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Table I.8.1:<br />

Basic experimental design of current methods to test the efficacy of hand <strong>hygiene</strong><br />

and surgical hand preparation formulations<br />

Method no. Test organism(s) Basic procedure<br />

EN 1499<br />

(hygienic<br />

handwash)<br />

EN 1500<br />

(hygienic<br />

handrub)<br />

ASTM E-1174<br />

(effectiveness<br />

of health-care<br />

worker or<br />

consumer<br />

handwash<br />

formulation)<br />

ASTM E-1838<br />

(fingerpad<br />

method for<br />

viruses)<br />

Escherichia coli<br />

(K12)<br />

Escherichia coli<br />

(K12)<br />

Serratia marcescens;<br />

Escherichia coli<br />

Adenovirus,<br />

rotavirus, rhinovirus<br />

and hepatitis A virus<br />

<strong>Hand</strong>s washed with a soft soap, dried, immersed<br />

in broth culture for 5 s, excess fluid drained off,<br />

and air-dried for 3 min. Bacteria recovered for the<br />

initial values by kneading the fingertips of each<br />

hand separately for 60 s in 10 ml of broth without<br />

neutralizers. <strong>Hand</strong>s removed from the broth and<br />

treated with the product following the manufacturer’s<br />

instructions (but for no longer than 1 min)<br />

or the reference solution (a 20% solution of soft<br />

soap). Recovery of bacteria for final values (see<br />

EN 1500).<br />

Basic procedure for hand contamination and initial<br />

recovery of test bacteria same as in EN 1499.<br />

<strong>Hand</strong>s rubbed for 30 s with 3 ml of isopropanol<br />

60% V/V; same operation repeated with a total<br />

application time not exceeding 60 s. The fingertips<br />

of both hands rinsed in water for 5 s and<br />

excess water drained off. Fingertips of each hand<br />

kneaded separately in 10 ml of broth with added<br />

neutralizers. These broths are used to obtain the<br />

final (post-treatment) values. Log10 dilutions of<br />

recovery medium containing neutralizer are<br />

prepared and plated out. Within 3 h, the same<br />

volunteers tested with the reference formulation<br />

or the test product. Colony counts obtained and<br />

log reductions calculated.<br />

To test the efficacy of handwash or handrub<br />

agents on the reduction of transient microbial<br />

flora. Before baseline bacterial sampling and<br />

prior to each wash with the test material, 5 ml<br />

of a suspension of test organism are applied to<br />

and rubbed over hands. Test material put onto<br />

hands and spread over hands and lower 1/3 of<br />

forearms with lathering. <strong>Hand</strong>s and forearms<br />

rinsed with water. Elutions are performed after<br />

required number of washes using 75 ml of eluent<br />

for each hand in glove. The eluates are tested for<br />

viable bacteria.<br />

10 μl of the test virus suspension in soil load<br />

placed at the centre of each thumb- and fingerpad,<br />

the inoculum dried and exposed for 10–30<br />

sec to 1 ml of test formulation or control. The<br />

fingerpads then eluted and eluates assayed for<br />

viable virus. Controls included to assess input<br />

titre, loss on drying of inoculum and mechanical<br />

removal of virus. The method applicable to testing<br />

both handwash and handrub agents.

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