Abstract
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.
- Medical device
- Catheter guides
- Reuse
- Sterilization
- Ethylene oxide
- Microbiological contamination
- Bacterial endotoxin
Footnotes
- Copyright © Parenteral Drug Association. All rights reserved.
PDA members receive access to all articles published in the current year and previous volume year. Institutional subscribers received access to all content. Log in below to receive access to this article if you are either of these.
If you are neither or you are a PDA member trying to access an article outside of your membership license, then you must purchase access to this article (below). If you do not have a username or password for JPST, you will be required to create an account prior to purchasing.
Full issue PDFs are for PDA members only.
Note to pda.org users
The PDA and PDA bookstore websites (www.pda.org and www.pda.org/bookstore) are separate websites from the PDA JPST website. When you first join PDA, your initial UserID and Password are sent to HighWirePress to create your PDA JPST account. Subsequent UserrID and Password changes required at the PDA websites will not pass on to PDA JPST and vice versa. If you forget your PDA JPST UserID and/or Password, you can request help to retrieve UserID and reset Password below.