Hand hygiene.pdf

tamination of smaller and well-defined areas on the skin in contrast to using whole hands.
The method can be applied to traditional as well as “new” viruses such as caliciviruses 142 .
ASTM E-2276 (fingerpad method for bacteria) 143
This method is for testing handwash or handrub against bacteria. It is similar in design and
application to the method (E-1838) 141 described above for working with viruses.
ASTM E-2011 (whole hand method for viruses) 144
In this method, the entire surface of both hands is contaminated with the test virus and
the test handwash or handrub formulation is rubbed on them. The surface of both hands is
eluted and the eluates assayed for viable virus.
8.1.2 SURGICAL HAND PREPARATION (SEE TABLE I.8.1)
In contrast to hygienic handwash or handrub, surgical hand preparation is directed
against the resident hand flora. No artificial contamination of hands is used in any existing
methods.
CEN prEN 12791 (surgical hand preparation) 145
This European prenorm is comparable with that described in EN 1500 except that the
bactericidal effect of a product is tested: (i) on clean, not artificially contaminated hands; (ii)
with 18–20 volunteers; (iii) using the split-hands model by Michaud, McGrath & Goss 146 to
assess the immediate effect on one hand and a 3-hour effect (to detect a possible sustained
effect) on the other, meanwhile gloved hand; (iv) in addition, a cross-over design is used; but
contrary to hygienic hand antisepsis, the two experimental runs are separated by one week
in order to enable regrowth of the resident flora; (v) the reference antisepsis procedure uses
as many as 3-ml portions of n-propanol 60% (V/V) as are necessary to keep hands wet for 3
minutes; (vi) the product is used according to manufacturer’s instructions with a maximum
duration of 5 minutes; (vii) the requirements are that the immediate and 3-hour effects of a
product must not be significantly inferior to those of the reference hand antisepsis; and (viii)
if there is a claim for sustained activity, the product must demonstrate a significantly lower
bacterial release than the reference at 3 hours.
ASTM E-1115 (surgical hand scrub) 147
This test method is designed to measure the reduction of microbial flora on the skin. It
is intended for determining immediate and persistent microbial reductions, after single or
repetitive treatments, or both. It may also be used to measure cumulative antimicrobial
activity after repetitive treatments.
In the USA, this method is required to assess the activity of surgical scrubs 135 . The TFM
requires that formulations: (i) reduce the number of bacteria 1-log 10
on each hand within 1
minute of product use and that the bacterial cell count on each hand does not subsequently
exceed baseline within 6 hours on day 1; (ii) produce a 2-log 10
reduction in microbial flora
on each hand within 1 minute of product use by the end of the second day of enumeration;
and (iii) accomplish a 3-log 10
reduction of microbial flora on each hand within 1 minute of
product use by the end of the fifth day when compared to the established baseline 135 .