MEDICAL DEVICES MANAGEMENT POLICY

Transcription

1 MEDICAL DEVICES MANAGEMENT POLICY DOCUMENT CONTROL: Version: 7.1 (Appendix 6 changed ) Ratified by: Risk Management Sub Group Date ratified: 21 May 2013 Name of originator/author: Head of Patient Safety & Experience Name of responsible Risk Management Sub Group committee/individual: Date issued: 1 July 2013 Review date: 21 May 2016 Target Audience This policy applies to Trust staff and any staff providing services under contract in both hospital and community services who are involved in any aspect of medical devices use and management.

2 CONTENTS Page 1 INTRODUCTION 3 2 PURPOSE 4 3 SCOPE 5 4 RESPONSIBILITIES, ACCOUNTABILITIES AND DUTIES Board of Directors and Chief Executive Nominated Lead Director Committees and Groups with responsibilities Directors Head of Patient Safety & Experience Health & Safety Lead Head of Health, Safety & Security Managers All staff Supplies/Purchasing Department Medical Device Leads Medical Device Link People Administrator of Medical Devices Inventory Head of Learning and Development 10 5 PROCEDURE / IMPLEMENTATION Procurement of Medical Devices Acceptance of New Medical Devices How the Trust Includes All Items of Diagnostic and Therapeutic Equipment on an 11 Inventory 5.4 Single-Use Medical Devices Single-Patient Use Medical Devices Medical Devices Used on Trial/On Loan Use of Medical Equipment for Non Designated Purposes Medical Devices Risk Classification How Reusable Diagnostic and Therapeutic Equipment is Maintained How Reusable Diagnostic and Therapeutic Equipment is Repaired Replacement/Disposal of Medical Devices Failure of a Medical Device Reporting Medical Device Incidents Disseminating Medical Device Alerts 18 6 TRAINING IMPLICATIONS 18 7 MONITORING ARRANGEMENTS 21 8 EQUALITY IMPACT ASSESSMENT SCREENING 23 9 LINKS TO ANY ASSOCIATED DOCUMENTS REFERENCES APPENDICES Appendix 1 Examples of Medical Devices used within the Trust 26 Appendix 2 MHRA Adverse Incident Report Form 28 Appendix 3 Medical Equipment On-Loan Check List 29 Appendix 4 Pre Purchase Questionnaire 30 Appendix 5 Mattress Audit Form 33 Appendix 6 Patient Equipment and General Cleaning Checklist Appendix 7 Maintenance/Disposal Flowchart for Reusable Medical Devices Appendix 8 Declaration of Contamination Status Appendix 9 WEEE (Waste Electrical & Electronic Equipment) Returns Form Page 2 of 41

3 1. INTRODUCTION 1.1 What are medical devices? The term medical device is legally defined in the Medical Devices Regulations 2002 as: an instrument, apparatus, appliance, material or other article, whether used alone or in combination, together with any software necessary for its proper 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 used within the Trust are shown in Appendix Provision of personalised care Medical devices should be used in a manner which has regard to the dignity, comfort and safety of the patient and promotes their independence. This will be achieved by: Actively listening to patients preferences and thoughts wherever possible about the equipment they need and how it is used. Religious belief will be respected regarding consent to use medical devices. If devices are advised which will result in a running cost to the patient e.g. electrical equipment, but the individual does not want to/is unable to fund the running costs, alternative equipment/care will be determined. It will be recorded in the patient notes if consent is not given for devices for any reason. Supporting the patient to understand how and why the equipment is being used. This includes ensuring that information about medical devices will be provided in a format to meet the patient/carer's individual requirements. Taking care in the way they use the equipment to make sure the patient is comfortable and safe. Individual requirements such as pregnancy will be taken into consideration if relevant when issuing any medical devices. Using the equipment in a way that ensures the person s privacy and dignity. Preference for a male or female health professional will be taken into consideration where required. Taking account of the training needs of patients with regard to any equipment they are given to use themselves Using best interest provisions where required (refer to Mental Capacity Act Policy). 1.3 Role of the Medicines and Healthcare products Regulatory Authority (MHRA) The role of the MHRA is to protect and promote public health and patient safety. It does this by ensuring that the manufacture and use of medicines and medical devices meet appropriate standards of safety, quality, performance and effectiveness. It aims to minimise the risk of new adverse incidents involving medical devices and reduce the risk of those that have already occurred from happening again. Page 3 of 41

4 The MHRA: Investigates adverse incidents involving medical devices and equipment Issues safety warnings Provides advice and guidance on safety and quality issues Acts as the UK Competent Authority, the regulator for the medical devices industry 1.4 The primary causes of incidents with medical devices include: Inappropriate management procedures Inadequate instructions for use Inadequate servicing or maintenance Shortcomings in the design or manufacture Lack of policies for disposal and replacement Inappropriate use (including incompatible devices) Inadequate training (staff and users/carers) Incompatible ancillary equipment, such as leads, infusion sets Inadequate documentation, such as missing service history or instructions for use. Unless medical devices are managed proactively and lessons learned from incidents, the same types of incidents will continue to occur. Good medical device management will greatly assist in reducing their potential for harm Medical Device requirements: Medical devices should: Be properly maintained, safe to use and operated by staff or others suitably trained and skilled to use the devices Be suitable for purpose Be installed, used and maintained in accordance with manufacturer s operating specifications and instructions, legislation and guidance from expert bodies Be available in sufficient quantities to meet the needs of people who use the service Be subject to an approved, monitored and recorded service, testing, and maintenance programme Be de-commissioned and/or replaced at the time recommended by the manufacturer or other expert body Promote well-being and/or independence Be comfortable and maintain the dignity of the patient Be compliant with all relevant legislation and guidance Be stored safely and securely to prevent theft, damage or misuse Be able to be safely decontaminated as per the Trust Infection Prevention and Control Decontamination Policy for reusable and single patient use devices. 2. PURPOSE The purpose of this policy is to: Support the effective implementation of the Trust s Risk Management Strategy by setting out the arrangements for minimising the risks associated with the use of medical devices, including purchasing, deployment, training, maintenance, storage, repair and disposal in accordance with legislation and published guidance. Page 4 of 41

5 Support the provision of personalised care through the use of medical devices in a way that has regard to the dignity, comfort and safety of patients and promotes their independence, using best interest provisions where required. The policy is set within the framework provided by MHRA DB2006 (05), November 2006, Managing Medical Devices, Guidance for healthcare and social services organisations and the relevant Care Quality Commission Essential standards of quality and safety, December SCOPE This policy applies to Trust staff and any staff providing services under contract in both hospital and community services who are involved in any aspect of medical devices use and management. It applies to medical devices which are used in In-Patient services, in the community and in patients own homes. 4. RESPONSIBILITIES, ACCOUNTABILITIES AND DUTIES 4.1 Board of Directors and Chief Executive The Board of Directors and Chief Executive have responsibility for medical devices management through nominated Directors, with clear lines of accountability throughout the Trust. 4.2 Nominated Lead Director The nominated Lead Director with overall responsibility for medical devices management is the Executive Director of Business Assurance. 4.3 Committees and group with responsibilities The Performance and Assurance Group is responsible for identifying and defining and requiring appropriate actions to facilitate trust-wide legislative, regulatory and qualifying performance and service delivery for mental health, learning disabilities and associated services and to receive assurances against those criteria. It is responsible for monitoring the Trust s Board Assurance Framework; monitoring and reviewing action plans for gaps against assurance; implementation of the Risk Management Framework, including monitoring the associated Corporate Risk Register and Directorate Risk Registers; and to receive the outcomes of assessments to provide positive assurances or other reports to the Board. The Risk Management Sub-Group is a sub-group of the Performance and Assurance Group and is responsible for approving certain policies and providing assurances around the Board Assurance Framework and Risk Registers. Key risk areas and assurances will be reported to the Risk Management Sub-Group by the Head of Patient Safety & Experience or the Executive Director of Business Assurance through the Health and Safety agenda item included at every meeting. The Health, Safety & Security Forum is a sub-group of the Risk Management Sub-Group and is responsible for monitoring and promoting effective health and safety measures at work (HASAWA, 1974, s 2 (7), through communication and Page 5 of 41

6 collaboration between the Trust as employer and its employees on health and safety matters. The Medical Devices Advisory Group is a sub-group of the Health, Safety & Security Forum and has a remit which includes: ensuring user group experience informs purchasing decisions, rationalisation of the type and number of devices required; acquisition, record keeping and equipment inventories; availability of manufacturer s standard operating procedures and instructions for use; training; repair and maintenance; single use devices; decommissioning; disposal and actions required on manufacturers corrective action notices, championing best practice and reviewing medical device incident reports. The Group report via the Head of Patient Safety & Experience to the Health, Safety & Security Forum through its minutes and by exception basis. The Purchasing Advisory Group is a sub-group of the Cash Releasing Efficiency Savings (CRES) Group and rationalises and standardises product choice, reduces risk, improves cost efficiency and is responsible for establishing the Trust Best Buy Guide. o Human Resources and Organisational Development (HR&OD) Group The HR&OD Group is responsible for receiving though the Head of Learning and development reports on Mandatory Risk Management Training compliance and for taking appropriate action as required. 4.4 Directors Directors are responsible for: Making sure that all the services for which they are responsible fully implement and monitor this policy. Where risks associated with medical devices are identified that these are entered on the appropriate Risk Register and action is taken to mitigate them. 4.5 Head of Patient Safety & Experience The Head of Patient Safety & Experience is responsible for: The development, management, monitoring and audit of a central inventory of all Medical Devices within the Trust. Provision of an annual report on medical devices management to the Health, Safety & Security Forum, including a summary of the medical device alerts issued by the MHRA of relevance to the Trust and assurance on required actions taken. 4.6 Health and Safety Lead The Health and Safety Lead is responsible for: Reporting incidents and near misses involving medical devices through the MHRA adverse incident reporting system (See Appendix 2) and to other relevant agencies as indicated e.g. National Patient Safety Agency (NPSA), Health and Safety Executive Page 6 of 41

7 Dissemination of medical device alerts and maintenance of an effective alerts system in order that robust evidence is available to provide assurance on completion of any identified actions. Analysing incidents and near misses involving medical devices reported via the Safeguard (IR1) electronic incident reporting system and reporting on them within the quarterly incident report to promote learning and ongoing improvements. 4.7 Head of Health, Safety & Security This member of staff will produce the Medical Devices Annual Report including Medical Device alerts. 4.8 Managers Managers are responsible for: Undertaking a risk assessment prior to the use of medical devices. This to include where relevant what will happen in the event of an emergency, including electricity, water or gas supply failure that affect the equipment used to meet the needs of patients. In the majority of cases it is not necessary for this risk assessment to be recorded as it forms part of the pre-use checks undertaken by the user. For example, when about to operate a hoist, a member of staff may determine is it positioned correctly? Is the floor clear and safe? Are the slings in good working order? However, a written risk assessment and checks prior to each use may be required for some high risk equipment such as Electroconvulsive Therapy (ECT) equipment. Promoting and delivering personalised care within their services through the use of medical devices in a way that has regard to the dignity, cultural competence, comfort and safety of patients and promotes their independence Using best interest provisions where required Taking account of the training needs of patients/carers within their service areas with regard to any equipment patients/carers are given by staff to use themselves Have agreed strategies and records in place where a patient refuses to allow use of equipment Ensuring an up to date medical devices inventory is maintained for their service, and identifying which staff are authorised to use the equipment listed. Making Directors aware when risks associated with medical devices are identified in order that these may be entered on the appropriate Risk Register and action taken to mitigate the risks. Ensuring manufacturers standard operating procedures and instructions are available to staff. All staff under their control being suitably inducted and trained in line with Training Needs Analysis (TNA) and aware with regard to this policy and Page 7 of 41

8 associated procedures and arrangements relating to the management of medical devices Releasing staff to attend training relating to this policy and liaising with the Head of Learning and Development to identify any additional medical device training required Undertaking routine monitoring and audit in relation to this policy Organising the maintenance, calibration and testing of medical devices The return of any medical devices which have been loaned to their area Acting on medical device alerts issued by the Health and Safety Lead and providing evidence for assurance purposes that any actions required have been completed Reporting adverse incidents involving medical devices via the Safeguard (IR1) electronic incident reporting system Supporting staff to address any concerns in a timely manner where they identify problems around the safety or suitability of equipment in a person s own home 4.9 All staff It is the responsibility of all staff to: Fully implement this policy and bring to the immediate attention of Managers any issues affecting the effective implementation of this policy Deliver personalised care through the use of medical devices in a way that has regard to the dignity, comfort and safety of patients and which promotes their independence and well-being Use best interest provisions where required Take account of the training needs of patients/carers with regard to any equipment the patient/carer is given to use themselves. Link in with Head of Learning & Development where appropriate. Report incidents and near misses involving medical devices via the Safeguard (IR1) electronic incident reporting system Address any concerns in a timely manner where they identify problems around the safety or suitability of equipment in a patient s own home Use medical devices safely and in the prescribed manner including ensuring that any safety checks required by manufacturers instructions or procedures/guidance are carried out prior to use of medical devices. Individual staff members must ensure they have received sufficient training i.e. verbal and/or written instructions and hence are competent to use a medical Page 8 of 41

9 device before attempting to operate it. If there is any doubt, the member of staff should consult their Manager and the manufacturers instructions. All prescribing decisions involving medical devices will be made by staff with appropriate professional qualifications and suitable experience. Preserve the Trust s assets and keep unnecessary expenditure to a minimum. Every member of staff must have ownership and responsibility for minimising the impact of risk Supplies/Purchasing Department The Supplies/Purchasing Department is responsible for purchasing devices from manufactures that are approved in accordance with Medical Devices Directive (MDD) 93/42/EEC Medical Device Leads The responsibilities of the Medical Device Leads can be described as follows: To attend the Medical Devices Advisory Group and raise pertinent issues. To discuss feedback from Medical Device Link People in their area at the Medical Devices Advisory Group. To progress actions agreed by the Medical Devices Advisory Group within their Business Division. To liaise with Medical Technical Services as required. To liaise with the Information Governance Team regarding devices which contain patient identifiable information. Feedback to Learning and Development of any training issues identified with introduction of any new medical device equipment or issues with existing devices. Medical Device Leads are usually clinical staff and there should be at least one per Business Division Medical Device Link People The responsibilities of the Medical Device Link People can be described as follows: To liaise with the Medical Device Lead for their Business Division, making them aware of any issues/problems. To ensure new devices in their area are logged onto the Safeguard database within 48 hours of receipt. To log any changes to their Medical Devices on the database as they occur e.g. change of location, decommissioned etc. To check the database monthly to ensure information contained is up to date, correct and comprehensive. To monitor service dates for Medical Devices and raise any overdue items with their Medical Device Lead who will liaise with Medical Technical Services. Medical Device Link People are usually administration staff and there should be at least one per Business Division Administrator of Medical Devices Inventory This member of staff will: Page 9 of 41

10 Oversee the inventory and liaise with Ulysses where required Facilitate the appropriate staff access rights to the inventory Be a point of contact and provide support/advice to staff regarding use of the inventory Provide inventory updates/reports to the Medical Devices Advisory Group Update the User Guide as appropriate Periodic cross checking of information from Specialists within the Trust and contract activity against the inventory Head of Learning and Development Medical Devices training is mandatory in association with the required clinical skill. The Head of Learning and Development is responsible for the implementation of the Mandatory Risk Management Training Policy and associated Training Needs Analysis, providing reports on compliance to the Human Resources and Organisational Development Group See Mandatory Risk Management Training Policy and Mandatory Risk Management Training Needs Analysis. The Head of Learning and Development will work with Managers to: - undertake the Training Needs Analysis (TNA) for medical devices in association with the required clinical skill and to ensure that training and updates are delivered as required, either through a standalone programme or through competency based learning. - Source the relevant expertise to deliver training where required. - Ensure that timely and accurate training records are maintained on the electronic staff training record system 5. PROCEDURE/IMPLEMENTATION 5.1 Procurement of Medical Devices All Medical Devices will be selected and procured in accordance with MHRA recommendations and the Trust s Requisition, Ordering and Receipt of Goods Procedure. If the Purchasing Department do not already have a Pre-Purchase Questionnaire (Appendix 4) completed for the medical device, they will forward one to the device supplier for completion. The Pre-Purchase questionnaire covers detailed information about the device, its safety standards, servicing, repair and maintenance, spare parts, training and decontamination/reprocessing. No new Medical Devices should be purchased unless the Manager has: Sought advice from the Supplies/Purchasing Department, relevant Trust policies and any appropriate Trust Advisor e.g. Back Care Advisor/Resuscitation Officer and Infection Prevention and Control Team. Undertaken a risk assessment of its design, function, performance, maintenance requirements, life cycle costs and staff training requirements. Ensured that the medical device can be decontaminated to a safe standard to reduce the risk of cross infection. Page 10 of 41

11 Sought advice around suitable manufacturers and suppliers. Undertaken an assessment of cost effectiveness against purchase /hire of the device. Sought advice from the ICT Department if the equipment is to be connected to the Trust s Network or any IT equipment. Sought advice from the Information Governance Team if the equipment is to store PID (person identifiable data) Purchasing of medical devices is governed by the Purchasing Advisory Group whose objectives are to develop systems to ensure value for money, to ensure equipment and suppliers are selected using sound rationale, to ensure purchasing is carried out in accordance with good practice guidelines, and to maximise purchasing power across the Trust. Please note that this purchasing section is not relevant for purchasing of devices using the FP10 prescription method. Where patients are prescribed dressings/appliances via FP10 prescriptions, the prescriber would consider the criteria in line with prescribing guidelines and formularies. 5.2 Acceptance of New Medical Devices All new medical devices will be delivered to the Purchasing and Supplies department on the St Catherine s site, Doncaster Purchasing and supplies will make arrangements for the delivery of the device to the medical devices department within the locality. Resuscitation equipment should then be sent to the Resuscitation Officer for checking/audit purposes; they will then be delivered to the wards. There will be documentation to provide evidence of the deployment, training, monitoring and control of medical devices. Medical devices will be accepted, checked, stored correctly and maintained, serviced and repaired by appropriately trained staff in accordance with manufacturers instructions/recommendations and relevant legislation with appropriate recording. Checks carried out when equipment is first delivered are to ensure the equipment: Is complete and in good condition without visible defects Is in full working order and meets performance expectations Meets relevant safety inspections e.g. electrical testing Has controls set to the correct level for its purpose (where applicable) Has gone through the correct requirements of Lifting Operations and Lifting Equipment Requirements (LOLER). There is a recommended list from the Health & Safety Executive - How the Lifting Operations and Lifting Equipment Regulations apply to health and social care 12/12 and Provision and Use of Work Equipment Regulations 1998 (PUWER). 5.3 How The Trust Includes All Items of Diagnostic and Therapeutic Equipment on an Inventory New medical devices are inputted onto a web-based inventory (on the Ulysses system) by Medical Device Link People in each service across the Trust (except for single-use items). This inventory contains information about each device such as its manufacturer, location, and servicing date. The inventory is monitored and updated by the Medical Device Link People. Guidance on how to use the inventory Page 11 of 41

12 is provided by the Safeguard Risk Management Systems Web Asset Module User Guide and support is provided on an as and when required basis by the Administrator of the Medical Devices Inventory. Periodic cross checking of information from Specialists within the Trust and contract activity will take place by the Administrator. Annual Clinical Audits are also used to monitor the accuracy of the inventory. 5.4 Single Use Medical Devices All single-use medical devices should have this symbol on the packaging or the device: 2 When a single-use device is used on an individual patient during a single procedure it must then be discarded. It must not be reprocessed and used again, even on the same patient. All equipment will be disposed of in accordance with the guidance given in HTM Safe Management of Healthcare Waste available on the Department of Health website and the Trust Waste Policy. Legal Implications - Anyone who reprocesses a single use device and passes it to a separate legal entity for use has the same legal obligations under the Medical Devices Regulations as the original manufacturer of the device. If the device is not considered fit for its intended purpose the re-processor and professional user may be committing an offence under one or more of the following acts: Health and Safety at Work Act 1974; Part 1 of the Consumer Protection Act 1987; The General Product Safety Regulations 1994; The Medical Devices Regulations Reasons Not To Re-Use Single Use Medical Devices - Reprocessing single-use devices may affect the capabilities and/or the materials from which the device is made. Single-use devices may not be designed to allow thorough decontamination and, if applicable, re-sterilisation processes. Many problems caused by inappropriate reuse fall into one or more of the following categories: inadequate cleaning and decontamination, material alteration, mechanical failure, potential for cross infection, reactions to endotoxins and retaining residues from chemical decontamination agents. Health Circular 1999/178, variant Creutzfeldt-Jakob Disease [vcjd]: Minimising the Risk of Transmission states that devices designated for single episodes of use must not be reused under any circumstances whatsoever. For single use emergency care equipment a stock of spares for instant replacement must be available. Page 12 of 41

13 5.5 Single-Patient Use Medical Devices Single-patient use means the medical device may be used for more than one episode of use on one patient only; the device may undergo some form of decontamination/reprocessing between each use. 5.6 Medical Devices Used On-Trial/On-Loan It is the responsibility of the staff to fully consider the risk exposure, when approached by manufacturer sales representatives endeavouring to market their products. This may result in the product/items of equipment being left for use on a trial/on-loan basis. Managers must be engaged in such decisions. Stakeholders must appreciate that these controls are essential to avoid the of risk exposure to both the clinician and patient. The control will allow the Trust to: 1. Comply with MHRA guidelines, which require supplier indemnity to be assured via the completion of standard NHS Indemnity forms available from the Purchasing Department. 2. That the relevant Medical Technical Services Department (through local SLA) are fully aware and have carried out the required safety checks as required. 3. Processes for safe storage, maintenance, calibration and eventual disposal of the device are in place and recorded with the loan agreement 4. All the training needs have been identified and appropriate training provided prior to use of the devices. If all the key issues have been fully considered and the decision made to accept the Medical Equipment on trial/on loan, the checklist in Appendix 3 must be completed by the manager of the department. Equipment Loaned to Patients Equipment is usually loaned to patients via Community Equipment Services. However, the Trust loans certain equipment to patients such as suction machines and syringe drivers. When equipment is loaned to patients, staff give to the patient/carer: a written copy of equipment instructions alternative formats will be arranged if required training in the use of the device equipment care & maintenance instructions cleaning/decontamination instructions how to obtain consumables malfunction instructions actions to take details about how the device will be returned contact details for any queries Any equipment loaned to patients is recorded on their patient notes so that the location of equipment is known. This record includes the make, model and serial number. It should be ensured that all equipment is returned at the end of the loan and that the normal cleaning/decontamination procedures are followed in line with Page 13 of 41

14 manufacturer s instructions. All equipment should be tested prior to the loan period to ensure it is working as required this should be recorded. 5.7 Use of Medical Equipment for Non-designated Purpose 1. Generally equipment should not be used for any purpose other than that intended by the manufacturer, or 2. Modified in any way prior to use. There is a clear risk to the Trust in the local modification of equipment, or in the use of equipment for non-designated purposes, but where there are demonstrable clinical advantages the Trust does not wish to ban such activities outright. New uses of equipment for unauthorised purposes will be approved by the Clinical Effectiveness Group. It should be noted that modification of equipment or use of any equipment for other than its intended purpose is a clear breach of the terms of the manufacturer s warranty. If a patient suffers harm in the process the Trust would have no redress, even if the equipment was found to be faulty. 5.8 Medical Devices Risk Classification Medical devices will be categorised by managers into one of the following three groups: High Risk Medium Risk Low Risk High Risk Device Items that have the potential to cause serious adverse effects or death should they be misused or fail. Managers will make users aware that it is not safe to proceed until they have either self-verified as competent or have been trained and assessed as competent. Medium Risk Devices Items that would have a significant impact on patient care or cause temporary adverse health consequences should they be misused or fail. Managers will make users aware that the user seeks advice or guidance from a person who has a working knowledge of the main operational features of a device in this category. Once obtained, the user will be advised to proceed with caution but also to pursue formal training in use of the device. Low Risk Device Items that would be unlikely to cause any serious harm should they be misused or fail. Managers will advise the user to proceed in a safe and sensible manner. No formal training is necessarily required. Page 14 of 41

15 5.9 How Reusable Diagnostic and Therapeutic Equipment is Maintained see flowchart at Appendix 7 The arrangements for the maintenance and repair of medical devices within the Trust localities are as below. Doncaster A combination of in house and service level agreements with the Doncaster and Bassetlaw Hospitals NHS Foundation Trust. Rotherham A combination of in house and service level agreements with the Rotherham NHS Foundation Trust. North Lincolnshire Medical Physics at Scunthorpe General Hospital, North Lincolnshire and Goole NHS Foundation Trust Servicing/electrical testing of equipment where required is carried out in accordance with guidance from each Trust. Certain types of medical device have separate maintenance contracts refer to User Guide for examples. Staff should ensure they comply with any documentation /processes required by external contractors. Each company will ensure a test label is attached to the medical device including the date tested and next test date/due date. The medical devices database should be updated by the Medical Devices Link Person following servicing in accordance with the User Guide. Storage Of Equipment - Department Managers have the responsibility to ensure that all equipment is stored correctly according to manufacturers instructions and to minimise deterioration when not being used. Any battery service or re-charging should also be maintained when equipment is being stored. The Trust will ensure that patients, staff and visitors are kept safe by having systems to ensure that all reusable medical devices are properly decontaminated prior to use, repair or disposal. For further guidance refer to the Trust s Decontamination Policy and Trust Cleaning Policy (inpatient units) for Environment, Service User Equipment, and Medical Devices. Mattress Audit all in-patient areas carry out a monthly Mattress Audit using the form attached at Appendix 5. All results are kept locally in the in-patient areas as evidence that the audit has been undertaken. Patient Equipment and General Cleaning Checklist a daily checklist is available for staff use (Appendix 6) How Reusable Diagnostic and Therapeutic Equipment is Repaired see flowchart at Appendix 7 Equipment is repaired when required via the same routes as described in Section 5.9 for maintenance. Staff should: Page 15 of 41

16 Never try to undertake repair work, which should only be undertaken by a qualified technician. Never use broken equipment alternatives must be sourced if necessary e.g. loan from other department. Broken items must be removed to a separate storage area or clearly labelled as broken until repair work is undertaken. The medical devices database should be kept up to date with broken items by the Medical Device Link Person, in accordance with the User Guide. Make sure that any equipment going for repair has been appropriately decontaminated, in accordance with the Trust Decontamination Policy and manufacturers instructions. The Decontamination form at Appendix 8 should be attached to the item. The Manager for each area which holds medical devices will have systems in place for the checking of equipment as recommended by the manufacturer and legal guidance Replacement/Disposal of Medical Devices see flowchart at Appendix 7 All medical devices/equipment will need to be replaced in any of the following situations: Worn out or damaged beyond economic repair Unreliable Clinically or technically obsolete Spare parts no longer available More cost effective or clinically effective devices have become available Unable to be decontaminated effectively. Manufacturers recall In response to relevant Medical Device Alerts Any equipment regarded as requiring disposal due to the above reasons should be agreed by the relevant manager/director of Service. For equipment with a value of 5000 or above, the Director of Finance must be consulted for final approval and the Trust Asset Register amended accordingly. The equipment should be removed to an area where it cannot be used until collection for permanent removal and clearly marked with a notice or stickers to prevent accidental re-use. The Waste Electrical & Electronic Equipment (WEEE) Returns Form attached at Appendix 9 should be completed for appropriate items which need disposing of. A Decontamination Form (Appendix 8) should also be completed if appropriate and kept with the item if possible. All equipment will be disposed of in accordance with the guidance given in HTM Safe Management of Healthcare Waste available on the Department of Health website and the Trust Waste Policy. Arrangements must be made to ensure patient data is erased where applicable. If staff are not sure how to erase patient data they should consult the device user manual. The medical devices database should be updated by the Medical Devices Link Person following disposal in accordance with the User Guide. Page 16 of 41

17 Before sale or donation of medical devices for reuse, the potential for future liability against the responsible organisation should be considered. Advice must be obtained from the Head of Procurement & Purchase Ledger Failure of a Medical Device In the event of there being a failure in the operation of a medical device staff must: Take any necessary action to protect the well being of patients and staff Seek immediate advice from either the manufacturer, or their local Medical Technical Services department. Report the failure to the Trust Health and Safety Lead. Report the incident via the Safeguard (IR1) incident reporting system (see Section 5.13) Arrange for the removal of the device for repair, unless the incident is subject to an inquiry, in which case the device is to be segregated but not disposed of. The Manager will complete a defect notification form if one is required. These forms are available from the Health and Safety Lead. Completed forms are to be sent to the Health and Safety lead for onward transmission to the MHRA. Arrange for replacement equipment if required Reporting Medical Device Incidents The Trust promotes an open and fair culture of safety where learning can take place and ongoing improvements in quality and safety can be made. All incidents and near misses involving medical devices must be reported via the Safeguard (IR1) electronic incident reporting system and will be analysed and reported on within the quarterly incident report by the Health and Safety Lead to promote learning and ongoing improvements. These will be reported onwards to the relevant agencies by the Health and Safety Lead. Local action must be taken to ensure the safety of patients, users and others. A defective/faulty device must be taken out of use as soon as it is safe to do so, and labelled to ensure it is not reused, but otherwise left exactly as it was at the time of the incident. The evidence must not be tampered with in any way except for safety reasons or to prevent its loss. If relevant, a record should be made of all readings, settings and positions of switches, valves dials, gauges and indicators, together with any photographic evidence and eyewitness reports. In serious cases, this record should be witnessed and the witness should also make a personal written record. Where equipment on loan is found to be defective/faulty then staff should report to the Community Equipment Services as well as the Trust. The responsible member of staff will keep copies of forms sent to the MHRA and outcomes will be reported to the Medical Devices Advisory Group. See Section 1.4 of this policy for the primary causes of medical devices incidents and refer to Trust Incident Reporting Policy for further guidance. Page 17 of 41

18 5.14 Disseminating Medical Device Alerts Medical device alerts will be circulated to Managers by the Health and Safety Lead via an approved distribution list, and responses and identified action required tracked to completion to provide robust evidence for assurance purposes. 6. TRAINING IMPLICATIONS The Training Needs Analysis (TNA) for this policy can be found in the Training Needs Analysis document which is part of the Trust s Mandatory Risk Management Training Policy located under policy section of the Trust website. The Trust believes that the following levels of training and frequency of training are adequate to provide safe clinical practice. This is based on current national drivers and the Trust internal TNA process via a blended learning approach and reference to this Policy. High risk medical devices Medium risk medical devices Annually or in line with manufacturers instructions where indicated Every three years or in line with manufacturers instructions where indicated or according to professional competency e.g. needles/syringes, gym equipment, baths etc. Low risk devices After basic training, as and when required or in line with manufacturers instructions where indicated Refer to Mandatory Risk Management Training Policy for some of the medical device relevant training which is included within e.g. Resuscitation Training and Manual Handling Training. The purchaser of devices must consider that all training issues are carefully considered prior to the equipment being bought in adherence to the Trust Supplies and Procurement Strategy (February 2007). Any training needs identified must be raised with the Head Learning and Development who is responsible for co-ordinating and arranging a Trust-wide approach to medical device training needs. Medical device training requirements that involve a particular clinical skill or interpretation of results in relation to that medical device e.g. an ECG machine or glucometer will be competency based with use of the Leicester Clinical Assessment Tool (LCAT) and will be approved by the RDaSH Clinical Effectiveness Committee and Clinical Skills Forum. Training based purely on functionality of the medical device does not require a competency based approach. Page 18 of 41

19 Level 1 Basic Training (Introductory or awareness) This applies to all medical equipment that medical, nursing, allied health professional or ancillary staff may use or handle. This level of training is intended to provide an overview including a basic understanding of the equipment, decontamination if required and an awareness of the principles of the equipment. This level of training may be included in the next level (Competent training) or stand alone as training given for instance to support staff who would not be expected to operate the equipment clinically but will need an appreciation of it for safety. Training may be provided by ward / department based key trainers, in-house training providers or suppliers /manufacturers. Level 2 Competent Training - (Full training) This applies to all medical equipment that medical, nursing, allied health professional or ancillary staff may use. This level of training is intended to provide comprehensive and detailed instruction in the use of the equipment, covering all aspects of the equipment including pre use testing, setting up, operation, user problems and decontamination. This will allow the staff to operate the equipment correctly and safely. Ward/department based key trainers; in house training providers or supplier/manufacturers may provide training. Level 3 Specialist Training to deliver education (Key Trainers) This level of training is intended for those members of staff who have been designated as key trainers and who have completed the level 2 competent training for the equipment. This level of training allows the key trainer to train others. Key trainers must have been trained by the Trust Lead Specialist or supplier / manufacturer. Elements of the Key Trainers Role are: - A professional and relevant delivery of the subject matter The content of the training is based on manufacturer s guidance material allowing for a consistent trust wide approach. Appropriate assessment tools are developed and incorporated into training packages All the required documentation is completed for individual, departmental and Trust records i.e. attendance sheets from training must be forwarded to Learning & Development to update staff personal records. Principles of Training No staff are to operate any medical device until they have been trained, and are proficient in the use of it. When training is undertaken as well being given a demonstration of how the equipment works staff will also be provided with full written and verbal instructions if required. During training, staff will be given the opportunity to ask questions, and express any concerns they may have in relation to the equipment. Training will only be provided by a representative of the manufacturer or practitioner designated competent by the Clinical Skills Expert Panel. Page 19 of 41

20 Any refresher training which is required will be organised by the Manager with attendance sheets sent to Learning & Development Service for capture on the training database Oracle Learning Management System (OLM). Authorisation of Staff to use Equipment The appointing Manager will determine which staff can use equipment according to their job role and competency, each area s Training Needs Analysis (TNA), and the local induction process. Recording of Staff Training Staff training is recorded on the Trust s Oracle Learning Management System/Electronic Staff Record (ESR). RDaSH facilitators or external facilitators must ensure the completed approved Attendance List is forwarded to the Learning and Development Service at the RED Centre following each training session, for population onto the Oracle Learning Management System to ensure accurate reporting of training for compliance reporting. Individuals who did not attend training sessions are determined by the Learning and Development Service by reviewing the individuals who originally booked on the training against the attendance lists. Monthly Did Not Attend (DNA) reports are produced for the Human Resources & Organisational Development Policy and Planning Group. This highlights areas where staff were booked on training and failed to attend or where courses had to be cancelled due to low uptake. This information is shared with Assistant Directors/Heads of Service highlighting individual members of staff. Staff training and risk level of medical devices in each service is monitored by an on-going programme of audit reports by the Learning and Development Service. Page 20 of 41

21 7. MONITORING ARRANGEMENTS Area for Monitoring Duties How the Trust includes all items of diagnostic and therapeutic equipment on an inventory How reusable diagnostic and therapeutic equipment is maintained How reusable diagnostic and therapeutic equipment is repaired How the Trust identifies which permanent staff are authorised to use the equipment listed on the inventory How the Trust decides the training required How the Trust decides the frequency of updates How Who by Frequency Reported to Internal Audit Clinical Audit Overview of system Report By Medical Device Link People/Leads in each location. Negative trends would be reported through Medical Device Advisory Group and Incident Reporting system. Clinical Audit Training Needs Analysis Level of Risk and Staff Training Reports Internal Audit Department Clinical Audit Department Business Division Medical Device Leads and Managers & Administrator of electronic inventory Administrator Medical Device Leads/ Medical Device Advisory Group Clinical Audit Department Head of Learning and Development Annual On-going Quarterly As and when required Annual Annual Risk Management Sub-Group Medical Devices Advisory Group Medical Devices Advisory Group Medical Devices Advisory Group Risk Management Sub-Group Medical Devices Advisory Group Page 21 of 41

22 required High Risk Medical Devices Staff Training How the Trust records that all permanent staff complete training How the Trust follows up those who do not complete training Action to be taken in the event of persistent non attendance Medical Device Incidents & update Medical Device Alerts Medical Devices including Alerts Patient Hoist and lifting equipment compliant with LOLER. Availability of emergency equipment required under Resuscitation Policy Patient Equipment and General Cleaning Checklist Monitoring arrangements as per Mandatory Risk Management Training Policy Monitoring arrangements as per Mandatory Risk Management Training Policy Monitoring arrangements as per Mandatory Risk Management Training Policy Report Report Medical Devices Annual Report Back Care Advisory Service Annual Report Report Visual Check Infection Prevention and Control Audit Health and Safety Lead Health & Safety Lead Head of Health, Safety & Security Back Care Advisor - Ergonomist Resuscitation Officer Ward Sister/Matron Infection Prevention and Control Team Quarterly Health, Safety & Security Forum 6 monthly Health, Safety & Security Forum. Exception reports to Risk Management Sub Group Annual Health, Safety & Security Forum. Annual Quarterly Weekly Annual Health, Safety & Security Forum Health, Safety & Security Forum Not applicable Infection Prevention and Control Committee Page 22 of 41

23 8. EQUALITY IMPACT ASSESSMENT SCREENING The completed Equality Impact Assessment for this Policy has been published on the Equality and Diversity webpage of the RDaSH website click here 8.1 Privacy, Dignity and Respect The NHS Constitution states that all patients should feel that their privacy and dignity are respected while they are in hospital. High Quality Care for All (2008), Lord Darzi s review of the NHS, identifies the need to organise care around the individual, not just clinically but in terms of dignity and respect. As a consequence the Trust is required to articulate its intent to deliver care with privacy and dignity that treats all service users with respect. Therefore, all procedural documents will be considered, if relevant, to reflect the requirement to treat everyone with privacy, dignity and respect, (when appropriate this should also include how same sex accommodation is provided). 8.2 Mental Capacity Act Central to any aspect of care delivered to adults and young people aged 16 years or over will be the consideration of the individuals capacity to participate in the decision making process. Consequently, no intervention should be carried out without either the individuals informed consent, or the powers included in a legal framework, or by order of the Court Therefore, the Trust is required to make sure that all staff working with individuals who use our service are familiar with the provisions within the Mental Capacity Act. For this reason all procedural documents will be considered, if relevant to reflect the provisions of the Mental Capacity Act 2005 to ensure that the interests of an individual whose capacity is in question can continue to make as many decisions for themselves as possible. Indicate how this will be met No additional requirements have been identified in relation to this policy. Privacy, dignity and respect underpin the implementation of this and the associated policies which set out a person centred approach to care, working in partnership with the service user and carers as appropriate. Indicate how this will be achieved All individuals involved in the implementation of this policy should do so in accordance with the Guiding Principles of the Mental Capacity Act 2005 (Section 1). 9. LINKS TO ANY ASSOCIATED DOCUMENTS Risk Management Strategy Incident Reporting Policy Decontamination Policy Mandatory Risk Management Training Policy and Training Needs Analysis The Trust Supplies and Procurement Strategy Requisition, Ordering and Receipt of Goods Procedure Trust Cleaning Policy (inpatient units) for Environment, Service User Equipment, and Medical Devices Page 23 of 41