Single-Use Bag Valve Masks: Evaluation of Device Design and Residual Bioburden Analytical Methods

Regulatory agencies define a single-use device (SUD) as a medical device that is designated by the manufacturer for use during a single medical procedure on a single patient and is intended to be discarded after the procedure. However, used SUDs are not discarded in all circumstances; rather, they are sometimes reprocessed for reuse using specific methods for cleaning and disinfection. Recent trends indicate regulated reprocessing is often performed by third-party reprocessors who are independent from healthcare facilities, but in-hospital reprocessing has been reported for many different types of SUDs and remains prevalent in many low- and middle-income countries (LMIC).

The current investigation was motivated by a recent survey of in-hospital reprocessing in Tanzanian hospitals that identified bag-valve masks (BVM) as a commonly reused SUD. In LMIC with a high burden of neonatal mortality, inadequate supplies and poorly functioning BVM can contribute to inconsistent resuscitation practices. Therefore, well-executed in-hospital reprocessing could support neonatal resuscitation strategies by helping to maintain adequate supplies of BVM.

The purposes of this study were: 1) to complete a comprehensive design review and identify challenges to reprocessing BVMs; and 2) to investigate three different residual bioburden analysis methods for assessing the efficacy of decontaminating a disposable BVM. New, unused bag-valve-masks were contaminated with Staphylococcus epidermidis and Artificial Mucus Soil to simulate the worst case soiling conditions. Devices underwent one of five disinfection protocols, including one currently used in a LMIC hospital. Three analytical (two quantitative and one qualitative) methods were selected to evaluate residual bioburden on the device following decontamination.

Of all protocols tested, only the positive control and the Soap and Bleach protocols met disinfection targets. Most cleaning outcomes were consistent from trial to trial for each protocol. However, cleaning outcomes varied greatly for the Alcohol Wipe protocol. For the residual bioburden analyses, the two quantitative methods produced similar results, but the qualitative measurement exhibited increased variability.

In conclusion, the results support positive decontamination outcomes using the bleach-based in-hospital reprocessing protocol currently in use in some Tanzanian hospitals. Given proper consideration of training time and available resources, well-executed in-hospital reprocessing could support neonatal resuscitation strategies and other demands for manual resuscitation by helping to maintain adequate supplies of BVM.

Article by Sarah Zemitis, et al, from Clemson University, Clemson, USA.

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