Standard Operating Procedure 2 (SOP 2) Trial, Loan or Lease - of Medical Devices from Manufacturers/Suppliers Why we have a procedure? There may be occasions when a Group or department wishes to trial, loan or lease a medical device. This procedure is intended to manage and minimise the liability of the trust when borrowing in equipment from another Trust, equipment supplier or other provider. The procedure is also intended to reduce the risk of harm by ensuring the quality of the borrowed in equipment and the competency of the persons using it. Equipment/goods can be introduced into the Trust for trial and evaluation purposes such as: Equipment on loan/trial Free issues with purchase of consumables Demonstrations on patients or staff Temporary replacement for equipment undergoing repair In all these instances, all devices must conform with all relevant standards and guidance pertaining to the type of device, the location and function for which it is to be used. Failure to comply with this procedure could adversely impact patient/ staff safety and hence put the Trust at risk of litigation. What overarching policy the procedure links to? Medical Devices Policy Which services of the trust does this apply to? Where is it in operation? Group Inpatients Community Locations Mental Health Services all Learning Disabilities Services all Children and Young People Services all Who does the procedure apply to? Team Leaders/Ward and Department Managers/Senior Nurses/Operational Managers whose Group/department wishes to trial, loan or lease a medical device. Trial, Loan or Lease - of Medical Devices from Manufacturers/Suppliers Page 1 of 5 Version 1.0 December 2015
When should the procedure be applied? When a Group or Department wishes to trial, loan or lease a medical device. How to carry out this procedure A summary of the process to be followed is shown in Purchase/ Replacement of Medical Devices Flowchart (Standard Operating Procedure 1 (SOP 1) Purchase- Procurement and Standardisation of Medical Devices) When a Group or Department wishes to trial, loan or lease a medical device, this must first be arranged with Procurement and MPCE Departments. This is to ensure all safety and pre-use checks and relevant indemnity/decontamination forms/equipment labels are completed prior to the trial commencing Full information, instruction, training and supervision must be undertaken by the manufacturer/supplier prior to and during any trial/loan Medical Device Trainers must be consulted and made aware so that any training can be captured and recorded No trial, loan or lease will commence until all relevant documentation and checks are completed MPCE must be informed when any trial, loan or lease equipment has been delivered so that an electrical safety check (if necessary) can be performed, following which an electrical safety sticker will be attached to the mains cable/device and an Equipment on Loan sticker attached to the equipment (see Medical Devices Policy- Appendix 2) Medical Devices that are on trial, loan or lease, as part of a tender evaluation, must have evaluation forms completed. These evaluation forms can either be from the manufacturer/suppliers or the Groups or departments All paperwork concerning the trial, loan or lease must be retained by the Trust and must be forwarded to MPCE for central filing or electronic file storage MPCE must be informed when a trial, loan or lease period is complete and prior to the equipment being returned to the manufacturer/supplier. This is to ensure that all patient identifiable data is securely and correctly removed/deleted from the equipment prior to being returned to the manufacturer/supplier. The Trust has a duty to maintain the security and confidentiality of patient information in compliance with Trust policy Medical representatives from companies must conform to the above protocols in relation to trial/loan/ lease or free purchase of medical devices, prior to acceptance from the trust. For acceptance of medical devices see Standard Operating Procedure 3 (SOP 3) Acceptance of Medical Devices from Manufacturers/ Suppliers What do these terms mean? MPCE - Medical Physics and Clinical Engineering Department provides a device management service to the Trust. Medical device management includes a wide range of activities: Advice and assistance with equipment evaluation prior to purchase Help with Deciding on the model that most fits the user department needs Trial, Loan or Lease - of Medical Devices from Manufacturers/Suppliers Page 2 of 5 Version 1.0 December 2015
Preparation ready for implementation of the device which includes commissioning the equipment and training the staff how to use it Technical and clinical support of the equipment and staff during its life time Planned end of life replacement Correct disposal of the old equipment Trial/ Loan/ Lease of Medical Device Flowchart Consult Procurement & MPCE Departments To ensure correct process is followed and relevant documentation is completed i.e. Indemnity/Specifications/Evaluations/PPQ/ Decontamination considerations. NB Equipment must not be used unless asset register label has been added by MPCE On delivery of equipment MPCE electrical safety test, labelled Indemnity forms completed, training recorded Contact MPCE if necessary to arrange Acceptance of Medical Devices Must be carried out by MPCE before equipment can be used. Please see Standard Operating Procedure 3 (SOP3)Acceptance of Medical Devices from Manufacturers/Suppliers During trial Evaluation forms completed and any training recorded End of trial/loan Prior to returning equipment, any patient identifiable data must be securely removed / deleted. Inform MPCE Trial, Loan or Lease - of Medical Devices from Manufacturers/Suppliers Page 3 of 5 Version 1.0 December 2015
Where do I go for further advice or information? Ensure that the Trust has access to appropriate expert advice as required to support this procedure Ensure compliance with the requirements of CQC Regulation 12: Safe Care and Treatment Ensure that financial implications are considered at all stages in relation to medical devices and develop close working with the Capital Programme lead within the Finance Directorate Nominated Medical Device Leads (Clinical Groups) and Team Leaders in Community Services Ensure that requests for medical devices include the Risk Assessment, Acceptance Checks, training and maintenance arrangements Ensure a common procedure is followed for accepting new devices into service including identifying significant risks associated with use, repair, cleaning and disposal and updating the inventory of new equipment Team Leaders/Ward & Department Managers/Senior Nurses/Operational Managers All clinical wards/departments have responsibility for having an up-to-date inventory of all their medical devices within the area under their control and work closely with MPCE in keeping their list up to date Infection Prevention & Control Team Advise accordingly in line with this procedure The Medical Physics and Clinical Engineering department Assist the Trust to develop an approved products list for all medical devices used across all departments Ensure all medical non-disposable devices in use are CE marked Training Staff may receive training in relation to this procedure, where it is identified in their appraisal as part of the specific development needs for their role and responsibilities. Please refer to the Trust s Mandatory & Risk Management Training Needs Analysis for further details on training requirements, target audiences and update frequencies. Monitoring / Review of this Procedure In the event of planned change in the process(es) described within this document or an incident involving the described process(es) within the review cycle, this SOP will be reviewed and revised as necessary to maintain its accuracy and effectiveness Equality Impact Assessment Please refer to overarching policy Data Protection Act and Freedom of Information Act Please refer to overarching policy Trial, Loan or Lease - of Medical Devices from Manufacturers/Suppliers Page 4 of 5 Version 1.0 December 2015
Standard Operating Procedure Details Unique Identifier for this SOP is State if SOP is New or Revised BCPFT-CLIN-POL-12-2 New Policy Category Executive Director whose portfolio this SOP comes under Policy Lead/Author Job titles only Committee/Group Responsible for Approval of this SOP Month/year consultation process completed Clinical Deputy Chief Executive & Director of Resources April 2015 Month/year SOP was approved November 2015 Next review due December 2018 Disclosure Status Key words relating to this SOP B can be disclosed to patients and the public Borrowed equipment, Free purchase of medical device Review and Amendment History Version Date Description of Change 1.0 Dec 2015 New Procedure established to supplement Medical Devices Policy Trial, Loan or Lease - of Medical Devices from Manufacturers/Suppliers Page 5 of 5 Version 1.0 December 2015