Policy Document Control Page

Transcription

1 Policy Document Control Page Title Title: Medical Devices Management Policy Version: 10 Reference Number: CO16 Supersedes Supersedes: Version 9 Description of Amendment(s): Originator Addition of 4.8 Sharps Safety Management Change of review responsibility New review date Originated By: Keith Pennington Designation: Medical Devices Liaison Officer Equality Impact Assessment (EIA) Process Equality Relevance Assessment Undertaken by: Keith Pennington ERA undertaken on: 22/02/2012 ERA approved by EIA Work group on: 08/03/2012 Where policy deemed relevant to equality- Equality Impact Assessment Undertaken by Keith Pennington EIA undertaken on: 22/02/2012 EIA approved by EIA Work group on: 08/03/2012 Medical Devices Policy V10 1

2 Integrated Governance Group Referred for approval by: Keith Pennington Date of Referral: 06 Approved by: Medical Devices Committee Approval Date: 06 Date Ratified at Executive Directors Meeting: Executive Director Lead: Medical Director Circulation Issue Date: 7 th April 2014 Circulated by: Performance and Information Issued to: (see below) Policy to be uploaded to the Trust s External Website? No Review Review Date: July 2016 Responsibility of: H Ticehurst An e-copy of this policy is sent to all wards and departments This policy is to be disseminated to all relevant staff. This policy must be posted on the Intranet. Date Posted: 7 th April 2014 Medical Devices Policy V10 2

3 Contents Page 1 Introduction Abbreviations 4 2 Scope 4 3 Medical Device Definition 5 4 Roles and Responsibilities 6 5 Management Structure for Medical Devices 8 6 Role of Estates Department 9 7 Adverse Incident reporting 10 8 Decontamination of Medical Devices/Equipment 10 9 Training Safety Alerts Risk Management Monitoring and Reviewing of Systems Audit of Policy & Procedure Related Polices General References Glossary 14 Medical Devices Policy V10 3

4 1 Introduction The Department of Health requirements assurance that the use and management of medical devices within any NHS organisation is to the highest possible standard and that - Management systems are robust to ensure that all medical devices used within the Trust are safe to use and fit for their intended purpose. Management system, to ensure all professional and end users are appropriately trained in the use of the medical device and that training is formally recorded reviewed and updated regularly, are in place and monitored Management system to ensure that the; sourcing, commissioning, maintenance and the decommissioning of medical devices equipment is of the highest standard and complies with current statutory and NHS requirements. 1.1 Abbreviations CAS EBME MESD MHRA PPM WEEE PPE MEMS Central Alerting System Electronic & Bio-Medical Engineering Medical Equipment Service Department Medicines & Healthcare Products Regulatory Agency Planned Preventative Maintenance Waste Electrical and Electronic Equipment Personal Protective Equipment Medical Equipment Management Service 2 Scope This policy covers the management systems and deployment of all Medical Devices used within the Trust regardless of whether purchased, leased, loaned on trial or donated. It specifically excludes medical devices purchased by a service user. The policy applies to all staff employed by the Trust involved in the use and management of medical devices and staff on honorary contracts, consultants from other Trusts, contractors and students, independent contractors associated with the Trust who will comply with this policy. The policy also covers independent contractors or their staff who have been specifically trained in the use of medical devices. The policy harmonises the management of all medical devices being used on any Trust premises including the wider community setting, served by the Trust The policy also covers any software and accessories that are required to operate or control the performance of medical devices The policy does not apply to medical devices purchased independently by service users although the Trust will work with and encourage such individuals to follow Trust policies, procedures and practices where practicable. Medical Devices Policy V10 4

5 3 Medical Device Definition The MHRA defines a Medical Device as: Any Instrument, Apparatus, Appliance, Material or Health Care Product, excluding drugs, used for, or by, a patient or service user for: Diagnosis, prevention, monitoring, treatment or alleviation of disease. Diagnosis, monitoring, treatment or alleviation of, or compensation for, an injury or impairment. Investigation, replacement or modification of the anatomy or of a physiological process. Control of conception. For the purposes of this document, the term Medical Device encompasses medical devices as legally defined in the Medical Devices Regulations 2002 Statutory Instrument 2002 No 618 (Amended 2003) Single-Use Medical Devices Medical devices designated for single use are not to be re-used under any circumstances. MDA 2000 (04) draws attention to the hazards and risks associated with re-processing and re-using single use items. Single use: means that the manufacturer: Intends the item to be used once and then disposed of. Considers the item unsuitable for use on more than one occasion. Has insufficient evidence to confirm that re-use would be safe. Single use Medical Devices should not be re-used as this affects the safety, performance and effectiveness of the device, and exposes staff and patients to unnecessary risk. DO NOT RE-USE 2 Synonyms for this are:- Single Use Use Once Only There is a European Standard Symbol used on packaging to show which Medical Devices are intended for single use only. All staff involved in the decontamination process should understand this symbol and its meaning. Single Patient Use - This means that the Medical Device is intended for more than one episode of use on one patient only. The Medical Device must be decontaminated between use to prevent re-infection; e.g. nebuliser. Medical Devices Policy V10 5

6 4 Roles and Responsibilities 4.1 The Medical Director The Medical Director has Trust board level responsibility for Medical Device Management. 4.2 Medical Devices Committee The Committee is the organisational focus for advice and best practice in regard to the acquisition, risk assessment, use and management of medical devices. The terms of reference of the Committee is to ensure that all activities undertaken within the organisation concerning the acquisition, appropriate use, maintenance, monitoring and disposal of medical devices meet the requirements of the relevant National and European legislation, Trust policies, Standing Financial Instructions and any other statutory requirements that may apply. 4.3 Medical Devices Liaison Officer (MDLO) The primary role of this post is to encourage and engage in the effective reporting of adverse incidents relating to medical devices. The post holder takes responsibility in conjunction with the Medical Director for ensuring the Trust stays up to date on issues relating to the use and management of Medical Devices. The MDLO will provide project support to services ensuring that all aspects of the policy are implemented. Regular progress reports will be submitted to the Medical Devices Committee on a three monthly basis. 4.4 Infection Prevention Control Committee The Infection Prevention Control Committee (IPCC) will support the Medical Devices Liaison Officer in the effective reporting of adverse events regarding infection control for medical device management The IPCC will advise and support the Medical Devices Committee on all aspects of infection control management for medical device managed by the Trust including acceptance testing, Introduction into services, daily use, storage, withdrawal from service for repair, maintenance or refurbishment or for disposal 4.5 Divisional / Borough Integrated Governance Groups The Divisional / Borough Integrated Governance Groups (DIGG / BIGG) are to review through their monthly meetings any medical devices issues, concerns or actions plans generated or approved by the Medical Devices Committee or by their services and implement as agreed or required. The minutes of the DIGG s & BIGG s are submitted to the Trust Quality Governance and Assurance Committee (QGAC) for Trust board assurance. 4.5 Service Directors / Service Managers It is the responsibility of the Service Directors and Service Managers to ensure that Services, Departments and Wards, implement the Medical Devices Management Medical Devices Policy V10 6

7 Policy. Service Directors and service managers will support departmental managers / ward managers to perform the duties required to implement the relevant parts of the policy. Service Directors and Service Managers will regularly check that the staff are receiving training and updating regarding the use of medical devices and that the information is entered on the staff training record to provide proof of the training delivered. 4.6 Departmental Managers / Ward Managers It is the responsibility of Departmental Managers and Ward Managers to take the lead role in implementing the Medical Devices Management Policy in their designated areas. Key Tasks of their role are:- To maintain an up to date inventory of all medical devices on their ward/unit. To ensure staff receives training in medical devices and that this training is reviewed and tested at least every two years. Records are created and maintained of the training attended to allow audits to be carried out and reported to the Medical Devices Committee two yearly. Monitor and report any incidents relating to the training, use and suitability of Medical Devices. 4.7 Risk Assessment Medical devices are to be risk assessed, by a competent person, and documented to ensure that any hazards and risks identified are appropriately recorded and mitigating actions taken in relation to such as: usage (including assembly and disassembly & accessories), training, maintenance, servicing, decontamination and disposal associated with a particular device. Risk assessments are to be conducted or reviewed as appropriate: a. prior to be accepted into Trust service b. prior to being allocated to a service user in the community for individual use c. post incident review d. change of model or function, e. as advised by the Trust or legislation f. change of management Risk assessments are to logged a copy retained within the service and are to be brought to the attention of users at the earliest opportunity. Risk assessments are to be reviewed periodically or at a time where legislation, a change of model or significant modification, a notified incident (i.e. CAS Alert) or as the Trust Medical Devices Committee or Board of Directors dictates. 4.8 Sharps Safety All employers are required under existing health and safety law to ensure that risks from sharps injuries are adequately assessed and appropriate control measures are in place. Medical Devices Policy V10 7

8 The main healthcare employer and their contractors must co-operate and share information to ensure that risks of sharps injuries are adequately controlled and that they have the appropriate arrangements to comply with the Health and Safety (Sharps Instruments in Healthcare) Regulations 2013 in particular regulation 5 below: Avoid the unnecessary use of sharps regulation 5(1)(a) Use safer sharps (incorporating protection mechanisms) regulation 5(1)(b) Prevent the recapping of needles regulation 5(1)(c) Place secure containers and instructions for safe disposal of medical sharps close to the work area regulation 5(1)(d) As required by the Management of Health and Safety at Work Regulations Finance Department The Finance Department ensure that Medical Devices are procured in line with Trust Standard Financial Instructions. They also monitor and report on spending to the Board as follows:- New equipment Replacement equipment Repairs to equipment Consumables Servicing charges Procurement Leverage Opportunities Contracting and service level agreements with external stakeholders (CCG) 5. Management Structure for Medical Devices Board of Directors Quality Governance and Assurance Committee Divisional / Borough Integrated Governance Groups Medical Devices Committee Medical Devices Liaison Officer Infection Prevention & Control Service Directors / Service Managers Ward Managers / Departmental Managers Professional User End User Medical Devices Policy V10 8

9 Designated service areas will include Elderly Mental Health Adult Mental Health Substance Misuse Services Specialist Services (including CAMHS, Drug and Alcohol, RHSD, Learning Disabilities) Community Services 6. Role of the Estates Department The Estates Department plays a major role relating to re-usable medical equipment (see 6.1) ensuring that:- The appropriate medical equipment is sourced in accordance with Standard Financial instructions. Maintained and repaired in accordance with contracted SLA s with third party maintenance organisations or existing service agreements. EBME / MESD Departments keep an inventory of medical devices up to date and audit annually. The results will be reported back to the Medical Devices Committee. Maintenance and repair of equipment will be audited annually by the Estates Department to ensure a satisfactory standard is being maintained. 6.1 Definition of Devices under Estates Management A re-useable Medical Device is an item of medical equipment if it is electronically (including battery) operated or has complex mechanical parts, such as a patient hoist or rise and fall bed Medical equipment will be managed in accordance with the guidelines contained in DB2006 (05), Managing Medical Devices, which includes the following: Acceptance Testing When a new medical equipment is delivered to the Trust an acceptance test is to be carried out to ensure that the equipment is correct and complete on delivery, the test will identify any fault with the equipment and any damaged in transit Manufacturers Instructions The User should have access to the manufacturer s operating instructions and MEMS to the manufacturer s service / maintenance instructions Handling / Storage Information will be made available to Users on the appropriate methods for handling / storing Medical Equipment & accessories. There will also be guidance on how internal batteries should be charged Inventory / Record Keeping The Trust MEMS will maintain an up to date inventory of Trust accepted medical equipment. Contractors will manage medical equipment by allocating each item with an asset number which they will record. Medical equipment can be identified and cross referenced between the MEMS and Contractors databases by their asset numbers Medical Devices Policy V10 9

10 for audit and PPM tracking purposes; however some contract medical equipment service records will be maintained by the MEMS only. Risk All Medical Equipment on the inventory will be risk assessed by the MEMS and categorised as high, medium or low based upon the items ability to cause harm. High / Medium risk devices will be subject to PPM at least once per annum. Low risk equipment will be managed locally Planned Preventative Maintenance (PPM) The PPM always follows the manufacturer s guidance with the identified service organisation documented within the equipment database, which will also point to the level of maintenance support required. The User is responsible for routine maintenance on the equipment i.e. regular cleaning, preparation for use and performing User checks Damaged / malfunctioning medical devices must be removed from service immediately, clearly labelled and reported to the Estates help-desk, who will organise the necessary action. Decontamination All Medical Devices requiring PPM, repair, removal, loaned, disposal etc must be decontaminated. The decontamination procedure will follow the manufactures / suppliers instructions or the Trust Decontamination Policy CL92 before release by the User or clinical service Equipment Disposal The manufacturer will provide details for the best methods for waste disposal, the process will be carried out in compliance with the Trusts Standing Financial Instruction, the CO45 Waste Management Policy and the Waste Electrical and Electronic Equipment (WEEE) Regulations Adverse Incident Reporting All adverse incidents involving medical devices/equipment are reported in accordance with the Trust Incident Reporting, Management & Investigation Policy CO10 and in accordance with MHRA Medical Devices Alert MDA/206/001. Any incident involving failure or error involving a medical devise must be reported through the Trust incident reporting procedures. 8. Decontamination of Medical Devices / Medical Equipment All medical devices and equipment to be inspected, serviced, or repaired that is returned, loaned, removed for repair or disposed of should undergo a decontamination procedure. The procedure will follow the manufactures / suppliers instructions or the Trust Decontamination Policy CL92 before release by the User or clinical service. Materials and substances used in the decontamination process should be those approved by the manufacture / supplier or the Trust as appropriate and used in conjunction the Trust Control of Substances Hazardous to Health (COSHH) CO32 policy and the Personal Protective Equipment policy CL76 Decontamination techniques include; sterilisation, disinfection and removal of dirt dust grime etc. Medical Devices Policy V10 10

11 9. Training Training in the use of medical devices is divided into two areas:- New Medical Devices A device that has not been used in any of the services will require detailed training of Users in their use and management. Initial training will be delivered by the manufacturer where appropriate, as part of the purchase agreement. As use expands, where appropriate a number of staff will be trained in the use of the device to cascade the training. Existing Medical Devices Before the use of any medical device end users must have completed basic instruction or the required training prior to using the device. Departmental/Ward staff have responsibility to ensure that they are compliant with the required training and mangers must ensure that the required training is accessible to staff. Manufactures user instructions will be available to staff for all medical devices from either the manufacturer directly or on request from the MEMS department. All training completed will be recorded by the Users manager and kept on file within the relevant service / department. A review of compliance with training requirements will be carried out annually by line managers and reported through Local Governance Groups any adverse findings. Local Governance Group representatives on the Medical Devices Committee will report any actions required to be developed and monitored on a meeting by meeting basis. All Users where appropriate will be trained in the safe operation of Medical Devices. Technical Staff can only maintain equipment on which they have received the appropriate training Services should identify what medical devices are used within their service, the level of training required and the delivery method by completing the Medical Equipment Job Training Analysis (JTA) form (available from the MDLO or the Trust Organisational Learning & development (OL&D) department) and returning to it the Trust Learning and Development department. 10. Safety Alerts All medical device safety alerts issued by the MHRA are distributed and catalogued in accordance with the relevant section of the Trust Central Alerting System (CAS) Policy CO36. A record is kept of distribution and any subsequent action taken. 11. Risk Management Medical device risks are identified by: An Initial risk assessments Review of incidents Review of safety notices etc Device inspections/assessments Review of audit reports Medical Devices Policy V10 11

12 Identified risks are documented together with action plans in accordance with the Trust Risk Assessment Policy CO21 policy and the Practical Guidance for Clinical Risk Assessment and Management CL94 Policy 12. Monitoring and Reviewing of Systems Management System: The Trust board monitors and reviews the medical devices management systems including: Procurement arrangements Accountability arrangements Processes Outcomes Internal Audits Via the QGAC who monitor issues of devices management. 13. Audit of Policy and Procedure The Medical Devices Committee on behalf of the Trust will audit its Medical Devices Policy, including the effectiveness of associated procedures and practices for compliance on an annual basis. Auditing will be conducted by: MDLO Policy and procedures documentation complies with current National and EU directives, DH / CQC requirements IPCC Compliance with recognised infection prevention control practices and standards Estates Department MEMS asset management and tracking of inventoried medical equipment Learning and Development Training delivery appropriate to professional user needs in terms of initial introduction to use and any refresher training schedules as identified on the Job Training Analysis tool - and in conjunction with the MEMS department regarding specified training packages as part of new medical equipment procurement process Risk Department Report of any adverse event / litigation cases involving medical devices recorded on the Trust Safeguard Electronic Reporting System. The audit will: Identify areas of operation that are covered by the Trust s procedures and ensure that they are robust and comply with the policy Follow a mechanism for adapting the policy and or procedures to cover missing areas if these are critical to the safety, procurement and use of medical devices. A subsidiary development/action plan will be developed through the Medical Devices Committee where actions are required. The results of the audit will be presented to the Medical Device Committee, who will be responsible for the development and monitoring of any actions recommended and implemented by: Medical Devices Policy V10 12

13 Reviewing existing and where necessary setting new procedural standards including obtaining feedback where the procedures do not match the desired levels of safety or performance. Monitoring the completion and effectiveness of action plans on a bi monthly basis. 14. Related Polices This policy should only be read in conjunction with the following Trust policies (not exhaustive): CO 10 Incident Reporting, Management and Investigation Policy CO 21 Risk Assessment Policy CL 94 Practical Guidance for Clinical Risk Assessment and Management Policy CL 04 Infection, Prevention and Control Policy CL 30 Latex Policy CO 32 Controls of Substances Hazardous to Health CL 76 Personal Protective Equipment CO 09 Health and Safety Policy CO 17 Minimal Lift Policy CO 36 Central Alert System Policy CL 92 Decontamination Policy SFI Trust Standing Financial Instructions 15. General References EU Directive 2010/32/EU MHRA DB 2006 (05) Managing Medical Devices Nov 2006 MDA DB 2000 (2) June 2000 MDA Directive 18a Department of Health (2001) LAC (2001) 13 Community Equipment Services HSC 2001/ Medicines and Healthcare Products Regulatory Agency (MHRA) 2007 Medical Devices Agency (2001) Reporting Adverse Incidents and Disseminating Safety Warnings MDA SN 2001 (01) Medical Devices Agency (2000) Single Use Medical Devices MDA DB 2000 (004) Medical Devices Agency (1998) Medical Device and Equipment Management for Hospitals and Community based Organisations MDA DB Managing Medical Devices Guidance for healthcare and social services organisations DB2006 (05) NHS Executive (2001) Controls Assurance Standard Medical Devices Management October 2002 NHS Litigation Authority Risk Management Standards The Health and Safety at Work etc. Act 1974 Control of Substances Hazardous to Health Regulations (COSHH) 2002 LOLER 98 PUWER 98 MHSWR 99 RIDDOR 13 Waste Electrical and Electronic Equipment (WEEE) Regulations 2006 Health and Safety (Sharp Instruments in Healthcare) Regulations 2013 Medical Devices Policy V10 13

14 16. Glossary User Professional User and or an End User, who is deemed competent and trained in the use, operation or application of a medical device Professional User A trained and / or qualified person who use s, operates or applies a medical device on or on behalf of an individual, for the provision of healthcare, on behalf of the responsible organisation. End user A service user / individual for whom the medical device has been prescribed Maintenance The correction of prevention of faults by a programme of inspection and replacement of parts in order to keep the medical device performing as intended by the manufacturer. Planned Preventative Maintenance Maintenance carried out at fixed intervals by properly trained and qualified staff. Repair The restoration of a medical device to correct working order, after it has either broken down or stopped working as designed. The repair process may also include maintenance or reconditioning. Responsible Organisation An organisation that owns medical devices and either uses medical devices or loans medical devices to an End User. Single-Use Medical Device A device that is intended to be used on an individual patient during a single procedure and then discarded; it must not be used on another patient. Sterilisation A process to render an object free from viable infectious agents, including viruses and bacterial spores. Medical Devices Policy V10 14