The distributor of certain dialysis devices, Althin Medical, has alerted centres about recent occurrences involving blood contamination of certain dialysis machines during haemodialysis treatment. The company has received some reports that Transducer Protectors (TP) became wetted when the blood level in the arterial drip chamber rises. To date, four facilities have reported that blood has been found inside dialysis machines beyond the external TP luer connector. The manufacturer of this device, Nissho Nipro, is investigating these reports.

The manufacturer believes that it is prudent to recall all of these Blood Tubing Sets until the reported events have been further studied. It is believed that the likelihood of contamination of the dialysis machine and the potential for patient injury due to cross-contamination is low.

The full name of the device concerned is: Seraflo Q-Set Hemodialysis Blood Tubing Set with IV Administration Set and Transducer Protectors, distributed by Althin Medical.

Nissho Nipro recommends that use of these blood tubing sets is discontinued immediately and that until suitable replacement products are obtained, users should take the following measures:

Inspect all dialysis equipment for evidence of blood or other contamination in the internal tubing or TP of the machine.

When connecting tubing connections to the dialysis equipment, tighten all connections to prevent air and/or blood leakage.

Closely monitor the blood levels in all tubing. If there is an indication that blood may wet the TP in the line, adjust the drip chamber levels to prevent occurrence.

If it is observed that a TP has been wetted, it should be replaced immediately with a new sterile TP using aseptic technique. In this event, it is extremely important that the wetted TP be thoroughly examined by the user to determine if any blood can be seen on the machine side of the TP. If evidence of strikethrough is seen, the event should be reported to the immediate supervisor or in accordance with facility protocols. The haemodialysis equipment should not be used on another patient again until the equipment has been thoroughly examined for any internal evidence of blood. Check the equipment to assure proper performance and disinfect it before future use.

If it is observed that a TP has been wetted and there is no evidence of strikethrough on the machine side of the TP, no action is necessary. TPs were designed to prevent blood transmission and if there has been no strikethrough the TP has functioned as intended. However, the wetted TP still needs to be replaced with a new sterile TP to maintain proper pressures in the tubing circuit to assure accurate monitoring.

As blood flow rates are adjusted, closely monitor arterial and venous drip chamber levels to ensure they are at the proper set points.

The company has been in communication with the Food and Drug Administration concerning this matter and the FDA has issued a Safety Alert providing guidance to haemodialysis treatment centres and hospitals with similar recommendations about how to minimize risk.

References:

1) Urgent product recall, Althin Medical, Ind., dated 7 May 1999.
[http://www.fda.gov/medwatch/safety/1999/hemodi.htm]

2) FDA Safety Alert: Potential Cross-Contamination Linked to Hemodialysis treatment. May 1999.