Quality Audit Trail Record Book
THE TRISTEL TRIO WIPES SYSTEM
The Tristel Trio Wipes System is a three-part system for high-level
disinfection of non-lumened invasive and non-invasive medical
devices. It comprises three wipes and an Activator Foam that in
sequence perform the steps of the decontamination procedure.
Tristel Pre-Clean Wipe
Impregnated with enzymatic detergent to clean instruments
as the first part of the decontamination process.
Tristel Sporicidal Wipe
Tristel Activator Foam
A high-level disinfectant wipe which generates chlorine dioxide
when activated with Tristel Activator Foam.
Tristel Rinse Wipe
Impregnated with de-ionised water and a low-level of antioxidant
to rinse instruments as the final stage of decontamination
process. The wipe is sterile packed.
Quality Audit Trail Record Book
Finally, the Quality Audit Trail Record Book records the
decontamination process through to use on a patient or to storage
of the device.
It tracks the following steps:
•
Identification of the medical device to be decontaminated and
the date and time it is decontaminated.
•
Cleaning of the medical device (with the Pre-Clean Wipe or by
other means).
•
Correct activation and use of the Sporicidal Wipe.
•
Rinsing of the medical device (with the Rinse Wipe or by other
means).
•
Identification of the next destination for the device – patient or
storage.
•
Identification of the person responsible for the
decontamination process.
Tristel Solutions Limited, Lynx Business Park, Fordham Road, Snailwell, Cambridgeshire CB8 7NY
T +44 (0)1638 721500 - F +44 (0)1638 721911 - E mail@tristel.com - W www.tristel.com
USING THE QUALITY AUDIT TRAIL RECORD BOOK
The Record Book will be maintained in the work area where the
device(s) will be decontaminated.
All decontamination procedures will be recorded in the Record
Book. A new section of the Record Book will be used for each
decontamination procedure – i.e. one device per section.
The person decontaminating the device will perform all stages
of the decontamination procedure and will then complete the
Record Book.
Device being decontaminated
Completion of this section of the Record Book will include:
•
Confirm the device being decontaminated.
•
A record of its serial number
or other means of
identification.
•
A record of the date
and time
of the decontamination
procedure.
Using the Pre-Clean Wipe
If the Pre-Clean Wipe has been used, confirm
log the batch number
and use by date
sachet used. If the Pre-Clean Wipe has not been used, confirm
in box and state other method employed.
Using the Sporicidal Wipe
When using the Sporicidal Wipe, write the Activator Lot No.
the traceability label, then peel off and affix the 'Record Book
Label' part of the traceability label to the box identified in the
book (2a Sporicidal Wipe).
To activate the Sporicidal Wipe, follow the detailed instructions
for use that are printed on the Sporicidal Wipe sachet and also in
the user guide. Confirm in the 2b Activator Foam section that the
following steps have taken place:
Remove the Wipe from its sachet and lay it out in
the palm of your hand. Remove the lid from the
Activator Foam bottle. Apply the required aliquots
of Activator Foam onto the Sporicidal Wipe.
Confirm
• If you are using Trio Wipes System
• If you are using Trio Wipes System
Fold the Wipe in on itself and scrunch together
15 seconds to activate. Ensure that the Wipe is
evenly covered with foam. Confirm
Wipe the surface of the device in one movement
to cover it with foam, ensuring all areas come
into contact with the Wipe. Pay special attention
to edges, ridges and indentations. Observe a
30-second contact time. Confirm
Using the Rinse Wipe
If the Rinse Wipe has been used, confirm
batch number
used. If the Rinse Wipe has not been used, confirm
in the box and
state the other method employed.
as indicated on the
Destination of device
If the device is to be used on a patient, the 'Patient's Notes Label'
part of the traceability label should be peeled off and attached to
the Patient's notes.
onto
If the device is to be stored and decontaminated again before
next use, peel off and affix the 'Patient's Note Label' part of the
traceability label to the box identified in the book .
Person Responsible
The person responsible for performing and completing the
decontamination procedure must print their full name
and sign
the Record Book.
in box.
, apply two aliquots of
Activator Foam onto the Sporicidal Wipe.
, apply four aliquots of
Activator Foam onto the Sporicidal Wipe.
in box.
in box.
in the box and log the
and use by date
as indicated on the sachet
in box and