[Glenys.Harrington@HEALTH.VIC.GOV.AU Subject: Re: Implant sets In-Reply-To:]

Tain,

The confusion seems to be around the interpretation of Section 8.5.2.1 of
AS/NZS4187.

Some interpret section 8.5.2.1 to mean the following: health services
should move away from screw banks to a system that can identify and tract
individual items to a patient.

The TGA interpretation of section 8.5.2.1 is the following:

a) that sets of orthopaedic screws and/or plates sterilized for use as a
packaged item must be labelled with batch control identification and

b) that the batch serial/lot number of the individual screws and/or
plates(supplied non-sterile)that are added to the set of screws and or
plates are incorporated in the batch control identification process.

Find in the TGA bulletin link information in relation to the following:
a) Traceability of Implant/s (device)
b) Patient Tracking.

See “Trade Practices Act and Medical Device Tracking” article –
http://www.tga.gov.au/docs/pdf/tdbultn/atdb32.pdf

It appears that “traceability” of implant/s (device) is covered by the
Trade Practices Act 1975 and that while “patient tracking” is desirable
currently it is not covered by the Trade Practices Act 1975 nor any other
acts/legislation.

Currently a hospital’s obligation to provide person/s who request
information with the name of the manufacturer of a device or implant(see
paragraph 9,page 2). If the hospital cannot or will not provide this
information then the hospital will be treated as a manufacturer for the
purposes of any litigation.

If a hospital meets its obligations in terms of the Trade Practices Act
1975 and traceability then the ongoing issue for the Re-Use Committees
relates to the interpretation of Section 8.5.2.1 of AS/NZS4187.

I understand that the issues has been discussed at the HE-023 Committee of
Standards Australia which has responsibility for reviewing AS/NZS4187. Due
to a reorganisation within Standards Australia there has been some delay
in progressing the review. It is hoped that the review of AS/NZS4187 will
recommence soon at which time this issue will be clarified.

In the interim we understand that some manufacturers can and do supply
these items as prepacked sterilised items.

Glenys Harrington & Michele Cullen

Glenys Harrington, Infection Control Consultant |Communicable Disease
Prevention and Control | Public Health
Department of Health | Level 14 50 Lonsdale Street Melbourne Victoria 3000
Australia
t. 1300 651 160 (03 909 65123) | f. 03 909 69174 | e.
glenys.harrington@dhs.vic.gov.au | http://www.health.vic.gov.au/ideas

From:
Tain Gardiner
To:
AICALIST@AICALIST.ORG.AU
Date:
12/08/2010 06:01 PM
Subject:
Implant sets
Sent by:
AICA Infexion Connexion

Good afternoon all
I am wondering if you can supply me with supporting information in regards
to implant sets. i.e. screw banks in particular.
There is discussion with the reprocessing of screw banks that are
supposedly single use devices and then not having them available anymore.
This option is causing great concern.
I would appreciate any information facilities are doing please.
Regards

Tain Gardiner | Clinical Nurse Manager
Infection Prevention & Management, Royal Darwin Hospital | Department of
Health and Families
Rocklands Drive, Casuarina, NT 0811 | ‘Postal Address’ PO Box 41326,
Casuarina, NT 0811
p… (08) 89228045 pager # 239| f… (08) 8928889 | e…
Tain.Gardiner@nt.gov.au | http://www.nt.gov.au/health
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