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Department Policies & Procedures Steven Lewis Clinical Engineering United Lincolnshire Hospitals NHS Trust

Departmental Policies and ProceduresWorking HoursThe Trust’s Flexible Working Policy1 covers all members of staff. The Trust operates flexiblepatterns of working, in order to assist staff in their work-life balance.Working hours totalling 37.5 have been agreed with Phillip Ward, Trust Lead ClinicalTechnologist and Andrew Darlow, Chief Clinical Technologist.Sickness NotificationThe Trusts Managing Attendance Policy2 states that all staff are required to personally inform,by telephone, their line manager (Phillip Ward) and/or a deputy (Andrew Darlow) of yourreason for absence and your likely return date. You must maintain contact with your managerto inform them of progress and expected date of return. On return to work if the absence wasmore than three days (to a maximum of seven) you will need to complete a ‘Self-CertificateSickness Form’ and submit this to your manager. If you are absent for more than sevenconsecutive days a Doctors’ note must be obtained. On return to work a ‘return to workinterview’ will take place with your manager. In exceptional circumstances a telephoneinterview may be conducted where a face to face interview is not possible.Booking of LeaveLeave can be requested by filling in your Annual leave card, which is then approved by themanger. The Clinical Engineering department runs a ‘buddy’ system, to ensure that thedepartment can provide a continuous service to the hospital. Each member of the team has a colleague who would be able to cover any of their roles whilston leave. Before booking any leave your ‘buddy’ should be consulted to check they do not wantto or have not already booked the same day, if they have try and arrange another suitable timeto take leave.Training/Study Leave ApplicationStaff are allowed up to 30 days study leave within a 3 year period subject to authorisation. Fulldetails can be found in the Medical Staff Leave Policy3.Personal Training RecordAll Members of staff have an electronic training record which can be accessed through theMedical Equipment Management System (MEMS), here you will find any courses or trainingcompleted and any certificates or paperwork to support them.1 Flexible working policy available –HTTP://ULHINTRANET/FLEXIBLE-WORKING-POLICY2 Managing Attendance Policy Available -HTTP://ULHINTRANET/DOWNLOAD.CFM?DOC=DOCM93JIJM4N2024.PDF&VER=34573 Staff Leave Policy Available - HTTP://ULHINTRANET/DOWNLOAD.CFM?DOC=DOCM93JIJM4N1498.PDF&VER=5822

Health & Safety Policy“To continually reduce risk and so improve safety as far as reasonably Practicable.”Health & Safety at Work Act (1974)The Health and Safety at Work Act (1974) (also referred to as HSWA, the HSW Act, the 1974 Actor HASAWA) is the primary piece of legislation covering occupational health and safety in GreatBritain. The Health and Safety Executive, with local authorities (and other enforcing authorities)is responsible for enforcing the Act and a number of other Acts and Statutory Instrumentsrelevant to the working environment.The Act sets out the general duties which employers have towards employees and membersof the public, and employees have to themselves and to each other.These duties are qualified in the Act by the principle of ‘so far as is reasonably practicable’.In other words, an employer does not have to take measures to avoid or reduce the risk ifthey are technically impossible or if the time, trouble or cost of the measures would be grosslydisproportionate to the risk.The main requirement on employers is to carry out a risk assessment. Employers with fiveor more employees need to record the significant findings of the risk assessment.(HSE, 2016)Electricity at Work Regulations (1989) (EAWR)The purpose of the Electricity at Work Regulations (1989) is to require precautions to be takenagainst the risk of death or personal injury from electricity in work activities.Electricity is a major hazard - not only can it kill directly, through shocks, it can also cause firesand explosions.These regulations aim to impose duties to limit the risks involved in using electricity at work.Regulation 3 places duties on; employers, employees and the self-employed - to comply withthe regulations as far as matters are under their control.Many employees in the electrical trades and professions have responsibilities, as part of theirduties, related to the safety of electrical installations and systems.The regulations quantify these responsibilities, by putting them under a legal duty to work inaccordance with the requirements of the regulations.General safety of electrical systemsRegulation 4 requires that all electrical systems should, so far as reasonably practicable, be ofsafe construction and maintained in that state.Work being carried out on or near systems must be carried out in such a manner as to avoiddanger.Any protective equipment provided must be suitable and properly maintained and used.Use of suitable equipmentRegulations 5 to 11, in effect, place a duty to ensure that electrical equipment is suitable forwhere and how it is to be used, and is adequately protected.

Regulation 12 states that all electrical equipment must have secure and safe means of isolationfrom all sources of electrical energy.Regulation 13 requires suitable precautions to be taken to ensure that, once equipment isisolated so that work can be carried out on it, it cannot become electrically charged again whilstthe work is in progress.In certain circumstances, it may be impossible to isolate a conductor from the electrical supply.Regulation 14 requires that such 'live' working only occurs when it is unavoidable, and aftersuitable protective equipment has been provided.Access, Space and LightRegulation 15 requires the provision of adequate working space, safe access and adequatelighting to enable work on electrical equipment to be carried out safely.CompetenceRegulation 16 requires that anyone working on electrical systems where technical knowledgeor experience is necessary must have the required knowledge and/or experience or be undersuitable supervision.The Electricity at Work Regulations (1989), require that electrical equipment is tested at regularintervals to ensure that it is electrically safe. As a minimum Clinical Engineering aims to visuallyinspect and test for electrical safety (where appropriate), all items of medical equipment on anannual basis. Any equipment identified or suspected of being unsafe should be removed fromservice immediately and labelled clearly to prevent further use. The equipment should then bereturned to Clinical Engineering for repair. All repaired equipment must undergo anappropriate verification process followed by electrical safety testing before being returned toclinical use. (HSE, 2015)Provision & Use of Work Equipment (1998) (PUWER)These Regulations, often abbreviated to PUWER, place duties on people and companies whoown, operate or have control over work equipment. PUWER also places responsibilities onbusinesses and organisations whose employees use work equipment, whether owned by themor not.When providing new work equipment for use at work, you must ensure it conforms with theessential requirements of European Community law (for new machinery this means theMachinery Directive). You must check it:  is CE marked  comes with a Declaration of Conformity  is provided with instructions in English  is free from obvious defects – and that it remains so during its working lifePUWER requires that equipment provided for use at work is:  suitable for the intended use  safe for use, maintained in a safe condition and inspected to ensure it is correctly installed and does not subsequently deteriorate  used only by people who have received adequate information, instruction and training accompanied by suitable health and safety measures, such as protective devices and

controls. These will normally include emergency stop devices, adequate means of isolation from sources of energy, clearly visible markings and warning devices  used in accordance with specific requirements, for mobile work equipment and power pressesThe Personal Protective Equipment at Work Regulations 1992 (PPE)Regulation 4 of the PPE at work regulations states; “Every employer shall ensure that suitable personal protective equipment is provided to his employees who may be exposed to a risk to their health or safety while at work except where and to the extent that such risk has been adequately controlled by other means which are equally or more effective.” (HSE, 1992)Personal Protective Equipment is;“All equipment (including clothing affording protection against the weather) which is intended tobe worn or held by a person at work which protects them against one or more risks to their health and safety.” (HSE, 1992)The ULHT PPE policy describes the requirements for the use of PPE necessary to safeguard thehealth of trust employees, although stating that PPE must always be regarded as a ‘last resort’ toprotect against risks to safety and health. Engineering controls and safe systems of work mustalways be considered first. This policy addresses the trusts legal obligations under the Health &Safety at Work Act 1974, and the Personal Protective Equipment at Work Regulations 1992.If items of Personal Protective Equipment are required they must be provided free of charge bythe employer. In the Clinical Engineering workshop all PPE can be found in either the COSHHroom or the mechanical area and should always be wornLone Worker PolicyThe Trust defines a lone worker as; “…any individual who, in the process of carrying out their duties on behalf of the Trust, may find themselves working alone or in an area isolated from colleagues.” (ULHT, 2012)The’ Lone Worker policy’4 applies to all United Lincolnshire Hospitals NHS Trust employed staffand also includes temporary and agency staff, contractors, volunteers, students and those onwork experience. The policy applies to all situations involving lone working arising inconnection with the duties and activities of staff.The aim of this policy is to ensure that the risk of working alone is assessed in a systematic andon-going manner, and that safe systems and methods of work are put in place to eliminate risksto staff working alone or to reduce those risks to the lowest practicable level.It is the responsibility of the Head of Section to ensure staff are given appropriate information,instruction and training, including training at induction, updates and refresher training asnecessary and so are adequately trained to undertake lone working.4 Lone Worker Policy Available -HTTP://ULHINTRANET/DOWNLOAD.CFM?DOC=DOCM93JIJM4N2085.PDF&VER=3580

Electrical and Mechanical Hazards PolicyThe objective of the ‘Electrical and Mechanical Hazards in the Workshop Policy’5 is to ensurethat staff are aware and carry out their responsibilities. In large part but not exclusively thisrelates to the Electricity at Work Regulations 1989, Provision and Use of Work EquipmentRegulations 1998 and the Health and Safety at Work Act 1974. The Head of Clinical Engineeringtakes overall responsibility, but this is delegated through the Trust Lead Clinical Technologist(Electronics) and Workshop Lead to ensure that safe working practice is followed.Laser Radiation Safety PolicyThe ‘Laser Radiation Safety Policy’6 was written to ensure safe working for staff providingservice support for surgical lasers. Each laser has associated with it a document that describesthe necessary working practices to ensure the safety of staff. These documents are linked to theparticular device they relate to on the MEMS database.Anaesthetic Vaporisers PolicyThe ‘Anaesthetic Vaporisers policy’7 applies to all staff. The objective is to ensure the safety andwelfare of all staff. The policy gives guidance on checking a vaporiser has been emptied, what todo if you suspect a vaporiser is leaking and, due to the weight, how to safely transport avaporiser. (See manual handling policy)DSE (Display Screen Equipment) PolicyThis policy covers all Display screen equipment defined as;“…any alphanumeric or graphic display screen, regardless of the display process involvedincluding portable display screen equipment, such as laptop computers, that are habituallyoperated by a display screen user as a significant part of normal work.” (ULHT, 2012)The objective of the ‘Display Screen Equipment policy’8 is to ensure compliance with the Health& Safety (Display Screen Equipment) Regulations 1992 as Amended 2002 and therefore combatthe main risks that may arise in working with DSE which are musculoskeletal disorders such asback pain or upper limb disorders, visual fatigue and mental stress.The policy applies to all persons employed by the trust who use display screen equipment atwork, and in relation to all relevant display screen equipment owned or operated by the trustand the whole workstation including equipment, furniture, and the work environment.It is the Department head who is responsible for compliance, however, Self-assessment forms9can be obtained for staff who think they could be at risk5 Hazards in the Workshop Policy Available –HTTP://EMS-L1/DOCUMENTS/CENGDOCS/DOC0047A.PDF6 Laser Radiation Policy Available -http://ems-l1/documents/cengdocs/Doc0047A.pdf7 Anaesthetic Vaporisers Policy Available –HTTP://EMS-L1/DOCUMENTS/CENGDOCS/DOC0047A.PDF8 DSE Policy Available –HTTP://ULHINTRANET/SEARCH/VIRTUAL-DOCUMENT/DISPLAY-SCREEN-EQUIPMENT--31989 Self-Assessment Form Available -HTTP://ULHINTRANET/DOWNLOAD.CFM?DOC=DOCM93JIJM4N3196.PDF&VER=5564

Manual Handling PolicyManual Handling can be described as;\"...any transporting or supporting of a load (including the lifting, putting down, pushing, pulling,carrying or moving thereof) by hand or bodily force” (HSE, 1992)This policy applies to any person on the trust premises, including patients, visitors, ULHT employees,contract staff and third parties working on behalf of the trust. The objective of the policy is to;  First : avoid hazardous manual handling operations so far as is reasonably practicable;  Second : assess any hazardous manual handling operations that cannot be avoided; and  Third: reduce the risk of injury so far as is reasonably practicableFirst Aid PolicyFirst aid is;“Emergency treatment administered to an injured or sick person before professional medical careis available.” (OED)The ‘First Aid Policy’10 policy applies in relation to the working activities of all trust employees.These activities may be carried out at premises owned or operated by the trust, or at otherlocations where work is carried out by or on behalf of the trust. The objective of this policy is toensure the health and safety of all members of staff.Control of Substances Hazardous to Health (COSHH) PolicyThe Control of Substances Hazardous to Health Regulations 2002 as amended (COSHH) andassociated Approved Codes Of Practice (ACOP), require employers to evaluate and control therisks which arise from the use, storage and disposal of hazardous substances that employeesand others may be exposed to. The ‘COSHH policy’11 sets out the responsibilities andarrangements made by the United Lincolnshire Hospitals NHS Trust in order to comply with theabove regulation, and also includes Dangerous Substances and Explosive Atmosphereregulations (DSEAR) 2002 and other related regulations.COSHH covers chemicals, products containing chemicals, fumes, dusts, vapours, mists and gases,and biological agents (germs).If the packaging has any of the hazard symbols (below) then it is classed as a hazardoussubstance.10 First Aid Policy Available –HTTP://ULHINTRANET/HEALTH-AND-SAFETY11 COSHH Policy Available - HTTP://ULHINTRANET/DOWNLOAD.CFM?DOC=DOCM93JIJM4N2413.PDF&VER=5761

Old Hazardous Substance Symbols Valid Until 2015New Hazardous Substance Symbols Valid Since 2010Dangerous to May May Cause May Risk of Flammable Explosive GasesAnimal Health Cause Lasting Skin Cause Serious Underand the Irritation or Fatal Health Effects PressureEnvironment Or Eye Damage PoisoningAllergyWaste Management PolicyThe trusts ‘Waste Management Policy’12 provides guidance on the safe management anddisposal of all types of waste generated within its premises and by community healthcareworkers as well as all contractors and temporary workers who are engaged to work on trustpremises. The policy specifies how waste should be segregated, sorted, handled, transportedand disposed of or recovered safely and efficiently. The policy aims to provide a safe system ofwork and to satisfy requirements of The Environmental Protection Act 1990, which requires allorganisations to manage waste responsibly. Where possible it promotes a strategy of wastemanagement, reduction and re-use.Waste Electrical and Electronic Equipment (WEEE)Regulations have been introduced to tackle the growing amount of WEEE, and these are coveredin the above policy. The new regulations require greater segregation to ensure that moreWEEE is separately collected for treatment and recovery.They affect the way WEEE is disposed of by setting treatment standards and recycling targetsand, importantly, by making producers, rather than end-users, pay for its treatment andrecycling in most cases. Trust members disposing of WEEE should also be aware of theirresponsibilities under other waste management legislation, such as the Duty of Care and theHazardous Waste Regulations. The WEEE skip can be found near the estates offices which iswhere the keys can be requested.12 Waste Management Policy Available –HTTP://ULHINTRANET/WASTE-MANAGEMENT-POLICY

Management of Work Related Stress PolicyStress can be described as;“…the psychological, physiological and behavioural response on the part of a person to a situation in which that person is unable to cope with the demands placed upon them, leading eventually to incapacity and ill health” (ULHT, 2012)The objective of the ‘Management of work related stress policy’13 is to guide people throughrecognising stress, reporting stress in yourself or a colleague, how to obtain support and how totry and avoid putting people under excess pressure. It is the department managers’responsibility to;  Ensure that stress risk assessments are carried out where appropriate and their conclusions are acted upon.  Ensure that individual stress risk assessments are carried out if staff have or are off sick with work related stress.  Ensure they have access to adequate support to manage the demands of their role and undertake the training that is provided to managers by the Trust  Be aware of the signs of stress in their staff and should address these signs when noticed. An Employees Guide to obtaining support for stress is also available in Appendix 4 of this policy.Fire PolicyThe trusts ‘Fire Policy’14 is based primarily on the avoidance of fire, however, in the event of afire there must be robust systems in place to detect, contain and control the fire while at thesame time allow staff, patients and visitors to evacuate the area in a controlled manner. A fire isa potential hazard in all hospitals and health premises. The consequences of a fire pose a seriousthreat to the lives of patients, visitors and staff.The effectiveness of plans for dealing with an outbreak of fire and the various aspects of fireprecautions training are tested by fire practice drills. The Nominated Officer (Fire) in conjunction with the Fire Safety Advisor will organisethese annually taking into account the need to maintain effective operation.The objective of this policy is to ensure the safety of all staff, patients and visitors byMaking sure that everyone working in the Trust understands the character of fire, smoke andtoxic fumes; knows the fire hazards involved in the working environment; practice and promotefire prevention; and has been instructed about the action to take for detecting the fire, raisingthe alarm, evacuating the area/building, containing and controlling the fire.Glove PolicyThe trusts ‘Glove Policy’15 is based on The Infection Control Nurses Association guidelines(1999). The role of gloves, both in preventing wound infections and protecting Healthcare13 Management of Work Related Stress Policy Available –HTTP://ULHINTRANET/HEALTH-SAFETY---WORK-RELATED-STRESS14 Fire Policy Available –HTTP://ULHINTRANET/DOWNLOAD.CFM?DOC=DOCM93JIJM4N2221.PDF&VER=380515 Glove Policy Available –HTTP://1.10B_GUIDE%20FOR%20CORRECT%20GLOVE%20USE.PDF

Workers from patients’ microorganisms, especially bacteria, and from the harmful effects ofantiseptics and chemicals, continues to be the primary reasons for glove use.This policy is made as part of the Trust’s Health & Safety Policy and states gloves should only beworn when necessary (i.e identified by a risk assessment). Glove should be latex free unless arisk assessment indicates the use of latex. When gloves are used they should be powder-free, fitcorrectly and disposed of after a single use and hands washed and dried after removal.Information GovernanceInformation Governance provides a framework to bring together all of the requirements, standardsand best practice that apply to the handling of information. The goal of it is to help organisations andindividuals to be consistent in the way they handle personal and corporate information and avoidduplication of effort, leading to improvements in, Information handling activities, Patient and serviceuser confidence in care providers and Employee training and development.Information Governance brings together the following initiatives:  Caldicott  Data Protection  Data Quality  Information Security  ISO27001 (code of practice for information security).Information on which can be found at http://ulhintranet/introduction-to-information-governance.There are many policies covered by information governance such as ‘Access to Health recordsPolicy’, ‘Confidentiality Code of Practice’ and ‘Network Security Policy’.To support the implementation and development of a robust information governanceframework, and in line with national Information Governance (IG) training requirements, theTrust has mandated that all staff must undertake a basic information governance e-learningmodule every 12 months in line with other Trust annual training.Additional modules may be completed as required and other modules will be mandated fordesignated staff groups following an assessment of need.All personnel employed by or working on behalf of the Trust who have access to personal dataare required to complete the e-learning module “Introduction to Information Governance.”All personnel employed by or working on behalf of the Trust who do not have access topersonal data are required to complete the e-learning module \"Information Governance: TheBeginners Guide\"All personnel employed by or working on behalf of the Trust are then required to complete thee-learning module ‘Information Governance: The Refresher Module’ in each of the following3 years and then complete the full module again and repeat this cycle.The trust provides E-Learning16 modules on various subjects such as Fire, Infection Control andInformation Governance some of which are mandatory where an annual refresher course mustbe taken.Paper copies of the relevant policies can also be found in the Clinical Engineering Office.16 E-Learning Modules Available –HTTP://ULHINTRANET/CORPORATE-TRAINING

BibliographyCEng, n.d. Clinical Engineering Documents. [Online]Available at: http://ems-l1/documents/cengdocs/Doc0047A.pdf[Accessed November 2013].HSE, 1992. HSE - Manual Handling. [Online][Accessed November 2013].HSE, 1992. HSE - Personal Protective Equipment. [Online]Available at: http://www.hse.gov.uk/pubns/indg174.pdf[Accessed November 2013].HSE, 2015. The Electricity at Work regulations (1989). 3rd ed. s.l.:HSE Books.HSE, 2016. Health and Safety at Work Act (1974). [Online]Available at: http://www.hse.gov.uk/legislation/hswa.htm[Accessed May 2016].OED, 2012. Oxford English Dictionary. 7th ed. Oxford: Oxford University Press.ULHT, 2012. Management of stress. [Online]Available at:http://www.nhsdirect.nhs.uk/about/freedomofinformation/foipublicationscheme/~/media/files/freedomofinformationdocuments/ourpoliciesandprocedures/healthandsafetypolicies/national_managing_stress_in_the_workplace_policy.ashx[Accessed November 2013].ULHT, 2012. ULHT Intranet. [Online]Available at: http://ulhintranet/download.cfm?doc=docm93jijm4n2085.pdf&ver=3580[Accessed November 2013].

Electrical Safety Testing Steven Lewis Clinical Engineering United Lincolnshire Hospital Trust

Electrical Safety TestingTo govern the design of medical equipment, the International Electro-technical Committee (IEC)has produced a standard to control all aspects of safety directly or indirectly relating to thehandling, use or connection to, of medical equipment. This standard is referenced as IEC 60601and was first published in 1977 (then referred to as IEC 601) and handles the electrical safety ofboth mechanical and electrical issues. It is constructed from 2 parts; IEC 60601-1 and IEC60601-2, each build-up from a number of collateral or particular standardsCollateral standards (numbered 60601-1-X) define the requirements for certain aspects ofsafety and performance. Particular standards (numbered 60601-2-X) define the requirementsfor specific products or specific measurements built into products, e.g. MR scanners (IEC 60601-2-33). (MDDI, 2015)The standard applies to medical electrical equipment intended to be used in the diagnosis,treatment, or monitoring of a patient. It focuses on the basic safety and essential performance ofmedical electrical equipment and medical electrical systems. A list of the various parts can befound in Appendix A.Electrical Safety ClassesThere are different methods of protection against electric shock; equipment is divided into fourclasses depending on the type of protection used;Class I In Class I appliances the user is protected by a combination of basic Insulation and theprovision of an EARTH connection to any conductive parts.Class II Class II equipment is either double insulation or reinforced insulation. In doubleinsulated equipment the basic protection is afforded by the first layer of insulation. If the basicprotection fails then supplementary protection is provided by a second layer of insulationpreventing contact with live parts.Class III In Class III Equipment protection against electric shock relies on supply at SELV andin which voltages higher than those of SELV are not generated.” SELV stands for “Separatedextra-low voltage” which means that the equipment operates at a voltage no greater than 25v acor 50v dc and has no protective earth connection.Internally Powered (IP)Equipment powered internally having no mains connection.

Electrical Applied Part TypesType B Applied Part Equipment providing a particular degree of protection against electric shock, particularly regarding allowable leakage currents and reliability of the protective earth connection (if present). Defibrillation Proof Type B Applied PartType BF Applied Part As type B but with isolated or floating (F - type) applied part or parts. BF is generally used for equipment with applied parts that have conductive contact with the patient Defibrillation Proof Type BF Applied PartType CF Applied Part Equipment providing a higher degree of protection against electric shock than type BF, particularly with regard to allowable leakage currents, and having floating applied parts. In medical equipment of this type the applied part is in direct conductive contact with the heart or other applications as deemed necessary. (EBME, 2013) Defibrillation Proof Type CF Applied PartVisual InspectionThe HSE states that; “a visual inspection can find more than 90% of faults and is the most important part of maintaining appliances.” (HSE, 2013)A visual inspection of equipment should comprise of the following checks;Cables  Fraying  Cuts  Heavy Scuffing  Crushing  No Joints or tape  Appropriate routing to prevent damage

Plug External  BS1363 marked  Sleeved pins  Pins not bent  Correct fuse  Signs of overheating/water damage  Cable grip secure  Correctly labelledPlug Internal  Wired correctly (see fig 1)  Terminal screws are tight  No bare wire visible (excluding at the terminals) Fig 1 – Correctly Wired Plug (h2g2, 2003)Equipment  Damage to case including cracks & corrosion  Signs of overheating/water damage  Rotation check – listen for any loose parts internally  Switches On/Off  Any screens functioning correctly  No access to live parts

Electrical Safety TestsEarth ContinuityThe resistance of the protective earth conductor is measured between the earth pin on themains plug and a protectively earthed point on the equipment enclosure. In IEC60601, the testis conducted using a 50Hz current not less than 1.5 times the fuse rating up to a maximum of26A for a period of at least 5 seconds. Damage to equipment can occur if high currents arepassed to points that are not protectively earthed, for example, functional earths. Great careshould be taken, when high current testers are used, to ensure that the probe is connected to apoint that is intended to be protectively earthed. The resistance measured should be less than0.2 Ω. (IEE, 2007) Fig 2 - Earth Continuity Test Diagram (EBME, 2013)Insulation ResistanceThis test is designed to measure the resistance of the insulation between the mains leads (liveand neutral together) and the protective earth conductor.The resistance is measured by applying a test voltage, specifically a stabilized DC voltage,between the protective earth conductor and the two mains leads and measuring the resistance.The measured resistance should be not less than 50MΩ (IEE, 2007) Fig 3 – Insulation Resistance Test Diagram (EBME, 2013)

Insulation Resistance (Applied parts to case)This test is designed to measure the insulation resistance between the protective earthconductor and the applied parts.The resistance is measured by applying a test voltage between the protective earth conductorand the applied part leads and measuring the resistance. The measured resistance should benot less than 50MΩ (IEE, 2007) Fig 4 – Insulation Resistance Test Diagram (Applied Parts) (EBME, 2013)Earth Leakage CurrentEarth leakage current is the current that normally flows in the earth conductor of a protectivelyearthed piece of equipment. In medical electrical equipment, very often, the mains is connectedto a transformer having an earthed screen. Most of the earth leakage current finds its way toearth via the impedance of the insulation between the transformer primary and the inter-winding screen, since this is the point at which the insulation impedance is at its lowest. Undernormal conditions, a person who is in contact with the earthed metal enclosure of theequipment and with another earthed object would suffer no adverse effects even if a fairly largeearth leakage current were to flow. This is because the impedance to earth from the enclosure ismuch lower through the protective earth conductor than it is through the person (EBME, 2013)The earth leakage current is measured with the instrument under test connected to the mainsnormally and then with the polarity reversed.The maximum leakage current should not exceed 0.5mA. (IEE, 2007).Higher values of earth leakage currents, in line with local regulation and IEC 60364-7-710(electrical supplies for medical locations), are allowed for permanently installed equipmentconnected to a dedicated supply circuit. (EBME, 2013) Fig 5 –Earth Leakage Current Test Diagram/Path (EBME, 2013)

Enclosure Leakage CurrentEnclosure leakage current or touch current is defined as the current that flows from an exposedconductive part of the enclosure to earth through a conductor other than the protective earthconductor. This test is designed to measure the current of any exposed metal parts of theinstrument under test. Enclosure leakage current is measured between an exposed part of theequipment which is not intended to be protectively earthed and true earth. The test isapplicable to both class I and class II equipment and should be performed with mains polarityboth normal and reverse. (EBME, 2013)The leakage current should not exceed 0.1mA or 0.5mA under fault conditions. (IEE, 2007) Fig 6 - Enclosure Leakage Current test Diagram/path (EBME, 2013)Patient LeakagePatient leakage current is the leakage current that flows through a patient connected to anapplied part or parts. It can either flow from the applied parts via the patient to earth or from anexternal source of high potential via the patient and the applied parts to earth. Great care mustbe taken when performing patient leakage current measurements that equipment outputs areinactive. In particular, outputs of diathermy equipment and stimulators can be fatal and candamage test equipment.Fig 7 – Patient Leakage test Diagram (EBME, 2013) Fig 8 - Current Path from Equipment (EBME, 2013)Fig 9 - Current Path to Equipment (EBME, 2013)

Patient Auxiliary CurrentThe patient auxiliary current is defined as the current that normally flows between parts of theapplied part through the patient, which is not intended to produce a physiological effect.Patient auxiliary current is measured between any single patient connection and all otherpatient connections of the same module or function connected together. Fig 10 – Patient Auxiliary Current Diagram/Path (EBME, 2013)All of the above tests are usually carried out automatically using an electrical safety analysersuch as the Rigel 288, the equipment under test (EUT) is plugged into the safety analyser, andthe earth and applied parts of the EUT are connected. The analyser will then run all the abovetests in sequence.The analyser can be set to run in Stepped/ Semi-Automatic mode, during this mode the analyserwill pause between applying power to the EUT so that the equipment can be shut down/startedup using the correct procedure. The test results are stored on the Rigel and from there they canthen be uploaded to a database. Fig 11 – Rigel 288 Electrical Safety Analyser (Rigel, 2016)

APPENDIX AIEC 60601-1 COLLATERAL STANDARDSIEC 60601-1-2 - Medical electrical equipment - Part 1-2: General requirements for basic safetyand essential performance - Collateral Standard: Safety requirements for medical electricalsystems & Electromagnetic disturbances - Requirements and tests.IEC 60601-1-3 - Medical electrical equipment - Part 1-3: General requirements for basic safetyand essential performance - Collateral Standard: Radiation protection in diagnostic X-rayequipment.IEC 60601-1-6 - Medical electrical equipment - Part 1-6: General requirements for basic safetyand essential performance - Collateral standard: UsabilityIEC 60601-1-8 - Medical electrical equipment - Part 1-8: General requirements for basic safetyand essential performance - Collateral Standard: General requirements, tests and guidance foralarm systems in medical electrical equipment and medical electrical systemsIEC 60601-1-9 - Medical electrical equipment - Part 1-9: General requirements for basic safetyand essential performance - Collateral Standard: Requirements for environmentally consciousdesignIEC 60601-1-10 - Medical electrical equipment - Part 1-10: General requirements for basicsafety and essential performance - Collateral Standard: Requirements for the development ofphysiologic closed-loop controllersIEC 60601-1-11 - Medical electrical equipment - Part 1-11: General requirements for basicsafety and essential performance - Collateral Standard: Requirements for medical electricalequipment and medical electrical systems used in the home healthcare environmentIEC 60601-1-12 - Medical electrical equipment - Part 1-12: General requirements for basicsafety and essential performance - Collateral Standard: Requirements for medical electricalequipment and medical electrical systems intended for use in the emergency medical servicesenvironmentIEC 60601-2 - PARTICULAR STANDARDSIEC 60601-2-1 - Medical electrical equipment - Part 2-1: Particular requirements for the basicsafety and essential performance of electron accelerators in the range 1 MeV to 50 MeVIEC 60601-2-2 - Medical electrical equipment - Part 2-2: Particular requirements for the basicsafety and essential performance of high frequency surgical equipment and high frequencysurgical accessoriesIEC 60601-2-3 - Medical electrical equipment - Part 2-3: Particular requirements for the basicsafety and essential performance of short-wave therapy equipmentIEC 60601-2-4 - Medical electrical equipment - Part 2-4: Particular requirements for the basicsafety and essential performance of cardiac defibrillatorsIEC 60601-2-5 - Medical electrical equipment – Part 2-5: Particular requirements for the basicsafety and essential performance of ultrasonic physiotherapy equipment

IEC 60601-2-6 - Medical electrical equipment - Part 2-6: Particular requirements for the basicsafety and essential performance of microwave therapy equipmentIEC 60601-2-8 - Medical electrical equipment - Part 2-8: Particular requirements for basicsafety and essential performance of therapeutic X-ray equipment operating in the range 10 kVto 1 MVIEC 60601-2-10 - Medical electrical equipment - Part 2-10: Particular requirements for thebasic safety and essential performance of nerve and muscle stimulatorsIEC 60601-2-11 - Medical electrical equipment - Part 2-11: Particular requirements for thebasic safety and essential performance of gamma beam therapy equipmentIEC 60601-2-16 - Medical electrical equipment - Part 2-16: Particular requirements for basicsafety and essential performance of haemodialysis, haemodiafiltration and haemofiltrationequipmentIEC 60601-2-17 - Medical electrical equipment - Part 2-17: Particular requirements for thebasic safety and essential performance of automatically-controlled brachytherapy after loadingequipmentIEC 60601-2-18 - Medical electrical equipment - Part 2-18: Particular requirements for thebasic safety and essential performance of endoscopic equipmentIEC 60601-2-19 - Medical electrical equipment - Part 2-19: Particular requirements for thebasic safety and essential performance of infant incubatorsIEC 60601-2-20 - Medical electrical equipment - Part 2-20: Particular requirements for thebasic safety and essential performance of infant transport incubatorsIEC 60601-2-21 - Medical electrical equipment - Part 2-21: Particular requirements for thebasic safety and essential performance of infant radiant warmersIEC 60601-2-22 - Medical electrical equipment - Part 2-22: Particular requirements for basicsafety and essential performance of surgical, cosmetic, therapeutic and diagnostic laserequipmentIEC 60601-2-23 - Medical electrical equipment - Part 2-23: Particular requirements for thebasic safety and essential performance of transcutaneous partial pressure monitoringequipmentIEC 60601-2-24 - Medical electrical equipment - Part 2-24: Particular requirements for thebasic safety and essential performance of infusion pumps and controllersIEC 60601-2-25 - Medical electrical equipment - Part 2-25: Particular requirements for thebasic safety and essential performance of electrocardiographsIEC 60601-2-26 - Medical electrical equipment - Part 2-26: Particular requirements for thebasic safety and essential performance of electroencephalographsIEC 60601-2-27 - Medical electrical equipment - Part 2-27: Particular requirements for thebasic safety and essential performance of electrocardiographic monitoring equipment

IEC 60601-2-28 - Medical electrical equipment - Part 2-28: Particular requirements for thebasic safety and essential performance of X-ray tube assemblies for medical diagnosisIEC 60601-2-29 - Medical electrical equipment - Part 2-29: Particular requirements for thebasic safety and essential performance of radiotherapy simulatorsIEC 60601-2-31 - Medical electrical equipment - Part 2-31: Particular requirements for thebasic safety and essential performance of external cardiac pacemakers with internal powersourceIEC 60601-2-33 - Medical electrical equipment - Part 2-33: Particular requirements for thebasic safety and essential performance of magnetic resonance equipment for medical diagnosisIEC 60601-2-34 - Medical electrical equipment - Part 2-34: Particular requirements for thebasic safety and essential performance of invasive blood pressure monitoring equipmentIEC 60601-2-36 - Medical electrical equipment - Part 2-36: Particular requirements for thebasic safety and essential performance of equipment for extra-corporeally induced lithotripsyIEC 60601-2-37 - Medical electrical equipment - Part 2-37: Particular requirements for thebasic safety and essential performance of ultrasonic medical diagnostic and monitoringequipmentIEC 60601-2-39 - Medical electrical equipment - Part 2-39: Particular requirements for basicsafety and essential performance of peritoneal dialysis equipmentIEC 60601-2-40 - Medical electrical equipment - Part 2-40: Particular requirements for thebasic safety and essential performance of electromyography and evoked response equipmentIEC 60601-2-41 - Medical electrical equipment - Part 2-41: Particular requirements for thebasic safety and essential performance of surgical luminaires and luminaires for diagnosisIEC 60601-2-43 - Medical electrical equipment - Part 2-43: Particular requirements for thebasic safety and essential performance of X-ray equipment for interventional proceduresIEC 60601-2-44 - Medical electrical equipment - Part 2-44: Particular requirements for thebasic safety and essential performance of X-ray equipment for computed tomographyIEC 60601-2-45 - Medical electrical equipment - Part 2-45: Particular requirements for basicsafety and essential performance of mammographic X-ray equipment and mammographicstereotactic devicesIEC 60601-2-46 - Medical electrical equipment - Part 2-46: Particular requirements for thebasic safety and essential performance of operating tablesIEC 60601-2-47 - Medical electrical equipment - Part 2-47: Particular requirements for thebasic safety and essential performance of ambulatory electrocardiographic systemsIEC 60601-2-49 - Medical electrical equipment - Part 2-49: Particular requirements for thebasic safety and essential performance of multifunction patient monitoring equipmentIEC 60601-2-50 - Medical electrical equipment - Part 2-50: Particular requirements for thebasic safety and essential performance of infant phototherapy equipment

IEC 60601-2-52 - Medical electrical equipment - Part 2-52: Particular requirements for thebasic safety and essential performance of medical bedsIEC 60601-2-54 - Medical electrical equipment - Part 2-54: Particular requirements for thebasic safety and essential performance of X-ray equipment for radiography and radioscopyIEC 60601-2-57 - Medical electrical equipment - Part 2-57: Particular requirements for thebasic safety and essential performance of non-laser light source equipment intended fortherapeutic, diagnostic, monitoring and cosmetic/aesthetic useIEC 60601-2-62 - Medical electrical equipment - Part 2-62: Particular requirements for thebasic safety and essential performance of high intensity therapeutic ultrasound (HITU)equipmentIEC 60601-2-63 - Medical electrical equipment - Part 2-63: Particular requirements for thebasic safety and essential performance of dental extra-oral X-ray equipmentIEC 60601-2-64 - Medical electrical equipment - Part 2-64: Particular requirements for thebasic safety and essential performance of light ion beam medical electrical equipmentIEC 60601-2-65 - Medical electrical equipment - Part 2-65: Particular requirements for thebasic safety and essential performance of dental intra-oral X-ray equipmentIEC 60601-2-66 - Medical electrical equipment - Part 2-66: Particular requirements for thebasic safety and essential performance of hearing instruments and hearing instrument systemsIEC 60601-2-68 - Electrical medical equipment - Part 2-68: Particular requirements for thebasic safety and essential performance of X-ray-based image-guided radiotherapy equipmentfor use with electron accelerators, light ion beam therapy equipment and radionuclide beamtherapy equipment

BibliographyEBME, 2013. EBME. [Online]Available at: http://www.ebme.co.uk/articles/electrical-safety/333-classes-and-types-of-medical-electrical-equipment[Accessed November 2013].EBME, 2013. EBME. [Online]Available at: http://www.ebme.co.uk/articles/electrical-safety/332-leakage-currents[Accessed November 2013].h2g2, 2003. h2g2. [Online]Available at: http://h2g2.com/approved_entry/A1004400[Accessed March 2016].HSE, 2013. HSE - Portable Appliance Testing. [Online]Available at: http://www.hse.gov.uk/pubns/indg236.pdf[Accessed November 2013].IEE, 2007. The IEE Code of Practice for In-service Inspection and Testing of Electrical Equipment.3rd ed. Stevenage: s.n.MDDI, 2015. Medical Device & Diagnostic Industry. [Online]Available at: http://www.mddionline.com/article/regulatory-strategies-third-edition-iec-60601-1[Accessed March 2016].Rigel, 2016. Rigel Medical. [Online]Available at: http://www.rigelmedical.com/products/electrical-safety/rigel-288-plus-electrical-safety-analyzer[Accessed March 2016].Seaward Group, 2009. Rigel 288 Electrical Safety Analyser. 3rd ed. s.l.:Seaward Group.IEC, 60601-1Available at: http://www.gobookee.org/iec-60601-1-checklist/[Accessed November 2013].MDDI, 2015. Medical Device & Diagnostic Industry. [Online]Available at: http://www.mddionline.com/article/regulatory-strategies-third-edition-iec-60601-1[Accessed March 2016].

Equipment Lifecycle Steven Lewis Clinical Engineering United Lincolnshire Hospital Trust

Equipment LifecycleEquipment management encompasses the whole life cycle process that applies to all medicaldevices, from selection through procurement, commissioning, configuration, training, use,maintenance, repair, upgrade, decommissioning and final disposal.Inappropriate management of medical devices at any stage of its life will lead to increasedpatient risk and poor value for money. The idea is that there must be teamwork betweenClinical User teams, Equipment Management teams and Purchasing in order for the trust tomaximise the benefits and minimise the risks of medical devices.To achieve this it is essential that new devices meet relevant safety and quality standards, aresuitable for purpose and represent good value for money. Devices in use must be maintained ina safe working condition and operated competently in accordance with required standards andprocedures. Old devices must be replaced when worn out, out of support or do not meet currentstandards in clinical practice. Clinical Engineering are constantly trying to reduce the number ofmakes/models of device that perform the same clinical tasks, allowing greater leverage whennegotiating for equipment purchases and for the associated consumable items. It also meansless varieties of spare parts are needed in stock and technical staff are more familiar with eachpiece of equipment reducing the down time of a device when in for service. Most importantly itreduces the risk to patients and users arising from variation in the application of clinicalprocedures. (MHRA, 2014)

Single UseSingle-use is the term used to describe any medical device intended to be used on an individualpatient during a single procedure and then discarded. It is best practice and ULHT policy that adevice designated as single-use must not be re-used. A single-use device is also not intended tobe reprocessed and used again, even on the same patient.‘Do Not Reuse’ symbol:Single Patient useA medical device marked single-patient use means the medical device may be used more thanonce but, on one patient only.SelectionMedical Devices must be selected taking into account the following factors;  Fitness for purpose as judged against a duly considered specification  Standardisation with other similar devices already in use  Software compatibility with archive systems, patient records etc.  The training needs of the users of equipment  Maintenance implications i.e. cost of maintenance, availability of in-house technical support, quality of support from the supplier etc.  Ensuring the operating/environmental conditions of the place where the device will be used are compatible with those of the device.  Any need for decontamination of the medical device and the availability of suitable decontamination facilities  Whole life costs to include consumables/disposables, maintenance, training etc.  The Medical Devices Directive, safety standards, Health & safety regulations  Risks to the Trust, both clinical and corporateProcurementProcurement of Medical Devices is undertaken by the Supplies Department in collaborationwith the user, Clinical Engineering, Health & Safety, Estates and others as required.All device purchases shall be made in accordance with the Corporate Governance Manual UnitedLincolnshire Hospitals NHS Trust.1 Clinical users are requested to contact Clinical Engineeringfor selection advice, before contacting suppliers or raising requisitions. Good practice is todefine the clinical need, draw up a specification and draw up a shortlist of possible suitableequipment. Careful control over sales representatives helps reduce the risk of users feeling thatthey have an obligation to purchase products from a particular supplier. Clinical Engineering work closely with the Supplies Department to check medicalequipment non-stock requisitions and gather further information as necessary to safeguard thefinancial and clinical impact to the trust. As necessary, Clinical Engineering will contact theclinical user to identify the underlying reason for requests for non-standard equipment andassist in making a timely decision on the request.1HTTP://INTRANET/APPLICATIONS/DOCUMENTS/VIEWS/BYDEPARTMENT.ASPX?DEPARTMENT=TRUST%20BOARD&TYPE=MANUAL

IndemnityWhen medical equipment is loaned to the trust the indemnity procedure must be followed toensure the trust is indemnified against any claims for injury arising from its use.To have this protection the supplier must have a current MIA (Master Indemnity Agreement).Details of all current MIA holders can be found on the Department Of Health website, under‘Publications/ MIA’2There are two forms of indemnity the trust uses, Indemnity - Form A (Equipment on Loan) andIndemnity – Form B (Transfer of Ownership) before either form is completed proof of thesupplier’s indemnity insurance should be seen.An NHS Delivery note must be signed for each piece of equipment or set of goods loaned orgiven to the trust. The NHS delivery note must contain full details of the equipment includingmake/model, serial number, value, description and location. It should also state the intendedpurpose of the equipment. If using Form A the length of loan period should also be stated. Aloan label can then be printed and attached to the equipment /accessories, and all paperworkscanned to the job.AcceptanceAll items of medical equipment entering the Trust must undergo appropriate acceptance andcommissioning tests in accordance with MDA DB2006(05) before being put into use. ClinicalEngineering or, in approved cases, the supplier undertakes the commissioning process. Whereequipment is installed by a third party (the manufacturer or supplier), checks must be made toensure it is tested for electrical safety before being used.Checks should be made to ensure that the device matches the acquisition specification, isundamaged, is accompanied by all the necessary information and documentation, and that it iscorrectly configured, supplied with appropriate accessories, supplied with appropriateconsumables, supplied with appropriate instructions for use. The device should then be testedto the appropriate electrical safety standard. This is to confirm the device is ‘fit for purpose’. A‘LCE’ label should be attached to the equipment for means of identification.The equipment information should be listed in a database; this database records the whole lifehistory of the device.The information should include;  Make, model, serial number, date of purchase, order number, price, end of warranty date.  Clinical location.  Configuration setting.  Full service history.  Service records that demonstrate the fulfilment of statutory requirements of the Electricity at Work Regulations (1989) and the Provision and Use of Work Equipment Regulations (1998).  Records of safety related additions and modifications required by the MHRA and manufacturer’s hazard and safety alerts.  Scheduled maintenance.  Significant accessories.  Photographs and user/service manuals.2 HTTP://NHSMIA.BIPSOLUTIONS.COM/REGISTER.PHP

TrainingClinical users must not use medical devices unless they have had appropriate and adequatetraining. Regulation 9 of PUWER states that; “Every employer shall ensure that all persons who use work equipment have received adequate training for the purposes of health and safety, including training in the methods which may be adopted when using work equipment, any risks such use may entail and precautions to be taken.”The Trust is committed to providing education and training to ensure that users of medicaldevices have the necessary clinical and technical knowledge, skill and competencies to safelyand effectively fulfil their duties. All staff have a personal responsibility not to use medicaldevices if they are not competent to do so, unless adequately supervised.Users need to understand how the manufacturer intends the device/equipment to be used, andhow it normally operates to be able to use it effectively and safely.Where relevant, they should;  Be aware of differences between models, compatibility with other products and any contraindications or limitations on use.  Be able to fit accessories and to be aware of how they may increase or limit the use of the device.  Be able to use any controls appropriately understand any displays, indicators, alarms etc.  Be aware of requirements for decontamination, including cleaning, in line with the manufacturer’s instructions and relevant local procedures.  Be aware of known pitfalls, including those identified in safety advice from the MHRA, manufacturers and other relevant bodies  Be able to recognise device defects or when a device is not working properly and know what to do.  Understand the importance of reporting device-related adverse incidents to the MHRA and be familiar with the organisations’ reporting procedure.All service staff should be adequately trained and competent on devices and have sufficientwork experience of the devices they repair and maintain. Those without adequate trainingshould not be allowed, nor should they attempt, to repair or maintain medical devices andequipment.All those undertaking repair and maintenance should be able to produce written evidence ofappropriate and up-to-date training, preferably as part of the documentation required by aquality management system. They should also be able to show that they are up to date on newmaintenance techniques, consistent with the devices they are servicing. This applies to ClinicalEngineering, contracted services or others.

Service RequirementsThe Medical Devices Regulations 2002 require a manufacturer to provide; “all the information needed to verify whether the device can operate correctly and safely, plus details of the nature and frequency of the maintenance and calibration needed to ensure that the device operates properly and safely at all times”.It is the responsibility of the equipment management teams to ensure that medical devicesunder their remit are properly configured, calibrated, serviced and repaired to therequirements of MDA DB 2006(05) ‘Managing Medical Devices: Guidance for healthcare andsocial services organisations’.The Electricity at Work Regulations (1989), require that electrical equipment is tested at regularintervals to ensure that it is electrically safe. As a minimum Clinical Engineering aims to visuallyinspect and test for electrical safety (where appropriate), all items of medical equipment on anannual basis. Any equipment identified or suspected of being unsafe should be removed fromservice immediately and labelled clearly to prevent further use. The equipment should then bereturned to Clinical Engineering for repair. All repaired equipment must undergo anappropriate verification process followed by electrical safety testing before being returned toclinical use.Any Routine maintenance/inspections recommended to be performed by the user shouldensure that the device continues to function correctly. These could include; checking that it isworking correctly before use, regular cleaning, or specific daily/weekly checks.If the user notices that the device has stopped working properly or when obvious damage hasoccurred, use should be discontinued, the device should be clearly labelled as faulty andreferred to Clinical Engineering for repair.DecontaminationHealthcare organisations should keep patients, staff and visitors safe and have policies andsystems in place to ensure that all reusable medical devices are properly decontaminated priorto use or maintenance to prevent the spread of infection and be labelled accordingly. At ULHTwe employ a “Green is Clean” sticker system to show that equipment has been cleaned in-between patient use. If the device to be sent to Clinical Engineering for repair a 3 colour stickersystem should be used these denote the state of contamination the equipment is in. Equipment has Equipment has Equipment has not been been beencontaminated but contaminated contaminatedhas been cleaned and is now clean and is still NOT clean

Medical Device Alerts & Field Safety NoticesThe Medicines and Healthcare products Regulatory Agency (MHRA) regulates a wide range ofmaterials from medicines and medical devices to blood and therapeutic products/services. TheMHRA don’t approve medical equipment before it is put into use like they do with medicines,medical devices are approved by private sector organisations called ‘Notified Bodies’ MHRAaudits the performance of these notified bodies.It is important that all serious incidents involving medical devices are reported to the MHRA sothe information can be used and dealt with in the correct manner.Patient safety incidents involving medical devices occur every day in the NHS. Although the vastmajority of incidents result in no harm to patients, in 2013, over 40,000 incident reportsrelating to medical devices were submitted to the National Learning and Reporting System(NRLS).The term ‘medical device’ covers a broad range of products, used every day in healthcaresettings to support the diagnosis, treatment and care of patients.The range of medical device products is very wide: it includes dressings, tubing, syringes,infusion pumps, heart valves, surgical instruments, resuscitators, radiotherapy machines,wheelchairs, walking frames or other assistive technology products.The analysis of NRLS reports has enabled new risks to be identified and communicated to theNHS through the use of Patient Safety Alerts.NHS England and the Medicines and Healthcare products Regulatory Agency (MHRA) areworking together to minimise harm from medical devices. A joint Patient Safety Alert,Improving medical device incident reporting and learning NHS/PSA/D/2014/005, was issuedin March 2014 requesting large healthcare provider organisations to identify a Medical DeviceSafety Officer (MDSO).A national network for MDSOs has now been established to improve communication andfeedback on reported safety issues, and enable safer practice to be discussed and sharedthrough monthly webinars and conferences.The Central Alerting System (CAS) is the medium through which Medical Device Alerts (MDAs)are issued to the NHS. Their key roles are to co-ordinate the effective reporting of adverseincidents involving medical devices, and the dissemination of MDAs.CAS enables alerts and urgent patient safety specific guidance to be accessed at any time.Safety alerts, emergency alerts, drug alerts, and Medical Device Alerts are all available on thiswebsite. They are issued on behalf of the Medicines and Healthcare products RegulatoryAgency, the National Patient Safety Agency, and the Department of Health. MHRA often has toissue Medical Device Alerts (MDAs) reminding users about manufacturers’ FSNs where there isinsufficient feedback that it has reached the appropriate people and been acted upon.A Field Safety Notice (FSN) is a communication sent by medical device manufacturers, or theirrepresentatives, in connection with a Field Safety Corrective Action (FSCA). FSNs outline actionsto be taken to reduce the risk of death or serious injury associated with the use of a medicaldevice.A manufacturer undertakes a FSCA for technical or clinical reasons connected with thecharacteristics or performance of a device, where death or serious injury might result.Manufacturers use a FSN to tell their customers about a FSCA that they are undertaking. (Gov.uk, 2014)The Trust’s Medical Device Safety Officer (MDSO) is responsible for the dissemination of allmedical device related safety information throughout the trust. All other medical devicerelated safety information, from whatever source, should be forwarded to the MDSO in Clinical

Engineering for determination of appropriate action and dissemination. Clinical engineeringwill distribute all such safety information and action plans to departments as appropriate.Technical actions required by such notices and bulletins will be co-ordinated by ClinicalEngineering where they relate to medical equipment. For technical advice relating to the safetyof medical equipment users should contact Clinical Engineering. (NHS, 2015)Incident Reporting (Including Near Misses)An adverse incident is an event that causes, or has the potential to cause, unexpected orunwanted effects involving the safety of patients, users or other persons. Any known problemsassociated with product design, software failure, documentation and common use related issuesshould be reported.All staff have a responsibility to ensure that adverse incidents involving medical devices arereported through the Trust’s Incident Reporting Procedure. Responsibility for investigatingincidents involving medical devices is delegated to Clinical Engineering. This responsibility mayinvolve reporting to the Medicines and Healthcare product Regulatory Agency (MHRA) of theDepartment of Health.If a serious incident involving a medical device occurs, the equipment should be quarantined(including accessories/consumables even if they are contaminated) and reported to ClinicalEngineering.It is important that all serious incidents involving medical devices are reported to the MHRA sothe information can be used and dealt with in the correct manner.Once the information is sent to the MHRA, the details are recorded on a database and a triageprocess completed by device specialists and clinical advisers. That assessment determineswhether an investigation is undertaken directly by the MHRA (‘specialist’ investigation) or bythe manufacturer on the Agency’s behalf (‘monitored’ investigation). Other incidents arerecorded for trending and surveillance purposes only - a one-off incident in one healthcareestablishment, when combined with information of several others, may identify the need forfocused awareness training or for the amendment of manufacturer's usage instructions. Allreports are acknowledged and reporters advised of the nature and outcome of the investigation.Software & Hardware UpgradesThroughout an equipment’s lifecycle it may undergo software or hardware upgrades. Often theupgrades are recommended by the manufacturer to improve function and reliability, but mayalso be the result of reported faults or incidents. Occasionally systems need to be downgradedwhen a newer version of software is found to have functional issuesConsiderations which need to be made when assessing whether an upgrade should beundertaken are;  Is the upgrade mandatory or optional  Will the upgrade be carried out ‘in-house’ or by manufacturer  Changes to function  Changes to configuration  Changes to service protocolWhen an upgrade is undertaken all equipment of the same type in that area must also beupgraded to avoid any confusion for the clinical user.

DisposalWhen a piece of equipment has reached the end of its useful life, either damaged or worn outbeyond economical repair, no longer needed by the clinical team, due to an absence ofmanufacturer support or unavailability of parts, subject of a safety notice, excessivelycontaminated etc. It must be correctly disposed of.After obtaining agreement from the user and budget holder, Clinical Engineering takes theresponsibility to decommission and arrange appropriate disposal of medical devices. If thedevice is faulty it is dismantled and disposed of in accordance with WEEE regulations. If theequipment is in good working order, but is just no longer required by the trust it is auctioned offto raise monies for new equipment.

BibliographyDoH, 2012. Department of Health - Device Bulletin DB 2006(03) v2.0. [Online]Available at: http://www.dhsspsni.gov.uk/db2006_03_v2.pdf[Accessed March 2014].Gov.uk, 2014. (MDA/2014/037). [Online]Available at: https://www.gov.uk/drug-device-alerts/medical-device-alert-all-medical-devices-mda-2014-037[Accessed May 2016].MHRA, 2013. Safety Information. [Online]Available at:http://www.mhra.gov.uk/Safetyinformation/Reportingsafetyproblems/Devices/index.htm[Accessed October 2014].MHRA, 2014. Managing Medical Devices. [Online][Accessed October 2014].NHS, 2015. Preventing Medical Device Incidents. [Online]Available at: https://www.england.nhs.uk/patientsafety/medical-device-incidents/[Accessed May 2016].

Medical EquipmentManagement System Steven Lewis Clinical Engineering United Lincolnshire Hospital Trust

Medical Equipment Management System (MEMS)ULHT uses an Equipment management system (MEMS). Good record keeping is essential forthe safe management of medical devices. The detail and complexity of the records will dependon the type of device and its usage during its lifetimeEach piece of equipment must have a complete audit trail should there be an incident whichinvolves injury or fatality to a patient. Accurate equipment management ensures the correctaction can be taken should there be a manufacturers recall, field correction or device alert.Records should include a unique identifying number, equipment delivery details, acceptancetesting, routine maintenance, spare parts used (traceable to supplier/manufacturer) and statethe person responsible for carrying out the task.Basic NavigationMEMS is navigated by clicking on the tabs at the top of the screen, seen in Fig 1. Each tab takesyou to the relevant section and queries can be performed such as searching for equipment by itsunique LCE number or a job number Fig 1 – Navigating around MEMSBooking a job inSelect ‘Add Job’ from the navigation bar at the top of the screen, by entering the unique LCEnumber of a piece of equipment into the box marked ‘ID No’ the information in the other boxeswill be filled in. This is also true for entering a serial or asset number into the correspondingboxes. Select correct ‘Job Type’, ‘Job Status’, and put relevant fault information into the‘Symptom’ box. Fig 2 – Booking in a job

Accessing Relevant DocumentationTo access any relevant documentation for equipment select ‘Documents’ from the top task bar.This will open a list of available documents for that model, including protocols, configurationdocuments, User manuals and Service Manuals. These documents can be filtered by pressingthe relevant button (Service, User, Protocol, Photographs etc.); the selected document can thenbe printed out if needed. Fig 3 –Equipment DocumentsOther documents can be viewed by hovering the cursor over ‘Utils’ on the navigation bar andthen clicking on CEng Documents. Here you will find, among others, Equipment Acceptanceforms, training forms, templates and Policies. Fig 4 – CEng Documents

Adding PartsSelecting the ‘Parts’ tab from the navigation bar enables you to add any parts used on the job.You can either enter a part in the ‘Search Part No’ box, or select ‘Show Equipment Model Parts’which will bring up a list of any parts which have been used on this particular model.With the desired part selected, select the quantity used, check price appears and is correct, andclick ‘Add’, the parts will have now been added to that job. Fig 5 – Adding PartsAdding Tasks‘Tasks’ should be selected to record all time taken for the job. Select correct ‘Task Type’ from thedrop down menu, fill in time taken for the task, and in the ‘Task Notes’ section explain what youhave done using as much detail as necessary, then click ‘Update’. Fig 6 – Adding Tasks

Completion of JobOn completion of the job, write a brief description of work carried out in the ‘Remedy’ boxchange the job status to complete and click ‘Update’. Any paperwork associated with the job(Acceptance checks, Protocol sheets etc.) can then be scanned in by using the central computerand selecting the ‘Job Scan’ icon, entering the job number and pressing scan. Always ensuredocuments have been successfully scanned in before disposing.Ordering PartsSelect ‘Stock’ from the navigation bar and select ‘Orders’. If there is no open order for therelevant supplier click ‘Add new’. Fill in the supplier’s details from the drop down menu, for calloff orders this will then generate an order number. Select order status, ‘Urgent’ or ‘Non Urgent’,then search for the part required, select quantity, add the job number and technicians name forwhich the part is required in the notes field or just stock, and click ‘Add’. Repeat the process forall parts required. Carriage must then be added to the order, even if it is free of charge. The partand any carriage charges must also be added to the relevant job. The order can then be emailedto the supplier in a click of a button.Adding New Parts/SuppliersUnder the ‘Stock’ tab new parts/ suppliers can be added by selecting ‘add new’ and filling in therelevant details, always ensuring part numbers are correct, descriptions and contact details areaccurate, and price is correct.AuthorisationFor orders over the value of £250 authorisation needs to be obtained from the head ofdepartment to go ahead with the purchase order. Orders of significant amounts may need to beauthorised by head of directorate. Orders over £3000 need to be authorised by Head of ClinicalEngineering for re-charging even if the order has already been authorised by the Head of theDirectorate.

NIBP - Aneroid Steven Lewis Clinical Engineering United Lincolnshire Hospital Trust

Non-Invasive Blood Pressure Measurement (Aneroid)When your heart beats, it provides all organs and tissues with freshly oxygenated, nutrient richblood. As the blood moves, it pushes against the sides of the blood vessels. The strength of thispushing is your blood pressure. If your blood pressure is too high, it puts extra strain on yourarteries and your heart and this may lead to heart attacks and strokes.Blood pressure is measured in ‘millimeters of mercury’ (mmHg) and is written as two numbers.For example, if your reading is 120/80mmHg, your blood pressure is ‘120 over 80’.The first number is your systolic blood pressure. It is the highest level your blood pressurereaches. This occurs during the contraction of the heart muscles, when blood is pumped fromthe heart to the rest of the body. The second number is your diastolic blood pressure. It is thelowest level your blood pressure reaches as your heart relaxes between beats.Measuring blood pressure can give information on cardiovascular status and is used to assist inthe diagnosis of disease or evaluation of treatment. Problems can occur when eitherhypertension (high blood pressure) or hypotension (low blood pressure) are present.HypertensionWhere there is no specific cause, high blood pressure is referred to by doctors as primary highblood pressure (or essential high blood pressure).Factors that can raise your risk of developing primary high blood pressure include;  Eating too much salt.  Not eating enough fruit and vegetables.  Lack of exercise.  Being overweight.  Excessive alcohol consumption.  Smoking.There are some factors that increase your risk of developing high blood pressure, which youcannot control. These include:  Age: as you get older, the effects of an unhealthy lifestyle can build up and your blood pressure can increase.  Ethnic origin: people from African-Caribbean and South Asian communities are at greater risk than other people of high blood pressure.  Family history: you are at greater risk if other members of your family have, or have had, high blood pressure. (BPUK, 2008)About 10% of high blood pressure cases are the result of an underlying condition or cause.These cases are referred to as secondary high blood pressure.Common causes of secondary high blood pressure include:  Kidney disease.  Diabetes.  Narrowing of the arteries.  Hormonal conditions, such as Cushing's syndrome (a condition where your body produces an excess of steroid hormones).

 Conditions that affect the body’s tissue, such as lupus.  Oral contraceptive pill.  Painkillers known as non-steroidal anti-inflammatory drugs (NSAIDs), such as ibuprofen.  Recreational drugs, such as cocaine, amphetamines and crystal methamphetamine.  Herbal remedies, such as herbal supplements. (NHS, 2012)HypotensionHypotension (low blood pressure) can be present naturally in some individuals due to lifestylechoices or inherited from parents and causes no problems. Low blood pressure could also becaused by Orthostatic Hypotension (drop in blood pressure on standing up), which could lead tofainting, neurally mediated hypotension (NMH –drop in blood pressure with prolongedstanding), this happens when your body tells the brain your blood pressure is too high when it'sactually too low. This causes your brain to slow down the heartbeat, further reducing yourblood pressure.Illness and underling health conditions can also attribute to hypotension, for instance;  Anaemia, where the amount of haemoglobin in the blood is below the normal level or there are fewer red blood cells than normal.  Heart condition, such as heart disease or a heart attack, can cause low blood pressure because your heart may not be able to pump blood around your body.  Neurological disorders, such as Parkinson's disease, can cause low blood pressure if part of your automatic nervous system (ANS) is affected. The ANS controls bodily functions you don't actively think about, such as sweating and digestion. It also controls the widening and narrowing of your blood vessels. If there's a problem with your autonomic nervous system, your blood vessels could remain too wide, which can cause low blood pressure.Severe hypotension associated with shock;  Septic shock and toxic shock syndrome are caused by bacterial infections. Bacteria attack the walls of the small blood vessels, causing them to leak fluid from the blood into the surrounding tissues. This causes a significant drop in blood pressure.  Anaphylactic shock, or anaphylaxis, is caused by an allergic reaction. During an allergic reaction, the body produces large amounts of histamine, which causes your blood vessels to widen, leading to a sudden severe drop in blood pressure.Hypotension can also be caused by medication;  Heart medicines such as Alpha & Beta-blockers.  Angiotensin-Converting Enzyme (ACE) inhibitors. ACE inhibitors can reduce the activity of an enzyme called angiotensin-converting enzyme. The enzyme is responsible for hormones that help control your blood pressure. It has a powerful narrowing effect on your blood vessels, which increases your blood pressure. ACE inhibitors inhibit or limit this enzyme, making your blood vessels relax and widen.  Some anti-depressants. (NHS, 2015)

Adult blood pressure values are categorised as shown below;  <100mmHg/60mmHg (systolic/diastolic) – Hypotension  100-140mmHg/60-90mmHg – Normal  >140mmHg/90mmHg – Hypertension Fig 1 – Blood Pressure Chart (QSOTA Medical, 2015)The measurement of blood pressure is important in the diagnosis and monitoring of a widerange of clinical conditions. Traditionally, blood pressure is measured non-invasively using theauscultatory technique (Korotkoff sounds) with the pressure in the cuff measured using amercury sphygmomanometer. This consequently became, and still is recognised as, the ‘goldstandard’. However, environmental concerns regarding mercury mean that there is no long-term future for these devices. These concerns have led to the imposition of bans in someEuropean countries and supply in the UK is now restricted to healthcare use. It is thereforerecommended that consideration be given to the selection of mercury-free products when theopportunity arises. ULHT no longer uses mercury sphygmomanometers and have moved ontoaneroid sphygmomanometers.

Korotkoff SoundsKorotkoff sounds (or K-Sounds) are the \"tapping\" sounds heard with a stethoscope as the cuff isgradually deflated. Traditionally, these sounds have been classified into five different phases -(K-1, K-2, K-3, K-4, and K-5).  K-1 (Phase 1): The appearance of the clear \"tapping\" sounds as the cuff is gradually deflated. The first clear \"tapping\" sound is defined as the systolic pressure.  K-2 (Phase 2): The sounds in K-2 become softer and longer and are characterized by a swishing sound since the blood flow in the artery increases.  K-3 (Phase 3): The sounds become crisper and louder in K-3 which is similar to the sounds heard in K-1.  K-4 (Phase 4): As the blood flow starts to become less turbulent in the artery, the sounds in K-4 are muffled and softer. Some professionals record diastolic during Phase 4 and Phase 5  K-5 (Phase 5): In K-5, the sounds disappear completely since the blood flow through the artery has returned to normal. The last audible sound is defined as the diastolic pressure.The Auscultatory TechniqueThe flow that normally occurs in arteries produces little vibration of the arterial wall andtherefore no sounds. However, when an artery is partially constricted, blood flow becomesturbulent, causing the artery to vibrate and produce sounds. Fig 2 – Open & Constricted Blood Vessel. (Mcgill, 2014)When measuring blood pressure using the auscultation method, turbulent blood flow will occurwhen the cuff pressure is greater than the diastolic pressure and less than the systolic pressure.The \"tapping\" sounds associated with the turbulent flow are known as Korotkoff sounds.Initially the cuff is inflated to a level higher than the systolic pressure and the artery iscompletely compressed, there is no blood flow, and no sounds are heard. The cuff pressure isslowly decreased. At the point where the systolic pressure exceeds the cuff pressure, theKorotkoff sounds are first heard and blood passes in turbulent flow through the partiallyconstricted artery. Korotkoff sounds will continue to be heard as the cuff pressure is furtherlowered. However, when the cuff pressure reaches diastolic pressure, the sounds disappear.Now at all points in time during the cardiac cycle, the blood pressure is greater than the cuffpressure, and the artery remains open.The Aneroid (without fluid) sphygmomanometer (Sphyg) is designed to monitor bloodpressure, there are various types of aneroid sphygs’ - handheld, desk top, wall mounted andmobile (on wheels), however, their principals of operation are the same. They all consist of apressure gauge, cuff, inflation bulb and valve. Aneroid gauges are based on a metallic pressuresensing element that flexes elastically under the effect of a pressure difference across theelement.

The Aneroid sphygmomanometer consists of a metal bellows, theinside of which is connected to the compression cuff. Variations ofpressure within the system cause the bellows to expand andcollapse. Movement of the bellows rotates a gear that turns apointer, pivoted on bearings, across a calibrated dial.A thin coiled spring (known as a hair spring) is also connected andreturns the pointer to zero when the pressure is released.Procedure Fig 3 – Diagram of Aneroid Sphyg (Proton Health Care, 2015)Step 1 - Choose the right equipment: A quality stethoscope and a calibrated AneroidSphygmomanometer.Step 2 - Prepare the patient: Make sure the patient is relaxed by allowing 5 minutes to relaxbefore the first reading. The patient should sit upright with their upper arm positioned so it islevel with their heart and feet flat on the floor. Remove excess clothing that might interfere withthe BP cuff or constrict blood flow in the arm. Be sure you and the patient refrain from talkingduring the reading.Step 3 - Choose the proper BP cuff size: Most measurement errors occur by not taking thetime to choose the proper cuff size. Wrap the cuff around the patient's arm and use the INDEXline to determine if the patient's arm circumference falls within the RANGE area. Otherwise,choose the appropriate smaller or larger cuff.Step 4 - Place the BP cuff on the patient's arm: Palpate/locate the brachial artery andposition the BP cuff so that the ARTERY marker points to the brachial artery. Wrap the BP cuffsnugly around the arm.Step 5 - Position the stethoscope: On the same arm that you placed the BP cuff, palpate thearm at the antecubital fossa (crease of the arm) to locate the strongest pulse sounds and placethe bell of the stethoscope over the brachial artery at this location.Step 6 - Inflate the BP cuff: Begin pumping the cuff bulb as you listen to the pulse sounds.When the BP cuff has inflated enough to stop blood flow you should hear no sounds through thestethoscope. The gauge should read 30 to 40 mmHg above the person's normal BP reading. Ifthis value is unknown you can inflate the cuff to 160 - 180 mmHg. (If pulse sounds are heardright away, inflate to a higher pressure.)Step 7 - Slowly Deflate the BP cuff: Begin deflation, the pressure should fall at 2 - 3 mmHg persecond, anything faster may likely result in an inaccurate measurement.Step 8 - Listen for the Systolic Reading: The first occurrence of rhythmic sounds (Korotkoffsound 1) heard as blood begins to flow through the artery is the patient's systolic pressure. Thismay resemble a tapping noise at first.

Step 9 - Listen for the Diastolic Reading: Continue to listen as the BP cuff pressure drops andthe sounds fade. Note the gauge reading when the rhythmic sounds stop (Korotkoff sound 5).This will be the diastolic reading.Manual techniques may suffer from observer bias including differences of auditory acuitybetween observers. Digit preference is common, with observers recording a disproportionatenumber of readings ending in five or zero. The observer may also be influenced by theknowledge that they have of the patient, such as earlier readings, expected effect of drugtherapy, gender, age, race and weight. However, formal training in blood pressuremeasurement can improve this situation. At the same time the observer may obtain additionaluseful information about the general health of the patient, such as the regularity and strength ofthe pulse, skin condition and any tremors.Maintenance & Service ProceduresAll blood pressure measuring equipment should be regularly checked and calibrated inaccordance with the manufacturer’s instructions or departmental procedures. An annual checkto CEng protocol is sufficient using an electronic pressure meter. Cuffs and their hoses shouldbe regularly inspected and replaced as necessary. Excessive air leakage from damaged cuffs,hoses and tubing connectors may reduce the accuracy of the readings. Both disposable (singlepatient use) and re-usable cuffs are available. Re-usable cuffs should be cleaned in accordancewith the manufacturer’s instructions, ensuring that cleaning fluid does not enter the cuffbladder or hoses. (MHRA, 2006)A Visual inspection should be done, checking hoses, bulb and cuff. Check security of wallmounting or rolling pole stand if applicable.The unit should then be Leak Checked by pumping the cuff to within 20mmHg of full scale, closebleed valve then check the leak rate is less than 12mmHg over 1 minute.Accuracy should then be checked by setting the pressure on the pressure monitor to thefollowing values and checking the gauge reads the same values ±3mmHg. 200mmHg - 197-203 150mmHg - 147-153 100mmHg - 97-103 50mmHg - 47-53 0mmHg -3 to +3



BibliographyBeckwith, T. G., 1993. Measurement of Low Pressures. 5th ed. MA: Reading.Beevers DG, L. G. a. O. E., 2007. ABC of Hypertension. 5th ed. s.l.:Blackwell.BPUK, 2008. Blood Pressure UK. [Online]Available at: http://www.bloodpressureuk.org/BloodPressureandyou/Thebasics[Accessed November 2013].Mcgill, 2014. Medicine. [Online]Available at: http://www.medicine.mcgill.ca/physio/vlab/cardio/auscul.htm[Accessed May 2016].MHRA, 2006. Blood Pressure Measurement Devices - DB2006 (03) v 2.0, s.l.: MHRA.NHS, 2012. NHS Choices. [Online]Available at: http://www.nhs.uk/Conditions/Blood-pressure-(high)/Pages/Causes.aspx[Accessed November 2013].NHS, 2015. NHS Choices. [Online]Available at: http://www.nhs.uk/Conditions/Blood-pressure-(low)/Pages/Causes.aspx[Accessed May 2016].Proton Health Care, 2015. Proton Health Care. [Online]Available at: http://protonhealthcare.com/PDF/training_spm_all.pdf[Accessed May 2016].QSOTA Medical, 2015. Blood Pressure. [Online]Available at: http://qsota.com/high-blood-pressure/[Accessed May 2015].

Thermometry Steven Lewis Clinical Engineering United Lincolnshire Hospital Trust

ThermometryThe body’s temperature is regulated by the hypothalamus within the brain. Core temperature isthe temperature below the subcutaneous tissue. The body temperature is recorded eitherorally, by axilla, by rectum or via the ear canal.The rise and fall of body temperature indicates a change in bodily function - for example, hightemperature could be an indication of infection. The recording of the temperature is a vital signand aids diagnosing illness and disease. Temperature is recorded for a number of reasons suchas; to establish a baseline; post-operatively; to monitor response to infection; when a patienthas hypothermia; in critically ill patients; during an operation; and when a patient is receiving ablood transfusion. (Nursing Times, 2007)The normal range of body temperature is 36-37.5°C this may vary according to the site used formeasurement. The core temperature can be more than 0.4°C higher than the oral temperatureand 0.2°C lower than rectal temperature. (Jamieson, 2002). In electronic thermometers anequivalence mode is used which adjusts the displayed temperature according to the site it isbeing taken.Tympanic ThermometersTympanic thermometers are commonly used within the clinical environment for their speed.They are generally inserted into the ear canal; however certain models can also be used for non-contact skin temperature measurement which is used in the diagnosis of a diabetic footcondition called Charcot neuroarthropathy.Tympanic thermometers work by using infrared radiation and a thermopile detector whichmeasures the infrared heat produced by the tympanic membrane (eardrum) and thesurrounding tissue.The eardrum shares the same blood supply as the part of the brain where core bodytemperature is controlled, the hypothalamus, enabling the thermometer to take an accuratereading of the body’s temperature.For these readings to remain accurate it is essential that the probe lens is free from debris, thismainly accumulates by:  Failure to attach a probe cover tip before use.  Finger print smudges.  Incorrect storage of the thermometer, allowing dust, micro pore tape etc. to settle on the lens.The Genius 2 can be configured for the user to work in °C or °F; it can also be set to takereadings in oral, rectal or core equivalence. If readings were actually taken either orally or rectally they would be different,equivalence mode is based on studies by the manufacturer on the average difference oftemperature at each of these sites. The desired setting can then be locked preventing the useraltering these by mistake.