This Signal relates to the risks from multiple use of injectable medicines intended for single use only.
The majority of injectable medicines are intended for immediate use with a single patient. Only a small number of injectable medicines, containing preservatives, are intended for multiple use, for example insulin and some sodium heparin products. There are risks of contamination if single use injectable medicines are used multiple times, as illustrated by the following incident which was reported at the University Medical Center Rotterdam, Rotterdam in The Netherlands.
An outbreak of severe sepsis in patients who underwent minor procedures in an operating theatre has been investigated. It was found that lapses in aseptic preparation were the most probable cause of the extrinsic contamination. The daily procedure of handling propofol was not performed according to the manufacturer's recommendations, the main departure being the use of a single-use vial for multiple patients. The study documents the risk of infection due to contaminated propofol and the importance of having written guidelines for its handling.
Contamination risks with propofol and other injectable medicines have been known for some time. Storage of open ampoules is a particular contamination risk, but vials and syringes can also become contaminated.
In the current environment of financial cutbacks, there is increased pressure for cost savings. However, using single use injectable medicines on more than one patient is an unlicensed use of these medicines and not in accordance with the manufacturer’s instructions. Using medicines in this way increases the risk of contamination and preventable harm to patients.
In 2007 the NPSA provided guidance in Patient Safety Alert 20 Promoting safer use of injectable medicines and organisations were required to identify high risk injectable medicines and procedures. Using single use injectable medicines for multiple use is a high risk procedure. The new list of Never Events, issued by the Department of Health in February 2011 in England includes severe harm arising from the preparation of injectable medicines in clinical areas. Healthcare organisations should reinforce the requirement that healthcare staff prepare injectable medicines in accordance with the manufacturer’s instructions and professional standards.
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