MEDICAL DEVICES MANAGEMENT POLICY

Policy Details NHFT document reference Version Date Ratified Ratified by Implementation Date Responsible Director Review Date Related Policies & other documents

Freedom of Information category

CLP009 Review v4 02/09/2014 Trust Policy Board 02/09/2014 Chief Operating Officer 02/09/2016 CRM002 – Incident Policy, HSC002 Policy and Guidance on the Use of Risk Registers HSC009 Policy on the reporting of Injury, Diseases and Dangerous Occurrences, HSC011 - Guidelines for the safe use of electric patients lifting hoists, HSC017 Provision and Use of Work Equipment Policy, HSC022 - Policy for the Prevention and management of Latex Allergy, HSC025 - Central Alert System (CAS) Policy, ICP003 - Infection Control Cleaning and Disinfection Guidelines Policy

The current version of any policy, procedure, protocol or guideline is the version held on the NHFT internet. It is the responsibility of all staff to ensure that they are following the current version Medical Devices Management Policy

1 of 44

Implementation Date: 02.09.2014

TABLE OF CONTENTS 1.

DOCUMENT CONTROL SUMMARY ...................................................... 4

2.

INTRODUCTION ..................................................................................... 5

3.

PURPOSE ............................................................................................... 5

4.

DEFINITIONS .......................................................................................... 5

5.

DUTIES .................................................................................................... 6 5.1. 5.2. 5.3. 5.4. 5.5. 5.6.

Chief Executive ............................................................................... 6 Director of Nursing and Quality ....................................................... 6 Infection Prevention Team .............................................................. 7 Head of Property Services .............................................................. 7 Medical Device Safety Officer ......................................................... 7 Heads of Service, Senior Departmental Managers, or their nominated representatives .............................................................. 7 5.7. All staff involved in the use of medical devices ............................... 7 5.8. All staff ............................................................................................ 8 5.9. The Purchasing Department ........................................................... 8 5.10. Medical Devices Policy ................................................................... 8 6.

POLICY PROCESS ................................................................................. 9 6.1. One-off Purchase of Medical Devices ............................................. 9 6.2. Medical Device Alerts...................................................................... 9 6.2.1. Recipients of Medical Device Alerts ................................... 9 6.2.2. Dissemination Procedure for Central Alerting System Alerts ........................................................................................... 9 6.2.3. NHS Estates Safety Alerts and Hazard Notices. .............. 11 6.2.4. NHS England Patient Safety Alerts .................................. 11 6.2.5. Department of Health Guidance Documents .................... 11 6.2.6. Follow Up Procedure ........................................................ 11 6.3. New Medical Devices .................................................................... 12 6.3.1. Purchasing of Medical Devices ........................................ 12 6.3.2. Acceptance Procedures and Storage ............................... 12 6.3.3. Storage Systems .............................................................. 13 6.3.4. Deployment, Monitoring and Control ................................ 14 6.3.5. Loan of Medical Devices for Evaluation (Trials) ............... 14 6.3.6. Maintenance and Repair .................................................. 15 6.3.7. Maintenance Requirements/ Service Instructors for Medical Devices............................................................................. 17 6.4. Disposal of Medical Devices ......................................................... 17 6.5. Incidents and Near Misses ............................................................ 18 6.6. Security/ Prevention or Future Use of Medical Devices ................ 18 6.7. Decontamination of Medical Devices etc. ..................................... 19 6.8. Medicinal Products ........................................................................ 19

The current version of any policy, procedure, protocol or guideline is the version held on the NHFT internet. It is the responsibility of all staff to ensure that they are following the current version Medical Devices Management Policy

2 of 44

Implementation Date: 02.09.2014

7.

TRAINING ............................................................................................. 19 7.1. Mandatory Training ....................................................................... 19 7.2. Specific Training not covered by Mandatory Training ................... 19

8.

MONITORING COMPLIANCE WITH THIS DOCUMENT ...................... 21

9.

REFERENCES AND BIBLIOGRAPHY ................................................. 21

10. RELATED TRUST POLICY ................................................................... 22 APPENDIX 1 - EXAMPLES OF MEDICAL DEVICES ................................... 23 APPENDIX 2 - EXAMPLES OF NON-MEDICAL DEVICES, ENGINEERING PLANT, INSTALLED SERVICES, BUILDINGS AND BUILDING COMPONENTS ..................................................................................... 24 APPENDIX 3 - EQUIPMENT FAULT REPORTING PROCEDURE APPENDIX 4 - TRAINING NEEDS FOR MEDICAL DEVICES ..................... 25 APPENDIX 5 - DECONTAMINATION OF RE-USABLE MEDICAL DEVICES FOR REPAIR, MAINTENANCE OR INSPECTIONAPPENDIX 6 DECONTAMINATION CERTIFICATE .................................................. 27 APPENDIX 6 - DECONTAMINATION CERTIFICATE .................................. 28 APPENDIX 7 - MEDICAL DEVICES PROCUREMENT FLOWCHART ........ 29 APPENDIX 8 - FORM OF INDEMNITY ......................................................... 30 APPENDIX 9 - NHS FORM OF INDEMNITY– A ........................................... 31 APPENDIX 10 - FORM OF INDEMNITY – B ................................................. 38 APPENDIX 11 - INDEMNITY PROCESS ...................................................... 40 APPENDIX 12 - CENTRAL ALERTING SYSTEM ........................................ 41 APPENDIX 13 - MEDICAL DEVICES GROUP - TERMS OF REFERENCE.. APPENDIX 14 – NHFT EQUALITY ANALYSIS TOOL ................................. 42

The current version of any policy, procedure, protocol or guideline is the version held on the NHFT internet. It is the responsibility of all staff to ensure that they are following the current version Medical Devices Management Policy

3 of 44

Implementation Date: 02.09.2014

1. DOCUMENT CONTROL SUMMARY

Document Title

Medical Devices Management Policy

Document Purpose (executive brief)

To help healthcare professionals to understand their role in the safe use, purchase, maintenance, decontamination and disposal of medical devices

Status: - New / Update/ Review Areas affected by the policy

Update All areas

Policy originators / authors

Andrew McLester – Head of Property Services Medical Devices Group, Risk Management, Estates, Health & Safety Risk Manager, Infection Control

Consultation and Communication with Stakeholders including public and patient group involvement Archiving Arrangements and register of documents Equality Analysis

The Trust Policy Lead is responsible for the archiving of this policy and will hold archived copies on a central register See Appendix 13

(including Mental Capacity Act 2007)

Training Needs Analysis

See section 7

Monitoring Compliance and See section 8 Effectiveness Meets national criteria with regard to NHSLA 5.4 & 5.5 NICE N/A NSF N/A Mental Health Act N/A CQC N/A Other N/A Further comments to be None considered at the time of ratification for this policy (i.e. national policy, commissioning requirements, legislation)

If this policy requires Trust Board ratification please provide specific details of requirements

TPB ratified

The current version of any policy, procedure, protocol or guideline is the version held on the NHFT internet. It is the responsibility of all staff to ensure that they are following the current version Medical Devices Management Policy

4 of 44

Implementation Date: 02.09.2014

2. INTRODUCTION This policy sets out to establish a framework for the management of medical devices owned and utilised by staff working for and on behalf of NHFT. It also sets out, in detail, the role of NHFT services and its relationship with the MHRA and the procedure to be adopted in the event of an adverse or potentially adverse incident involving a medical device. Medical devices used by staff and patients must be:  Procured in line with the organisations procurement procedures as outlined in Appendix 7 and in line with the Trusts Purchasing Policy for the provision of Goods and Non-Clinical Services;  Recorded on the organisations central medical device database as part of the procurement process;  Suitable for (and only used for) its intended purpose and in accordance with British statutory standards;  Properly understood by users and that staff and patients are appropriately trained and competent;  Maintained on an annual basis or in accordance with the manufacturers guidance. The device should always be kept in a safe and reliable condition;  Decontaminated in accordance with the organisations decontamination policy;  Decommissioned in accordance with the organisations decommissioning policy and / or manufacturers guidance. In order to mitigate incidents involving medical devices and minimising any recurrence after an initial incident has been recorded, the MHRA collates information on all relevant adverse incidents, and as a result issues MDAs about hazardous medical devices; associated procedures of which are outlined in the organisations Incident Reporting Policy. 3. PURPOSE This policy aims to ensure that all Medical Devices in use within NHFT are suitable for (and only used for) its intended purpose, staff are properly trained and competent in their use, devices are maintained in a safe and reliable condition and they are recorded on a central data base. 4. DEFINITIONS MDA - Medical Device Alerts MHRA - Medicines and Healthcare Products Regulatory Agency NHFT - Northamptonshire Healthcare NHS Foundation Trust MDSO - Medical Device Safety Officer The current version of any policy, procedure, protocol or guideline is the version held on the NHFT internet. It is the responsibility of all staff to ensure that they are following the current version Medical Devices Management Policy

5 of 44

Implementation Date: 02.09.2014

The term ‘medical device’ covers a wide range of products used every day in health care settings, hospital and care units, residential and nursing homes. For the purpose of this policy the term ‘medical device’ includes any instrument, apparatus, appliance, material or health care product (excluding pharmaceuticals) used by a member of staff on a patient or by a patient, and/ or carer for:  The diagnosis, prevention, monitoring, treatment or alleviation of disease;  The diagnosis, monitoring, treatment or alleviation of or compensation for an injury or impairment;  Custom made appliances used in therapies and dental services; A non-exhaustive list of the medical devices used within the trust is included as Appendix 1 and 2, which also identifies the main services involved in the use of medical devices. Diagnostic Equipment is used to aid a diagnosis and can include such items as medical imaging machines Therapeutic Equipment is used for the delivery of patient care and treatment Single Use - All single use items are clearly marked ‘single use only’, and by law must only be used once. Reusable Equipment is equipment designed to be used more than once, appropriately decontaminated between patient usage Single Patient Use - All items marked by the manufacturer as single patient use must only be used by a single named patient. All the manufacturers’ usage guidelines must be adhered to. Decontamination - Decontamination is a combination of processes, which removes or destroys contamination and thereby prevents microorganisms or other contaminants reaching a susceptible site in sufficient quantities to initiate infection or any other harmful response. This is achieved by cleaning, disinfection and/ or sterilisation. 5. DUTIES 5.1. Chief Executive Has overall accountability with the organisation for the management of medical devices. 5.2. Director of Nursing and Quality Is the nominated Director accountable for management of medical devices issues.

The current version of any policy, procedure, protocol or guideline is the version held on the NHFT internet. It is the responsibility of all staff to ensure that they are following the current version Medical Devices Management Policy

6 of 44

Implementation Date: 02.09.2014

5.3. Infection Prevention Team Has responsibility to provide input into the medical devices working group and to advise accordingly in line with this policy and other related policies and procedures. 5.4. Head of Property Services The Head of Property Services is the lead for Medical Equipment Management and is responsible for updating the central data base of medical equipment and ensuring maintenance arrangement are in place. The Head of Property Services is responsible for the Trusts Inventory of medical devices whom service managers or staff may contact for access to the Inventory. 5.5. Medical Devices Safety Officer The health and safety risk manager is the Trusts nominated medical device safety officer (MDSO) with the MHRA. The key purpose of this role is to promote reporting and learning and safe use of medical devices across the organisation and be the main expert resource in this practice area 5.6.

Heads of Service, Senior Departmental Managers, or their nominated representatives Are responsible for ensuring that:  Staff are appropriately trained in the safe and proper use of all devices in accordance with manufacturers instructions;  The training needs of staff are properly identified and recorded in the staff personal file and training records maintained. Staff Training records shall be held locally by a Senior Manager (More detail on training is covered within section 7.2);  Training records are maintained within the staff personal file; Please see Appendix 4 for associated form.  Instructions for medical devices use are available;  Appropriate clinical policies and risk assessments, associated with the use of medical equipment, are in place with in each ward/ department area;  All medical devices are appropriately and properly stored.  Will participate in the dissemination and any relevant action of medical device alerts published by the MHRA and in reporting adverse or potentially adverse incidents. (See CRM002 – Incident Policy and HSC025 Central Alerting System (CAS) Policy.

5.7. All staff involved in the use of medical devices Must:  Be trained in their safe and appropriate use;  Be familiar with operating procedures and risk assessments; The current version of any policy, procedure, protocol or guideline is the version held on the NHFT internet. It is the responsibility of all staff to ensure that they are following the current version Medical Devices Management Policy

7 of 44

Implementation Date: 02.09.2014

  

Be responsible for ensuring that end users are given appropriate training in the safe and effective use of medical devices; Be familiar with arrangements for reporting adverse or potentially adverse incidents involving medical devices; Ensure that they have the appropriate knowledge and skills to use the medical device in the provision of care to patients.

5.8. All staff It is the responsibility of each individual member of staff to ensure that they are conversant with the content of this policy and are appropriately trained (see Appendix 4 – Training and On-going Support) and competent to use the medical devices which they need to use in the execution of their duties and that they report any problems relating to use, maintenance, servicing or decontamination as contained in this policy. 5.9. The Purchasing Department Are responsible for ensuring all new equipment purchases have been approved by the Medical Devices Group. In addition they will inform the following of new devices coming into the Trust:  Clinical Engineering Contractors  The maintenance contractor  The inventory holder 5.10. Medical Devices Group The Medical Devices Group will be responsible for : o Review and update the Medical Devices Policy. o Provide assurance that competencies are in place and validated. o Inform the Patient Safety Report with issues and good practice from the group. o Act as a forum to discuss complex medical devices alerts. o Review the Medical Device Safety Officers reports, and other data as available, to identify, prioritise and address medical device risks to minimise harm to patients. o Identification, development and promotion of the best practices for medical device safety. This will include supporting the implementation of external medical device safety alerts and guidance from NHS England, MHRA, NICE, manufacturers’ FIELD SAFETY NOTICES and other organisations. Implementation will require co-ordination and support for process and system changes to reduce the likelihood of occurrence and reoccurrence of serious medical device incident reports.

The current version of any policy, procedure, protocol or guideline is the version held on the NHFT internet. It is the responsibility of all staff to ensure that they are following the current version Medical Devices Management Policy

8 of 44

Implementation Date: 02.09.2014

o Provide regular feedback to clinical staff, patient care areas and hospital committees on medical device risks and planned action to minimise these risks. o Co-ordinate education and training support to improve the quality of medical device incident reports and safe medical device practices. o Assist in development and review of medical device use policies and procedures. o Review any new Medical Devices as requested and link to any standardisation as appropriate. The Terms of Reference for the Medical Devices Group can be found at Appendix 13.

6. POLICY PROCESS 6.1. One-off Purchase of Medical Devices Advice should be sought when purchasing medical devices on a one-off basis as to the appropriate models in current use within the Trust. Please refer to section 6.3 of this document for further guidance. 6.2. Medical Device Alerts 6.2.1. Recipients of Medical Device Alerts Recipients of MHRA medical device alerts are responsible for:  Determining, upon receipt of such notices, whether or not any remedial/ preventative action is necessary;  Ensuring, if such action is required, that department/ first line managers under their control:  Are adequately instructed as to what action is required of them;  Actually implement the required action;  Completing the Datix safety alert response:  Assess relevance of alert;  Action underway (in progress);  Action complete – matter resolved;  No action required;  Not applicable. 6.2.2. Dissemination Procedure for Central Alerting System Alerts The Central Alert System (CAS) is managed by the health and safety team.

The current version of any policy, procedure, protocol or guideline is the version held on the NHFT internet. It is the responsibility of all staff to ensure that they are following the current version Medical Devices Management Policy

9 of 44

Implementation Date: 02.09.2014

The nominated officer (CAS liaison officer) for the management of the CAS System is the Health and Safety Risk Manager who is also the Medical Device Safety Officer. The Health and Safety Risk Manager has the responsibility for the co-ordination and effective reporting of incidents involving medical devices and the dissemination of hazard and safety notices. The CAS system is managed by the health and safety team. Upon receiving an alert the Health and Safety Risk Manager will acknowledge the alert within two working days and identify which distribution list the alert should be sent to, where necessary consulting with key individuals to determine whether the alert requires Trust-wide distribution. On receiving an alert via the Datixweb safety alert module recipients will:  Assess relevance and where necessary further disseminate and action through their area of responsibility updating the risk register where necessary to reflect identified risks.  Respond to the alert in Datixweb indicating actions taken, where applicable and within the timescale stated on the alert. Indicate where no action is required. (A step by step guide on how to use the safety alert module is available from the Health and Safety Risk Manager).  Recipients should ensure that CAS alerts are actioned promptly they must therefore make arrangements for action when they are on leave or away from the site. This may be done by nominating one or more named deputies, who are authorised to carry out the duties of the original recipient, to receive alerts through Datixweb in their absence. Where the original recipient delegates the action of responding to the safety alert then that person must ensure the Health and Safety Risk Manager is aware of the name of the nominated person. The Health and Safety Risk Manager will:  Monitor that responses are received within the required timeframe. In the event that any recipient of a safety alert has failed to respond before the pending action complete email is received into the SABS in-box, send a reminder to the original recipient through the Datixweb safety alert module.  Ensure the CAS website is updated within the specified timescales.  Provide status update reports on alerts to the Medical Devices Group showing details of alerts received, alerts The current version of any policy, procedure, protocol or guideline is the version held on the NHFT internet. It is the responsibility of all staff to ensure that they are following the current version Medical Devices Management Policy

10 of 44

Implementation Date: 02.09.2014



relevant to the Trust and action required and status of alerts requiring on-going action. Maintain the Datixweb safety alert module showing details of all alerts sent out and responses.

6.2.3. NHS Estates Safety Alerts and Hazard Notices. It will often be fairly easy to determine any limited distribution list required by these notices, therefore, on receipt of the notices the Health and Safety Risk Manager will forward the notices by e-mail to the most appropriate person. 6.2.4. NHS England - Patient Safety Alerts On receipt of a Patient Safety Alert, the Health and Safety Risk Manager will disseminate the Alerts to all those recipients held on the list by e-mail. The recipients must action and disseminate as necessary. A Safety Alert Lead Person will be appointed as necessary by the Safer Services and Environment Group. 6.2.5. Department of Health Guidance Documents On receipt of a Department of Health Guidance Document, the Health and Safety Risk Manager will liaise with the Chief Executives Department to determine the correct distribution and priority of actions necessary. 6.2.6. Follow Up Procedure In the event that any recipient of a Safety Alert Notice or other addressee fails to reply to the distribution e-mail, which accompanies the Central Alerting System Alert, the Health and Safety Risk Manager will send a reminder to the original recipient. It is a fundamental facet of this procedure that recipients ensure that they have a robust system in place to action all Central Alerting System notices in a timely manner, including arranging for a prompt, consolidated reply to the Health and Safety Risk Manager (Central Alerting System Liaison Officer). If any further advice or guidance is required relating to a Safety Alert, this maybe obtained from the Health and Safety Risk Manager. Addressees should note the response timescales on individual alerts and ensure that actions taken are commensurate with the timeframe specified. The Central Alerting System website is situated within the public domain; therefore members of the public may log onto the system and will have access to the alert information, including the time taken for Northamptonshire Healthcare NHS Foundation Trust to action and close down the relevant notice.

The current version of any policy, procedure, protocol or guideline is the version held on the NHFT internet. It is the responsibility of all staff to ensure that they are following the current version Medical Devices Management Policy

11 of 44

Implementation Date: 02.09.2014

6.3. New Medical Devices 6.3.1. Purchasing of Medical Devices All new purchases of medical devices will be agreed by the Medical Devices Group and by doing so the Infection Prevention Team will be liaised with as a result. New devices coming into Northamptonshire Healthcare NHS Foundation Trust should be checked whether or not they are newly purchased, leased or rented, on loan or trial or returning from maintenance or repair. All purchases will be made in line with Northamptonshire Healthcare NHS Foundation Trust Standing Financial Instructions, the Purchasing Policy for the provision of Goods and Non-Clinical Services and with reference to Managing Medical Devices’ (April 2014) published by the Medicines and Healthcare products Regulatory Authority. The Purchasing Department will ensure that a pre-purchase questionnaire (PPQ)is completed by the supplier before purchase and that all financial protocols are satisfied. They will also inform the relevant maintenance/ clinical engineering contractor that new a medical device is being purchased. New medical devices will be added to the inventory of medical devices on delivery. Any medical device purchased as a result of a donation or gift should be carried out through this process to ensure that appropriate medical devices is bought. Northamptonshire Healthcare NHS Foundation Trust will not accept any medical device that has been donated which has not been procured through the mechanisms described in this policy. Refer to purchasing flow chart - see Appendix 7. 6.3.2. Acceptance Procedures and Storage All new medical devices, whether gas or electrically powered or not, and ancillaries introduced to the services must undergo comprehensive safety and acceptance testing by Avensys UK Ltd, who will also attach an asset label and add to the equipment to the asset inventory. Time Immediately on delivery

Checks Check packaging for damage; Check goods against order – leads accessories, manuals, consumables; Check any identification labels against invoice – model numbers, mains voltage;

The current version of any policy, procedure, protocol or guideline is the version held on the NHFT internet. It is the responsibility of all staff to ensure that they are following the current version Medical Devices Management Policy

12 of 44

Implementation Date: 02.09.2014

During functional and safety tests

Before first use

Check device for obvious defect or damage. Follow manufacturers instructions for setting up and testing device; Check that device performs within original specification (these checks will need technical or clinical training); Unless manufacturer’s instructions specifically advise against, perform relevant safety test (e.g. electrical safety tests, hoist load tests etc). Perform the same checks as and when a device is returned to use after maintenance (these checks will need technical or clinical training); Recheck suitability of device for intended application (these checks will need technical or clinical training).

This process will ensure that the correct device has been delivered complete and is without visible defects and performance and electrical testing is also completed and documented before the medical device is deemed fit for use. An approved/ tested label will be attached to the medical device. Other less complex medical devices, e.g. wheelchairs must be checked for functionality against the supplier’s documentation by professional users as part of their operational readiness. 6.3.3. Storage Systems Inappropriate storage of items affects their subsequent safe use. Manufacturer’s information and instructions both on storage conditions and shelf life should be followed. The chosen system/ location for storage of devices and ancillary goods should be appropriate to the device, i.e. fragile or heavy medical devices should not be stored on high level shelving. The physical condition of the storage facility also requires consideration, i.e. dirty, wet conditions, inappropriate temperatures; humidity etc will impact on the device performance. It is important that medical devices requiring decontamination or awaiting repair be stored separately and clearly labelled. Where devices may be stored for sometime their shelf life must be monitored with a ‘first in, first out’ stock rotation system. Excessive storage time can cause rubber components to set in position (ventilators) or perish, lubricants to migrate (motor driven devices) and wood to dry out and shrink (crutches). The current version of any policy, procedure, protocol or guideline is the version held on the NHFT internet. It is the responsibility of all staff to ensure that they are following the current version Medical Devices Management Policy

13 of 44

Implementation Date: 02.09.2014

6.3.4. Deployment, Monitoring and Control Medical devices will be allocated to individual wards, teams or services. Medical devices should not be moved from department to department either on a temporary or permanent basis without notification to the Head of Property Services, who will adjust the inventory and advise the relevant maintenance/ clinical engineering contractor. The inventory of medical devices owned by NHFT is held on a spreadsheet and updated to reflect additions and decommissioned items as they are notified to the Head of Property Services. All purchasers of medical equipment must advise the Head of Property Services, by e-mail, so that new equipment can be added to the Inventory (Appendix 7). In addition the Head of Property Services conducts and annual audit of the Inventory. All medical devices carry a supplier’s serial number and in addition appropriate items carry maintenance/ clinical engineering asset number and bar code for inventory and maintenance purposes and a ‘next service due’ label where appropriate. Medical devices intended for single use only must be disposed of in the most appropriate manner as soon as they have been used. These items must never be re-used. 6.3.5. Loan of Medical Devices for Evaluation (Trials) Manufacturers or other organisations often loan medical devices for evaluation, as part of a consumables agreement, as an incentive to purchase or as part of a clinical trial. The person initiating the trial or loan must ensure that all aspects of this policy have been addressed and is responsible for the safe use of the medical devices. All requests for equipment on loan or trial should be directed via the Purchasing Department. Northamptonshire Healthcare NHS Foundation Trust operates a rigid ‘No Indemnity - No Loan’ approach to the loan or trial of medical devices - see Appendix 8, 9, 10 and 11 for associated indemnity forms and processes. The Head of Property Services must be informed of any proposed trial or loan medical devices at least 2 weeks in advance; to ensure that the appropriate indemnity documentation is completed. Companies having Master Indemnity Agreements with the NHS can be checked via the Government Procurement Service website, at http://nhsmia.bipsolutions.com/register.php

The current version of any policy, procedure, protocol or guideline is the version held on the NHFT internet. It is the responsibility of all staff to ensure that they are following the current version Medical Devices Management Policy

14 of 44

Implementation Date: 02.09.2014

Companies having a Master Indemnity Agreement with the NHS must still sign the Trust’s Form of Indemnity outlining details of the loan – see appendix 9. Companies who are not covered by master indemnity agreements must complete a Trust Indemnity Form, Form A for medical devices on loan - see Appendix 9 or Form B for medical devices or consumable which are donated - see Appendix 10, and the Trust Form of Indemnity. The relevant Indemnity Form and appropriate schedule must be completed and signed to ensure that Northamptonshire Healthcare NHS Foundation Trust is covered in the event of any incident. All medical devices loaned or donated to Northamptonshire Healthcare NHS Foundation Trust must also receive appropriate acceptance checks, provided by our maintenance/ clinical engineering contractors prior to use. If any medical devices are to be used as part of a clinical research trial the Research and Development Manager must be informed. Where there are funding implications (e.g. who pays for any disposable items used) the budget must be identified and agreed in advance with the relevant service Manager/ Budget Holder. The Head of Property Services will keep a record of all loans and ensure when the indemnity period expires, the medical device is returned to the company or the indemnity is extended. This is a standard Department of Health requirement. 6.3.6. Maintenance and Repair All requests for the maintenance or report a fault with medical devices should be reported by telephone or email to the Estates Help Desk (01604 682682 or [email protected]) who will log it into the Trusts Facilities Management System where the Estates Team will then action the request through contractual arrangements with the appropriate maintenance providers. When reporting a fault, an Avensys UK Ltd fault report card should be completed and attached to the faulty item – see appendix 3. When reporting a fault the following information should be provided:  Name of medical device;  Location;  Manufacturers name;  Serial and Asset number;  Nature of fault (with as much detail as possible);  Statement of Decontamination status; (Appendix 6)  Name and contact details of person reporting the fault; The current version of any policy, procedure, protocol or guideline is the version held on the NHFT internet. It is the responsibility of all staff to ensure that they are following the current version Medical Devices Management Policy

15 of 44

Implementation Date: 02.09.2014

Maintenance of medical devices falls in to two categories:  Routine checks and daily maintenance carried out by the users – these will be described in the manufacturers operating instructions. Routine checks for presence, function and availability of ancillary items (and any daily maintenance) must be carried out by users as part of their ‘start of day’ procedures or ‘before use’ procedures. All checks will be recorded, i.e. running temperatures of autoclaves, refrigerated medical devices etc. 

Planned, preventative maintenance carried out by maintenance/ clinical engineering departments and other specialist contractors who also manage ad-hoc repairs on an ad-hoc basis when required.

Planned, preventative maintenance of all medical devices whether gas or electrically powered or not and electronic medical devices is contracted out to a number of maintenance providers. Contractors carry out an annually agreed planned, preventative maintenance programme on our behalf. The maintenance cycle must be reviewed annually by the Head of Property Services against the supplier’s recommendations, local experience and technical advice from the maintenance/ clinical engineering departments. No modifications to medical devices shall be allowed unless they are authorised by the person responsible for technical servicing, in conjunction with manufacturers to ensure that the safety of medical devices is not compromised. The contracts for the maintenance of electrical medical devices are provided by: (the following list is an indication of medical equipment maintenance providers and may be subject to change and review)         

Avensys UK Ltd – for most medical equipment; Cambridge University Hospital – Sterilisers / Autoclaves J&D Mobility – Wheelchairs Caretech – Hoists, Plinths and Beds Scaleways – Weighing Scales Bard – Bladder Scanners CME – McKinley Syringe Drivers Wrights Dental – Dental Equipment Arjo - Baths

Servicing and maintenance records will be kept by the servicing organisation and will made available for inspection by Northamptonshire Healthcare NHS Foundation Trust at least annually as part of a formal Service Level Agreement review, and The current version of any policy, procedure, protocol or guideline is the version held on the NHFT internet. It is the responsibility of all staff to ensure that they are following the current version Medical Devices Management Policy

16 of 44

Implementation Date: 02.09.2014

will form part of the annual audit review for medical devices. Copies of service reports will be held locally, by the Service Manager. When necessary or as requested a Decontamination Label (see Appendix 6) will be despatched to the location of the faulty/ contaminated medical device. Faulty or non-operating medical devices should be taken out of use as soon as it becomes faulty or inoperative. The medical device should be clearly identified as ‘Out of Action’. 6.3.7. Maintenance Requirements / Service Instructions for Medical Devices. There are obligations under the ‘Health and Safety at Work Act’ and the ‘Management of Health and Safety at Work Act’ to ensure that the Trust provide safe systems of work and assess risk to staff (and patients). Further recommendations advise that medical devices should be regularly inspected - in practice this will take place by users/ staff prior to the use of medical devices. All medical equipment will require an annual inspection, service or calibration, including an electrical safety test. See Appendix 3 6.4. Disposal of Medical Devices Responsibility for the safe disposal of medical devices rests with the Service Manager and appropriate maintenance / clinical engineering department. Third parties involved in the disposal of medical devices will be required to sign a safe disposal form, available from Helpdesk on 01604 682682. Helpdesk must be informed of ALL disposals of medical devices to ensure the Trusts inventory is kept up to date. Clinical staff have a duty to ensure that the equipment to be disposed if clean and appropriately decontaminated. Based on advice received from maintenance contractors and / or other specialist advisors, the Head of Property Services will condemn any medical devices deemed to be unrepairable or beyond economical repair (subject to the provisions of Northamptonshire Healthcare NHS Foundation Trust’s Standing Financial Instructions). Disposal of less complex medical devices will be arranged at a local level by contacting the Head of Property Services. Mattresses and pillows should be disposed of as clinical waste. They must be bagged and tagged. Bags and tags are available through NHS Logistics catalogue. Mattress bags code MVN003. For further advice contact the Purchasing Department on 01604 480352.

The current version of any policy, procedure, protocol or guideline is the version held on the NHFT internet. It is the responsibility of all staff to ensure that they are following the current version Medical Devices Management Policy

17 of 44

Implementation Date: 02.09.2014

When medical devices are disposed of the inventory will be adjusted as necessary. 6.5. Incidents and Near Misses All staff are responsible for bringing to the attention of their department/ first line manager details of any adverse incident, reactions etc. in accordance with Northamptonshire Healthcare NHS Foundation Trust and instructions issued to them by their department/ first line manager. Please refer to the Incident Policy CRM002 for further guidance. 6.6. Security/ Prevention or Future Use of Medical Devices All material evidence related to an adverse incident, which could include:  The medical device/ product etc. itself;  Where appropriate, packaging material;  Other means of batch identification;  Instructions for use;  Should be:  Labelled to facilitate future identification;  Marked to prevent further use;  Quarantined, i.e. kept in a secure place under the control of the department/ first line manager. Material evidence should not be interfered with in any way, except for safety reasons or to prevent its loss and, if necessary, a record should be made of:  All readings and settings;  Positions of switches, valves, dials, gauges and indicators;  Eye witness reports and/ or and photographic evidence. In serious cases, this record should be witnessed and the witness should make a personal written record. In the case of defective items associated with adverse incident, they should not be allowed to:  Be repaired;  Be returned to the supplier;  Be discarded;  Before an investigation has been carried out. The Medicines and Healthcare Products Regulatory Agency should be able to advise in this respect. The manufacturer / supplier should be informed promptly by the Head of Property Services and allowed to inspect the items who is aware of the limitations of the action the manufacturer / supplier can take the manufacturer/ supplier must not be allowed to:  Exchange;  Interfere with;  Remove any part of the medical device, as to do so could prejudice the Medicines and Healthcare Products Regulatory Agency’s, or other, investigations; The current version of any policy, procedure, protocol or guideline is the version held on the NHFT internet. It is the responsibility of all staff to ensure that they are following the current version Medical Devices Management Policy

18 of 44

Implementation Date: 02.09.2014

In the case of a large batch it may be possible to release a sample to the manufacturer/ supplier if to do so would facilitate the investigation. 6.7. Decontamination of Medical Devices etc. Prior to the inspection, service, repair or transportation of any medical devices by any person, where a risk of contamination is likely, the medical devices should be appropriately treated so as to eliminate or minimise the risk of infection or exposure to other hazards, e.g. chemical; bodily fluids etc. Please refer to the Cleaning and Disinfection Guidelines Policy ICP003 for further detail and liaise with the Infection Prevention Team accordingly. 6.8. Medicinal Products The United Kingdom operates a reporting scheme, commonly known as the Yellow Card Reporting Scheme, which collates reports from doctors, dentists etc. on spontaneous adverse drug reactions to medicinal products administered for one of the following reason:  Treating or preventing disease;  Diagnosing disease or ascertaining the existence, degree or extent of a psychological condition;  Contraception;  Inducing anaesthesia;  Otherwise preventing or interfering with the normal operation of a physiological function. Or in respect of:  Fluids used with contact lenses. NHFT staff who become aware of any spontaneous adverse drug reaction associated with any of the above should draw it to the attention of the appropriate doctor/ dentist responsible for making such reports. 7. TRAINING 7.1. Mandatory Training There is no mandatory training associated with this policy. 7.2. Specific Training not covered by Mandatory Training Training requirements for staff should be identified using a Training Needs Assessment which will be based on the complexity of the equipment, risk to the patients and the frequency of use by the staff member Staff who have not been trained on a medical device MUST not use it – please refer to Appendix 4 for relevant training form to be completed.

The current version of any policy, procedure, protocol or guideline is the version held on the NHFT internet. It is the responsibility of all staff to ensure that they are following the current version Medical Devices Management Policy

19 of 44

Implementation Date: 02.09.2014

It is the responsibility of Line Managers to identify which of their staff are authorised to use equipment and ensure that this information is recorded and to identify what training is required for each role. This ensures that all staff are trained in the use of any new medical device when introduced, and that refresher training is provided for existing equipment. The frequency of refresher training will be determined by the Heads of Service, Senior Departmental Managers, or their nominated representatives, having taken account of the frequency of use of the medical device, complexity of use and risk of harm to the patient as a result of user error. A Training Needs Analysis should be undertaken for individual staff and should address both clinical and technical matters. Training should then be planned to meet individual needs. This should include:  Staff understand the principles underlying the use of medical devices;  Are familiar with the practical aspects of the medical devices they are likely to encounter;  Have had their competence assessed in relation to the safe use of medical devices;  All staff who attend for training for the use of any medical device (regardless of who is providing the training) must have the training documented and placed on their personal file;  All new medical devices introduced must be issued with the supplier’s instructions and copies must be kept in a designated area and updated as necessary. Identified training will be met through a variety of methods including training by a competent person, manufacturers training, internal training and external training. Managers are responsible for monitoring the completion of medical devices training by staff within their area. Non-attendance should be managed in the first instance by the individual’s line manager. Where training is cancelled through sickness or other issues, details must be given to their Line Manager. After which if training still does not occur the manager is obliged to report this to the Service Manager/Lead – who must resolve the situation. Every effort must be made to ensure the training occurs. In the event that a member of staff persistently fails to attend training it may be necessary to invoke the Trust’s Disciplinary Procedure and/or Performance Management. Healthcare professionals working for the Trust as employees, contractors, or agency staff have a professional duty to ensure their own skills and training are appropriate and remain up to date. Heads of Service / Senior Departmental Managers will review training requirements of individual staff depending on the frequency of use and The current version of any policy, procedure, protocol or guideline is the version held on the NHFT internet. It is the responsibility of all staff to ensure that they are following the current version Medical Devices Management Policy

20 of 44

Implementation Date: 02.09.2014

complexity of the medical equipment. This process will be done periodically but no less than annually as part of an appraisal process. 8. MONITORING COMPLIANCE WITH THIS DOCUMENT The table below outlines the Trusts’ monitoring arrangements for this document. The Trust reserves the right to commission additional work or change the monitoring arrangements to meet organisational needs. Individual responsible for the monitoring

Group or committee who receive the findings or report

Group or committee or individual responsible for completing any actions

Aspect of compliance or effectiveness being monitored

Method of monitoring

Duties

To be addressed by the monitoring activities below.

Accuracy of the inventory

Audit of service areas

Head of Property Services

Annually

Medical Devices Group

Head of Property Services

Repair and Maintenance of reusable diagnostic and therapeutic equipment

Performance meetings and reports from service contractors. 10% of service records will be audited.

Head of Property Services

Quarterly

Medical Devices Group

Head of Property Services

Effectiveness of Procurement of medical equipment

Reports from Procurement Department

Head of Property Services

Annually

Medical Devices Group

Head of Procurement

Review of training needs versus training delivered

Review of Training Needs Analysis

Services Managers

Annually

Medical Devices Group

Medical Devices Group

Compliance with MHRA Alerts

Audit of Medical Device Alerts

Head of Property Services

Annually

Medical Devices Group

Head of Property Services

Monitoring frequency

Where a lack of compliance is found, the identified group, committee or individual will identify required actions, allocate responsible leads, target completion dates and ensure an assurance report is represented showing how any gaps have been addressed.

9. REFERENCES AND BIBLIOGRAPHY Managing Medical Devices – Published by MHRA – April 2014 Provision and Use of Work Equipment Regulations 1998 Standards for Better Health – Outcome 11 NHS Litigation Authority, (2012). NHSLA Risk Management Standards 201213 for Trust providing Acute, Community, or Mental Health & Learning Disability Services and Non-NHS providers of NHS Care. [s.l.] [s.n.] The current version of any policy, procedure, protocol or guideline is the version held on the NHFT internet. It is the responsibility of all staff to ensure that they are following the current version Medical Devices Management Policy

21 of 44

Implementation Date: 02.09.2014

Health and Social Care Act 2008 10. RELATED TRUST POLICY  CRM002 – Incident Policy  HSC009 - Policy on the reporting of Injury, Diseases and Dangerous Occurrences  HSC011 - Guidelines for the safe use of electric patients lifting hoists  HSC017 - Provision and Use of Work Equipment Policy  HSC022 - Policy for the Prevention and management of Latex Allergy  HSC025 – Central Alerting System (CAS) Policy  ICP003 - Infection Control Cleaning and Disinfection Guidelines

The current version of any policy, procedure, protocol or guideline is the version held on the NHFT internet. It is the responsibility of all staff to ensure that they are following the current version Medical Devices Management Policy

22 of 44

Implementation Date: 02.09.2014

APPENDIX 1 - EXAMPLES OF MEDICAL DEVICES Medical Devices used in the diagnosis/treatment of disease or monitoring of patients Syringes and needles Thermometers Dressing Catheters (e.g. urinary, cardiac) Surgical instruments Endoscopes IV administration sets and pumps Cardiac monitors Anaesthetic Ultrasound images and CT/MR scanners Surgical implants, e.g. orthopaedic prostheses; bone cements; heart valves Powered implants, e.g. pacemakers; implantable defibrillators Radiotherapy (external beam) Syringe drivers Nebulisers Glucometer Portable suction machines Oxygen concentrator Mattresses Sphygmomanometers (all medical devices/products used in the treatment/monitoring of patients, in the diagnosis of disease in dentistry, in surgery and in life support) Medical Devices used in life support Ventilators Defibrillators Oxygen cylinders Medical Devices used in the care of disabled people Orthotic and prosthetic appliances Aids for the disabled Wheelchairs Patient hoists, lifting and transfer Pressure care prevention Aids to daily living Commodes Urine drainage systems Domiciliary oxygen therapy systems Other Medical Devices Medical textiles Hospital beds Mattresses and covers Medical devices also include products which may be indirectly involved in patient care, including invitro diagnostic products, transportable disinfecting and sterilising, blood and tissue storage systems, arming cabinets and chemical and biological indicators used in sterilisation processes. Some medical devices are designed to be permanently connected to installed services, e.g. medical gas pipe work, ducting or the electrical supply. In these cases the device should be regarded as comprising all parts up to and including the means of connection to the installed services. The only type of electrical plug regarded as part of the device is the “Red Plug” used on certain types of X-ray.

The current version of any policy, procedure, protocol or guideline is the version held on the NHFT internet. It is the responsibility of all staff to ensure that they are following the current version Medical Devices Management Policy

23 of 44

Implementation Date: 02.09.2014

APPENDIX 2 - EXAMPLES OF NON-MEDICAL DEVICES, ENGINEERING PLANT, INSTALLED SERVICES, BUILDINGS AND BUILDING COMPONENTS 1.

Incidents associated with the categories below which give rise to, or have the potential to produce unexpected or unwanted effects involving the safety of patients, users or others may, in general, be reported in writing: Buildings, building components and lifts. Construction/demolition, including plant, regulations (CDM). Engineering plant and services of all types, e.g. boilers, generators, heating, ventilating water, drainage and electrical installations and any other fixed plant (but not fixed medical) Fire protection installations and. Permanently installed bedpan washers, disposal units and sterilisers. Medical devices in laundries, catering departments, workshops and any plant or used for maintenance or cleaning. Piped medical gas and vacuum installations, vacuum insulated evaporators (VIEs) and anaesthetic gas scavenging systems. Fixed luminaries, including operating and examination lamps. Communications, e.g. telephone and bedhead services, i.e. nurse call, paging, alarm and radio. Lighting protection and electrostatic discharger. Incinerators and other clinical waste treatment. Building environmental aspects of Control of Substances Hazardous to Health Regulations (COSHH). 2. Incidents associated with the categories below will require immediate telephone notification: Fatal or major injury accidents associated with work activities. Explosions or sudden fractures of any pressure vessel, pressurised system or steam/high pressure hot water mains whether or not injury was sustained. Major electrical explosions, e.g. of a power transformer or high voltage switchgear whether or not injury was sustained. Runaways and crashes of passenger lifts whether or not injury was sustained. N.B. The above accidents/occurrences are also immediately reportable to the Health and Safety Executive (see the NHfT’s Accidents and Incident Reporting Policy) 3. NHS Estates should also be informed, in writing, not only of safety related defects, but also of serious deficiencies in the technical or economic performance of products

The current version of any policy, procedure, protocol or guideline is the version held on the NHFT internet. It is the responsibility of all staff to ensure that they are following the current version Medical Devices Management Policy

24 of 44

Implementation Date: 02.09.2014

APPENDIX 3 – EQUIPMENT FAULT REPORTING PROCEDURE

Equipment Fault Reporting Procedure Clinical Staff identify faulty equipment, and fill in Faulty Equipment Card with ALL requested information. Equipment should be cleaned and decontamination certificate attached (if applicable).

Ring Helpdesk on 01604 682682 and report fault, Helpdesk will give you a job reference number to be written on the Faulty Equipment Card next to “Avensys Job Card No:”

Estate Staff will call Avensys and request either immediate call-out for emergencies or wait until Avensys Engineer is next on site.

Staff to attach fault report card and isolate faulty equipment. Large equipment to be left in situ.

Avensys will contact the site to arrange a convenient time and date to attend the call out.

Equipment will be repaired and returned to user. Faulty equipment card to be stored in maintenance folder.

1. 2. 3.

Equipment that has not been cleaned will be returned to clinical staff. Equipment that has not had fault report card completely filled in will be returned to clinical staff. Equipment that does not have a Helpdesk job number on the card will be returned to clinical staff.

The current version of any policy, procedure, protocol or guideline is the version held on the NHFT internet. It is the responsibility of all staff to ensure that they are following the current version Policy for the Production and Management of all Policies Within NHFT

25 of 44

Implementation Date: 02/ 09 / 2014

APPENDIX 4 - TRAINING NEEDS FOR MEDICAL DEVICES Speciality/ Ward: Medical devices Please specify type and model

Date: Level of Clinical Risk

No. of Operators requiring training

Nurses E.g. ECG machines

Med

Doctors Yes

Others OT

Training required

Training in Training place Records

Training Frequency1 to be set up

ECG Mandatory Course

Patchy

Yes

No

Key: Level of Risk of harm to patient due to user error High Medium Low

serious harm to patient leading to death or disability semi permanent harm to patient or increased length of stay discomfort, delay and inconvenience to patient

1

The frequency of refresher training will be determined by the Head of Service / Department Manager having taken account of the frequency of use of the equipment, the complexity of use and manufacturer’s recommendations. The current version of any policy, procedure, protocol or guideline is the version held on the NHFT internet. It is the responsibility of all staff to ensure that they are following the current version Policy for the Production and Management of all Policies Within NHFT

26 of 44

Implementation Date: 02/ 09 / 2014

APPENDIX 5 - DECONTAMINATION OF RE-USABLE MEDICAL DEVICES FOR REPAIR, MAINTENANCE OR INSPECTION

Anticipated location for repair Send Away

On-site repair

Is decontamination required/ possible?

Is decontamination required / possible? possible? No

No Yes

Inform repair organisation

Inform repair organisation

Decontaminate equipment thoroughly

Yes

Arrange visit by repair organisation

Repair organisation agrees despatch?

No

Arrange visit by repair organisation

Yes

Pack and despatch with declaration of contamination status and note of fault/defect

Label with declaration of contamination status and quarantine

Pack well, label and despatch with declaration of contamination status and note of fault/defect

Decontaminate equipment prior to visit and complete declaration of contamination status

The current version of any policy, procedure, protocol or guideline is the version held on the NHFT internet. It is the responsibility of all staff to ensure that they are following the current version Medical Devices Management Policy

27 of 44

Implementation Date: 02.09.2014

APPENDIX 6 - DECONTAMINATION CERTIFICATE Available from the Help Desk on 01604 682682 ……………………………………………………….NHS TRUST (complete as appropriate) DECONTAMINATION CERTIFICATE For issue prior to inspection, service or repair of any medical or laboratory equipment. To …………………………………………………………………………………….…………………… From ……………………………………………………………………… Date …………………….… Item …………………………………………………………..Serial/Inventory No ………………….… Fault/Repair ……………………………………………………………………………………………… Job Reference no ……………………………………………………………………………………….. Tick box A if applicable, otherwise you must complete sections B and C overleaf A.

This equipment has not been in contact with blood, body fluids, respired gases or pathological specimens and is not visibly contaminated

Declaration I declare that I have taken all reasonable steps to ensure the accuracy of the above information Signature ………………………………………… Print name ………………………………… Position ………………………………………………………….. Contaminated Equipment

Has this equipment been exposed to hazardous materials? Blood, body fluids, respired gases, pathological specimens Chemicals or substances hazardous to health Other hazards

YES/NO Please circle YES/NO Please circle YES/NO Please circle

Details of contamination

C. Has the equipment been cleaned and decontaminated? Please circle

YES/NO

If Yes, state method (Please check manufacturers’ guidelines or your local infection control policy) If No, state why Please note: Equipment that has not been decontaminated must not be returned/ presented without prior agreement with the appropriate Technical Department Declaration I declare that I have taken all reasonable steps to ensure the accuracy of the above information Signature ………………………………………. Print name ……………………………………….. Position ………………………………………………………….. The current version of any policy, procedure, protocol or guideline is the version held on the NHFT internet. It is the responsibility of all staff to ensure that they are following the current version Medical Devices Management Policy

28 of 44

Implementation Date: 02.09.2014

APPENDIX 7 - MEDICAL DEVICES PROCUREMENT FLOWCHART All medical devices brought in to NHFT should follow this route, regardless of the source of funding, budget holder or donation etc

Need for new item of medical device identified

Yes

Check preferred make and model against current inventory for standardisation (via the Head of Property Services or Purchasing Department)

No

Case of need to be reviewed by the Medical Devices Group and the relevant Head of Service / Manager

Supported

Requisition to be raised and sent to Purchasing Department

Alternative device to be agreed

Purchasing Department to send out Pre-Purchase Questionnaire to manufacturer (if required)

Medical device delivered

Maintenance Contractor to unpack and carryout acceptance procedures

New medical device to be added to Inventory (Head of Service / Manager to advise Head of Property Services)

Head of Service / Manager to ensure Staff are trained on the use of the new device (if appropriate) – before first use.

Head of Property Services to set up maintenance arrangements The current version of any policy, procedure, protocol or guideline is the version held on the NHFT internet. It is the responsibility of all staff to ensure that they are following the current version Medical Devices Management Policy

29 of 44

Implementation Date: 02.09.2014

APPENDIX 8 - FORM OF INDEMNITY

The Schedule Supplier Representative Contact No:

IFA ref Status:

_____ _____

Serial

Value

1. The Medical Device Medical Device

Model

The above medical device will only be used in the premises or location identified in section 3, below, and will not be used elsewhere or for any other purpose than that specified in section 4, below, without the written consent of the supplier.

2. Period of Loan Commencing on the: Ending on the: 3. The Premises/ Location Hospital:

Contact_Name:________

Location:

Contact Phone________

4. The Purpose of the Loan Loan Purpose:

___________________________________________

5. Health and Safety By signing this schedule both parties acknowledge their responsibilities under the Health and Safety at Work Act 1974 and COSHH 1994.

6. Confidentiality By signing this schedule both parties acknowledge the confidentiality requirements of this agreement. SIGNED on behalf of the Supplier

SIGNED on behalf of the Trust

Print name

Print name

Estates use

INDEMNITY CLOSED BY

Date:__________

The current version of any policy, procedure, protocol or guideline is the version held on the NHFT internet. It is the responsibility of all staff to ensure that they are following the current version Medical Devices Management Policy

30 of 44

Implementation Date: 02.09.2014

APPENDIX 9 - NHS FORM OF INDEMNITY– A Reference Number [

]

Medical Device on loan A DEED made the ……………day of ……………………….. ……..………...201_ BETWEEN:

Northamptonshire Healthcare NHS Foundation Trust ……………………………………………………………………………………(“the Trust”); AND Supplier ……………………………………………………………(“the Supplier”). WHEREAS The Supplier is the owner of the medical device (the “medical device”) and wishes to make the Medical device available directly to the Trust or to NHS Trusts, NHS Foundation Trusts, Health Trust and other users (“Users”) agreed by the parties for a specified period in accordance with the terms of this Deed. The Medical device and the period for which the Medical device will be on loan to the Trust 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 Trust 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. “Medical device” shall be deemed to include any part or parts of the Medical device 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 Medical device available to the Trust or the relevant User(s) by way of loan free of charge for the period agreed between the Trust 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 1982.

2.

Title to the Medical device shall remain for all purposes fully vested in the Supplier.

The current version of any policy, procedure, protocol or guideline is the version held on the NHFT internet. It is the responsibility of all staff to ensure that they are following the current version Policy for the Production and Management of all Policies Within NHFT

31 of 44

Implementation Date: 02/ 09 / 2014

3.

The Medical device (other than Medical device which the Trust 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 Trust or the relevant User(s) be at the sole risk of the Trust or relevant User(s) as regards damage, loss or destruction. The Trust or the relevant User(s) shall be liable for the repair or replacement of any such Medical device which is damaged, destroyed or lost whilst in its possession or control.

4.

Subject to Clause 5, Medical device which the Trust 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 Trust or the relevant User(s) be at the sole risk of the Supplier as regards damage, loss or destruction and neither the Trust nor the relevant User(s) shall be under any obligation to keep the Medical device insured. For all pieces of Medical device on loan to the Trust at any one time the Supplier shall keep a record of the purpose of the loan and, when requested by the Trust upon reasonable notice, communicate the purpose of the loan to the Trust within a reasonable time.

5.

The Trust or the relevant User(s), as the case may be, shall be liable for the repair of:

5.1

Any damage to the Medical device occurring at the Premises (or during transit in the event that the Trust or relevant User collects the Medical device pursuant to Clause 6) and caused by the Trust or the relevant User(s) failing to use or operate such Medical device in accordance with the express instructions of the Supplier; and

5.2.1 Any damage to the Medical device occurring at the Premises (or during transit in the event that the Trust or relevant User collects the Medical device pursuant to Clause 6) and caused by the act or omission of the Trust 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 Medical device to the Premises on a date agreed between the Supplier and the Trust or the relevant User(s). Except where carried out solely by the Trust or the relevant User(s), delivery shall be effected by the Supplier delivering the Medical device to the Premises or (if otherwise agreed) by the Trust or the relevant User(s) collecting the Medical device from the Supplier’s premises or any other premises agreed by the parties. Unless otherwise agreed, the Trust or relevant User(s) shall be responsible for installation of the Medical device at the Premises such that it is in working order for use by the Trust or the relevant User(s). The Trust responsibility shall also extend to any and all costs and damage caused by or arising out of the failure to correctly install the Medical device, provided always that it is the Trust which has installed the Medical device. For the avoidance of doubt, should the Supplier be

The current version of any policy, procedure, protocol or guideline is the version held on the NHFT internet. It is the responsibility of all staff to ensure that they are following the current version Medical Devices Management Policy

32 of 44

Implementation Date: 02.09.2014

responsible for installing the Medical device, the Trust shall have no responsibility to meet any costs and damage caused as a result of the installation. 7.1.1 Subject to Clauses 7.2 and 7.3 below, the Supplier shall indemnify and hold harmless the Trust, the relevant User(s) and the Secretary of State for Health against all losses suffered by the Trust, the relevant User(s) or the Secretary of State for Health: (i) in connection with any defect in the design or manufacture of the Medical device; 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 Medical device to the Trust, the relevant User(s) or the Secretary of State for Health 7.1.2 The Supplier shall not be liable for any loss suffered by the Trust, 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 Trust, 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 Medical device in accordance with the operating instructions and other relevant information of which the Trust 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 Medical device; (ii) a failure by the Trust or relevant User(s) to ensure that the Medical device is operated by persons who have been made aware of the method of operation in accordance with Clause 9; and (iii) use of the Medical device 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 Medical device.

The current version of any policy, procedure, protocol or guideline is the version held on the NHFT internet. It is the responsibility of all staff to ensure that they are following the current version Medical Devices Management Policy

33 of 44

Implementation Date: 02.09.2014

(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 Medical device or (b) the provision of negligent training or instruction in the use of, or preparation for use, of the Medical device, 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 Trust or the relevant User(s) on terms sufficient to cover its liability to the Trust 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 Trust or the relevant User(s) in writing). On request the Supplier shall provide documentary evidence of such insurance cover to the Trust or the relevant User(s). If at any time the Supplier shall default in its obligations to insure as aforesaid then the Trust 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 Trust or the relevant User(s) shall recharge to the Supplier (who hereby undertakes to make payment to the Trust 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 Trust 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 Trust or the relevant User(s) instructions for use relating to the Medical device 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 Medical device and shall be in the English language and contain appropriate directions as to the operation of the Medical device. The Supplier shall provide a telephone number to the Trust 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 Trust or the relevant User(s) may have in relation to the operation of the Medical device. The Trust or the relevant User(s) will notify Supplier promptly of any fault or safety issue arising with or damage to the Medical device

The current version of any policy, procedure, protocol or guideline is the version held on the NHFT internet. It is the responsibility of all staff to ensure that they are following the current version Medical Devices Management Policy

34 of 44

Implementation Date: 02.09.2014

and will use its reasonable endeavours to ensure that the Medical device 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 Medical device complies with the Essential Requirements of the Medical Devices Directive (93/42) and is CE marked. The Supplier further warrants that the Medical device is fit for the intended purpose for which the Medical device is supplied.

11.

The Supplier and the Trust or the relevant User(s) shall complete and sign a Delivery Note in relation to each item of Medical device 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 Medical device which is in the possession of the Trust or the relevant User(s) from time to time and shall not apply to Medical device 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 Trust 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 Medical device during the period in which the Medical device was on loan to the Trust or the relevant User(s) sufficient to facilitate compliance by the Supplier with statutory and other reasonable requirements to make safe the Medical device, 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 Trust or the relevant User(s) shall accept no liability whatsoever for any failure by the Supplier to make safe the Medical device 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 Trust or the relevant User(s) under this condition, except that the Trust or the relevant User(s) shall be responsible for any and all costs where Medical device 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 Trust or the relevant User(s), their servants or agents to use the Medical device for the Supplier’s intended purpose, the Trust or the relevant User(s) shall bear the reasonable cost of making safe the Medical device, the contamination and any other known hazard.

14.

The Medical device shall not be modified or repaired by the Trust or the relevant User(s) without the prior written agreement of the Supplier.

The current version of any policy, procedure, protocol or guideline is the version held on the NHFT internet. It is the responsibility of all staff to ensure that they are following the current version Medical Devices Management Policy

35 of 44

Implementation Date: 02.09.2014

15.

Neither the Trust nor the relevant User(s) shall be liable for any charge for maintenance, repair, consumable materials or accessories required for the operation of the Medical device during the period in which the Medical device is on loan to the Trust 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 Trust or the relevant User(s).

16.

Upon receipt of a written request at any time from the Trust or the relevant User(s) or at the end of the loan period specified in the relevant Delivery Note, the Supplier shall remove the Medical device from the Premises with all practicable speed, free of charge, and at that time shall provide the Trust or the relevant User(s) with a receipt for the Medical device, and shall have the right to enter onto the Trust or relevant User(s) premises to exercise such removal.

17.

The Supplier shall provide the Trust or the relevant User(s) with reasonable written notice of the time at which it intends to remove the Medical device 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 Trust or the relevant User(s) following the removal of the Medical device provided always that if the Medical device 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 Trust 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 Medical device and the Supplier acknowledges that it has not relied on any representation on behalf of the Trust or the relevant User(s) as to any future business between the Supplier and the Trust or the relevant User(s) (except that nothing in this clause shall exclude the Trust liability for fraudulent misrepresentations) and the Supplier warrants that neither the Trust nor any relevant User(s) is under any obligation to the Supplier in connection with the Medical device (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 Trust 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

The current version of any policy, procedure, protocol or guideline is the version held on the NHFT internet. It is the responsibility of all staff to ensure that they are following the current version Medical Devices Management Policy

36 of 44

Implementation Date: 02.09.2014

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. EXECUTED AND DELIVERED AS A DEED BY AND ON BEHALF OF:NORTHAMPTONSHIRE HEALTHCARE NHS FOUNDATION TRUST 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 Signature: 2nd Signatory Name: Position: Director Signature:

The current version of any policy, procedure, protocol or guideline is the version held on the NHFT internet. It is the responsibility of all staff to ensure that they are following the current version Medical Devices Management Policy

37 of 44

Implementation Date: 02.09.2014

APPENDIX 10 - FORM OF INDEMNITY – B Reference Number [

]

Free issues A DEED made the ……………day of ……………………….. ……..………...201_ BETWEEN: Northamptonshire Healthcare NHS Foundation Trust …………….(“the Trust”); 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, Health Authorities and other users ('Users) 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 (October 2006 edition) shall be incorporated into this Deed.

EXECUTED AND DELIVERED AS A DEED BY AND ON BEHALF OF NORTHAMPTONSHIRE HEALTHCARE NHS FOUNDATION TRUST [

]

acting by: Name: Position: Signature:

The current version of any policy, procedure, protocol or guideline is the version held on the NHFT internet. It is the responsibility of all staff to ensure that they are following the current version Medical Devices Management Policy

38 of 44

Implementation Date: 02.09.2014

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: Position: Director/Company Secretary** Signature:

The current version of any policy, procedure, protocol or guideline is the version held on the NHFT internet. It is the responsibility of all staff to ensure that they are following the current version Medical Devices Management Policy

39 of 44

Implementation Date: 02.09.2014

APPENDIX 11 - INDEMNITY PROCESS The diagram below identifies the process that must be followed:

Estates Department / Maintenance Provider & Purchasing Department

Notification of Potential Loan

RAISE / EXTEND NHS OR TRUST INDEMNITY

Indemnified Equipment

PRE-USE ACCEPTANCE CHECKS

USER

Notification of Indemnity Expiration

INDEMNITY PERIOD ENDS

Indemnity Agreement

Equipment delivered SUPPLIER

Notification of Indemnity Expiration

Equipment Returned

The current version of any policy, procedure, protocol or guideline is the version held on the NHFT internet. It is the responsibility of all staff to ensure that they are following the current version Medical Devices Management Policy

40 of 44

Implementation Date: 02.09.2014

APPENDIX 12 - CENTRAL ALERTING SYSTEM Distribution of Safety Alert Notices Instructions for Recipients Alert Notice Distributed to Nominated Recipients For information only? Recipient to decide on action to be taken

Action necessary – not yet started Reply to ALERTS via Datix (to be done within 2 weeks) You will need to state what action is needed and provide an action plan to meet the alert deadline

Action is necessary – ongoing Reply to ALERTS via Datix (to be done within 2 weeks) You will need to provide a statement on progress / actions taken to date

Reply to ALERTS via voting button (to be done within 2 weeks)

No action required

Action complete – matter resolved Reply to ALERTS via Datix(to be done within 2 weeks) You will need to indicate that actions are completed and when this was done

Reply to ALERTS via Datix (to be done within 2 weeks) You will need to explain why no action is required

Distribute to all staff, as necessary within your service area The current version of any policy, procedure, protocol or guideline is the version held on the NHFT internet. It is the responsibility of all staff to ensure that they are following the current version Policy for the Production and Management of all Policies Within NHFT

41 of 44

Implementation Date: 02/ 09 / 2014

APPENDIX 13 – MEDICAL DEVICES GROUP – TERMS OF REFERENCE

Terms of Reference Medical Devices Group Function: The functions of the Medical Devices Group for Northamptonshire Healthcare NHS Foundation Trust are to: 1. Review and update the Medical Devices Policy. 2. Provide assurance that competencies are in place and validated. 3. Inform the Patient Safety Report with issues and good practice from the group. 4. Act as a forum to discuss complex medical devices alerts. 5. Review the Medical Device Safety Officers reports, and other data as available, to identify, prioritise and address medical device risks to minimise harm to patients. 6. Identification, development and promotion of the best practices for medical device safety. This will include supporting the implementation of external medical device safety alerts and guidance from NHS England, MHRA, NICE, manufacturers’ FIELD SAFETY NOTICES and other organisations. Implementation will require co-ordination and support for process and system changes to reduce the likelihood of occurrence and reoccurrence of serious medical device incident reports. 7. Provide regular feedback to clinical staff, patient care areas and hospital committees on medical device risks and planned action to minimise these risks. 8. Co-ordinate education and training support to improve the quality of medical device incident reports and safe medical device practices. 9. Assist in development and review of medical device use policies and procedures. 10. Review any new Medical Devices as requested and link to any standardisation as appropriate.

Quorum: A minimum of 8 group members must be in attendance. Core members of the Group are expected to send appropriate representation to the meeting if on occasion they are unable to attend. Frequency of Meetings: The Group will meet monthly but may convene additional meetings as appropriate. The current version of any policy, procedure, protocol or guideline is the version held on the NHFT internet. It is the responsibility of all staff to ensure that they are following the current version Policy for the Production and Management of all Policies Within NHFT

42 of 44

Implementation Date: 02/ 09 / 2014

Reporting: The Group will report to Trust Board via the Governance Committee. Core Group members are responsible for providing feedback from meetings to their respective teams. Circulation of Minutes: The Agenda will be distributed to Group members only. Minutes of the meeting will be distributed directly to all members of the Group. Review: The Terms of Reference and membership of the Group will be reviewed annually. Core Membership of the Safer Services and Environment Group 1. Executive Nurse (Chair) 2. Health and Safety/ Patient Safety Lead 3. Operations Lead 4. Nurse representative 5. Procurement Lead 6. Estates and Medical Devices Lead 7. In patient representation 8. Community representation 9. Pressure Ulcer Prevention Lead 10. Quality Lead 11. Infection Prevention and Control Lead 12. Patient Carer representation 13. Medical Devices Safety Officer (MDSO). 14. Pharmacy Lead st

Terms of Reference are to be reviewed on the 1 March 2015.

The current version of any policy, procedure, protocol or guideline is the version held on the NHFT internet. It is the responsibility of all staff to ensure that they are following the current version Medical Devices Management Policy

43 of 44

Implementation Date: 02.09.2014

The current version of any policy, procedure, protocol or guideline is the version held on the NHFT internet. It is the responsibility of all staff to ensure that they are following the current version Policy for the Production and Management of all Policies Within NHFT

44 of 44

Implementation Date: 02/ 09 / 2014