REPROCESSING CARDIAC ELECTROPHYSIOLOGY CATHETERS: RECOMMENDATIONS OF PAK HRS TASK FORCE AND REVIEW OF LITERATURE

Abstract

Cardiac Electrophysiology Study (EPS) and Ablation procedures are definitive treatment for multiple common arrhythmias the major component of the cost of the procedure is the expense of the catheters. Many centres around the world used to  reuse these catheters but few years ago started noticing Single Use Device (SUD) labelling appearing on them without any change in the catheters (1). This SUD labelling certifies that this can be safely used once but does not mean that it cannot be used again. Based on this the Federal Drug Authority of the United States shifted the liability of the reused device on the entity reprocessing it. Despite this, due to their high cost these catheters are reused not just in low income countries but also in many European and North American centres (1) (2). This reuse is supported by extensive literature showing safety in reusing these catheters.

Currently there are no specific regulatory guidelines either at the federal or provincial levels for reuse of electrophysiology catheters in Pakistan. The Pakistan Heart Rhythm Society created this task force to review the literature and give recommendations to guide both the Heart Rhythm physician community as well as provide basis for discussion with regulatory authorities.  This task force includes members from major public and private institutions performing cardiac electrophysiology procedures. The members included specialists in cardiac electrophysiology, infectious diseases and certified infection control staff.

This literature review has been done to give recommendations for use of reprocessed electrophysiology catheters specifically for the patients in Pakistan. Since more than 90 percent of EP procedures in Pakistan are for supraventricular tachycardia (SVT) ablations, costs and other measures in this document are calculated using SVT ablation for modelling. Moreover, connecting cables and other equipment that are located outside the body but in the sterile field are not addressed in this document as they do not have significant safety impact. Similarly, catheters with lumens or balloons are not addressed in this document due to paucity of studies to demonstrate safety.

The following aspects of using SUD or reprocessed catheters were compared and reviewed before final recommendations of this committee at the end of this paper.

1. Cost
2. Safety
3. Unused expired catheters
4. International practices
5. Ethics
6. Hospital Policies and personnel
7. Cleaning and sterilization procedures