FDA: Dialysis equipment can be contaminated
July 1, 1999
FDA: Dialysis equipment can be contaminated
In an alert specifically addressed to risk managers, the Food and Drug Administration (FDA) is warning hospitals, hemodialysis facilities, and others to be alert for signs of contaminated equipment transferring bloodborne pathogens from patient to patient.
The FDA safety alert says recent incidents of blood contamination of internal components of hemodialysis equipment at a number of treatment centers have raised concerns about patient safety. The FDA is still investigating the causes of the contamination, which may include faulty blood lines and transducer protectors. Dialysis facilities should have qualified personnel inspect all machines, according to the letter from Elizabeth Jacobson, PhD, acting director of the Center for Devices and Radiological Health in Washington, DC.
Staff at several institutions have noticed fluctuation of fluid levels in the arterial drip chamber, rapid and frequent change in blood line pressures, and/or wetted transducer protectors, the FDA alert says. Some of these incidents resulted in breach of transducer protectors and subsequent contamination of the hemodialysis machine.
"It is important to note that under normal conditions of daily use, such internal contamination with blood of the hemodialysis machine would not be readily evident to staff members," the alert says. "Under certain conditions, cross-contamination is possible despite the use of new blood tubing sets and external transducer protectors. Please also note that routine maintenance is not adequate to detect internal machine contamination."
The FDA recommends taking these steps to minimize the risk:
• Immediately have qualified personnel inspect all machines, including the internal pressure tubing set and pressure sensing port, for possible blood contamination. If contamination has occurred, the machine must be disinfected before it is used again.
• Always use an external transducer protector and pressure alarm capabilities as indicated in the manufacturer’s instructions.
• If the external transducer protector becomes wet, replace it immediately and inspect it. If fluid is visible on the side of the transducer protector that faces the machine, have qualified personnel open the machine and check for contamination after the treatment is completed. If contamination has occurred, the machine must be taken out of service and disinfected before further use.
The alert also notes that frequent blood line pressure alarms or frequent adjusting of blood drip chamber levels may be an indicator that this problem is occurring.
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