Recent incidents of blood contamination of internal components of
equipment at a number of treatment centers have raised concerns about patient
cause of the contamination is still being determined and may include many
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
cross-contamination with blood could permit the transfer of blood-borne
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
Although FDA has not received any MDR reports, we have learned that since
1998, several incidents of blood contamination of equipment during
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,
frequent change in blood line pressures, and/or wetted transducer protectors.
these incidents resulted in breach of transducer protectors and subsequent
of the hemodialysis machine.
It is important to note that under normal conditions of daily use, such
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
maintenance is not adequate to detect internal machine contamination.
FDA is continuing to work with industry, ECRI and the healthcare community
characterize the problem and identify a solution. In the meantime, we
following steps be taken to minimize risk:
- Immediately have qualified personnel inspect all machines, including
pressure tubing set and pressure sensing port, for possible blood
contamination has occurred, the machine must be disinfected before it is
- Always use an external transducer protector and utilize pressure alarm
indicated in the manufacturers 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
the first bullet) after the treatment is completed.
- If contamination has occurred, the machine must be taken out of service
before further use.
- Frequent blood line pressure alarms or frequent adjusting of blood drip
may be an indicator that this problem is occurring.
REPORTING ADVERSE EVENTS TO FDA
While these incidents, taken separately, might be characterized as
malfunctions, we believe that the number of incidents, and their public
significance, makes it imperative that all future incidents of equipment
reported without delay. We therefore urge hemodialysis facilities to
these and similar problems, so that we can quickly identify trends and
expedite a solution
Submit voluntary reports directly to the FDAs voluntary reporting
MedWatch; by telephone at (800) FDA-1088, by FAX at (800) FDA-0178, or by
MedWatch, Food and Drug Administration (HFA-2), 5600 Fishers Lane, Rockville,
GETTING MORE INFORMATION
Send questions about this Safety Alert to the Issues Management Staff,
Surveillance and Biometrics, HFZ-510, 1350 Piccard Drive, Rockville,
Maryland, 20850, FAX
(301) 594-2968, or e-mail firstname.lastname@example.org. 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
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text of the message, type: subscribe dev-alert.
|Elizabeth D. Jacobson, Ph.D.
Acting Director, Center for Devices and