QUICK REFERENCE GUIDE



36379157620000-1104907366000.175260127635Working together to drive excellence in care for our patients and communitiesour patients and communities00Working together to drive excellence in care for our patients and communitiesour patients and communitiesMEDICAL DEVICES MANAGEMENT POLICYVersion4Name of responsible (ratifying) committeeMedical Devices Management Committee (MDMC)Date ratified22 October 2018Document Manager (job title)Consultant Anaesthetist, Chair of MDMCDate issued15 November 2018Review date01 April 2021Electronic locationManagement PoliciesRelated Procedural DocumentsStanding Financial Instructions Policy; IT Procurement & Asset Management Policy; IT Security Policy; Infection Control Policy; Decontamination Policy; Managing Medical Devices April 2015Key Words (to aid with searching)Procurement; record keeping; prescribing; maintenance; decontamination; storage; replacement; disposal; loan; single-use; adverse incidentVersion TrackingVersionDate RatifiedBrief Summary of ChangesAuthor422.10.2018Update of policy references, minor changes and addition of IT and HSDU references and pointsS Chivers316.03.2015Update of policy references and minor changesS ChiversCONTENTS TOC \o "1-3" \h \z \t "Equality Impact Screening,1" QUICK REFERENCE GUIDE PAGEREF _Toc529878403 \h 31.INTRODUCTION PAGEREF _Toc529878404 \h 42.PURPOSE PAGEREF _Toc529878405 \h 43.SCOPE PAGEREF _Toc529878406 \h 44.DEFINITIONS PAGEREF _Toc529878407 \h 45.DUTIES AND RESPONSIBILITIES PAGEREF _Toc529878408 \h 56.PROCESS PAGEREF _Toc529878409 \h 66.1 Procurement PAGEREF _Toc529878410 \h 66.2 Record-keeping PAGEREF _Toc529878411 \h 86.3 Acceptance of Medical Devices PAGEREF _Toc529878412 \h 86.4 Clock Setting PAGEREF _Toc529878413 \h 96.5 Monitoring, Deployment and Control PAGEREF _Toc529878414 \h 96.6 Procedures PAGEREF _Toc529878415 \h 106.7 Prescribing PAGEREF _Toc529878416 \h 106.8 Maintenance and Repair PAGEREF _Toc529878417 \h 106.9 Decontamination PAGEREF _Toc529878418 \h 116.10 Storage PAGEREF _Toc529878419 \h 126.11 Replacement Planning PAGEREF _Toc529878420 \h 126.12 Disposal PAGEREF _Toc529878421 \h 136.13 Loan Equipment PAGEREF _Toc529878422 \h 136.14 Single-use Equipment PAGEREF _Toc529878425 \h 146.15 Manufacturing and Modifications of Medical Devices PAGEREF _Toc529878426 \h 146.16 Adverse Incidents and Management of Safety Notices PAGEREF _Toc529878427 \h 157.TRAINING REQUIREMENTS PAGEREF _Toc529878428 \h 157.1 Responsibilities PAGEREF _Toc529878429 \h 157.2 Process for Standard Medical Devices PAGEREF _Toc529878430 \h 167.3 Process for Specialist Medical Devices PAGEREF _Toc529878436 \h 178.REFERENCES AND ASSOCIATED DOCUMENTATION PAGEREF _Toc529878437 \h 178.1 Internal PAGEREF _Toc529878438 \h 178.2 External PAGEREF _Toc529878439 \h 178.3 Care Quality Commission’s Schedule of Applicable Publications PAGEREF _Toc529878440 \h 179.EQUALITY IMPACT STATEMENT PAGEREF _Toc529878441 \h 1810.MONITORING COMPLIANCE WITH PROCEDURAL DOCUMENTS PAGEREF _Toc529878442 \h 19EQUALITY IMPACT SCREENING TOOL PAGEREF _Toc529878443 \h 20APPENDIX A: Medical Device Categories & Subgroups PAGEREF _Toc529878444 \h 22APPENDIX B: Purchase of a new medical device PAGEREF _Toc529878446 \h 24APPENDIX C: Guidance to follow in a Medical Device Adverse Incident PAGEREF _Toc529878447 \h 25QUICK REFERENCE GUIDEThis policy must be followed in full when developing or reviewing and amending Trust procedural documents.Identify source of funding in principleSeek advice from chair of SubgroupPrepare proposal for evaluation Proposal approved Clinical, technical, cyber security and decontamination evaluation – result to SubgroupProposal for purchase approved by subgroup?New Technology?Prepare proposal for purchase NoYesYesNo< ?25000?Completion and approval of MEP form on IntranetYesYesNoNoSubmit to TPC or equivalent for approvalRequest Placed by ClinEng Purchase made by Procurement TeamDelivery to MEDTraining of usersCommissioning the equipmentIdentify source of funding in principleSeek advice from chair of SubgroupPrepare proposal for evaluation Proposal approved Clinical, technical, cyber security and decontamination evaluation – result to SubgroupProposal for purchase approved by subgroup?New Technology?Prepare proposal for purchase NoYesYesNo< ?25000?Completion and approval of MEP form on IntranetYesYesNoNoSubmit to TPC or equivalent for approvalRequest Placed by ClinEng Purchase made by Procurement TeamDelivery to MEDTraining of usersCommissioning the equipmentINTRODUCTIONThe term “medical device” covers a broad range of products, used every day throughout the Trust to support the diagnosis treatment and care of patients. These devices have a direct impact on the quality of care and can also be a source of risks to the patients and the staff. Regulations and safety of medical devices are guided by national legislations REF _Ref302041999 \h \r \t \* MERGEFORMAT [6]. Care Quality Commission Domains, KLoE’s and specifically Outcome 11 REF _Ref302042327 \h \r \t \* MERGEFORMAT [8] require NHS Trusts to ensure that there is a system in place to manage risks associated with the use of medical devices. This policy, when read in conjunction with other relevant policies and procedures, ensures that whenever a medical device is used throughout the Portsmouth Hospitals NHS Trust (PHT), it is:Suitable and available for its intended purposeProperly understood by the userUsed in accordance with the manufacturer’s instructionsMaintained in a safe and reliable conditionDisposed of safely and legallyPURPOSEThis policy is written to enable the safe, efficient and effective deployment, monitoring and control of medical devices throughout the Trust. If in exceptional circumstances it is necessary to contravene any part of this policy, approval must be sought from the most senior manager on duty and the details recorded as an adverse incident.SCOPEThis policy applies to all permanent, locum, agency, bank and voluntary staff of Portsmouth Hospitals NHS Trust and the MDHU (Portsmouth) who have involvement in evaluation, selection, purchasing, commissioning, training, storage, maintenance, prescribing, professional use or use and disposal of all medical devices owned wholly, in part, or loaned to the Trust, whilst acknowledging that for staff other than those directly employed by the Trust the appropriate line management or chain of command will be taken into account. ‘In the event of an infection outbreak, flu pandemic or major incident, the Trust recognises that it may not be possible to adhere to all aspects of this document. In such circumstances, staff should take advice from their manager and all possible action must be taken to maintain ongoing patient and staff safety’DEFINITIONSMedical DeviceAccording to Medical Devices Directive REF _Ref302042102 \h \r \t \* MERGEFORMAT [10], any instrument, apparatus, appliance, material or health care product (excluding drugs), used for a patient or client for the purpose of:Diagnosis, prevention, monitoring, treatment or alleviation of diseaseDiagnosis, monitoring, treatment or alleviation of or compensation for, an injury or HandicapInvestigation, replacement or modification of the anatomy or of a physiological processControl of ConceptionPrescriberA person who decides which is an appropriate device for a given patient or client.Professional usersThose appropriately trained and qualified to operate medical devices for the benefit of a patient. UserQualified person using devices as tools. End UserA patient or client who uses a medical device unsupervised at home (e.g. wheelchair user).IT EnabledAny medical device that has any connection (physical or non-physical) to the Trust’s network; or includes requirements for transportable storage media it uses to be connected to the Trust’s network (e.g. flash drives, SD cards, Bluetooth data transfers, USB, etc.).DUTIES AND RESPONSIBILITIESMedical Devices Management Committee (MDMC) is responsible for monitoring the implementation of this policy throughout the organisation. This will be achieved through monitoring and ensuring adherence to this policy by the Care Groups and Divisions. MDMC will have responsibility for managing all pieces of medical devices owned by or used within the Trust and for monitoring training implementation to ensure the safety of staff, visitors and others.Subgroups will be chaired by clinicians and be responsible for ensuring good governance in relation to the management of disposable and non-disposable medical devices governed by their subgroup. This will be achieved through:Safe use of devices by promoting responsibility of the Divisions, Care Groups and individual clinicians ensuring users are appropriately and adequately trained in the use of medical devicesRecord keeping of: lifecycle history, maintenance and repair, utilisation, training of usersResponding to alerts from various sources: internal adverse incident reports; MHRA alerts and manufacturer recalls/alertsAnalysis of technical, clinical and, where appropriate, cyber security evaluations of medical devicesEnsuring appropriate procurement of medical devicesThe Chair has responsibility for ensuring the appropriate membership and meetings of the subgroup and providing leadership to the subgroup. They will ensure minutes of meetings are produced and kept.The Chair of the subgroups will:Advise the Divisions, Care Groups and the MDMC on the priorities for the annual replacement of existing equipment to assist the them in developing their annual business plans (see flow chart for purchase of replacement medical devices).Advise the MDMC and the Trust Planning Committee (TPC) or equivalent on whether new medical devices should be introduced into clinical practice in the Trust Be standing members of MDMC and will be expected to attend meetings as required or to ensure appropriate deputies attend in their place. The Chairs will report to the Chair of MDMC and will on occasion be asked to deputise for them. The structure of subgroups can be found in REF _Ref335641160 \r \h APPENDIX A.Divisional and Care Group Management Teams, Department and Line Managers are responsible for ensuring this policy is implemented in their areas. They must also ensure necessary resources are available to enable staff to attend appropriate training and keep a record of such training.Professional users are those appropriately trained and qualified to operate medical devices for the benefit of a patient. They have a duty of care to the patient and others to ensure they understand the purpose, operation, and limitations of devices together with measures to minimise risks. Those who are competent to decide on the appropriateness of a device for use with a specific patient, may act as prescribers.Clinical Engineering Department (ClinEng) Is responsible for providing an in-house maintenance and repair facility to the Trust for Medical devices agreed at purchase. They are responsible for accepting medical devices to the Trust and disposing of equipment at the end of their life cycle. Acceptance and disposal is in line with recommendations made in MHRA Managing Medical Devices REF _Ref302042254 \h \r \t \* MERGEFORMAT [7].Is in charge of the medical devices management database and central inventory. Provides assistance and advice to all Trust members on procuring, selecting devices, selecting maintenance, co-ordinating training and investigating adverse incidents.Procurement Department will lead tender / quotation exercises and place purchase order(s) after Medical Equipment forms (MEP’s) and pre purchase questionnaires (PPQ’s) have been approved and the requisition has been placed on the system by the ClinEng Support Team.IT Department will advise and provide support for cyber security standards relating to medical devices, including undertaking of necessary due diligence when procurement of new or replacement equipment is planned.All staff involved directly or indirectly in healthcare are responsible for following the procedures laid down in this policy and for ensuring that they have the skills and knowledge required to work safely with any medical device.PROCESS6.1 ProcurementA flowchart that details the steps to be taken during a procurement procedure can be found in REF _Ref335641289 \r \h APPENDIX A. This flowchart is a guidance tool and must be used in conjunction with the Trust’s Standing Financial Instructions Policy. Medical Equipment Procurement (MEP) form and relevant documents can be found on the MDMC page on the Trust’s Intranet. Any specific standards or guidance that needs to be met will be considered prior to writing suitable specifications. Following the instructions and guidance will ensure that these issues will be appropriately considered:Life cycle / replacementFitness for intended applicationsCyber security and IT due diligenceGuarantee/WarrantySafetyReliabilityService SupportMaintenance RequirementsTechnical SupportTraining (including onsite training if appropriate)Decontamination & Infection Control (Centrally at HSDU and/or locally on ward)StandardisationOnce the need for the device and the source of funding are identified, a risk assessment procedure and full consideration of relevant standards and guidelines will result in technical specifications for the device.Procurement of medical devices (new and replacement) that are IT Enabled shall be:Subject to completion of satisfactory IT Department due diligence review prior to placement of any purchase order or contractComply with cyber security standards and protective measures as defined in the Trust’s IT Security Policy and Network Security PolicyThe medical device subgroup determines if the device should be considered as a Trust Medical Device Standard (MDS). If identified as an MDS it will generally remain current for the term negotiated by the Procurement Department with the supplier, typically 5 years. This period may be extended if the device remains suitable beyond the end of the initial contract. Prior to any purchase, a multidisciplinary team will evaluate the available medical devices that meet the clinical need and comply with necessary information and cyber security requirements. The relevant Subgroup of MDMC is in charge to design and carry out the technical and clinical appraisals. Ideally a minimum of three alternative suppliers should be considered to ensure compliance with EU procurement legislation and the Trust’s Standing Financial Instructions. Completed NHS Pre-Acquisition Questionnaire form (PAQ) will be obtained from each candidate supplier and reviewed by the specialist areas, such as ClinEng and HSDU to verify compliance with national standards.Using a scoring system, devices will be evaluated against the following criteria:Compliance with national legislationMinimisation of all risks (including cyber security)Ability to provide essential clinical functionReliability and availability of technical and user training and supportThe subgroup will report the results together with full lifetime costs to MDMC who will inform the relevant Division for items costing under ?25000 or the Trust’s Planning Committee (TPC) or equivalent for items costing over ?25000. Maintenance arrangements must also be considered at this stage. Next, the signed MEP form will be notified to ClinEng who will place the order on SBS for the Procurement team to place the order.Further guidance and advice can be sought from MDMC, Managing Medical Devices April 2014 REF _Ref302042254 \h \r \t \* MERGEFORMAT [7] and Trust’s Standing Financial Instructions. A flowchart at Appendix B REF _Ref302042650 \h \* MERGEFORMAT PURCHASE OF A NEW MEDICAL DEVICE will be used to assist with the procurement process.6.2 Record-keepingClinEng keep a record of all medical devices in the Trust, which provides evidence of:A unique identifier for the device, where appropriateA full history, including date of purchase and where appropriate when it was put into use, deployed or installedAny specific legal requirements and whether these have been metProper installationWhere it was deployed and utilisationScheduled maintenanceMaintenance and repairsThe end-of-life date.The ClinEng Medical Device Training team records will also show that users:Know how to use the device safelyCan carry out routine user checks and maintenanceHave been trained and had relevant refresher training.6.3 Acceptance of Medical DevicesWhen a new medical device is delivered to ClinEng, a series of tests will be carried out to ensure safety and verify the performance of the device, before it is deployed in service. Delivery checks will include:Checking that the correct product, complete with usage and maintenance information and any relevant accessories, has been suppliedEnsuring that devices have been delivered in good condition and, where relevant, in good working order.The details of the tests can be found in Managing Medical Devices April 2014 REF _Ref302042254 \h \r \t \* MERGEFORMAT [7]. Assembly of the device and performance checks will be performed in line with manufacturer’s recommendations to ensure the accuracy prior to clinical use. The manufacturer’s user instructions will be supplied at purchase and delivered with the equipment. A signature will be obtained from the recipient user. A maintenance manual must be requested if not already provided, logged and filed. According to Managing Medical Devices April 2014 REF _Ref302042254 \h \r \t \* MERGEFORMAT [7], some devices must be risk assessed before first use. See the table below for details:Category ExamplesMedical devices manufactured outside the scope of the Medical Devices Regulations.Purchased by an individual outside EU.In-house manufacture.Equipment which has, or may have, been used before.Bought second-hand.Lent by another responsible organization.Equipment re-issued to second or subsequent users.Devices within scope of Medical Devices Regulations, but not CE marked.Custom-made for a named patient.Under clinical investigation.The Medical Device Training Team (MDTT) will be informed of all new equipment purchases and they will decide the level of training required for staff, organise the training and record the user training.For equipment beyond the resources of the MDTT users are to arrange training by the supplier or manufacturer of the device. To include train the trainer if applicable.6.4 Clock SettingThe clock on all medical devices must be set to the correct time by the user. In some equipment the clock is not user settable and will be left at Greenwich Mean Time (GMT) and these devices will carry a label to that effect.6.5 Monitoring, Deployment and ControlClinical Engineering Department (ClinEng) must ensure an inventory of all medical devices is maintained. This will enable the organisation to take appropriate action following manufacturer’s recall or the issue of hazard warning notice. The inventory will ensure that medical devices are examined annually for electrical safety, calibrated and/or serviced as necessary and that scheduled maintenance takes place.All inventories must include the following:Order NumberDate of purchaseUnique asset numberSupplierManufacturer, Model, Manufacturer’s serial number, serial numbers of components modulesNominated team of ClinEng in charge of the deviceResults of acceptance testWarranty detailsIdentified Maintenance/repair OrganisationDate of first service and subsequent service dates (to include calibration)Information about/instructions relating to application e.g. safe working load, cleaning, infection control and decontamination etc.Whether the device is IT Enabled6.6 ProceduresClinEng holds an inventory and service log of all diagnostic and therapeutic equipment used within the organization. Medical Devices Training Team (MDTT) will use separate matrices of “equipment vs. members of staff” for every ward and department within the Trust. ClinEng will notify the MDTT of relevant newly purchased equipment, who will add them to the relevant matrices and ensure that appropriate training is arranged in advance. This will be supported and managed by MDMC to ensure that information is cascaded to ClinEng and MDTT to facilitate training at the earliest point. Training can be arranged in clinical areas, in the Education Centre or in ClinEng meeting room or MDTT office. This can be facilitated in a number of ways and can include workshops, one to one training; ad hoc training can also be arranged. Once the training is provided, records of this training will be uploaded onto ESR. A completed competency statement will form evidence of competence. 6.7 PrescribingThe prescription of medical devices must be made by healthcare professionals who are suitably qualified and experienced to understand the function of the device and its application.Those responsible for selection need to have been trained and need ready access to information about the device, including:The manufacturer’s description of the intended user, usage and the instructions for useSafety issues and any limitations on usePre-use set up or testing requirementsMaintenance and cleaning or decontamination requirements.Devices are chosen to best meet the requirements of the intended medical procedure or needs of the end user. Any short-term loan/issue of a device should be considered to provide benefit to end users until the most appropriate device is available. The needs of the carer should be taken into account where appropriate.In some instances devices remain with patients for periods extending beyond original episode (e.g. patient taking a device from acute to secondary care or patient with an implanted device) cross-boundary prescribing may exist. In such cases the prescribing professional must clarify where professional and legal responsibility for prescription lies and where continuing responsibility lies to monitor the device and the condition of the end-user. 6.8 Maintenance and Repair All medical devices require routine maintenance and/or calibration at a frequency recommended by the manufacturer whether it be checks by the user, maintenance by ClinEng or maintenance by the manufacturer or authorised contractor. It is a requirement of NHSLA standard 5 – criterion 4 REF _Ref335637801 \r \h [9] that the Trust has an approved documented process for managing the maintenance of reusable diagnostic and therapeutic equipment. Guidance is taken from MHRA Managing Medical Devices April 2014 REF _Ref302042254 \h \r \t \* MERGEFORMAT [7].Maintenance may be provided by the manufacturer or supplier, in-house organisation, third party provider or partnership arrangements between any of these. Accurate detailed records of all maintenance and repair work must be provided by the maintenance provider and kept by the ClinEng on the equipment management database with copies readily available to user manager if required. Labels are affixed to devices to show when next maintenance is due. The equipment management database will also hold details on the servicer, service schedule and contract reference.It is the responsibility of each individual to ensure the equipment they use is in a serviceable state prior to clinical use. Serviceable state would mean there is no visible damage to the equipment, the equipment passes pre use checks, the equipment has not been reported as faulty and that the service due date hasn’t expired.All reusable medical devices must be scheduled for Planned Safety and Performance Testing (PSPT). Medical devices are retrieved from their location by ClinEng with the agreement of the user and returned to service after the completion of the PSPT. The level and frequency of maintenance is decided based on manufacturer’s recommendation but may be adjusted to take account of local factors and experience.All faulty medical devices must be removed from service immediately. For all faults occurring on medical devices ClinEng should be contacted either by email, by phone or web based reporting page. Email - helpdesk.clinicalengineering@porthosp.nhs.uk, Phone: 02392 286000 (7700) 6101PHT intranet Useful Links reached from the home page ClinEng Medical Device Fault Reporting, ClinEng will then initiate the process to resolve the problem depending on how the maintenance support is provided i.e. in-house or by external contract.All medical devices must be decontaminated by the user and provided with a decontamination certificate according to the Trusts procedure prior to release for maintenance or repair by internal or external organisations.Any spare parts used will be supplied by the manufacturer or to the same specification. Pre-used parts will only be used under exceptional circumstances for example to replace a faulty part that is no longer available from the manufacturer. A record of spare parts replaced during maintenance or repair will be kept by ClinEng with traceability of critical parts back to the manufacturer.6.9 Decontamination Most medical devices can become contaminated and hence present a risk to patients, users and support staff. Contamination may be chemical, biological, or radiological in nature. Specific guidance on decontamination can be found in the Trust Decontamination Policy February 2015. However the following basic principles must be followed:All medical devices must be free from contamination and if necessary sterile prior to use.A medical device must be decontaminated as soon as practicable after use.If it is not possible to decontaminate a device it must be isolated, e.g. correctly bagged and labelled, with the nature of contamination, date and ClinEng asset number if known.Medical devices must be decontaminated prior to service and provided with a decontamination certificate according to the Trusts procedure.Medical devices must be decontaminated before loan to other organisations or end users provided with a decontamination certificate according to the Trusts procedure.Decontamination must be performed according to procedures specified in Trust policy. Manufacturers are required to provide information regarding suitable methods of decontamination.6.10 StoragePoor storage conditions prior to deployment can adversely affect medical devices. Ward and Department managers who have responsibility for use of medical devices must operate systems to avoid the following:Dirty or wet storage conditionsInappropriate temperature or humidityPhysical damage due to poor stacking Mix of contaminated and decontaminated items due to inadequate space or zone demarcation.Failure to maintain charge and capacity of device batteriesThe Medical Equipment Library (MEL) provides a central repository of widely used medical devices. This will be the preferred storage location for many common devices.The Supply Chain team within the Procurement Department is responsible for ensuring the majority of disposable or single use medical devices are:-Available when required Stored with appropriate stock rotationUse by and sterilisation dates are not exceeded.Storage records will be maintained and periodic audit of the above factors will be undertaken. Stock takes of all library equipment, verifying locations within the hospital, should be performed on a quarterly basis.6.11 Replacement PlanningA device will not be considered serviceable if any of the following criteria apply:Worn / damaged beyond economical repairUnreliable (poor service history)Clinically or technically obsolete with no support by any internal or external organisationSpare parts no longer available with no support by any internal or external organisationIf because of design, wear and tear or damage the equipment cannot be cleaned effectively prior to disinfection / sterilisationSubject to MHRA Issued Medical Device Alert/ Safety Notice/Manufacturer recommended removal from use / serviceIt is the responsibility of the Divisions and Care Groups to secure funds for medical devices either through revenue monies, capital, Trust funds or charitable funds. The Trust Planning Committee (TPC) or equivalent, are responsible for monitoring and authorising capital bid purchases. MDMC is responsible for monitoring and authorising all medical device purchases although responsibility for routine purchase is delegated to ClinEng. The flowchart in REF _Ref302042650 \r \h APPENDIX B is an assistive tool for this procedure.6.12 DisposalThe reuse, resale and disposal of medical devices is described in MHRA Medical Device Management April 2014 REF _Ref302042254 \h \r \t \* MERGEFORMAT [7]. Prior to disposal the device will be removed from any maintenance schedule and be marked as disposed on the equipment management database.ClinEng arrange the disposal of medical devices for resale through the Trust approved auction company. Funds from the sale are controlled by South of England Procurement Services (SoEPS) (formerly Solent Supplies Team) and the Trust finance officers. All reusable medical devices for disposal or which are no longer required should be notified to ClinEng well in advance of disposal so they can make the necessary arrangements or advise accordingly.6.13 Loan EquipmentMedical Devices loaned to the Trust for Trials, Evaluation or Clinical UsePrior to any agreements/arrangements for delivery of such equipment to the Trust, members of staff must liaise with the general manager of the relevant Division who will contact South of England Procurement Services (SoEPS) and ClinEng for advice on the appropriate procedure (Representative Policy). SoEPS will then contact the clinical lead for the project and, if appropriate, the MDMC Subgroup chair. All such equipment is subject to acceptance checks and procedures as described in section REF _Ref338168953 \r \h 5.3 above. Appropriate indemnity forms and delivery notes must be completed prior to clinical use. All users must be given instruction in the safe use of the equipment prior to the equipment being put into service. All guidelines relating to the cleaning and decontamination of medical devices must be applied to any equipment on loan to the Trust. Full certification must be provided confirming that the equipment is fully traceable and has been effectively decontaminated prior to delivery. Equipment and devices (including surgical instruments) loaned to the Trust must be accompanied by appropriate reprocessing instructions (if relevant) and a comprehensive inventory detailing all contents.All surgical instruments loaned to the Trust will be processed in HSDU prior to and following use. Loan equipment must be collected promptly when no longer required or when the date on the indemnity expires.Medical Devices Loaned to Other (Third Party) OrganisationsMedical Devices (including surgical Instruments) that are the property of the Trust must not be loaned to any third party unless the borrower can guarantee full systems of traceability, safe transport, competency of users and effective decontamination. The duration of the loan can be realistically forecast. This process will be managed by ClinEng under MDMC’s guidance.6.14 Single-use Equipment Some medical devices are designated by the manufacturer as “single use” and are identified with the symbol shown above either on the device or the packaging. Devices with this designation may be either, unsuitable for sterilisation or decontamination due to their materials or construction or be insufficiently robust to withstand more than one use. Governance arrangements of these devices will come under the relevant MDMC Subgroup ( REF _Ref335641543 \r \h APPENDIX A)Under the Medical Device Directive (93/42/EEC) REF _Ref302042102 \h \r \t \* MERGEFORMAT [10], if a device has been reprocessed for reuse, it is no longer the original manufacturer but the re-processor who must ensure that they comply with the requirements of the Medical Device Directive.When reprocessing single use devices, whether for in-house reuse or for reprocessing to supply to others, if the device causes damage or injury during reuse, the re-processor and the user may become personally liable.The MHRA has published advice on this matter. In almost all circumstances the MHRA advice is pertinent to medical device use within PHT. As a default requirement, no medical device designated as single use by the manufacturer shall be reused or reprocessed.In exceptional circumstances, where there could be higher probability of other risks, the Trust may authorise re-use of single use devices after a full risk assessment by MDMC.6.15 Manufacturing and Modifications of Medical DevicesPHT policy is not to modify medical devices.All plans to manufacture or modify medical devices locally within the Trust must be reported to the MDMC via the appropriate subgroup.Whilst the Medical Devices Regulations REF _Ref302041999 \h \r \t \* MERGEFORMAT [6] do not apply to devices manufactured “in-house” provided they are used only within the same legal entity, the standards of manufacture must be equivalent. Adequate documentation must be produced for all devices manufactured in-house and of modifications to commercial devices. The documentation must include details of risk assessment in accordance with BS EN 14971 REF _Ref302041940 \h \r \t \* MERGEFORMAT [11]. In-house manufactured devices must comply with the principles of this policy.6.16 Adverse Incidents and Management of Safety NoticesAn adverse incident is any event or circumstances arising during NHS care that could have or did lead to unintended or unexpected harm, loss or damage.All adverse incidents involving medical devices must be reported to the Trust in accordance with the Adverse Incident Reporting Policy. A flowchart providing guidance is shown in REF _Ref335407310 \r \h \* MERGEFORMAT APPENDIX A.The Risk Management Department (RMD) will notify the MHRA and the Medical Devices Safety Officer (MDSO) if appropriate. The Trusts nominated Central Alert System (CAS) officer is notified via the email group Central Alert System Recipient Group - CentralAlertSystemRecipientGroup@porthosp.nhs.ukCAS alerts and process are administered by the RMD.Users are requested not to contact MHRA direct except in the case of incidents where there is extreme and immediate danger of reoccurrence. Devices involved in an adverse incident together with other material evidence (e.g. packaging of single use device) must be clearly labelled and where practicable kept in quarantine until the incident investigation is complete. If this is not practical, the identification and state of the device at the time of the incident must be recorded. Any clearly dangerous device must be effectively disabled to prevent it being used.The RMD will send copies of adverse incidents involving medical devices to the relevant Subgroup. Adverse incidents will be considered at each Subgroup meeting.If the RMD has considered it necessary to report to MHRA the subgroup will be required to communicate with RMD all measures taken to prevent reoccurrence.Receipt and distribution and response to MHRA and manufacturer safety notices on medical devices is managed by the MDSO.The MDSO receives NHS Digital CareCERT alerts concerning cyber security issues. The MDSO and IT Department will liaise as appropriate concerning these alerts and necessary responses.TRAINING REQUIREMENTSTraining is a key element in medical device safety and is a requirement of the CQC (2010) outcome 11c.7.1 ResponsibilitiesMDMC has the responsibility to ensure that the training of medical devices is provided to all the users of medical devices and the service personnel. They will promote the safe and appropriate use of medical devices available in the Trust and ensure members of staff have access to training which provides them with the necessary knowledge and skills to correctly and safely operate medical devices they may be required to use.Line Managers at all levels have a duty to ensure that their staff required to use medical devices are competent and supporting records exist, e.g. training and assessment. They must also support the medical device training program and allow staff time for adequate and appropriate training.Medical Device Training Team (MDTT), Specialist Technical/ Clinical Advisers & Practice Educators act as a source of expert information and, where appropriate, training for other staff. Such advisers must ensure that their own competences are continually updated, verified and recorded. Medical Device Training Team can be contacted via telephone extension (7700) 3786 /6976 or medicaldevice.training@porthosp.nhs.ukUsers Department managers are responsible for identifying training needs within their areas of responsibility and organising appropriate training. Healthcare professionals working for the organisation, as employees or contractors, have a professional duty to ensure their own skills and training are appropriate and remain up to date.End UserThe Prescriber is responsible for ensuring that the End Users receives training for the prescribed device and is competent in its use prior to releaseTechnical StaffThe ClinEng Section Head is responsible for identifying training needs of technical staff maintaining and repairing medical devices and for arranging appropriate training as described in local quality procedures.7.2 Process for Standard Medical DevicesMedical Device Training information is included in mandatory corporate induction; this provides all new staff with awareness of the existence and role of the MDTT.Permanent staff are identified through the Electronic Staff Record (ESR).Self-assessment documents and associated questions for standard medical devices are available from the MDTT or can be accessed on the Intranet. They are validated every two years or when new equipment is added to the inventory. The statements (Medical Devices Group Competency Statement) are completed by staff and returned to the MDTT. This information is then recorded on ESR and staff will receive automatic notification on ESR before their competency expires. The competency statement identifies whether the user is currently competent, requires training or does not use any items of the listed equipment.Staff who require training complete the relevant box on the form giving details of their availability for training in the next month. If the member of staff does not give suitable dates for training or does not attend, they, and their ward manager, receive a reminder email and have two weeks to respond. This ensures that staff absence does not compromise receipt of required training. If there is no response after this period it is assumed that training is no longer required and their form will be updated to indicate that they no longer require training.During the yearly Appraisal and Personal Development Review (APDR) process, Line Managers go through the training records of each permanent member of staff to verify that their training is up-to-date on all the Medical Devices they use as part of their role.Training is delivered in a variety of ways: ward based; attendance at specialty or pre-booked training sessions (days); ad hoc and on a one to one basis. This ensures all staff can receive appropriate training. In addition E-learning refresher courses and user instruction manuals for Medical Devices are available to all members of staff on the Medical Devices Training Intranet page and ward resource files. This ensures all staff can receive appropriate trainingStaff verification of competence for each item of standard equipment are recorded on ESR. Line Managers can access this information in ESR under Manager Self-service, Manage Staff Careers heading, the Competence section. This allows the Line Managers to ensure that any member of staff who does not complete and return the Medical Devices Group Competency Statement form can be followed up.Once training is completed for a department, Care Group or Division, information on staff competence is sent to the Department Managers, Heads of Nursing and Governance LeadsCompliance is further monitored through the Divisional performance reviews with the Executive TeamOnce trained, the member of staff is deemed competent for the following two years, when a further self-assessment Medical Devices Group Competency Statement form must be completed7.3 Process for Specialist Medical DevicesTraining for devices not listed on the Medical Devices Group Competency Statement should be sought from the manufacturer and complimented by PHT cascade trainers who have undertaken specialist training from the said manufacturerStaff who undertake this training should complete a self-assessment document provided by the manufacturer or devised in house by the relevant clinical specialtyTraining records for specialist devices is the responsibility of the training department/Care Group to ensure their self-assessment document is applied to ESR as per Trust policyREFERENCES AND ASSOCIATED DOCUMENTATION8.1 InternalPolicy for the Management of Adverse Incidents and Near MissesPolicy for the Management of Serious Incidents Requiring InvestigationCentral Alert System PolicyDecontamination Policy v3 February 2015Standing Financial Instructions8.2 ExternalMedical Device Regulations, 2002 & Medical Devices (Amendment) Regulations 2012Managing Medical Devices April 2014 - Guidance for healthcare and social services organisations: MHRA, Apr 2014. .uk/PublicationsThe Essential Standards of Quality and Safety: Care Quality Commission, 2010NHSLA Risk Management Standards 2013-14 Version 2. NHS Litigation Authority (NHSLA), March 2013Medical Devices Directive: The Council of the European Communities, Directive 93/42/EEC, 1993The Application of Risk Management to Medical Devices: EN 14971:2012 Standard, British Standards InstitutionThe Electricity at Work Regulations. Statutory Instrument 1989 No. 635. ISBN 011096635X. and Safety at Work etc. Act 1974. London: HMSO, 1974. ISBN 01054377438.3 Care Quality Commission’s Schedule of Applicable PublicationsMHRA DB2008(03) Guidance on the safe use of lasers, IPL systems and LEDsMHRA DB 2006 (4) Single-use Medical Devices: Implications and Consequences of Reuse (MHRA, 2006)MHRA April 2014 Managing Medical Devices: Guidance for health care and social care organisations (MHRA, 2014)Safety alerts, rapid response alerts, guidance and directives relating to equipment published by expert and professional bodies including:National Institute of Clinical ExcellenceNational Patient Safety AgencyMedicines and Healthcare products Regulatory AgencyRoyal Pharmaceutical Society of Great BritainDHProduct manufacturers and suppliersDH IRMER Guidance and Good Practice NotesMental Health Act 1983 and Mental Health Act Code of Practice (DH, 2008 relating to seclusion facilities)EQUALITY IMPACT STATEMENTPortsmouth Hospitals NHS Trust is committed to ensuring that, as far as is reasonably practicable, the way we provide services to the public and the way we treat our staff reflects their individual needs and does not discriminate against individuals or groups on any grounds.This policy has been assessed accordinglyOur values?are the core of what Portsmouth Hospitals NHS Trust is and what we cherish. They are beliefs that manifest in the behaviours our employees display in the workplace. Our Values were developed after listening to our staff. They bring the Trust closer to its vision to be the best hospital, providing the best care by the best people and ensure that our patients are at the centre of all we do.We are committed to promoting a culture founded on these values which form the ‘heart’ of our Trust:Working together for patientsWorking together with compassionWorking together as one teamWorking together always improvingThis policy should be read and implemented with the Trust Values in mind at all times.MONITORING COMPLIANCE WITH PROCEDURAL DOCUMENTSMinimum requirement to be monitoredLeadToolFrequency of Report of ComplianceReporting arrangementsLead(s) for acting on RecommendationsProcess for ensuring that all reusable medical devices and equipment are maintained: 95% maintained within designated timescalesHead of Clinical EngineeringAudit of Clinical Engineering DashboardAnnuallyPolicy audit report to:Medical Devices Management CommitteeChair of Medical Devices Management CommitteeProcess for ensuring that all reusable medical devices and equipment are repaired: 95% repaired within designated timescalesHead of Clinical EngineeringAudit of Clinical Engineering DashboardAnnuallyPolicy audit report to:Medical Devices Management CommitteeChair of Medical Devices Management CommitteeProcess for identifying which permanent staff are authorized to use the equipment identified on the inventory: 95% of staff identifiedMedical Devices Training TeamMedical Devices Training DatabaseAnnuallyPolicy audit report to:Medical Devices Management CommitteeChair of Medical Devices Management CommitteeProcess for determining the training required to use the equipment identified on the inventory and the frequency of updates required: 100%Medical Devices Training TeamMedical Devices Training DatabaseAnnuallyPolicy audit report to:Medical Devices Management CommitteeChair of Medical Devices Management CommitteeProcess for ensuring that the identified training needs of all permanent staff are met: 85%Medical Devices Training TeamESRAnnuallyPolicy audit report to:Medical Devices Management CommitteeChair of Medical Devices Management CommitteeThis document will be monitored to ensure it is effective and to assure compliance. EQUALITY IMPACT SCREENING TOOLTo be completed and attached to any procedural document when submitted to the appropriate committee for consideration and approval for service and policy changes/amendments.Stage 1 - Screening Title of Procedural Document: Medical Devices Management PolicyDate of Assessment01 September 2018Responsible DepartmentClinical EngineeringName of person completing assessmentSteve ChiversJob TitleHead of Clinical EngineeringDoes the policy/function affect one group less or more favourably than another on the basis of :Yes/NoCommentsAgeNoDisabilityNoGender reassignmentNoPregnancy and MaternityNoRaceNoSexNoReligion or BeliefNoSexual OrientationNoMarriage and Civil PartnershipNoIf the answer to all of the above questions is NO, the EIA is complete. If YES, a full impact assessment is required: go on to stage 2, page 2More Information can be found be following the link below.uk/ukpga/2010/15/contentsStage 2 – Full Impact AssessmentWhat is the impactLevel of ImpactMitigating Actions(what needs to be done to minimise / remove the impact)Responsible Officer Monitoring of ActionsThe monitoring of actions to mitigate any impact will be undertaken at the appropriate levelSpecialty Procedural Document: Specialty Governance CommitteeClinical Service Centre Procedural Document:Clinical Service Centre Governance CommitteeCorporate Procedural Document:Relevant Corporate CommitteeAll actions will be further monitored as part of reporting schedule to the Equality and Diversity CommitteeAPPENDIX A: Medical Device Categories & Subgroups 4319905-254000Currently there are 5 subgroups of the MDMC:General Medical TechnologyPatient Handling and MobilitySpecialist Surgical DevicesImaging and RadiotherapyPoint of Care Testing (POCT)Medical equipment is generally categorised below for device management purposes.Pathology Autoclaves (Laboratory)ACT monitorsBlood gas analysers (Laboratory)Fridge & Freezers (non-domestic) Fume cabinets Microscopes (Laboratory)Other IVDs Pharmacy devices Specimen collection receptacles, syringes, swabsPOCTBlood gas, Haemoglobin and other Point Of CareBlood glucose & HbA1C measuring devicesCoagulation testingPregnancy test kitsUrine test stripsImaging & RadiotherapyCT scannersGamma Cameras Linacs & RT devicesMR scannersNuclear medicine equipmentRadiation monitorsUltrasound imaging systemsX ray imaging systemsX ray therapy systemsSpecialist SurgicalAnaesthesia machinesAutoclaves and HSDU equipmentCryosurgical EquipmentCardiac Pacemakers (implantable)Dental equipment and materials Implants e.g. orthopaedic prosthesesIncontinence aidsInsulin injectorsLasersOperating and diagnostic microscopes Operating tablesOphthalmology devicesPowered implants e.g. pacemakersPlaster sawsRigid Endoscopes & video systemsSurgical and dental instrumentsSurgical diathermyPatient handling & mobilityBathing equipmentChiropody and podiatry equipCommodesClinical chairsDental chairsHospital beds & mattressesPatient hoistsPat slides Prescribable footwearPressure relief equipmentProsthesesStretchers and trolleysWalking aidsWheelchairsGeneral Medical TechnologyAudiometersBlood warmersContinuous passive motion devices (CPM) DefibrillatorsDialysis equipmentDomiciliary O2 therapy equipDrip standsECT devicesEEG EMG analysis systemsFlexible Endoscopes & video systemsEndoscope washersElectrocardiographsHumidifiers RespiratoryInfusion control devices Laryngoscopes etc.Illuminating Light Sources Light therapy sourcesMedical gas equip. regulators suction controller’s cylinder holders etc.Nebuliser compressorsNebuliser ultrasonicPatient monitoring, NIBP, SpO2, ECG etc.Patient warming/cooling devicesPeak flow metersPhysio. electro-therapy Pulse oximetersRespiratory lung function analysisResp. support devices, domiciliary vents.General Medical TechnologyResuscitation equipmentSphygmomanometersStress test systemsSuction equipmentThermometersUltrasound DopplerVentilators ICU & AnaesthesiaWeighing scalesAPPENDIX B: Purchase of a new medical deviceIdentify source of funding in principleSeek advice from chair of SubgroupPrepare proposal for evaluation Proposal approved Clinical, technical, cyber security and decontamination evaluation – result to SubgroupProposal for purchase approved by subgroup?New Technology?Prepare proposal for purchase NoYesYesNo< ?25000?Completion and approval of MEP form on IntranetYesYesNoNoSubmit to TPC or equivalent for approvalRequest Placed by ClinEng Purchase made by Procurement TeamDelivery to MEDTraining of usersCommissioning the equipmentIdentify source of funding in principleSeek advice from chair of SubgroupPrepare proposal for evaluation Proposal approved Clinical, technical, cyber security and decontamination evaluation – result to SubgroupProposal for purchase approved by subgroup?New Technology?Prepare proposal for purchase NoYesYesNo< ?25000?Completion and approval of MEP form on IntranetYesYesNoNoSubmit to TPC or equivalent for approvalRequest Placed by ClinEng Purchase made by Procurement TeamDelivery to MEDTraining of usersCommissioning the equipmentAPPENDIX C: Guidance to follow in a Medical Device Adverse IncidentIncident OccursPATIENT HARM?NOYESRespond to patient and carer needAlert all relevant clinical staff Mark all devices clearly as potentially faultyQuarantine device and accessories (e.g. infusion pump AND disposable item including packaging) Do not send to supplierIdentify “lead” staff member to act as contact/liaisonGrade incident and follow procedure as detailed in Adverse Event Reporting policy. Complete Adverse Incident Report form on DATIXStaff “Lead” review incident with Liaison Officer re further action/roles i.e. incident investigation, contact with MRHA, Clinical Engineering, Manufacturer etc.Staff “Lead” to feedback results of investigation/incident to staff (including Risk Management) highlighting any lessons learnedContact Clinical Engineering or other specialist technical department for adviceAdvise Trust Liaison Officer of incident via email In required contact MRHA directly via Yellow Card Scheme other areas/users of potential problem if appropriate.Report results of investigation/incident to Chair of appropriate Medical Device SubgroupNotify Manufacturer or SupplierIncident OccursPATIENT HARM?NOYESRespond to patient and carer needAlert all relevant clinical staff Mark all devices clearly as potentially faultyQuarantine device and accessories (e.g. infusion pump AND disposable item including packaging) Do not send to supplierIdentify “lead” staff member to act as contact/liaisonGrade incident and follow procedure as detailed in Adverse Event Reporting policy. Complete Adverse Incident Report form on DATIXStaff “Lead” review incident with Liaison Officer re further action/roles i.e. incident investigation, contact with MRHA, Clinical Engineering, Manufacturer etc.Staff “Lead” to feedback results of investigation/incident to staff (including Risk Management) highlighting any lessons learnedContact Clinical Engineering or other specialist technical department for adviceAdvise Trust Liaison Officer of incident via email In required contact MRHA directly via Yellow Card Scheme other areas/users of potential problem if appropriate.Report results of investigation/incident to Chair of appropriate Medical Device SubgroupNotify Manufacturer or Supplier ................
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