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baxter ARENA - Responsibilities

baxter ARENA
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9. Disinfection
sepsis. The onset of these symptoms usually occurs one to two
hours after initiation of the treatment, but may happen as early as
one-half hour.
9.9.3 Responsibilities
AAMI states that the "physician in charge of dialysis" or the
"medical professional" appointed by the physician is responsible
for monitoring the water for levels of contamination (AAMI, 1990,
pp. 55-58). This is often the service person.
Sampling for bacteria levels of water and dialysate should be
accomplished at least monthly (AAMI, 1990, pp. 55-58). This
requires taking a sample of not only the incoming water supply to
the dialysis machine, but also a sample from each dialysis
Instrument (see Section 9.9.1). Additionally, repeat samples must
be taken when evidence of contamination exceeds the maximum
allowable level or when patients exhibit pyrogenic reaction or
septicemia (AAMI, 1990, pp. 55-58). Pyrogenic reactions are
primarily shaking and rigors accompanied by lowered blood
pressure (AAMI, 1990, pp. 81-94).
Home patients can sample less frequently if the patient is
considered reliable and the levels of contamination are always
below the recommended levels (AAMI, 1990, pp. 55-58).
The supplier of the water system is responsible at the time of
installation or initial qualification to provide equipment that meets
or is below the maximum safe contamination levels, or standards
specified by the physician at the time of initial qualification
(AAMI, 1990, pp. 55-58).
The supplier of water equipment is also responsible for
recommending a method of disinfection that continually produces
culture test results at or below the prescribed standards (AAMI,
1990, pp. 46-47).
After installation of the equipment, the physician or his appointee
is then responsible for maintaining recommended safe
contamination levels (AAMI, 1990, pp. 55-58).
157-1278-916, Rev A 9-37
March 2004

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