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

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

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 re- packaged 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.

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

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

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).

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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

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

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 re-processes).

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

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

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

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.