General Principles; Cleaning And Disinfection; Basic Principles - Henry Schein MAXIMA Bedienungsanleitung

RE-PROCESSING

GENERAL PRINCIPLES

All instruments must be cleaned, disinfected and sterilised
prior to each use; this applies the first time instruments sup-
plied in a non-sterile condition are used, to instruments de-
livered in a sterile condition that are intended for repeated
use, and to damaged or opened sterile packaging. Thorough
cleaning and disinfection are essential prerequisites for effec-
tive sterilisation.
As part of your responsibility for instruments sterility, always
make sure that only validated methods for cleaning/disinfec-
tion and sterilisation are used, that devices (washer-disinfec-
tor, thermal disinfector or steriliser) are regularly serviced and
inspected and that the validated parameters are maintained
with each cycle. For your own safety, always wear protective
gloves, glasses and a mask when handling contaminated in-
struments.
In addition, always observe all applicable national legal regu-
lations (e.g. KRINKO/RKI/BfArM Re-Processing recommenda-
tions) and regulations on hygiene relating to your practice or
the hospital. This applies in particular to the guidelines re-
garding prion inactivation (does not apply to the USA).
Procedure A:
Instruments that fit in the interim stand
(see Table 3)
• Place in the interim stand prior to pre-dis-
infection/ cleaning and for transport (mini-
mum storage time according to the disin-
fecting agent manufacturer's directions for
use: Max. two hours).
• A prepared interim stand with a new foam
disc must be used for each patient. The in-
terim stand must be filled at least two thirds
of the way with disinfecting agent.
The following must be taken into account when selecting a disinfecting agent:
• It must be suitable for disinfecting instruments made from metal and plastic;
• It must be aldehyde-free (Cidex OPA is permitted due to its special recipe);
• Its effectiveness must have been verified (e.g. VAH/DGHM approval, FDA clearance or CE
mark);
• It must be compatible with the instruments (see section "Important notes on material re-
sistance").
The concentration and minimum contact time specified by the disinfecting agent manufacturer
must be strictly adhered to. Only use freshly prepared solutions and low-germ (< 10 CFU/ml)
water (e.g. purified water (PW)).
Please note that the disinfecting agent used during pre-treatment is for personal protection
only and is not a substitute for the disinfection stage required after cleaning.
Warning: Under no circumstances may instruments that have already come into contact
with disinfecting agent be used to treat a patient again.
in Line with DIN EN ISO 17664/AAMI ST81

CLEANING AND DISINFECTION

Basic Principles

We recommend an automated procedure to clean and dis-
infect the instruments (washer-disinfector). A manual meth-
od- including the use of an ultrasonic bath, should only be
used if it is not possible to use an automated method, as it is
less effective and demonstrates a lower reproducibility. The
pre-treatment process should be performed in every case.
Pre-Treatment at the place of use
Cross contamination (particularly pulp and dentine remnants)
must be removed immediately after the instrument has been
used on a patient (within maximum 2 hrs).
The following procedures must be used to ensure that any
contamination on the instruments cannot dry on and to make
subsequent preparation more effective:
All further steps in the preparation process must be performed
on the same day.
Procedure B:
Instruments that do not fit in the interim
stand (see Table 3)
• Place in a pan containing disinfecting agent
within two hours (minimum storage time
according to the disinfecting agent man-
ufacturer's directions for use: Max. two
hours) and brush at both the start and end
of pre-treatment.
• The pan is also used to transport the in-
struments.
Procedure C:
Boxes and modules
(see Table 3)
• Within two hours, clean to remove conta-
mination under flowing water at least 3 x
1 min. on the outside and particularly on
the inside.
• Then place in a pan (not together with the
instruments!).
• The pan is also used to transport the boxes
and modules.
Use only low-germ (< 10 CFU/ml) water (e.g.
purified water (PW)); tap water that is particu-
larly hard (≥ 14 °dH) is not suitable for this
(risk of lime residue).