Bacterial contaminants have been traced back to a robot in a Winston-Salem, N.C. health center pharmacy
Automated medication management systems are a common component of the pharmacy process in healthcare facilities. The integration of such devices has been shown to improve efficiency and patient safety. However, if automated devices are not used appropriately, their maintenance and education requirements can compromise patient safety.
Pharmacy personnel at Wake Forest Baptist Health in Winston-Salem, N.C., recently discovered bacterial contamination of the automated pharmacy robot used for intravenous medication preparation at the facility. As reported in Infection Control and Hospital Epidemiology, the staff discovered Bacillus cereus bacteria during routine quality assurance testing of the automated device, IntelliFill i.v. (Baxa). Bacillus, a spore-forming bacterium, is resistant to most commonly used disinfectants, including alcohol – a factor that has played a role in healthcare-associated infections.
"To our knowledge, this is the first published report of a pharmacy robot being contaminated with Bacillus with resultant contamination of intravenous drug product," the article's authors write. Katarzyna Gejdel, PharmD, BCPS, pharmacy manager at Bronx-Lebanon Hospital Center, Bronx, N.Y., concurred.
A detailed investigation revealed that the washing station and its associated tubing were the potential source of contamination, as it was the only culture-positive site.
However, the authors report that they may never know how the organism was first introduced into the sterile environment of the robot. They have considered the possible risk of contamination from human hands during cleaning and setup. They advocate that current cleaning and maintenance requirements may need to be strengthened, since "the company's recommendations to monitor the robot's environment do not involve surface testing of the washing station, and has no defined schedule for exchanging the tubing or container."
The report's authors point out that the contamination was identified early, and confirm that, fortunately, no patient was harmed. But they caution that "the implications of contaminated intravenous product are potentially severe, most notably life-threatening bloodstream infections."
To prevent other users of the robot from experiencing the same problem, the authors suggest that the manufacturer should consider "establishing a formal procedure for cleaning and maintaining the washing station, with detailed recommendations to change the drain tube, container, and possibly the washing station itself." Furthermore, use of the robot in the pharmacy's clean room could further decrease the risk of contamination.
While Gejdel acknowledges the authors' concerns, she is not convinced that additional protocols are required at this time. "We have not experienced any such problem with our automated device or seen a report where patient safety has been potentially compromised, so I think it's fair to say that the sterility assurance protocols currently provided by the manufacturer are sufficient," she says.
Studies have shown that human-borne contamination is a principal threat to the sterility of compounded preparations and is a pivotal factor that needs to be controlled in an aseptic environment. Gejdel believes that, if used properly, the deployment of automation to remove the human element from the compounding of sterile preparations should significantly reduce the potential for microbial contamination. She advises that institutions that use automated pharmacy robots understand the limitations of technology and establish policies and procedures around competent use, quality assurance, and foreseeable complications.
"Ultimately, the pharmacy personnel are the most important determinants of quality. Following standard operating procedures and ensuring that all staff members who use the automated device receive initial and ongoing competency education are the cornerstone for promoting patient safety," Gejdel says.
The American Society of Health-System Pharmacists' guidelines on the safe use of automated dispensing devices (ADD) advocate that "the automated system should comply with applicable federal and state consumer protection laws and regulations, and state boards of pharmacy may have different requirements for the use of ADD in practice settings." Gedjel supports this recommendation and believes that the state board of pharmacy's involvement and legislation, where necessary, would be an added step in enhancing patient safety.
Monica Shah is a writer and hospital pharmacist in New Jersey.