New Orleans—Boston researchers have developed a bar code–based syringe-labeling system they believe has the potential to significantly improve patient safety and work flow in the operating room.

A pair of studies by the investigators revealed that the technology not only provides full compliance with requirements from both the Joint Commission and the American Society of Anesthesiologists (ASA), it also improves the efficiency of the clinicians who use the device.

“This project started about three years ago as an internal compliance project and very quickly became a patient safety project,” said Wilton C. Levine, MD, clinical director of anesthesia, critical care and pain medicine at Massachusetts General Hospital, who led the research. “We suspected we had difficulty meeting all the regulatory compliance for properly labeling syringes, and we knew from talking to our colleagues around the country that we were not the only ones who struggled with this.”

Dr. Levine and his colleagues set out to create a simple, user-friendly system that could quickly and easily generate a label meeting all of the regulatory compliance requirements of the Joint Commission.

The result is the SmartLabel system, which produces Joint Commission- and ASA-compliant syringe labels on demand at the point of care. “When you use this new bar-coding system, you take a vial of medication that you want to draw up into a syringe and scan it,” said co-investigator Karen Nanji, MD, a resident at Mass General. “A few seconds later, it prints a label with the name of the medication, the concentration, the date and time it was drawn up, expiration information and the name of the person who drew it up.”

The system produces an audible readout of the drug name and concentration where appropriate, as well as any alerts if the vial has expired.

“And all of that happens as you’re drawing up the medication,” Dr. Nanji said. “So by the time it’s in the syringe, the label is ready to go. This is where the time-saving comes in, because you don’t have to manually write all the information after you’ve drawn up the drug.”

In the first of two studies presented at the 2009 annual meeting of the ASA (abstract A609), the researchers evaluated their physicians’ baseline compliance with labeling requirements over a one-month period. Syringes were assessed for a variety of elements, including drug name, concentration, preparation date and time and clinician initials. SmartLabel was then installed in five operating rooms.

The study found that of the 1,090 syringes evaluated as part of the baseline study, 497 (45.6%) were prefilled by the pharmacy or a third-party vendor, whereas 593 (54.4%) were prepared by the clinician. Of those prepared by clinicians, only 269 met Joint Commission requirements for proper labeling.

Failure took many forms: 257 labels carried only the drug name; 35 had the drug name and concentration but no expiration date; 32 syringes had no label at all (Figure).

After the labeling system was implemented, the researchers evaluated 340 labels, 139 of which (41%) were prefilled. Of the remaining 201 (59%) prepared by clinicians, 100% were fully compliant with both Joint Commission and ASA requirements.

In a second study (abstract A612), the investigators observed and timed 64 clinicians during preparation of three medications—succinylcholine, propofol and atropine—using the SmartLabel system and conventional, manual-entry techniques. At the conclusion of the study, participants also completed a survey about their experiences.

Preparation times were shorter using the SmartLabel system (129.9 vs. 138.6 seconds; P=0.01). This difference persisted for all three drugs: propofol, 50 versus 56.6 seconds; succinylcholine, 43.7 versus 44.6 seconds; and atropine, 38.2 versus 41.4 seconds.

Twenty errors were found in the 192 syringes prepared using the conventional method (10.4% error rate). These errors included incorrect time or date and wrong concentration of the drug. No errors were found using the SmartLabel system.

As Dr. Nanji told Anesthesiology News, clinicians readily accepted the automated labeling system. “We found that 86% perceived it to be faster,” she said. “A full 95% thought it fit well into the work flow, 97% thought it was user-friendly and easy to use, while 98% thought it improved patient safety. That kind of satisfaction data says a lot about how easy it is to implement as a system, because one of the biggest barriers to implementing new technology is physician resistance due to the technology not fitting well into their work flow.”

Yet as with any type of technology, there is room for error. “Any technological solution has failure potential,” Dr. Levine said. “The power could go out, or the machine could run out of ink or labels. All machines have failure modes, but we accept them as part of the proposition.”

Robert G. Loeb, MD, associate professor of anesthesiology at the University of Arizona in Tucson, cited several reasons the technology could be important. “The system scans the medication vial label and speaks aloud the name of the medication, which could decrease the error of filling a syringe with a different medication than the one intended,” Dr. Loeb said. “The system then prints a complete and machine-readable syringe label, which could decrease drug administration errors and facilitate entry of medications into an electronic anesthesia record.”

The Mass General group has a financial stake in the SmartLabel system, which has been licensed to Codonics, Inc. The company had no involvement in the current research, the researchers said.