The (Human Factors) Devil in Blue Scrubs

Written By: David Orenstein, Human Factors Engineer at Gilero

Isn’t developing novel medical devices that solve both simple and/or complex problems exciting? You work for months, which quickly turns into years spent identifying a problem, brainstorming solutions, determining which one is the most feasible, elegant, cost-effective, etc., and then you build your prototype, test it in the lab, and it works freakin’ fantastic. You (and your team of geniuses) just figured out how to solve a problem, and the best part is that it actually works! Now of course you must work through all of the red tape to get this awesome product on the market. You’ve submitted your data to the FDA, and the FDA says, “Let me see your validation data.” “Oh shoot, we never did any human factors testing. I’m sure it will be fine.”

Now, fast forward to validation testing. The first nurse is in the human factors observation suite and the moderator has just finished explaining the scenario.

Moderator: “You have been asked to draw blood for labs from your patient’s peripheral IV and have been provided ‘Product X’ to help you in the process. Please proceed and let me know once you are finished.”

The nurse is getting up and walking towards the patient. The nurse is carefully inspecting ’Product X.’ Everything is going well as she correctly connects the product to the patient’s peripheral catheter. You finally relax a little bit and then, WHAT THE HECK! Why did she disconnect at the syringe? CLAMP THE LINE! THE “PATIENT” IS NOW BLEEDING ON THE FLOOR. WHAT IN THE WORLD IS SHE DOING?

I could continue the story, but I think you get the idea. What happened in this simulation? How could this have been prevented? The problem is negative transfer – AKA the Human Factors devil in blue scrubs. You may think it’s the nurse’s fault, but let’s take a step back and think about what is going on. Our nurse draws labs from a peripheral catheter several times each week, maybe even multiple times per day. The problem is that nurses often do this activity with a syringe that has no extra attachments, work at a fast pace and have a thousand things on their mind to ensure they are not harming patients as they complete procedures. They start to rely on muscle memory. So, without even giving it a second thought, the nurse just did what she always does – disconnect the syringe from the peripheral line directly at the syringe. It never even occurred to this user that she should adjust her habits to account for the new part you added to their syringe. When a product or process is new or different than what a user is familiar with, they may negatively transfer knowledge from their previous experiences onto that new product, even though it may operate or function differently.

Now, how could this have been avoided?  As a human factors professional, the answer is clear: formative testing. I just can’t stress this enough. Had the product development team spent some time putting their product in front of users early on and iteratively (as appropriate), instead of focusing solely on bench testing and design verification, they would have caught this use error early when it was relatively cheaper to address (and less stressful). But now, they are left between a rock and a hard place as they figure out how to fix their product before running out of time and being required to restart the regulatory submission.

Formative usability testing allows users to interact with the device and run through simulated tasks and scenarios that are realistic to the use of the device. Formative testing and other human factors research allow medical device development teams to focus on how people perform when using the device in a real- life setting.  Being able to see how people use the device firsthand permits the product development team to do the following:

• Identify and evaluate user needs
• Evaluate anticipated critical tasks
• Identify unanticipated use errors
• Analyze the strengths and weaknesses of the product

In addition, human factors activities can seek out and capture useful feedback from users to guide the development of product labeling and marketing. This data will be used to help generate conclusions about the product and offer recommendations for what to do next. If changes are needed, design and development teams can implement these changes while the product is still in the design phase.

Human factors is core to the Gilero process.  We offer a full suite of medical device design and development services.  Our in-house human factors team is skilled at conducting market evaluations, risk analysis, formative usability testing, human factors validation, summative studies, and more. All human factors engineering is completed in accordance to the latest applicable regulatory guidance and standards and more.  We deliver devices that perform safely and effectively in real world environments.

When human lives are at stake, human factors is an invaluable investment.