Trust Policy The Management and Use of Medical Devices Policy

Transcription

1 Trust Plicy The Management and Use f Medical Devices Plicy Purpse Issue Date Review Date Versin March 2017 March 2022 Versin 6 This is a plicy fr the effective management f re-usable medical devices, including medical equipment frm purchase thrugh t dispsal. The plicy identifies the key duties and respnsibilities f staff in respect f the prcurement, use, maintenance, repair and dispsal f medical devices. The plicy als sets ut the requirement fr all clinical staff, wh use medical devices, t have received training in the use f each device relevant t them; and where necessary, t have been assessed as cmpetent t use them. Wh shuld read this dcument? All clinical staff, including senir clinicians and senir managers, because they need t be aware f their respnsibilities in respect f delivering the safe use f medical devices All ther staff, wh might be required t assist in the use f medical devices, because the same respnsibilities and cmpetency requirements apply Relevant staff in the Human Resurces & Organisatinal Develpment Directrate, because they need t be aware f their rle in verseeing the prvisin f training in medical devices Key Messages New medical devices shuld nly be intrduced t the Trust thrugh the crrect apprval and prcurement prcess All staff are respnsible fr ensuring that they are adequately trained and assessed as cmpetent t use any medical device that they are asked t use Clinical managers are respnsible fr ensuring that all staff within their respnsibility are suitably and adequately trained in the use f each medical device that they are asked t use All medical devices shuld be kept adequately serviceable thrugh a prgramme f planned maintenance and thugh prmpt identificatin and repair f faulty devices Cre accuntabilities Owner Review Ratificatin Disseminatin Cmpliance J. Applebee Medical Devices Strategy Grup Medical Directr / Directr f Healthcare Science and Technlgy J. Applebee Links t ther plicies and prcedures Medical Devices Strategy Grup MEMS Medical Equipment Users Guide Medical Device Training Plicy Clinical Risk Classificatin Scheme fr Medical Devices Management f Cntaminatin Incidents SOP Versin Histry 1 Sept 2008 Written M. Webber, C. Stne 2 Oct 2010 Reviewed J. Applebee, C. Stne 3 Jan 2012 Revisins t reflect NHSLA expectatins 4 July 2012 Revisin f HR&OD Directrate name and Decn Cert versin 5 Jan 2013 Revisin t incrprate Single Use Plicy and LOLER requirements 6 Mar 2017 Reviewed and updated J. Applebee TRW.MED.POL The Management and Use f Medical Devices Plicy 1

2 The Trust is cmmitted t creating a fully inclusive and accessible service. Making equality and diversity an integral part f the business will enable us t enhance the services we deliver and better meet the needs f patients and staff. We will treat peple with dignity and respect, prmte equality and diversity and eliminate all frms f discriminatin, regardless f (but nt limited t) age, disability, gender reassignment, race, religin r belief, sex, sexual rientatin, marriage/civil partnership and pregnancy/maternity. An electrnic versin f this dcument is available n Trust Dcuments n StaffNET. Larger text, Braille and Audi versins can be made available upn request. TRW.MED.POL The Management and Use f Medical Devices Plicy 2

3 Cntents Sectin Descriptin Page 1 Intrductin 4 2 Purpse, including legal r regulatry backgrund 4 3 Definitins 5 4 Overall Duties 6 5 Duties in Relatin t Selectin and Prcurement f Medical Devices 8 6 Duties in Relatin t the Medical Equipment Asset Register 11 7 Duties in Relatin t Acceptance, Cmmissining, Installatin and Cnfiguratin f Medical Devices 12 8 Duties in Relatin t Clinical Use f Medical Devices 13 9 Duties in Relatin t Medical Devices Laned by the Trust t Anther Trust 10 Duties in Relatin t Decntaminatin, Maintenance and Repair f Medical Devices Duties in Relatin t Decmmissining f Medical Devices Overall Respnsibility fr the Dcument Cnsultatin and Ratificatin Disseminatin and Implementatin Mnitring and Reprting Cmpliance and Effectiveness References and Assciated Dcumentatin 17 Appendix 1 Audit Tl fr Management and Use f Medical Devices 19 Appendix 2 Disseminatin Plan and Review Checklist 20 Appendix 3 Equality Impact Assessment 22 TRW.MED.POL The Management and Use f Medical Devices Plicy 3

4 1 Intrductin Medical devices represent a substantial investment by any NHS trust. Plymuth Hspitals NHS Trust (the Trust) currently uses ver 28,000 pieces f medical equipment, wrth mre than 87 millin. Used crrectly, they will enhance the quality f care that the trust can ffer. Hwever, reliance n medical devices intrduces new risks t patients and staff. Medical devices are widely used in the Trust fr the diagnsis, mnitring and treatment f patients. It is essential that the use f medical devices meets relevant safety and quality standards; that they are suitable fr purpse and represent value fr mney. Devices in use need t be maintained in a safe wrking cnditin and perated cmpetently in accrdance with required standards and prcedures. This plicy cvers the wnership and use f reusable and single use medical devices in the Trust. It addresses the evaluatin and prcurement f new equipment, training, decntaminatin, maintenance and repair, and arrangements fr mnitring the effectiveness f cntrls. It applies t devices used in the care f the Trust s patients, whether they are purchased, dnated, laned, hired r leased. Thrughut this dcument, the term medical device will be used t include equipment, apparatus and instruments unless specifically indicated therwise. This plicy des nt cver medicines r their use. This plicy des nt cver pathlgy / labratry equipment r its use. Please refer t separate plicies and prcedures fr these items. 2 Purpse, including legal r regulatry backgrund The Trust recgnises its respnsibilities as an emplyer t ensure that staff are cmpetent and safe in the rles that they are perfrming within their wrk envirnment. The Trust has a legal and mral duty t prvide adequate training in medical devices in rder t minimise the risk f harm t patients, staff and the rganisatin thrugh the curse f its wrk. The aim f this plicy is t ensure that the benefits t patients frm the use f medical devices are maximised and risks minimised; and t ensure that safe and best practice is applied at this Trust in relatin t the management and use f medical devices. Cmpliance with external regulatins This plicy has been written and applied with the aim f enabling the Trust t cmply with relevant legislatin and guidance and in particular with the Health and Scial Care Act 2008 and the requirements f the Medicines and Healthcare Prduct Regulatry Agency (MHRA) dcument Managing Medical Devices April 2015 and IEC 62353:2014 Medical Electrical Equipment Recurrent test and test after repair f medical electrical equipment, alngside ther key references as detailed in Sectin 15. In relatin t the use f medical devices, the fllwing regulatins are als required t be addressed: The Prvisin and Use f Wrk Equipment (1998) regulatins require all equipment t be maintained such that it is safe and regularly inspected t ensure the same. The Electricity at Wrk Regulatins (1989) requires that electrical equipment is tested at regular intervals t ensure that it is electrically safe. TRW.MED.POL The Management and Use f Medical Devices Plicy 4

5 3 Definitins Medical device - any instrument, apparatus, appliance, material r ther article, whether used alne r in cmbinatin, including the sftware necessary fr its prper applicatin, intended by the manufacturer t be used in human clinical care fr the purpse f: diagnsis, preventin, mnitring, treatment r alleviatin f disease diagnsis, mnitring, treatment, alleviatin f r cmpensatin fr an injury r handicap investigatin, replacement r mdificatin f the anatmy r f a physilgical prcess cntrl f cnceptin and which des nt achieve its principal intended actin in r n the human bdy by pharmaclgical, immunlgical r metablic means, but which may be assisted in its functin by such means. Fr the purpse f this standard, the term Medical device shuld be taken t include: active implantable medical devices medical devices in vitr diagnstic medical devices Medical equipment - term used t describe the sub-grup f medical devices that includes electr-mechanical medical Equipment - The wrds equipment and device are ften interchanged Reusable medical device any medical device that is designed t be used n mre than ne patient, n mre than ne ccasin. When the terms medical device r medical equipment are used in this dcument they refer t reusable medical devices / equipment unless the term single-use is specifically stated. Single patient use medical device - any medical device intended t be used n an individual patient during a treatment perid and then t be discarded. Single use medical device - any medical device intended t be used n an individual patient during a single prcedure and then t be discarded. Maintenance, servicing perfrming planned rutine actins which keep the device in wrking rder, r prevent truble frm arising. Fr the purpses f this plicy, this excludes the everyday gd practice that device peratrs shuld fllw t ensure that the device remains in gd wrking rder. In this plicy, the wrd maintenance is used t include calibratin and repair, unless specifically stated. Calibratin setting the crrectness and magnitude f measurements made by a piece f equipment against a device, r reading with the knwn r assigned crrectness, called the standard. Repair perfrming un-planned actins t make gd a device, which is n lnger functining as it shuld. Medical Equipment Library (MEL) - implementing NPSA recmmendatins, a central resurce f ready t use general purpse medical equipment accessible 24/7 and TRW.MED.POL The Management and Use f Medical Devices Plicy 5

6 manned during ffice hurs t prvide equipment distributin, cllectin, testing, strage and advice. 4 Overall Duties Trust Bard and Chief Executive The Bard recgnises its respnsibilities under the Health and Safety at Wrk Act 1974 and related regulatins under this and ther related acts fr safeguarding the health and safety f its emplyees. The Bard is required t ensure that staff have access t apprpriate educatin, training and supervisin in the peratin f medical devices. The Trust als has a duty f care t patients t ensure they are nt placed at risk f harm frm the inapprpriate use f medical devices caused by nn-cmpetent practitiners. Respnsibility fr gaining assurance that these statutry respnsibilities are delivered is delegated t the Safety and Quality Cmmittee. The Chief Executive is ultimately respnsible fr ensuring that the Trust maintains adequate prcedures fr ensuring that, as far as pssible, patients and staff are kept safe frm the risk f harm frm incidents invlving medical devices. Medical Directr Under delegated authrities, the Medical Directr is respnsible fr gaining assurance that adequate arrangements are in place fr the management f medical devices acrss the Trust. The assurance is delivered thrugh mnitring f the recrd f meetings f the Medical Devices Strategy Grup, the Safe Care Grup and the Capital Steering Grup. Medical Devices Strategy Grup (MDSG) Reprting t the Medical Directr and thrugh the Safe Care Grup and the Capital Steering Grup, the Medical Devices Strategy Grup (MDSG) is a Trust-wide multidisciplinary grup which is frmed in accrdance with MHRA guidance. The key duties f the MDSG are t: determine the directin and pririties fr current and future medical devices resurcing within the Trust, taking accunt f reprting frm varius equipment reference grups and the Trust s Rlling Replacement Prgramme fr medical equipment. receive and review clinical gvernance, risk management and incident review reprts, including MEMS audit reprts Directr f Healthcare Science and Technlgy Reprting t the Medical Directr, is respnsible fr: reviewing the wrk f the Medical Equipment Management Service Medical Equipment Management Service (MEMS) Managed by the Head f Clinical Technlgy, wh has verall respnsibility fr the service; and reprting t the Directr f Healthcare Science and Technlgy and the MDSG, MEMS is respnsible fr ensuring that all medical devices are prperly managed within a structured prgramme. The Head f Clinical Technlgy is respnsible fr ensuring that MEMS staff are apprpriately trained and cmpetent t prvide, r administer maintenance and repair services fr medical equipment. TRW.MED.POL The Management and Use f Medical Devices Plicy 6

7 The Healthcare Science and Technlgy (HCST) Quality Management System ensures that all in-huse technical and scientific services are accredited t industry-standards fr quality management. MEMS has respnsibility fr: advising the Trust n selectin, cmmissining, redeplyment, safe use, decmmissining and dispsal f medical equipment determining apprpriate service and supprt requirements fr all medical equipment managing the medical equipment library prviding technical supprt and advice t users f devices investigating and acting upn medical devices alerts and disseminating device related safety infrmatin t users respnding t relevant medical devices alerts and ntices, develping actin plans investigating clinical incidents invlving medical devices and reprting t MHRA if required cntributing t clinical user training maintaining a cmputerised asset register f the Trust s medical equipment calling upn specialist advice at any stage f the management prcess frm within and utside the Trust as required. Medical Devices Safety Officer This persn supprts lcal medical device incident reprting and learning, acts as the main cntact fr NHS England and the MHRA and medical device manufacturers and is a member f the Natinal Medical Devices Safety Netwrk as required by MHRA and NHS England Patient Safety Alert NHS/PSA/D/2014/006 Imprving medical device incident reprting and learning Patient Safety Manager Reprting t the Head f Quality Gvernance, the Patient Safety Manager has verall respnsibility fr acting as the link fr MHRA infrmatin thrugh the DOH-Safety Alerts inbx. This includes distributin f Safety Ntices frm MHRA, manufactures and suppliers and the reprting f adverse incidents t the MHRA. Clinical Directrs and Department Heads Are respnsible fr all relevant aspects f medical device management within their departments. Ward and Department Managers Are respnsible fr: ensuring that staff, under their management respnsibility, wh use medical devices are suitably trained and cmpetent t d s infrming MEMS f lng term relcatin f equipment liaising with MEMS t dispse f equipment in an apprpriate manner when it is n lnger required. TRW.MED.POL The Management and Use f Medical Devices Plicy 7

8 All Clinical Staff All Trust clinical staff are respnsible fr ensuring that medical devices are used apprpriately. Staff are respnsible fr: ensuring that they are adequately trained and can demnstrate cmpetence fr any medical devices that they use, r are wrking under direct supervisin by a suitably trained persn ensuring that the medical devices they use are in gd wrking rder, clean and safe t use equipment is apprpriate fr the patient, their cnditin and required treatment and suitable fr the purpse (i.e. nt using equipment in a manner ther than that intended by the manufacturer) ensuring that they knw where t access advice, user manuals r lcally written instructins. reprting any incidents invlving medical devices thrugh the Trust s (Datix) Incident Reprting system, in accrdance with the Trust s risk management plicy. Specific rules apply where a medical device is linked t an adverse incident, as fllws: the device, including any accessries and cnsumables, shuld be remved frm service and quarantined. It shuld nt be decntaminated. It shuld be clearly labelled as being quarantined. the incident shuld be reprted t the line manager and MEMS, as quickly as pssible, s that investigatin f the cause f the prblem can begin as sn as practicable MEMS has initial respnsibility fr investigating devices invlved in adverse incidents. This respnsibility may invlve reprting t the Medicines and Healthcare Prducts Regulatry Agency (MHRA) f the Department f Health. Fr serius adverse incidents an internal investigatin will be cmmissined in accrdance with Trust plicy. 5 Duties in Relatin t Selectin and Prcurement f Medical Devices General Rules All medical device purchases shall be made in accrdance with the Standing Orders and Standing Financial Instructins (SFIs) f Plymuth Hspitals NHS Trust. It is cnsidered t be best practice, as far as practicable, t reduce the variety f makes and mdels f devices that perfrm the same clinical task t a reasnable minimum. This allws ptential ecnmies f scale fr equipment purchases and fr assciated cnsumable items. This apprach: reduces the cst f hlding spares imprves flexibility in management f the Trust s medical devices, including transferability f devices and trained staff between teams and departments reduces training csts reduces the risk t the patient and rganisatin arising frm variatin in the applicatin f clinical prcedures and the assciated difficulties in maintaining cmpetence and skills TRW.MED.POL The Management and Use f Medical Devices Plicy 8

9 Decisins regarding the selectin and prcurement f medical devices are determined thrugh the interactin f 3 disciplines fulfilling the essential functins fr this prcess, MEMS, Prcurement and the Clinical Users. Decisins are reprted t the MDSG. Specific duties include: MEMS is respnsible fr: perating the Trust s Rlling Replacement Prgramme (RRP) and prducing regular prgress reprts fr MDSG ensuring that all devices purchased are CE (cnfrmée eurpéenne) marked. Assessing the maintenance requirements f ptential new medical devices t help in decisin making. This prcess includes assessment f Pre-Purchase Questinnaires seeking advice frm the Trust s Infectin Cntrl functin prir t the prcurement f medical devices MDSG is respnsible fr: Mnitring and reviewing recmmendatins frm the RRP Reprting RRP utput t Capital Steering Grup mnitring and reprting n requisitining activity, by exceptin, thrugh reprts received frm the Prcurement Team. reviewing reprts frm equipment sub-grups and apprving, r rejecting applicatins fr nn-standard medical device requisitins Ward and Department Managers Are respnsible fr: identifying and priritising the need fr additinal medical devices. Clinical users are requested t cntact MEMS fr selectin advice, ahead f raising requisitins. Gd practice is t define the clinical need, draw up a specificatin and draw up a shrtlist f pssible suitable equipment ensuring that existing and future budgets are sufficient t fund the lifetime f the prpsed additinal medical devices preparing bids fr investment and submitting them t Hspital Medical Staff Cmmittee (HMSC) and RRP (within their delegated authrity) rdering and prcuring medical devices. Prcurement Team Reprting t the Directr f Financial Services and Perfrmance, the Prcurement Team, is respnsible fr: purchasing apprved medical devices in cmpliance with the Trust s SFls and plicies and natinal guidelines supprting MEMS and MDSG in prviding initial cst, running cst and cntract infrmatin f ptential new medical devices t help decisin making TRW.MED.POL The Management and Use f Medical Devices Plicy 9

10 safeguarding the financial and clinical impact t the Trust and recrding indemnity recrds. Clinical users are requested t cntact Prcurement fr qutatin advice, ahead f raising requisitins. Specialist Advice Specialist advice must be btained t infrm purchasing decisins fr certain types f medical device, including the fllwing: Inising Radiatin Devices - Advice shuld be sught frm the Head f Clinical and Radiatin Physics r the Head f Raditherapy Physics as apprpriate. Please als refer t the Inising Radiatin Safety Plicy and assciated prcedures. Nn-Inising Radiatin Devices - Advice shuld be sught frm the Head f Clinical Measurement and Innvatin Pint f Care Testing and Labratry Equipment - Advice shuld be sught frm the Pint f Care Testing team in Derrifrd Cmbined Labratries. Medical Devices Rented r Leased by the Trust Medical devices may be rented t the Trust by an external supplier t fulfil a shrt term requirement fr that device r leased t the Trust as an alternative t direct purchase. The requirement fr the device may be identified by MEMS, Prcurement r the clinical users. Liaisn f all these parties is imprtant t achieve the mst cst effective and clinically apprpriate slutin t fulfil the equipment requirement This includes the fllwing duties: MEMS Is respnsible fr: Advising n apprpriate medical devices fr rental and assisting with the rental prcess where required carrying ut full cmmissining checks n leased medical devices keeping recrds f medical devices being leased t the Trust Prcurement Is respnsible fr: Achieving the mst cst effective rental r leasing f medical devices fr the Trust Prcessing the rental r leasing requisitin and rder fr medical devices rented r leased by the Trust Ward and Department Managers Are respnsible fr checking that leased equipment has been crrectly accepted and cmmissined befre use ntifying MEMS and Prcurement when rental perid has finished Assisting with the identificatin f apprpriate medical devices fr rent r lease TRW.MED.POL The Management and Use f Medical Devices Plicy 10

11 Medical Devices laned t r trialled by the Trust Medical devices may be laned t the Trust by an external supplier either t fulfil a shrt term requirement fr that device r t trial the equipment as part f a selectin prcedure leading t purchase. The need t carry ut clinical r user trials f medical equipment in the Trust may be identified by MEMS, Prcurement r the clinical users. Hwever all f these parties must liaise in rder that the trial fully achieves its bjectives. This includes the fllwing duties: MEMS Is respnsible fr: carrying ut pre-use checks n laned medical devices keeping recrds f medical devices being trialled in the Trust ensuring indemnity is in place befre equipment use Prcurement Is respnsible fr: recrding indemnity agreement infrmatin relating t medical equipment n trial in the Trust Ward and Department Managers Are respnsible fr ntifying MEMS and Prcurement when trial r lan perid has finished checking that equipment has been checked and indemnified befre use Trust Staff agreeing t the lan r trial f devices may find themselves persnally liable fr lsses if they d nt fllw the abve plicy 6 Duties in Relatin t the Medical Equipment Asset Register MEMS Is respnsible fr: maintaining a cmputerised asset register f all medical devices, that are wned, leased r rented by the Trust, r therwise used n Trust premises and in accmmdatin used, but nt wned, by the Trust. The recrd will include:- device details; manufacturer, mdel, serial number financial details; supplier, purchase date, rder number, initial value clinical lcatin full service histry TRW.MED.POL The Management and Use f Medical Devices Plicy 11

12 schedule fr in-huse and external planned preventative maintenance external maintenance cntract arrangements dispsal details labelling all medical devices recrded n the medical equipment asset register with Trust identificatin and an asset register device number. mnitring the accuracy f the asset register, thrugh peridic audits f asset lcatin. Delivery f the rle may be delegated. Ward and Department Managers Are respnsible fr (rles may be delegated): infrming MEMS f all lng-term relcatins f medical devices labelled with an asset register device number cmpleting an as required medical equipment inventry check in cnjunctin with MEMS. 7 Duties in Relatin t Acceptance, Cmmissining, Installatin and Cnfiguratin f Medical Devices MEMS Is respnsible fr: taking receipt f all new medical equipment received at the Trust cmpleting acceptance testing n all new medical equipment, in accrdance with MDA 2006(05) befre they can be put int use. Testing includes: checking the received gds, supprt and warranties against specificatin ensuring that equipment is functining crrectly, calibrated and electrically safe ensuring that servicing and supprt arrangements are determined recrding all new medical equipment n the asset register. Labels will be attached t all equipment that has been thrugh this prcess t indicate the device number. ensuring that permanently installed medical equipment is installed in cmpliance with the MHRA guidance: Medical Electrical Installatin Guidance Ntes, (MEIGaN), 2007 ensuring that equipment requiring specialist installatin and safety checks are installed in accrdance with the relevant regulatins. Fr Inising Radiatin Devices cntact Clinical & Radiatin Physics r Raditherapy Physics and refer t the Inising Radiatin Safety Plicy and assciated prcedures as apprpriate. Fr Laser Equipment cntact Clinical Measurement and Innvatin. ensuring that, where equipment is installed by a third party, (manufacturer r supplier), it is tested fr functin and electrical safety t BS EN :2006 befre being put int use Ward and Department Managers Are respnsible fr: ensuring that relevant staff are given adequate training in advance f, r as sn as TRW.MED.POL The Management and Use f Medical Devices Plicy 12

13 pssible after, installatin f the new equipment r intrductin f new devices ensuring that new medical devices delivered directly t clinical areas are re-directed t MEMS fr acceptance testing befre use. Staff wh allw the use f medical devices that have nt passed acceptance tests and/r indemnity paperwrk may be made persnally liable by the Trust in the event f an adverse incident invlving that equipment. 8 Duties in Relatin t Clinical Use f Medical Devices All Medical Device Users Are respnsible fr ensuring that they are apprpriately trained in the clinical use f a medical device befre using it n a patient ensuring that the apprpriate medical device is being used fr the clinical treatment prescribed and the device is being used as intended by the manufacturer. cmpleting the required pre-testing and preparatry wrk befre using the medical device ensuring that single use devices are nly used nce and dispsed f safely after use ensuring that single patient use devices are nly used fr ne patient and dispsed f safely after use. Ward and Department Managers Are respnsible fr ensuring that their staff receive apprpriate Medical Device training ensuring that there are apprpriate medical devices available fr use in the ward r department. ensuring that medical devices invlved in clinical incidents are withdrawn frm use, quarantined pending investigatin and that the device number is recrded n the incident reprt Clinical Educatin and Training Please refer t the Trust s Medical Device Training Plicy fr further detail 9 Duties in Relatin t Medical Devices Laned by the Trust t Anther Trust Clinical Staff The requirement fr equipment lans t ther Trusts will be determined by clinical staff MEMS TRW.MED.POL The Management and Use f Medical Devices Plicy 13

14 All medical devices being laned t anther NHS trust must be laned via MEMS ensure that the device is safe and in full wrking rder and if applicable decntaminated befre hand ver. MEMS shuld carry ut suitable tests. Nrmal practice is fr devices t be taken r sent t the equivalent equipment management team s that they can carry ut the pre-use checks and paperwrk fr their NHS trust. A declaratin f cntaminatin status is required fr medical devices sent via all nrmal transprt rutes. A service histry f the medical device is prvided t the receiving Trusts maintenance department at the time f the lan. 10 Duties in Relatin t Decntaminatin, Maintenance and Repair f Medical Devices MEMS In respect f decntaminatin, MEMS is respnsible fr: reprting, t the equipment users and t MDSG thrugh the audit tl, instances where inadequately cleaned medical devices are transferred fr strage, maintenance, repair r relcatin In respect f maintenance and repair, MEMS is respnsible fr: ensuring that all medical devices are subject t an apprpriate maintenance prgramme and that recrds f this prcess are kept. Each prgramme shuld, as far as is practicable, aim t achieve the standards recmmended in the MHRA DB 2006(05) Managing Medical Devices, subject t an apprpriate risk based assessment f the required maintenance frequency, risk prfiles and manufacturer s guidance managing and delivering a prgramme f maintenance, servicing and calibratin fr all medical devices requiring planned preventative maintenance. Delivery f these rles may be cntracted ut t ther service prviders, such as the manufacturers, r suppliers f the devices. ensuring that external service and maintenance persnnel called t wrk n medical devices are able t prve that they are apprpriately trained and accredited ensuring apprpriate external resurces are called in t enable cmpliance with external regulatins and calibratin standards such as LOLER (lifting regulatins fr patient hists), NAWI (calibratin f weighing scales) and relevant British Standards. ensuring that unscheduled repairs are carried ut t the required standard and in a timely manner by agreeing realistic dates and times, with ward and department managers fr the devices t be taken ut f cmmissin, whilst the required maintenance is carried ut. ensuring that befre returning t clinical use, all repaired equipment underges functinal and electrical safety tests. discuss ptins with department and ward managers in instances where the cst f repair exceeds a predefined level, r the repair histry f the device indicates that further repair may nt be advisable TRW.MED.POL The Management and Use f Medical Devices Plicy 14

15 Ward and Department Managers Are respnsible fr: ensuring there is an adequate audit trail prcess in place fr cleaning f equipment: when, by whm last cleaned. ensuring that all equipment, including medical equipment is made available fr inspectin and test annually r at the required frequency. planning, with MEMS, the mst effective times fr maintenance f devices t be carried ut. arranging, where required and where pssible, fr substitute devices t be made available, t reduce the impact f the devices being taken ut f cmmissin whilst they are maintained. All Clinical Staff All users f medical devices are respnsible fr ensuring that the devices are adequately cleaned and decntaminated, in accrdance with the Trust s Decntaminatin Guidelines and Prcedures, befre and after use. Users are respnsible fr: ensuring that befre use, medical devices are adequately clean in accrdance with manufacturer s instructins and Trust plicy reprting defects in devices t MEMS, remving thse devices frm use and labelling them clearly as defective ensuring that befre returning medical devices t the medical equipment library, submitting devices fr crrective r preventative maintenance, fault investigatin, decmmissining r any ther prcedure invlving service r technical persnnel, the device has been apprpriately decntaminated. Devices invlved in adverse incidents, hwever, shuld nt be decntaminated but shuld be quarantined t await investigatin by MEMS signing and attaching decntaminatin certificates t the medical device prir t its transfer t any ther lcatin Fault Reprting Prcedures Please refer t the MEMS Medical Equipment Users Guide fr device fault reprting prcedures. 11 Duties in Relatin t Decmmissining f Medical Devices Devices are either cndemned r withdrawn because they d nt meet current clinical, quality r safety standards; are unserviceable (e.g. spares n lnger available); are beynd ecnmic repair; are the subject f a safety ntice; clinical prcedures have changed; r they have been part f a replacement prgramme. MEMS Fr devices included in the medical devices asset register, the MEMS team are respnsible fr: cnfirming with the department, r ward manager, r budget hlder that the device shuld be decmmissined TRW.MED.POL The Management and Use f Medical Devices Plicy 15

16 arranging fr apprpriate and safe dispsal f the device. Where relevant, this prcess shuld invlve: an assessment f whether the device is available fr resale, r dnatin. cmpletin f Trust s Sale Particulars frm which abslves the Trust frm prduct liability. dispsal f scrap devices thrugh the Trust s Waste Electrical and Electrnic Equipment (WEEE) cntractr updating the medical devices asset register, nce dispsal has been cmpleted. 12 Overall Respnsibility fr the Dcument The Head f Clinical Technlgy is the wner f this dcument and the Medical Devices Strategy Grup are respnsible fr reviewing it. 13 Cnsultatin and Ratificatin The design and prcess f review and revisin f this plicy will cmply with The Develpment and Management f Frmal Dcuments. The review perid fr this dcument is set as default f five years frm the date it was last ratified, r earlier if develpments within r external t the Trust indicate the need fr a significant revisin t the prcedures described. This dcument will be reviewed by the Medical Devices Strategy Grup and ratified by the Medical Directr Nn-significant amendments t this dcument may be made, under delegated authrity frm the Medical Directr, by the nminated wner. These must be ratified by the Medical Directr. Significant reviews and revisins t this dcument will include a cnsultatin with named grups, r grades acrss the Trust. Fr nn-significant amendments, infrmal cnsultatin will be restricted t named grups, r grades wh are directly affected by the prpsed changes. 14 Disseminatin and Implementatin Fllwing apprval and ratificatin, this plicy will be published in the Trust s frmal dcuments library and all staff will be ntified thrugh the Trust s nrmal ntificatin prcess, currently the Vital Signs electrnic newsletter. Dcument cntrl arrangements will be in accrdance with The Develpment and Management f Frmal Dcuments. The dcument wner will be respnsible fr agreeing the training requirements assciated with the newly ratified dcument with the Medical Directr and fr wrking with the Trust s training functin, if required, t arrange fr the required training t be delivered. TRW.MED.POL The Management and Use f Medical Devices Plicy 16

17 15 Mnitring and Reprting Cmpliance and Effectiveness The Medical Directr is respnsible fr ensuring that adequate arrangements are in place t mnitr and review cmpliance with this plicy; and that the results f these are recrded and reprted apprpriately. MEMS is respnsible fr mnitring cmpliance with this plicy and fr reprting the results f this mnitring, by exceptin and thrugh MEMS Key Perfrmance Indicatrs t the MDSG and t the Medical Directr. Cmpliance will als be subject t annual audit by the Clinical Audit department and the results f these audits reprted t the Medical Devices Strategy Grup fr actin, (see Audit Tls in Appendix A). The inventry f Medical Devices will be mnitred each mnth by the MEMS Department. Additins and deletins will be reprted t the Finance Department. This prcess will be audited by the MEMS Department thrugh 6 mnthly internal audits and annual external audits in accrdance with MEMS ISO9001:2008 Quality System Mnitring f all aspects f device maintenance will be cmpleted by MEMS thrugh 6 mnthly internal audits and annual external audits in accrdance with ISO9001:2008 Quality System. Reprted thrugh HCST Directrate Bard. Nn-cmpliance with the Quality System will be reprted thrugh the 6 mnthly ISO9001:2008 MEMS Quality System s Management Review Meetings and any serius nn-cnfrmances will be escalated t the Medical Device Strategy Grup. The Bard will receive reprts by exceptin. 16 References and Assciated Dcumentatin The fllwing dcuments are referred t in this plicy, r are further infrmatin and guidance relevant t management f medical devices 1. Guidance abut cmpliance. Essential standards f quality and safety. Care Quality Cmmissin, March NHSLA Risk Management Handbk, 2011/12. NHS Litigatin Authrity, February NHSLA Risk Management Standards fr NHS Trusts prviding Acute, Cmmunity r Mental Health & Learning Disability Services and Independent Sectr Prviders f NHS Care, 2011/12. NHS Litigatin Authrity, January Risk Management Framewrk, Aug 2012 Versin 10, Plymuth Hspitals NHS Trust 5. Medical Equipment Management Service, Medical Equipment Users Guide, March 2017 Versin 6, Plymuth Hspitals NHS Trust 6. Medical Devices Training Plicy, January 2015 Versin 5, Plymuth hspitals NHS Trust 7. Prcurement (2006) Guidelines Fr The Evaluatin Of Medical Devices and Technlgies Plymuth Hspitals NHS Trust 8. Medical Devices Strategy Grup Terms f Reference Nv 2010 Plymuth Hspitals NHS Trust TRW.MED.POL The Management and Use f Medical Devices Plicy 17

18 9. Medical Electrical Installatin Guidance Ntes, (MEIGaN) (2007), Medicines and Healthcare Prducts Regulatry Agency, Lndn 10. Single-Use Medical Devices: Implicatins and Cnsequences f Reuse MHRA DB2006(04) v Management f In Vitr Diagnstic Medical Devices MDA DB2002(02) Medical Devices Agency, Lndn 12. Management and use f IVD Pint f Care Test Devices MDA DB 2002(03) Medical Devices Agency, Lndn 13. Reprting Adverse Incidents and Disseminating Medical Device Alerts MHRA /2004/001. Medical Devices Agency, Lndn 14. Safeguarding Public Health: The Medical Devices Regulatins: Implicatins n Healthcare and ther related Establishments Bulletin 18. Medicines and Healthcare prducts Regulatry Agency (2003), Lndn 15. Managing Medical Devices: Guidance fr healthcare and scial services rganisatins - April 2015 Medicines and Healthcare prducts Regulatry Agency, Lndn 16. The Management f Medical Equipment in NHS Acute Trusts in England Natinal Audit Office (1999), Lndn 17. Fr The Recrd - Managing recrds in NHS Trusts and Health Authrities HSC 1999/ NHS Executive 18. Risk Management AS / NZS 4360:1999. Standards Assciatin f Australia. Strathfield NSW 19. The Inising Radiatins Regulatins 1999, SI 1999/3232 Statinery Office 1999 ISBN Guidance n the safe use f lasers, IPL systems and LEDs MHRA DB 2008(03) 21. BS EN :2007 Safety f Laser Prducts Part 1: Equipment classificatin and requirements 22. BS EN :2006 Safety f Laser Prducts Part 8: Guidelines fr the safe use f laser beams n humans 23. BS EN :2004 Safety f Laser Prducts Part 14: A user s guide 24. BS EN 207:1999 Persnal Eye-Prtectin Filters and eye-prtectrs against laser radiatin (laser eye prtectrs) 25. BS EN :2006 Medical Electrical Equipment, General Requirements fr Basic Safety and Essential Perfrmance 26. IEC 62353:2014 Medical Electrical Equipment Recurrent test and test after repair f medical electrical equipment, 27. BS EN :1996 Medical Electrical Equipment Part 2: Particular requirements fr safety Sectin Specificatin fr diagnstic and therapeutic laser equipment 28. Health and Safety at Wrk Act HMSO 1974 ISBN TRW.MED.POL The Management and Use f Medical Devices Plicy 18

19 29. Safe Use f Wrk Equipment, Prvisin and Use f Wrk Equipment Regulatins Apprved Cde f Practice and Guidance L22 HSE Bks 1998 ISBN Electricity at Wrk Regulatins 1989 SI 1989/635 HMSO 1989 ISBN X 31. PHNT Appraisal Prcess 32. Training Recrd 33. PHNT Incident Reprting Plicy 34. Decntaminatin Certificate and Fault Reprt, Issue 4 Sept 2016, Plymuth Hspitals NHS Trust 35. Cmbined Labratries Management f Equipment, SOP M0024, versin 1.4 Standard fr the Medical Labratry, Clinical Pathlgy Accreditatin (UK) Ltd Sept Pressure Ulcer Preventin and Management Guidance Plymuth Hspitals NHS Trust September Health and Scial Care Act 2008 (regulated Activities) Regulatins Lifting Operatins and Lifting Equipment Regulatins (LOLER) 1998 Audit Tl fr Management and Use f Medical Devices Appendix 1 1. The use f this plicy will be mnitred annually by the Clinical Audit Department and the results f these audits reprted t the Medical Devices Strategy Grup fr actin 2. A randm selectin f Medical Devices will be identified using the MEMS cmputerised inventry 3. The pathway f each device thrugh the plicy will then be audited, recrding the fllwing audit pints: a. Is there a PPQ and equipment assessment recrd indicating that Prcurement / MEMS were cntacted prir t requisitin and that advice n selectin, maintenance and decntaminatin was sught? b. Were acceptance tests undertaken by MEMS? c. Des the device have a valid MEMS service label with device number? d. Are the fllwing details n the MEMS cmputerised inventry present and crrect? i. Device details ii. Financial details iii. Custmer iv. Service histry v. Maintenance schedule e. Has equipment gt a service manual indexed in MEMS. f. Is there a recrd f Training Needs Analysis and which staff are trained in use f the device? g. Is there evidence f user maintenance fr apprpriate equipment at ward / department level TRW.MED.POL The Management and Use f Medical Devices Plicy 19

20 h. If the device is malfunctining has it been remved frm use and clearly labelled t indicate the fault 4. In additin t these audit pints, n visiting a clinical area the Clinical Audit Team will check all devices fr valid MEMS service labels and check any devices that are thught t be faulty. 5. Whilst in the clinical area a sample f clinical staff will be asked the fllwing questins a. Hw is a medical device identified as single use nly b. What d the terms single use and single patient use mean 6. A reprt f Adverse Incidents invlving Medical Devices will be btained frm the DATIX system and checked t ensure that in these cases the device was quarantined and reprted t MEMS. 7. The Clinical Audit Team will visit the Medical Equipment Library and check returned equipment fr the apprpriate decntaminatin certificate. Disseminatin Plan and Review Checklist Appendix 2 Disseminatin Plan Dcument Title The Management and Use f Medical Devices Plicy Date Finalised March 2017 Previus Dcuments Actin t retrieve ld cpies T be managed by the Disseminatin Lead Disseminatin Plan Recipient(s) When Hw Respnsibility All Trust staff March 2017 Vital Signs Infrmatin Gvernance Team Review Checklist Title Is the title clear and unambiguus? Is it clear whether the dcument is a plicy, prcedure, prtcl, framewrk, APN r SOP? Des the style & frmat cmply? Ratinale Are reasns fr develpment f the dcument stated? Develpment Is the methd described in brief? Prcess Are peple invlved in the develpment identified? Has a reasnable attempt has been made t ensure relevant expertise has been used? Is there evidence f cnsultatin with stakehlders and users? Cntent Is the bjective f the dcument clear? Is the target ppulatin clear and unambiguus? Are the intended utcmes described? Are the statements clear and unambiguus? TRW.MED.POL The Management and Use f Medical Devices Plicy 20

21 Evidence Base Is the type f evidence t supprt the dcument identified explicitly? Are key references cited and in full? Are supprting dcuments referenced? Apprval Des the dcument identify which cmmittee/grup will review it? If apprpriate have the jint Human Resurces/staff side cmmittee (r equivalent) apprved the dcument? Des the dcument identify which Executive Directr will ratify it? Disseminatin & Is there an utline/plan t identify hw this will be dne? Implementatin Des the plan include the necessary training/supprt t ensure cmpliance? Dcument Cntrl Des the dcument identify where it will be held? Mnitring Cmpliance & Effectiveness Have archiving arrangements fr superseded dcuments been addressed? Are there measurable standards r KPIs t supprt the mnitring f cmpliance with and effectiveness f the dcument? Is there a plan t review r audit cmpliance with the dcument? Review Date Is the review date identified? Overall Respnsibility Is the frequency f review identified? If s is it acceptable? Is it clear wh will be respnsible fr c-rdinating the disseminatin, implementatin and review f the dcument? N/A TRW.MED.POL The Management and Use f Medical Devices Plicy 21

22 Equalities and Human Rights Impact Assessment Appendix 3 Cre Infrmatin Date January 2012 Title What are the aims, bjectives & prjected utcmes? Scpe f the assessment The Management and Use f Medical Devices Plicy EIA nt required fllwing advice frm Equality and Diversity Manager (Service) Cllecting data Race Religin Disability Sex Gender Identity Sexual Orientatin Age Sci-Ecnmic Human Rights What are the verall trends/patterns in the abve data? Specific issues and data gaps that may need t be addressed thrugh cnsultatin r further research TRW.MED.POL The Management and Use f Medical Devices Plicy 22

23 Invlving and cnsulting stakehlders Internal invlvement and cnsultatin External invlvement and cnsultatin Impact Assessment Overall assessment and analysis f the evidence Actin Plan Actin Owner Risks Cmpletin Date Prgress update TRW.MED.POL The Management and Use f Medical Devices Plicy 23