[20155946]
Six documented hepatitis c virus seroconversions possibly associated with dialysis procedures in a facility. One contributing factor may be related to the design of the baxter arena dialysis machine. The inherent design makes it extremely difficult and labor intensive to determine if the internal transducer tubing and transducer protector have been contaminated with blood during a procedure. Since a visual inspection is not possible without removing electronic components, this is unlikely to occur on a routine basis. Biomedical technicians, nurses and others using these machines need to observe for external transducer contamination and if detected remove the machine from use until a 2-4 hour inspection of the internal components with potential changing of tubing and decontamination can occur. According to instruction manual, this process, may damage the electronic components of the machine. The design of the baxter arena does not allow users to visually inspect and determine if there has been blood contamination of the internal transducer tubing and transducer protector without removing electronic component. To be able to observe internal transducer tubing and the transducer protector for potential contamination would require a 2-4 hour process by a biomedical technician. According to the manufacturer's instructions, removing the necessary hardware to view the internal transducer tubing and transducer transmission protector may result in damage to electronic components. This design may result in transmission of bloodborne pathogens between patients. They are currently investigating transmission of hepatitis c virus in six dialysis patients of a facility, that uses baxter dialysis machines (1550s and arenas). The agency is concerned with the design of the baxter arena. This is an early warning to the fda, we have yet to conduct our full epidemiologic assessment and quite frankly, we are unlikely to prove that this is the only contributing factor to disease transmission but felt it was critical to alert the fda and possibly other users of these machines of the potential risk as soon as possible.
Patient Sequence No: 1, Text Type: D, B5