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About Potential Cross-Contamination Linked to Haemodialysis Treatment
As per USFDA , recent incidents of blood contamination of internal components of haemodialysis equipment at a number of treatment centers have raised concerns about patient safety. The cause of the contamination may include many factors, including faulty blood lines and transducer protectors.
The principal concern is the possibility that the equipment cross-contamination with blood could permit the transfer of blood-borne pathogens from patient to patient. It is thus critically important that haemodialysis facilities be on the alert for signs of equipment contaminated by blood, and that they take corrective steps as necessary.
It is important to note that under normal conditions of daily use, such internal contamination with blood of the haemodialysis machine would not be readily evident to staff members. 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.
FDA is continuing to work with industry, ECRI and the healthcare community to better characterize the problem and identify a solution. The recommendations regarding the steps be taken are given at
link : http://www.fda.gov/cdrh/safety/althin.html
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