Y-90 microsphere therapy: prevention of adverse events.
OBJECTIVE
Thirty-three (33) events that were inconsistent with intended treatment for 471 Y-90 microsphere deliveries were analyzed from 2001 to 2007.


METHODS
Each occurrence was categorized, based on root-cause analysis, as a device/product defect and/or operator error event. Events were further categorized, if there was an adverse outcome, as spill/leak, termination, recatheterization, dose deviation, and/or a regulatory medical event.


RESULTS
Of 264 Y-90 Therasphere (MDS Nordion, Ottawa, Ontario, Canada) treatments, 15 events were reported (5.7%). Of 207 Y-90 SIR-Spheres (Sirtex, Wilmington, MA) treatments, 18 events were reported (8.7%). Twenty-five (25) of 33 events (76%) were device/product defects: 73% for Therasphere (11 of 15) and 78% for SIR-Spheres (14 of 18). There were 31 adverse outcomes associated with 33 events: 15 were leaks and/or spills, 9 resulted in termination of the dose administration, 3 resulted in recatheterization for dose compensation, 2 were dose deviations (doses differing from the prescribed between 10% and 20%), and 2 were reported as regulatory medical events. Fifty-five (55) corrective actions were taken: 39 (71%) were related to the manufacturer and 16 (29%) were hospital based.


CONCLUSIONS
This process of analyzing each event and measuring our outcomes has been effective at minimizing adverse events and improving patient safety.
Schultz
Cheryl C
CC
Department of Radiation Safety, Beaumont Hospitals , Royal Oak, Michigan 48073, USA. cschultz@beaumonthospitals.com
Campbell
Janice
J
Bakalyar
Donovan
D
Beauvais
Michele
M
Feng
Wenzheng
W
Savin
Michael
M
D006528:Carcinoma, Hepatocellular / Q000532:radiotherapy; D004307:Dose-Response Relationship, Radiation; D006801:Humans; D008113:Liver Neoplasms / Q000532:radiotherapy; D008863:Microspheres; D011832:Radiation Injuries / Q000209:etiology / Q000517:prevention & control*; D016019:Survival Analysis; D016896:Treatment Outcome; D015021:Yttrium Radioisotopes / Q000008:administration & dosage* / Q000009:adverse effects*
D015021:Yttrium Radioisotopes