by Ted J. Clarke, MD
Featured in the September/October 2018 Colorado Medicine.
You’ve probably never heard of Certa Dose. The small medical device company is bringing its products to market this year. At first glance, the syringes it sells may seem pretty simple (more on these later). However, the compelling part of the Certa Dose story is not so much what it does, but more about how the company originated. It’s a story that reminds us how keen observations and a desire to improve health care can lead to great ideas that make a life-saving difference.
Treating a child with an emergent condition is one of the most stressful and challenging situations that a medical professional can face. In 2005, Caleb Hernandez, MD, an emergency medicine physician, was attempting to resuscitate a little girl. In the process, a nurse almost injected the girl with 10 times the correct dosage of medication. Luckily, Hernandez stopped the nurse and the child recovered.
Reflecting on that near tragedy, Hernandez realized that the medical space is set up for accidental overdoses because of a communication gap: doctors work in milligrams, or units of mass, while nurses use milliliters, which is a volume measurement. “We’re speaking two different languages,” he said. So, he came up with an idea to create color-coded syringes to simplify how much of a drug to give a child based on age and weight.
Hernandez assembled a team to conduct a research study using simulated pediatric emergency resuscitation scenarios. The study was designed to evaluate the effectiveness of prefilled, color-coded medication syringes, compared with conventional medication administration. Among the partners that Hernandez reached out to for support was the COPIC Medical Foundation. Recognizing how well this project aligned with COPIC’s goal of improving quality of care, the Foundation provided grant funding for the team’s study in 2012.
The study’s results were impressive:
- Median time to delivery of all doses for the conventional versus color-coded delivery groups was 47 seconds and 19 seconds, respectively.
- When 118 doses were administered using the conventional method, 20 critical dosing errors occurred. Using the color-coded approach, 123 doses were administered without a single critical dosing error.
These results went on to be published in the Annals of Emergency Medicine(1) and Resuscitation.(2) The articles garnered national attention and were significant milestones that moved Certa Dose forward to become a viable company. In November 2017, Certa Dose won the Johnson & Johnson Innovation, JLABS Advancing the Safe Use of Healthcare Products QuickFire Challenge, which provides support for the “best ideas on how to educate, inform and provide clarity around health care product safety.”
The company is now taking the first steps in rolling out its product to the medical community. Health care professionals introduced to the color-coded syringes can easily understand the benefits – they no longer have to do complex arithmetic under stress and, instead, simply draw up a dose to the appropriate color zone for the child. The first product released was a U.S. FDA-cleared syringe for use with the administration of epinephrine, and the company is exploring offering additional products in the future.
There are several reasons why I love the Certa Dose story. First, it is a simple, but brilliant solution that is incredibly effective. Second, it demonstrates that with the right support and vision, innovative ideas can grow with the potential to transform health care. Finally, the story of Certa Dose’s success means that we are going to hear numerous accounts about how the distinct, color-coded syringes have saved the lives of thousands of our pediatric patients.