Bacterial contamination of single- and multiple-dose vials after multiple use and intravenous admixtures in three

Hossein Khalili1, Mehdi Sheikhbabayi, Nasser Samadi

  • 1Department of Pharmacotherapy, Faculty of Pharmacy, Tehran University of Medical Sciences, Tehran, Iran.

Insights

Preparing medications in a clean room significantly reduces microbial contamination risk compared to treatment rooms. This study found no contamination in clean room preparations, highlighting its importance for patient safety and preventing bloodstream infections.

Area of Science:

  • Microbiology
  • Hospital Pharmacy
  • Infection Control

Background:

  • Microbial contamination of parenteral products can lead to bloodstream infections.
  • Single-dose vials (SDVs), multiple-dose vials (MDVs), and admixtures (ADXs) are susceptible during preparation and administration.
  • Current practices involve preparation by nursing staff in treatment rooms or pharmacists in clean rooms.

Purpose of the Study:

  • To compare microbial contamination rates of MDVs and SDVs after multiple uses.
  • To evaluate contamination in ADXs prepared by nurses in treatment rooms versus pharmacists in clean rooms.
  • To identify the optimal preparation environment for parenteral products to minimize infection risk.

Main Methods:

  • Sterility testing of 43 opened MDVs and SDVs.
  • Membrane filtration method used for 92 ADXs prepared in treatment rooms.
  • Sterility assessment of 17 ADXs prepared in a clean room.

Main Results:

  • One admixture (1.1%) prepared in the treatment room was contaminated with Bacillus subtilis.
  • No microbial contamination was detected in ADXs prepared in the clean room.
  • No contamination was found in the opened MDVs and SDVs.

Conclusions:

  • Preparation of parenteral products in a clean room is the most effective strategy to prevent microbial contamination.
  • While good practices can reduce risk in traditional settings, clean room preparation offers superior safety.
  • Implementing clean room protocols is crucial for enhancing patient safety and preventing healthcare-associated infections.

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