Microbiological evaluation of reused catheter guides in a Brazilian hospital
Da Silva, M.ôn.V.; Martinez, M.B.; Andreoli Pinto, T.D.J.
PDA Journal of Pharmaceutical Science and Technology 60(6): 356-365
2006
ISSN/ISBN: 1079-7440 PMID: 17260901 Document Number: 599853
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.
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