In the wake of the fungal meningitis outbreak associated with contamination in a compounding pharmacy, ICU Medical is introducing the Diana Hazardous Drug Compounding System to help improve the safety and accuracy of the compounding process.
First introduced in Europe and now being brought to the United States, Diana was originally developed to protect patients and clinicians from hazardous drug exposure during chemotherapy preparation, but it “may also keep the drugs themselves safe from exposure to outside contaminants,” according to the company.
“Diana is a user-controlled sterile automated compounding system that utilizes ICU Medical’s microbiologically and mechanically closed components,” Robert Houde, RPh, ICU Medical’s Oncology Division director, told Pharmacy Practice News. “With the pharmacy technician using proper technique, Diana can ensure the drug product is sterile and safe for the patient.”
Tom McCall, the San Clemente, Calif.-based company’s vice president of marketing, added, “The system is designed so that nothing gets in, and nothing gets out.”
The microbiologically and mechanically closed design of the Diana system is achieved through a series of needle-free components, including closed-vial access devices, male luers and connectors, according to a company press release. Throughout the automated compounding process, the components protect the drug from exposure to environmental contaminants and protect the user from exposure to the drug and accidental needlesticks. Additionally, the Diana system components “have all been tested extensively” and shown to “maintain sterility throughout the process,” said Mr. Houde.
“While we aren’t saying that the system could prevent an incident like the meningitis outbreak, in light of calls for more control of compounding, the Diana system is a tool that could improve the process and increase sterility, accuracy and safety,” said Mr. McCall.
Asked how the Diana system differs from existing products, Mr. Houde answered, “Unlike other automated compounding technologies that require huge investments and do not fit within existing workflows, the Diana system fits inside an existing biologic safety cabinet and keeps pharmacists and technicians in control of the compounding process from beginning to end.”
The Diana system has been used in Europe for more than a year. Birgit Tans, PharmD, the chief oncology pharmacist at University Hospitals Leuven, in Belgium, told Pharmacy Practice News that her institution has used it since May 2011. “We use the Diana system to work faster and more accurately, with no risk for drug contamination thanks to the closed-system components that are a part of the system,” Dr. Tans said. Regarding the system’s disadvantages, she added, “It would be great if there was a greater degree of traceability of the preparation by integrating a bar-code reader for the drug input, and a scale to double-check that we have added the right amount of drug to the patient container.” On the other hand, she noted that the system has the following advantages: “All of the fluid transfer connection points are completely closed with the Diana system. And they are the same components used in the ICU Medical ChemoClave system [a closed-system transfer device], so I know I can trust them.”
The first U.S. Diana customer, OhioHealth in Columbus, planned to implement the system in November, Mr. Houde said, with official product rollout occurring at the American Society of Health-System Pharmacists Midyear Clinical Meeting in December.
Dr. Tans reported no relevant financial conflicts of interest.