- OBJECTIVE: To implement a comprehensive infection control (IC) program for prevention of cardiac device-associated infections (CDIs). DESIGN: Prospective before-after trial with 2 years of follow-up. SETTING: A tertiary-care university-affiliated medical center. PATIENTS: A consecutive sample of all adults undergoing cardiac device implantation between 1997 and 2002. INTERVENTION: An IC program was implemented during late 2001 and included staff education, preoperative modification of patient risk factors, intraoperative control of strict aseptic technique, surgical scrubbing and attire, control of environmental risk factors, optimization of antibiotic prophylaxis, postoperative wound care, and active surveillance. The clinical endpoint was CDI rates. RESULTS: Between 1997 and 2000, there were 7 CDIs among 725 procedures (mean annual CDI incidence, 1%). During the first 9 months of 2001, there were 7 CDIs among 167 procedures (4.2%; P = .007): CDIs increased from 7 among 576 to 3 among 124 following pacemaker implantation (P = .39) and from 0 among 149 to 4 among 43 following cardioverter-defibrillator implantation (P = .002). Of the 14 CDIs, 5 involved superficial wounds, 7 involved deep wounds, and 2 involved endocarditis. Following intervention, there were no cases of CDI among 316 procedures during 24 months of follow-up (4.2% reduction; P = .0005). CONCLUSIONS: We observed a high CDI rate associated with substantial morbidity. IC measures had an impact on CDI. Although the relative weight of each measure in the prevention of CDI remains unknown, our results suggest that implementation of a comprehensive IC program is feasible and efficacious in this setting.