to be connected to each other. And if a human is connecting it, eventually a misconnection is going to happen.
| Even in the home setting, multiple lines can get confusing - especially in the middle of the night in a dark room.
I’d like to share a story about Robin. Robin had hyperemesis gravidarum—that pregnancy-induced condition where you throw up all the time. She had it with her first baby and then again the second time around. They put Robin on hydration because she was constantly dehydrated from vomiting. As she got close to term, it got worse and they put her in the hospital. They put her on an intravenous feeding as well because she was not getting the nutrition she needed. They planned to get her stabilized, and then deliver her healthy baby.
Robin’s mother is an experienced obstetrical nurse. She was with Robin the day a nurse came in and accidentally connected an enteral feeding to the intravenous line. Again, like pouring concrete into someone’s heart. Robin noticed immediately that the baby died. Then she realized she couldn’t breathe. As her mother stood at her bedside, Robin died, too.
This is a preventable error. If these tubes did not have the same connectors, this nurse would not have to carry this to her grave. Nurses I’ve talked to who have been involved in these incidents are some of the most grief-stricken, tortured people I have ever talked to. They went to work trying to help somebody, and they made an inevitable human error.
At that time, Robin had a three-year-old son. I ask you to think about him. He is now thirteen years old and he doesn’t have his mother because of this.
Evolution of Change
Several years ago in California, Nancy Pratt went to the legislature advocating for change because chemotherapy was put in the spinal infusion system of a young man (see sidebar, page 11). He died an agonizing death over twenty-four hours. It did not involve tube feeding, but it was due to one of the Luer locks that connects to everything.
Immediately the industry started reacting. One of the reactions I am most disappointed in was that Luer lock manufacturers formed a lobby and put pressure on the law that delayed it for four years. They said they needed four more years to work on this. Now that law comes due. That is really what is driving this change.
Other states probably don’t have these laws, so whatever we do moving forward will depend on what you do yourselves. We know today without a doubt that this is an error that needs to be fixed. It has been there for too long. I’m embarrassed to tell you I did this research a decade ago and it has not changed. It is present still in almost every health-care situation. The first published case was in 1972 and the first expert group to recommend a change was at the American Association for Medical Instrumentation in 1996. This has been going on for decades.
I know today there are people that live at home who have misconnected their own tube feeding. I cite the example of a young man who woke up in the middle of the night—he had both a PICC (IV) line and tube feeding—and accidentally misconnected. I know every major safety organization needs this to change. I know it’s been ten years, and I know there is no reason for you to tolerate this any longer. I ask you for support of this change, and support of it now.
I also know that GEDSA has brought vendors together to get consensus about this design change. And I know that one major manufacturer has pulled out at the last hour, asking to wait another three to four years. I find that unconscionable. I do not understand how anybody that understands safety can say we will wait another three to four years for this change and allow people to be unsafe for that period of time.
Adjusting to Change
For all of you who are handling your condition at home, I know this is going to mean you’re going to have to adjust your routines. You’re going to have to find ways to make this work. But I do want you to recognize that if you have more than one line, you are at risk of this happening to you in your home. If you are hospitalized and you have one of these universal connectors attached to your feeding tube and then you have an IV line put in, this puts you at risk. I want you to be very, very aware of that. I also want you to think of all the people who do this repetitive task in our health-care organizations every day. They are changing these tubes constantly. This change is big and there is a reason—it is a big danger.
I know there is a controversy right now about this new [ENFit®] design. What I would say to you is there is no system I know of in this world that is perfect. My grandmother would say perfect is the enemy of good. Right now folks, the system we have is bad. So although we may move forward with a system that causes you inconvenience, we are resilient, smart people, and we will find a way to make this work.
I hope all of you think that yes, life is inconvenient, and yes, there are problems with some of these designs, but yes, we need to change this because this is for the greater good of people. I appreciate so much your advocacy, and your voice for other people who are being hospitalized, or who deal with this on a daily basis.
Questions & Answers:
FC (consumer): Thank you. This is very interesting and terrifying. Is this a state change, or a national change? Where does the advocacy need to be directed? What can we do? What overriding body should we contact?
Debora Simmons: Part of the problem is there is no overriding regulatory body that is going to say this is mandatory, change it. This problem is happening in every country, by the way, not just the United States. In the UK they have already changed to another system.
Your advocacy is welcome on the FDA level, on the national level, and certainly, you need to be talking to your local folks about this. Because that’s where you’re going to go if you’re going to need acute care.
I don’t particularly care what the connectors are as long as they don’t connect to each other. What I do care about is the delay. The connectors are moving forward and I would ask that you support that.
Dr. Lyn Howard: I think one of the issues here is that a lot of professionals in the field did not appreciate until very recently how many consumers at home actually opt to blend their foods and therefore need a delivery set that can tolerate that kind of consistency. In general, the people who do it feel—perhaps without a lot of science, but nonetheless they do feel—that their child or whoever has made a lot of serious progress with a blenderized diet. This was not in front of the committee making these decisions—they were very hospital-oriented, and this whole group of people therefore were not at the table. There has to be a solution going forward, and it’s not probably that hard, but people need to know exactly how to do it in a way that is effective. I think it needs to be really, really clear.
DS: Again, any solution that you put forward in a design change is not going to be perfect. What I would ask you to do, because I am not an expert in blenderized diets, and I certainly want to maintain your ability to choose for yourself, is to get a special group together and start looking at what your options are.
This is not unusual that we have a problem with the design. We can get past this. What I would hope is that we do get a special group together—and certainly this organization has the expertise for that—and then get your menu of options set so we can get past it. (See pages 3 and 13 for more on this topic.)
DR (consumer): I want to say that no one values a life more than me. We all value life; we don’t want to see anyone hurt by a misconnection. However, the other side of the story is that I’ve been a tube feeder for four years, and one thing I don’t understand is how you can implement a California law that says no enteral misconnections can happen when ENFit connectors will still misconnect with other things, such as certain trachs, intravenous cannulas, and so forth. That’s disturbing. The law is in violation of itself.
I am also concerned about blenderized food. With the 2.9 mm diameter of the new ENFit connectors, you just can’t do it. I’ve tried. You’d have to have so much force that you can’t do it.
DS: It sounds like you’ve identified several different issues. Anything I can do to help you, any of the papers I have, I am willing to do. We still have some work to do. And the hospitals have a lot of things to work through. There are a lot of things with supply chains. For example, I want to make sure that anyone who shows up with an old fitting in the emergency department can be taken care of. There are a lot of things we need to take care of. That’s a good point, sir.
Dr. Darlene Kelly: I want to say that everyone who is being fed parenterally is at risk as well if there are misconnections. I also want to make everyone aware that Oley is meeting on a regular basis with FDA, GEDSA, some of the engineers involved in the new designs, and clinicians. There are studies on a variety of different tubes, different sizes, etc. under way now. Also, some manufacturers have changed their designs, which is probably not known generally among Oley members. Oley is working to try to get things so that our population can benefit from the changes.
DS: This is a huge change for health care. I appreciate your support.
More Tubing Misconnection Articles to Read
An article published in the New York Times on August 20, 2010, provides more details about the misconnection that led to Robin’s death, as well as an interesting look back at the discussions that were taking place six years ago. (See “U.S. Inaction Lets Look-Alike Tubes Kill Patients,” www.nytimes.com/2010/08/21/health/policy/21tubes.html?_r=1, accessed 10/13/16.)
In 2010, Nancy Pratt, who was a senior vice president at Sharp HealthCare in San Diego, California, was advocating for change. In the article she is quoted as saying, “The regulators have been waiting for the manufacturers to come up with a solution, and the manufacturers won’t spend the money to design and produce something different until the regulators force them to. And now the international standards organization is taking forever to get the whole world onto the same page.”
Today, the law Pratt was advocating for is in effect in California, and the International Organization for Standardization (ISO) has set a standard for enteral connectors. Many of the manufacturers involved in producing supplies for tube feeding have come together (through the Global Enteral Device Supplier Association, or GEDSA) to coordinate the launch of new connectors that incorporate this standard, known by the trademark ENFit®. As our readers involved with tube feeding know, these new connectors are now being transitioned into use. The ISO is still at work on standards for the connectors used in other health-care applications, such as breathing systems.
The New York Times article also cites another issue that has slowed change: “No one knows the real toll [from misconnections], because this kind of mistake, like medication errors in general, is rarely reported.” In “Tubing Misconnections: Normalization of Deviance” (Nutrition in Clinical Practice 26:3, June 2011), Deb Simmons et al. reviewed “116 case studies involving feeding intended for enteral routes misconnected to IV lines” between 1972 and 2010. They write, “Healthcare safety experts maintain that underreporting and nondetection of errors in healthcare, on both a national and institutional level, are barriers to recognizing threats to patient safety, learning how to avoid errors and quantifying errors.” They go on to describe the case studies and to discuss, among other issues, why the errors may occur and why they are often not reported.
If you have an interest in this topic, we recommend you read both of these articles. Links can be found to both on the Oley website at oley.org/ENFitConnectors.
Tubing Misconnections and New Connectors: Oley Answers Frequently Asked Questions
Q: What is being done today, in 2016, about tubing misconnections?
A: The International Organization for Standardization (ISO) is developing ISO 80369, a standard for small-bore connectors used in tubing, syringes, and so on in different medical systems, such as respiratory systems; enteral devices; neuraxial devices; and intravascular devices. The goal is to create connectors unique to each of these systems so those from one system will not be able to connect to those from another.
The standard for the enteral connector was published in July 2016. The FDA recognizes this standard and manufacturers are transitioning to products that meet this standard. The new connector is known as ENFit®.
Updates on the guidelines for all of the systems noted above are available at www.fda.gov/MedicalDevices/Safety/AlertsandNotices/TubingandLuerMisconnections/ucm313322.htm.
Q: I am a home enteral consumer. How does this change affect me?
A: It’ll mean extension sets, syringes, and G and J tubes with new connectors. You have probably already received at least tubing—and maybe syringes—with ENFit connectors, along with the adapters needed to make ENFit work with your existing G or J tube. It’s been a rolling transition to new products: first extension sets, then syringes, lastly tubes. Once the transition is complete and your whole system uses ENFit, you will no longer need the adapters.
Note that Luer lock, catheter tip, and oral syringes are not compatible with ENFit connectors.
If you also have an IV line or another medical device with a small bore connector, now or in the future, this change will help protect you from a tubing misconnection.
Q: I am a home parenteral consumer. How does this change affect me?
A: This change will help protect you from a tubing misconnection.
Q: I have read about concerns with the ENFit connectors. Will people still be able to use a blenderized diet? Will we be able to get enough syringes to meet our needs? Will we be able to vent? What about medication dosing issues? What is being done to address these concerns?
A: Sometimes people use their tubes in ways the manufacturers hadn’t anticipated. It’s going to take time for everyone involved to fully understand these needs, and for manufacturers to figure out how they can meet them. In the meantime, there are going to be some bumps.
The Oley Foundation has been working to bring your concerns to the manufacturers. We have brought consumers, clinicians, product manufacturers, the Global Enteral Device Supplier Association (GEDSA), home care companies, and the FDA together, and will continue to do so. We have also worked with the American Society for Enteral and Parenteral Nutrition (ASPEN), other nonprofit patient organizations, and the Institute for Safe Medication Practices (ISMP) on some of these issues.
There is research on blenderized diets and ENFit under way now at FDA and Mayo Clinic (see article on page 3). When that research is completed, we will have a sense of what effect the new connectors may have on blenderized tube feeding, and what the next steps should be. Oley and other organizations are also meeting to discuss issues about syringes and insurance reimbursement.
Open communication between industry and consumers over the past 12 months has led to increased understanding and accommodations, such as keeping the legacy products available at this time. In addition, in the prototypes of the new feeding tubes we’ve seen, it is evident that manufacturers are looking at how they can modify design variables (more than just bore size) in the new products to address consumer concerns. We won’t know whether some things will be successful or need amending until they have been released and we see them in action.
The Oley Foundation remains committed to facilitating an open dialogue between consumers, members of industry, the FDA and the clinical community, and to work towards seeing these issues resolved. We welcome your comments.
Q: How do I report problems with the new, or with existing, medical devices or supplies?
A: Report any problem to the supplier who provided your medical device or supplies; the product manufacturer; and the FDA (at www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM349464.pdf). If you do not have access to the Internet, call us (518-262-5079) and we can help you figure out how to file the report.
Q: How do I report a tubing misconnection? Should I report a “near miss”?
A: Report all tubing misconnections and near misses to the FDA following the instructions found at www.fda.gov/MedicalDevices/Safety/AlertsandNotices/TubingandLuerMisconnections/ucm313323.htm. If you do not have access to the Internet, call Oley (518-262-5079) and we can help you figure out how to file the report.
LifelineLetter, September/October 2016