Pharmaceutical & Medical Packaging News staff

Strict regulations and standards guide the preparation of medication at hospitals, but unfortunately, these are not always followed. In the operating room, where procedures and decisions often happen rapidly, noncompliance is especially common and can have dangerous consequences.

Safe Label System (SLS), a medication management solution from Codonics, is designed to reduce some of these drugs errors. Last month, the SLS won a Medical Design Excellence Awards (MDEA) silver award at the 2014 MDEA ceremony, which was held at MD&M East 2014. Gary Enos, Vice President of Business and Technology Integration and International Affairs at Codonics, says that the company is honored to have received this award.

“We felt that this was a significant award for our company to try to win for all of the merits that MDEA reviews, from the medical device’s impact on the market space, impact on healthcare costs, things of this nature,” says Enos. “We are very proud to be in the winner’s circle. We recognize that we are in the company of many tremendously innovational and capable companies, and that means a lot to us.”

SLS uses bar code technology and a comprehensive database to scan and identify medication with audible and visible prompts. It then prints labels compliant with many safety guidelines and standards. The labels include information on a drug’s name, preparer, preparation time, diluents, diluter, concentration, volume, expiration time, and messages or alerts. When integrated with an electronic medical record system or anesthesia information management system, it also enables bar code confirmation of the printed label for record-keeping purposes. Codonics can make customized versions of the SLS for medical device manufacturers, who then place it on their anesthesia work stations.

The system is especially useful in the operating room, where fewer guidelines exist for medication preparation compared with pharmacies, and where the hectic environment means hospital staff does not always follow the guidelines that do exist. SLS is primarily intended for the transfer of a medication from a vial or ampule into a syringe or IV bag. The Joint Commission, which accredits hospitals, doesn’t require clinicians to label such syringes if they never put them down, but errors still happen in these circumstances, says Enos. For example, a rushed physician may take the wrong vial or the wrong concentration.

When a label is placed on a syringe, it doesn’t always comply with TJC’s standards, says Cristy Berg, Vice President of Communications at Codonics.

“If they are outside of the OR and they have to label the drug and don’t have SLS, they are supposed to pick a colored label that matches the drug classification, and then they have to hand-write all the information that the Joint Commission requires on that label,” says Berg. ”It takes a lot of time to write that information, and they usually don’t…. Most operating rooms are not compliant with the Joint Commission’s requirements.”

SLS also can be useful for pharmacies, says Enos.

“Under the pharmacist’s control, one would think things are pretty good, but to be human is to err,” Enos says. “Even they benefit from having a device like SLS that encompasses all of the guidelines, criteria, and site-specific rules at the time a preparation is made.”

SLS is said to be unique because it incorporates a variety of standards and guidelines into its database, including those for pharmacies, pharmacists, medical staff, anesthesiologists, international labeling, and hospital accreditation standards, and because this data can be incorporated into medical record systems.

Hospitals also can access administration tools, for example, to input new drugs into the system. Pharmacies have their own medication management systems, but these are designed for pharmacists and don’t meet all the requirements for the operating room, says Enos.

“FDA first struggled with where this device would fit, because there was none other one like it,” says Enos. “There was no predicate device. FDA reviewed the SLS on its own without reference to an accredited device."

By Camilla Andersson
Freelance Journalist