Medical Devices Maintenance Policy

1. Introduction
2. Policy Statement
3. Managment Arrangements and Ownership
4. Acceptance of Devices into Use
5. Maintenance and Repair of Medical Devices
6. Decontamination of Medical Devices
7. Safety and Incidents
8. Condemnation, Removal and Disposal of Medical Devices
9. In House Manufacture of Medical Devices
10. Training
11. Related Policies
12. External References
13. Appendices

1. Introduction
This policy is supplementary to the Policy for Medical Devices Management, version 4.0 and covers the
maintenance and repair of medical devices.
Medical Device Management Services (MDMS) provide managerial, technical and training support for the
medical devices used in the Trust.
The Medical Electronics team within MDMS is responsible for the repair and maintenance of medical devices
within the Trust. There are exceptions for specialised equipment i.e. radiological equipment which is managed
by an external contractor in liaison with the Radiology Department.
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2. Policy Statement
This policy applies to all grades and disciplines of staff.
The policy applies to all medical devices which are brought into the Trust, whether purchased through
exchequer funding, charitable donation, research funding, loaned or donated.
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3. Management Arrangements and Ownership

The Trust owns and accepts responsibility for all purchased or donated medical devices which have been
appropriately brought into the Trust (excluding leased or contracted arrangements).
The Trust will ensure that its medical devices will continue to perform their specified functions through the
management of maintenance and repair procedures utilising either in-house services or external contractors
as appropriate.
Managerial ownership of a medical device lies with the relevant ward or department manager, who is
responsible for ensuring that the item is maintained and used in a safe manner, and that all staff are
competent and confident in its use.
Departmental managers should ensure that appropriate arrangements for maintenance and repair are in place
for when the equipment warranty expires and when Planned Preventive Maintenance (PPM) is due.
The Medical Electronics team undertake much of the medical device maintenance; there are items which are
outside their expertise, for example Radiological equipment. It is then the managers responsibility to ensure
that a suitable maintenance contract is negotiated. Specialist support on this matter can be provided by the
Procurement Department.
Medical Electronics provides a quality engineering support service for medical devices used by medical and
non-medical departments within Salisbury NHS Foundation Trust.
Medical Electronics provides advice on the appropriate maintenance arrangements for medical devices.
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4. Acceptance of Devices into Use

All medical devices must go through an appropriate acceptance test before being put into patient use.
Electronic portable items must be sent to Medical Electronics for these tests to be carried out; large or fixed
items of equipment e.g. x-ray machines, should be installed and commissioned in the appropriate manner by
qualified personnel. Items owned by the Trust will be recorded on the MDMS equipment database system
and/or the Trust Asset Register. Equipment on long term loan will also be recorded on the MDMS database.
The Acceptance Procedure is attached as Appendix A to this policy.
When an item is delivered to a ward or department after having been formally accepted by the Medical
Electronics team, the manager must ensure that any local acceptance tests that may be undertaken are
performed. In the case of reusable non-electronic medical devices delivered direct to the ward or department,
the manager must advise Medical Electronics of the arrival of all reusable medical devices.
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5. Maintenance and Repair of Medical Devices

Medical Electronics provides a planned maintenance service to ensure medical equipment is performing within
specification and is safe and reliable for the patient and user when required.
Service records for devices maintained by Medical Electronics are held electronically within their database
system. Medical Electronics will carry out an appropriate rolling programme of annual PPM for items on their
database. This will be monitored by the production of a list of devices approaching and beyond the recorded
service date.
During the PPM, devices that can no longer be found will be highlighted and the ward managers asked to
locate these devices. If after two further attempts to locate the devices have failed, they will be removed from
the registers. If a device is found not to be on the register, ownership will be established and will be
registered, if Trust property. This annual programme allows the systematic monitoring of the MDMS database.
All users are responsible for immediately withdrawing from service any device or accessory which is suspected
of malfunctioning or which is outside its service interval, and reporting this information to Medical Electronics
as a matter of urgency.
Service records for devices maintained by an external contractor should be held by the department manager
and be available for inspection.
Repairs are undertaken at the request of the user department, or if found necessary at the time of a planned
service procedure. Ward managers can request repairs by telephone or email, or alternatively arranging for
the equipment to be delivered to Medical Electronics. A Medical Equipment Repair Request Form
(see Appendix B) should be completed with the relevant fault details and attached to the equipment. On
return of the equipment details of the work undertaken, or advice will be provided on request.
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6. Decontamination of Medical Devices

It is the ward or department managers responsibility to ensure that their medical devices are properly
decontaminated prior to leaving the area for either repair or to be returned to a manufacturer or third party
maintenance provider. A decontamination certificate must be attached to the device or marked on the
Equipment Repair Request Form.
A copy of the Trust Decontamination Certificate is attached as Appendix C.
If a device is contaminated internally, and therefore cannot be adequately cleaned before dispatch for
maintenance or repair, this fact must be communicated to the technical organisation undertaking the work and
the equipment transported in a safe and agreed manner.
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7. Safety and Incidents

It is staffs responsibility to report where a medical device is involved in an adverse incident via completion of a
Datix electronic incident report. Selection of the Medical Devices Management Centre Manager option in the
notify section will send an automatic email notification of the incident. The Medical Devices team can also
access all incidents involving medical equipment to look at themes, trends and learning opportunities.
Medical Electronics receives MHRA and manufacturers safety or modification instructions and will ensure that
they are implemented with appropriate urgency for any medical devices for which they are responsible.
 No modification to any medical device will be permitted unless it has been approved by the manufacturer or
else has been thoroughly reviewed by senior technical staff and evaluated for any risk associated with the
modification.
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8. Condemnation, Removal and Disposal of Medical Devices

The removal of a device can be the result of a failure or a change of clinical practice requiring an alternative
item of equipment. Alternatively it could be superseded by a modern replacement offering enhanced features.
In the event that a faulty device cannot be repaired, considered unsafe, or replaced then a Condemnation
Form will be completed by Medical Electronics and copies provided to the Finance Department, Estates
Technical Services Asset Manager and the user Department Manager.
Condemned devices will be removed from the user department and made safe or unusable and arrangements
made for its disposal.
The device will be recorded as disposed of in the MDMS database and Trust registers, but the service history
will be kept for the statutory time period. The Removal of Devices protocol is attached as Appendix D to this
policy.
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9. In House Manufacture of Medical Devices

Medical Electronics does not manufacture medical devices in-house.
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10. Training
Medical Electronics will highlight the training requirements of its staff, to ensure their continuous professional
development to meet current requirements and development of its service.
MDMS can provide to the user formal or informal training in the correct use of a variety of technically
supported devices, either in-house or by a third party.
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11. Related Policies

Medical Devices Management Policy
Medical Devices Training Policy
Adverse Events Reporting Policy
Infection Control Policy
Decontamination of Medical Devices, Patient Equipment and Endoscopes
Risk Management Policy and Procedure
CAS Alerts Management Policy
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12. External References

1. Care Quality Commission: Regulation 12: Safe care and treatment and Regulation 15: Premises
and equipment (2014)
2. Medicines and Healthcare Products Regulatory Agency: Managing Medical Devices, April 2015
3. Medicines and Healthcare Products Regulatory Agency: Devices in Practice, June 2014
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13. Appendices
Appendix A Acceptance Procedure for New Equipment
Appendix B Medical Equipment Repair Request form
 Appendix C Decontamination Certificate
Appendix D Removal of Medical Devices Protocol
Appendix E Equality Impact Assessment
ratified 22/12/2015