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Prepared for the Auditor General for Scotland Better equipped to care? Follow-up report on managing medical equipment February 2004

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Prepared for the Auditor General for Scotland

Better equipped to care? Follow-up report on managing medical equipment

February 2004

Auditor General for ScotlandThe Auditor General for Scotland is the Parliament’s watchdog forensuring propriety and value for money in the spending of public funds.

He is responsible for investigating whether public spending bodiesachieve the best possible value for money and adhere to the higheststandards of financial management.

He is independent and not subject to the control of any member of theScottish Executive or the Parliament.

The Auditor General is responsible for securing the audit of the ScottishExecutive and most other public sector bodies except local authoritiesand fire and police boards.

The following bodies fall within the remit of the Auditor General:

• departments of the Scottish Executive eg the Health Department• executive agencies eg the Prison Service, Historic Scotland• NHS boards and trusts• further education colleges• Scottish Water• NDPBs and others eg Scottish Enterprise.

AcknowledgmentsAudit Scotland is grateful to those who acted as advisors to the study.We would like to thank the wide range of NHS Scotland staff whoparticipated in the audit.

The study team was Fiona Gailey, Catherine Vallely, Rhona Jack, andCraig McKinlay under the general direction of Barbara Hurst, Director ofPerformance Audit (Health & Community Care).

Audit Scotland is a statutory body set up in April 2000under the Public Finance and Accountability (Scotland) Act2000. It provides services to the Auditor General forScotland and the Accounts Commission. Together theyensure that the Scottish Executive and public sector bodiesin Scotland are held to account for the proper, efficient andeffective use of public funds.

Contents1

Main findingsPage 2

Part 1. IntroductionPage 4

Why medical equipment is importantPage 4

Our baseline studyPage 4

The follow-up auditPage 5

Part 2. Strategic management ofmedical equipmentPage 6

Main findingsPage 6

Why strategic input is neededPage 6

Strategic management at nationallevelPage 7

Strategic management at local levelPage 8

RecommendationsPage 10

Part 3. Risk managementPage 11

Main findingsPage 11

Good risk management processesare essential Page 11

Supporting risk management atnational levelPage 12

Risk management and risk exposureat local levelPage 13

RecommendationsPage 21

Part 4. Information to supportmanagementPage 22

Main findingsPage 22

Why management information isimportantPage 22

Sources of medical equipment dataPage 22

Quality of management informationPage 25

Using the management informationPage 26

RecommendationsPage 33

Appendix 1.Key points from Equipped to Careexecutive summaryPage 34

Appendix 2.Definition of medical equipment usedin this auditPage 35

Appendix 3.Membership of study advisory panelPage 38

Appendix 4.Trust operating income, 2001/02Page 39

2

Main findings

We did not follow up the more operational aspects of managing medical equipment, where our baseline work highlighted widespread good practice.

Main findings 3

Our follow-up audit of themanagement of medical equipmentinvolved all trusts

1, health boards

2and

the Scottish Executive HealthDepartment (SEHD). We havereviewed progress across Scotlandsince we published good practiceguidelines and recommendations inour 2001 report, Equipped to Care

3.

We did not follow-up the moreoperational aspects of managingmedical equipment, where ourbaseline work highlightedwidespread good practice. Wefocused on the main performanceissues arising from our baselinestudy, and found that:

• There are still significant risksfor patients where medical equipment is not managedwell, and there remainssubstantial room forimprovement across Scotland.

• There is limited strategic involvement in themanagement of medicalequipment at both national andlocal levels, so the SEHD andNHSScotland cannot be surethat any gaps between equipment needs andresources are being addressed.Trust boards need sufficient investment to replace medical equipment as it ages and to meet changes in services and technology.

• Progress is being made on riskmanagement at local level tosupport the delivery of highquality care. Overall, trustsfollow good practice for mostkey areas of medicalequipment policy. This includes

policies for acquiring and usingmedical equipment. But trustsneed to do more to show howthey are managing the risksassociated with operator errorand maintenance.

• Trusts lack the information tomanage their medicalequipment effectively. Thismeans that it is still notpossible to provide a clearpicture of key aspects of thecost, availability and use ofmedical equipment, andbenchmarking is impossible.

1 The term ‘trust’ includes island health boards throughout this report.2 During the course of this audit, the structure of NHSScotland began to evolve towards NHS boards with operating divisions. Our recommendations reflect these

new arrangements.3 Equipped to Care. Managing Medical Equipment in the NHS in Scotland. Audit Scotland, March 2001. Key points from the executive summary of this report are in

Appendix 1.

Part 1. Introduction

1.1 In this chapter we outline:

• the importance of managingmedical equipment

• our baseline audit

• the scope of our follow-up audit.

Why medical equipment is

important

1.2 Medical equipment is essential togood patient care. It is used in thecare of every patient and by mostfront-line staff. Some equipment isused for diagnosis, including X-rayand laboratory equipment. Otherequipment is used to treat patients,including radiotherapy machines,operating department andrehabilitation equipment. Theincreasing sophistication of medicalequipment can provide benefits topatients through better clinicaloutcomes and new, less invasivetechniques. There are also benefitsto the NHS, including shorter hospitalstays and the ability to treat morepatients.

1.3 Managing medical equipment iscomplex. Ensuring that the rightpiece of equipment is in the rightplace at the right time, together withtrained staff to use it, is a majorchallenge. The range of staff involvedin managing medical equipmentmeans that good coordination isrequired. Risks to patients and staffcan arise if medical equipment is notavailable when needed, not fullyfunctional and safe, or not usedproperly. Failure to manage theserisks can result in poor quality patientcare and lead to clinical negligenceclaims.

1.4 The investment in medicalequipment is substantial. Medicalequipment includes high cost, lowvolume items such as CT or MRIscanners

4and low cost, high volume

items such as blood pressuremonitors. Both types need to bemanaged well. Equipment can befinanced by capital procurement orlease for high cost items, andthrough revenue expenditure for lowcost items.

1.5 Management informationcontinues to be inadequate, so it isstill not possible to provide a clearpicture of key aspects of medicalequipment and assurances of valuefor money. We had to make specialarrangements to collect andcoordinate basic management data.Medical equipment purchased fromcapital in 2001/02 is estimated atover £60 million with a further £25 million purchased from revenuefunds. More than £44 million is spenton maintenance each year coveringequipment with an estimatedreplacement value of more than£630 million

5.

Our baseline study

1.6 Our baseline study was carriedout at local level on behalf of theAccounts Commission and so thenational position, including the SEHDrole, was outwith its scope. Althoughnot all trusts, health boards and theSEHD were included in this audit, ourkey findings and recommendationswere for all those with a role inensuring good planning andmanagement of NHSScotlandmedical equipment.

4 Descriptions of selected examples of equipment can be found in Appendix 2.5 See Exhibits 14 and 15 for expenditure details.

4

Part 1. Introduction 5

1.7 In Equipped to Care wehighlighted that trusts were good atmanaging many operational aspectsof medical equipment. For example,we found that finance departmentsensure compliance with EUprocurement legislation and standingfinancial instructions. And cliniciansreported satisfaction with responsetimes for equipment repairs.

1.8 But we also drew attention tothree key weaknesses where themanagement of medical equipmentcould be improved:

• lack of strategic involvement

• high exposure to risks

• lack of adequate information formanaging medical equipment.

The follow-up audit

1.9 We did not follow-up the moreoperational aspects of managingmedical equipment where ourbaseline work highlightedwidespread good practice. Instead,we focused on the main areas ofweakness highlighted above.

1.10 The follow-up audit was carriedout in trusts, health boards

6and the

SEHD. During the course of thisaudit, the structure of NHSScotlandbegan to evolve towards NHS boardswith operating divisions. Althoughour findings relate to the previousNHSScotland structure, ourrecommendations reflect these newarrangements.

1.11 Our audit approach wasdeveloped in consultation with astudy advisory panel (see Appendix 3for membership of the group).

1.12 In December 2002, we askedtrusts to complete a self-assessmentquestionnaire. This focused on themain areas where scope forimprovement was highlighted in ourbaseline report. External auditorsvalidated the completedquestionnaires.

1.13 External auditors also carried outa limited review at the 12 mainlandhealth boards about their strategicrole in relation to medical equipment.And we looked at the SEHD’sstrategic role in relation to medicalequipment.

1.14 The main messages arisingfrom our follow-up audit relate to:

• strategic management (Part 2)

• risk management (Part 3)

• management information (Part 4,and included in Parts 2 and 3).

1.15 Our key recommendations arehighlighted at the end of eachchapter and these supplement localactions plans.

6 Our follow-up audit did not include the special health boards.

6

Part 2. Strategic management of medicalequipment

Main findings

Strategic management of medicalequipment needs to be given ahigher priority at national and locallevels. Responsibility for medicalequipment is not always clear andpolicymakers still view medicalequipment only as an operationalissue.

We believe that there are somelimitations in the way the SEHDholds NHSScotland to account forplanning and providing medicalequipment to meet local needs inline with national strategies. Healthboards have not made clear whatinformation they require from trustsfor performance monitoring purposes.

Approximately two-thirds of trustboards cannot show that theirinvestment programmes arebased on realistic forward planningfor medical equipment or thatinvestment is sufficient to meetclinical governance requirementsor service priorities.

All trusts lack the information tomanage their medical equipmenteffectively. This means that it is

still not possible to provide a clearpicture of key aspects of the cost,availability and use of medicalequipment, and benchmarking isimpossible.

2.1 This chapter looks at strategicinvolvement in medical equipment atnational and local levels.

Why strategic input is needed

2.2 A strategic overview of medicalequipment is needed to make sure:

• the current level and condition ofmedical equipment is broadlyknown

• current and future needs formedical equipment are properlyassessed, so that the level andtype of medical equipment in useis in line with national and localhealthcare strategies, and supportsplanned service developments

• priorities for meeting equipmentneeds are agreed and resourced

• day-to-day management ofmedical equipment is carried outeffectively.

This will help ensure patient and staffsafety, support quality of care andachieve value for money.

2.3 Robust information is needed tosupport the planning and governanceof medical equipment at national andlocal level to show whether:

• levels of equipment are adequatefor identified healthcare needs

• rolling programmes of equipmentreplacement and additionalinvestment are adequate

• health & safety requirements aremet

• financial management is rigorousand is used to support effectivemanagement of equipment

• benchmarking is being used byNHSScotland organisations aspart of their performancemanagement processes

• value for money is beingachieved.

Part 2. Strategic management of medical equipment 7

Strategic management at national

level

Planning, needs assessment and

resource allocation

2.4 At a national level, the SEHD’sinvolvement is needed to ensure thatmedical equipment is available tosupport national strategies andclinical priorities.

2.5 Most responsibility for planning,needs assessment and resourceallocation is delegated to healthboards to allow them to decide localpriorities. The SEHD is generally onlydirectly involved in local plans toinvest in medical equipment when a business case needs to beapproved

10. Most funds are

distributed to health boards as part oftheir overall allocation

11.

2.6 However, the SEHD can getinvolved where national policy issuesimpact on medical equipmentrequirements, for example, for

cancer services (Exhibit 1). The aimof this approach is to ensure that theclinical and operational aspects ofdelivering care for cancer patientscan be delivered as a whole package.

Accountability at national level

2.7 The SEHD’s role is to ensure thathealth boards are discharging theirdelegated responsibilities effectively.As part of this, the SEHD has newlyintroduced a requirement to discloseforward capital investment in medicalequipment as part of the financialplanning regime that supports thelocal health plans.

2.8 There are also arrangements inplace for safety and clinicalgovernance issues to be consideredat national level. For example:

• The SEHD expects medicalequipment to be operated in linewith manufacturers’ instructionsas well as meeting any regulatoryrequirements such as the

radiological protection regulationscovering imaging devices.

• The SEHD has agreed to workwith the National Institute forClinical Excellence in England todevelop proposals to regulate theuse of new surgical instrumentsor existing instruments in newand innovative procedures.

• The Chief Medical Officer hasoverall responsibility for the safetyand efficacy of medicalequipment. The Medicines andHealthcare products RegulatoryAgency (MHRA) regulates this ona UK-wide basis.

• The SEHD has delegatedresponsibility for inspecting thequality of the healthcare systemto NHSQIS, and their standardsetting and review of a specificclinical area can involve medicalequipment.

7 A nuclear medicine imaging technique.8 Now part of NHSScotland Quality Improvement Scotland (NHSQIS).9 NSD is part of the NHSScotland Common Services Agency.10 NHS HDL (2002) 40, Capital Planning and Approval Processes.11 The allocation is made through the Arbuthnott formula, adjusted for cross-boundary flows and weighted to take account of regional specialist services.

1. Setting up a national group to look at Positron Emission Tomography (PET)7scanners in response to a report by

the Health Technology Board for Scotland (HTBS)8.

2. Commissioning a national programme for breast screening which is managed through the National ServicesDivision

9(NSD) and which has a rolling programme to replace mobile screening vans and associated

mammography equipment.

3. Spending about £1.4 million through NSD to introduce Liquid Based Cytology into the cervical screeningprogramme, which included equipment and training.

Exhibit 1Examples of SEHD input to the management of medical equipment for cancer care

Source: SEHD, 2003

8

2.9 The SEHD believes it dischargesits role in holding NHSScotland toaccount for its management ofmedical equipment by addressing itwithin policy areas such as cancer.The department’s aim is to ensurethat the clinical and operationalaspects of delivering care for cancerpatients can be delivered in a holisticway. In our view, the SEHD’sapproach has some limitations:

• It tends to focus on new and highcost items. But the level andstate of the existing stock ofmedical equipment including lowcost items also needs to beaddressed. The new requirementabout disclosing capitalinvestment will only give a partialview as it does not cover lowcost, high volume items.

• Items of medical equipment areoften used across policy areas; forexample, MRI scanners are usedto help diagnose a range ofconditions, not just cancer.

• It does not enable SEHD to holdNHS boards to account for theoverall planning and provision ofmedical equipment to meet localneeds in line with nationalstrategies. Medical equipment isnot directly covered by thePerformance AssessmentFramework (PAF) and is notroutinely covered in AccountabilityReviews.

The approach also contrasts with theDepartment of Health (DOH) inEngland which has introduced aspecific standard for managingmedical devices as part of its controlsassurance requirements for theNHS.

12

We recommend that the SEHDshould take a coordinated approachto the governance of medical

equipment and specify its reportingrequirements. This would enable thedepartment to routinely monitor themangement of all medicalequipment, not just items boughtfrom capital, in Accountability Reviewmeetings.

Strategic management at local

level

2.10 Health boards have a strategicrole in managing medical equipmentbut are not involved in day-to-dayoperational matters. They need to besure that their trusts have themedical equipment to deliverappropriate care for the localpopulation, in line with nationalpolicies and clinical priorities. Thismeans proper arrangements need tobe put in place to ensure clarity ofresponsibility, adequate needsassessment, appropriate prioritisationof expenditure, and performancemanagement and reporting.

Planning, needs assessment and

resource allocation

2.11 Health boards and over three-quarters of trust boards continue toview medical equipment only as anoperational issue. (Exhibit 2 highlightsthe six trust boards that were able todemonstrate important aspects ofstrategic involvement). Policymakers,overall, are not involved in medicalequipment needs assessments,performance monitoring andmanagement, and in ensuring accessto sufficient resources to meetpatient need. For example, onlyabout half of trust boards have needsassessment reports and medicalequipment investment programmeson their agendas. And approximatelytwo-thirds of trust boards cannotshow that their investmentprogrammes are based on realisticforward planning for medicalequipment or that investment issufficient to meet clinical governancerequirements or service priorities.

Accountability at local level

2.12 There is seldom an individual orgroup with overall responsibility formedical equipment throughout thehealth board area. But examples ofgood practice in accountabilityarrangements are beginning toemerge. For example, in Dumfries &Galloway, a member of the new NHS board has been given leadresponsibility for medical equipmentand it is developing an area-wide‘Equipped to Care Committee’.

2.13 In Equipped to Care werecommended that responsibility formedical equipment be delegated tosomeone on the trust boardsupported by a multidisciplinarygroup. At trust level, almost half stillhave no executive directorresponsible for medical equipment(Exhibit 2), and a third of trusts do nothave a broad-based committee (orarea-wide alternative) that deals withmore than equipment funding bids.A broad-based medical equipmentcommittee is one that is involved inplanning, needs assessment andother aspects of medical equipmentmanagement.

2.14 Performance monitoring ofmedical equipment is limited at locallevel. Neither health boards nor trustboards have made clear theirperformance reporting requirements.Three-quarters of trusts had notsubmitted any type of formal reportabout medical equipment to theirhealth board, and when they do,these tend to be about financialissues such as major capitalexpenditure or public privatepartnership projects. Also, trustreporting to trust boards tends tofocus on finance rather than qualityof care, (Exhibit 3 overleaf).

12 Medical Devices Management Standard, Department of Health, October 2001 (revised 2003).

Part 2. Strategic management of medical equipment 9

Trust & Island Health Boards

There is an

executive

director with

specific overall

responsibility

for medical

equipment

management.

There is a

broad-based

medical

equipment

committee

(trust or area).

There are

reporting

arrangements

and

accountabilities

for medical

equipment

which are

clear.

We have

received a

report(s) on

progress

towards

implementing

the good

practice

guidelines in

Equipped to

Care.

We can

demonstrate a

formal medical

equipment

investment

programme,

which enables

realistic

forward

planning.

Argyll & Clyde Acute Hospitals Trust ✓ ✓ ✓ ✗ ✗

Ayrshire & Arran Acute Hospitals Trust ✓ ✓ ✓ ✓ ✓

Ayrshire & Arran PCT ✓ ✓ ✓ ✓ ✓

Borders General Hospitals Trust ✓ ✓ ✗ ✓ ✗

Borders PCT ✗ ✗ ✗ ✗ ✗

Dumfries & Galloway Acute Hospitals Trust ✗ ✓ ✓ ✗ ✓

Dumfries & Galloway PCT ✗ ✓ ✓ ✗ ✓

Fife Acute Hospitals Trust ✓ ✓ ✓ ✗ ✗

Fife PCT ✓ ✓ ✓ ✓ ✗

Forth Valley Acute Hospitals Trust ✗ ✓ ✓ ✓ ✓

Forth Valley PCT ✗ ✗ ✗ ✗ ✗

Grampian PCT ✗ ✗ ✗ ✓ ✗

Grampian University Hospitals Trust ✓ ✓ ✓ ✓ ✓

Greater Glasgow PCT ✓ ✓ ✗ ✗ ✗

Highland Acute Hospitals Trust ✓ ✓ ✓ ✓ ✗

Highland PCT ✗ ✗ ✓ ✗ ✗

Lanarkshire Acute Hospitals Trust ✓ ✗ ✓ ✗ ✗

Lanarkshire PCT ✓ ✓ ✓ ✓ ✓

Lomond & Argyll PCT ✓ ✓ ✓ ✗ ✗

Lothian PCT ✗ ✓ ✗ ✗ ✓

Lothian University Hospitals Trust ✓ ✓ ✓ ✓ ✗

North Glasgow University Hospitals Trust ✗ ✓ ✗ ✓ ✓

Renfrewshire & Inverclyde PCT ✗ ✗ ✓ ✗ ✗

South Glasgow University Hospitals Trust ✗ ✓ ✓ ✓ ✓

Tayside PCT ✓ ✓ ✗ ✗ ✗

Tayside University Hospitals Trust ✓ ✓ ✓ ✓ ✓

Yorkhill Trust ✓ ✓ ✓ ✓ ✓

West Lothian Healthcare Trust ✗ ✗ ✓ ✗ ✗

Western Isles Health Board ✓ ✗ ✗ ✗ ✗

Shetland Health Board ✗ ✗ ✓ ✗ ✓

Orkney Health Board ✗ ✓ ✗ ✗ ✗

Source: Audit Scotland, 2003

Exhibit 2Important aspects of strategic involvement in medical equipment by trust boards

Only six trust boards were able to demonstrate these five important aspects of strategic involvement.

10

Exhibit 3Trust staff reporting to trust boards on medical equipment matters

2.15 But some health boards take amore active interest in medicalequipment managementperformance. For example, LothianHealth Board requires postimplementation reviews of specificprojects, and medical equipment ison the agenda for their trustaccountability reviews. Ayrshire &Arran, Dumfries & Galloway andGrampian Health Boards followed upthe recommendations from Equippedto Care with their local trusts toensure that medical equipment isbeing managed effectively. Andexamples of good practice inaccountability at trust level includefive trust boards having received thereports about medical equipmentclinical governance mattershighlighted in Exhibit 3: Ayrshire &Arran Acute Hospitals Trust, FifeAcute Hospitals Trust, GreaterGlasgow PCT, Lanarkshire AcuteHospitals Trust and Yorkhill Trust.

Recommendations

National1. The SEHD should consider

introducing a specific medicalequipment management standardto provide assurances that properstrategic and operational practicesare in place.

2. The SEHD should improvegovernance and accountability formedical equipment by usingperformance information toinform Accountability Reviews.This should include seekingassurances that any gapsbetween equipment needs andresources are being addressed.

Local3. NHS boards should assign

responsibility for all aspects ofmedical equipment in the area toan executive board member,supported by a multidisciplinarygroup. This would help ensurethat medical equipment isavailable to deliver care in linewith national strategies andclinical priorities.

4. NHS boards should ensure thattheir operating divisions haveprocesses in place to assess theirmedical equipment needs andagree priorities. They should alsoensure that medical equipmentinvestment programmes arebased on realistic forwardplanning.

5. NHS boards should specify theirreporting requirements formedical equipment and monitoroperating division performanceregularly.

6. Operating divisions should ensurethat responsibility for medicalequipment is clear throughouttheir organisations.

Overall, trust boards are better informed of medical equipment financial matters than they are of clinical

governance issues. Seven trust boards had not received any reporting at all for key clinical governance

issues.

Medical equipment matters Percentage

reporting

Clinical governance reporting • Risk analyses 58%to trust boards • Policies & procedures 55%

• Needs assessment 48%• Training 45%• Quality assurance, including accreditation 32%

Financial reporting to trust boards • Expenditure: capital 97%revenue 65%

• Funding bids 87%• Depreciation levels 71%• Medical equipment replacement programme 55%

Source: Audit Scotland, 2003

11

Part 3. Risk managementPart 3. Risk management

Main findings

The SEHD should do more to helpNHSScotland reduce riskexposure. The national riskmanagement scheme, CNORIS,has not brought about thereduction in risk expected whenwe published Equipped to Care.

The SEHD should make better useof information from existingnational information systems,including the Adverse Incidentreporting scheme, to identify risksand keep local health servicesinformed of them.

Some trusts are still relying heavilyon old equipment. Trust boardsneed sufficient investment toreplace medical equipment as itages and to meet changes inservices and technology.

Progress is being made on riskmanagement at local level.Overall, trusts follow good practicefor most key areas of medical

equipment policy, includingmanaging clinical incidentsinvolving medical equipment.

But trusts need to do more toshow how they are managingrisks associated with operatorerror and maintenance. Forexample, trusts must improve themanagement of staff training,such as systematically planningand recording the training receivedby healthcare staff for usingmedical equipment.

3.1 In this chapter, we review thenational arrangements to help riskmanagement of medical equipmentat local level. We then focus on thelocal level by examining riskmanagement arrangements andspecific medical equipment risks.

Good risk management processes

are essential

3.2 The aims of risk management areto avoid harming patients and staff,and to limit financial risk.

3.3 Using medical equipment carriesrisks:

• a patient, user, carer orprofessional can be injured as aresult of a medical device failureor its misuse

• a patient’s treatment can beinterrupted or compromised by amedical device failure

• a misdiagnosis can be made dueto medical device failure, resultingin inappropriate treatment

• a patient’s health can deterioratedue to a medical device failure

13.

Our baseline report included a seriesof recommendations and a goodpractice checklist to improve medicalequipment risk management inNHSScotland. This checklist is basedon guidance from the former MedicalDevices Agency

14.

13 Controls Assurance, Medical Devices Management Standard, Department of Health, 2003.14 Now, Medicines and Healthcare products Regulatory Agency (MHRA).

12

Supporting risk management at

national level

3.4 The SEHD has a supporting rolein managing risk at local level so thatcommon problems are identified andaction is taken to avoid recurrence. InEngland, the DOH has introduced aMedical Devices ManagementStandard as part of its controlsassurance system for the NHS. Thesystem provides the DOH withassurances that the risks associatedwith the acquisition and use ofmedical devices are minimised

15. The

outcomes of trust controls assuranceassessments are published on theDOH website. In addition, the DOHpublishes a summary of trustreported medical equipment risks.There is no equivalent in Scotland.

3.5 This section looks at the SEHDnational risk management scheme(CNORIS)

16, and the national Incident

Reporting and Investigation Centre.

The national risk management

scheme (CNORIS)

3.6 The national risk managementscheme for NHSScotland, CNORIS,is a compulsory insurance schemecovering clinical and non-clinical risks.Risks are assessed against an agreedset of standards. CNORIS operateson three levels (Exhibit 4). Levels twoand three can give real assurancesthat formal risk managementprocedures work, including those formedical equipment. AlthoughCNORIS does not have a specificstandard for medical equipment,aspects are included in somestandards. For example, the ClinicalIncident Reporting and ManagementStandards cover the use of medicalequipment

17.

3.7 By December 2002, only two-thirds of trusts and island healthboards had achieved the minimumstandard, CNORIS level one. Veryfew trusts had applied for level two,and no trust had achieved it.Therefore, trusts were not able to

use their CNORIS level rating todemonstrate that they had effectiverisk management processes in place.

3.8 The SEHD has decided to changethe national risk managementscheme from 1 April 2004

18. The

Healthcare Risk ManagementStandards established by CNORISare being merged with the NHSQISGeneric Clinical GovernanceStandards

19. Like CNORIS, NHSQIS

does not have a specific standard formedical equipment, but somestandards refer to it. There is now anopportunity for NHSScotland toconsider implementing a specificmedical devices managementstandard along the lines introducedby the DOH

20.

The national Incident Reporting and

Investigation Centre

3.9 The SEHD set up a nationalIncident Reporting and InvestigationCentre

21within Scottish Healthcare

Supplies (SHS)22. SHS investigates

adverse incidents that involve the

Exhibit 4Summary of CNORIS Healthcare Risk Management Standards

15 The standard includes 31 criteria of good practice for managing medical equipment. 16 Clinical Negligence and Other Risks (Non-clinical) Indemnity Scheme (CNORIS), NHS MEL(1999)86. 17 CNORIS Risk Management Standards, SEHD, July 2001.18 NHS HDL(2003)29. Clinical negligence and other risks indemnity scheme (CNORIS): integration of standards with NHSQIS generic clinical governance standards.

Standard Level Summary of CNORIS Healthcare Risk Management Standards

One Focuses on corporate ownership of risk through effective policies and procedures.

TwoSeeks evidence of implementation throughout the organisation and addresses operationalissues, in particular, challenging the organisation to strive for continual improvement.

Three

Necessitates a high degree of integration into culture and activities, and requires evidence thatthe organisation has dynamic risk management systems in operation, evidenced by continualimprovement.

Source: CNORIS Risk Management Standards, SEHD, July 2001

Part 3. Risk management 13

use of medical devices withinNHSScotland on behalf of the SEHD.Trusts must report on potential andactual problems covering, forexample: design and construction;user instructions, ease of operationand staff training; and technical oreconomic performance. SHS issuestop priority Hazard Notices (Exhibit 5)as well as standard Safety ActionNotices to help prevent problemsoccurring in the future. SHS alsoliaises with MHRA to keepNHSScotland up to date on problemsidentified elsewhere in the UK.

3.10 Currently, these adverseincident data are not centrallyanalysed or reviewed according totype of medical equipment incident,such as equipment failure or operatorerror. More use could be made ofthis management information toimprove the management of medicalequipment across NHSScotland. SHSis now looking at a system togenerate trend data of this type byApril 2004.

Risk management and risk

exposure at local level

3.11 NHS boards need to satisfythemselves that medical equipmentrisks are being managedappropriately. However, there are noformal reporting requirements onmedical equipment at local level, so itis not clear how boards know theextent of risk exposure. With theabolition of trusts, NHS boards havethe opportunity to ensure thatarrangements are consistent andcomprehensive across their areas. In this section, we examinearrangements for managing medicalequipment risks at local level, andspecific medical equipment risks.

Risk management arrangements

Risk management strategies3.12 Given the importance of medicalequipment in the provision of patientcare, local risk managementstrategies should include planningand using medical equipment. But42% of trust risk management

strategies included medicalequipment only in a partial way, and afurther 13% do not cover medicalequipment at all. The PCTs in ForthValley, Argyll & Clyde and Lothianparticularly need to develop their riskmanagement strategies to covermedical equipment.

Trust compliance with formal medical equipment policies3.13 Trusts have made progress inagreeing formal policies on acquiringand using medical equipment (Exhibit 6 overleaf). Theimplementation of these policieshelps to limit risk exposure. Forexample, a policy on commissioningnew equipment would set out whatneeds to be done when a device isfirst put into service: equipmentregisters need updating, staff mayneed training and a timetable ofplanned preventive maintenanceneeds to be established. Compliancewith the formal policy limits risk byhelping to ensure consistency inapproach and that all necessary tasks

Exhibit 5An example of Scottish Healthcare Supplies, Hazard Notice to NHSScotland

19 Formerly Clinical Standards Board for Scotland Generic Clinical Governance Standards. 20 Controls Assurance, Medical Devices Management Standard, Department of Health, England, October 2001 (revised 2003).21 NHS MEL(1995)74. Reporting of adverse incidents and defective equipment.22 Part of the Common Services Agency of NHSScotland.

Source: Scottish Healthcare Supplies, 2003

Risk of misconnection and over-compression

SHS recently issued a Hazard Notice where an incident had been reported in which a patient was injured as aresult of continuous high pressure being applied for some time to both legs by a sequential pressure device. The device is used to apply pressure to the lower limbs to help prevent deep vein thrombosis, for example, aftersurgery. The Notice advised that if a connection is damaged, the tubing set should be discarded.

Warning: Do not attempt to repair or replace broken tubing connectors as hazardous inflation of the sleeves may occur.

14

Exhibit 6Trust implementation of formal medical equipment policies

Trust staff mostly comply with formal policies for acquiring, commissioning and using medical equipment,

but there were four clear exceptions:

• Orkney Health Board could only demonstrate good practice for purchasing decisions, meeting health & safety requirements and reporting critical incidents

1.

• Lothian PCT could only demonstrate good practice for reporting critical incidents, meeting health & safetyrequirements, and using personal electronic equipment.

• Forth Valley Acute Hospitals Trust and Highland PCT could only demonstrate good practice for about half of thekey policy areas audited.

Medical equipment policies Percentage of

trusts

demonstrating

implementation

Acquiring medical equipment • Purchasing decisions 77%• Standardising on models of equipment 77%• Involving clinicians throughout the process 74%

Commissioning medical • Acceptance testing (eg, electrical testing) 90%equipment • Registering on inventories 87%

• Decommissioning of equipment 81%

Using medical equipment • Reporting critical incidents 100%• Health & safety requirements 97%• Personal electronic equipment

(eg, mobile phones) in clinical areas 87%• Maintenance and fault reporting 84%• Training 74%• Modified equipment 71%

Source: Audit Scotland, 2003

1 Critical incidents include clinical and non-clinical incidents where patient safety is at risk.

Part 3. Risk management 15

are completed. Overall, trusts couldshow that they generally follow goodpractice for most key areas ofmedical equipment policy. But therewere four clear exceptions: OrkneyHealth Board, Lothian PCT, ForthValley Acute Hospitals Trust andHighland PCT.

Specific medical equipment risks

3.14 The main risks to patient andstaff safety when using medicalequipment arise from inappropriatetraining and maintenance

23. Trusts

can reduce these risks bystandardising on makes and models.There are also other risks associatedwith the financial management ofequipment, including relying on olderequipment that may need to bereplaced at short notice and failing tomake adequate provision to replaceequipment.

Training3.15 According to the MDA

24,

operator error is the most commoncause of incidents involving medicalequipment. But only half of trustscould provide assurance that thoseoperating diagnostic or therapeuticequipment have a sufficientunderstanding of it to do so in a safeand efficient manner.

3.16 Training is a key element inreducing these risks. Training isprovided in a range of ways,including by equipmentmanufacturers and in-house trainers,all of which needs to be recordedand managed. But two-thirds oftrusts cannot identify theirinvestment in medical equipmenttraining. Therefore it is not clear howthese trust boards know how muchtraining is required and if they aremaking sufficient investment intraining. Also, Arygll & Clyde NHS,

Forth Valley Acute Hospitals Trust,Highland PCT, Lothian PCT, OrkneyHealth Board and Shetland HealthBoard could not demonstrate fromtheir training records that they adhereto medical equipment trainingpolicies. These training policiesgenerally state the requirement tomaintain records to demonstrate themedical equipment training receivedby healthcare professionals for usingspecific medical equipment.

Maintenance3.17 The other main risk to patientsafety is equipment problems as aresult of inadequate maintenance

25.

Trusts need to identify and plan forthe level of maintenance required formedical equipment and monitor itsdelivery. Equipment suppliers andmanufacturers, and NHS teams

26,

all provide trust equipmentmaintenance.

3.18 Four trusts could not identifytheir spend on maintenance and afurther 15 could only provide partialdata

27. No trust is involved in

maintenance benchmarking, so it isunclear how trusts could provideassurances that they are making bestuse of their maintenance resources.

3.19 While almost three-quarters ofthe trusts had undertaken a formalreview of medical equipment sincetrust reorganisation in 2001, almosthalf of trusts with in-housemaintenance did not include staffinglevels and skills as part of this review.Therefore, it is not clear how thesetrust boards know that theirinvestment in the in-housemaintenance team is appropriate.

3.20 External accreditation to arecognised quality standard for NHSmaintenance teams can provide

assurances of a quality service (Exhibit 7). But accreditation for in-house maintenance is notwidespread. Of the 23 trusts with in-house maintenance provision, only six are externally accredited,although some others have partialaccreditation. But Dumfries &Galloway Acute & MaternityHospitals Trust, Fife Acute HospitalsTrust, Forth Valley Acute HospitalsTrust, Highland Acute Hospitals Trust,Lothian University Hospitals Trust,Yorkhill Trust, plus the three islandhealth boards, all have in-housemaintenance with no externalaccreditation.

Standardisation3.21 As well as reducing safety risks,standardising equipment can helpreduce the cost of servicing andspares, and there may be benefitsfrom bulk purchasing. Exhibit 8demonstrates that there is stillconsiderable scope for furtherstandardisation across NHSScotland.Older models of equipment mayexplain this. But five trusts - FifeAcute Hospitals Trust, Forth ValleyAcute Hospitals Trust, Forth ValleyPCT, Renfrewshire & Inverclyde PCTand Tayside University HospitalsTrust – were not actively pursuing apolicy of standardisation for keyitems.

23 Medical device and equipment management for hospital and community based organisations, Medical Devices Agency (MDA) (now MHRA), 1998. 24 Now, MHRA. 25 The term maintenance is used in this report to cover all associated activities of repair, planned preventative maintenance, servicing, reconditioning, modification and

refurbishment, MHRA, 2000.26 For example, most acute trusts also provide maintenance services to other parts of the NHS.27 From the data available, about 38% of spend on medical equipment maintenance is for in-house maintenance.

Exhibit 7Medical devices and equipment management: repair and maintenance provision

Source: Medical Devices Agency (now MHRA), 2000

Quality Assurance Standards:

User organisations should only use a service provider who can demonstrate compliance with relevant qualitysystem standards, for example, BS EN 46002 or BS EN ISO 9002. Such systems provide a framework on whichservice providers can build the necessary structures to ensure their work is of the nature and quality intended.

16

Part 3. Risk management 17

Exhibit 8Number of different models for selected examples of medical equipment

Num

ber o

f tru

sts

Number of different models

0

2

4

6

8

10

12

14

1 - 3 4 - 6 7 - 9 10 - 12N

umbe

r of t

rust

s

Number of different models

0

2

4

6

8

10

12

1 - 3 4 - 6 7 - 9 10 - 12 13

Num

ber o

f tru

sts

Number of different models

0

1

2

3

4

5

6

1 - 3 4 - 6 7 - 9 10 - 12 13 - 16

7

8

Num

ber o

f tru

sts

Number of different models

0

1

2

3

4

5

6

1 - 3 4 - 6 7 - 9 10 - 12 21 - 3813 - 15 16 - 20

Num

ber o

f tru

sts

Number of different models

0

1

2

3

4

5

6

1 - 3 4 - 6 7

7

Source: Audit Scotland, 2003

Trusts are not always following good practice for standardising models of equipment.

Volumetric pumps Syringe pumps

Defibrillators ECG recorders

Dialysis machines

Perc

enta

ge ‘a

ge p

rofil

e’

0

20

40

60

80

100

Standard life of equipment

mostly 10 years 8 - 10 years 5 - 7 years

Within standard life

Reached standard life

Beyond standard life

Total number of items

Ang

iogr

aphi

c un

its

Volu

met

ric p

umps

Dia

lysi

s m

achi

nes

Gam

ma

Cam

eras

Den

tal X

-ray

units

Def

ibril

lato

rs

ECG

reco

rder

s

Fixe

d X-

ray

units

with

flur

osco

py

Gen

eral

pur

pose

X-ra

y un

its

Mob

ile X

-ray

units

CT

scan

ners

MR

I sca

nner

s

Syrin

ge p

umps

Dia

gnos

tic u

ltras

ound

sca

nner

s

Flex

ible

end

osco

pes

350 349 70 1202 1707 353 36 595 4612 34 6400 22 40 1245 543

18

Exhibit 9‘All Scotland’ age profiles for selected examples of medical equipment

Planning to replace ageing medicalequipment3.22 NHS boards need to ensure thatthey invest sufficiently in their medicalequipment replacement programmes.

3.23 Potentially, there are risks toquality of care and financial riskswhen medical equipment is olderthan its standard life. Equipmentbecomes obsolete in different ways,for example, when maintenancecosts become excessive, spares arenot available, equipment becomesunreliable and when new technologyoffers significant advantages.

Although the standard life varies withthe type of equipment, for manyitems it is between 7-10 years, basedon assumptions about levels ofusage, availability of spares, servicesupport and new equipmentimprovements

28. Twenty-five percent

of the medical equipment that welooked at is outwith its standard life,Exhibit 9.

3.24 Depreciation can be a usefulindicator to assess whether or notthe annual spend on medicalequipment is adequate because itshould reflect the standard life ofequipment. Equipment is typicallywritten down for financial purposes,over 5, 10 or 15 years throughdepreciation

29. In Equipped to Care,

we drew attention to a shortfallbetween depreciation and the capitalinvestment that had been made inmedical equipment. And weconcluded that trusts would faceincreasing problems due tosystematic underinvestment.

3.25 In 2001/02, capital expenditurein 42% of trusts fell short ofdepreciation levels, particularly inPCTs, indicating that their capitalinvestment is not keeping pace with estimated replacementrequirements. And for acute trustswhere there are larger numbers ofequipment on the fixed assetregister, on average 37%

30of

equipment still in use has no valueon the fixed asset register

31. NHS

boards need to be aware of thefinancial risks involved in placing somuch reliance on old equipment,which may need to be replaced atshort notice when it can no longer beadequately maintained

32.

Spending up at year end3.26 In Equipped to Care, we drewattention to the potential forinefficient spending on medicalequipment. This happens whentrusts, for example, ‘spend up’ foryear end cash managementpurposes rather than purchasing onthe basis of rational selection andprioritisation.

3.27 Fourteen trusts cannot provide aprofile of the timing of their revenueexpenditure. All trusts can, however,provide the profile for capitalexpenditure, demonstrating thatmost medical equipment capitalexpenditure continues to take place

28 Advice from Medical Equipment Managers, Study Advisory Panel, 2003. 29 The estimated value of the equipment used up in the year.30 The range was 11% - 62%.31 Note: Where equipment is working well, can be maintained and is still fit for purpose, there is no need to replace it.32 Part 4 provides trust-specific age profiles for selected equipment, and depreciation levels for 2001/02.

Source: Audit Scotland, 2003

Note: Includes trust data where complete age profiles were provided.

Approximately 25% of these items of medical equipment are older than the standard life.

'All

Sco

tland

' per

cent

age

quar

terly

spe

nd

Financial year 2001/02

0

30

40

50

60

70

80

Quarter 1 Quarter 2 Quarter 3 Quarter 4

20

10

March 2002 only

Exhibit 10‘All Scotland’ timing of medical equipment capital expenditure

Part 3. Risk management 19

towards the end of the financial year(Exhibit 10). There may be somelegitimate reasons for this pattern ofexpenditure – for example, to complywith EU procurement legislation –but trusts should avoid spendingsimply for cash managementpurposes. Altogether, for 2001/02,72% of trust medical equipmentcapital expenditure was in the lastquarter of the financial year, with41% of capital expenditure being inMarch alone. Only Orkney HealthBoard, Forth Valley PCT, BordersGeneral Hospitals Trust and Ayrshire& Arran PCT had less than 50% ofcapital expenditure in the last quarter.

3.28 We investigated whether thiscould be explained by late allocationsfrom health boards or whether theproblem was at trust level in terms ofnotifying spending departments oftheir budgets. We found that onlyabout half of trusts could providedetails of when they receivedallocations from health boards. Andone third could not tell us when theyhad issued medical equipmentbudgets to spending departments.

For the trusts that were able to showthe timing of medical equipmentcapital allocations and budgets, theoverall position is summarised inExhibit 11, which shows 57% of thebudget being issued to spendingdepartments late in the year. Thereare risks to the quality of care, andvalue for money, where medicalequipment expenditure is poorlyplanned or rushed at the end of thefinancial year.

Source: Audit Scotland, 2003

Almost three-quarters of capital expenditure on medical equipment occurred in the final quarter.

Exhibit 12Example of financial benefits gained by collaborating over medical equipment procurements

20

Exhibit 11‘All Scotland’ timing of medical equipment capital allocations and budgets

• North Glasgow University Hospitals Trust collaborated with Forth Valley and led the procurement of anaestheticmachines and ventilators. This saved Forth Valley an estimated £62,000.

• North Glasgow University Hospitals Trust led a collaboration with South Glasgow University Hospitals Trust andYorkhill Trust for the installation of a common platform for digital radiology systems, with an estimated saving of£235,000 for the trusts involved.

Source: Audit Scotland, 2003

Perc

enta

ge a

lloca

tion/

budg

ets

Capital allocation from health board/other to trusts

Capital budget from trusts to spending departments

Before 2001/02financial year

0April - June 2001 July- Sept 2001 Oct - Dec 2001 Jan - Mar 2002

10

20

30

40

50

60

Source: Audit Scotland, 2003

The timing of trust capital budgets to spending departments is especially late in the financial year.

21

Collaborating on procurement3.29 Reduced costs can also beachieved by collaborating with otherparts of NHSScotland to obtaindiscounts. And joint procurement toenhance spending efficiencies is anSEHD priority. Collaborating overprocurement also has other benefits,such as developing productexpertise.

3.30 Eighty-four percent of trustshave collaborated with ScottishHealthcare Supplies (SHS) whenprocuring medical equipment. Forexample, for the financial year endingMarch 2003, SHS purchasedequipment to the value of £16.6million on behalf of others throughspecial projects, including a CTscanner, diagnostic imagingequipment, and dental equipment.Trusts sometimes also collaboratewith each other and an example ofthe financial benefits realised is inExhibit 12. However, this kind ofprocurement arrangement is notcommon. And four trusts do notcollaborate with SHS or other trustson medical equipment procurement:Ayrshire & Arran PCT, Forth ValleyPCT, Renfrewshire & Inverclyde PCTand West Lothian Healthcare Trust.Our follow-up audit of managingsupplies in NHSScotland will reviewnew developments in NHSScotlandprocurement arrangements

33.

Recommendations

National7. The SEHD should ensure that the

new national risk managementscheme addresses the risksassociated with medicalequipment.

8. The SEHD should rationalise andmake use of the data fromexisting national systems thatcover medical equipment,including adverse incidents,clinical risk incidents andoccupational health & safety.

Local9. NHS board risk management

strategies should explicitly includemedical equipment.

10.NHS boards should discuss medical equipment risks andperformance information atperformance reviews withoperating divisions.

11.Operating divisions should ensurethat they manage risks,particularly in relation to:

• training, by ensuring that allstaff expected to useequipment are appropriatelytrained and that this is properlyrecorded

• maintenance, by ensuring thatthe split between differenttypes of service provider isevidence based and that in-house teams are adequatelyresourced

• forward investmentprogrammes, by ensuring thatthese are realistic in terms ofmeeting formally assessedmedical equipment needs.

12.Divisional management teamsshould ensure that they have theinformation needed to managemedical equipment effectivelyand to minimise risk.

33 In Good Supply? Managing Supplies in the NHS in Scotland, October 2001. A baseline audit report by Audit Scotland.

Part 3. Risk management

22

Part 4. Information to supportmanagement

Main findings

NHSScotland cannot demonstratethat it is making best use of itsmedical equipment resources forpatient care because of a lack ofinformation.

Where data do exist, their qualityis variable and they are not alwaysused to best effect.

From the data we were able toobtain, it is clear that substantialvariations remain among trusts forimportant aspects of medicalequipment.

4.1 This chapter looks at:

• why management information isimportant

• the main sources of medicalequipment data

• the quality of management data

• using the data.

Why management information is

important

4.2 Trusts need to know whatequipment they have and where thatequipment is for operationalpurposes to ensure that equipment isin the right place at the right time for patient care. Managementinformation is also required tosupport the planning, managementand governance of medicalequipment at local and nationallevels, as highlighted already in Parts2 and 3 of this report.

Sources of medical equipment

data

4.3 Good management informationrelies on the availability of robust,consistent data. Much of that data isneeded at trust level, to beaggregated, when required, for areaand national purposes. The mainsources for the data are trust medicalequipment maintenance registersand financial asset registers. Alltrusts maintain registers for financialand maintenance purposes, butwhere a device is (or should be) on

both registers, the data are notalways consistent. Exhibit 13 showsthe percentages of trusts whichcould readily identify key data forindividual items of equipment fromtheir registers. Overall, Forth ValleyPCT, Lothian PCT, Tayside PCT,Western Isles Health Board andOrkney Health Board had registerswith less complete data for individualitems of medical equipment.

4.4 Four trusts were not able todemonstrate readily from theirregisters, their complete inventory ofequipment – Western Isles HealthBoard, Orkney Health Board, LothianUniversity Hospitals Trust and LothianPCT. And Tayside UniversityHospitals Trust had particularproblems demonstrating fromregisters, the current location ofequipment.

23

Exhibit 13Ready access to key management information held on registers for individual items of medical equipment

Most trusts have ready access to key management information for individual items of medical equipment.

Part 4. Information to support management

Management information

held for individual medical

equipment items

Percentage of trusts able to

readily identify the information

Trusts not able to readily

identify the information

Current location of medicalequipment items, eg, by serialnumber

97% Tayside University

Model 100%

Make 100%

Supplier 100%

Purchase /Acquisition date 94% Lothian PCT and Tayside PCT

Purchase cost 87% Forth Valley PCT, Lothian PCT,Renfrewshire & Inverclyde PCT andWestern Isles Health Board

Expected /Standard life 90% Forth Valley PCT, Tayside PCT andWestern Isles Health Board

Annual depreciation 90% Forth Valley PCT, Tayside PCT andWestern Isles Health Board

Estimated replacement cost for items > £5,000

90% Forth Valley PCT, Lothian PCT andWestern Isles Health Board

Preventive maintenance and repairs 90% Tayside PCT, Western Isles HealthBoard and Orkney Health Board

Service histories 90% Tayside PCT, Western Isles HealthBoard and Orkney Health Board

Source: Audit Scotland, 2003

24

Exhibit 14Summary of important medical equipment management information

Source: Audit Scotland, 2003

Note: To be interpreted in conjunction with Exhibit 16 which highlights data quality information.* A third of capital expenditure was for Lothian University Hospital Trust 2001/02.

Type of information Summary for data provided Trusts not able to

demonstrate information

Financial information For financial year 2001/02

Total expenditure

Capital expenditure*Revenue expenditureLease expenditure

£71,480,000

£60,801,000£3,811,000£6,868,000

7 PCTs, 5 acute trusts and 1 other body1 acute and 2 other bodies/not relevant for 13 trusts

Total replacement value

(excluding replacement value for

leased equipment)

Medical equipment replacementvalues for items on the fixed assetregisterThe estimated replacement value ofthe medical equipment which is>£500 & <£5,000 including VAT

£483,731,000

£377,745,000

£105,986,000

5 PCTs, 2 acute trusts and 1 other body3 provided partial data

1 PCT, 1 acute trust and 2 otherbodies

Net Book Value £190,635,000 1 other body

The level of depreciation held onfixed asset registers

£32,311,000

Maintenance expenditure

Commercial third partyIn-house departmentOther NHS

£23,150,000

£13,955,000£8,730,000£465,000

3 PCTs and 1 other body

15 provided partial data

Investment in training 32% of Trusts can identify theirinvestment in training for the use ofmedical equipment

10 PCTs, 6 acute trusts and 5 otherbodies

Leasing agreements 18 trusts have leasing agreements£34,435,000 is the estimated value ofequipment leased across trusts

Not relevant for 13 trusts

Other management information

Monitoring usage of major items of equipment

18 trusts have systems in place tomonitor major items of medicalequipment

Not relevant for some PCTs

Performance indicators 32% of trusts have formally specifieda range of medical equipmentperformance indicators (PIs) that theykeep under review

10 PCTs, 6 acute trusts and 5 otherbodies

Benchmarking initiatives 36% of trusts are actively engaged in formal medical equipmentbenchmarking initiatives with similarorganisations

7 acute trusts, 9 PCTs and 4 otherbodies

Part 4. Information to support management

Exhibit 15Gaps in basic financial management data and estimated ‘All Scotland’ position

25

Quality of management

information

4.5 Given the importance of medicalequipment, it is vital that decisionsare made based on soundinformation. But we found both gapsand quality issues in the supportingdata.

Gaps in the data

4.6 It is still not possible to provide aclear picture of key aspects ofmedical equipment held inNHSScotland (Exhibit 14 opposite).Overall, Lomond & Argyll PCT,Dumfries & Galloway PCT, HighlandPCT, Tayside University HospitalsTrust and Western Isles Health Boardhad poorer access to summarymanagement information for theirholdings of medical equipment. AndRenfrewshire & Inverclyde PCT haddifficulty in providing collatedmanagement information for our2002 trust questionnaire.

4.7 For example, there were gaps inbasic financial management data,2001/02 (Exhibit 14). The main gapsin financial data are:

• 42% of trusts were not able toprovide total figures for theirrevenue expenditure on medicalequipment. So the figure of £11 million (including leaseexpenditure), which wasidentified through the audit,significantly understates the ‘AllScotland’ position, which weestimate at £25 million (Exhibit 15).

• Trusts should be aware ofreplacement values for medicalequipment so that they can makerealistic provision for it in theirinvestment programmes. Buteight trusts could not providetheir estimated replacement valuefor medical equipment purchasedfrom capital and four trusts could

not give it for equipment boughtfrom revenue. So the £378 millionand £106 million reported bytrusts, significantly understate the‘All Scotland’ position which weestimate at £630 million. Trustsalso lease medical equipmentwith a replacement valueestimated at £34.5 million.

• It is important to ensure thatthere is sufficient investment inmaintenance for medicalequipment because this, alongwith training, has the greatestimpact on device safety. But fourtrusts could not provide theirmaintenance figures, and 15trusts could only provide partialdata, so the £23 million reportedby trusts understates the ‘AllScotland’ position which weestimate at over £44 million

38.

34 These estimates are extrapolated from the trusts that did provide the required information on the basis that the rest would have a similar profile. 35 Trusts also estimated the replacement value of leased equipment at £34.5 million, 2001/02.36 This covers items held on the fixed asset register.37 This covers items with a purchase value of >£500 and < £5,000, including VAT.38 Estimated at 7% of the ‘grossed up’ replacement value, as advised by the Medical Equipment Managers on our Study Advisory Panel (Exhibit 15).

Source: Exhibit 14

Financial management

data

Data provided by

trusts for financial

year 2001/02

£million

Trusts not able to

provide information

Estimated ‘All Scotland’

position34

£million

Revenue expenditure £11 7 PCTs; 5 acute; 1 other body

£25

Replacement values35

• Capital36

• Revenue37

£378

£106

5 PCTs; 2 acute; 1 other body

1 PCT; 1 acute; 2 other bodies

£510

£120

Maintenance expenditure £23 3 PCTs; 1 other; 15 partial data

£44

26

Reliability of the data

4.8 External auditors assessed thequality of data that were provided bytrusts and we found that datareliability varied among trusts andamong data types. For the majority ofdata categories reviewed, trustswere able to demonstrate, overall,that they had robust data (Exhibit 16).In particular, financial managementdata, where available, were mostlyreliable. Trusts with more reliablemanagement data, overall formedical equipment are: Argyll &Clyde Acute Hospitals Trust, Ayrshire& Arran Acute Hospitals Trust,Yorkhill Trust, West LothianHealthcare Trust, Shetland HealthBoard and Lanarkshire AcuteHospitals Trust. But several trustscould only provide estimates thatcould not be substantiated for somekey data. There is room forimprovement, in particular, in thereliability of medical equipmentmanagement data for: GreaterGlasgow PCT, Lothian PCT, ForthValley PCT, Fife PCT and OrkneyHealth Board.

Using the management

information

4.9 Management information onlyadds value if it is reported and used.Agreed PIs can be a useful tool tosupport benchmarking andperformance management. But theSEHD and health boards do not usemedical equipment PIs for thispurpose. Ten trusts make use of PIsfor medical equipment, but these aremostly limited to operational aspectsof medical physics teams. Forexample, North Glasgow UniversityHospitals Trust uses some medicalequipment PIs of this type, which arereviewed at their ISO-accreditedbioengineering meetings. Theseinclude statistics on utilisation forequipment in imaging, radiotherapyand laboratories; and equipmentinstallations with more than fourservice calls in six months.

4.10 Some informal comparisons aremade at the Scottish MedicalEquipment Manager meetings.However, without agreed PIs,benchmarking initiatives betweensimilar organisations are impossible.The lack of an agreed minimum dataset to provide managementinformation for medical equipmentmeans that it is difficult forNHSScotland to demonstrate that itis using its resources well. We had tomake special arrangements to collectand coordinate basic managementdata. From the data we did obtain,we have provided some provisionalbenchmarking data (Exhibits 17 - 21following). And these highlightcontinued unexplained variationsamong trusts.

4.11 Exhibits 17 - 21 provideexamples of PIs that would be usefulfor managing medical equipment. Asa minimum, we would expect truststo benchmark medical equipment interms of: age profile; investing inmedical equipment to maintain andimprove levels of equipment; thelevel of equipment available; and,spend on maintaining the equipment.

4.12 The substantial variations shownin the Exhibits need to be explainedby trusts. Some variation will beexplained by the use of estimatesand incomplete (partial) data, or bydifferences in accounting proceduresas discussed in the explanatory notesto Exhibits. Once data issues of thiskind have been identified andaddressed, the remaining variationswould reflect real differencesbetween trusts. Meanwhile, theExhibits should be interpreted withcare. It is important to resolve thedata issues as quickly as possible sothat real differences between trustscan be shown and the benchmarkingresults can then be used to informthe development of good practice.

Age profiles (Exhibit 17)4.13 The age of key items ofequipment varies substantiallybetween trusts and some trusts arerelying heavily on equipment that isbeyond its standard life.

Part 4. Information to support management 27

Exhibit 16Auditor data quality ratings for validated trust medical equipment management data

The quality of some medical equipment management data needs to improve.

Quality rating descriptions

Reliable: Where auditors found responses to be reliable, ie, based on actuals or generally reliable with some basedon estimates.

Estimated: Responses based on estimates.

No clear audit trail for the data.

Data Overall quality rating No clear audit trail for the data

Net Book Value Reliable Greater Glasgow PCT

Depreciation Reliable

*Replacement value on fixed asset register

Mostly reliable and 1 estimated

Replacement value for items >£500and <£5,000

Mixture of reliable and estimated Orkney Health Board

Leasing data Mixture of reliable and estimated

*Timing of medical equipmentallocations

Mixture of reliable and estimated Fife PCT, Forth Valley PCT,Lanarkshire PCT and Lothian PCT

*Timing of medical equipmentexpenditure

Mostly reliable and 1 estimated Fife PCT, Forth Valley PCT, LothianUniversity, Lothian PCT and WesternIsles Health Board

*Maintenance expenditure Mixture of reliable and estimated Ayrshire & Arran PCT, Dumfries &Galloway Acute, Fife PCT, ForthValley PCT, Greater Glasgow PCT andOrkney Health Board

Financial benefits for collaboratingover procurement

Mixture of reliable and estimated Lomond & Argyll PCT, GreaterGlasgow PCT, Highland Acute andOrkney Health Board

Investment in training Mixture of reliable and estimated Grampian PCT and South GlasgowUniversity

*Age profiles of equipment Mixture of reliable and estimated Orkney Health Board

Standardisation Mostly reliable and 1 estimated Greater Glasgow PCT

Systems for monitoring usage ofmajor items of equipment

Mixture of reliable and estimated Highland Acute and Lothian PCT

Source: Audit Scotland, 2003

Note: To be interpreted in conjunction with Exhibit 14, which highlights where management data were/not available.* Where partial data was provided by some trusts.

Perc

enta

ge ‘a

ge p

rofil

es’

0

20

40

60

80

1005 6 11

General purpose X -rays units

Total number of items

Equipment age

3 3 37 2 3 124 8 43 14 19 1913 12 67 35 16 24524

Lana

rksh

ire P

CT

Gre

ater

Gla

sgow

PC

T

Wes

t Lot

hian

Hea

lthca

re

York

hill

Dum

fries

& G

allo

way

Acu

te

Ayr

shire

& A

rran

PCT

Tays

ide

Uni

vers

ity

Forth

Val

ley

Acu

te

Nor

th G

lasg

ow U

nive

rsity

Ayr

shire

& A

rran

Acu

te

Gra

mpi

an U

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Hig

hlan

d A

cute

Loth

ian

PCT

Fife

Acu

te

Gra

mpi

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Sout

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Arg

yll &

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ian

Uni

vers

ity

Ren

frew

shire

& In

verc

lyde

PC

T

Lom

ond

& A

rgyl

l PC

T

Shet

land

Hea

lth B

oard

Lana

rksh

ire A

cute

Bor

ders

Gen

eral

Hos

pita

ls

Fife

PC

T

Ork

ney

Hea

lth B

oard

>0 - 3 years

>3 - 5 years

>5 - 7 years

>7 - 10 years

>10 - 15 years

>15 years

Perc

enta

ge ‘a

ge p

rofil

es’

0

20

40

60

80

10011 24 95 72 74 40 83 84 84 39 90 32 31 19 13 54 67 7244 12013 10213 1428632

Defibrillators

Total number of items

Equipment age

Lana

rksh

ire P

CT

Gre

ater

Gla

sgow

PC

T

Wes

t Lot

hian

Hea

lthca

re

York

hill

Dum

fries

& G

allo

way

Acu

te

Ayr

shire

& A

rran

PCT

Tays

ide

Uni

vers

ity

Forth

Val

ley

PCT

Nor

th G

lasg

ow U

nive

rsity

Ayr

shire

& A

rran

Acu

te

Gra

mpi

an U

nive

rsity

Hig

hlan

d A

cute

Loth

ian

PCT

Fife

Acu

te

Gra

mpi

an P

CT

Sout

h G

lasg

ow U

nive

rsity

Arg

yll &

Cly

de A

cute

Loth

ian

Uni

vers

ity

Ren

frew

shire

& In

verc

lyde

PC

T

Lom

ond

& A

rgyl

l PC

T

Shet

land

Hea

lth B

oard

Lana

rksh

ire A

cute

Bor

ders

PC

T

Forth

Val

ley

Acu

te

Ork

ney

Hea

lth B

oard

Bor

ders

Gen

eral

Hos

pita

ls

Hig

hlan

d PC

T

>0 - 3 years

>3 - 5 years

>5 - 7 years

>7 - 10 years

>10 - 15 years

>15 years

28

Exhibit 17Age profiles for selected examples of medical equipment by trust

Perc

enta

ge ‘a

ge p

rofil

es’

0

20

40

60

80

1004 2 47 6 6 21 5 85 189 123 21 58 38 105 128 60 82 23 102 2 6 132

Flexible endoscopes

Total number of items

Equipment age

>0 - 3 years

>3 - 5 years

>5 - 7 years

>7 - 10 years

>10 - 15 years

>15 years

Wes

t Lot

hian

Hea

lthca

re

York

hill

Dum

fries

& G

allo

way

Acu

te

Ayr

shire

& A

rran

PCT

Tays

ide

Uni

vers

ity

Nor

th G

lasg

ow U

nive

rsity

Ayr

shire

& A

rran

Acu

te

Gra

mpi

an U

nive

rsity

Hig

hlan

d A

cute

Loth

ian

PCT

Fife

Acu

te

Gra

mpi

an P

CT

Sout

h G

lasg

ow U

nive

rsity

Arg

yll &

Cly

de A

cute

Loth

ian

Uni

vers

ity

Lom

ond

& A

rgyl

l PC

T

Shet

land

Hea

lth B

oard

Lana

rksh

ire A

cute

Forth

Val

ley

Acu

te

Ork

ney

Hea

lth B

oard

Bor

ders

Gen

eral

Hos

pita

ls

Dum

fries

& G

allo

way

PC

T

Perc

enta

ge ‘a

ge p

rofil

es’

0

20

40

60

80

1004 26 79 148 149 383 175 17 922 253 596 81628 14 12 17 32 16139 213 262 201 110

Volumetric pumps

Total number of items

Equipment age

>0 - 3 years

>3 - 5 years

>5 - 7 years

>7 - 10 years

>10 - 15 years

>15 years

Lana

rksh

ire P

CT

Wes

t Lot

hian

Hea

lthca

re

York

hill

Dum

fries

& G

allo

way

Acu

te

Ayr

shire

& A

rran

PCT

Tays

ide

Uni

vers

ity

Forth

Val

ley

PCT

Nor

th G

lasg

ow U

nive

rsity

Ayr

shire

& A

rran

Acu

te

Gra

mpi

an U

nive

rsity

Hig

hlan

d A

cute

Tays

ide

PCT

Fife

Acu

te

Gra

mpi

an P

CT

Sout

h G

lasg

ow U

nive

rsity

Arg

yll &

Cly

de A

cute

Loth

ian

Uni

vers

ity

Lom

ond

& A

rgyl

l PC

T

Shet

land

Hea

lth B

oard

Bor

ders

PC

T

Bor

ders

Gen

eral

Hos

pita

ls

Forth

Val

ley

Acu

te

Hig

hlan

d PC

T

Part 4. Information to support management 29

Source: Audit Scotland, 2003

Note: Only includes trust data where complete ages profiles were provided. Certain items of equipment were not relevant for some trusts.

£000

Depreciation

Lothian Universitydepreciation £4.7mcapital expenditure £21m

Capital expenditure

Dum

fries

& G

allo

way

Acu

te

Fife

Acu

te

Bor

ders

Gen

eral

Hos

pita

ls

Tays

ide

Uni

vers

ity

Forth

Val

ley

Acu

te

Nor

th G

lasg

ow U

nive

rsity

Ayr

shire

& A

rran

Acu

te

Gra

mpi

an U

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rsity

Sout

h G

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rsity

Arg

yll &

Cly

de A

cute

Lana

rksh

ire A

cute

Hig

hlan

d A

cute

0

1,000

2,000

3,000

4,000

5,000

6,000

7,000

8,000

9,000

10,000

Acute trusts

£000

Depreciation

Capital expenditure

Shetland Health Board

Mixed/Other bodies

0

500

1,000

1,500

2,000

2,500

3,000

3,500

Orkney Health Board Western Isles HealthBoard

West Lothian Healthcare Yorkhill

30

Exhibit 18Capital expenditure and depreciation of medical equipment by trust

In 2001/02, capital expenditure for medical equipment did not always match depreciation

£000

Depreciation

Capital expenditure

Forth

Val

ley

PCT

Gre

ater

Gla

sgow

PC

T

Hig

hlan

d PC

T

Ayr

shire

& A

rran

PCT

Dum

fries

& G

allo

way

PC

T

Lom

ond

& A

rgyl

l PC

T

Lana

rksh

ire P

CT

Bor

ders

PC

T

Primary Care Trusts (PCTs)

Loth

ian

PCT

Gra

mpi

an P

CT

Ren

frew

shire

& In

verc

lyde

PC

T

Tays

ide

PCT

0

100

200

300

400

500

600

Fife

PC

T

Source: Audit Scotland, 2003

Note: These graphs show a one-year snapshot of expenditure and depreciation. Financial year 2001/02.

Part 4. Information to support managementPe

rcen

tage

Financial year 2001/02

Lana

rksh

ire P

CT

Gre

ater

Gla

sgow

PC

T

Wes

t Lot

hian

Hea

lthca

re

York

hill

Dum

fries

& G

allo

way

Acu

te

Ayr

shire

& A

rran

PCT

Tays

ide

Uni

vers

ity

Forth

Val

ley

Acu

te

Nor

th G

lasg

ow U

nive

rsity

Ayr

shire

& A

rran

Acu

te

Gra

mpi

an U

nive

rsity

Hig

hlan

d A

cute

Loth

ian

PCT

Fife

Acu

te

Gra

mpi

an P

CT

Sout

h G

lasg

ow U

nive

rsity

Arg

yll &

Cly

de A

cute

Loth

ian

Uni

vers

ity

Ren

frew

shire

& In

verc

lyde

PC

T

Lom

ond

& A

rgyl

l PC

T

Shet

land

Hea

lth B

oard

Lana

rksh

ire A

cute

Bor

ders

Gen

eral

Hos

pita

ls

Fife

PC

T

Ork

ney

Hea

lth B

oard

0

2

4

6

8

10

12

14

Tays

ide

PCT

Dum

fries

& G

allo

way

PC

T

Hig

hlan

d PC

T

Bor

ders

PC

T

Forth

Val

ley

PCT

Acute trusts Primary Care Trusts (PCTs) Mixed/Other bodies

Exhibit 19Total Net Book Value of medical equipment held by trusts as a percentage of trust operating income

31

Investing to maintain and improvelevels of equipment (Exhibit 18)

Capital4.14 Depreciation information helpsto assess whether or not theexpenditure on equipment purchasedfrom capital is sufficient at least tocover ‘replacement’ equipment

39. It

needs to be presented as trend dataso that fluctuations in investment areseen in context. We have onlyprovided a one-year snapshotbecause trend data are not routinelyavailable. If 2001/02 reflects thetrend, then investment in at least42% of trusts is insufficient toreplace equipment and maintainexisting levels of equipment, far lessimprove them. While Exhibit 18shows that acute trusts appear to beperforming better than PCTs, this hasto be seen in the context that, onaverage, 37% of equipment still inuse has no value on their fixed assetregister.

Revenue4.15 Annual expenditure on medicalequipment funded from revenue alsoneeds to be shown as trend data toensure that investment in low cost/high volume items is adequate tomeet service requirements.

Net Book Value40

(Exhibit 19)4.16 Net Book Value as a percentageof trust operating income is ameasure that can be used to indicatetrust levels of medical equipmentprovision. For example, Exhibit 19shows that there is a three-folddifference between acute trusts, butsome of this might be explained bydifferences in the way trustsdepreciate their medical equipmentand record equipment on fixed assetregisters.

Replacement value41

(Exhibit 20)4.17 Replacement value as apercentage of trust operating incomeis another way of measuring trust

levels of medical equipmentprovision. Exhibit 20 showsreplacement value of medicalequipment as a percentage ofoperating income, for capital andrevenue. Again, this highlights thedegree of variation between truststhat were able to providereplacement values. There are manygaps in the data and some figuresare based on estimates.

Maintenance spend (Exhibit 21)4.18 We would expect maintenancespend to be related to trustreplacement values and these dataare shown in Exhibit 21. This showsthat there are still substantialvariations in how much trusts spendon the maintenance of their medicalequipment. However, somereplacement values are estimated, asdescribed previously, and themajority of trusts could only giveincomplete data on maintenanceexpenditure (Exhibit 14).

39 It is not always possible or meaningful to separate expenditure between ‘replacement’ equipment and ‘new’ equipment purchased to, for example, provide anincreased level of service.

40 The estimated value of the equipment after depreciation has been taken into account.41 The estimated investment the organisation would require to replace the equipment.

Source: Audit Scotland, 2003

Note: Net Book Value of medical equipment on fixed asset register. To be interpreted in conjunction with explanatory notes below.For operating income, see Appendix 4.

Exhibit 21Maintenance expenditure as a percentage of total replacement value by trust

Financial year 2001/02

Perc

enta

ge

0

5

10

15

20

25

Medical equipment items costing>£5,000

Medical equipment items costing<£5,000 and >£500

Lana

rksh

ire P

CT

Gre

ater

Gla

sgow

PC

T

Wes

t Lot

hian

Hea

lthca

re

York

hill

Dum

fries

& G

allo

way

Acu

te

Ayr

shire

& A

rran

PCT

Tays

ide

Uni

vers

ity

Forth

Val

ley

Acu

te

Nor

th G

lasg

ow U

nive

rsity

Ayr

shire

& A

rran

Acu

te

Gra

mpi

an U

nive

rsity

Hig

hlan

d A

cute

Loth

ian

PCT

Fife

Acu

te

Gra

mpi

an P

CT

Sout

h G

lasg

ow U

nive

rsity

Arg

yll &

Cly

de A

cute

Loth

ian

Uni

vers

ity

Ren

frew

shire

& In

verc

lyde

PC

T

Lom

ond

& A

rgyl

l PC

T

Shet

land

Hea

lth B

oard

Lana

rksh

ire A

cute

Bor

ders

Gen

eral

Hos

pita

ls

Fife

PC

T

Ork

ney

Hea

lth B

oard

Tays

ide

PCT

Hig

hlan

d PC

T

Bor

ders

PC

T

Dum

fries

& G

allo

way

PC

T

Forth

Val

ley

PCT

Acute trusts Primary Care Trusts (PCTs) Mixed/Other bodies

Perc

enta

ge

Lana

rksh

ire P

CT

Wes

t Lot

hian

Hea

lthca

re

York

hill

Dum

fries

& G

allo

way

Acu

te

Ayr

shire

& A

rran

PCT

Tays

ide

Uni

vers

ity

Forth

Val

ley

Acu

te

Nor

th G

lasg

ow U

nive

rsity

Ayr

shire

& A

rran

Acu

te

Gra

mpi

an U

nive

rsity

Hig

hlan

d A

cute

Fife

Acu

te

Gra

mpi

an P

CT

Shet

land

Hea

lth B

oard

Lana

rksh

ire A

cute

Bor

ders

Gen

eral

Hos

pita

ls

0

2

4

6

8

10

12

14

Tays

ide

PCT

Bor

ders

PC

T

Acute trusts Primary Care Trusts (PCTs) Mixed/Other bodies

32

Exhibit 20Replacement value for *capital and **revenue medical equipment items as a percentage of trust operating income

Source: Audit Scotland, 2003*Medical equipment items originally costing ≥£5,000.**Medical equipment items originally costing <£5,000 and >£500.

Note: Eight trusts did not provide replacement value for capital items and four trusts did not provide estimated replacement value for revenue items. To beinterpreted in conjunction with explanatory notes on previous page.For operating income, see Appendix 4.

Source: Audit Scotland, 2003

Note: Only includes trusts that gave maintenance expenditure and replacement values, many of which are estimated. Some data are partial. Tobe interpreted in conjunction with explanatory notes previous page.

Part 4. Information to support management 33

Recommendations

(Also, see recommendations in Parts2 and 3.)

National13.The SEHD should ensure that a

minimum data set for managingmedical equipment is agreed andimplemented.

14.The SEHD should make use ofthis performance information toinform Accountability Reviewsand other performancemonitoring processes.

Local15.Operating divisions should ensure

that the information held onmedical equipment registersmeets agreed minimum data setrequirements, is up to date,accurate and easily accessible.Regular reviews of the availability,reliability and consistency of datashould be undertaken byoperating divisions.

16.NHS boards should ensure thismedical equipment performanceinformation is used to assesswhether the local area is makingbest use of its medical equipmentresources for patient care.

34

Equipped to Care:

Managing Medical Equipment in

the NHS in Scotland, 2001

Key points and conclusion from theexecutive summary of this report.

Key points

Trusts are responsible for managing asignificant investment in medicalequipment. In 1997/98:

• the total value of medicalequipment was in the region of£170 million

• expenditure on new andreplacement equipment was £25 million

• expenditure on maintenance wasaround £20 million.

Despite its financial significance, andthe important implications for clinicalgovernance if medical equipment isnot managed well, few trust boardstake an active role in:

• determining priorities for theacquisition of medical equipment

• examining trust procurementpractices

• monitoring training, usage andmaintenance issues.

There continues to be scope forimprovements in the combinedpurchasing of medical equipment:

• we were unable to obtaininformation from trusts on theuptake of national contracts

• a substantial amount ofequipment is purchased at a locallevel without consideration givento the potential benefits ofaggregating purchases.

Trusts are managing many of theoperational medical equipmentissues well …

• finance departments are ensuringcompliance with EU procurementlegislation and Standing FinancialInstructions

• multidisciplinary involvement inprocurement is commonplace

• clinicians reported satisfactionwith response times forequipment failure, so interruptionsto services are rare.

… but some trusts are exposingthemselves to unnecessary risks:

• data on total expenditure (capitaland revenue) are not availablefrom national financial returns

• Audit Scotland had to obtaininformation by surveying trustsdirect

• not all trusts could easily providebasic information on expenditureand usage.

… although our snapshot dataindicated that:

• there are variations in trustexpenditure on medicalequipment, and the level ofequipment available, not fullyexplained by differences in typeof trusts

• expenditure on new andreplacement equipment is failingto match depreciation.

Conclusion

There is room for improvement inthe management of medicalequipment. A common themethroughout the study was inadequatemanagement information andreporting systems. In particular, givenits strategic importance and clinicalgovernance considerations, it isdisappointing that, at many trusts,board members do not have accessto robust information which wouldhelp them set priorities and managethe risks associated with medicalequipment. For example, they needto ensure that they are aware of andunderstand the implications of anyshortfall between depreciation andthe combined capital and revenuepurchases. Board members shouldensure that responsibility for medicalequipment is delegated to someoneon the trust board. In turn, theyshould ensure that good practiceguidelines (outlined in the mainbaseline report) are implemented andmonitored.

Appendix 1

Appendix 2 35

Appendix 2

Definition of medical equipment

used in this audit

Medical devices are all instruments,apparatus, appliances, materials orother articles, used for the purposesof diagnosis, prevention, monitoring,treatment or alleviation of disease orinjury or handicap. Medical devicesdo not include estates relatedequipment such as catering andlaundry equipment. Medical devicesdo not include hospital computingequipment unless the IT equipmentis linked to patient connectedmedical equipment, or laboratoryequipment or is part of a PictureArchiving Communication System.

Medical equipment is a subset ofmedical devices. We have definedmedical equipment as all devicesthat are connected to the patientas part of their treatment and carein hospitals and health centres,and devices used for diagnostic,therapeutic and laboratorypurposes.

Medical equipment does not includeconsumable medical devices such assyringes and dressings.

Medical equipment excluded fromthis audit were: equipment locatedwithin Sterile Supply Units (ie, inTheatre Sterile Supplies Unit (TSSU)or Central Sterile SupplyDepartments (CSSDs)); plant,including operating lights, piped gassystems; small operating instrumentsprocessed through TSSU; implanteddevices (eg, pacemakers); “normal”beds, trolleys, chairs, wheelchairs,and low cost rehabilitation equipment(eg, crutches).

Examples of medical equipmentincluded in this audit are describedoverleaf:

36

Groups of Equipment Description

Imaging Equipment

Equipment that gives a picture of physiological structures, eg, X-ray, Ultrasound, MRI, CT, Gamma Cameras. Seebelow. Some of these items represent high cost items, for example, CT and MRI. Imaging equipment includes:

CT Scanners Computerised Tomography Scanner. Uses a thin beam of X-raysrotated around the body to computer generate an image of a ‘slice’through the body. Found in X-ray Departments. Costs around£600,000.

Diagnostic Ultrasound Scanners Uses high frequency sound waves ‘bounced’ off body structures toproduce images of organs. Found in X-ray Departments, Cardiology,Obstetrics, Urology Departments / Units. Costs from £15,000 to£150,000.

MRI Scanner Magnetic Resonance Imaging Scanner. Using magnetic fields, thehydrogen nucleus within the body are caused to spin, giving awaytheir location to the scanner. The scanner builds up an image of thedensity of the spinning nucleus. Shows detailed images of forexample, sections of the brain. Found in X-ray Departments. Costaround £1,000,000.

Gamma Cameras Gamma cameras detect and build up a picture of gamma radiationemanating from the patient. The patient is usually injected with aradioactive gamma emitter that concentrates in parts of the patient’sbody that are growing actively such as tumours. This gives an imagebased on the biological activity rather than structure. These will befound in Radiology or Medical Physics Departments and will costabout £300,000.

Other X-ray Equipment

Angiographic Units Uses X-rays and opaque dyes to produce moving images of bloodflow. This finds blockages and abnormalities in blood vessels. Thesecan be treated with tools passed through the veins and the radiologist/ cardiologist can treat the problem while observing the screen. Foundin X-ray Departments. Cost around £800,000.

Dental Units Used to take X-rays of the teeth. Found in most dental clinics. Costaround £5,000. More complex dental units can cost £30,000.

General Purpose X-ray Units This is the basic kit of an X-ray Department. Takes images of mostparts of the body. Costs from £40,000.

Fixed Units with Fluoroscopy These take moving images for barium swallows and enemas. Found inmany X-ray Departments. Cost around £330,000.

Mobile Units Basic X-ray machines on wheels – goes to wards, theatres, A&E etc.Costs around £30,000.

Appendix 2 37

IV Systems

Intra-venous systems are used for accurately controlling the injection of drugs into the patient. They are usuallysyringe drivers or infusion pumps. Some may be specially designed for a particular purpose – anaesthetic agents,epidurals etc. IV Systems include:

Syringe Pumps (routine) Syringe pumps are normally used to deliver small quantities of drugwith a high degree of accuracy. The drug is contained in a syringe.These will be found in most wards, theatres and intensive care. Costswill be between £1,000 and £2,000.

Volumetric Pumps (routine) Volumetric pumps control the delivery of larger quantities of drugs orfluids. They can also pump at greater rates than a syringe driver. Thesewill also be found in most wards and departments. Cost is upwards of£2,000.

Other Medical Equipment

Defibrillators Delivers an electric shock to a fibrillating heart to restore normalbeating. This is emergency equipment found in most hospital wardsand departments. Also carried by ambulances. Costs between £1,500and £9,000.

Dialysis Machines (haemodialysis) This is an artificial kidney. Patients will be connected to these threetimes a week for about 6 hours at a time to ‘clean’ the blood. Found inRenal Units. Cost around £14,000.

ECG Recorders Produces a trace of the electrical activity of the heart. The trace can beused to diagnose heart disease. Found in ECG Departments, somewards and A&E. Costs from £2,000 to £8,000.

Flexible Endoscopes Used to look inside the body. Modern equipment has a video cameraat the tip; older equipment uses a fibre optic bundle to take the picturefrom the tip to a microscope at the eyepiece. The tips can be steeredby the operator and tools can be passed through to take biopsies, stopbleeding etc. Small instruments can look into the bladder, sinuses,airway and lungs. Larger instruments are passed into the stomach andinto the colon. Individual instruments cost between £8,000 and£28,000. A complete set-up including video monitor, light source, videoprocessor and some flexible endoscopes would cost about £150,000.

Source: MHRA; and Medical Equipment Managers on our Study Advisory Panel, 2003.

38

Appendix 3

Study Advisory Panel

Mike Nieman Trust Medical Equipment Manager on baseline study advisory panel, Aberdeen Royal Infirmary, Grampian and Scottish Medical Equipment Manager Group nominee

Mike Sik Scottish Medical Equipment Manager Group nomineeCrosshouse Hospital, Ayrshire & Arran

Robin Pollock Scottish Medical Equipment Manager Group nomineeRaigmore Hospital, Highland

Michael Baxter SEHD nominee, finance specialistHead of Private Finance and Capital Unit, SEHD

Brian Howarth Senior Audit Manager, involved in baseline auditAudit Scotland

Miles Moorhouse On baseline study advisory panel, supplies specialistDirector, Scottish Healthcare Supplies, CSA

Charles Swainson Medical Director on baseline study advisory panel, and Trust ChiefLothian University Hospitals Trust Executive nominee

Appendix 4 39

Appendix 4

Source: Audit Scotland Trust Survey, 2002

Trust Operating Income 2001/02

Acute Trusts £000

Argyll & Clyde 171,220

Ayrshire & Arran 163,866

Borders General Hospitals 44,074

Dumfries & Galloway 60,000

Fife 112,441

Forth Valley 111,000

Grampian University 236,705

Highland 87,768

Lanarkshire 232,726

Lothian University 381,792

North Glasgow University 438,582

South Glasgow University 202,051

Tayside University 233,000

Primary Care Trusts (PCT)

Ayrshire & Arran 196,538

Borders 65,000

Dumfries & Galloway 93,676

Fife 194,304

Forth Valley 163,096

Grampian 305,000

Greater Glasgow 470,000

Highland 139,347

Lanarkshire 297,000

Lomond & Argyll 94,583

Lothian 344,177

Renfrewshire & Inverclyde 165,472

Tayside 251,000

Mixed/Other Bodies

Yorkhill 86,815

Orkney Health Board 24,577

Shetland Health Board 30,000

Western Isles Health Board 44,517

West Lothian Healthcare 142,492

Better equipped to care? Follow-up report on managing medical equipment

Audit Scotland110 George StreetEdinburgh EH2 4LH

Telephone0131 477 1234Fax0131 477 4567

www.audit-scotland.gov.uk ISBN 1 904651 31 3 AGS/2004/2