Standard Test Methods for Determination of Bactericidal Efficacy on the Surface of Medical Examination Gloves

Importancia y uso:

4.1 In the course of patient care, gloves of healthcare providers are often contaminated with microorganisms. This may occur when they come in direct or indirect contact with contaminated skin, oozing wounds, respiratory droplets, blood, amniotic fluid, saliva, or other potentially infectious materials (OPIM). It has been demonstrated that several bacteria known to be nosocomial pathogens, can survive for days, weeks and even months on surfaces that are touched by gloved hands. The presence of an effective antibacterial treatment on or in the glove that can rapidly reduce the number of viable bacteria on its surface, may also decrease the number of bacteria transferred from a contaminated source (reservoir) to a vulnerable patient or naïve site. These test methods enable assessment of bactericidal efficacy against a broad spectrum of bacteria and conditions, providing a means of efficacy comparisons for manufacturers, purchasers and users.

4.2 Four specific bacteria are listed to enable inter- and intra- laboratory test calibration and to provide common targets against which to compare antibacterial efficacy among products.

4.3 Manufacturers may additionally develop their own list of bacteria against which they will evaluate their products reflecting the circumstances in which their product will be used, the requirements set forth by the various agencies with which they are regulated, and the claims they are seeking. Alterations in test parameters must be validated and documented.

Subcomité:

D11.40

Referida por:

D7103-19R23

Volúmen:

09.02

Número ICS:

11.140 (Hospital equipment)

Palabras clave:

antibacterial; antimicrobial; bactericidal; bacteriocidal; biocidal; exam glove; examination glove; gloves; medical; medical glove; organic load; surface active;