General Note
NHS Fife acknowledges and agrees with the importance of regular and timely review of policy statements and aims to review policies within the timescales set out. New policies will be subject to a review date of no more than 1 year from the date of first issue.
Reviewed policies will have a review date set that is relevant to the content (advised by the author) but will be no longer than 3 years.
If a policy is past its review date, then the content will remain extant until such time as the policy review is complete and the latest version published, or if national policy or legislative changes are made.
1. FUNCTION
1.1 This policy sets out the organisation required to manage medical equipment ensuring it is; available when and where required, suitable for the intended purpose, maintained in a safe and reliable condition, and that users are appropriately trained in its safe use.
1.2 Effective implementation of this policy requires that an equipment management organisation must be in place. This must include anyone who may be involved in any aspect of using medical equipment and its management throughout its full life cycle from procurement to final disposal.
1.3 The aims of this policy are to ensure that:-
1.3.1 All medical equipment is safe when correctly used for the clinical purpose it has been designed for.
1.3.2 All personnel involved in use and maintenance of medical equipment, whether NHS employees or contract personnel, are suitably qualified and trained for their responsibilities.
2. LOCATION
2.1 The policy applies to all medical equipment used in, or supplied directly by NHS Fife, or otherwise donated by external organisations or individuals.
2.2 It applies to equipment that may be supplied on long term loan as part of consumables usage deal, or short term loan for one off procedures or trial purposes (document GP/E4-05 applies).
2.3 It applies wherever such equipment is used, throughout all sites within NHS Fife, and where NHS Fife provides services through provision of medical equipment.
3. RESPONSIBILITY
3.1 This policy applies to all staff involved with any function in the management, supply, use, and maintenance of medical equipment. All staff have a duty to report failures in implementation of this policy through line managers to their Capital Equipment Management Group representative.
3.2 The Chief Executive of NHS Fife has overall executive responsibility for ensuring that effective arrangements are in place to manage all safety, health, and risk matters within NHS Fife. This responsibility may be delegated to an appropriately senior manager, but the Chief Executive remains accountable to the Board.
3.3 The Director of Property & Asset Management holds delegated responsibility for medical device management. They have responsibility for the overall management of the provision of technical services in support of this policy.
3.4 The Estates Department is responsible for provision of asset management systems for recording asset details and history, technical maintenance and repair services, by all trades and specialties controlled by the relevant Estates Sector Managers, Estates Officers, and Medical Physics Manager.
3.5 The Medical Physics Manager NHS Fife is responsible for the day to day running of the Medical Physics Service across NHS Fife where such services exist. They will provide assistance to other groups that may be set up in support of this policy, reporting failures to implement and adhere to this policy at the Capital Equipment Management Group.
3.6 Ward and Department Managers have overall responsibility for the management, care, and safe use of equipment in their area, ensuring all such equipment is fit for use at all times.
3.6.1 They must keep and maintain an accurate equipment inventory, informing the Estates Department Service when changes are required.
3.6.2 A procedure to record the locations and movements of equipment in the inventory should be implemented to ensure equipment is available in the area when required. Areas that send equipment home with patients must have a robust system in place to record where the equipment is and a method of ensuring it is returned when no longer required to support clinical activity.
3.6.3 Where equipment is missing and all attempts to locate it have failed, Form LTD/1 - Fife Health Board, Loss, Theft or Damage Report Form (Appendix A to NHS Fife Financial Operating Procedures) is to be completed to report the loss.
3.6.4 Ward or Department Managers are to ensure arrangements are in place to make equipment available for maintenance when requested. The Ward or Department Manager will be the first point of contact for all routine equipment matters.
3.7 Equipment users have the final responsibility for ensuring a piece of equipment is the correct item for intended clinical purpose at the point of use, and safe to use for both the patient and operator.
3.7.1 Equipment shall not be operated by anyone who is not sufficiently trained and competent to do so.
4. OPERATIONAL SYSTEM
4.1 Equipment Management - The overall purpose of equipment management is to ensure that all items of equipment are available, when and where required, and are in a clean, safe, and serviceable condition. This covers all aspects from selection and procurement, through to decommissioning and disposal. The Capital Equipment Management Group has been established to oversee these management processes for capital equipment only.
4.2 Equipment Replacement Planning - It is essential that a program of replacement and development is set out.
4.2.1 Planning for higher value Capital Equipment will be undertaken at the Capital Equipment Management Group; Ward and Department Managers attend the group to present their requirements for discussion and approval. Replacement planning for lower value, high volume equipment used across NHS Fife sites must also be brought to the Capital Equipment Management Group for consideration.
4.2.2 For other low value equipment, individual wards and departments should have an equipment replacement plan in place, based on their own equipment inventory which must detail the age of equipment as a start point. This plan must be managed by Ward and Department Managers in consultation with their Directorate Managers.
4.2.3 Equipment age should not be considered as the overriding reason for replacement. Old equipment may still be perfectly safe to use, but equally equipment that is not of significant age may become obsolete through advances, change in technology or clinical procedure.
4.3 Condemnation Fund - The condemnation fund, managed by the Capital Equipment Management Group is for unexpected failures only. It is not intended as an alternative to replacing equipment that should have been replaced as scheduled by a department’s equipment replacement plan.
4.4 Selection of Equipment - Clinical users need to be provided with equipment that is good quality, available when required, reliable, safe to use, but represents value for money.
4.4.1 The responsibility for the final selection of equipment rests with the Ward or Department Manager purchasing the equipment. All equipment purchased for use in NHS Fife must carry a CE marking or UK Conformity Assessed (UKCA) mark. Further detailed guidance on equipment selection is contained in documents GP/E4-02.
4.4.2 Where required for specialist complex procedures or treatment that may be specific to a patient or group of patients, the clinical service involved must take full responsibility for justifying and funding the increased costs that will be incurred for equipment that is likely to be unique. Short term rental or loan may be more appropriate than purchase.
4.5 Acceptance of Equipment Into Use - Equipment delivered to NHS Fife must be formally accepted into service.
4.5.1 Delivery - On delivery, the Ward or Department Manager will confirm the order has been received as complete and correct. They should then contact Estates to have the item registered in the Asset Register. An “Acceptance Check” job request will be initiated by Estates. Equipment on long term loan must also be similarly registered.
4.5.2 Acceptance/Commissioning Checks - Where these are carried out by the manufacturer or supplier as part of the supply agreement, departments must ensure they inform Medical Physics or Estates when this takes place and forward any reports provided. Otherwise, on receipt of an Acceptance Check work instruction, the Medical Physics Manager and/or an appropriate Estates Officer will then arrange for any assembly, installation work and acceptance checks to be carried out.
4.5.3 Configurable options or settings for a device must be specified and documented by an appropriate Ward or Department Manager so they can be set on the device before use.
4.5.4 Handover to User - On completion of Acceptance Checks equipment will be delivered to the clinical area and handed over to the Ward or Department Manager present. By accepting the equipment, the Ward or Department Manager acknowledges all requirements for its safe use have been fulfilled including any necessary staff training.
4.6 Care of Equipment by Users:
4.6.1 Users must follow the manufacturer’s guidelines for the care and user maintenance of equipment.
4.6.2 Pre-use inspections including checks specified by the user instructions must be carried out before each use.
4.6.3 Ward or Department Managers must arrange for suitable storage of medical equipment when not in use, ensuring any equipment with rechargeable batteries is kept on charge, and that procedures are in place to ensure equipment is returned in a safe condition after cleaning and decontamination.
4.7 Servicing and Maintenance of Equipment:
4.7.1 Maintenance Requests - All repair requests are to be reported online via “Quicklinks” using the “MICAD - Estates on-line Job request” option. Declaration of Decontamination Status certificates must accompany all equipment for repair or condemnation and disposal.
4.7.2 Routine Planned Servicing - It is the user departments responsibility to make equipment available for routine servicing when due. They must have procedures in place to do this including, where required, making arrangements for obtaining alternative equipment.
4.7.3 Equipment Modifications - Modification of equipment is prohibited and must not take place under any circumstances.
4.8 Disposal and Replacement of Obsolete or Condemned Equipment - The general procedure for condemnation and disposal of equipment is set out clearly in document GP/E4-07. Departments must not dispose of equipment themselves; there may be hazardous substances involved or other disposal regulations to be considered.
4.9 Equipment Safety Alerts - NHS Fife may receive information from many external sources on incidents or safety concerning medical equipment. NHS Fife has an established procedure for receipt and distribution of these notices which is detailed at Reference E.
4.10 Adverse Incidents and Near Misses - All adverse incidents or near misses involving an item of medical equipment must be reported using the online Datix reporting system in accordance with Reference F. Particular attention must be given to paragraph 4.7 of that document.
5. RISK MANAGEMENT
The key risks involved in the implementation of this policy and compliance by wards and department are:
5.1 Lack of staff awareness of this policy, resulting in non-compliance. This risk is reduced by:-
5.1.1 Policy is published on NHS Fife website under the General Policies section.
5.1.2 Publication and any revision or updates notified via NHS Fife Stafflink newsfeed.
5.2 Lack of robust organisational arrangements and failure to implement and maintain the required procedures associated with the policy. This risk is to be reduced by:-
5.2.1 Internal Audit processes highlighting non-compliance.
5.2.2 Significant departures are to be reported at Capital Equipment Management Group and recorded as Datix Risks if required.
6. SUPPORTING DOCUMENTS
6.1 Appendix 1 – Equipment Maintained by Medical Physics
6.2 Appendix 2 – New Equipment Handover Certificate
6.3 GP/E4-01 - Medical Physics Service Provision Procedure
6.4 GP/E4-02 - Equipment Procurement
6.5 GP/E4-03 - Accessing Equipment
6.6 GP/E4-04 - Equipment Inventory
6.7 GP/E4-05 - Equipment on Loan or Free Issue
6.8 GP/E4-06 - Permanent Location Change of Equipment
6.9 GP/E4-07 - Condemnation of Equipment
6.10 GP/E4-08 - Transfer of Liability for Written-Off Equipment
6.11 GP/E4-09 - Equipment Maintenance
7. RELATED DOCUMENTS
7.1 GP/E5 Processing External Hazard and Safety Notices and Alerts Policy
7.2 GP/I9 Adverse Events Policy
8. REFERENCES
8.1 MHRA Managing Medical Devices Guidance for Healthcare and Social Services Organisations. Dated April 2015.
8.2 CEL 35 (2010) A Policy for Property and Asset Management In NHS Scotland Dated 27 September 2010.
8.3 SHTN 00-04 Guidance on Management of Medical Devices and Equipment in Scotland's Health and Social Care Services
