You are having surgery. It’s relatively minor, hoping to relieve the leg pain you have while walking. After the procedure is done, the surgeon tells you everything went well expects you will soon experience relief from the pain.
But the pain actually gets worse. You see the surgeon in clinic the next week and follow-up testing reveals that the tip of a long catheter used in your leg had sheared off and was unknowingly left inside your body. That 2-cm catheter fragment has been sitting in your artery, causing blood to clot around it, impeding blood flow to your leg. You will need emergency surgery to remove the catheter fragment and restore circulation. You may have residual weakness in that leg.
Medical devices sometimes fail; a piece may break off inside of a patient. We don’t know how often this happens, as the data relies on recognition (which is unreliable) and reporting (which is voluntary). Regardless of the incidence, any one of these retained catheter fragments could severely harm the patient depending on the size of the fragment and where gets lodged inside their body.
The outcome hinges on early recognition that the entire device wasn’t removed. Early recognition allows the clinician to determine if removal is needed and intervene promptly to prevent complications such as infection, thrombus (clot), and aneurysm. As technology advances, we perform more minimally-invasive procedures and outpatient therapies that use endovascular catheters. As we use more catheters, reliable identification of incomplete removal becomes increasingly important.
Medical devices are designed for when they perform as intended. We need the same thoughtfulness in design for when they fail.
In patient safety, we often get involved when things go wrong. We are generally successful in preventing adverse event recurrence by changing things in control: our environment, internal processes, or the equipment we purchase. However, we see a recurring issue that is also plaguing other healthcare organizations, and we fear we cannot improve it without seeking external change.
When medical devices fail, we report it to the manufacturer, and the response in our experience is often that it was due to “user error.” We are writing this as a call to action for better human factors design across/between medical device manufacturers.
If “user error,” one would simply re-educate the user. In the case of identifying broken catheter tips, there are several reasons why re-education won’t work without design standardization:
- Multiple manufacturers produce those devices, and the catheters/devices all look different. Sometimes there are markings or a taper closer to the end, other times not.
- The clinician removing a catheter is often not the same person who placed it. The removing clinician may not know what the catheter looked like before use.
- Patients move between different hospitals and clinics. The first time you see “brand X” catheter may be the first time you remove it and have to account for tip integrity.
- Catheters are sometimes stretched or navigated through tortuous blood vessels. Even if there is an unused catheter available for comparison, it may not look the same.
We need to think differently.
For decades, cars from all manufacturers have been made with similar design requirements: gas pedal on the right and brake pedal beside it to the left, all lights on the rear of the vehicle are the same color red, etc. Driving cars is risky; that basic standardization helps the humans at the wheel.
Delivering healthcare is also high risk. Why not require some level of design standardization to help clinicians who are already struggling with an overburdened cognitive load?
Our proposed solution: Require the tip of every catheter made by any manufacturer to have the same visual indicator. A suggestion from our work is to color the 5-mm tip of every catheter lime green.
A colored tip indicator helps in two ways:
- Easier identification from anyone removing any catheter. This is key to early identification. If the clinician does not see the lime green indicator (tip), they would be cued to investigate.
- Easier education. Any clinician or student (e.g., nurse, physician, pharmacist) needs only to be taught to visually check for the lime green tip after removing a catheter.
This easy identification strategy frees up cognitive space for the tasks that deserve more thought, such as assessing the patient or performing complex procedures.
Safer healthcare is an imperative. We work with incredibly talented healthcare providers who challenge themselves to provide innovative, high-quality care, every day. This sentiment is echoed by the Institute of Medicine: “People working in healthcare are among the most educated and dedicated workforce in any industry. The problem is not bad people; the problem is that the system needs to be made safer.”
We can create that safer system by designing devices in a way that promotes early identification of failure and minimizing cognitive load.
Rebekah Friedrich, MS, RN, CCRN, CPPS, is the senior performance improvement leader at the University of Maryland Medical Center.
Jason Custer, MD, is the director of patient safety and medical director of the pediatric intensive care unit at the University of Maryland Medical Center and an associate professor of pediatrics and the University of Maryland School of Medicine.