Who is reviewing the data review systems of automated external defibrillators? Implications of flawed time lines for clinicians and researchers.
The unintentional print-out by two different software programmes of the same resuscitation-related events stored on a data card of a Laerdal FR2-automated external defibrillator (AED), led to the discovery of flaws in the registration of the time line by one of the commercially available Laerdal software programmes. This observation stresses the need for a continuation of the medical supervision of AED projects, the close co-operation between clinicians and AED manufacturers, the well-controlled introduction of new devices and strict postmarket surveillance programmes.
Calle
Paul A
PA
Department of Emergency Medicine, Ghent University Hospital, De Pintelaan 185, 9000 Ghent, Belgium. paul.calle@ugent.be
Monsieurs
Koenraad G
KG
De Paepe
Peter
P
D000328:Adult; D016477:Artifacts; D016887:Cardiopulmonary Resuscitation / Q000295:instrumentation*; D047548:Defibrillators; D004562:Electrocardiography / Q000379:methods; D001330:Electronic Data Processing; D006323:Heart Arrest / Q000503:physiopathology* / Q000628:therapy; D006801:Humans; D008297:Male; D012984:Software