NOTTINGHAM UNIVERSITY HOSPITALS NHS TRUST. Managing Loan Medical Devices in Nottingham University Hospitals NHS Trust Procedure Documentation Control

Transcription

1 NOTTINGHAM UNIVERSITY HOSPITALS NHS TRUST in Nottingham University Hospitals NHS Trust Procedure Documentation Control Reference CL/CGP/051 Approving Body Directors Group Date Approved 23 Implementation Date 23 Summary of Changes from See Executive Summary Previous Version Supersedes NUH Version 2 (November 2010 ) Consultation Undertaken Medical Devices and Equipment Committee Sub-group Date of Completion of September 2014 Equality Impact Assessment Date of Completion of We September 2014 Are Here for You Assessment Date of Environmental September 2014 Impact Assessment Legal and/or Accreditation Implications CQC (Outcome 11) NHSLA Standards 5.4 and 5.5 Target Audience All clinical staff and Duty holders Review Date January 2016 Lead Executive Medical Director Author/Lead Manager Professor Daniel Clark Chair of Medical Devices and Equipment Committee (MDEC) Extension: Further Guidance/Information Professor Daniel Clark Chair of Medical Devices and Equipment Committee (MDEC) Extension:

2 CONTENTS Paragraph Title Page 1. Introduction 3 2. Executive Summary 3 3. Definitions 3 4. Roles and Responsibilities 4 6. Procedural Requirements 5 7. Implementation and Resources 9 8. Impact Assessments Monitoring Matrix Relevant Legislation, National Guidance and 13 Associated NUH Documents Appendix (1) Equality Impact Assessment 15 Appendix (2) Environmental Impact Assessment 18 Appendix (3) Here For You Assessment 20 Appendix (4) Certification Of Employee Awareness 23 Appendix (5) List of associated appendices from version

3 1.0 Introduction 1.1 When devices or equipment are loaned by the Trust, the procedures outlined below must be followed to ensure that the Trust discharges its duty of care to the device users, the patients, carers and other users. When devices or equipment are loaned to the Trust (from whatsoever source) this loan procedure must be followed to ensure that: the device is safe and fit for purpose before it goes into clinical use; the device is appropriately managed as set out in MDA SN 2002(17) and MDA SN 2000(18); the Trust is indemnified against any claims for injury resulting from its use 2.0 Executive Summary 2.1 This policy supersedes version 2.0 It has a number of re-formating changes plus technical updates but no material changes to the procedure. It is recognised that significant changes to the governance arrangemnets for medical devices are currently taking place in response to national and local initiatives. These changes will require an early review of this procedure and the review date has been set accordingly. 3.0 Definitions 3.1 Medical Devices (as defined in law) are instruments, apparatus, appliances, equipment, materials or articles, whether used alone or in combination (including software necessary for the proper application) intended by the manufacturer to be used for human beings for the purpose of: diagnosis, prevention, monitoring, and treatment or alleviation of disease or injury, diagnosis, monitoring, treatment, alleviation or compensation 3

4 of injury or disability, investigation, replacement or modification of the anatomy or of a physiological process, control of conception, and which do not achieve their principal intended action in or on the human body by pharmacological, immunological or metabolic means, but which may be assisted in their function by such means. Medical device management principles apply to their accessories too; ( accessory means an article which whilst not being a device is intended specifically by its manufacturer to be used together with a device to enable it to be used in accordance with the use of the device intended by the manufacturer of the device). Medical Equipment is the term adopted by this policy to describe those Medical Devices that warrant inventorying and individual lifetime management by virtue of their - asset value, and/or performance assurance requirements, and/or servicing requirements, and/or control and traceability requirements, and/or compliance obligations. Medical Equipment also includes non-medical devices that are used in conjunction with medical devices and includes devices used for the testing and servicing of medical devices. Single-use Medical Device is the term used to describe any nonreusable Medical Device intended to be used on an individual patient during a single procedure and then discarded. Items labelled or recommended by the manufacturer as single-use must not be reprocessed and reused on the same or on another patient. 4.0 Roles and Responsibilities 4.1 Committees The Medical Devices and Equipment Committee (MDEC) are responsible for setting overall strategy and policy to support the 4

5 effective identification and management of risks associated with the acquisition, use, maintenance and repair of medical devices and equipment. For further information refer to the Management of Medical Devices and Equipment Strategy Sub-groups of the Medical Devices and Equipment Committee (MDEC) advise on specialist areas including acquisition. 4.2 All Trust staff have a responsibility to make themselves familiar with and follow policy and procedures appropriate to their duties. Trust Staff agreeing to the loan of devices or equipment may find themselves personally liable for losses if they do not follow these procedures 5.0 Procedural Requirements 5.1 Medical Devices on Loan TO the Trust from Manufacturer or Supplier Trust staff arranging the loan of medical device to the Trust must ensure that the supplier has a Master Indemnity Agreement (MIA) with NHS Supplies or completes an Indemnity Form specific to that device. In the latter case, the supplier must complete either Indemnity Form A (Equipment for trial or testing) or Form B (Equipment for other purposes) before the devices made available for use. Surgical Instrument sets on loan must fully conform to MDA SN 2000(18) and in line with MDA SN 2002(17) Copies of forms A and B are included in Appendix A. Suppliers with an MIA need only sign a delivery note of the form shown in Appendix B when providing goods. A list of supplies with MIA is maintained on the Department of Health (DoH) website Trust staff arranging a device loan must also ask the supplier to provide a completed PPQ form (Appendix C) as evidence that the 5

6 device meets the essential requirements of the Medical relevant Devices Directive. All medical equipment should be tested for functionality and safety by Clinical Engineering (or a delegated agent under the supervision of Clinical Engineering) upon arrival on site. Trust staff arranging a device loan must make advance arrangements with Clinical Engineering to facilitate this testing. PPQ forms will be inspected and indemnity forms and delivery notes completed and retained by the Clinical Engineers for equipment tested. The level and frequency of ongoing maintenance needs to be determined together with clear statement of who is responsible for this maintenance. Arrangements must be in place to ensure that at the end of the loan period, the device is removed from service or additional indemnities provided The device(s) must be either sterilised or decontaminated according to Trust policy and a decontamination certificate must accompany the equipment. The device(s) must be securely packaged and checklists with manufacturer s instructions for use and decontamination must be included with the device(s) 5.2 Medical Devices on Loan TO the Trust from another trust, healthcare provider or other third part (for example a University Medical devices loaned to the Trust by another Trust or Healthcare organisation or any other third party must also be tested and recorded by the Clinical Engineers before being put in clinical use. Where the third party organisation cannot provide full indemnity cover or any other element of the acceptance procedures above, the device can only be accepted into clinical practice with the approval of the Medical Devices and Equipment Committee (MDEC). See procedure for allowing non-compliant medical devices into clinical practice Devices arriving from another Trust with a patient as part of a clinical transfer must be replaced by Trust devices as soon as possible to avoid risks arising from its unknown state of repair or unfamiliarity to staff. The original device must be returned to the other Trust as soon as possible. 6

7 5.3 Medical Devices on Loan TO the Trust from as part of a research study or trial Devices on loan to Nottingham University Hospital as part of a research project or clinical trial must only be used as part of a research study approved by the Research and Development Department. Suitable ethics approval may also be required as determined by the Research and Development Department All devices brought into NUH as part of such an approved study must also be tested for functionality and safety by Clinical Engineering (or a delegated agent under the supervision of Clinical Engineering) upon arrival on site. Trust staff arranging a device loan under such a research study must make advance arrangements with Clinical Engineering to facilitate this testing. The level and frequency of ongoing maintenance needs to be determined together with clear statement of who is responsible for this maintenance. Arrangements must be in place to ensure that at the end of the study period, the device is removed from service Where the loan is provided to the Trust pursuant to a commercially sponsored clinical trial a fully executed Clinical Trial Agreement (between the Trust and Sponsor will ensure that indemnity is provided to the Trust to a value of not less than 5 million.. The R&D Department is responsible for ensuring such an agreement is in place. Further advice is available from the R&D Department Where such an agreement (as under 4.3 above) is not in place or where the loan is from a third party organisation who cannot provide full indemnity cover or any other element of the acceptance procedures above, then the device can only be accepted into clinical practice with the approval of the Medical Devices and Equipment Committee (MDEC) or the Director of Research and Development. See Procedure for Allowing Non-compliant Medical Devices into Clinical Practice. 7

8 5.4 Medical Devices loaned BY the Trust to another Trust or Healthcare Organisation Nottingham University Hospital does not loan medical equipment to other hospitals, either NHS or private sector The only exception to 5.1 is where Nottingham University Hospital has a contract or contracts to supply services that are externally accredited to appropriate quality standards. MDEC can advise on what constitutes appropriate quality standards 5.5 Medical devices loaned BY one NUH department to another NUH department The Trust operates an Equipment Library. The portfolio of services provided and operating policy of the Library are included in Appendix D. Wherever possible, loans between clinical departments should be facilitated by the Equipment Library. Staff in the receiving department, training lead staff must ensure competence and not allow devices into their area without documentation. 5.6 Medical devices loaned BY the Trust to a patient, relative, carer or other end user Trust staff arranging the loan of devices to a patient, relative, carer or other end user should ensure that they understand the intended use and normal functioning of the device in order to use it effectively and safely. Where relevant, training should cover: Any limitation on use How to fit accessories and be aware of how they may increase or limit the use of the device How to use any controls appropriately The meaning of displays, indicators, alarms etc and how to respond to them Requirements for maintenance and decontamination, including 8

9 cleaning How to recognise when the device is not working properly and what to do about it Understand the know pitfalls in the use of the device, including those identified in safety advice from the MHRA, manufacturers and other relevant bodies Understand how to report any problems and incidents Trust staff must also ensure that they provide clear written instructions on the use of the device. These would normally be as supplied by the device manufacturer. Where these instructions are prepared by NUH staff, they should seek advice from the original manufacturer before issuing to patient, relative, carer or other end user. The patient, relative, carer or end user must be instructed to stop using the device and arrange for its return to the hospital if they suspect a malfunction as well as clear instructions as to how to return the device after use The Agreement form for patient use of a medical device(s) when leaving hospital (End user Agreement) (Appendix F) must be completed and signed by the patient/carer and retained in the patient s notes as evidence that the above training has been given Additional handover documentation must be maintained by the clinical team issuing or prescribing the device as a record of the issue of the device. An example handover form is included in Appendix E. 7.0 Implementation and Resources 7.1 Implementation This policy covers medical devices at NUH. Dissemination of this procedure will be via the MDEC and Medical Devices Training Group members who will distribute through local 9

10 governance forums. MDEC will review incidents and monitor any related use of medical devices 7.3 Resources No additional resources are anticipated for the implementation of this procedure. 8.0 Trust Impact Assessments 8.1 Equality Impact Assessment An equality impact assessment has been undertaken on this draft and has not indicated that any additional considerations are necessary. 8.2 Environmental Impact Assessment An environmental impact assessment has been undertaken on this draft and has not indicated that any additional considerations are necessary. 8.3 Here For You Assessment A Here For You assessment has been undertaken on this document and has not indicated that any additional considerations are necessary. 10

11 9.0 Policy / Procedure Monitoring Matrix The Medical Devices & Equipment Committee [MDEC] will monitor compliance with this policy through: Reports received from its sub committees on performance against agreed action plans and audits of practice. Analysis of incidents and claims data relating to medical devices / equipment. Periodic review of the Trust s servicing and maintenance arrangements Review of appropriate entries from the CAS System Log Review of risks / Risk Registers relating to medical devices / equipment Review of the medical devices / equipment backlog replacement programme In relation to the above, MDEC will make recommendations for improvement and oversee the development and implementation of action plans. The Chair of MDEC, an integral member of the Clinical Risk Committee [CRC] will provide CRC with bi monthly reports including work in progress, specific risk issues and actions taken to improve practice. All risks will be entered onto the Trusts Risk Register, with those scoring 20 and above being reported to the Risk Management Committee. Minimum requirement to be monitored Responsible individual/ group/ committee Process for monitoring e.g. audit Frequency of monitoring Responsible individual/ group/ committee for review of results Responsible individual/ group/ committee for development of action plan Responsible individual/ group/ committee for monitoring of action plan 11

12 Dissemination via MDEC and MDTG membership Review of Incidents MDEC and MDTG membership MDEC NA NA NA NA NA Datix incident reports Bi-monthly MDEC meeting MDEC chair MDEC chair MDEC chair Bi-monthly reports to CRC MDEC Chair CRC minutes Bi-monthly CRC meeting MDEC chair MDEC chair MDEC chair 12

13 10.0 Relevant Legislation, National Guidance and Associated NUH Documents 10.1 Legislation The Medical Devices Regulations Statutory Instrument 2002 No ISBN Significant additional legislation is relevant to elements of this policy see MDEC chair for details 10.2 National Guidance MHRA Publications Managing Medical Devices Guidance for healthcare and social services organisations April MHRA. DB2011(01) Reporting adverse incidents and disseminating Medical Device Alerts Essential standards of quality and safety 2010 Care Quality Commission Significant additional legislation is relevant to elements of this policy see MDEC chair for details 10.3 Associated NUH Documents 1. Management of Medical Device and Equipment Strategy (available from MDEC chair). 13

14 2. Management of Point of Care Testing (POCT) Devices (March 2010). CLCGP Procedures for Managing Medical Devices and Equipment in NUH: Selection and Procurement of Medical Devices (Standardisation) Procedure 3.2. Procedure for in NUH 3.3. Decontamination and Reprocessing of Medical Devices Procedure 3.4. Medical Devices Training Procedure 3.5. Protocol for Setting Clocks in Medical Equipment 3.6. Withdrawal and Decommissioning of Medical Equipment Procedure 3.7. Responsibilities of the Centralised Alerting System (CAS) Officer and the Medical Devices Liaison Officer 4. Dissemination of Information received via the national Central Alerting System Procedure. (HS/SP/001). 5. Incident Reporting and Management Policy (GG/CM/021) 6. The Risk Management Policy. (GG/CM/007) 7. Personal Development Review Policy (HR/T&D/001) 14

15 Insert templates of relevant impact assessments (page break after each) APPENDIX 1 Equality Impact Assessment (EQIA) Form (Please complete all sections) Q1. Date of Assessment: Q2. For the policy and its implementation answer the questions a c below against each characteristic (if relevant consider breaking the policy or implementation down into areas) Protected Characteristic a) Using data and supporting information, what issues, needs or barriers could the protected characteristic groups experience? i.e. are there any known health inequality or access issues to consider? The area of policy or its implementation being assessed: b) What is already in place in the policy or its implementation to address any inequalities or barriers to access including under representation at clinics, screening Race and None Not Applicable None Ethnicity Gender None Not Applicable None c) Please state any barriers that still need to be addressed and any proposed actions to eliminate inequality Age Ability to give informed consent Existing trust procedures for None for young children consent Religion None Not Applicable None Disability Ability to give informed consent for mental incapacity or physical Existing trust procedures for consent None 15

16 inability (e.g. the unconscious patient in emergency setting) Sexuality None Not Applicable None Pregnancy and None Not Applicable None Maternity Gender None Not Applicable None Reassignment Marriage and None Not Applicable None Civil Partnership Socio-Economic None Not Applicable None Factors (i.e. living in a poorer neighbour hood / social deprivation) Area of service/strategy/function Q3. What consultation with protected characteristic groups inc. patient groups have you carried out? None Q4. What data or information did you use in support of this EQIA? None Q.5 As far as you are aware are there any Human Rights issues be taken into account such as arising from surveys, questionnaires, comments, concerns, complaints or compliments? None 16

17 Q.6 What future actions needed to be undertaken to meet the needs and overcome barriers of the groups identified or to create confidence that the policy and its implementation is not discriminating against any groups What By Whom By When Resources required None Q7. Review date December

18 APPENDIX 2 Environmental Impact Assessment The purpose of an environmental impact assessment is to identify the environmental impact of policies, assess the significance of the consequences and, if required, reduce and mitigate the effect by either, a) amend the policy b) implement mitigating actions. Area of impact Waste and materials Soil/Land Water Environmental Risk/Impacts to consider Is the policy encouraging using more materials/supplies? Is the policy likely to increase the waste produced? Does the policy fail to utilise opportunities for introduction/replacement of materials that can be recycled? Is the policy likely to promote the use of substances dangerous to the land if released (e.g. lubricants, liquid chemicals) Does the policy fail to consider the need to provide adequate containment for these substances? (e.g. bunded containers, etc.) Is the policy likely to result in an increase of water usage? (estimate quantities) Is the policy likely to result in water being polluted? (e.g. dangerous chemicals being introduced in the water) Does the policy fail to include a mitigating procedure? (e.g. modify procedure to prevent water from being polluted; polluted water containment for adequate disposal) Action Taken (where necessary) No No Not Applicable No Not Applicable No No Not Applicable 18

19 Air Energy Nuisances Is the policy likely to result in the introduction of procedures and equipment with resulting emissions to air? (e.g. use of a furnaces; combustion of fuels, emission or particles to the atmosphere, etc.) Does the policy fail to include a procedure to mitigate the effects? Does the policy fail to require compliance with the limits of emission imposed by the relevant regulations? Does the policy result in an increase in energy consumption levels in the Trust? (estimate quantities) Would the policy result in the creation of nuisances such as noise or odour (for staff, patients, visitors, neighbours and other relevant stakeholders)? No Not Applicable Not Applicable No No 19

20 APPENDIX 3 We Are Here For You Policy and Trust-wide Procedure Compliance Toolkit The We Are Here For You service standards have been developed together with more than 1,000 staff and patients. They can help us to be more consistent in what we do and say to help people to feel cared for, safe and confident in their treatment. The standards apply to how we behave not only with patients and visitors, but with all of our colleagues too. They apply to all of us, every day, in everything that we do. Therefore, their inclusion in Policies and Trust-wide Procedures is essential to embed them in our organization. Please rate each value from 1 3 (1 being not at all, 2 being affected and 3 being very affected) Value Score (1-3) 1. Polite and Respectful Whatever our role we are polite, welcoming and positive in the face of adversity, and are always respectful of people s individuality, privacy and dignity. 2. Communicate and Listen We take the time to listen, asking open questions, to hear what people say; and keep people informed of what s happening; providing smooth handovers. 3. Helpful and Kind All of us keep our eyes open for (and don t avoid ) people who need help; we take ownership of delivering the help and can be relied on. 4. Vigilant (patients are safe) Every one of us is vigilant across all aspects of safety, practices hand hygiene & demonstrates

21 attention to detail for a clean and tidy environment everywhere. 5. On Stage (patients feel safe) 1 We imagine anywhere that patients could see or hear us as a stage. Whenever we are on stage we look and behave professionally, acting as an ambassador for the Trust, so patients, families and carers feel safe, and are never unduly worried. 6. Speak Up (patients stay safe) 1 We are confident to speak up if colleagues don t meet these standards, we are appreciative when they do, and are open to positive challenge by colleagues 7. Informative 2 We involve people as partners in their own care, helping them to be clear about their condition, choices, care plan and how they might feel. We answer their questions without jargon. We do the same when delivering services to colleagues. 8. Timely 1 We appreciate that other people s time is valuable, and offer a responsive service, to keep waiting to a minimum, with convenient appointments, helping patients get better quicker and spend only appropriate time in hospital. 9. Compassionate 1 We understand the important role that patients and family s feelings play in helping them feel better. We are considerate of patients pain, and compassionate, gentle and reassuring with patients and colleagues. 10. Accountable 2 Take responsibility for our own actions and results 11. Best Use of Time and Resources 1 Simplify processes and eliminate waste, while improving quality 12. Improve 1 Our best gets better. Working in teams to innovate and to solve patient frustrations TOTAL 15 21

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23 APPENDIX 4 CERTIFICATION OF EMPLOYEE AWARENESS Document Title in Nottingham University Hospitals NHS Trust Procedure Version (number) 23 Version (date) 3 I hereby certify that I have: Identified (by reference to the document control sheet of the above policy/ procedure) the staff groups within my area of responsibility to whom this policy / procedure applies. Made arrangements to ensure that such members of staff have the opportunity to be aware of the existence of this document and have the means to access, read and understand it. Signature Print name Date Directorate/ Department The manager completing this certification should retain it for audit and/or other purposes for a period of six years (even if subsequent versions of the document are implemented). The suggested level of certification is; Clinical directorates - general manager Non clinical directorates - deputy director or equivalent. The manager may, at their discretion, also require that subordinate levels of their directorate / department utilize this form in a similar way, but this would always be an additional (not replacement) action. 23

24 APPENDIX 5 Associated Documents. The following documents were appendices of version 2.0 of this procedure. Many are currently being reviewed and amended/withdrawn. Please contact the Chair of the Medical Devices Committee for further information Indemnity forms A and B NHS Delivery Note PPQ/PAQ forms Equipment Library Portfolio (web link( Reusuable Medical Equipment Loan Certificate 24