Health technology assessment on reprocessing single-use catheters for cardiac electrophysiology: results of a three-years study.

The study aims to define the technical, ethical, juridical and economic issues involved in the assessment of a reprocessing policy for single-use interventional cardiac devices (SUDs). The feasibility of reprocessing was evaluated for cardiac electrophysiology catheters by comparing the chemical, physical and functional properties of new and reprocessed devices. The issue of hygiene was addressed by developing microbiological tests for the quantification of bioburden, sterility and pyrogenic load. The results of more than 1500 tests, conducted on 531 catheters, suggested a precautionary number of regenerations of five cycles. The ethical aspects were reviewed and the European juridical framework was assessed, revealing a need for harmonization. Applying a specific economic model, potential savings were calculated for a representative cardiology department and estimated at national and European level. Potential savings of 41.2% and 32.9% were calculated for diagnostic and ablation catheters, respectively. Safe and effective reprocessing of SUDs could be pursued if quality control processes and certified procedures are met. A reprocessing policy in EP laboratory could lead to savings of about 27,250 euros per 100,000 population, but the economic benefits are strongly dependent on the maximum number of regenerations and the regeneration rate.

Different experimental protocols for decontamination affect the cleaning of medical devices. A preliminary electron microscopy analysis.

The aim of the present study was to examine the efficiency of different decontamination-cleaning protocols on blood-soiled catheters used for interventional cardiology. Electrophysiology and cardiac ablation disposable devices were contaminated with bacteria-spiked human blood and underwent four different pre-sterilization protocols, including a chlorine-releasing agent, a polyphenolic emulsion, and an enzymatic detergent. Treated samples were examined by optical microscopy, scanning electron microscopy and transmission electron microscopy to identify and characterize biological and inorganic residuals. The use of chlorine as a first treatment caused denaturation of serum proteins and adherence of blood components to the surface of the device, thus hindering the cleaning efficiency of subsequent treatments with enzymatic detergents. An enzymatic/chlorine protocol was more efficient, but was considered to be a greater risk to healthcare staff. Polyphenolic-based treatments had the highest level of efficiency in bioburden removal, but interaction and adsorption of this class of chemicals onto biopolymers might lead to serious concerns about toxicity on subsequent reuse. Adequate pre-sterilization cleaning is fundamental for sterilization success and high-resolution electron microscopy can provide significant and detailed information about the efficiency of chemicals used for cleaning a blood-soiled device.