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Medical Devices Maintenance Policy Appendix D

This document provides guidance on removing medical devices that have reached the end of their lifecycle. It outlines removal criteria such as equipment failure, changes in clinical practice, or the availability of modern replacements. Faulty equipment will be inspected and either repaired or condemned. A condemnation form is completed to document the reason for removal and the device is properly decommissioned, including removing patient data. Based on the condition and decontamination status, devices may be resold, sent to an electronic waste facility, or disposed of as hazardous waste.

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335 views3 pages

Medical Devices Maintenance Policy Appendix D

This document provides guidance on removing medical devices that have reached the end of their lifecycle. It outlines removal criteria such as equipment failure, changes in clinical practice, or the availability of modern replacements. Faulty equipment will be inspected and either repaired or condemned. A condemnation form is completed to document the reason for removal and the device is properly decommissioned, including removing patient data. Based on the condition and decontamination status, devices may be resold, sent to an electronic waste facility, or disposed of as hazardous waste.

Uploaded by

Ver Bautista
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
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Download as DOCX, PDF, TXT or read online on Scribd
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APPENDIX D REMOVAL OF MEDICAL DEVICES PROTOCOL

Introduction
The Removal of Devices Protocol provides guidance on the removal and eventual disposal
of equipment reaching the end of their life cycle.
Removal Criteria
The removal of an item of equipment can be the result of a failure of the equipment or a
change of clinical practice requiring an alternative item of equipment. Alternatively it
could be superseded by a modern replacement offering enhanced features.
A faulty item of equipment will be inspected by the organisation undertaking the
technical support and repaired and returned to the owner. In the event that it cannot be
repaired then a Condemnation Form will be provided.
The user should report
faulty/broken equipment for condemnation to Medical Electronics (not to Recycling or
other department).
A change of clinical practice may often result in an item of equipment being relocated to
another ward or department.
Replacement of Equipment
The expected life of an item of equipment is recorded at the time of acceptance but may
be modified by the extent of use, the availability of more cost effective devices or a
change of clinical practice. An equipment recall by a manufacture will take precedence
over other considerations.
Replacement Criteria
Routine or planned maintenance along with manufactures life cycle information can aid
the decision when to replace an item of equipment.
Factures to consider are:

whether the device is damaged or worn out, beyond economic repair


its reliability (check service history)
clinical or technical obsolescence
absence of manufacturer/supplier support
non-availability of correct replacement parts
non-availability of specialist repair knowledge
possible benefits of new model (features, usability, more clinically effective, lower
running costs)
lifecycle of the medical device.
changes in local policies for device use
users' opinions

Following the decision to withdraw a device from use the Condemned Notification form
(shown below with an example) will be completed and copies sent to the device owner,
Financial Accountant, and the Asset Manager.

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Medical Devices Maintenance Policy v2.0
MDMS November 2015

APPENDIX D REMOVAL OF MEDICAL DEVICES PROTOCOL

Condemned Notification
M.D.M.S Medical Electronics
Ref. No:

Equipment Owner:

The equipment detailed below was examined by Medical Electronics on and has been
condemned for the following reasons:
Beyond economical repair
Unreliable (check service history)
Clinically or technically obsolete
Absence of manufacturer/supplier support
Manufacturers replacement parts not available
Non-availability of specialist repair knowledge
Provision of replacement product
Change of policy for device use
Removed by User
Patient data was removed
Comments:

Asset ID:
Equipment:
Company:
Description:
Serial No:
Site Name:
Dept./Ward:
Commissioned:
Purchase Cost:
Purchase Type:

Technician:

Send Copies to: Equipment Owner


Financial Accountant, Finance Department
Asset Manager, Estates Technical Services

Decommissioning
Decommissioning aims to make equipment safe and unusable, while minimising damage
to the environment. Any equipment deemed unfit for reuse should be decommissioned.
Decommissioning should include decontamination, making safe, and making unusable.
This is to ensure that an inappropriate person does not use the equipment and expose
themselves to potential hazards.
Prior to replacement or removal from service, all medical devices should first be
decontaminated. Whether the item is still working satisfactorily will determine how it can
safely be disposed.
It is the users responsibility to ensure that any patient identifiable information stored
within the equipment should be securely deleted. Event logs that cannot be related to
identifiable patients need not be deleted. Medical Electronics will check that patient
identifiable information is removed.
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Medical Devices Maintenance Policy v2.0
MDMS November 2015

APPENDIX D REMOVAL OF MEDICAL DEVICES PROTOCOL


The manufacturer can provide information on suitable decommissioning, and should be
able to provide details of any environmental, disposal, recycling or structural
requirements.
If the manufacturer has ceased trading, the MHRA will be able to provide further
guidance.
Disposal of Equipment
The manufacturer should be consulted for the most appropriate method of waste disposal
and should be able to provide details of the current techniques and processes applicable
to their products.
If a medical device is still in working condition and can be fully decontaminated, it can be
sold and this will be co-ordinated by Medical Devices Management Services.
If the medical device is no longer working and can be fully decontaminated then
to meet the Waste Electrical and Electronic Equipment (WEEE) regulations the
device must be sent to an authorised treatment facility. This will be co-ordinated
by the ETS Energy & Waste Manager.
If a medical device is no longer working and cannot be fully decontaminated, it will be
exempt from the WEEE regulations, but must be disposed of as hazardous waste. Further
information on this process can be obtained form the ETS Energy & Waste Manager.

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Medical Devices Maintenance Policy v2.0
MDMS November 2015

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