[karenbooth1@BIGPOND.COM Subject: Re: AS/NZS 4187. Validation – performance qualification In-Reply-To:]

Hi All,

from a general practice / primary clinic point, we always use accredited
external validation services. Pressure readings, printouts, spore test are
all required to be done 6 monthly. All electrical equipment, vax fridges,
monitors etc. are checked & tagged annually.

Cheers

Karen

Karen Booth

RN BHSCN GAICD

President APNA

Australian Primary Health Care Nurses Association

M: 0411 898 884

karenbooth1@bigpond.com

APNA Office
Level 2, 159 Dorcas St, South Melbourne VIC 3205
T: (03) 9669 7400 F: (03) 9669 7499 http://www.apna.asn.au

Sylvia (Health)
performance qualification

Validation is a complex business and it is easier going with companies that
do this on a regular basis for most equipment rather than try and do it in
house. Generally the people who are the manufacturers/suppliers of the
equipment can provide a validation service. Occasionally people use
validation staff from a competitor or companies set up to perform
validations.

For simple equipment such as heat sealers and benchtop ultrasonic machines,
dryers and these can be validated by commercial products and electrical
checks and done primarily in house. However the standards for dryers and
ultrasonic cleaners are currently being updated so this may get more
complicated.

However validation of a washer disinfector and steam or low temperature
sterilisers should be done by people who do this on a regular basis in con
junction with staff from the facility. The validation of each type of
machinery is different so individual reports are required other than a one
report for all.

I don’t believe there is conflict of interest if the correct process is
followed and sterilisation services overviews the process. The main issue is
being very clear on what is being asked for and planning the process in
advance. The company should follow ISO and Australian Standards. It is also
critical for validators to work closely with staff and use the
instrumentation and sets processed in the facility.

The reports are usually self explanatory and should be accepted and if
successful countersigned by both the validator and manager and a copy kept
in the CSSD.

Hope this helps.

Best wishes

Sylvia

Sylvia Morris

Sterilising and Reusable Medical Device Reprocessing State Coordinator
Infection Control Service
Communicable Disease Control Branch
Public Health and Clinical Systems
SA Health
Government of South Australia

HCW infection prevention:

http://www.sahealth.sa.gov.auinfectionprevention

General public:
http://www.sahealth.sa.gov.au/hospitalinfections

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Mandy DAVIDSON
qualification

Hello brains trust,

I am seeking information about what different organisations do for the
performance qualification (PQ) aspect of the annual validation for the
reprocessing of reusable medical devices. The standards mention that this
can be performed by “suitably trained in-house personnel or a suitably
experienced and qualified external contractor.”

So the question is do you do this yourself in house? Or do you contract out?

If you do this in house – would be prepared to share how you report this?

If you contract out – can you share details of the contractor offline
please?

I am curious about a contracted service, historically this seems to have
been part of the service provided by the equipment supplier. I wonder if
this is a conflict of interest? I have also noted that the reports generated
by the supplier tend to only focus on the equipment supplied and not on the
‘whole of RMD process’ which is going to be the requirement.

Any assistance is greatly appreciated and information received will be
treated confidentially and with respect.

Kind regards,

Mandy Davidson

RN; GCert Inf Pre & Cont; MPHTM; Cert III Sterilisation; Cert IV TAE;
Immunisation cred; CICP-A

Clinical Nurse Consultant – 4187 Implementation project

Infection Prevention & Control

T

07 4433 1873 | 0402 987 432

E

Mandy.Davidson@health.qld.gov.au

W

http://www.health.qld.gov.au/townsville

Townsville Hospital and Health Service

100 Angus Smith Drive, Douglas, QLD 4814

Townsville Hospital and Health Service acknowledges the Traditional Owners
of the land, and pays respect to Elders past, present and future

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