RUBBER EMBOLI

Objective: To investigate the potential for embolisation, due to the p iercing of suspect rubber seals ('coring') of intravenous (IV)-solutio n bottles by the sharp (plastic, non-patient end) spike of commonly us ed infusion sets. Methods: The suspect seals of 50 bottles were pierce d with an infusion-set spike and the respective solutions were examine d for visible particles, filtered and the filtrate examined both macro scopically and microscopically. As controls, 36 IV-solution bottles of other brands with pierced seals and 10 units of the suspect brand wit h unpierced seals were examined in the same way. Results: Macroscopic and microscopic particles (maximum longest axis > 1 mm), including fib rils, were invariably present in the solutions from bottles with pierc ed suspect seals, but no such debris was detected in the control solut ions. Conclusions: The defectively packaged solutions (from B. Braun) have been used extensively in at least 21 different countries during t he past decade and, unknown to clinicians, constituted a source of pot ential rubber emboli. The multinational manufacturer responsible has l argely rectified the fault. Discovery of such defects requires prompt reporting to relevant government departments and the manufacturer, so that appropriate action may be taken nationally and internationally. G ood manufacturing practice and drug regulatory surveillance should ext end to the way in which the final packaged forms are used.