(You are encouraged to copy and distribute this Alert)
May 1999
| To: | Hemodialysis Treatment Centers | Hospital Renal Dialysis Director |
| Hospital Risk Manager | VA Hospitals |
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:
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 240-276-3356, or e-mail phann@cdrh.fda.gov.
You may photocopy or print this notice from the CDRH homepage at www.fda.gov/cdrh/safety.html.
Additionally, a voice mail message may be left at 240-276-3357 and your call
will be returned as soon as possible. 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, visit:
http://service.govdelivery.com/service/subscribe.html?code=USFDACDRH_10
| Sincerely yours,
|
| Elizabeth D. Jacobson, Ph.D. Acting Director, Center for Devices and Radiological Health |
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Updated May 11, 1999
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