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US Food and Drug Administration

FDA Safety Alert: Potential cross-contamination linked to hemodialysis treatment

FDA Alert (May) May: 1999

Recent incidents of blood contamination of internal components of hemodialysis equipment at a number of treatment centers have raised concerns about patient safety. The cause of the contamination is still being determined and may include many factors, including faulty blood lines and transducer protectors. We will update you as to the cause of this problem as soon as we have the proper information

In the meantime, our 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 hemodialysis facilities be on the alert for signs of equipment contaminated by blood, and that they take corrective steps as necessary.

BACKGROUND

Although FDA has not received any MDR reports, we have learned that since December 1998, several incidents of blood contamination of equipment during hemodialysis treatments have occurred. During an ECRI investigation of these incidents, it was reported that staff members noticed fluctuation of fluid levels in the arterial drip chamber, rapid and frequent change in blood line pressures, and/or wetted transducer protectors. 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. 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.

RECOMMENDATIONS

FDA is continuing to work with industry, ECRI and the healthcare community to better characterize the problem and identify a solution. In the meantime, we recommend the following steps be taken to minimize 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 utilize pressure alarm capabilities as indicated in the manufacturer’s instructions.
  • If the external transducer protector becomes wetted, 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 (as identified in the first bullet) after the treatment is completed.
  • If contamination has occurred, the machine must be taken out of service and disinfected before further use.
  • Frequent blood line pressure alarms or frequent adjusting of blood drip chamber levels may be an indicator that this problem is occurring.

REPORTING ADVERSE EVENTS TO FDA

While these incidents, taken separately, might be characterized as isolated malfunctions, we believe that the number of incidents, and their public health significance, makes it imperative that all future incidents of equipment contamination be reported without delay. We therefore urge hemodialysis facilities to voluntarily report these and similar problems, so that we can quickly identify trends and expedite a solution strategy.

Submit voluntary reports directly to the FDA’s voluntary reporting program, MedWatch; by telephone at (800) FDA-1088, by FAX at (800) FDA-0178, or by mail to: MedWatch, Food and Drug Administration (HFA-2), 5600 Fishers Lane, Rockville, MD 20857-9787.

GETTING MORE INFORMATION

Send questions about this Safety Alert to the Issues Management Staff, Office of Surveillance and Biometrics, HFZ-510, 1350 Piccard Drive, Rockville, Maryland, 20850, FAX (301) 594-2968, or e-mail czh@cdrh.fda.gov. You may photocopy or print this notice from the CDRH homepage at www.fda.gov/cdrh/safety.html. Future FDA Safety Alerts, Public Health Advisories, and other FDA postmarket safety notifications can be obtained by list server subscription via e-mail. To subscribe, send an e-mail request to fdalist@www.fda.gov. In the text of the message, type: subscribe dev-alert.
 

Sincerely yours,

 
Elizabeth D. Jacobson, Ph.D.
Acting Director, Center for Devices and
Radiological Health