INFECTION CONTROL MANUAL

RE-USE OF SINGLE USE MEDICAL DEVICES

POLICY
Page 1 of 4

Date Issued
Date Last Revised:
Next Review Date:
Approved By:

08/01
06/14
06/17
Policy Committee

Key Words: re-use, single use, medical device,

Policy Applies to:
All Mercy hospital staff who deal with medical devices
Related Standards:
EQuIP Standard 1. 5 Criterion 1.5.2
EQuIP Standard 3. 2 Criterion 3.2.1
Infection Prevention and Control Standards NZS 8134.3:2008
Australian / New Zealand Standard 4187:2003. Cleaning, disinfecting and
sterilizing reusable medical and surgical instruments and equipment, and
maintenance of associated environments in healthcare facilities.
Rationale:
This policy outlines the process for the approval and safe use of single use medical /
clinical devices within Mercy Hospital
Definitions:
Single Use
Medical equipment that is labelled or recommended by the manufacturer as
disposable or single use only.
Re-use
The use of a single-use medical device that has already been used on a patient, that
has been cleaned, decontaminated, high-level disinfected, or re-sterilised and repackaged for use on another patient.
Re-process
A process where a medical device is sterilized and re-packaged after the sterile
packaging, has been breached but where there has been no contact between device
and the patient.
Re-sterilisation
See above. Also includes the situation where an intact packaged device as supplied
by the manufacturer is re-sterilised and re-packaged.

F:\Mercy Shared\Policy Manuals\Infection Control Policy Manual\Re Use of Single Use Medical Devices\Re-use of Single
Use Medical Devices.docx

INFECTION CONTROL MANUAL

RE-USE OF SINGLE USE MEDICAL DEVICES
POLICY
Page 2 of 4

Date Issued
Date Last Revised:
Next Review Date:
Approved By:

08/01
06/14
06/17
Policy Committee

Objectives:
To identify where single use items can be safely reused
To ensure the process for reuse of medical devices is both appropriate and
safe
General
In general, medical or clinical items originally labelled as single-use items must
not be re-used.
Occasional exceptions may be permitted e.g. where it is already established practice
to re-use an item after cleaning, re-sterilisation and re-packaging. It is expected that
the number of exceptions will diminish over time.
Medical or clinical items that have been opened but not used may be approved for
re-processing (re-sterilisation and re-packaging) on a case by case basis.
To meet current and proposed standards, any items re-used must reach original
manufacturing standards.
The use of a re-processed item must be without increased risk.
All items re-processed will have:
A defined life period, and
A defined number of times they may be re-processed (opened and un-used).
All items will be safely discarded when one or other of these criteria are met, or the
item has been used for its intended purpose.
Some items designated as single use (such as oxygen masks, nebulisers, connecting
tubing, intravenous tubing and syringes for cuff inflation) may be identified as
single patient use only and may be re-used by the same patient, subject to
approval.
Approval
All requests for approval must be submitted to the Product Evaluation Committee
Approval for an unused item to be re-processed will only be granted if:
The device can be shown to be safe, within agreed boundaries of acceptable risk,
and there is a demonstrable cost benefit.
A use of re-processed item protocol is developed (i.e. processing standards, safe
shelf-life and/or maximum number of re-processes).

F:\Mercy Shared\Policy Manuals\Infection Control Policy Manual\Re Use of Single Use Medical Devices\Re-use of Single
Use Medical Devices.docx

INFECTION CONTROL MANUAL

RE-USE OF SINGLE USE MEDICAL DEVICES
POLICY
Page 3 of 4

Date Issued
Date Last Revised:
Next Review Date:
Approved By:

08/01
06/14
06/17
Policy Committee

Approval for a used, single-use item to be re-used will only be granted if:
The device can be shown to be safe, within agreed boundaries of acceptable risk,
and there is a demonstrable cost benefit.
A suitable protocol is developed (i.e. Cleaning, re-packaging and re-sterilising
standards, and definition of a safe life-time and/or maximum number of reprocesses).
Re-processing is able to meet original manufacturing standards.
Implementation:
Assessment and information on each item must cover the areas outlined in appendix
one and be submitted to the Product Evaluation for consideration and the outcome
reported to the Infection Prevention and Control Committee.
Evaluation:
Product Evaluation Committee approval process record
Document protocol for each approved re-use item
Tracking Records for monitoring use of each approved item
Infection Prevention and Control Committee reports

Associated Documents:
Internal
Product Evaluation Policy, Hospital Policy and Information Manual
Decontamination, Disinfection and Sterilisation policy, Infection Control
Manual
Infection Prevention and Control Committee Terms of Reference, Hospital
Policy and Information manual
Acknowledgements
Southern District Health Board, Single-Use Medical Devices (SUD) Policy, Midas
21411
Southern District Health Board, Assessing the Possible Re-Processing of Single-Use
Medical Devices (SUD) (Guidelines), Midas
Southern District Health Board, Application for the Re-Use of Single-Use Medical
Devices, Midas 38898

F:\Mercy Shared\Policy Manuals\Infection Control Policy Manual\Re Use of Single Use Medical Devices\Re-use of Single
Use Medical Devices.docx

INFECTION CONTROL MANUAL

RE-USE OF SINGLE USE MEDICAL DEVICES
POLICY
Page 4 of 4

Date Issued
Date Last Revised:
Next Review Date:
Approved By:

08/01
06/14
06/17
Policy Committee

Appendix One
Assessing the Possible Processing of Single-Use Medical Devices
These guidelines outline the process for approval and monitoring re-processing
opened and un-used medical or clinical devices.
Where a single-use medical device is being assessed for re-use after its initial clinical
use, the same process will be followed.
Risk Assessment;
Assess level of infection and performance risk using the criteria:
Infection risk
Performance risk (taking into account the age of the item)
Satisfactory clinical outcome
Documentation
Check the manufacturers recommendations for the device and attach to application
Complete a cost benefit analysis including:
Cost of device
Cost of re-processing device
Cost of resource requirements to meet all standards
Savings to the hospital through re-processing of the device
Develops a protocol for re-use including:
Cleaning process(for used items)
How many times for re-use, providing there has been no contact between devices
and patent
Tracking number of times re-processed
Details of inspection and testing continuing functionality of the device
Point at which the device is discarded
Ensure all the above items are attached to the Product Evaluation Committee
application.

F:\Mercy Shared\Policy Manuals\Infection Control Policy Manual\Re Use of Single Use Medical Devices\Re-use of Single
Use Medical Devices.docx