Complete nationwide survey on umbilical cord blood freezing bag breakage in Japan.

Abstract

Although umbilical cord blood (UCB) has now become a common stem cell source, UCB bag breakage is a known risk in UCB transplantation (UCBT). This survey provides the first comprehensive data on the frequency and causes of UCB bag breakage in Japan. Data regarding UCB bag breakage from all causes, identified between April 1, 2010, and September 3, 2013, were collected from all transplant centers registered for UCBT (209 hospitals) and all public cord blood banks (CBBs) (8 CBBs) in Japan. Seventeen incidents of UCB bag breakage at CBBs were confirmed, none of which resulted in bags being shipped to transplant centers. From among 3836 UCBT, 16 incidents (0.4%) of UCB bag breakage were confirmed at transplant centers. Although all these bags were used for transplantation, no direct health hazard was reported. The major cause of UCB bag breakage confirmed at transplant centers was considered to be external force (75%). In addition, 11 incidents of unexplained UCB bag breakage at sealing between compartments were reported. UCB bag breakage was confirmed at both CBBs and transplant centers. UCB bags should be handled with particular care and attention.