Trends and patterns in electrophysiologic and ablation catheter reuse in the united states

R the reuse of medical equipment marked by its original equipment manufacturer as a single-use device has become highly publicized in the USA.1,2 Many devices such as pacemakers, hemodialysis catheters, and coronary angioplasty and radiologic catheters are often resterilized and reused throughout the world.3–15 However, hospital policies regarding this practice in the USA have remained controversial. In October 1999, in its first public statement on the subject, the Food and Drug Administration suggested that a scientific risk-based approach will be required to evaluate the safety and economic impact of reuse of single-use devices. This study examined the prevalence, methods, and trends for electrophysiology catheter reuse within the USA. • • • We conducted a phone and written survey of every electrophysiologic laboratory included in the North American Society of Pacing and Electrophysiology database listed in December 1998 (n 5 487). We initially called all the prospective laboratories 1 to 4 times for a response to our survey. If laboratory personnel were unable to complete a telephone interview, a written survey was faxed or mailed to the hospital. Of the 487 laboratories contacted from the database, 108 did not have functional electrophysiologic laboratories at the time of the survey, 237 laboratories would not provide information despite repeated telephone and written requests, and 2 laboratory directors refused to provide information. The remaining 140 laboratories that provided complete information form the basis of this study. All data were compiled between July 1998 and April 1999. The survey specifically evaluated the use of diagnostic catheters, ablation catheters, and specialty catheters. Specialty catheters were defined as any catheter with a lumen or .4 electrodes. The cost analysis was performed by calculating the catheter cost for each procedure (actual catheter cost paid by the hospital multiplied by the number and type of catheters used). For the laboratories that reused catheters, the catheter cost per procedure was determined by adding resterilization costs to the initial catheter cost and dividing the sum by the average number of times a catheter was reused. Total cost savings of catheter reuse was calculated by estimating catheter cost if a single-use policy was followed and subtracting the actual calculated catheter cost. Statistical analysis was performed using chi-square analysis for categorical variables and a 2-tailed Student’s t test for continuous variables. All values are listed as mean 6 SD and a p value ,0.05 was considered significant. Of 140 electrophysiology laboratories in which full data are available, 68 laboratories (49%) reuse electrophysiology catheters in some capacity and 72 have a single-use policy (Figure 1). Of the laboratories that reuse catheters, most (74%) reuse ablation catheters, diagnostic catheters, and specialty catheters, 21% reuse diagnostic and specialty catheters but do not reuse ablation catheters, 3% reuse only ablation and specialty catheters, and 2% reuse only specialty catheters. Eighty-seven percent of the laboratories that reuse catheters have some specific limit on the number of times a catheter may be reused. The number of times a diagnostic catheter was reused varied widely: 43% reused catheters 6 to 10 times before discarding them, 33% reused catheters ,6 times, and 23% reused catheters .10 times. For laboratories that reused ablation catheters, 52% reused catheters between 1 and 5 times before discarding them, 29% reused catheters 6 to 10 times, and 19% reused catheters .10 times. Methods for resterilization varied among laboratories. Most laboratories (65%) reprocess their catheters in house, and of these, 87% use ethylene oxide as the sterilizing agent, whereas the remaining 13% use hydrogen peroxide plasma. Thirty-five percent of laboratories outsource the sterilization processing of their catheters to specialized device reprocessors; all reprocessors used by the electrophysiology laboratories in the study used ethylene oxide sterilization techniques. Of the electrophysiology laboratories that process their catheters in house, 44% routinely measured electrode resistances, 23% visually inspected the catheters with a microscope, and 44% maintained a written log. One center reported a series of complications related to catheter reuse. A soap residue left on catheters that were sterilized in house was associated with an allergic skin reaction in several patients, with no significant clinical sequelae. Once the rinsing process was standardized, no further allergic complications occurred. Of the electrophysiology laboratories that had a single-use policy, the major reasons for their policy included liability (67%), patient safety (37%), inadequate facilities (19%), and inconvenience (21%). We compared the characteristics of laboratories that reuse catheters with laboratories that have a single-use policy (Table 1). Laboratories that reused catheters had significantly larger volumes of electrophysiologic studies and ablations currently and 5 years From the Electrophysiology and Pacing Service, Cardiology Department, Lovelace Medical Center, Albuquerque, New Mexico. Dr. Kusumoto’s address is: Lovelace Cardiology, Electrophysiology and Pacing Service, 5400 Gibson Avenue S.E., Albuquerque, New Mexico 87108. E-mail: fred.kusumoto@lovelace.com. Manuscript received June 13, 2000; revised manuscript received and accepted August 14, 2000.