Medical device tracking: results of a case study of the implantable cardioverter defibrillator.
Case reports were received of a fatal tachycardia caused by a malfunction of an implantable cardioverter defibrillator (ICD), a device that is subject to the tracking regulations of the Food and Drug Administration's Center for Devices and Radiological Health. The case reports led to a decision to notify 5,604 patients of the need for reprogramming of their ICDs to prevent the tachycordia. In the first 60 days, a total of 98.7% of the patients were successfully located and their devices reprogrammed. Multiple logistic regression analysis was conducted to examine an extensive array of factors that might have been related to the time to reprogramming. Patient-specific factors such as age, sex, and ejection fraction did not serve as a barrier to reprogramming in the first week (p = NS). Patients whose regular physician had >5 patients with the ICD subject to the recall were significantly more likely to have their ICDs reprogrammed in the first week (odds ratio [OR] 2.11, 95% confidence interval [CI] 1.85 to 2.43, p<0.001). Patients who changed physicians were significantly less likely to undergo reprogramming in the first week (OR 0.73, 95% CI 0.63 to 0.86, p<0.001). The experience of the recall of this tracked device is highly encouraging because it demonstrates that most tracked device recipients can be successfully located and receive medical intervention. Although tracking devices is a manufacturer's responsibility, the clinical community plays a critical role in its success. This report highlights the importance of understanding that role among physicians.
Kaczmarek
R G
RG
Center for Devices and Radiological Health, Food, and Drug Administration, Rockville, Maryland 20850, USA.
Beaulieu
M D
MD
Kessler
L G
LG
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D017147:Defibrillators, Implantable / Q000706:statistics & numerical data; D004868:Equipment Failure; D005260:Female; D006801:Humans; D016015:Logistic Models; D008297:Male; D008875:Middle Aged; D011358:Product Surveillance, Postmarketing / Q000379:methods / Q000706:statistics & numerical data; D012984:Software; D013610:Tachycardia / Q000209:etiology / Q000517:prevention & control; D013997:Time Factors; D014481:United States; D014486:United States Food and Drug Administration