About 15 years ago, a hospital in New York asked me to investigate the case of an 11-year-old boy who died while under anesthesia. Justin Micalizzi was a healthy child who needed a routine surgical procedure to clean out an infection in his ankle. But the outcome of the operation was not routine.
In the middle of the procedure, Justin's blood pressure inexplicably shot up to such dangerous levels that it caused his heart to stop. The medical team restarted Justin's heart but was unable to stabilize his oxygen and blood pressure levels.
He was transferred to a nearby pediatric intensive-care unit, but he died the next morning.
In an effort to determine what went wrong, the hospital hired me as an investigator. I examined the medical records of the operation but they offered no indication of how this could have happened. An autopsy was similarly unrevealing, and the cause of Justin's death remained a mystery.
Several years later, Justin's family and I learned details of his case that were not provided to us during the initial investigation.
Whenever an unexpected reaction occurs in a patient under anesthesia, the medication wastebasket in the operating room is examined. When we learned its contents in Justin's OR, we were finally able to determine his cause of death.
The contents of the wastebasket revealed that the cause of Justin's death was human error.
A vial of phenylephrine — a potent drug that rapidly boosts blood pressure in critically ill patients — was identified in the wastebasket but not marked on the medical records of the procedure. It was determined that Justin's anesthesiologist unknowingly administered the wrong drug.
When Justin's anesthesiologist reached into his supply cart to retrieve ondansetron — a drug that safely prevents postoperative nausea — he mistakenly chose phenylephrine. The medication vials look very similar and were stocked next to each other.
The information was not provided in the initial investigation but we learned of it years later from another doctor at the hospital.
To understand how this tragic event could happen, we need to look at the working space of the anesthesiologist.
Many people don't know that the operating room is the only area of the hospital where drugs are prescribed, prepared, and administered by the same person (the anesthesiologist). This happens every day without assistance or technological support, and sometimes under stressful or chaotic conditions.
There are two ways in which the wrong drug can be administered. The anesthesiologist could accidentally choose the wrong drug vial, as happened to Justin. Vials can look similar, and it takes only a split-second loss of focus to pick the wrong one without ever knowing that it happened. The second type of error is when the anesthesiologist accidentally administers the wrong syringe after the drug has been removed from the vial.
If operating rooms have not been equipped with the means to avoid these errors, patients have no choice but to rely on the anesthesiologist's vigilance to get it right, every time, many times a day. But, of course, human errors are inevitable. Therefore, the system of drug administration in the operating room must be engineered to prevent the error from occurring in the first place.
So how can these mistakes be avoided in the operating room of the future?
The mistaken-vial error can be eliminated by supplying the anesthesiologist with syringes that are pre-filled with a drug — a process that more hospitals are investing in. This pre-filling process can be performed by the drug manufacturer, third-party drug distributors, or the hospital pharmacy. However, not all anesthesia drugs are currently supplied this way.
The mistaken-syringe error is a harder problem to solve because there exists no system that would physically stop an anesthesiologist from accidentally administering the wrong drug. But bar-coding scanners could help to lessen this error.
Every drug syringe contains a label that lists the name of the drug and its concentration. A bar code that is universally recognizable by electronic health records can also be added to drug-filled syringes. When the anesthesiologist scans the code, two important processes occur: first, the anesthesiologist is forced to take a more focused look at the syringe, thus confirming that it is the correct drug; and second, a screen will appear on the anesthesiologist's computer that confirms the name of the drug and can warn of any allergies or incompatibilities.
Bar-coding drug systems have routinely used on hospital wards around the country but have only recently made their way into operating rooms. As the sophistication of electronic health records continues to improve and evolve, they will seamlessly integrate with the use of pre-filled syringes in the hope that tragedies like Justin's will never happen again.
To learn more about the Pediatric Safety Project sparked by Justin's case, visit http://justinhope.tumblr.com.
Ronald S. Litman, D.O., M.L., is the medical director of the Institute for Safe Medication Practices, based in Horsham, and a pediatric anesthesiologist at Children's Hospital of Philadelphia. Follow him on Twitter at @DrRonLitman.