Microbiological evaluation of reused catheter guides in a Brazilian hospital.

Within Brazilian hospitals, as well as in hospitals in other countries, the safety of reusing single-use medical devices is being questioned. At the same time, there has been a constant, growing increase in the number of such reprocessed products. In an attempt to evaluate such procedures, we analyzed 30 catheter guide units that were reused four times in patients at a public hospital of the state of São Paulo, Brazil. After each use, the catheter guides had been sterilized with a mixture of ethylene oxide/chlorofluorocarbons (12:88). Each unit analyzed was provided by the hospital individually packed and ready for a possible new use. For each catheter guide, a series of measurements were taken and tests run: microbial counts (pour plate), direct inoculation sterility test, bacterial endotoxin, in vitro cytotoxicity, physical evaluation by scanning electron microscopy, and microbial identification via biochemical assays. The results confirmed the presence of bacteria considered pathogenic to immunologically-compromised patients with a maximum limit of 10(4) cfu/unit (catheter guide). Furthermore, bacterial endotoxins and significant modifications of the catheter guides' physical structure were also detected. Thus, the common practice of reusing single-use devices may increase patients' risk of infection or pyrogenic reactions, adding to the total period of hospitalization.

Safety evaluation of single-use medical devices after submission to simulated reutilization cycles.

Pyrogenic and toxic reactions, especially in immunologically compromised patients, are among the risks associated with reuse of single-use medical devices (SUDs) with recurrent damaged surfaces. These drawbacks have raised serious doubts about the true benefits of the reprocessing practice. Taking into consideration prolonged patients' stay in hospitals due to adverse reactions provoked by recycled SUDs, the safety of these reprocessed materials was evaluated. The reprocessing cycles were simulated after intentional contamination of selected test material such as intravenous catheters, 3-way stopcocks, and tracheostomy tubes with Bacillus subtilis var. niger ATCC 9372 spores (10(7) CFU/unit). The repeated reprocessing cycles consisted of subsequent wash with enzymatic detergent followed by drying and sterilization with ethylene oxide-CFC (12 + 88), 600 mg/L at 55 degrees C, relative humidity 60%, for 3 h. After each reprocessing cycle, specimen samples were evaluated by pour plate microbial counts, direct and indirect inoculation sterility tests, cytotoxicity evaluation, and scanning electron microscopy (SEM). Microbial counts as high as 10(3) CFU were evident even after the 10th reprocessing cycle, besides scratched and damaged surfaces observed by SEM. Risk-benefit viewpoints are discussed.