Making critical dosing errors a thing of the past
A half of a second changed Riddley Barron’s life. His story moved me to tears. In 2004, Riddley lost his wife Sarah in a car accident. Their 17-month old son Josh was taken to the hospital with head injuries. Their 2 other children survived the accident. Josh was recovering, but five days later another half of a second also took the life of Josh, after a fatal mistake. Josh was administered an adult-strength overdose of seizure medication.
“It only took one error to rob Josh of his life. Why do we have this complacency in healthcare, where a fatal error is OK? As a society, we have to get to a point where this is not acceptable. We need to convert the practice of medicine into a high reliability organization.”
“We do not realize that we are killing three times as many kids with medical overdose than children who die from cancer.” According to Dr. Hernandez approximately 7,000 American kids a year die from fatal pediatric dosing errors. And approximately 2,000 die from cancer. “It’s so devastating for the family and also for the medical professional. That’s the secondary damage that happens. Healthcare providers are terrified to make mistakes. For me that’s why we do what we do.”
Passion for patient safety
Dr. Hernandez is board certified in emergency medicine by the American Board of Emergency Medicine and is an American College of Emergency Physicians Fellow. Additionally, he is an EMS Medical Director in Fort Collins, Colorado where he oversees First Responder Services.
Certa Dose® is the result of Dr. Hernandez’s passion for patient safety. His experience in emergency medicine and pediatrics led him to develop a solution to help reduce dosage errors and adverse drug events. “The problem of dosing error often arises because doctors and nurses use different systems to measure medicines. The complicated math needed to convert one standard to the other based on the patient’s weight leads often to mistakes, especially in emergencies,” explains Dr. Hernandez.
Dr. Hernandez was in an emergency room in Brooklyn where a five-year-old girl came in with cardiac and respiratory arrest. “A lot of things had to happen very quickly to bring her back. The nurse was about to give too much volume of a medicine. I said I think it’s wrong, she noticed it, put it down and she said thank you, I realize this is wrong.”
Thanks to Dr. Hernandez she gave the girl the right amount of medicine and they brought the child back to life and got her to the pediatric ICU. They could have just as easily lost a life. “I am glad it didn’t happen, but it was too close,” tells Dr. Hernandez.
This is a problem I noticed
This is where the story of Certa Dose® started. A story about a real-life event where a near overdose in the emergency room inspired the company to find a better way. “Everybody notices a different problem, and this is a problem of critical dosing errors I noticed.” Dr. Hernandez went back to the emergency room and when getting ready for new patients he thought about finding a better way to dosing children.
“Why ask health care professionals to effectively take a complex math test under incredible stress while they are busy practicing medicine and trying to save a life? I saw this overdosed syringe still there and the Broselow tape, and my mind put them together.”
Epinephrine: the most overdosed medicine
Dr. Hernandez founded Certa Dose®, an early-stage medical device company based in New York. The company developed an innovative system that uses color confirmation to deliver accurate dosing. Certa Dose® was named the winner of Johnson & Johnson Innovation, JLABS QuickFire Challenge*: Advancing the Safe Use of Healthcare Products.
“For me the vision is not let’s put colors, but let’s create a system where we incorporate everything we know about reducing errors for the medicines that are the most dangerous. There are about 20 drugs we commonly use in Emergency Medicine that are high-risk for overdosing with potentially fatal outcomes.” Last year the company received FDA clearance to use their syringe in delivering epinephrine to pediatric patients. The company is manufacturing it since last December.
Life already in danger
Epinephrine is an essential medicine according the WHO and should be available “at all times in adequate amounts, in the appropriate dosage forms, with assured quality and adequate information at the price the individual and community can afford.”
“People are making incorrect doses with epinephrine up to 60% of the time. The state of Pennsylvania said there are so many mistakes with epinephrine that they had an epidemic safety advisory. This is the most overdosed medicine you have. A life is already in danger, you cannot afford to make those mistakes.”
Correct dose during clinical trials
This fall the company is releasing their syringe for the safe administration of midazolam, a medication used for anesthesia, procedural sedation, trouble sleeping, and severe agitation. The company is doing licensing deals right now with top-tier pharmaceutical companies to incorporate their technology into various drugs. “In addition, our technology gives pharmaceutical companies the confidence that healthcare providers will give the correct dose during clinical trials when going through regulatory approval.”
A life cannot be replaced
To conclude Dr. Hernandez told us “When you take a life, you can’t take that back. If you think about all the things that you can replace nowadays. If I were to lose my phone, I can replace it with a better phone. But imagine a whole life, you can’t bring that back.”
*Winning the JLABS quickfire challenge allowed Certa Dose to become JLABS residents at JLABS@NYC. Read the article on how JLABS has helped Certa Dose.