Health & Safety. All staff. Trustwide. Internet / Intranet

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1 Name of Policy: Type of Policy: Medical Devices, Equipment & Safety Alerts Management Policy Health & Safety Reflects specific legislation or NHS guidance: Staff group to whom it applies: Device Bulletin: Managing Medical Devices Guidance for healthcare and social services organisations (2006) All staff Version: 1.6 Distribution Trustwide How to access Internet / Intranet Issue Date: September 2012 Next Review: September 2015 Approved by: Executive Management Team Developed by: Director leads: Safety Alerts & Medical Devices subgroup Noreen Young, Director of Nursing, Clinical Governance and Safety Contact for advice: Ann Hargate, Telephone , Dawn Thomas, Assistant Director of Nursing , Ces Crump Roland Webb, Health & Safety Manager Telephone

2 SAFETY ALERTS AND MEDICAL DEVICES POLICY TABLE OF CONTENTS 1.0 Introduction: Medical Devices, Equipment & Safety Alerts Management Purpose of the Policy Scope of policy Rationale for Development Responsibility for Document Development Development Process Approval Process Review and Revision arrangements Equality Impact Assessment Dissemination and implementation arrangements Process for monitoring compliance and effectiveness Definitions Medical Devices Safety Alerts Duties The Chief Executive Director of Nursing, Clinical Governance and Safety Estates Asset Officer / Facilities Information Analyst Officer Business Delivery Units (BDU) Safety alerts Business Delivery Units (BDU) Medical devices Ward/Unit Managers/Team Leaders/Modern Matrons safety alerts Ward/Unit Managers/Team Leaders/Modern Matrons medical devices The Patient Safety Support Team All staff The Medical Devices & Safety Alert Sub-Group The Health and Safety Steering Group Nominated Contractor The Procurement Department Management of Safety Alerts Adverse Incidents (Device related) Action required in the event of an incident involving a medical device (including single use and consumable devices) Notification to the MHA Procurement of Medical Devices Procurement process Role of the Estates Asset Officer Equipment Procurement & Replacement Strategy Training Training, Education & Competency medical devices Training related to Safety Alerts Loan Equipment Procedures Equipment loaned from external organisations Loans from other NHS organisations Medical Devices, Equipment & Safety Alerts Management Policy Version 1.6 2

3 10.3 Internal loans Guidance on the use of service users own medical equipment (by Trust staff). during a period of admission to a Trust bed External loans/prescriptions to Service Users/Carers Multi-agency loans/prescriptions External loans to other organisations Record keeping Single use devices Decontamination and cleaning of medical devices Decontamination forms Maintenance and repair of medical devices Routine equipment checks by Users User manuals Reporting equipment failures or requests for servicing Replacement/disposal and transfer of ownership of medical devices Sale of medical devices/equipment Safe disposal of hazardous waste References/related policies and procedures Appendices Appendix A Equality impact assessment tool Appendix B Checklist for the review and approval or procedural document Appendix C Version control sheet Appendix D Scoring Mechanism to determine replacement priorities for medical... devices and equipment Appendix E Purchase of new equipment and equipment trials form option appraisal tool Appendix G Incident Algorithm Appendix H Sample equipment loan agreement form Appendix I Sample form for sale of medical device acceptance certificate Appendix J Medical devices training record Appendix K Personal medical devices training record Appendix L Medical devices maintenance checklist Appendix M Guidance on the use of service users own medical equipment (by Trust staff) during a period of admission to a Trust bed Medical Devices, Equipment & Safety Alerts Management Policy Version 1.6 3

4 1.0 Introduction: Medical Devices, Equipment & Safety Alerts Management The South West Yorkshire Partnership NHS Foundation Trust recognises that the organisation works within a high-risk environment, and that there are health and safety risks associated with the use of medical devices and equipment. The Trust attaches great importance to the health, safety and well-being of its staff, service users and visitors and is committed to fulfilling its statutory obligations within Health and Safety law. Managing medical devices, including reusable diagnostic and therapeutic equipment, safely and effectively, and acting on safety alerts from external agencies is an essential element of maintaining health and safety. The Trust is supported to manage and maintain medical devices via contractual arrangements with an external supplier. 2.0 Purpose of the Policy The purpose of this policy is to ensure that systems are in place to minimise the risks associated with the acquisition and use of medical devices and equipment, and to ensure that the important information contained in safety alerts is communicated and acted on within the organisation in a responsible and timely way. The policy supports the organisation to comply with Outcome 11 (safety, availability and suitability of equipment) of the Care Quality Commission Essential Standards and the NHS Litigation Authority Risk Management Standards 5.4 maintenance of medical devices and equipment. Risks associated with the acquisition and use of reusable diagnostic and therapeutic equipment can be minimised through ensuring that all medical devices are:- Maintained in a safe and reliable condition. Purchased in accordance with Trust procedures through the procurement department Procured in such a way which affords best (qualitative and quantitative) value for the Trust taking into account whole-life costs. Properly understood by the user, so that they may be used and managed safely and effectively. Used only by individuals trained who have received training in their use Suitable for their intended purpose. Used only for their intended purpose. Listed on the Estates Asset Register The policy also describes the systems which are in place to effectively manage safety alerts. These alerts inform the Trust of risks which have been identified outside the organisation and recommend actions to manage the risk effectively. The Trust intends to work in accordance with the guidance laid down in the Medicines & Healthcare products Regulatory Agency (MHRA) bulletin, Device Bulletin - Managing Medical Devices, Guidance for Healthcare and Social Services Organisations DB2006(05) which will be referred to in order to resolve any complex issues relating to medical devices use and management. Medical Devices, Equipment & Safety Alerts Management Policy Version 1.6 4

5 2.1 Scope of the Policy This policy applies to all Trust employees including contractors and employees of other organisations on site, and volunteers. Any breach of this policy may lead to disciplinary and/or legal action. 2.2 Rationale for Development The Trust aims to balance the rights and responsibilities of people using its services with those of employees, with a clear approach to health and safety, and patient safety risk management. It also aims to support staff, by ensuring that working environments which are controlled by the Trust have safe medical equipment that is appropriately maintained or repaired and that staff have prompt access to alerts issued by the Department of Health s Central Alerting System. Safe working environments, including the correct and safe use of medical devices and equipment are essential to healthcare provision. This will ensure that stakeholders are protected from incidents, accidents, injury and infection as far as reasonably practicable and to provide a safe place in which high quality clinical care is provided. During visits to the Trust individuals have a right to have their needs assessed and action taken so they are protected from harm. When adverse incidents occur, appropriate responses should be taken to support individuals. This document outlines how these aims will be addressed and indicates the Trust s responsibilities and those of its staff. 3.0 Responsibility for Document Development The Medical Devices, Equipment and Safety Alerts Management policy has been developed by the medical devices and safety alerts sub-group which reports to the Health and safety TAG via the Health and Safety Manager (west). 3.1 Development Process Consultation has been via the Health & Safety TAG, the Medical Devices & Safety Alerts subgroup and, clinical/professional leads before amendment and approval via the EMT. 3.2 Approval Process The policy has been approved by the Health & Safety Trust Wide Action Group, the Medical Devices & Safety Alerts subgroup and has been accepted as an organisation-wide policy by the Executive Management Team. 3.3 Review and revision arrangements This document will be reviewed by the agreed review date in line with the Policy for the development, approval and dissemination of policy and procedural documents or earlier if required. Responsibility for initiating a review and taking the new policy to the executive management team for approval lies with the lead director. Review of the policy will be managed by the medical devices and safety alerts sub group Medical Devices, Equipment & Safety Alerts Management Policy Version 1.6 5

6 The integrated governance manager is responsible for placing the new version of the policy in the electronic document store, for ensuring the document being replaced is removed from the document store and that an electronic and paper copy, clearly marked with the version details, are retained as a corporate record. 3.4 Equality Impact Assessment The policy has no differential impact on equality, as identified by the equality impact assessment tool as included in the policy for the development, approval and dissemination of policy and procedural documents appendix A. 3.5 Dissemination and implementation arrangements Once approved, the integrated governance manager will be responsible for ensuring the updated version is added to the document store on the intranet and is included in the staff brief. The policy will be cascaded from members of the medical devices and safety alerts sub group to BDUs and relevant clinical networks. Training needs related to the policy should be identified as part of the KSF/appraisal process. 3.6 Process for monitoring compliance and effectiveness Use of the policy in clinical practice will be monitored on a six weekly basis via the medical devices and safety alerts sub group and via the annual health and safety audit. The sub group will receive information regarding safety alert distribution and exception reporting. The Estates Asset Officer will attend the medical devices and safety alerts sub-group on a 6 weekly basis to report on any issues related to the management and maintenance of medical devices. Compliance will also be monitored via the Trusts internal unannounced CQC visit programme. The Health and Safety TAG will, via the Health and safety Manager (west), receive a ¼ update of any identified risk issues related to the procurement and use of medical devices. Compliance with the use of the Medical Devices Training Record and the Medical Devices Maintenance Checklist will be reviewed via the medical devices and safety alerts sub-group on a ¼ basis. Completed returns, by local managers, from the annual health & safety monitoring forms (which includes information regarding the use of medical devices) will be analysed by the clinical governance support team and presented to the Health & Safety TAG for further action/sign off. 4.0 Definitions 4.1 Medical Devices The MHRA defines a medical device as an instrument, apparatus, appliance, material or other article, which is intended by the manufacturer to be used for the purposes of: diagnosis, investigation, prevention, monitoring, treatment or alleviation of disease. A medical device is also that which is intended to be used for alleviation of, or compensation for, an injury or physical impairment. Examples would include glucose meters, sphygmomanometers, walking aids, supportive seating and pressure care equipment, thermometers, resuscitation equipment. Medical Devices, Equipment & Safety Alerts Management Policy Version 1.6 6

7 4.2 Safety Alerts Safety alerts, emergency alerts, drug alerts, Dear Doctor letters and Medical Device Alerts are issued on behalf of the Medicines and Healthcare products Regulatory Agency (MHRA), the National Patient Safety Agency, and the Department of Health and are the means by which nominated individuals in healthcare organisations receive information about risks associated with medical devices, medicines, security matters, and estates issues. 5.0 Duties The Chief Executive The Chief Executive has overall responsibility for the management of safety alerts and medical devices, but this responsibility has been delegated to the Director of Nursing, Clinical Governance and Safety Director of Nursing, Clinical Governance and Safety The Director of Nursing, Clinical Governance and safety has lead responsibility for the safe management of medical devices and safety alerts. This responsibility is delegated to the Assistant Director of Nursing who has the assistance of the medical devices and safety alerts sub group, BDUs and other departments to manage the dissemination of safety alerts and the safe use of medical devices Estates Asset Officer /Facilities information Analyst Officer The Estates Asset Officer is responsible for liaising with the Trusts EBME provider for the day to day management and maintenance of medical devices and for maintaining the medical devices inventory/asset register. The Estates Asset Officer is also responsible for preparing and presenting an inventory/asset replacement programme/lifecycle costings to the medical devices and safety alerts sub group. The Asset Officer will also ensure that the medical devices inventory/asset register is updated with purchasing and condemning information and that all statutory maintenance and calibration is undertaken and, a subsequent report presented to the medical devices and safety alerts sub group. The Estates Asset Officer will attend the medical devices and safety alerts subgroup to report on any issues related to the day to day management of medical devices, inventory and asset issues Business Delivery Units (BDU) Safety Alerts BDU directors are responsible for identifying appropriate managers and other personnel to assess whether alerts are applicable to their service area and then to ensure that actions are taken to comply, or if this is not necessary, to declare this within stipulated time scales via Datix. BDU directors are also responsible for reviewing safety alert exception reports as part of the Trusts quality compliance reporting arrangements. Medical Devices, Equipment & Safety Alerts Management Policy Version 1.6 7

8 5.1.5 Business Delivery Units (BDU) Medical Devices BDU directors will need to ensure that medical devices used within their directorate are:- Asset tagged so as to ensure that all devices are maintained in accordance with manufacturer s recommendations, legislative requirement and any advice or instructions from the organisations preferred provider of medical device services Fit for purpose and that a budget for a replacement programme is in place Stored securely and kept free, as far as reasonably practicably, from risk of accidental damage or loss. Only used by competent personnel, who are appropriately trained. Only purchased using the Trust s procurement procedures. Disposed of or sold in accordance with Trust policy and legal requirements BDU directors will also ensure that the Estates Asset officer is informed when a medical device or piece of equipment is disposed of. BDU directors should also ensure that all staff are aware that equipment should be checked prior to use, within service date (and if not) that the equipment should not be used and that the Estates Asset Officer should be informed immediately. BDU directors will need to support/or present an application for specific equipment where a bid is made for central funding to support Trust wide initiatives. BDU directors are also responsible for ensuring that any identified risks related to the purchase, availability and use of medical devices are placed on the appropriate risk register Ward/Unit Managers/Team Leaders/Modern Matrons - safety alerts All ward/unit managers/team leaders/modern Matrons have a responsibility to assess whether alerts are applicable to their service area and then to ensure that actions are taken to comply, or if this is not necessary, to declare this within stipulated time scales via Datix. All ward/unit managers/team leaders/modern Matrons have a responsibility for ensuring that all relevant training records and equipment checklists related to medical devices are maintained Ward/Unit Managers/Team Leaders/Modern Matrons - medical devices All ward/unit managers/team leaders/modern matrons are responsible for: Contacting the estates/facilities helpdesk when there are problems or concerns regarding specific medical devices. Ensuring that processes are in place for the safe use of all medical devices, authorising the purchase of new or replacement equipment and for the removal/disposal of defective or redundant devices/equipment. Ensuring that equipment removed from their service (broken, redundant, loaned or quarantined) is reported to the Estates Asset Officer in order to ensure that the Trusts inventory/asset register is up to date. Ensuring that the estates Asset Officer is notified when their service moves locations or specific pieces of equipment are moved, this will ensure that the Trusts inventory/asset register is updated. Medical Devices, Equipment & Safety Alerts Management Policy Version 1.6 8

9 5.1.8 The Patient Safety Support Team The Trusts patient safety support team are responsible for distributing safety alerts via the Trusts risk management database All Staff All staff will be responsible for using medical devices and equipment in accordance with their training and will promptly report problems or defects to their immediate manager, who will ensure arrangements are made with the appropriate department to effect corrective action. Every health care employee has a duty to see that all safety-related incidents and potentially harmful products are reported, even if on suspicion only. This includes incidents that have led to, or could lead to:- Death, life threatening illness or injury. Deterioration in health. The necessity for surgical or medical intervention or prolonged hospital stay. Unreliable test results leading to inappropriate diagnosis or therapy. Minor faults and discrepancies should also be reported. These may take on greater significance when aggregated with other similar events. All staff who use medical devices must ensure that the equipment is asset tagged and that the Estates Asset Officer is informed of any equipment transfers (including when staff relocate to new premises) The Medical devices and safety alerts sub group The medical devices and safety alerts sub group are responsible for monitoring the use of medical devices throughout the organisation and reviewing safety alerts. The group is also responsible for approving equipment trials and reviewing any incidents associated with the use of medical devices. Key performance indicators for medical devices will be presented quarterly to the Health & Safety TAG. This will primarily be from statistical data gleaned from DATIX. The Medical Devices & Safety Alerts subgroup will consider all notifications from the Department of Health s Central Alerting System at each meeting, together with any correspondence from the Trust to the Central Alerting System The Health and Safety Steering Group The Health and Safety Steering Group will maintain an overview of safety alerts, medical devices and equipment via verbal/written reports received from the medical devices and safety alerts subgroup Nominated Contractor The Trusts contracted EBME provider (Key Health Solutions) will provide servicing and maintenance of medical devices as per contract The Procurement Department will: Ensure that all requests for purchase, loan or trial of medical devices follows a robust and auditable process as described in section 8 Ensure that all requests to sell or dispose of medical devices/equipment follows Trust policies and is compliant with legal requirements Medical Devices, Equipment & Safety Alerts Management Policy Version 1.6 9

10 Liaise with specialist advisors and the Medical Devices and Safety Alerts Sub Group to ascertain appropriate and clinically suitable medical devices/equipment to create a Trustwide standard list of procured equipment. Interrogate the Trust finance system to ascertain purchasing history in response to Datix requests and other safety alerts relating to medical devices/equipment. Provide advice on all aspects of purchase, supply and disposal of medical devices and equipment. Provide advice on all aspects of purchase, supply and disposal of medical devices and equipment Trust specialist advisors will identify equipment issues within their remit and liaise with the Procurement Department and the Estates Asset Officer so as to ensure that any risks/identified areas of concern associated with specific equipment can be shared across the organisation. 6.0 Management of Safety Alerts Medical device safety alerts are disseminated throughout the organisation via the Patient Safety Team who use the Trusts risk management database Safety Alert Bulletins (SABs) module to send and receive feedback on alert actions. Actions required by alerts are the responsibility of BDU Directors who will ensure that identified staff within the BDU complete the safety alert feedback loop as identified above. 7.0 Adverse Incidents (Device- related) Information from adverse incident reporting indicates that the factors that have the greatest impact on the safety of devices involve the instructions written by the manufacturer, their availability and clarity (MHRA DB2006 (05) November 2006). In addition to the Trust s risk management arrangements and incident reporting procedures, the Trust intends to follow the guidance laid down by the MHRA in their annual bulletin (first medical device alert issued in each year) which contains details on how to report adverse incidents. Managers have a responsibility to ensure that all staff, including contractors, at all levels are aware of their responsibilities and of the procedures to be followed with regard to the reporting of incidents and the isolation and retention of defective items. The causes of incidents may include:- Inadequate instructions for use from the manufacturer Poor training Problems arising from the design or manufacturing process Inappropriate local modifications or adjustments Inadequate maintenance Inadequate or inappropriate replacement parts Unsuitable storage or use conditions Medical Devices, Equipment & Safety Alerts Management Policy Version

11 Inadequate end of life or scrapping information Equipment not being asset tagged and listed on the asset register 7.1 Action required in the event of an incident involving a medical device (including single use & consumable devices) Ensure the health, safety and well-being of any individuals involved. Report the event in accordance with the Trust s Incident Reporting and Management Policy and Procedure (appendix G). Where medicinal products are involved, the on-call pharmacist should be contacted. Ensure devices involved in an incident are kept in isolation/quarantine or left in situ and labelled NOT TO BE USED IN QUARANTINE (date). If the incident does not require the equipment to be drawn from use, the state of the device at the time of the incident should be recorded for use in subsequent investigations. and the device stored in the workplace. Clean and/or decontaminate the device as appropriate and label as such. Where this is not possible (e.g. single-use devices) equipment must be made socially clean and all efforts made to protect those who may need to handle the device. Further advice can be sought from the infection control team. Record the incident using the Trusts incident management system, seeking advice from the patient safety team/specialist advisor where appropriate DO NOT contact the Medicines & Healthcare Products Regulatory Agency (MHRA) directly. If equipment cannot be moved due to size, fixtures, etc., it must be clearly labelled Not for Use or Out Of Order and rendered safe so others cannot use, e.g. lock away, disconnect, have fuse removed, etc., and staff notified of the problem. Make a record of all readings, settings and position of switches, valves, dials, gauges and indicators. A personal record should be made of the incident. Keep packaging and make a note of batch number if possible; if the device is part of a batch, check any remaining stock. As part of the MHRA s investigative procedures, they may ask the manufacturer to explore the matter. Equipment must not be released from quarantine or shown to the manufacturer without the express permission of the Director of Nursing, Clinical Governance and Safety or their nominated deputy. Do not allow manufacturer s representatives to look at the device or take it away. If the MHRA require further exploration, the equipment must not be released until the MHRA liaison officer (Assistant Director of Nursing/nominated deputy) has received permission from the MHRA. Once the MHRA has concluded its investigation/findings, a copy of the manufacturer s response will be forwarded to the Medical Devices and Safety Alerts subgroup. The nature of the equipment and type of fault will determine what happens to the equipment. Adequate and effective communication between all departments concerned will be necessary if the reporting and investigation process is to serve its purpose. Medical Devices, Equipment & Safety Alerts Management Policy Version

12 7.2 Notification to the MHRA The Assistant Director of Nursing with responsibility for medical devices or their nominated deputy will be responsible for notifying the MHRA of untoward incidents related to medical devices and equipment. To ensure a co-ordinated approach when reporting concerns or defects, nominated recipients of safety alerts should inform the Assistant Director of Nursing of any incident involving medical devices/equipment. 8.0 Procurement of Medical Devices All equipment purchases must be made in accordance with the Trust s Financial Standing Instructions and EU Procurement rules. All medical devices must be purchased using the Trusts procurement process and ordered using Agresso. Staff should not deal direct with suppliers Procurement will arrange demonstrations or samples if required. Purchase of equipment not previously supplied to the Trust or an equipment trial must be agreed by the Medical Devices and Safety Alerts Sub Group prior to a purchase or trial taking place. Appendix E provides an option appraisal tool which is required to assess the suitability and cost effectiveness of new purchases and trial equipment. Procurement will cover PPQ (Pre Purchase Questionnaire) and supplier indemnity as part of the risk management process. Re-conditioned, Refurbished and Ex Demo Equipment Procurement must be advised if the ward / unit managers / team leader/modern matron is considering the purchase of Re-conditioned, Refurbished and Ex Demo Equipment as assurances from the supplier must match the warranties and performance as given to equipment and devices purchased as new. Note: Any equipment not purchased through the correct procurement route poses a risk to the Trust and therefore it is the responsibility of all ward / unit managers / team leaders/ modern matrons to ensure that equipment is only purchased through the correct purchasing route. 8.1 Procurement Process The process for purchasing a medical device can be broken down as follows:- Assessment of need Purchase of new equipment / equipment trial option appraisal tool completed o Consideration given to: Costs Training Maintenance Consumables Disposal Approval given by Medical Devices and Safety Alerts Group RFQ entered onto Agresso Tender / Waiver completed if relevant Medical Devices, Equipment & Safety Alerts Management Policy Version

13 Purchase order placed Inspection and acceptance of equipment New equipment added to Trust inventory Note: Procurement will examine the possibility for Trustwide purchases where funds can be pooled 8.2 Role of the Estates Asset Officer/Facilities Information Analyst Officer The estates asset/ officer facilities information analyst officer will: Ensure that purchase orders on Agresso for medical devices are identified and the information used to manage the process of capturing new equipment on to Planet (Estates & Facilities data management system), which hosts the medical devices inventory / asset register. Ensure that new equipment is bar-coded and added to the medical devices inventory / asset register. ensure that staff follow the correct procedure and log a call through to the estates/facilities department to ensure that medical devices are asset tagged and added to the medical devices asset register. Manage day to day contact and work requests with the Trusts EBME Provider Receive and action all requests for the disposal of redundant or obsolete medical devices by liaising with Procurement or following contracted disposal routes. Update the records held on the medical devices inventory / asset register to reflect the actions taken with regard to disposal. The equipment history is to be retained and not removed from the register. Advise Trust staff as to what steps are required when a medical device is required to be quarantined or removed from service the medical devices inventory / asset register will be updated to reflect the actions taken. Provide information for Health & Safety and MHRA Alerts Ensure that all statutory maintenance and calibration is undertaken, by liaising with and undertaking the day to day contact with the Trusts contracted EBME provider and identifying equipment where external maintenance contracts are required and, that equipment complies with current legislation and good practice guidelines. The Estates Asset Officer will also prepare and present an asset replacement programme/life cycle costings to the medical devices and safety alerts sub group to ensure old or problematic equipment can be removed from service where agreed. The Estates Asset Officer will prepare information for each BDU, identifying equipment which requires consideration for replacement. NB: The Barnsley Community Equipment Service is responsible for the management of the majority of equipment needed in a person s home and operates a separate asset management register for the management of these devices. Medical Devices, Equipment & Safety Alerts Management Policy Version

14 8.3 Equipment Procurement & Replacement Strategy The budgetary responsibility for replacement of equipment lies with the BDU where the equipment will be used, however to ensure quality, safety, clinical effectiveness and best value the Trust is working towards standardisation of equipment. BDU representatives and Trust specialist advisors participate in the evaluation of equipment and influence the standard equipment list which is being developed. The Estates Asset Officer will prepare information for each BDU, identifying equipment which requires consideration for replacement. The Priority Replacement Scoring Tool (appendix D) will assist managers to determine priorities for equipment replacement. Items which have been placed on the BDU or corporate risk register will be considered for purchase from funds specifically allocated for risk reduction. Priority will be given to equipment issues which present the highest risks to the Trust where the purchase of new/replacement equipment will significantly reduce the risks. In exceptional circumstances the Trust may agree to purchase equipment using the minor capital process. 9.0 Training 9.1 Training, Education & Competency for the use of medical devices Training is a key element in the safe use of medical devices and therefore training needs, together with a training programme, need to be identified as part of the medical devices procurement process. All staff using a medical device need to be able to evidence training on how to safely operate the device. This training should be based on the manufacturer s instructions and include information about how the device would normally work. The Medical Devices Training Record (appendix J) is a record of staff who have been trained to use a particular medical device and must be completed by the individual member of staff receiving the training and the person providing this. This training record must remain with the medical device or in a designated place within the ward/unit/team base. The above training records are specific to individual models of medical device and not to groups of devices (i.e. a particular sphygmomanometer). Individual members of staff should complete a Personal Medical Devices Training Record (appendix K) to allow transfer of competence to use between work areas. Individual staff evidence should be transferred to the Medical Devices Training Record that remains with each medical device. of the ward/unit manager or team leader to ensure that systems are in place for staff to receive training in the use of medical devices and that the medical devices training record is completed. It is the responsibility of the nurse in charge of a shift to ensure that agency staff are competent to use medical devices within the care area. Medical Devices, Equipment & Safety Alerts Management Policy Version

15 As part of their induction all clinical staff new to the Trust or a department must undergo a competency assessment, organised by their manager, to demonstrate that they are competent to use medical devices which are present in the department. Where appropriate an action plan with timescale(s) for assessment and achievement of competency will be agreed. The frequency of refresher training will be determined by the individuals competency to use the device. Competence will be monitored and reviewed through KSF development review and risk management processes or earlier if indicated by clinical practice. The following risk factors will be considered when determining the timescale required between competence reviews:- Complexity and hazards of the equipment. Experience of the operator. Frequency of use by the individual. Errors made by the operator (incidents). All staff have a responsibility to carry out dynamic competency assessments, i.e. a continual assessment and questioning of knowledge and skills prior to and during use, based on the circumstances in which a device is used. Questions may include, but not be limited to:- When did I last use the device? Am I wholly familiar with the specific functions of the device I will use today? What training have I received? Have I read the instruction manual? Am I aware of all the risk factors and control measures? Do different circumstances/service users, etc. cause changes in risk factors? Am I up-to-date with latest guidance or changes in practice? The Trust runs a mandatory training programme for all equipment that is used in a life saving situation. Staff will undergo refresher training for this equipment at intervals stipulated in the Trusts Cardiopulmonary Resuscitation Policy. Only staff who have achieved certification are deemed competent to use these medical devices. Misuse of medical devices can result in negligence claims both against the Trust and individual practitioners. Any records on ward/department-based training will be kept by each clinical area for 11 years. Records of training required/received will need to be available for audit purposes and external assessments (e.g. NHS Litigation Authority Risk Management Standards for Mental Health and Learning Disability Trusts, 2012/13), and may be required for legal purposes. 9.2 Training related to Safety Alerts All identified staff will be provided with information about how to manage safety alerts using the Datix SABs module Loan Equipment Procedures The loan of equipment can pose a number of risks to the Trust and the procedures laid out below are designed to minimise those risks to the lowest practicable level. The scope of the policy applies to equipment loaned: Medical Devices, Equipment & Safety Alerts Management Policy Version

16 Equipment loaned from Manufacturers or Suppliers From other NHS organisations which accompany the patient into the Trust Internal loans (between departments within the Trust) External Loans / Prescriptions to service users / carers Multi-Agency loans / prescriptions Loans to other organisations Loans include medical devices and equipment for research and when the equipment is FOC (free of charge) whilst using particular consumables. The Estates Asset Officer must be informed of the all loan equipment (product, make, serial number) together with who has made the loan (equipment owner). Loan equipment still requires maintenance in accordance with the manufacturer s instructions Equipment Loaned from manufacturers or suppliers All borrowed devices must go through the same acceptance procedure/tests as new equipment. No new electronic medical devices may be trialled in the Trust without prior discussion with the Trust s procurement department. Staff must ensure that all standard user maintenance is carried out upon equipment during the period of the loan. See Procurement Procedures Frequently asked questions for further information concerning loaned equipment:- Completed Indemnity forms are required from external organisations prior to equipment use to ensure that product liability does not pass to the Trust. Procurement will confirm whether indemnity forms are required 10.2 Loans from other NHS Organisations Again, wherever it is practical, devices borrowed from other NHS organisations must be subject to the same acceptance procedures as new equipment. It is accepted that sometimes service users have equipment which cannot practically be subject to such tests. In such circumstances equipment will be cleaned and returned to the lender in the condition in which it arrived at the earliest opportunity. Any such equipment will not be put into use again without being subject to the usual acceptance procedures Internal Loans When a piece of equipment is loaned to another ward/department, it is the responsibility of the senior member of staff responsible for loaning to check over the equipment with the borrower and to ensure that the staff who will use the equipment have been trained and are competent to use the equipment. The borrower must also be aware of the maintenance/care/cleaning requirements whilst the equipment is in their possession. The Estates Asset Officer should also be informed of all medical devices that are loaned so that equipment can be located on the asset register thus ensuring equipment is available for servicing and maintenance. Medical Devices, Equipment & Safety Alerts Management Policy Version

17 A record must be kept of the loan with the borrower s signature. This serves as an exchange of responsibilities and also preserves the traceability of the device concerned. A decontamination form must accompany any equipment when it is moved between areas (refer to infection control policies for further details) Guidance on the use of service users own medical equipment (by Trust staff) during a period of admission to a Trust bed In order to comply with MHRA Regulations the Trust has produced guidance (appendix M) to assist staff when service users may be admitted with their own medical equipment. Examples of such equipment are, Syringe drivers, slings, hoists, walking aids, moulded seating, wheelchairs etc. Staff require training in any medical equipment that they have to use. There is a potential risk of injury in using service users own equipment where correct training has not been received. The service users own equipment may also not be of a standard required by the Trust. Therefore, in the first instance, service users own equipment should not be used. If an occasion arises where service users own equipment needs to be used then a risk assessment process must take place and the occurrence classed as an incident and appropriate forms completed 10.5 External Loans/Prescriptions to Service Users/Carers (This includes equipment on permanent loan or equipment not expected to be returned, e.g. single-use or custom-made). Some equipment may be loaned or given to service users/carers (e.g. upon discharge from hospital) as part of their ongoing care needs. The manager or staff responsible for arranging the loan or prescription must ensure that the equipment is in good condition and that, where appropriate, documentation exists within the Trust to demonstrate that the equipment has been regularly serviced. It is important to assess whether those being loaned the equipment are capable of taking responsibility for it, i.e. that they are competent to use and maintain the equipment and will, where appropriate, return it in good and clean condition. Equipment is provided to the individual and not to the home or environment where they live. Accurate records of any loans to outside agencies/service users/carers are essential, these might include:- Individual s name, address, telephone number and hospital number. Details of carer/agency taking responsibility for the equipment on the service user s behalf where applicable, plus name, address and telephone number. Signature by the service user or carer/agency taking responsibility for the device, following instruction from the person issuing the device. Instruction should include training on how to use the equipment; necessary care and maintenance, availability of disposable supplies essential to the equipment, and a telephone help line number where appropriate. See also training section of policy. Where appropriate the borrower must also agree to return the equipment to the ward/department for maintenance or exchange when requested. Medical Devices, Equipment & Safety Alerts Management Policy Version

18 Prescription decisions should be recorded in service users notes for custommade or modified devices, e.g. walking aids. The example loan form (see appendix H) may be adapted to suit the circumstances of the loan. All managers and staff involved in the loan or prescription of devices must carry out risk assessments to determine the level/type of documentation, training, etc. required. Medical devices will only be issued to service users (e.g. prosthetic devices, walking aids, etc.) by staff with the appropriate professional qualifications or who have been formally assessed for competency Multi-Agency Loans/Prescriptions Where loans/prescription of devices occur on a multi-agency basis (e.g. equipment may be owned by a PCT or Social Services but prescribed or modified by Trust staff), all responsibilities and accountabilities must be clearly defined. For example, responsibility for maintenance, any follow-up work required, any on-going training or monitoring of equipment usage where appropriate, reporting of any adverse incidents etc External Loans to Other Organisations Loans to NHS organisations should only take place in circumstances where a service user or NHS research, etc. would benefit from such a loan. When any such loan is made the manager responsible for arranging the loan must ensure:- A record of the loan is made and there are adequate systems in place to ensure its safe return along with the service manual and any accessories (e.g. leads). That the equipment is in good condition and has been regularly serviced. The borrower is made aware of who to contact should any problems with the equipment occur. The borrower understands that only staff appropriately trained to use the device may use it. User manuals are made available to the borrower. Equipment may only be loaned to non-nhs organisations with the express permission of relevant BDU director or their nominated person. All risks should be assessed and reduced by ensuring our responsibilities described in section 13.4 are carried out. An external organisation may request that we indemnify them against any adverse incident. However, no officer of this Trust may sign any indemnity which unfairly places responsibility upon the Trust. The level of indemnity which can be deemed as fair will depend upon the purpose of the loan. For example, it may be considered fair to sign a full indemnity similar to the standard NHS Form of Indemnity if the loan is prior to the sale of equipment. However, it may not be fair to accept most risks where we are providing assistance to another organisation Record Keeping Service Records must be retained for a minimum of 11 years All ward / unit managers / team leaders will keep records on training, transfers and daily / weekly checks associated with the equipment within their service. Procurement will retain all records relating to the purchase of medical devices where the Trusts procurement procedures have been followed. This will include PPQ s, tenders, quotations and assessment reports. Medical Devices, Equipment & Safety Alerts Management Policy Version

19 Delivery notes must be copied and provided to the Estates Asset Officer and Procurement by the Trusts receipting points in order that relevant information can be added to equipment and purchase order records. The Estates Asset Officer will retain records of any inspection / safety or functional tests made in connection with medical devices Single Use Devices These are medical devices which are intended to be used on an individual service user during a single procedure and then discarded, they do not require asset tagging. Single use devices must be discarded after use and not used a second time. The above symbol is used on medical device packaging indicating Do Not Re-use Decontamination and Cleaning of Medical Devices Medical devices should be cleaned and stored in accordance with manufacturer s instructions and best practice requirements. The Trusts Infection Control Policy should be referenced. Staff handling used medical devices should assume that they are contaminated and take precautions to reduce risk to themselves and others. Infection prevention and control team can provide advice with regards to decontamination. Before being transferred between areas, presented for maintenance / servicing /repair, loaned or disposed of, all medical devices must be physically cleaned to at least a socially acceptable standard and accompanied by a decontamination form Decontamination Forms The decontamination form must be completed and signed by the person with delegated responsibility for the equipment, or the user who knows the current condition of the equipment. Please also refer to the Trusts Decontamination of equipment and the use of disinfectants and antiseptics policy The Estates Asset Officer requires a copy of the decontamination form if the equipment is removed from its current location. Within the Barnsley Community Equipment Store evidence of equipment decontamination is recorded electronically. Medical Devices, Equipment & Safety Alerts Management Policy Version

20 14.0 Maintenance and Repair of Medical Devices Routine preventative maintenance and servicing of medical devices must be carried out in accordance with manufacturer s instructions. The registration of equipment on the Trusts inventory / asset register determines the actions required for ongoing servicing and inspection by the Trusts EBME provider, external specialist supplier or Estates and Facilities Departments. The Estates Asset Officer can advise which supplier will provide maintenance for each piece of equipment / device. All service sheets must be scrutinised by a competent person to ensure that the equipment / device is safe for use. The role of competent person is provided by specific members of the Estates and Facilities Department and the Trusts contracted EBME provider. The Estates Asset Office will liaise with the most relevant competent person to ensure that non compliant equipment is removed immediately and dealt with appropriately. Where service sheets are left with the equipment, a copy should be kept with the equipment and the original sent to the Estate Asset Officer for entry on to the Trusts inventory / asset register. The Estates Asset Officer oversees the planned maintenance schedule for all equipment which falls within the remit of the Trusts EBME provider and some specialist external providers. Where ward / unit managers / team leaders/modern matrons have specialist equipment with their own maintenance contracts, they must ensure that the servicing takes place Routine equipment checks by Users Routine equipment checks are required to be carried out in accordance with manufacturer s instructions to ensure that the equipment is functioning correctly and that any clinical decision made as a result of equipment use is reliable and accurate. Appendix L provides a record that equipment users are checking the equipment regularly and reporting any issues to the relevant Estates & Facilities Helpdesk Routine checks by users will include, but not limited to:- Batteries fully charged Evidence of damage Evidence of missing pieces / parts Maintenance sticker is within date Equipment is clean Equipment users must also ensure that all storage arrangements within their area of responsibility are configured to optimum standards within available resources to secure, protect and manage equipment appropriately. Inadequate storage arrangements should be notified to more senior staff User Manuals All ward / unit managers / team leaders must ensure that equipment user manuals are available to users. Some user manuals are available via the Trusts intranet. Medical Devices, Equipment & Safety Alerts Management Policy Version