The impact of device recall on patients and family members of patients with automatic implantable cardioverter defibrillators.
BACKGROUND
Patients often depend on life-saving technology as a permanent part of their lives. Sometimes these devices become defective and are recalled.


OBJECTIVE
To investigate how the urgent device recall of three models of the Automatic Implantable Cardioverter Defibrillator (AICD) affected confidence in the device and the psychosocial responses of patients and their family member caregivers.


METHODS
All patients (N = 31) and caregivers (N = 21) affected by the recall at one heart center completed a survey instrument consisting of a series of visual analog scales designed to measure confidence before and after learning of the recall, fear, anger, depression, anxiety, helplessness, loss of control, uncertainty, and confusion associated with having a recalled AICD. Surveys were completed immediately after being told of the recall and 1 month later.


RESULTS
Confidence of patients decreased significantly from a mean of 87% to 74% when comparing perceptions of before learning of the recall to those immediately after (t30 = 3.65, p < 0.0005). For caregivers, mean confidence dropped from 92% to 73% (t19 = 5.0, p < 0.0005). Confidence remained significantly lower 1 month later. Caregiver scores were consistently, although not significantly, higher (less favorable) on the measures of emotional response than patient scores. Caregivers of patients who had received shocks from the AICD and those of patients who had the device for more than a year were generally more affected.


CONCLUSIONS
Patient and caregiver confidence in the AICD was significantly reduced. Further research is needed to investigate the trends in the data from caregivers.
College of Nursing, Medical University of South Carolina, 171 Ashley Ave., Charleston 29425.
N V
NV
Sneed
N J
NJ
Finch
R B
RB
Leman
D000328:Adult; D000368:Aged; D001007:Anxiety; D017028:Caregivers / Q000523:psychology*; D017147:Defibrillators, Implantable; D004868:Equipment Failure; D004869:Equipment Safety; D005239:Fear; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D010361:Patients / Q000523:psychology*