Medical Devices Management Policy

SH CP 40 Medical Devices Management Policy Version: 3 Summary: Keywords: Target Audience: This Policy sets out the process and responsibilities for safe and effective management of medical devices throughout Southern Health NHS Foundation Trust. Buying, Disposal, Equipment, Medical Devices, Maintenance, Management, Procurement, Safety, Servicing. All clinical or identified staff who use medical devices. Next Review Date: October 2018 All staff who manage, order or transport medical devices. Approved & Ratified by: The Medical Devices Forum Date of meeting: 11 August 2016 Date issued: Author: Director: Tracy Hammond, Medical Devices Safety Officer Julie Dawes, Director of Nursing 1

Version Control Change Record Date Author Versio n Page Reason for Change 13-07-12 Marie Corner V1 Various Syntax & clarification following circulation 30-06-14 Marie Corner V2 Various Review and update of DB 2014 20-05-16 Tracy Hammond V3 Various Review and update. New Template, organisational structure and quick reference guide. Amendments made throughout. Reviewers/contributors Name Position Version Reviewed & Date Tracy Mackenzie Head of Audit and Compliance V1 17-05-12 Theresa Lewis Infection Prevention and Control Lead V1 21.05.12 Sarah Baines Clinical lead for OPMH V1 29-06-12 Philomena Winterbourne Areal Director Mid -west Hampshire ICS V1 02-07-12 Karl Beanland Estates Operations Manger V1 02-07-12 Mandy Norris TQTwentyone Business Support Manager V1 02-07-12 Steve Coopey Clinical Development Lead V1 10-07-12 Liz Ranger Locality Clinical Manager Health Visiting/School V1 13-07-12 Nursing Romsey The Medical Device Forum V1 Tracy Hammond Medical Device Lead for Specialised Services V2.2 26-08-14 David Batchelor Compliance Officer V2.2 26-08-14 Claire Bennett Trust Manual Handling Adviser V2.2 26-08-14 Simon Johnson Trust Resuscitation Lead V2.2 26-08-14 Paula Hull Head of Professions SW ISD V2.2 26-08-14 Anne Leitch AMH V2.2 26-08-14 Joanne Spencer Clinical Service Manager LNFH V2.2 26-08-14 David White Trust Health Safety and Security Lead V2.2 26-08-14 Theresa Lewis Infection Prevention and Control Lead V2.2 26-08-14 The Medical Device Forum V2.2 26-08-14 Tracy Hammond Medical Devices Safety Officer V3 July 2016 2

Quick Reference Guide For quick reference, this page summarises the actions required by this policy. This does not negate the need to be aware of and to follow the further detail provided in this policy. The chart below shows the flow of information from clinical staff to Trust Board. Clinical Staff Service Managers Divisional Leads Medical Devices Forum Patient Safety Forum Trust Board Multiple services are available to provide assistance with the management of medical devices in Southern Health NHS Foundation Trust. Procurement Medical Devices Safety Officer (MDSO) BCAS Biomedial Services Ltd. Infection, Prevention and Control Assist and advise with purchasing and hiring of medical devices. Advises staff on medical devices Trust-wide. Provide maintenance, repair and servicing of medical devices. Provide advice and assistance on the cleaning and decontamination of medical devices. 3

Contents Section Title Page 1. Introduction 5 2. Who does this policy apply to? 5 3. Definitions 5 4. Duties and responsibilities 5 5. Main policy content 8 6. Training requirements 14 7. Monitoring compliance 15 8. Policy review 16 9. Associated trust documents 16 10. Supporting references 16 Appendix 1 Training needs analysis 17 Appendix 2 Equality Impact Assessment Tool (to be completed) 18 4

Medical Devices Management Policy 1. Introduction The purpose of this document and its related tool kit is to ensure that the Trust is able to identify the risks associated with medical devices, reduce them to an acceptable level or where possible eradicate them totally. Effective management of medical devices in the Trust is necessary to ensure that National Standards are adhered to. Good management of medical devices greatly assists in reducing their potential for harm. 2. Who does this policy apply to? This policy applies to all staff who use medical devices and any staff who manage, order or transport medical devices. 3. Definitions Medical device means any instrument, apparatus, implement, machine, appliance, implant, reagent for in vitro use, software, material or other similar or related article, intended by the manufacturer to be used, alone or in combination, for human beings, for one or more of the specific medical purpose(s) of: diagnosis, prevention, monitoring, treatment or alleviation of disease, diagnosis, monitoring, treatment, alleviation of or compensation for an injury, investigation, replacement, modification, or support of the anatomy or of a physiological process, supporting or sustaining life, control of conception, disinfection of medical devices providing information by means of in vitro examination of specimens derived from the human body; and does not achieve its primary intended action by pharmacological, immunological or metabolic means, in or on the human body, but which may be assisted in its intended function by such means. 4. Duties and Responsibilities Chief Executive Officer The overall accountability for the safe and effective management of medical devices resides with the Chief Executive Officer of the Trust as accountable officer to the Trust s Board. Director of Nursing and Quality The Director of Nursing and Quality has been designated as the trust lead for medical devices by the Board. The Trust lead has the responsibility to ensure the Trust meets all relevant legislation and standards. 5

They are responsible for: Receiving information and making recommendations to the Trust via the Trust Board and the Trust s patient Safety Forum on the appropriate application of medical equipment for clinical service, research and education. Making arrangements to ensure that medical equipment is utilised on the basis of evidencebased healthcare and that if such evidence is unavailable that a structured evaluation programme is undertaken. Director of Finance The Director of Finance for the Trust will determine the available capital budgets for the replacement of medical equipment, and for: Ensuring compliance with the Trust s Standing Orders and Standing Financial Instructions and financial probity associated with the acquisition, use, and disposal of any item of equipment. Ensuring that satisfactory arrangements are in place for the provision or procurement of medical equipment. Ensuring the appropriate mechanism is in place for the adjudication on the purchase of specific items of medical equipment and for the receipt and assessment of individual business cases for major capital purchases. Maintaining an operational overview of the provision and utilisation of medical equipment for clinical service requirements of the Trust in line with the Controls Assurance Standard for Medical Devices Management. Medical Device Safety Officer (MDSO) The MDSO is appointed by the trust to work in support of the director with responsibility for medical devices. The officer helps support and set out long term objectives for the management of medical devices; including strategic replacement, development and equipment procurement. In addition to: Active membership of the National Medical Devices Safety Network. Improving reporting of and learning from medical devices incidents in the organisation. Managing medical device incident reporting in the organisation, review all medical devices incident reports to ensure data quality for local and national learning, and where necessary investigate and get additional information from reporters. Ensure that medical device incidents are sent to the NRLS as and when required. Receive and respond to requests for more information from the Patient Safety Domain in NHS England and the MHRA about medical device incident reports. Work as a member of the medical devices safety forum to deliver the responsibilities listed in the Patient Safety Alert: Improving medical device incident reporting and learning (NHS/PSA/D/2014/006). Act as an additional senior point of contact for manufacturers and support local actions on Field Safety Notices. Improve reporting of medical devices incidents and support the dissemination of medical devices safety communications from NHS England and the MHRA throughout the organisation. Report adverse incidents to the MHRA and other official agencies. C-ordinate medical device safety and management arrangements across the organisation to ensure relevant statutory, mandatory, regulatory and best practice requirements are met. To be the key point of contact for all medical devices related queries for frontline staff and managers. 6

Divisional Leads Divisional leads are responsible for representing their division at the medical devices forum, collating the divisional response and disseminating information for their area in line with the medical device forum terms of reference. Service / Locality Manager s The manager for any service that uses medical devices is responsible for ensuring that procedures and organisational arrangements are in place for the appropriate management of medical equipment in their area. That adequate numbers of staff are designated to achieve the obligations below. Work with the Trust Contractor to maintain an accurate and up-to-date inventory for medical devices in their area. The provision of appropriate training for staff and others (e.g. academic staff, medical students and agency staff) in the safe, appropriate use and decontamination of equipment, as per the manufacturer s guidelines. The administration of documentation, the training given to staff for devices and their competency (where required) to use such equipment. The reporting and subsequent investigation of any adverse incident or untoward event involving medical devices and ensuring that any resulting action plans are monitored. Ensuring that when alerts are received regarding medical devices they are acted upon promptly. If responsible for equipment needing specific decontamination e.g. endoscopy or dental, service managers must ensure staff are trained and competent and records are held locally. Ensuring the appropriate storage of medical devices. Provision of sufficient, appropriate equipment to deliver care and reduce risks to staff and service users. All staff All staff involved directly and indirectly in health care provision are responsible for ensuring that they: Identify and undertake any training or competency needs required for their role Decline to use or operate any medical device which they have not been adequately trained to use and / or do not feel competent and confident to operate Use medical devices in a safe and effective manner in accordance with guidance and the manufacturers intended use Maintain ongoing records of their training in relation to medical devices for appraisals and Continued Professional Development (CPD) Report any concerns relating to the safe usage of medical devices to their line manager Report any defects via the appropriate channels Participate and contribute to audit, risk assessment and service improvement Know how to decontaminate reusable devices and dispose of single use devices. BCAS Biomed The Trust has subcontracted the management of the medical device inventory, the scheduling, servicing and maintenance of medical devices to BCAS Biomedical. They are contracted to: Schedule servicing (PPM) and repair medical devices 7

Undertake the responsibility of maintaining the records of Lifting Operations and Lifting Equipment Regulations 1998 (LOLER). Provide monthly contract updates and annual reports. BCAS also work with the trust to set out a long-term approach and objectives for the management of their medical devices, including strategic replacement and equipment procurement planning. This includes the monitoring of breakdowns and expected life expectancy of medical devices. The Medical Devices Forum The Trust has a Medical Devices Forum which is a sub-group of the Patient Safety Forum. The Forum is chaired by the Head of Governance, Assurance and Quality. Membership of the MDF includes representatives from all areas of the Trust: Core Members Representative from the East ISD Representative from the West ISD Representative from Children s Services Representative from Adult Mental Health Representative from Social Care Representative from Learning Disability Services Representative from Learning & Development (LEaD) Representative from Procurement Representative from Infection Prevention and Control Representative from the Contracts manager & Provider Trust Medical Devices Safety Officer Co-opted Members Representative from the Resuscitation Team Representative from the Manual Handling Team Representative from Quit for life Representative from Estates Services Representative from Health and Safety Representative from Medicines Management Reporting to the Board The reporting line to the Trust Board is through the Patient Safety Meeting who report to the Quality & Safety Committee (sub-board committee). Divisional Leads report from their areas to the Medical Devices Forum on a quarterly basis. 5. Main policy content Procurement of Medical Devices All procurement of medical devices must to go through the Trust procurement team. The procurement team offer advice with regard to any contracts currently in place for the purchase of equipment. Decisions to purchase medical devices will be authorised by the relevant manager or Division. Where appropriate, advice should be sought from the relevant lead (e.g. Manual Handling, LEaD, Medical Device Safety Officer, Health and Safety). 8

In situations where medical equipment has specific associated hazards (e.g. ionising radiation, laser radiation, ultra-violet radiations, magnetic fields, radio frequencies etc.) the relevant adviser or specialist must be consulted on the acquisition of the equipment and the installation. A written risk assessment must be completed. Medical equipment must not be purchased unless it is CE marked. Clinical Trials are an exception; clinical trials are only to be conducted to this as use or being evaluated in respect of the conditions contained within EN540 for example ONLY under conditions set out under the control of the research and development department. This is so specialist criteria such as the conditions contained within EN540 for example can be assessed. Free or Donated Devices Devices donated by company representatives may be free but will usually incur consumable and maintenance costs. These devices should be declined unless specific authority to accept has been granted by the division and risk manager. All such devices if assessed as acceptable must be added to the relevant inventory and covered by the relevant indemnity. Responsibility for the service repair and maintenance costs will need to be financed by the division Equipment Standardisation The Trust, wherever practical, operates a standardisation policy on the purchase of medical devices. This ensures that equipment is purchased from the same supplier in order to ensure: Ease of user training Reduction in risk due to users being familiar with type of equipment Availability of in-house expertise and ease of servicing Cost benefits in terms of purchase of equipment and consumables Cost reduction if equipment is to be placed on external contract Note: Standardised equipment must meet clinical need and where possible be standardised across all divisions in the Trust. Capital and Revenue Business Case Submissions Information on accessing capital and on procedures to be followed for the procurement of medical equipment can be sought from the Financial Procedures policy (SH FP 1) and the Capital Management Group. Divisional medical device leads and the medical device adviser can also assist with the process. Whilst capital purchase is likely to be the preferred option for the acquisition of equipment, alternative arrangements should be explored according to the intended purpose, frequency of use and the expected life span e.g. the hire of medical equipment for a short term provision may be perfectly adequate. Leasing may also be considered and details can be obtained from our procurement partners. The lease hire of highly technical equipment may remove the need for capital expenditure and be more cost effective. For capital purchase it will be necessary to prepare a business case for consideration at managerial level. The Service Manager concerned is responsible for ensuring that both clinical and technical specifications are developed and put forward to the Medical Device Lead for the divisions in a detailed business case and using standard Outline Business Case (OBC) proforma. This will then be scored in a manner approved by the Medical Device Forum and prioritised. As far as is possible, replacement of equipment should be part of an cyclic replacement programme, and submissions made to the Medical Device Forum and Capital Planning Group via 9

the Medical Device lead for the division in good time for the forthcoming financial year. In this way, equipment planning can be more closely linked to the service and business planning process. The request for capital funding will be scored using a criteria approved by the Medical Device Forum Wherever possible the advice of persons with specialist knowledge should be sought in the development of the business case and specification and subsequent selection and/or adjudication process e.g., Health and Safety Adviser, Infection Prevention and Control Nurse and maintenance contractor, Research Governance lead. After completion of the business case it is required that informal approval is obtained from the appropriate director. Once the plan is approved by the relevant Director it should be submitted to the Medical Device Safety Officer (MDSO) to consider the request and ensure consideration of health, safety and maintenance have been made. The Procurement Department will advise on an appropriate system to be used to ensure that the process is fair to all suppliers in the process. It is essential to discuss in detail with the procurement department clinical requirements and revenue costs (in particular maintenance and training). Financial provisions The service manager must make financial provision and arrangements for medical equipment to be subject to maintenance and repair programme as appropriate to ensure compliance with statutory requirements. This should be undertaken in association with our procurement team. This can be arranged, via tender and contract. Guidance on maintenance and maintenance of records where they are involved should also be provided. Whichever is the case, maintenance must be in consideration of the manufacturer s instructions. As a guide price 6% of the cost of the equipment should be set aside for maintenance per annum. There may be cost to the equipment users for service/repairs carried out by contractors. The responsibility for the cost of this lies with the division Repairs required due to equipment abuse are addition to contract and are costed to the user departments cost code. The capital asset value of the equipment and the relative cost of entering into a maintenance agreement might be such that the most cost effective solution is to replace the item of medical equipment when defective and only have inspections to ensure safety. Advice should be sought from the relevant specialist as appropriate. Clinical Evaluations/Trials Clinical Evaluation is the evaluating of equipment prior to purchase. A piece of equipment must be CE marked and approved for sale. All requests for evaluations should be made via procurement in association with a tender prior to making any arrangements with external companies. Before such evaluations are carried out the equipment must be reviewed to ensure it is traceable, is suitable for its intended purpose and that electrical safety is assured. On acceptance the equipment will be given a unique reference number. Equipment obtained for clinical evaluations is treated as loan equipment. It is to be safety assured and the master indemnity completed. A loan label is placed upon the equipment to distinguish it. It is important to note that evaluation of any equipment /device must only be carried out in association with the procurement partner. Relevant indemnity forms to protect the Trust should there be a clinical incident associated with the evaluation must be obtained by the Trust prior to the start of the trial. 10

Evaluations must be documented equitable and transparent this requires time, effort, suitable clinical environment and patients. It is therefore advisable to reduce number of evaluations as far as practically possible. If the Medical Device Safety Officer (MDSO) considers that there are significant areas of nonconformity with the safety standards and hence that the Trust are not meeting its statutory requirements, they will advise the user not to evaluate or purchase the equipment on safety grounds. This will be reported to the Medical Devices Forum. Medical devices inventory The Trust maintains an inventory of medical devices and that the Trust identifies and implements appropriate strategies for inspecting, testing and maintaining all equipment on the inventory. This responsibly has been out sourced to BCAS Biomedical Services Ltd. All new assets acquired by the Trust, from whatever source, will be registered on the Trust s / BCAS database on approval to purchase and/or on commissioning. Databases maintained by other agencies working for the Trust, will be used to provide records on behalf of the trust where contracted (such as BCAS). It is the responsibility of line mangers to ensure the inventory is maintained, accurate and audited. Managers must inform BCAS on the purchase of new equipment or the redeployment or disposal of equipment. In line with the statutory requirements, all maintenance and testing records will be subject to a retention period of 11 years. Prescribers of Medical Equipment / Devices A Prescriber of medical devices is defined as a person who decides which is an appropriate device for a given patient. Examples of such equipment are: infusion devices, pain relief equipment, aids and appliances. Where required, equipment and device prescribers need to be competent in the use of the medical device in order to safely discharge their duties. In addition to this, patients (wherever applicable) must also be given written instruction relating to safe use of the devices issued to them. Prescribers of medical or daily living equipment from the Hampshire Equipment Service will hold a unique personal identification number (PIN) given to them after the completion of the Access to Stores course (Part 1). This is to ensure that they have a broad understanding of the range of equipment provided by the service and some information on correct use, application and selection. Day-to-day maintenance by the user The user will carry this out in accordance with training or instructions given by the manufacturer or supplied in the user manual, in association with operating procedures. It is every member for staffs responsibility to ensure equipment is fit for use prior to use, performs as expected and is cleaned and safely stored after use. Manuals, service and maintenance records The maintenance of all records associated with any aspect of medical equipment management is the responsibility of the Manager supported by the divisional lead. Records must be maintained to ensure that all of their medical equipment is in date for test and /or managed with supporting risk assessment. Manuals and records need to be available for inspection. Maintenance records will be held centrally by BCAS Biomedical Services Ltd. 11

Managing / reporting incidents / accidents involving a medical device All incidents involving medical devices must be reported via the trust reporting process Safeguard. It is the responsibility of any member of staff, who finds a problem with a medical device to report it. Ensure that the asset number (SHxxxxx) and/or serial number is on the incident form. The key element in any such incident is to ensure the safety of the patient and staff. There is a requirement to identify and quarantine devices. The Medical device tool kit provides guidance with regard to the identification, quarantine, reporting and investigation of incidents. The incident and near miss policy also provides information. All medical device related risks and incidents should be reviewed at a divisional Level. Then reviewed at trust level, by the Medical Device Forum to identify trends and monitor actions for service improvement and development. Loan of medical equipment and devices Loan equipment has three categories: Equipment received from the Joint Equipment and Wheel Chair Stores Equipment loaned to other users either inside or outside the NHS. Equipment on loan from inside or outside the NHS Managers of all wards and departments are responsible for ensuring that all equipment allocated to the area of their responsibility is maintained, fit for use and accounted for. Managers are responsible for ensuring that all staff, patients, and carers required to use or operate this equipment are trained in its use, care and daily maintenance. Equipment should not be loaned unless it is fit for use, regularly maintained and that the manager concerned is confident that those using it are trained to do so. Where an electrical supply is required for the piece of equipment staff should carry out a risk assessment of the patient environment before ordering equipment. If there are any concerns about the safety of the electrical supply available staff should seek advice from the Estates department. External loans to carers, patients and other agencies Equipment is loaned to patients/carers as part of their ongoing care needs or as part of their treatment. Such equipment is normally prescribed to an individual and not to the home or environment where they live. This may be through the Equipment Store who make this equipment available for loan to the patient. Certain equipment has a policy for eligibility criteria for its loan under the heading of specialist equipment. This includes a matrix of responsibility and outlines the responsibilities of different agencies and providers. This includes all equipment except for the very standard issue. Accurate records of any loans to outside agencies/patients/carers are essential. There are occasions that equipment is loaned to patients for home use. The Trust must ensure safe hand over and return of medical equipment from the user / patient. It is also important to ensure that there is a full audit trail of whereabouts of loaned equipment is for recall and safety testing purposes. It is the department manager s responsibility to keep records for recall of the equipment as and when necessary as indicated by maintenance provider or risk assessment. 12

Equipment alteration Medical equipment must be used in accordance with the manufacturer s instructions. If this requirement cannot be satisfied then written permission must be obtained from the manufacturer or the equipment used in accordance with BS EN ISO 14155:2011. No alteration or adaptation of use of medical equipment can be made without advice of the manufacturer and acceptance by the Head of Risk Management. Whilst any apparently insignificant alteration or adaptation of use may seem trivial, such actions will invalidate any manufacturer product liability and the associated CE mark. Medical equipment should not be manufactured within the Trust or in conjunction with other parties, without the advice and prior knowledge of the Head of Risk Management and the Medical Devices Safety Officer. Medical equipment to be used clinically must only be repaired or refurbished by a person competent to do so. Decontamination Three processes of decontamination are commonly used: Cleaning a process that physically removes contamination but does not necessarily destroy micro-organisms Disinfection a process used to reduce the number of viable micro-organisms but which may not necessarily inactivate some bacterial agents such as certain viruses and bacterial spores Sterilisation - a process used to make an object free from all viable micro-organisms including viruses and bacterial spores Reusable medical devices should always be decontaminated according to the manufacturer s instructions and in accordance with guidance from the infection, prevention and control team and the Trust decontamination of medical devices policy (SH CP 100). Reusable medical devices must be decontaminated after use and before use on another patient. Medical devices must be provided with a declaration of decontamination prior to being inspected, serviced or repaired. Advice should be sought where possible and a declaration of decontamination must be provided (SH CP 100 Appendix 12.10). A declaration of decontamination status must be attached to any device or packaging which is being transported for repair or service. It is illegal to send contaminated items through the post. Decontamination of re-usable devices must be considered prior to the purchase of equipment. This is to ensure the correct decontamination method can be carried out effectively and reduce the risk of cross infection form contaminated devices. The infection control team will advise. Equipment returns Medical Devices should always be decontaminated according to the manufacturer s instructions prior to being returned advice should be sort from the receiving body. 13

A declaration of decontamination status must be attached to any device or packaging which is being retuned. These are available Appendix 12.10 of the Decontamination of Medical Devices Procedure. Advice is available from the infection control team. Equipment will usually be returned to the department to which it is logged, if the equipment has been loaned from another department and needs to be returned clean to that department then this information must be recorded. A declaration of decontamination status must be attached to any device or packaging which is being retuned. Medical equipment replacement and decommissioning Equipment type and operation systems vary widely across the whole spectrum of medical equipment and life expectancy. It can be as low as 5 years for software driven systems to 15 years plus for solid made devices with simple control circuits. Each item of equipment must be taken on merit. Services must have plans for the replacement and revision of equipment to meet their needs for service delivery. Reasons for condemning and decommissioning equipment are varied consideration must be given to the following: Environmental and services needs for new equipment If the cost of repair is equal to or above two thirds of the cost or replacement. Obtaining a certificate of disposal / condemnation Realising any revenues that might be made available by disposal Removal form inventory assets list and maintenance schedule Retention of records to provide audit trail Tendering of replacement equipment and maintenance The safest compliant method of cost effective disposal 6. Training requirements Medical devices must only be used / operated by trained staff who feel confident and are competent to do so. Training requirements should be identified by line manager at induction, reviewed at appraisals and raised by staff. It should be recorded at appraisal if staff training is complete and an objective formulated if this is deficient. The Leadership Education and Development (LEaD) department support on advising on training issues. Support available from LEaD should be utilised when undertaking a training needs analysis and assessing the need for training provision. This will include the frequency of retraining, revalidation and or assessment. All records of training must be kept ready to be available upon request for inspection. High risk devices identified as in use trust wide will be managed by LEaD and stored centrally. For other items the records must be kept in the work place and a copy of the training given by whom and the attendees should be maintained. This record should be stored locally so identification of staff competent to use equipment on the inventory can be ascertained. A copy of all training undertaken must also be kept by the member of staff for use in CPD and as evidence for their manager at appraisal. An action plan of training will be developed at appraisal where outstanding training is identified. It is vital staff undertake all identified training requirements for their role. Persistent failure to undertake identified training without just cause should be viewed as a performance matter and managed as such. 14

The Medical Devices Forum acknowledges that some devices have a high risk associated with use due to clinical safety issues. Some devices clearly require more intensive training to enable users to use them in a safe and effective manner. The purchase of new devices should be considered in association with LEaD so that training needs analysis can be completed. The frequency of training will be determined in accordance with the manufacturer s instructions and on the advice of LEaD. All devices training should consider having competencies in place to meet the training needs analysis: This should be based on level of risk and level of competency required and should take account of how the training will be logged, recorded and reaffirmed. A method for this is included in the tool kit Decontamination of specialist equipment e.g. endoscopy should only be undertaken by staff that have been deemed competent to undertake this process, who have received additional training and where required, and have been deemed competent. 7. Monitoring compliance Element to be monitored Lead Tool Frequency Reporting arrangements Organisational Learning Staff duties and responsibilities Process for including all equipment on an inventory Process for identifying which permanent staff are authorised to use the equipment listed on the inventory Process for deciding the training required Process for deciding the frequency of training updates required Process for recording that all permanent staff complete training Medical Device Divisional / Service Lead / Medical Device Adviser Line Manager Medical Device Divisional / Service Lead Line Manager Line Manager Line Manager/ LEaD Line Manager Review of incident reports and risk registers Appraisal Inventory audit Appraisal and staff identification of training Completion of Training Needs Analysis Completion of Training Needs Analysis Appraisal and equipment At least Quarterly Six monthly Annually Appraisal (Six monthly) Upon purchase and reviewed as per the device needs Upon purchase and reviewed as per the device needs Six monthly Medical Device Forum by exception Escalated through service line management Medical Devices Forum Escalated through service line management Escalated through service line management Escalated through service line management Escalated through service line management 15

Process for following up those who do not complete training Process for action to be taken in the event of persistent non-attendance Line Manager Line Manager training records Appraisal and training records Appraisal and training action plan Six monthly Six monthly Escalated through service line management Line Manager 8. Policy review The policy will be reviewed every 2 years or sooner upon amendment to statutory legislation 9. Associated trust documents Decontamination of Medical Devices Financial Procedures Policy Incident and Near Miss Policy Incident Reporting Policy Infection Prevention and Control Policy Managing Performance Policy Medical Devices Toolkit Procurement Policy Risk Management Policy Risk Management Strategy 10. Supporting references Medicines and Healthcare Products Regulatory Agency (MHRA). 2014. Managing Medical Devices Guidance. [ONLINE] Available at: https://www.gov.uk/government/publications/managing-medical-devices. [Accessed 15 July 2016] 16

Appendix 1: Training Needs Analysis If there are any training implications in your policy, please complete the form below and make an appointment with the LEaD department (Louise Hartland, Quality, Governance and Compliance Manager or Sharon Gomez, Essential Training Lead on 02380 874091) before the policy goes through the Trust policy approval process. Training Programme Medical Devices Training Medical Device Link/ Lead Training Frequency Course Length Delivery Method Facilitators Recording Attendance As per the needs of the service. Once for Medical Device divisional service leads. Medical Device links if indicated by manger in TNA As per the needs of the service. 3hours As per the needs of the service. Face to face As per the needs of the service. Medical Device Safety officer Directorate Service Target Audience If booked via LEaD then LEaD will hold the records, if not the service will have to hold the records locally. Booked Via LEaD Strategic & Operational Responsibility Medical Director Medical Director MH/LD/TQ21 ISD s ISD s ISD s Corporate Adult Mental Health Learning Disabilities TQtwentyone Older Persons Mental Health Adults Childrens Services All All clinical staff using medical devices. All administrative and managerial staff who oversee, order, transport or manage medical devices. All clinical staff using medical devices. All administrative and managerial staff who oversee, order, transport or manage medical devices. All clinical staff using medical devices. All administrative and managerial staff who oversee, order, transport or manage medical devices. All clinical staff using medical devices. All administrative and managerial staff who oversee, order, transport or manage medical devices. All clinical staff using medical devices. All administrative and managerial staff who oversee, order, transport or manage medical devices. All clinical staff using medical devices. All administrative and managerial staff who oversee, order, transport or manage medical devices. All clinical staff using medical devices. All administrative and managerial staff who oversee, order, transport or manage medical devices. 17

Appendix 2: Equality Impact Assessment The Equality Analysis is a written record that demonstrates that you have shown due regard to the need to eliminate unlawful discrimination, advance equality of opportunity and foster good relations with respect to the characteristics protected by the Equality Act 2010. Stage 1: Screening Date of assessment: Name of person completing the assessment: Job title: Responsible department: Intended equality outcomes: Who was involved in the consultation of this document? Please describe the positive and any potential negative impact of the policy on service users or staff. In the case of negative impact, please indicate any measures planned to mitigate against this by completing stage 2. Supporting Information can be found be following the link: www.legislation.gov.uk/ukpga/2010/15/contents Protected Characteristic Positive impact Negative impact Age Disability Gender reassignment Marriage & civil partnership Pregnancy & maternity Race Religion Sex Sexual orientation Stage 2: Full impact assessment What is the impact? Mitigating actions Monitoring of actions 18