The 30 minute rule for red blood cells: in vitro quality assessment after repeated exposure to 30°C.

BACKGROUND

Red blood cells (RBC) may be out of temperature control only for 30 minutes before they must be discarded, but evidence for this rule is weak. We investigated the effect on RBC quality of multiple exposures to 30°C.

STUDY DESIGN AND METHODS

RBC units made after 24 hours of whole blood ambient hold were pooled and split into adult and pediatric units and exposed to permitted deviations (5-hr core temperature 10°C, 12-hr surface temperature 10°C). Test units were exposed to 30°C once, twice, or three times on each of Days 15, 17, and 21, for 30 or 60 minutes. Negative controls were not exposed to 30°C; positive control was exposed to 30°C for 24 hours.

RESULTS

Adult units exposed once for 30 or 60 minutes (×3 occasions) showed no more hemolysis than negative control. Units exposed to 30°C for two or three periods of 60 minutes showed more hemolysis from Day 28. Hemolysis in pediatric units exposed for 30 minutes (×3) was not increased but units exposed to one or two periods of 60 minutes (×3) showed higher hemolysis. No differences were seen in supernatant potassium. ATP remained at an acceptable level on Day 28 in all but positive controls.

CONCLUSIONS

There was no evidence of significant damage to RBC after exposure to 30°C for three periods of 30 minutes. Multiple exposures of 60 minutes caused limited damage but this was within current regulatory limits if there were three or fewer exposures, suggesting that a 60-minute rule may be feasible.