Medical Devices Policy

Medical Devices Policy Who Should Read This Policy Target Audience All Clinical Staff Version 1.0 December 2015

Ref. Contents Page 1.0 Introduction 4 2.0 Purpose 4 3.0 Objectives 4 4.0 Process 5 4.1 5.0 How and When to Contact MPCE Department Procedures Connected to this Policy 5 6 6.0 Links to Relevant Legislation 6 6.1 Links to Relevant National Standards 7 6.2 Links to Other Key Policy/s 8 6.3 References 8 7.0 Roles and Responsibilities for this policy 10 8.0 Training 13 9.0 Equality Impact Assessment 14 10.0 Data Protection Act and Freedom of Information Act 14 11.0 Monitoring policy s effectiveness 14 Appendices 1.0 Examples of Medical Devices 16 2.0 Examples of Labels Seen on Medical Devices 17 Version 1.0 December 2015 2

Explanation of terms used in this policy Medical Devices- Refers to an instrument, apparatus, appliance, material or other article, whether used alone or in combination, together with any software necessary for its application, which is intended by the manufacturer to be used for the purposes of: Diagnosis, prevention, monitoring, treatment or alleviation of disease Diagnosis, monitoring, treatment, alleviation of, or compensation for an injury or physical impairment Investigation, replacement or modification of the anatomy or of a physiological process Control of conception Examples of medical devices can be seen in Appendix 1 Single Use Medical Devices- A device that is intended to be used on an individual patient during a single procedure and then discarded. It must not be used on another patient. These can be identified by the single use symbol used on all packaging MPCE- Medical Physics and Clinical Engineering Department (RWT) MHRA- Medicines and Healthcare Products Regulatory Agency MDA- Medical Device Alerts Adverse Incident- Incident is an event which gives rise to, or has the potential to produce, unexpected or unwanted effects involving the safety of patients, users or other persons Version 1.0 December 2015 3

1.0 Introduction The Black Country Partnership Foundation Trust (hereafter referred to as the Trust) has a general duty under the Health and Safety at Work Act to safeguard health, safety and welfare of patients and staff when using medical equipment. These general duties are further extended under the Management of Health and Safety at Work Regulations and the Provision and Use of Work Equipment Regulations. There is also a requirement for the Trust to have in place good management procedures for medical devices as identified through: Managing Medical Devices (MHRA) April 2014 Institute of Physics and Engineering in Medicine (IPEM) Report 95 Risk Management and its Application to Medical Device Management CQC Fundamental Standards This policy does not apply to medical devices purchased by private individuals. Where Trust staff use a medical device that does not fall within the management responsibility of the Trust, the staff member should take reasonable steps to ensure that the medical device has been subject to the same management procedures as those applied by the Trust. Where a member of staff cannot satisfy themselves of this or has concerns about a device they should seek to use alternative equipment that is subject to Trust management procedures. It is also noted that some patients in the community setting will have medical devices on loan. 2.0 Purpose It is a requirement that all NHS Trusts have in place a comprehensive organisation wide policy on the deployment, monitoring and control of medical devices, as outlined in Managing Medical Devices: Guidance for Healthcare and Social Services Organisations 2014. This policy covers the provision for systems and process to ensure that whenever / wherever a device is used it is: Suitable for its intended purpose Properly understood by the professional and end user Maintained in a safe and reliable condition This policy and the related standard operating procedures include reference to three factors, which have a significant impact on device safety: Training of staff and end users including parents/carers of children or adults with complex health care needs who have a medical device(s) for use at home Maintenance of the medical device Decontamination of the medical device 3.0 Objectives This policy provides the guidance that managers and staff need to ensure that the process of selecting medical devices is suitable for the purpose intended and that systems and processes for the management of medical devices are fully understood by all managers, staff and end users. This will include: Risk management Device deployment Decontamination Version 1.0 December 2015 4

Training/competency Maintenance and repair Review of Medical Devices Annual Project Plan To understand life cost in relation to Medical Devices The Trust has set the following objectives to protect staff, volunteers and end users as far as is reasonably practical by: Adopting appropriate risk management measures identified through risk assessments and Central Alerting System (CAS) Clear accountability of everyone involved in the management and use of medical devices Ensuring that adequate time, training and resources are made available to meet these objectives Liaison with the Medical Devices Safety Officer (Trusts Governance and Risk Manager), Medicines Device Safety Officer, the Trusts Health and Safety Manager and Infection Prevention and Control Nurse for advice and guidance This policy and procedures applies to diagnostic and therapeutic equipment used within the Trust by authorised staff whether it be owned, leased or loaned. (See Appendix 1 for examples of Medical Devices). 4.0 Process The process for the procurement, maintenance, repair and use of medical devices is detailed in the Standard Operating Procedures (SOPs) which are linked to this policy. These are listed in section 5.0. In addition to this policy further information is available to all Trust staff via the Medical Devices intranet page and Devices in Practice - a checklist for using Medical Devices (June 2014) MHRA. N.B. Modifying medical devices or using them for purposes not intended by the manufacturer (off-label use) has safety implications and the individual may be held accountable. 4.1 How and When to Contact MPCE Department Staff should contact MPCE Department: For advice prior to purchase or replacement of medical devices For information on the standard approved list of medical devices When a medical device is faulty - always retain for inspection even if the device is single use and disposable When a device is due for service When staff require training on the use of medical devices To add new staff to the database for staff training Version 1.0 December 2015 5

Essential Contacts Name Designation Phone No Estates & Facilities Trust Helpdesk 0121 612 8068 Robert Millard RWT Head of Clinical Engineering 01902 695522 Elizabeth Showell Medical Device Nurse Trainer 01902 695530 07920 278520 Geoff Nixon Medical Devices Contract Manager & Head of Procurement 0121 612 8010 07786 625009 5.0 Procedures connected to this Policy To support the implementation of this policy the following core standard operating procedures are connected to this policy: Standard Operating Procedure 1 (SOP 1) Purchase Procurement and Standardisation of Medical Devices Standard Operating Procedure 2 (SOP 2) Trial, Loan or Lease of Medical Devices from Manufacturers/Suppliers Standard Operating Procedure 3 (SOP 3) Acceptance of Medical Devices from Manufacturer s Suppliers Standard Operating Procedure 4 (SOP 4) Training User Training on Medical Devices Standard Operating Procedure 5 (SOP 5) Transportation of Medical Devices Standard Operating Procedure 6 (SOP 6) Service, Repair and Maintenance of Medical Devices Standard Operating Procedure 7 (SOP 7) Decontamination of Medical Devices Prior to Service, Repair or Disposal Standard Operating Procedure 8 (SOP 8) Adverse Incidents Reporting of Adverse Incidents for Medical Devices Standard Operating Procedure 9 (SOP 9) Loaning Medical Devices to Patients within the Trust or Community Based Healthcare Standard Operating Procedure 10 (SOP 10) Replacement/Disposal of Medical Devices Standard Operating Procedure 11 (SOP 11) Battery Maintenance for Medical Devices Standard Operating Procedure 12 (SOP 12) Dissemination of Alerts within the Trust for Reusable Medical Devices Standard Operating Procedure 13 (SOP 13) Transfer of Ownership of Medical Devices 6.0 Links to Relevant Legislation Health and Social Care Act (2008) Revised Jan 2015 The primary focus of the Health and Social Care Act 2008 was to create a new regulator whose purpose was to provide registration and inspection of health and adult social care services together for the first time, with the aim of ensuring safety and quality of care for service users. The Care Quality Commission was established by statute, with enhanced powers to regulate primary care services, including hospitals, GP practices, Dental practices, Ambulance Services and Care Homes. These powers include failing registration, fines and even closing practices down which do not adhere to the Fundamental Version 1.0 December 2015 6

Standards in Quality and Safety. This cohesive approach has led to the CQC becoming one of the most powerful regulatory bodies in the UK. Health and Safety at work etc. Act 1974 This Act is the major piece of health and safety legislation in Great Britain. The Act introduced a comprehensive and integrated system to deal with workplace health and safety and the protection of the public from work activities. The Act places general duties on employers, employees, self-employed, manufacturers and importers of work equipment and materials. Responsibilities are placed to produce solutions to health and safety problems, which are subject to the test of reasonable practicability. Various regulations are made under the Act, which have the same scope, many of these evolving from European Directives, which enables the potential to achieve clear and uniform standards. Consumer Protection Act (1987) The aim of the Consumer Protection Act is to help safeguard the consumer from products that do not reach a reasonable level of safety. Part I of the Act, which implements into UK law the provisions of the Product Liability Directive (85/374/EEC), came into force on 1 May 1988. Part II of the Act, containing consumer safety provisions, came into force on 1 October 1987. Part III of the Act regulates price indications for goods, services, accommodation, or facilities. In the safety field, this Act establishes a civil law right of redress for death, or injury, caused by using defective consumer goods. The Act also makes it a criminal offence to give consumers a misleading price indication about goods, services, accommodation or facilities. Links to other legislation: Medical Devices Regulation (2010) The Management of Health and Safety at Work Regulations (1999) The Provision and Use of Work Equipment Regulations (1998) Waste Electrical and Electronic Equipment Regulations (WEEE Regulations) (2006) Carriage of Dangerous Goods and Use of Transportable Pressure Equipment 2009 and 2011 Amendment Regulations European Agreement Concerning the International Carriage of Dangerous Goods by Road (2013) COSHH Regulations (2002) Electrical Equipment (Safety) Regulations (1974) The Electricity at Work Regulations (EWR 13) General Product Safety Regulations (2005) The Lifting Operations and Lifting Equipment Regulations (1998) The Pressure Systems Safety Regulations (2000) Version 1.0 December 2015 7

6.1 Links to Relevant National Standards Managing Medical Devices (MHRA, April 2014) Managing Medical Devices outlines a systematic approach to the acquisition, deployment, maintenance (preventive maintenance and performance assurance), repair and disposal of medical devices. It is intended primarily for people in hospital and community based organisations that are responsible for the management of reusable medical devices, to help them set up and develop systems that promote the use of the medical devices for safe and effective health care. CQC Fundamental Standards- Regulation 12 The intention of this regulation is to prevent service users from receiving unsafe care and treatment, in order to prevent any avoidable harm or risk of harm. CQC understands that there may be inherent risks in carrying out care and treatment, and will not consider it to be unsafe if providers can demonstrate that they have taken all reasonable steps to ensure the health and safety of service users, and to manage any risks that may arise during care and treatment. To meet the requirement of this regulation, the provider must take appropriate steps to assure itself that the care and treatment it delivers is safe for all service users. A provider would not be able to meet any of the requirements of this regulation if it did not have access to the necessary equipment or medicines, or did not use equipment safely. CQC Fundamental Standards- Regulation 15 To meet the requirements of this regulation, providers must ensure that equipment is used for its intended purposes and in accordance with the manufacturer s instructions. Where the equipment required to deliver care and treatment is owned by the service user, or is supplied by a third party (for example, a different service or an independent supplier) the provider must make every effort to ensure the equipment is suitable for use. If the equipment is unsuitable or not clean, the provider may decide not to provide care and treatment until it is clean (which may mean the provider needs to clean it, if appropriate) and/or suitable, or when replacement(s) are available. CQC would expect the provider to have taken all reasonable steps to ensure that it addressed the issue in a timely manner, and that it made appropriate support or alternative arrangements for the service user to receive their care and treatment. 6.2 Links to other key policy/s Infection and Control Assurance Policy The aim of the policy is to: Ensure that robust arrangements for the prevention and control of infection are in place within the Trust Ensure that infection prevention and control is embedded at all levels of the organisation from the Board to the Ward Ensure Standard operating procedures and policies for effective infection prevention and control are in place (See Manual of Infection Control Standard Operating Procedures) Version 1.0 December 2015 8

Incident Reporting Policy The purpose of this policy is to make clear the system used for reporting incidents involving patients, staff and others undertaking activities on behalf of the Trust. Health and Safety Policy This policy aims to promote and enable an organisational and systematic approach to the development of Health and Safety procedures and protocols throughout the Trust and to set out the requirements of the Trust to demonstrate and achieve legislative compliance. 6.3 References MHRA Managing Medical Devices - Guidance for healthcare and social services organisations (April 2014) MHRA Devices in Practice Checklists for using Medical Devices (June 2014)http://webarchive.nationalarchives.gov.uk/20141205150130/http://www.m hra.gov.uk/home/groups/dts-bs/documents/publication/con007424.pdf (Link accessed June 2014) The Management and decontamination of surgical instruments used in acute care (DoH 2013).https://www.gov.uk/government/publications/managementand-decontamination-of-surgical-instruments-used-in-acute-care (Link accessed June 2014) BS EN 60601-1:2006 Medical electrical equipment, general requirements for basic safety and essential performance BS EN 60601-1-2:2007 Medical electrical equipment, general requirements for basic safety and essential performance. Collateral standard. Electromagnetic compatibility. Requirements and tests BS EN 60601-1-11:2010 Medical electrical equipment, general requirements for basic safety and essential performance. Collateral standard. Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment European Council Directive 93/42/EEC concerning medical devices (1993) CQC: Guidance for Providers on Meeting the Fundamental Standards and on CQC s Enforcement Powers (July 2014) Version 1.0 December 2015 9

7.0 Roles and Responsibilities for this Policy Title Role Responsibilities Deputy Chief Executive & Director of Resources Trust Board Executive Lead Strategic - Implementation of this policy - Agreeing action plans to address issues relating to this policy - Strategies and innovations to improve current practice - Updating the Trust Board regularly on any issues connected to this policy - Medical devices management - Strategic overview and final responsibility for setting the direction of this policy - Ensure that it fulfils its statutory responsibilities for the management of medical devices Quality and Safety Committee Monitoring - Monitor and review performance in connection with this policy and receive exception and progress reports Quality and Safety Steering Group Group Quality & Safety Steering Groups Medical Devices Group Infection Prevention & Control Committee Governance Assurance Unit Scrutiny and Performance Monitor Responsible - Scrutinise the implementation of a systematic and consistent approach to this policy - Provide exception and progress reports to the Quality and Safety Committee - Monitor and review all incidents, complaints and claims relating to this area of practice and policy within their Group - Receive results and recommendations of all related completed audits and be responsible for monitoring action plans to implement changes to current practice until completion - Support Deputy Chief Executive and Director of Resources in Trust wide medical devices management - Responsible for the development and implementation of the Medical Devices Policy and associated procedures - Responsible for improving communication about medical devices within the organisation - Ensure involvement of clinicians, technical staff and users in relation to any proposed changes, including configuration settings relating to devices where appropriate - Define persons responsible for device management task, training and safe device operation - Define and review The Management of Medical Devices policy - Review incidents including governance issues relating to medical device management - Review Medical Devices Project Plan Quarterly - Responsible for approving this policy Responsible - Support Deputy Chief Executive and Director of Resources in Trust wide medical devices management - Includes; a purchasing advisory, risk management and estates function Governance - Provide central point of contact for the Medicines and Healthcare products Regulatory Agency (MHRA) - Disseminate safety alerts and other notices issued by agencies such as NHS England, Medicines and Healthcare Products Regulatory Agency (MHRA) and NHS Estates to a nominated representative in each Service when relevant - Maintain a record of actions taken as a result of the safety notices/alerts - Produce a monthly Central Alerting System (CAS) status for the Quality and Safety Steering Group - Ensure failure to meet deadlines for action is recorded on the Trust risk register and escalated in line with the Trusts escalation procedures - Ensure incidents involving medical devices are appropriately investigated and reported to the MHRA Version 1.0 December 2015 10

Title Role Responsibilities Procurement Managers/Buyers Finance Department Infection Prevention & Control Team Medical Physics and Clinical Engineering Department (at RWT) Clinical Directors/Group Directors Nominated Medical Device Leads (Clinical Groups) & Team Leaders in Community Services Group Managers Procurement Costing Guidance and Support Support Operational Leads Implementation Operational Medical Devices Policy - Lead in all procurement matters associated with medical devices and act as first point of contact when Groups and Departments require the purchase of medical devices - Restrict purchase of medical devices which are not on the approved list of products provided by MPCE - Work closely in relation to procurement, trials and tenders of medical devices ensuring compliance of this policy and all relevant legislation - Manage and maintain the Trust Medical Devices Intranet web page - Responsible for all asset lifetime costing of medical devices. MPCE and Procurement will work closely with them for new devices purchased and for devices being condemned or replaced - Responsible for providing input into the Medical Devices Group and to advise accordingly in line with this policy and other related policies and procedures - Advise on decontamination methods of re-useable medical devices in line with the manufacturers recommendations - Assist the Trust to develop an approved products list for all medical devices used across all departments - Ensure all medical non-disposable devices in use are CE marked - Provide a service to the Trust as detailed within the service specification - Be an active member of the Trust s Medical Devices Group meetings - Provide monthly reports in relation to devices maintenance and training - Assist the Trust with the investigation of incidents involving medical devices - Provide advice as authorised and competent MDSO as support to the Trust - Lead discussions around this topic area and policy at Group Quality and Safety Steering Group meetings - Oversee the completion of audits in respect of this topic area and policy - Provide updates on this area of practice and policy within their Group to the Quality and Safety Steering Group - Key point of contact for ensuring Medical Device Alerts, Patient Safety Notices and other Safety Alerts are acknowledged by their managers and to act on the managers behalf when they are unavailable - Responsible for ensuring the safe use and operation of medical devices within their clinical areas - Ensure that requests for medical devices include the Risk Assessment, Acceptance Checks, training and maintenance arrangements - Ensure all medical devices have been identified within their areas of responsibility - Ensure all managers, staff, and end users have completed a competency review form and return it to the Medical Device trainers so that staff are trained appropriately and highlight when there are any areas for further training i.e. patient specific training. This will ensure that adequate training in the safe use, operation and decontamination of medical devices is evidenced on the devices record folder. See SOP 4 - Ensure medical devices are purchased to meet the needs of the users and ensure the best practicable patient experience within budgetary constraints to meet clinical need, whilst allowing for ease of decontamination and maintenance - Ensure a common procedure is followed for accepting new devices into service including identifying significant risks associated with use, repair, cleaning and disposal and updating the inventory of new equipment as set out in the standard procedures which support the implementation of this policy - Provide support and guidance regarding resources to enable this policy to be implemented - Ensure systems are put in place to enable this policy to be implemented within their service areas - Ensure all managers are aware of the policy and promote good practice Version 1.0 December 2015 11

Title Role Responsibilities Team Leaders/Ward & Department Managers/Senior Nurses All Clinical Staff Operational Adherence Medical Devices Policy - Take ownership and be responsible for the medical devices used in their areas - Identify the level of clinical risk and training required for medical devices in use within their service - Ensure that all staff who use equipment have completed a competency review form and return it to the Medical Device trainers so that staff are trained appropriately and highlight when there are any areas for further training, i.e. patientspecific training. This will ensure that any training undertaken is recorded on the Trust s medical device training database by the Medical Device Trainers in line with SOP 4 - Retain instruction manuals, technical instructions etc. relating to medical devices and make them available to end users - Ensure all staff within their area of responsibility are made aware of the policy and the standard procedures are followed - Identify a link person for coordination of medical devices issues in each area - All clinical wards/departments have responsibility for having an up-to-date inventory of all their medical devices within the area under their control and work closely with MPCE in keeping their list up to date. This is in order to demonstrate compliance with CQC Regulation 12: Safe Care and Treatment - All clinical wards/departments must have in place a procedure where by all medical devices are functionally checked in accordance with the manufacturers user guides prior to use on a patient and decontaminated in line with Trust infection prevention protocols at regular intervals and in line with manufacturers recommendations - Report incidents associated with medical devices in line with Trust policy and to the MHRA if appropriate - Familiarise themselves with this policy and adhere to its principles in order to be able to respond to the immediate needs of patients and service users - Responsible for checking devices and alerting the attention of Trusts Estates and Facilities Helpdesk when items are found requiring service/repair - Ensure the medical device competency review forms are completed and submitted as/when requested (see SOP 4) - Be trained in the safe and appropriate use of medical devices (see SOP 4) - Be familiar with operating procedures and risk assessments - 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 - Ensure medical devices are appropriately decontaminated according to Infection Prevention and Control Policies - Ensure that all disposable/single use items are CE marked - Ensure expiry dates, PPM dates, service due dates etc., are checked prior to use - Report incidents and near misses associated with the performance or safety of diagnostic and/or therapeutic equipment including entry onto the DATIX reporting system - Use all medical devices for their intended purposes. Modifying medical devices or using them for purposes not intended by the manufacturer (off-label use) has safety implications and the individual may be held accountable Version 1.0 December 2015 12

8.0 Training What aspect(s) of this policy will require staff training? Generic Medical Device Training Specialist Devices Training Manual Handling and Cardiopulmonary Resuscitation Equipment Training Which staff groups require this training? Clinical staff who use generic medical devices as determined by the individuals medical devices competency review form (See SOP 4) Clinical staff who use specialist medical devices as determined by the individuals medical devices competency review form (See SOP 4) Is this training covered in the Trust s Mandatory and Risk Management Training Needs Analysis document? No No If no, how will the training be delivered? Internally - The training provided will be in the safe use of the device itself with relevant assessment of competency in the use of the equipment checked by trainers Internally - Specific training packages that are competency based for high risk Equipment Who will deliver the training? Training will be delivered by any of the following personnel: Manufacturers / Company Trainers Medical Device Trainers and / or other Matron/Practice Development Nurse Ward/Department Staff who have undertaken relevant Train the Trainer courses Train the Trainers or Company Trainers All clinical staff Yes Learning and Development Team How often will staff require training As required for new starters Prompts for refresher training: High risk devices- every 3 years Medium risk devices- every 6 years Low risk devices- one off training As required For new starters Prompts for refresher training every 3 years Annually Who will ensure and monitor that staff have this training? Ward/Department Managers in conjunction with the Medical Device Trainers Database Ward/Department Managers in conjunction with the Medical Device Trainers Database Workforce Development Group Version 1.0 December 2015 13

9.0 Equality Impact Assessment Black Country Partnership NHS Foundation Trust is committed to ensuring that the way we provide services and the way we recruit and treat staff reflects individual needs, promotes equality and does not discriminate unfairly against any particular individual or group. The Equality Impact Assessment for this policy has been completed and is readily available on the Intranet. If you require this policy in a different format e.g. larger print, Braille, different languages or audio tape, please contact the Equality & Diversity Team on Ext. 8067 or email EqualityImpact.assessment@bcpft.nhs.uk 10.0 Data Protection and Freedom of Information This statement reflects legal requirements incorporated within the Data Protection Act and Freedom of Information Act that apply to staff who work within the public sector. All staff have a responsibility to ensure that they do not disclose information about the Trust s activities in respect of service users in its care to unauthorised individuals. This responsibility applies whether you are currently employed or after your employment ends and in certain aspects of your personal life e.g. use of social networking sites etc. The Trust seeks to ensure a high level of transparency in all its business activities but reserves the right not to disclose information where relevant legislation applies. 11.0 Monitoring this policy is working in practice What key elements will be monitored? (measurable policy objectives) Where described in policy? How will they be monitored? (method + sample size) Who will undertake this monitoring? How Frequently? Group/Committee that will receive and review results Group/Committee to ensure actions are completed Evidence this has happened All wards/departments will ensure all new medical devices are entered onto the asset data base. This includes devices used in the community by Trust staff All medical devices will be maintained, clean and ready for use SOP 3 Routine checking of devices against each department asset register Risk and safety audit Matrons/Departmental Managers SOP 7 Audit check Matrons/ Departmental Managers IPC audit check Infection Prevention and Control Team Annually Monthly Monthly Medical Devices Group Medical Devices Group Group Quality & Safety Steering Groups Group Quality & Safety Steering Groups Inventory number and user training identification label/ Completed action plan signed off/ minutes of meeting Manufacturer sheets retained/ Service and maintenance Version 1.0 December 2015 14

What key elements will be monitored? (measurable policy objectives) All staff will be trained & competent in the use of medical devices as required by their manager Where described in policy? How will they be monitored? (method + sample size) Announced and unannounced visitsresults recorded and reported Who will undertake this monitoring? SOP 4 Annual Appraisal Departmental Managers/Team Leaders Supervision/1-1s How Frequently? Group/Committee that will receive and review results Group/Committee to ensure actions are completed Evidence this has happened Risk Facilitators Annually interventions recorded on Medical Devices Asset Database/ completed action plan signed off/ minutes of meeting Annually Groups Group Quality & Safety Steering Groups Appraisal Reports/ action plan signed off/ minutes of meetings Training records will be maintained for each staff member Wards/departments and team bases that are noncompliant with responding/actioning alerts from GAU Compliance from medical devices managers responding to Central Alerting System (CAS) SOP 4 Reports to Groups The Medical Physics and Clinical Engineering department Risk and safety audit Matrons SOP 12 Report Governance Assurance Unit SOP 12 Report Governance Assurance Unit Quarterly Quarterly Quarterly Health and Safety Committee and the Medical Devices Group Medical Devices Group and Infection Prevention & Control Committee Medical Devices Group and Infection Prevention & Control Committee Group Quality & Safety Steering Groups Group Quality & Safety Steering Groups Group Quality & Safety Steering Groups Records of training delivered/ Group Attainment, Service Group, Speciality Attainment and Medical Attainment Reports Action plan signed off/ minutes of meeting Action plan signed off/ minutes of meeting Version 1.0 December 2015 15

Appendix 1 Examples of Medical Devices Used in the diagnosis or treatment of disease, or monitoring of patients Used in life support In vitro diagnostic medical devices and their accessories Used in general care Equipment used by people with disabilities Devices supplied by pharmacists Anaesthetic machines Blood glucose measuring devices Chiropody and Podiatry equipment CT scanners Dental instruments, equipment and materials Dressings Endoscopes Examination gloves Intravenous (IV) administration sets and pumps Nebulisers Ophthalmic equipment Pacemakers Peak Flow Meters Surgical instruments Suction equipment Syringes and needles Ultrasound Dopplers Urinary Catheters Defibrillators Patient monitors Pulse Oximeters Ventilators Blood glucose measuring devices Cholesterol test kits Pregnancy test kits Urine test strips Adjustable beds Patient hoists and other transfer equipment Pressure relief equipment Stoma care equipment External prostheses and orthoses Hearing aids Incontinence aids Prescribable footwear Standing frames Urine drainage systems Walking aids Wheelchairs and special support seating. Condoms Contact lens care products Chlamydia test kits Cholesterol test kits Pregnancy test kits Stoma equipment Urine test strips Version 1.0 December 2015 16

Appendix 2 Examples of Labels Seen on Medical Devices Decontamination/Equipment Status Label Equipment On Loan Label Inventory Labels Electrical Safety Test Labels Service Labels Low, Medium or High Risk Equipment Version 1.0 December 2015 17

Policy Details Title of Policy Unique Identifier for this policy State if policy is New or Revised Medical Devices Policy BCPFT-CLIN-POL-12 New Previous Policy Title where applicable Policy Category Clinical, HR, H&S, Infection Control etc. Executive Director whose portfolio this policy comes under Policy Lead/Author Job titles only Committee/Group responsible for the approval of this policy Month/year consultation process completed * N/A Clinical Deputy Chief Executive & Director of Resources Medical Devices Group Medical Devices Group April 2015 Month/year policy approved November 2015 Month/year policy ratified and issued December 2015 Next review date December 2018 Implementation Plan completed * Equality Impact Assessment completed * Previous version(s) archived * Disclosure status Key Words for this policy Yes Yes Yes B can be disclosed to patients and the public medical equipment, maintenance, risk management, device deployment, decontamination, repair, MHRA, MDA, Adverse Incident * For more information on the consultation process, implementation plan, equality impact assessment, or archiving arrangements, please contact Corporate Governance Review and Amendment History Version Date Details of Change 1.0 Dec 2015 Alignment of policies following TCS and new policy format Version 1.0 December 2015 18