managing loan medical devices procedure - … review date september 2013 lead executive stephen...

Managing Loan Medical Devices

Version 2 November 2010

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Managing Loan Medical Devices in Nottingham University Hospitals NHS Trust Procedure

Documentation Control

Reference

CL/CGP/051

Date Approved

19 November 2010

Approving Body

Directors’ Group

Implementation Date

19 November 2010

Version

2

Consultation Undertaken

MDEC and Sub Groups

Supersedes

NUH Version 1(December 2009)

Target Audience

All Staff

Supporting Procedure(s)

Refer to NUM Management of Medical Equipment and Devices Policy

Review Date

September 2013

Lead Executive

Stephen Fowlie

Author/Lead Manager

Dan Clark

Further Guidance/Information

Medical Devices Executive Committee



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CONTENTS

Paragraph Title Page

1

Trust Staff Responsibilities 3

2

Medical Devices on Loan TO the Trust – from Manufacturer or Supplier

3

3

Medical Devices on Loan TO the Trust – from another trust, healthcare provider or other third part (for example a University)

4

4

Medical Devices on Loan TO the Trust from as part of a research study or trial

4

5 Medical Devices loaned BY the Trust to another Trust or Healthcare Organisation

5

6

Medical devices loaned BY one NUH department to another NUH department.

5

7

Medical devices loaned BY the Trust to a patient, relative, carer or other end user

6

8 Equality and Diversity 7

9 We Are Here For You Mission Statement 7

Appendix A

Indemnity forms A and B 8

Appendix B

Delivery Note 19

Appendix C

PPQ 21

Appendix D

Equipment Library Portfolio (or link to website)

23

Appendix E

Reusable Medical Equipment Loan Certificate

24

Appendix F

End User Agreement 26

Appendix G

Equality Impact Assessment 27

Appendix H

Employee Record of Having Read the Procedure

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Medical Devices Training Procedure Version 2 March 2008

1. Trust Staff Responsibilities

1.1 When devices or equipment are loaned by the Trust, the procedures outlined below must be followed to ensure that the Trust discharges its duty of care to the device users, the patients, carers and other users.

1.2 When devices or equipment are loaned to the Trust (from whatsoever

source) this loan procedure must be followed to ensure that:

the device is safe and fit for purpose before it goes into clinical use;

the device is appropriately managed as set out in MDA SN 2002(17) and MDA SN 2000(18);

the Trust is indemnified against any claims for injury resulting from its use

1.3 Trust Staff agreeing to the loan of devices or equipment may find

themselves personally liable for losses if they do not follow these procedures.

2. Medical Devices on Loan TO the Trust – from Manufacturer or

Supplier 2.1 Trust staff arranging the loan of medical device to the Trust must ensure

that the supplier has a Master Indemnity Agreement (MIA) with NHS Supplies or completes an Indemnity Form specific to that device. In the latter case, the supplier must complete either Indemnity Form A (Equipment for trial or testing) or Form B (Equipment for other purposes) before the devices made available for use. Surgical Instrument sets on loan must fully conform to MDA SN 2000(18) and in line with MDA SN 2002(17).

2.2 Copies of forms A and B are included in Appendix A. Suppliers with an

MIA need only sign a delivery note of the form shown in Appendix B when providing goods. A list of supplies with MIA is maintained on the Department of Health (DoH) website.

2.3 Trust staff arranging a device loan must also ask the supplier to provide

a completed PPQ form (Appendix C) as evidence that the device meets the essential requirements of the Medical relevant Devices Directive. All medical equipment should be tested for functionality and safety by Clinical Engineering (or a delegated agent under the supervision of Clinical Engineering) upon arrival on site. Trust staff arranging a device loan must make advance arrangements with Clinical Engineering to facilitate this testing. PPQ forms will be inspected and indemnity forms



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and delivery notes completed and retained by the Clinical Engineers for equipment tested. The level and frequency of ongoing maintenance needs to be determined together with clear statement of who is responsible for this maintenance. Arrangements must be in place to ensure that at the end of the loan period, the device is removed from service or additional indemnities provided.

2.4 The device(s) must be either sterilised or decontaminated according to

Trust policy and a decontamination certificate must accompany the equipment. The device(s) must be securely packaged and checklists with manufacturer’s instructions for use and decontamination must be included with the device(s)

3. Medical Devices on Loan TO the Trust – from another trust,

healthcare provider or other third part (for example a University) 3.1 Medical devices loaned to the Trust by another Trust or Healthcare

organisation or any other third party must also be tested and recorded by the Clinical Engineers before being put in clinical use. Where the third party organisation cannot provide full indemnity cover or any other element of the acceptance procedures above, the device can only be accepted into clinical practice with the approval of the Medical Devices and Equipment Committee (MDEC). See procedure for allowing non-compliant medical devices into clinical practice.

3.2 Devices arriving from another Trust with a patient as part of a clinical

transfer must be replaced by Trust devices as soon as possible to avoid risks arising from its unknown state of repair or unfamiliarity to staff. The original device must be returned to the other Trust as soon as possible.

4 Medical Devices on Loan TO the Trust from as part of a research

study or trial. 4.1 Devices on loan to Nottingham University Hospital as part of a research

project or clinical trial must only be used as part of a research study approved by the Research and Development Department. Suitable ethics approval may also be required as determined by the Research and Development Department.

4.2 All devices brought into NUH as part of such an approved study must

also be tested for functionality and safety by Clinical Engineering (or a delegated agent under the supervision of Clinical Engineering) upon arrival on site. Trust staff arranging a device loan under such a research study must make advance arrangements with Clinical Engineering to facilitate this testing. The level and frequency of ongoing maintenance needs to be determined together with clear



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statement of who is responsible for this maintenance. Arrangements must be in place to ensure that at the end of the study period, the device is removed from service.

4.3 Where the loan is provided to the Trust pursuant to a commercially

sponsored clinical trial a fully executed Clinical Trial Agreement (between the Trust and Sponsor will ensure that indemnity is provided to the Trust to a value of not less than £5 million. . The R&D Department is responsible for ensuring such an agreement is in place. Further advice is available from the R&D Department.

4.4 Where such an agreement (as under 4.3 above) is not in place or where

the loan is from a third party organisation who cannot provide full indemnity cover or any other element of the acceptance procedures above, then the device can only be accepted into clinical practice with the approval of the Medical Devices and Equipment Committee (MDEC) or the Director of Research and Development. See Procedure for Allowing Non-compliant Medical Devices into Clinical Practice.

5 Medical Devices loaned BY the Trust to another Trust or Healthcare

Organisation 5.1 Nottingham University Hospital does not loan medical equipment to

other hospitals, either NHS or private sector. 5.2 The only exception to 5.1 is where Nottingham University Hospital has a

contract or contracts to supply services that are externally accredited to appropriate quality standards. MDEC can advise on what constitutes appropriate quality standards.

6. Medical devices loaned BY one NUH department to another NUH

department.

6.1 The Trust operates an Equipment Library. The portfolio of services provided and operating policy of the Library are included in Appendix D. Wherever possible, loans between clinical departments should be facilitated by the Equipment Library. Staff in the receiving department, training lead staff must ensure competence and not allow devices into their area without documentation.

7. Medical devices loaned BY the Trust to a patient, relative, carer or

other end user 7.1 Trust staff arranging the loan of devices to a patient, relative, carer or

other end user should ensure that they understand the intended use and normal functioning of the device in order to use it effectively and safely.



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Where relevant, training should cover:

Any limitation on use How to fit accessories and be aware of how they may increase

or limit the use of the device How to use any controls appropriately The meaning of displays, indicators, alarms etc and how to

respond to them Requirements for maintenance and decontamination, including

cleaning How to recognise when the device is not working properly and

what to do about it Understand the know pitfalls in the use of the device, including

those identified in safety advice from the MHRA, manufacturers and other relevant bodies

Understand how to report any problems and incidents. 7.2 Trust staff must also ensure that they provide clear written instructions

on the use of the device. These would normally be as supplied by the device manufacturer. Where these instructions are prepared by NUH staff, they should seek advice from the original manufacturer before issuing to patient, relative, carer or other end user. The patient, relative, carer or end user must be instructed to stop using the device and arrange for its return to the hospital if they suspect a malfunction as well as clear instructions as to how to return the device after use.

7.3 The ‘Agreement form for patient use of a medical device(s) when

leaving hospital (End user Agreement)’ (Appendix F) must be completed and signed by the patient/carer and retained in the patient’s notes as evidence that the above training has been given.

7.4 Additional handover documentation must be maintained by the clinical

team issuing or prescribing the device as a record of the issue of the device. An example handover form is included in Appendix E.



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8 Equality and Diversity Statement All patients, employees and members of the public should be treated fairly

and with respect, regardless of age, disability, gender, marital status, membership or non-membership of a trade union, race, religion, domestic circumstances, sexual orientation, ethnic or national origin, social & employment status, HIV status, or gender re-assignment.

9 We Are Here For You Mission Statement

This Trust is committed to providing the highest quality of care to our patients, so we can pledge to them that ‘we are here for you’. This Trust supports a patient centred culture of continuous improvement delivered by our staff. The Trust established the Values and Behaviours programme to enable Nottingham University Hospitals to continue to improve patient safety, outcomes and experiences. The set of twelve agreed values and behaviours explicitly describe to employees the required way of working and behaving, both to patients and each other, which would enable patients to have clear expectations as to their experience of our services.



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Appendix A

NHS Form of Indemnity – A Reference Number [ ] Equipment on loan A DEED made the ……………day of ……………………….. ……..………...201_ BETWEEN: EITHER* NHS Trust/NHS Foundation Trust/Health Authority* …………………………………………………………………………………………… (“the Authority”); OR The Secretary of State for Health (“the Department”); 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 or through the Department to NHS Trusts, 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 an NHS delivery note 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



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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 1982. 2.- Title to the Equipment shall remain for all purposes fully vested in the

Supplier. * Delete as appropriate 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

5.2 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.



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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:

(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;



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(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

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 7. 8.- 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 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)



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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 1999. 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 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



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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 16.

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.

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



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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 1999. 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 1999.



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EXECUTED AND DELIVERED AS A DEED BY AND ON BEHALF OF: -

Name of NHS Trust/ NHS Foundation Trust/ Health Authority:-

[ ]

OR The Secretary of State for Health *

acting by:

Name:

Position:

Signature:

EXECUTED AND DELIVERED AS A DEED BY, FOR AND ON BEHALF OF: -

Supplier Name:

acting by:

1st Signatory

Name:

Position: Director/Company Secretary**

Signature:

2nd Signatory

Name:


Signature:



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*Delete as appropriate (the form should be executed by the Authority OR by The Department – see Guidance Notes) ** Delete as appropriate Form of Indemnity – B Reference Number [ ] Free issues A DEED made the ……………day of ……………………….. ……..………...201_ BETWEEN:

EITHER*

NHS Trust/NHS Foundation Trust/Health Authority* ………………………………………………………………………………… (“the Authority”);

OR

The Secretary of State for Health (“the Department”);;

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 or to NHS Trusts, NHS Foundation Trusts, Health Authorities and other users agreed with the Department 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.



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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 (July 2007 edition) shall be incorporated into this Deed.

*Delete as appropriate

EXECUTED AND DELIVERED AS A DEED BY AND ON BEHALF OF: -

Name of NHS Trust/ NHS Foundation Trust/ Health Authority:-

[

]

OR The Secretary of State for Health *

acting by:

Name:

Position:

Signature:

EXECUTED AND DELIVERED AS A DEED BY, FOR AND ON BEHALF OF: -

Supplier Name:

acting by:

1st Signatory

Name:



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Signature:

2nd Signatory

Name:


Signature:

*Delete as appropriate (the form should be executed by the Authority OR by Secretary of State for Health – see Guidance Notes) ** Delete as appropriate



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Appendix B

NHS Delivery Note

Date ______________________ day of _________________________ 200_____ Supplier ____________________________________________________________ Form of Indemnity Reference Number _____________________________________ Authority _________________________________________________ This NHS Delivery Note specifies the Equipment provided under the NHS Form of Indemnity with the reference number shown above.

Model/make _________________________________________________

Serial Number _______________________________________________

Value ______________________________________________________

Description __________________________________________________

Purpose _____________________________________________________

Form of Indemnity A

Period of loan:

[ ] years and [ ] months commencing on [ ] day of [ ] 200[ ]

The trial/testing to be undertaken by the Authority (if any) _____________

___________________________________________________________

Premises at which the Equipment will be kept:

_____________________________________________________________

_____________________________________________________________



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The Authority acknowledges receipt of the Equipment detailed above on the terms of the Form of Indemnity detailed above:

SIGNED on behalf of the Authority _______________________________

The Supplier confirms delivery of the Equipment detailed above to the Authority for loan on the terms of the Form of Indemnity detailed above:-

SIGNED on behalf of the Supplier ________________________________

Form of Indemnity B

The Authority acknowledges receipt of the Goods detailed above from the Supplier on the terms of the Form of Indemnity detailed above:-

SIGNED on behalf of the Authority ________________________________

The Supplier confirms delivery of the Goods detailed above and transfer of the legal and equitable title to those Goods to the Authority as from the date hereof on the terms of the Form of Indemnity detailed above:-

SIGNED on behalf of the Supplier ________________________________

----------------------------------------------------------------------------------------------------------------- Form of Indemnity A – collection at the end of the loan period The Authority confirms collection by the Supplier of the Equipment detailed above: SIGNED on behalf of the Authority ________________________________ The Supplier acknowledges receipt of the Equipment detailed above: SIGNED on behalf of the Supplier ________________________________ DATE: ________________________________________



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Appendix B



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Appendix C Equipment Library Portfolio

NUH link: http://nuhnet/diagnostics_clinical_support/clinical_engineering/Pages/default.aspx

http://nuhnet/diagnostics_clinical_support/clinical_engineering/Pages/default.aspx



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Appendix D

Reusable Medical Equipment Loan Certificate

The medical equipment identified within this Loan Certificate is the property of Nottingham University Hospitals NHS Trust. As part of the clinical treatment the Trust has agreed to temporarily loan the listed medical equipment to the patient residing at the following address indicated, for a limited period as recorded in section a) and b). The loan is subject to the following terms and conditions, that the medical equipment is;

Provided for the use of the named prescribed patient only Used for the treatment as explained by the Issue Ward /Dept

Used as instructed (verbal and written end user instructions given and

completion of End User Agreement Form) Returned to the issuing ward/department due to end of loan or for

essential scheduled maintenance by ………/……../…… or prior if treatment is stopped or suspended (replacement equipment will be provided where necessary during maintenance activity)

Kept secure, used and transported with reasonable care

If you have any concerns with the use of this equipment please contact the issuing Ward/Department detailed in section C below.



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Appendix E

a) Medical Equipment Details

Description…………………………………………………………………. Model………………………………………..Asset No…………………… Accessories………………………………………………………………… b) Patient Details

Title…………..Name……………………………………………………….. Address……………………………………………………………………... Post Code…………………………………….Tel. No…………………….

c) Patient/Parent/Carer Declaration

I agree to the above loan terms and conditions and confirm I have understood the end user training (together with written instructions) to enable correct use of the above equipment.

I will advise the issuing ward/department of any change of address as may occur during the loan period.

Patient/Parent/Carers Signature…………………… Date……/……./……

Patient/Parent/Carers Name (please print)………………………………… Issue Ward/Dept…………………………………………………Site……….. Issuing Officer (please print)…………………….Tel. No……………………

d) End of Loan (to be completed upon return of the loan equipment) I confirm the above medical equipment was returned on the ……/……./… Issuing Ward/Depart/Officer…………………………………………………… Patient/Parent/Carer…………………………………………………………….

Affix Patient label here

Patient name………………………..

Hospital No. ………………………..

Date of birth………………………….



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This information can be provided in different languages and formats. For more information please contact Clinical Engineering on ext 61101.

Appendix F

Agreement form for patient use of a medical device(s) when leaving hospital

(End User Agreement) Name(s) of medical device(s): ……………………………………………………………………………………………………………………………………………………………………………………………… ……………………………………………………………………………………………… I have explained the use of the medical device(s) to the patient

and/or their carer: I have explained the intended benefits/reasons of the medical device(s):

I have explained the potential problems of the medical device(s):

I have explained how to get further advice: Statement of patient/carer I understand how this/these medical device(s) work and their intended purpose is: Signature……………………………………..Print Name……………………………..…. Date …………………….....Relationship to patient (if applicable)…………………….. I have confirmed that the patient/carer has no further questions regarding the use of this/these medical device(s) Signature……………………………………..Print Name…………………………..….. Date ………………………………………… Contact Number……………………….... Job Title……………………………………..

Affix Patient label here

Patient name………………………..

Hospital No. ………………………..

Date of birth………………………….



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Appendix G Equality Impact Assessment Report Outline Remember that your EIA report should demonstrate what you do (or will do) to make sure that your service/policy is accessible to different people and communities, not just that it can, in theory, be used by anyone. A one size fits all approach can often inadvertently exclude. 1. Name of Policy or Service Procedure for Managing Loan Medical Devices 2. Responsible Manager

Dan Clark 3. Name of person Completing EIA

Amanda Pottinger

4. Date EIA Completed September 2010

5. Description and Aims of Policy/Service (including relevance to equalities)

Medical devices are widely used in the Nottingham University Hospitals NHS Trust for diagnosis, monitoring and treatment. The over-arching ‘Management of Medical Equipment and Devices Policy’ aims to ensure that the benefits to patients from the use of medical devices are maximised and risks minimised. To achieve this it is essential that loan devices meet relevant safety and quality standards.

6. Brief Summary of Research and Relevant Data

MHRA DB2006 (05) Managing Medical Devices Guidance for healthcare and social services organisations November 2006 Care Quality Commission National Health Service Litigation Authority Department of Health



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7. Methods and Outcome of Consultation

Consultations have been carried out with the following: Medical Devices and Equipment Committee Product Standardisation Group Estates Procurement Comments from the above consultations have been received and incorporated where appropriate

8. Results of Initial Screening or Full Equality Impact Assessment:

Equality Group Assessment of Impact

Age None

Gender None

Race None

Sexual Orientation None

Religion or belief None

Disability None

Dignity and Human Rights

None

Working Patterns None

Social Deprivation None

9. Decisions and/or Recommendations (including supporting rationale) Following initial screening no impact has been identified therefore a full

Impact Assessment is not required. This procedure sets out the steps necessary for staff to take to ensure all

medical devices used within NUH are loaned and acquired to support the policy aim.

10. Equality Action Plan (if required) N/A 11. Monitoring and Review Arrangements (including date of next full review) Recommend that this policy and EIA be reviewed 3 years in order to

assess its functionality. An earlier review date may be implemented if any patient safety issues are raised or changes to regulations are identified.



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Appendix H Title of Policy/Procedure:

Managing Loan Medical Devices in

Nottingham University Hospitals NHS Trust Procedure

I have read and understand the principles contained in the named policy.

PRINT FULL NAME

SIGNATURE

DATE

managing loan medical devices procedure - … review date september 2013 lead executive stephen...

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