NOTTINGHAM UNIVERSITY HOSPITALS NHS TRUST Documentation Control Reference CL/CGP/061 Approving Body Directors Group Date Approved 26 Implementation Date 26 Version Summary of Changes from Previous Version No substantive changes, just updates to current version Supersedes NUH version 1 (May 2010) Consultation Undertaken Reviewed and approved by MDEC Date of Completion of 4 th December 2012 Equality Impact Assessment Date of Completion of We 4 th December 2012 Are Here for You Assessment Date of Environmental 4 th December 2012 Impact Assessment (if applicable) Legal and/or Accreditation CQC (Outcome 11) Implications NHSLA Standards 5.4 and 5.5 Target Audience Users of Medical Devices, particularly those with authority to select the type of devices used for given clinical procedures Review Date November 2015 Lead Executive Medical Director Author/Lead Manager Name Professor Dan Clark Job title Head of Clinical Engineering Extension 61131 Further Guidance/Information Name Professor Dan Clark Job title Head of Clinical Engineering Extension 631131 1
CONTENTS Paragraph Title Page 1. Introduction 2. Executive Summary 3. Policy Statement 4. Definitions (including Glossary as needed) 5. Roles and Responsibilities 6. Policy and/or Procedural Requirements 7. Training, Implementation and Resources 8. Impact Assessments 9. Monitoring Matrix 10. Relevant Legislation, National Guidance and Associated NUH Documents Appendix 1 Procedural Flowchart Appendix 2 List of Supporting Information likely to be required Appendix 3 Equality Impact Assessment Appendix 4 Environmental Impact Assessment Appendix 5 Here For You Assessment Appendix 6 Certification Of Employee Awareness 2
1.0 Introduction 1.1 This procedure is designed to ensure that all medical devices at Nottingham University Hospital NHS Trust are used in way which conforms to established regulatory and best practice guidance. Clinical practice that requires the use of non-conforming medical devices (including the off-label use of medical devices) shall only be permitted where that practice has been risk assessed, appropriately challenged, recorded and reviewed so as to ensure the patient benefit out-weighs any risks. 2.0 Executive Summary 2.1 To comply with national guidance and minimise the risk of medical device related clinical incidents, Trust staff MUST: Only use appropriately CE marked medical devices Only use medical devices for their intended purpose Not modify or alter the function or structure of medical devices unless specifically sanctioned by the manufacturer s instructions for use Not use non-medical products for clinical purpose In exceptional circumstances where there is no alternative but to use non-conforming medical device, Trust staff MUST: Carry out and document a risk assessment Consider the ethical and legal implications Implement suitable precautions to minimise the risk Review the risk assessment at suitable intervals Ensure the patient is fully informed during the consent procedure Record the use of the non-conforming device in the patient s record Gain and document approval of the Medical Devices and Equipment Committee, before use. 3
3.0 Policy Statement 3.1 The Trust will fully comply with national regulations in relation to the use of medical devices. The Trust will only use appropriately CE marked medical devices and use them only for their intended purpose. Where the Trust judges that there is no alternative but to use nonconforming medical devices it will follow the recommendations of the MHRA, as detailed in this procedure, to ensure all risks are addressed and minimised. 4.0 Definitions 4.1 Non-conforming medical device. For the purposes of this procedure, a medical device for use at NUH is defined as nonconforming if: It is not CE-marked to the appropriate Medical Devices Directorate. It has not been or cannot be functionally and safety tested before being clinically used It is not owned by NUH and is not covered by an appropriate contract or indemnity agreement It is not or cannot be maintained according to the manufacturer s instructions (this includes appropriate planned maintenance, cleaning and decontamination) It has been modified or adapted in any way Off-Label use of medical device is when a CE-marked medical device is used in a way not specifically intended by the manufacturer. Examples of off-label use include: a foley catheter being used as an enteral feeding tube or a tongue depressor being used as a neonatal splint. 4
5.0 Roles and Responsibilities 5.1 Committees 5.1.1 The Medical Devices and Equipment Committee (MDEC)will: Assess all applications to use non-conforming medical devices making a judgement on the necessity of use, the patient benefit and the clinical risks Maintain a register of all approved uses of non-conforming medical devices Review the registered at least annually 5.1.2 The Clinical Risk Committee CRC will: When MDEC decides that insufficient evidence is presented to support the use of non-conforming or off-label devices the originator has a right of appeal to Clinical Risk Committee (CRC). This should be done in writing to the chair of CRC (with a copy of the appeal to the chair of MDEC also). 5.2 Individual Officers 5.2.1 Chair of MDEC In exceptional situations where decisions need to be made before the next MDEC meeting, the chair of MDEC can take chair s action to temporarily approve the application. However, the full application must be submitted to the next MDEC meeting. 6.0 Policy and/or Procedural Requirements 6.1 6.1.1 Under normal circumstances non-conforming devices and offlabel devices must not be used. If a clinical department judges that there is no alternative but to use a non-conforming medical device or to use a medical device off-label then a case, supported by risk assessments and additional evidence, must be made. 5
The standard Trust Risk Assessment Tool must be completed The completed Risk Assessment, together with any supporting evidence, must be submitted to the Medical Devices and Equipment Committee (MDEC) via its chair. MDEC will consider the Risk Assessment taking into account all relevant supporting information. MDEC reserve the right to ask the originator of the Risk Assessment to present it to the committee. MDEC will then either: o Decide that insufficient evidence is presented to support use or that the arguments made to support the use of this particular device are not persuasive. In this case the originator will be informed of the outcome and instructed not to use the non-conforming or off-label device. o Decide that sufficient evidence is presented and that the case for use of non-compliant device has been made. In this case MDEC will make a recommendation that the non-conforming or off-label device can be used clinically but will expect controls and reviews to be recorded and that the patient be fully informed during the consent procedure and a note made in the patient s record. In exceptional situations where decisions need to be made before the next MDEC meeting, the chair of MDEC can take chair s action to temporarily approve the application. However, the full application must be submitted to the next MDEC meeting. In emergency situations where patient-well being depends on prompt action, healthcare workers should use their judgement and use non-conforming devices if there is no alternative. However, they must notify MDEC as soon as possible after the event and seek retrospective approval. MDEC will monitor all such cases on the risk register and review at appropriate intervals. 7.0 Training and Implementation 7.1 Training All users of Medical Devices are responsible for ensuring that they 6
acquire and maintain knowledge and skills in the use of medical devices appropriate to their scope of practice. This will include the completion of competency statements signed by an Authorised Trainer (as defined by the Authorised Trainers List) for appropriate medical devices and ensuring copies of these statements are passed to their line manager and recorded (by Clinical Engineering) on MAPS or OLM. This procedure covers the use of non-conforming medical devices in exceptional circumstances. As such, training requirements for the specific device and specific clinical procedure may need to be reviewed. Advice is available from MDEC or the Medical Devices Training Unit, Clinical Engineering. 7.2 Implementation This procedure covers the use of non-conforming medical devices in exceptional circumstances. Dissemination of this procedure will be via the MDEC and Medical Devices Training Group members who will distribute through local governance forums. MDEC will review incidents and monitor any related to nonconforming use of medical devices (including off label use). 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 7
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. 8
9.0 Policy / Procedure Monitoring Matrix 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 Dissemination via MDEC and MDTG membership Review of register of approved nonconforming devices MDEC and MDTG membership MDEC NA NA NA NA NA See MDEC work plan Bi-monthly MDEC meeting MDEC chair MDEC chair MDEC chair Review of Incidents MDEC Datix incident reports Bi-monthly MDEC meeting MDEC chair MDEC chair MDEC chair 9
10.0 Relevant Legislation, National Guidance and Associated NUH Documents 10.1 MHRA Publications MHRA DB2006 (05) Managing Medical Devices Guidance for healthcare and social services organisations November 2006 http://www.mhra.gov.uk MDA/2010/001 Medical devices in general and non-medical products January 2010 http://www.mhra.gov.uk Single-use Medical Devices: Implications and Consequences of Reuse - DB 2006(04) v2.0 http://www.mhra.gov.uk Trust Documentation Policy for the Management of Medical Devices and Equipment (CLCGP003) Management of Loan Medical Devices Procedure (CLCGP051) Trust Consent to Examination or Treatment (CLCGP020) APPENDIX 1 FLOWCART 10
Use of Non-conforming devices (including off-label medical devices) Clinical area identifies a procedure that requires the use of a device that does not fully conform with current regulatory or best practice guidance (including off-label use of medical devices) Clinical area completes the Risk Assessment Tool: compiles as much evidence as possible particularly with regard to alternative devices Clinical area instructed NOT to -use this non-conforming device Completed risk assessment submitted to MDEC (chair). MDEC reviews the RA and decides if sufficient evidence has been produced and that risks identified are adequately controlled Unacceptable Risk MDEC delegates authority to decide where risk is scored lower than a predefined generic risk assessment held by MDEC Acceptable Risk Practice involving non-conforming device (including off-label use) is added to the Risk Register MDEC notifies clinical area MDEC reviews (all) non-conforming devices risks Clinical area instructed that they can use this non-conforming device APPENDIX 2 SUPPORTING INFORMATION 11
About the Device Name of device Manufacturer Manufacturer s description of intended use Supplier or source of device Clinical Use What is the intended (non-conforming) use of this device at NUH? Has the manufacturer been approached? What is their opinion of the (NUH) intended use of this device? Can the device be re-used? If so have cleaning decontamination instructions been approved by Sterile Services What controls are in place to minimise the risks Are procedures in place to ensure patient consent Commissioning Who owns the device? If not NUH, have contracts and/or indemnities and appropriate insurances been agreed Are instructions for safety and functional testing available o For medical equipment, has this been confirmed/agreed with Clinical Engineering o For Instrument Sets, has this been agreed/confirmed by Sterile Services Maintenance Have appropriate maintenance arrangements been put in place Patient Benefit Why has this device been chosen? What are the alternatives? Describe the impact if this device was not approved? Risks What would be the risk to the patient if the device was to fail in use? For non-nuh devices, is appropriate insurance cover in place Alternatives Are there alternative, conforming medical devices that could be used? If so, why are they not? What do other centres use? 12
Insert templates of relevant impact assessments (page break after each) APPENDIX Equality Impact Assessment (EQIA) Form (Please complete all sections) Q1. Date of Assessment: December 2012 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 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 c) Please state any barriers that still need to be addressed and any proposed actions to eliminate inequality None 13
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 14
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 2012 15
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 Air 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) Is the policy likely to result in the introduction of procedures and equipment with resulting emissions to air? (e.g. use of a Action Taken (where necessary) No No Not Applicable No Not Applicable No No Not Applicable No 16
Energy Nuisances 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)? Not Applicable Not Applicable No No 17
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 1 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 1 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 1 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) 2 Every one of us is vigilant across all aspects of safety, practices hand hygiene & demonstrates attention to detail for a clean and tidy environment everywhere. 18
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 19
APPENDIX 6 CERTIFICATION OF EMPLOYEE AWARENESS Document Title Use of Non-Conforming Medical Devices (Including Off-Label Use) Procedure Version (number) 2 Version (date) 26 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. 20