POLICY FOR THE USE OF MEDICAL EQUIPMENT USED "ON-TRIAL / ON-LOAN"

Transcription

1 POLICY FOR THE USE OF MEDICAL EQUIPMENT USED "ON-TRIAL / ON-LOAN" This procedural document supersedes: CORP/PROC 1 v.3 Policy for the Use of Medical Equipment Used On-Trial/On-Loan Name and title of author/reviewer: (this version) Andrew Leverton Medical Technical Services Manager Ian Allcock General Manager Supplies and Procurement Date revised: May 2010 Approved by (Committee/Group): Medical Equipment Sub-Group Theatre Procurement Group Date of approval: 3 June 2010 Date issued: October 2010 Next review date: June 2013 Target audience: Trust-wide WARNING: Always ensure that you are using the most up to date policy or procedure document. If you are unsure, you can check that it is the most up to date version bylooking on the Trust Website: under the headings Freedom of Information Information Classes Policies and Procedures Page 1 of 32

2 POLICY FOR THE USE OF MEDICAL EQUIPMENT USED "ON-TRIAL/ON-LOAN" Amendment Form Please record brief details of the changes made alongside the next version number. If the APD has been reviewed without change, this information will still need to be recorded although the version number will remain the same. Version Date Brief Summary of Changes Author Version 3 June 2007 Page 8 - Contact details only Andrew Leverton Ian Allcock June 2010 Page 1 - Policy dates Page 2 - Amendment form added Andrew Leverton Ian Allcock Page 3 - Contents page Page 4 - Introduction Page Equipment Controllers changed to Training Coordinators. Page paragraph changed to include HSDU. Page paragraph added. Page (MHPRA) changed to (MHRA). Page paragraph added. Page 9 paragraph 3 "sent back to supplier" changed to "collected by supplier or the supplier's representative". Page 9 Equality Impact Assessment added. Page 9 Monitoring of Policy added. Page 10 References Pages 13, 19, 20 & 21 OR NHS Purchasing and Supply Agency ("PASA") deleted. Page 13 main paragraph "or through PASA to NHS Trusts" deleted. Page 20 & 21 Updated Form of Indemnity B Page 22 Updated NHS Delivery Note. Page 23 Paragraph 4 deleted. Page 24 Paragraphs 15.6 and 15.7 deleted. Page 29 Flowchart changed. Page 31 Loan Kit Request Form added. Page 2 of 32

3 POLICY FOR THE USE OF MEDICAL EQUIPMENT USED "ON-TRIAL/ON-LOAN" CONTENTS 1.0 Introduction The Problem The Objective The Policy Queries/Concerns Equality Impact Assessment Monitoring of Policy 9 References 10 List of Appendices Appendix A Appendix B NHS Form of Indemnity - A NHS Form of Indemnity - B Delivery Note Guidance Notes Equipment Evaluation Form Guidance Notes for Completion of Equipment Evaluation Form Appendix C Flow Chart of Procurement of Medical Equipment Appendix D Loan Kit Request Form On Loan Check List Page 3 of 32

4 1.0 Introduction 1.1 This Policy does not cover the HIRE of equipment. It relates purely to the LOAN of equipment. 1.2 Individuals in the Trust s Departments/Directorates are often approached by manufacturer's sales representatives endeavouring to market/sell their products. This may result in products and/or items of equipment being left for use on a trial/on-loan basis within the Trust. Divisions and Business Units may also originate such arrangements, for example orthopaedic surgical instruments for specific operations. 1.3 Such items may be supplied directly to the point of use by the representative, or company, in good faith and with good intent. This may often fulfil an urgent requirement, but at the same time avoids a number of essential and necessary control checks, which are in place to protect the user and the patient. 1.4 By following the guidance contained in this Policy, unnecessary delays will be avoided and a safe system put in place to protect both the user and the patient. Litigation against the Trust will therefore be both managed and minimised. 2.0 The Problem 2.1 The Trust could be placed in a position of significant "risk exposure" by equipment: Not complying with Medical Health-care Product Regulatory Agency (MHRA) guidelines, which require supplier indemnity to be assured, via the completion of appropriate documentation Being used without the Trust Medical Technical Services Department/HSDU knowledge; and without the necessary end user safety checks being performed by them Being used without adequate training and operational support and the knowledge of the Trust designated Training Coordinators Infringing manufacturer's warranties and liabilities by undertaking inappropriate repairs to equipment, which are not in the legal ownership of the Trust. Page 4 of 32

5 2.1.5 Being used without the Trust Decontamination Manager (Sterile Services) being aware, and without the necessary checklists, training and decontamination guidance. 2.2 In addition, staff: The Objective Could encourage and promote "cold calling" by manufacturers sales representatives, at the expense of preplanned appointments, which facilitate the efficient and effective use of the Trust resources and individual s time Could lead to enhancing the sales representative's expectations of a positive sale outcome, which may not ultimately materialise; hence creating a "verbal contractual" condition, which may be pursuable in law by the supplier Could potentially inhibit the Trust negotiating position with regard to achieving the best price / discount for these products. (Note - It is the responsibility of the Trust s General Manager Supplies & Procurement to negotiate all matters concerning prices/discounts for all purchases made on behalf of the Trust) May not consider the implication of compatibility of accessories used in conjunction with some equipment or the processing/ decontamination requirements Could place themselves and their colleagues at risk of litigation by adopting ownership of non-trust equipment. 3.1 To enjoy the benefits and opportunities afforded by participating in equipment trials and on-loan arrangements with suppliers, and at the same time identifying, "managing out" and reducing to a minimum the associated risks. 3.2 To develop a policy to be adopted Trust-wide, that will be used both internally and shared with equipment suppliers which fulfils the objective at 3.1 above. 3.3 To manage the use of trail and on-loan medical equipment in line with this Policy and to restrict cold calling by suppliers sales representatives. 3.4 To establish a monitoring and review mechanism, whereby the Policy can be enhanced from time to time. Page 5 of 32

6 3.5 To ensure that any adverse findings associated with the proper use of any such medical equipment is properly documented. Such information to be conveyed appropriately throughout the Trust to highlight awareness of the issue(s). 4.0 The Policy 4.1 All trials are to be co-ordinated via the Trust s Clinical Procurement Specialist. Where the use of medical equipment either Ontrial/On-loan, results from a meeting by Trust staff with a representative of an equipment supplier, then the following shall apply: Prior to the trial of any medical device or medical product (where applicable), the Trust Supplies Department should obtain a Pre-Purchase Questionnaire (PPQ) from the supplying firm. This would confirm conformity to relevant standards and regulations and would need to be reviewed and agreed by (in the case of medical devices) Medical Technical Services Department/HSDU Any requirement for loaned equipment that is on trial with a view to purchase, can only be impartially evaluated against a pre-written specification and evaluation criteria. Such specification criteria must be completed before the loan trial commences and submitted to the Medical Technical Services Manager and Clinical Procurement Specialist A flow chart taken from the Trust s Guide to the Procurement of Medical Equipment is included at Appendix "C" which illustrates the procedure for the procurement of items of equipment With regard to the loan of Operating Theatre Instrumentation for ELECTIVE Theatre lists, it is essential that such instrumentation be delivered to HSDU at Doncaster Royal Infirmary by 9.00 am, 48 hours [minimum] prior to the Elective episode. This will allow sufficient time for the HSDU staff to process such instrumentation. Where training of HSDU staff is required [ie new equipment] then it is the responsibility of the Theatre co-ordinator and the manufacturer to ensure this is adequately carried out prior to the specified theatre slot and before the minimum 48 hour period. Page 6 of 32

7 Note: To ensure adequate staffing is available, Theatres must inform HSDU in writing [fax number ] that loan equipment has been ordered immediately after placing the order. Since loan instrumentation is generally provided in packing containers or trunks, one of the containers should carry an identification mark to indicate that the paperwork relating to the instrumentation is contained within. The containers should ideally be bar coded with an unique traceability label to assist with this process. The paperwork should be clear and concise and contain the following information: The Trusts Purchase Order Number The Supplier s Name, address and contact telephone no. The specific Hospital (there are 3 within the Trust) and the Operating Theatre in question The date of the operation. Full contents list/check list. Photographs of instrumentation*. Decontamination instructions*. Date of collection from HSDU. Instructions for use*. *It may be that these are held in a central library with HSDU and need not be supplied each time loan instrumentation is supplied. Such matters will be agreed between the Trust s Decontamination Manager, Sterile Services (or the Managers Representative) and the supplier Ensure that the appropriate Form of Indemnity (copies included at Appendix "A") are completed. Officers of the Trust Supplies Department shall do this on behalf of the Trust The supplier shall deliver the equipment to the Trust s Medical Technical Services Department or HSDU, by prior appointment no less than 3 working days before equipment is required, which shall be made via telephone - Extension 3558 for MTS or 4710/3525 for HSDU. Page 7 of 32

8 4.1.7 The supplier shall deliver surgical instrumentation to HSDU by prior appointment no less than 3 working days before equipment is required, which shall be made by via telephone Extension 4710/3525. Note: In terms of orthopaedic prosthesis, HSDU will accept and sign that they have been delivered only. They take no responsibility for the contents and suitability of these items The Medical Technical Services Department/HSDU will inform the Trust Supplies Department that such equipment has been received Medical Technical Services Department/HSDU undertake pre-use checks and confirm the status of contamination of the equipment. Where these fail or doubt exits, advice should be sought from the manufacturer An On Loan check form will be completed by the above department, (see Appendix D) ensuring that all the required supporting information is available. Equipment may not be released for use if insufficient time has been given to safely carry out the appropriate tests, or if the supplier has failed to provide the necessary information It is the responsibility of the supplying company and/or HSDU to deliver the equipment to the point of use, for entering into operation by the end user. At this time confirmation will be required by the Ward/Department Manager that training has been undertaken to the required standard. All training records should be sent to the Medical Technical services Department upon completion The end user shall monitor the equipment's effectiveness and document findings by completing the standard Equipment Evaluation form. (Copy included at Appendix "B") and forward this to the Clinical Procurement Specialist The end user advises the Medical Technical Services/ HSDU of any such adverse findings and provides a copy of the standard evaluation form The Medical Technical Services reviews adverse findings and formally advises the supplier, (MHRA), the Trust's Supplies Department and raises awareness via all other departments within the Trust as is deemed appropriate. Page 8 of 32

9 5.0 Queries/Concerns The end user returns equipment to the Medical Technical Services Department/HSDU on completion of trial or loan period All medical equipment must be decontaminated prior to returning to the supplier, and the necessary forms completed in accordance with MHRA requirements. The Medical Technical Services Department/HSDU completes "pre-return" checks and arranges for return to take place. Allow 48 hours after surgery for the safe decontamination of medical equipment prior to being collected by the supplier or the supplier's representative In the event of instrumentation being in contact with patients or procedures suspected of having vcjd, such instrumentation must be identified and quarantined in accordance with the vcjd Policy. Any queries or concerns regarding this policy should be directed to:- Andrew Leverton, Medical Technical Services Manager Sheila Murphy, Acting HSDU Decontamination Manager Allison O Donnell, Clinical Procurement Specialist Ian Allcock, General Manager Supplies & Procurement 6.0 Equality Impact Assessment As part of its development, this policy and its impact on equality have been reviewed in consultation with the Equality Impact Assessment Group. An Equality Impact Assessment (EIA) has been conducted in line with the principles of the Equality Impact Assessment Policy and the Fair Treatment For All Policy. The purpose of the EIA is to minimise and if possible remove any disproportionate impact on employees on the grounds of race, sex, disability, age, sexual orientation or religious belief. No detriment was identified. A copy of the EIA is available on request from the HR department. 7.0 Monitoring of Policy This policy will be reviewed at the meetings of the Theatre Procurement Group and the Medical Equipment Sub Group. Page 9 of 32

10 REFERENCES 1. Core Quality Commission Standards, including:- 1.1 Decontamination of Medical Devices 1.2 Medical Devices Management 1.3 Infection Control 1.4 Management of Purchasing & Supply 2. Standards for Better Health 2.1 Core Standard C4c Decontamination 2.2 Core Standard C4b Safe Use of Devices 3. Managing Medical Devices DB2006(05). 4. MDA Safety Notice SN2000(18) Handling of surgical Instruments on loan from another organisation. (October 2002) 5. MDA Safety Notice SN2002(17) Management of Loan Device, Equipment or Accessories from Manufacturer or other Hospitals (June 2002) 6. Medical Devices Agency (MAC) Manual, sterilisation, disinfection and cleaning of medical equipment: Guidance on decontamination from the Microbiology Advisory Committee to the Department of Health. 7. DB Management of Medical Devices prior to review, service of investigation 8. HSC 2000/032 Decontamination of Medical Devices. 9. PAT/IC 4 v.2 - Variant Creutzfeldt-Jakob Disease (vcjd) and Transmissible Spongiform Encephalopath Agents (TSE): Minimising the Risks of Transmission 10. CORP/RISK Medical Equipment Training for Trust Staff 11. CORP/RISK Policy and Procurements Relating to the Reporting of Adverse Incidents Involving Medical Devices and Dissemination of Safety Altert Notices. 12. Trust Standing Orders/Standing Financial Instructions 13. Representatives Policy Page 10 of 32

11 APPENDICES Appendix "A" Forms of Indemnity Delivery Note Guidance Notes Appendix "B" Equipment Evaluation Proforma Guidance Notes for Completion of Equipment Evaluation Proforma Appendix "C" Flow Chart of procurement of Medical Equipment Appendix D Loan Kit Request Form On Loan Check List Page 11 of 32

12 APPENDIX A NHS Form of Indemnity A NHS Form of Indemnity B NHS Delivery Note Guidance Notes for NHS Forms of Indemnity and NHS Delivery Notes Page 12 of 32

13 NHS Form of Indemnity A Reference Number [ ] Equipment on loan A DEED made the day of...200_ BETWEEN: EITHER* NHS Trust/NHS Foundation Trust/Health Authority*. ( the Authority ); AND Supplier.. ( the Supplier ). WHEREAS The Supplier is the owner of equipment (the Equipment ) and wishes to make the Equipment available directly to the Authority, NHS Foundation Trusts, Health Authorities and other users ( Users ) agreed by the parties for a specified period in accordance with the terms of this Deed. The Equipment and the period for which the Equipment will be on loan to the Authority or the relevant User(s) shall be specified in either an NHS delivery note or, where this Deed acts as a master indemnity agreement for all loans made by the Supplier, a Supplier standard delivery note, in each case completed by the Supplier and the Authority or the relevant User(s) at the outset of the loan (a Delivery Note ). For the avoidance of doubt, there shall be no limit on the number of Delivery Notes which may be completed pursuant to this Deed. Equipment shall be deemed to include any part or parts of the Equipment and all replacements and additions supplied by the Supplier during the continuance of this Deed. IT IS HEREBY AGREED that the Supplier shall make the Equipment available to the Authority or the relevant User(s) by way of loan free of charge for the period agreed between the Authority or the relevant User(s) and the Supplier, at the premises ( the Premises ) specified in the relevant Delivery Note on the terms set out in this Deed:- 1. For the avoidance of doubt, this Deed is not a contract for hire pursuant to the Supply of Goods and Services Act * Delete as appropriate 2. Title to the Equipment shall remain for all purposes dully vested in the Supplier. Page 13 of 32

14 3. The Equipment (other than Equipment which the Authority or relevant User(s) has taken on loan for the purposes of trial or evaluation at the request of the supplier) shall at all times after its delivery to the Authority or the relevant User(s) be at the sole risk of the Authority or relevant User(s) as regards damage, loss or destruction. The Authority or the relevant User(s) shall be liable for the repair or replacement of any such Equipment which is damaged, destroyed or lost whilst in its possession or control. 4. Subject to Clause 5, Equipment which the Authority or relevant User(s) has taken on loan for the purposes of trial or evaluation at the request of the Supplier shall at all times after its delivery to the Authority or the relevant User(s) be at the sole risk of the Supplier as regards damage, loss or destruction and neither the Authority nor the relevant User(s) shall be under any obligation to keep the Equipment insured. For all pieces of Equipment on loan to the Authority at any one time the Supplier shall keep a record of the purpose of the loan and, when requested by the Authority upon reasonable notice, communicate the purpose of the loan to the Authority within a reasonable time. 5. The Authority or the relevant User(s), as the case may be, shall be liable for the repair of: 5.1 any damage to the Equipment occurring at the Premises (or during transit in the event that the Authority or relevant User collects the Equipment pursuant to Clause 6) and caused by the Authority or the relevant User(s) failing to use or operate such Equipment in accordance with the express instructions of the Supplier; and any damage to the Equipment occurring at the Premises (or during transit in the event that the Authority or relevant User collects the Equipment pursuant to Clause 6) and caused by the act or omission of the Authority or the relevant User(s) their employees, agents or contractors or any third party beyond reasonable control of the Supplier. 6. The Supplier shall use its reasonable endeavours to deliver the Equipment to the Premises on a date agreed between the Supplier and the Authority or the relevant User(s). Except where carried out solely by the Authority or the relevant User(s), delivery shall be effected by the Supplier delivering the Equipment to the Premises or (if otherwise agreed) by the Authority or the relevant User(s) collecting the Equipment from the Supplier s premises or any other premises agreed by the parties. Unless otherwise agreed, the Authority or relevant User(s) shall be responsible for installation of the Equipment at the Premises such that it is in working order for use by the Authority or the relevant User(s). The Authority s responsibility shall also extend to any and all costs and damage caused by or arising out of the failure to correctly install the Equipment, provided always that it is the Authority which has installed the Equipment. For the avoidance of doubt, should the Supplier be responsible for installing the Equipment, the Authority shall have no responsibility to meet any costs and damage caused as a result of the installation. 7.1 Subject to Clauses 7.2 and 7.3 below, the Supplier shall indemnify and hold harmless the Authority, the relevant User(s) and the Secretary of State for Health against all losses suffered by the Authority, the relevant User(s) or the Secretary of State for Health: Page 14 of 32

15 (i) in connection with any defect in the design or manufacture of the Equipment; or (ii) arising directly as a result of the provision by the Supplier of negligent training or instruction in the use, or preparation for use, of the Equipment to the Authority, the relevant User(s) or the Secretary of State for Health 7.2 The Supplier shall not be liable for any loss suffered by the Authority, the relevant User(s) or the Secretary of State for Health to the extent that such loss was caused by the negligent acts or omissions of or breach of statutory duty by the Authority, the relevant User(s) or the Secretary of State, save where such acts, omissions or breaches were occasioned as a result of following the instructions of the Supplier or the Supplier's agents, employees or contractors. For the avoidance of doubt, but without prejudice to the generality of the foregoing, the following circumstances shall amount to negligent acts: (i) a failure to use or operate the Equipment in accordance with the operating instructions and other relevant information of which the Authority or relevant User(s) has been made expressly aware by the Supplier; including failure to observe requirements for the safe disposal or reprocessing of the Equipment; (ii) a failure by the Authority or relevant User(s) to ensure that the Equipment is operated by persons who have been made aware of the method of operation in accordance with Clause 9; and (iii) use of the Equipment for a use or in a manner for which it was not I intended. 7.3 (i) The Supplier shall be liable for physical damage to the Premises resulting from its negligence up to a maximum of five million pounds ( 5,000,000.00) (in respect of any one event or series of connected events). (ii) Nothing in this Deed shall exclude or limit the Supplier's liability for death or personal injury caused by its negligence or any liability the Supplier may have pursuant to the Consumer Protection Act 1987 to a person who has suffered damage caused by defective Equipment. (iii) The Supplier shall not be liable for any loss of profit, income, business, revenue or goodwill or any indirect or consequential losses. (iv) Without prejudice to Clauses 7.3(i) and 7.3(ii) above, the Supplier's maximum aggregate liability arising in connection with (a) any defect in the design or manufacture of the Equipment or (b) the provision of negligent training or instruction in the use of, or preparation for use, of the Equipment, whether arising in contract, tort (including negligence) or otherwise, shall in no circumstances exceed five million pounds ( 5,000,000.00) (in respect of any single event or series of connected events). 7.4 The Supplier does not accept and hereby excludes, any liability for negligence save as provided in this Clause The Supplier shall take out and maintain insurance cover with an insurer reasonably acceptable to the Authority or the relevant User(s) on terms sufficient Page 15 of 32

16 to cover its liability to the Authority or the relevant User(s) and the Secretary of State for Health under this Deed and in any event with a minimum indemnity cover of 5 million in any year (or such other amount as may be agreed by the Authority or the relevant User(s) in writing). On request the Supplier shall provide documentary evidence of such insurance cover to the Authority or the relevant User(s). If at any time the Supplier shall default in its obligations to insure as aforesaid then the Authority or the relevant User(s) shall hereby be irrevocably appointed by the Supplier as the Supplier s agent to effect such insurance cover as the Supplier would have taken out and maintained and accordingly the Authority or the relevant User(s) shall recharge to the Supplier (who hereby undertakes to make payment to the Authority or the relevant User(s) promptly on demand) the full cost of effecting such insurance cover together with such sum as shall cover all costs reasonable incurred by the Authority or the relevant User(s) in effecting such insurance provided that such sum shall not exceed an amount equivalent to five per cent (5%) of the cost of the policy effected. 9. The Supplier shall provide to the Authority or the relevant User(s) instructions for use relating to the Equipment and detailed instructional manuals (where available) for the intended purpose stated by the Supplier, including any information and documents required by the Control of Substances Hazardous to Health Regulations The instruction manual shall accompany the Equipment and shall be in the English language and contain appropriate directions as to the operation of the Equipment. The Supplier shall provide a telephone number to the Authority which telephone line shall be manned during normal working hours by those of the Supplier s staff who are trained and qualified to deal properly with any enquiries the Authority or the relevant User(s) may have in relation to the operation of the Equipment. The Authority or the relevant User(s) will notify Supplier promptly of any fault or safety issue arising with or damage to the Equipment and will use its reasonable endeavours to ensure that the Equipment is not used until such fault or damage has been repaired or the safety issue resolved. 10. Where appropriate, the Supplier warrants and represents that the Equipment complies with the Essential Requirements of the Medical Devices Directive (93/42) and is CE marked. The Supplier further warrants that the Equipment is fit for the intended purpose for which the Equipment is supplied. 11. The Supplier and the Authority or the relevant User(s) shall complete and sign a Delivery Note in relation to each item of Equipment to be covered by this Deed. 12. This Deed shall continue in force from the date hereof until it is terminated by either party in accordance with this clause. For the avoidance of doubt, the parties obligations under this Deed shall apply only to Equipment which is in the possession of the Authority or the relevant User(s) from time to time and shall not apply to Equipment which has been returned to the Supplier in accordance with Clause 16. This Deed will terminate if either party serves on the other party not less than 3 months written notice to expire at any time. 13. Upon termination of this Deed for whatever reason the Authority or the relevant User(s) shall forthwith provide the Supplier with written particulars of any contamination or other hazard including any safety hazard that has arisen in respect of the Equipment during the period in which the Equipment was on loan to the Authority or the relevant User(s) sufficient to facilitate compliance by the Page 16 of 32

17 Supplier with statutory and other reasonable requirements to make safe the Equipment, the contamination and any other hazard so that it may be maintained, repaired, removed, transported or otherwise dealt with by the Supplier as may be appropriate provided that the Authority or the relevant User(s) shall accept no liability whatsoever for any failure by the Supplier to make safe the Equipment or to deal with any contamination or other hazard in accordance with any statutory or other requirements whether or not such failure has arisen out of or is connected with any written particulars provided by the Authority or the relevant User(s) under this condition, except that the Authority or the relevant User(s) shall be responsible for any and all costs where Equipment is returned to the Supplier with insufficient or incorrect information of a hazard or contamination. If such contamination or other hazard has resulted from the failure of the Authority or the relevant User(s), their servants or agents to use the Equipment for the Supplier s intended purpose, the Authority or the relevant User(s) shall bear the reasonable cost of making safe the Equipment, the contamination and any other known hazard. 14. The Equipment shall not be modified or repaired by the Authority or the relevant User(s) without the prior written agreement of the Supplier. 15. Neither the Authority nor the relevant User(s) shall be liable for any charge for maintenance, repair, consumable materials or accessories required for the operation of the Equipment during the period in which the Equipment is on loan to the Authority or the relevant User(s) or for any carriage or installation charges except as provided in this Deed or by agreement and the issue of an official purchase order by the Authority or the relevant User(s). 16. Upon receipt of a written request at any time from the Authority or the relevant User(s) or at the end of the loan period specified in the relevant Delivery Note, the Supplier shall remove the Equipment from the Premises with all practicable speed, free of charge, and at that time shall provide the Authority or the relevant User(s) with a receipt for the Equipment, and shall have the right to enter onto the Authority s or relevant User(s) premises to exercise such removal. 17. The Supplier shall provide the Authority or the relevant User(s) with reasonable written notice of the time at which it intends to remove the Equipment from the Premises in accordance with Clause 18. The Supplier shall be solely responsible for the cost of making good and reinstating the Premises to the reasonable satisfaction of the Authority or the relevant User(s) following the removal of the Equipment provided always that if the Equipment is free-standing and not in any way attached to the fabric of the Premises then there shall be no obligation on the Supplier under this clause. Page 17 of 32

18 19. Nothing in this Deed shall create any obligation on the Authority or the relevant User(s) to purchase or take on paid hire either during the period of this Deed or at any time thereafter any quantity of the Equipment and the Supplier acknowledges that it has not relied on any representation on behalf of the Authority or the relevant User(s) as to any future business between the Supplier and the Authority or the relevant User(s) (except that nothing in this clause shall exclude the Authority s liability for fraudulent misrepresentations) and the Supplier warrants that neither the Authority nor any relevant User(s) is under any obligation to the Supplier in connection with the Equipment (save as expressly set out herein) or future orders therefore. 20. Each party, and its employees and agents, shall at all times keep confidential and secret and shall not (without the prior written consent of the disclosing party) disclose to any person any information or other matters acquired by the receiving party in connection with this Deed save where required to comply with the requirements of any regulatory or other competent authority or as otherwise required by law. 21 Nothing in this Deed is intended to confer on any person any right to enforce any term of this Deed which that person would not have had but for the Contracts (Rights of Third Parties) Act The parties acknowledge that the provisions of this Clause 21 shall not affect any right or remedy which exists or is available, whether express or implied, apart from the Contracts (Rights of Third Parties) Act Page 18 of 32

19 EXECUTED AND DELIVERED AS A DEED BY AND ON BEHALF OF: - Name of NHS Trust/ NHS Foundation Trust/ Health Authority:- [ ] acting by: Name: Position: Signature: EXECUTED AND DELIVERED AS A DEED BY, FOR AND ON BEHALF OF: - Supplier Name: acting by: 1 st Signatory Name: Position: Director/Company Secretary** Signature: 2 nd Signatory Name: Position: Director/Company Secretary** Signature: ** Delete as appropriate Page 19 of 32

20 Form of Indemnity B Reference Number [ ] Free issues A DEED made the day of _ BETWEEN: EITHER* NHS Trust/NHS Foundation Trust/Health Authority*. ( the Authority ); OR NHS Purchasing and Supply Agency ( PASA ); AND Supplier... ( the Supplier ). WHEREAS The Supplier is the owner of goods (the "Goods") and wishes to transfer the legal and equitable title in the Goods to the Authority or to NHS Trusts, NHS Foundation Trusts and Health Authorities in accordance with the terms of this Deed. The Goods shall be specified in a NHS Delivery Note completed by the parties at the time of the transfer. For the avoidance of doubt, there shall be no limit on the number of NHS Delivery Notes which may be completed by the parties pursuant to this Deed. IT IS HEREBY AGREED that the Supplier shall transfer the legal and equitable title in the Goods to the Authority or the relevant User(s) free of charge on the terms set out below: 1. Sections 12 to 15 of the Sale of Goods Act 1979 (as amended) are to be implied into this Deed. 2. Clause 16 (Limitation of liability) and Clause 17 (Insurance) of the NHS Conditions of Contract for the Purchase of Goods (March 2004 edition) shall be incorporated into this Deed. *Delete as appropriate Page 20 of 32

21 EXECUTED AND DELIVERED AS A DEED BY AND ON BEHALF OF: - Name of NHS Trust/ NHS Foundation Trust/ Health Authority:- [ ] OR NHS Purchasing and Supply Agency * acting by: Name: Position: Signature: EXECUTED AND DELIVERED AS A DEED BY, FOR AND ON BEHALF OF: - Supplier Name: acting by: 1 st Signatory Name: Position: Director/Company Secretary** Signature: 2 nd Signatory Name: Position: Director/Company Secretary** Signature: *Delete as appropriate (the form should be executed by the Authority OR by NHS PASA see Guidance Notes) ** Delete as appropriate Page 21 of 32

22 NHS Delivery Note Date day of 20 Supplier Form of Indemnity Reference Number Authority ("Premises") This NHS Delivery Note is supplementary to the NHS Form of Indemnity with the reference number shown above. Model/make Serial Number Value Description Purpose Form of Indemnity A The Supplier wishes to make the Equipment detailed above available to the Authority for the following period of time:- Period [ ] years and [ ] months commencing on [ ] day of [ ] 20[ ] The trial/testing to be undertaken by the Authority (if any) The Authority acknowledges receipt of the Equipment detailed above on the terms of the Form of Indemnity detailed above and this NHS Delivery Note:- SIGNED on behalf of the Authority The Supplier hereby loans the Equipment detailed above to the Authority on the terms of the Form of Indemnity detailed above and this NHS Delivery Note:- SIGNED on behalf of the Supplier Form of Indemnity B The Authority hereby receives the Goods detailed above from the Supplier on the terms of the Form of Indemnity detailed above and this NHS Delivery Note:- SIGNED on behalf of the Authority The Supplier hereby transfers the legal and equitable title to the Goods detailed above to the Authority as from the date hereof on the terms of the Form of Indemnity detailed above and this NHS Delivery Note:- SIGNED on behalf of the Supplier Page 22 of 32

23 GUIDANCE NOTES FOR STAFF FOR NHS FORMS OF INDEMNITY AND NHS DELIVERY NOTES Part A Forms and Delivery Notes 1. The Forms of Indemnity provide protection to a trust when the trust is in receipt of equipment or goods from a supplier in cases where the equipment is being loaned to the trust or where the ownership of goods is being transferred free of charge to the trust. The Forms seek to achieve this by placing on the supplier the financial risk arising from certain types of damage to the equipment/goods or to people or property on the supplier. However the trust will remain liable for the cost of repairing accidental damage (except where caused by the Supplier). 2. NHS Form of Indemnity A ("Form A") is to be used for equipment on loan from a supplier to a trust. Only one Form A needs to be executed by a supplier. 3. NHS Form of Indemnity B ("Form B") is to be used for goods in which the legal rights of ownership are to be transferred by the supplier to the trust (namely, when the trust is the beneficiary of a gift from a supplier). Only one Form B needs to be executed by a supplier. 4. Before executing Form A or B, it is advisable that proof of the Supplier s public and product liability insurance is seen. The indemnity insurance must be in the name of whoever signs Form A or B. This will usually be the Supplier. Alternatively, where a Supplier is acting as an agent for a manufacturer, and the manufacturer has signed Form A or B, the indemnity insurance must be in the name of the manufacturer. On expiry of the insurance, proof of renewal should be obtained from the Supplier (or manufacturer, where the Supplier is acting as an agent). 5. Form A states that the loan of the equipment shall not be deemed to be a contract for the hire of goods as per the Supply of Goods and Services Act As the Sale of Goods Act 1979 (as amended) does not automatically apply to Form B (because the trust is not paying for the goods of which it is likely to become the owner), certain parts of it have been incorporated. 7. Forms A and B are to be executed as deeds to avoid the supplier's undertakings not being enforceable because of a lack of consideration (that is, a promise given by the trust, which prevents the supplier's promises from being purely gratuitous). 8. An NHS Delivery Note or where the Deed acts as a master indemnity agreement for all loans made by the Supplier, a Suppliers standard delivery note must be completed and signed by the Supplier and the Authority or the user of the equipment, at the outset of the loan. 9. The NHS Delivery Note contains different sections for completion according to whether the Delivery Note is being used in conjunction with Form A or Form B. In either case, i.e. use of Form A or B the reference number given to the Form of Indemnity must be recorded on the Delivery Note, or Suppliers standard delivery note whichever is used, so that it is clear which goods or items of equipment relate to which Form of Indemnity. Page 23 of 32

24 10. The NHS Delivery Note, or Suppliers standard delivery note, must record the details of the equipment including model/make, serial number, value, description and location. If appropriate, diagrams should accompany the Delivery Note or Suppliers standard delivery note, whichever is used. It should also state the intended purpose of the equipment, as the supplier is warranting that the equipment is fit for this stated purpose. For Form A the period of the loan should also be specified on the Delivery Note, or Suppliers standard delivery note whichever is used, and trusts should ensure that they amend the expiry date should the original loan be extended. 11. Provided that the transaction is one entered into at trust level, each Form of Indemnity and NHS Delivery Note, or Suppliers standard delivery note whichever is used, once entered into, should be retained by the trust. 12. If in doubt about any aspect of the Forms of Indemnity or the NHS Delivery Note, or Suppliers standard delivery note whichever is used, you should contact PASA s purchasing helpdesk in the first instance. 13. If for any reason the equipment remains on the premises after the period of loan (covered by the indemnity) has expired, then it remains at the Suppliers risk, and the Supplier should be informed accordingly, making it clear that the Authority accepts no liability for any equipment remaining on its premises after the period of loan has expired. (Ideally, the Supplier should be so informed when making the arrangements for the equipment to be collected, prior to the end of the applicable loan term.) In the absence of any agreement replacing that applicable during the term of the loan, all efforts should be made to have the equipment removed as soon as the term ends. Part B Completing the forms 14. Instructions 14.1 On the indemnity forms A and B on the first page, the company's name will need to be completed. Please leave the space for the date blank Two signatures by the supplier s director(s)/company secretary are required at the back of each form in the second block of signatures. The upper block is used for endorsement of the agreement by appropriate trust signatories (whichever is applicable) Forms A and B bearing original signatures should be passed (normally by post) to the trust Proof of insurance for both public and product liability will also be required, showing a minimum of 5,000,000 cover for each Once the agreement has been checked, and signed by both parties, a copy will be posted to the supplier for retention. Page 24 of 32

25 APPENDIX B Equipment Evaluation Form Guidance Notes for Completion of Equipment Evaluation Form Page 25 of 32

26 Equipment Evaluation See Guidance Notes Prior to Undertaking the Equipment Evaluation Process If the equipment to be evaluated is listed in the latest Best Buy Guide, state reason why such evaluation is being undertaken. Use a separate equipment evaluation form for each different piece of equipment. Type of equipment Has the Equipment on Loan Policy been followed? Yes/No (if No do not continue, but refer to Policy Document). Area(s) in which the evaluation took place: Name(s) of staff who undertook the evaluation exercise: State date of evaluation exercise:. Finish date of evaluation exercise: Reason(s) for undertaking evaluation: Comments on equipment performance: Please continue on additional sheet if necessary. Attach to this form the clinical evaluation criteria and ranked score for this piece of equipment and forward all documents to the Supplies Manager. Signed:.. Date:.. Designation/Grade: Print Name:.... Tel No.:... Ext No: Advice and assistance is always available from Medical Technical Services Manager and/or General Manager Supplies & Procurement. Once completed please send this form to the General Manager Supplies & Procurement. Page 26 of 32

27 Guidance Notes for Completion of the Equipment Evaluation Form When evaluating equipment there are three main components to take into consideration:- Clinical Technical Financial The Clinical component should be undertaken by the staff group who would use the equipment, should acquisition take place. Prior to the evaluation, a criteria and ranking should be agreed against which the equipment will be scored. The evaluation criteria should be specific to the type of equipment being evaluated. The evaluation criteria should be divided into two categories ESSENTIAL and DESIRABLE, and be of a generic nature, i.e. the criteria should not be written around the specification of a particular (favoured) piece of equipment, since the criteria should be able to stand scrutiny by independent sources. The Technical component will relate to the maintenance aspects of such equipment and will be undertaken by the Medical Technical Services Department. The Financial component will be undertaken by the Supplies Department, with assistance provided by the Finance Department, the Medical Technical Services Department and the staff group requiring the equipment. The aim is that the WHOLE LIFE COST of the equipment is established. Whole Life Costs include Purchase price of equipment Depreciation costs over the life of the equipment Approx. cost of consumables over the expected life of the equipment Warranty period of equipment Cost of maintenance Cost of staff time, e.g. training, additional work Standardisation to existing equipment Note The lowest purchase price of the product does not necessarily mean the lowest whole life cost. Undertaking an Equipment Evaluation Process does not preclude the requirement of inviting quotation or tender offers. This requirement is part of the Trust Standing Orders and Financial Instructions, and in the case of expenditure exceeding 100,000, European law. Page 27 of 32

28 APPENDIX C Flow Chart of Procurement of Medical Equipment Page 28 of 32

29 MEDICAL EQUIPMENT PROCUREMENT FLOWCHART Equipment Requirement Identified Is the Purchase via the Best Buy Guide? No Yes Specification drawn up by users Yes Is Item a Replacement? Identify approved Funding Source Specification Verified by Estates/Medical Technical Services/Clinical Specialist No Is a Trial Required? Yes Pre-Purchase Questionnaire (PPQ) Obtained and Checked Manufacturer/ Supplier Sourced by Supplies Department No On Loan Trials Arranged. Evaluation Forms Completed Business Case Submission Prepared Revenue Consequences Costed Training Requirements Identified Business Case Presented to Medical Equipment Sub-Committee Order Placed with Reference to Condemnation Note Number Purchase Order Placed Yes Approved Delivery to Medical Technical Services/Estates for Acceptance Tests No Feedback Given TRAINING AND INTO SERVICE Page 29 of 32

30 APPENDIX D Loan Kit Request Form On Loan Check List Page 30 of 32

31 Patient Details Name: LOAN KIT REQUEST FORM ID Number: Surgeon Requesting Proposed Procedure: Are there any alternatives available as stock: (please tick) Yes No If yes why not suitable for use: Is this a new procedure within DRI: Yes No If yes is training required: Yes No The above is for the surgeon to complete in clinic Equipment Details Product Name: Supplier: Approx costing for procedure: Loan charge cost: Carriage Cost: Company rep contact details: The above is for the Secretary to complete and then bring to theatre Theatre Suggestions Does this qualify as bespoke: Yes No Are frames required: Yes No Is training required: Yes No Have HSDU been informed: Yes No Has this loan been requested before: Yes No If yes on how many occasions; Alternative Suggestions: The above is for Theatre Staff to complete and send to clinical lead AUTHORISED BY:.. Clinical Lead.... General Manager (Please send completed form to waiting list office/secretary who manages list. Once TCI date agreed send to theatres for processing) TCI DATE- Page 31 of 32

32 DONCASTER AND BASSETLAW HOSPITALS NHS FOUNDATION TRUST Medical Equipment On-Loan Check List Indemnity Ref Supplier Details Manufacturer/Supplier Contact telephone No. Contact name Equipment Details Description Specific Model Serial Number/s (where applicable) Loan Details Loan reason - Trial/testing Case/procedure specific Site.Ward/Department Loan co-ordinator.loan period Tick boxes as appropriate YES NO N/A Decontamination form Function and E.S.T. (Electrical Safety Tests) where applicable User instructions Contents Check List (where applicable) Decontamination instructions/training identified and agreed Relevant training identified and agreed Moving and handling identified (where applicable) Storage identified and agreed User calibration/maintenance identified and agreed (where applicable) Technical maintenance identified and agreed i.e. provided by the Supplier Site services identified (special requirements, where applicable) and agreed Consumables identified and agreed Signed for the Trust... Signed for the company Name The Loan Equipment scheduled above has been checked, verified as complete and removed from the Trusts premises. Decontamination form attached Date. Date.. Signed.. (Supplier) Signed..(Trust) Page 32 of 32