RT Journal Article
SR Electronic
T1 Microbiological Evaluation of Reused Catheter Guides in a Brazilian Hospital
JF PDA Journal of Pharmaceutical Science and Technology
JO PDA J Pharm Sci Technol
FD Parenteral Drug Association (PDA)
SP 356
OP 365
VO 60
IS 6
A1 Mônica Valero Da Silva
A1 Marina Baquerizo Martinez
A1 Terezinha De Jesus Andreoli Pinto
YR 2006
UL http://journal.pda.org/content/60/6/356.abstract
AB 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 immunologicallycompromised patients with a maximum limit of 104 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.