OPERATIONAL DIRECTIVE
Enquiries to:
Office of the Chief Medical Officer
OD number: OD: 0531/14
Date:
19/06/2014
Supersedes:
OD 0024/06
File No:
F-AA-25497
Subject:
RE-USE OF SINGLE USE DEVICES
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Phone number: 08 9222 2072
Compliance with this Operational Directive is mandatory for all public hospitals and
those private healthcare facilities, including satellite haemodialysis units, contracted
to provide services to public patients.
PURPOSE OF THE CIRCULAR
The purpose of this circular is to clarify regulations with regards to re-use of Single Use
Devices (SUDs).
In keeping with Therapeutic Goods Administration (TGA) regulations, SUDs should not be
re-used in any WA public health system facility. Re-use of all SUDs ceased from 1 July
2007.
Professor Bryant Stokes
A/DIRECTOR GENERAL
DEPARTMENT OF HEALTH WA
This information is available in alternative formats
on request from a person with disability.
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Re-use of Single Use
Devices (SUDs)
TITLE:
RE-USE OF SINGLE USE DEVICES
1. SINGLE USE MEDICAL DEVICES
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Single Use Devices (SUDs) are medical devices that are labelled by the original
manufacturer as “single use” or “single patient use”.
Single Use: If a device is for single use, the manufacturer’s intention is that the device
can only be used once and should then be disposed of.
Single Patient Use: If a device is for single patient use, the manufacturer’s intention is
that the device can be used multiple times on one patient. Single patient use devices
are able to be reprocessed and re-used on the same patient in accordance with the
manufacturer’s instructions.
Do not re-use symbol:
The internationally recognised symbol described in ‘ISO
15223-1:2012(E) Medical devices - Symbols to be used with medical device labels,
labelling and information to be supplied’ means DO NOT RE-USE. This indicates a
medical device that is intended for one use, or for use on a single patient during a single
procedure. The synonyms for this symbol are "single use" or "use only once".
Do not resterilise symbol:
The internationally recognised symbol described in
‘ISO 15223-1:2012(E) indicates a medical device that is not to be resterilised.
SUDs are classified according to their potential risk to a human body. Therapeutic
Goods Administration (TGA) classification is as follows:
Class I
Low-medium risk devices, including devices that are sterile and /or
have a measuring function,
Class IIa
Low-medium risk devices,
Medium-high risk devices,
Class IIb
Class III
High risk medical devices, and
Class AIMD Active Implantable Medical Devices. These are treated in a similar
way to Class III medical devices.
Re-use of any medical device potentially increases the risk of cross infection or
contamination. Additional risks are associated with re-use of SUDs. These include
material degradation, bio-compatibility reactions, endotoxic reactions caused by
residues from the cleaning and sterilisation process and device failure, because SUDs
were not designed or validated for re-use.
2. BACKGROUND
In 2001, the Australian Health Ministers Advisory Council (AHMAC) agreed that any reuse of SUDs is a manufacturing activity requiring regulation by the TGA. The regulation
for re-manufacturing was introduced in December 2003. A 2-year “phase in” period was
allowed for implementation of these requirements up to December 2005. The National
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Co-ordinating Committee on Therapeutic Goods (NCCTG) twice extended the transition
period with the legislation full implemented for all classes of medical device from 1 July
2007.
Under the current legislation, SUDs may only be re-used if the device is re-manufactured
according to the TGA regulations. Re-manufacturing can only be performed by a facility
that has been approved and licensed by TGA. At present, while an opportunity exists for
a re-manufacturing facility under the new regulations, Australia does not have a licensed
re-manufacturer for SUDs.
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3. REGULATION SURROUNDING SUDs



Therapeutic Goods Act 1989
Therapeutic Goods Regulations 1990
Therapeutic Goods (Medical Devices) Regulations 2002
4. RELATED NATIONAL AND WA HEALTH POLICIES

National Health and Medical Research Council (NHMRC)
Australian Guidelines for the Prevention and Control of Infection in Healthcare (2010)
5. FURTHER ACTIONS THAT ARE REQUIRED OF ALL WA PUBLIC HEALTH
FACILITIES
All public health facilities:
 must ensure compliance with TGA in using SUDs and
 should hold adequate supplies of SUDs to ensure patient safety is not compromised.
6. MORE INFORMATION


Further advice regarding SUDs in Western Australian Hospitals can be obtained from
Medical Engineering & Physics, Royal Perth Hospital on (08) 9224 2500.
More information on the regulation of the re-manufacture of SUDs, including links to
the relevant Australian Government legislation, is available on the TGA website at:
http://www.tga.gov.au/ or from the TGA information line for medical devices on
1800 141 144.
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This document is available in
different formats, upon request from
a person with disability.
© Department of Health 2014