Background

Health technology context

Health Technology covers a wide range of apparatus, consumables, devices, equipment and instruments that would require many volumes of documents to cover effectively. This document, as part of the broader IUSS Norms and Standards project, aims to look at the key elements of Health Technology and its management as it manifests in healthcare facilities. The document specifically aims at framing the subject of Health Technology within the infrastructure development and operations domain.

The various definitions of Health Technology are listed in the Glossary but it is important to note that this document focuses on durable medical equipment and related consumables used in healthcare facilities. Hospital plant and machinery, normally associated with the building and most often installed as part of the building, are dealt with in various other documents in the IUSS document bouquet, either under the respective hospital engineering disciplines or under the respective clinical service area.

Application of the Guidelines

This document, published under the Health Facility guides, would be useful for practitioners of Health Technology Management both at the level of an individual facility and for groups of facilities (for example, in a district) and at any level of care. It would also be of great value for HTM practitioners and facility managers in general who might lack the first-hand experience of this relatively specialised field. In many cases the guidelines show the way towards developing specific and applicable solutions rather than being prescriptive. This approach is necessary to ensure that they remain sufficiently generic to be applied across a broad spectrum of scenarios. The document would also be of interest to health infrastructure professionals who might need specific insight into the domain of Health Technology and its management, recognising that technology and infrastructure are closely inter-related and will become ever more so in future healthcare systems.

Associated process and related documents

This document should be considered in the context of the solid platform provided by the Health Technology Policy and the Health Facilities Planning Directorates of the National Department of Health. This includes the Framework for Health Technology Policies which outlines the vision of a National Health Technology System; the draft Health Technology Management Policy document which inter alia outlines the organisational and structural requirements at all levels of governance pertaining to such a system; the Health Technology Strategy which outlines specific objectives and activities, with associated timeframes, for establishing a National Health Technology System; the Report of the Interim Steering Committee on Health Technology Assessment, which underlines the importance of having formal processes in place to assess issues of health technology cost-effectiveness, access, service-fit and social impact, amongst other “evaluative dimensions”; and lastly the draft Medical Device Regulations and associated background documents which – in their final form – will be promulgated under the South African Health Products Regulatory Agency (SAHPRA) Act .

Life cycle of Health Technology

Planning

Introduction

Planning and budgeting are often considered jointly since planning – for it to be effective – needs to take place within the context of policy, financial, and other constraints. Box 1 shows the overall process.

BOX 1: The planning and budgeting process (start-up)


Steps	People responsible	Actions
Plan and budget within the framework of guidance and direction from the national level.	Health service managers at national level in consultation with managers at other levels.	Framework requirements follow regulations and standards set by government; develop a Healthcare Technology Policy including decisions on standardisation, maintenance provision, finances for HTM activities, and the organisational structure for an HTM service; define the overall “Vision” for healthcare delivery at each level of the health service; develop “Standard Equipment Lists” which define the essential equipment stock for the healthcare to be delivered at each level; use “Generic Equipment cifications” for acquisition ofequipment; develop good policies for purchasing, donations, replacement, and disposal of equipment; and participate in the planning, equipping and operation of health facilities.
Increase the availability of planning skills for equipment at all service levels, by developing planning “tools” through one-off exercises.	HTM working groups and sub-groups. Finance officers.	Knowing where one is starting from establish an Equipment Inventory to keep up-to-date records of the current equipment stock; estimate the equipment stock values; define the usage rates of equipment-related consumable items so that realistic estimates can be made of the finances required for equipment accessories, consumables, and spare parts; and set up budget lines to record and monitor expenditure on all the different equipment activities.
	Health management teams. HTM working groups and sub-groups.	Knowing where one is headed develop a library of literature and resources which will help with equipment planning and budgeting; adapt the vision for healthcare delivery at their service level; adopt good policies for purchasing, donations, replacement, and disposal of equipment; adapt the Standard Equipment List for their service level; develop generic equipment specifications and technical and environmental data; and estimate human resource requirements and associated “acquisition” and capacity building.
Ensure realistic estimates are made for all equipment-related allocations at all service.levels, by using budgeting “tools” to calculate expenditures required.	HTM working groups and sub-groups. HTM managers and their teams.	Capital budget calculations calculate expenditure requirements for replacement items; calculate expenditure requirements for new purchases; calculate expenditure requirements for support activities linked to purchases and donations; calculate expenditure requirements for pre-installation work; and calculate expenditure requirements for major rehabilitation work.
Ensure realistic estimates are made for all equipment-related allocations at all service levels, by using budgeting “tools” to calculate expenditures required.	HTM managers and their teams. Heads of section. HTM working groups and sub-groups.	Recurrent budget calculations calculate recurrent expenditure requirements for maintenance; calculate recurrent expenditure requirements for consumable operating costs; calculate recurrent expenditure requirements for administrative expenses; and calculate recurrent expenditure requirements for ongoing training.
Use the tools to make long-term plans and budgets	HTM working groups and sub-groups.	Long-term planning establish an Equipment Development Plan covering the priorities for equipment needs across their service level over time; establish an Equipment Training Plan to cover the ongoing rolling programme of training required in relation to equipment activities; establish a Core Equipment Expenditure Plan which prioritises equipment spending across the facility over the long term; and establish a Core Equipment Financing Plan indicating possible sources of funds and related options.
Review the plans and budgets annually, and monitor progress in order to improve planning and budgeting.	HTM teams. HTM working groups and sub-groups.	Annual planning update the Equipment Inventory; update the Equipment Development Plan; update the Equipment Training Plan; cost the capital and recurrent requirements for the current year, and update the Core Equipment Expenditure Plan and Core Equipment Financing Plan; and prioritise across their service level to obtain the annual purchase activities, annual rehabilitation activities, annual corrective activities, annual training activities, and thus the annual equipment budget.
Review the plans and budgets annually, and monitor progress in order to improve planning and budgeting.	HTM working groups. Heads of department and HTM managers. Health management teams.	Monitoring progress ensure annual plans are implemented; study the implications arising from planning and budgeting; request help for any deviations from plans such as emergency purchases, maintenance and consumable contingencies; monitor actual expenditure against allocations; seek the funding identified; consider linking allocation of budgets to whether departments achieve their performance targets; monitor progress through establishing planning and budgeting tools and associated indicators; and ensure that the information generated is used to improve stock control, training, procurement, utilisation, etc.

Service and related technology planning

For healthcare technology to be managed effectively, a clear idea of healthcare delivery goals and targets is needed, as well as the context in which the technology is operating. Equipment should not be viewed in isolation – it is there for a purpose, and must be managed according to set objectives. For effective planning, access to a wide range of information and reference materials is needed, as well as a clear vision of the direction in which the health service is headed, plus identification of what equipment is required to help achieve the health service goals.

To inform the technology part of the debate, the HTM working group (at each level) should consider the equipment implications of the healthcare interventions suggested, and then offer technical advice to their health management team. Box 2 and Checklist 1 show some of the issues that the national, province/district- and facility level HTM working groups, respectively, should consider.

BOX 2: Baseline information on medical devices


Medical device situation	Considerations	Result
Availability and condition of medical devices (including type, number, location and physical condition). Status of electrical, water, and waste disposal systems related to medical device use.	Medical equipment inventory including status and condition. Current health technology management infrastructure (or lack thereof).	Facility map. Medical equipment inventory (quantitative and qualitative). Outline of health technology management infrastructure.

CHECKLIST 1: Equipment considerations for vision at national level


Issues	Example
What expansion of services is necessary or feasible?	What should be the role of a hospital (central, referral, district) in terms of the interventions and procedures to be carried out? What does this mean in terms of equipment availability? What type of care can be offered by rural, district or town health centres? Can any types of care be transferred over to them? What does this mean in terms of equipment availability? It may be best to locate certain specialised services (such as intensive-care units) only at certain hospitals. Some specialised services, such as radiotherapy, may only ever be offered at national level. With pressures to reduce costs, improve efficiencies, and possibly to reduce staff numbers, can service provision be rationalised? Is expansion based only on needs that can be realistically met?
What are the implications in terms of staff, skills, resources, patient referral networks?	Introducing a new service has knock-on implications for human, material and financial resources. For example, should eye instruments be bought for a facility if there is no eye surgeon, or prospects of one becoming available? Or if the referral system is such that dialysis is only undertaken and supported at a central facility, one should think carefully before placing dialysis machines at other further locations. However, if such expanded “satellite” services are required, then all the resources required to ensure effective service provision should be identified, provided and maintained.
Are desired expansions financially affordable?	Although many hospitals may ideally wish to have fluoroscopy facilities (for example), at a cost of approximately $500 000 per suite, is this a feature each hospital can necessarily invest in?
Do the services suggested fit into the overall health service in the country?	Is it possible to develop a vision which fits in with the other health service provider organisations?

Planning and budgeting when starting out

Box 3 shows the minimum requirements for a scenario for an HTM system in its infancy, where the initial focus is not on long-term forward planning, but concentration on planning and budgeting on a yearly basis. As the system matures, other elements for forward planning can be added.

Box 3: Minimum planning and budgeting requirements


Planning and budgeting element	If just starting out
1. Equipment inventory 2. Stock value estimates 3. Budget lines for equipment expenditures. 4. Usage rates for equipment-related consumable items. 5. Reference materials. 6. Developing the vision of service delivery for each facility type. 7. Standard Equipment Lists. 8. Purchasing, donations, replacement, and disposal policies. 9. Generic equipment specifications and technical data. 10. Capital budget calculations. 11. Recurrent budget calculations. 12. Equipment development plan. 13. Equipment training plan. 14. Core equipment expenditure plan. 15. Core equipment financing plan. 16. Annual equipment planning and budgeting. 17. Monitoring progress.	1. Essential to have. 2. Useful to carry out this exercise later on when rough estimates needed for long-term forward planning. 3. This alteration to budget layout can be done later, but it will help with analysis. 4. Useful to do this exercise as it helps with calculation of specific (annual) estimates. 5. These can be developed over time. 6. Should have an understanding of this, even if full exercise not undertaken. 7. Initially, list of urgent equipment needs drawn up by departments can be used. Later on, Standard Equipment Lists obtained elsewhere can be used. 8. Essential to have. 9. Initially learn from others. Later, develop own. 10. Initially learn how to make specific (annual) estimates; only learn the rough estimation methods when undertaking long-term planning. 11. Initially learn how to make specific (annual) estimates. Only learn the rough estimation methods when undertaking long-term planning. 12. Use the basic equipment development planning process only, and only apply it to the short term. 13. Develop a straightforward one for the short term 14. Initially only plan annually (see below). 15. Initially only plan annually (see below). 16. Create annual actions plans and an equipment budget showing income and expenditure. 17. Undertake the basic elements only – progress with annual plans and tools, coping with emergencies, providing feedback.

Needs assessment

Standard lists of equipment

Once the vision for the direction of health service delivery has been developed, the healthcare interventions and procedures to be offered will be known. Based on this information, the Essential Service Packages can be developed; these will translate the vision into:

human resource requirements, and training needs;
space requirements, and facility and service installation needs; and
equipment requirements.

The tool used in the process of defining what equipment is needed for each healthcare intervention is the Standard Equipment List. This is:

a list of equipment typically required for each healthcare intervention (such as a healthcare function, activity, or procedure). For example, health service providers might list all equipment required for eye-testing, delivering twins, undertaking fluoroscopic examinations, or for testing blood for malaria;
organised by activity space or room (such as reception area or treatment room), and by department;
developed for every different level of healthcare delivery (such as district, province) since the equipment needs will differ depending on the vision for each level;
usually made up of everything including furniture, fittings and fixtures, in order to be useful for planners, architects, engineers and purchasers, and
a tool which allows healthcare managers to establish if the Vision is economically viable.

The Standard Equipment List must reflect the level of technology of the equipment. It should describe only technology that the facility can sustain (in other words, equipment which can be operated and maintained by existing staff, and for which there are adequate resources for its use). For example a department could have:

an electric suction pump or a foot-operated one;
a hydraulic operating table or an electrically controlled one;
a computerised laundry system or electro-mechanical machines; and
disposable syringes or re-usable/sterilisable ones.

It is important that any equipment suggested:

can fit into the rooms and space available. Reference should therefore be made to any building norms defining room sizes, flow patterns, and requirements for water, electricity, light levels and so on;
has the necessary utilities and associated plant (such as the power, water, waste management systems) available for it on each site - if such utilities are not available, it is pointless planning to invest in equipment which requires these utilities in order to work; and
can be operated and maintained by existing staff and skill levels, or for which the necessary training is available and affordable.

Usefulness of the standard equipment lists

A Standard Equipment List is an aid to the planning process. In order to plan what equipment to purchase, awareness of any shortfalls in equipment is needed. To determine such shortfalls, the Equipment Inventory needs to be compared with the Standard Equipment List. This will indicate whether any equipment is currently missing or needs to be purchased. Thus, the Standard Equipment List will assist in determining what equipment is:

necessary;
surplus;
extravagant; and
missing

in relation to the Vision for the service.

Responsibility for developing the Standard Equipment Lists varies from country to country. It is most important that this task is undertaken by a multidisciplinary team, so that decisions benefit from the skills and views of many disciplines, not just one or two. The health service planners at central/national level should consider developing Standard Equipment Lists in collaboration with staff from each level of the service, as indicated in Box 4 below.

Who/which level?	Takes what action?
HTM working group at each level	Organises special meetings of different types of staff to work on the Standard Equipment List. Then reports back to the Health Management Teams.
National level	Takes the first step and runs specific exercises to establish the Standard Lists of Equipment for each clinical and support area, at each operational level.
Province/district level	Takes the second step and adjusts the list on a regional/district basis to cover local variations.
Facility level	Takes the third step and assesses: - how they can provide the healthcare interventions; and - what numbers of equipment they require depending on how they organise their work. Organisational decisions influence the quantity of equipment. For example, the timing of clinics can reduce or increase the workload in the laboratory. Before ordering new equipment, its level of use will need to be assessed.

Equipment development plan

Especially for an HTM system that is not mature, it is essential to have important to have [BvR1] an equipment development plan; one suggestion for the development planning process is presented in Flowchart 1 below.

Flowchart 1: The basic equipment development planning process

Prioritising and appraisal of options

It is equally important, in the context of needs assessment, to critically examine the process and its outputs and outcomes. Checklist 2 below poses some key questions for consideration by the appropriate stakeholder/s.

Checklist 2: Key questions for prioritising and appraisal of options

Impact Which changes would have the greatest positive impact in meeting needs? Do the identified needs relate to a local or a national priority (e.g., maternal and child health, HIV/AIDS, etc.)? What would be the implications of not addressing the needs?
Changeability Which things can be changed and effectively improved? What evidence is there of effective interventions? Can negative impacts be stopped or reduced? Are there national or local, professional or organisational policies that set out guidelines on what should be done (e.g. national frameworks, national guidance, etc.)?
Acceptability Which of the options for change are likely to be most acceptable to the health service providers, to the target population, and to the managers? What might be the “knock-on” effects, or unintended consequences, of making a change?
Resource feasibility Which resources are required to implement the proposed changes? Can existing resources be used differently? Which resources will be released if ineffective actions are stopped/changed (e.g., proper management of health technology, etc.)? Are there other resources available which have not been given prior consideration (e.g., income generation of laboratory services, consideration of public-private partnerships, assistance from NGOs, etc.)? Which of the actions will achieve the greatest impact for the resources used?

Consumables

Consumables are a major contributor to equipment-related cost of ownership, and form a significant portion of recurrent and operational expenditure. It is therefore important to establish the consumables needs so that adequate provision is made and service delivery is not interrupted. Flowchart 2 below suggests a process to facilitate the needs assessment related to equipment-related consumables.

Asset management

Inventory

It is essential that an inventory (asset register) of medical equipment is maintained. However, it is both costly and time-consuming to include each and every medical device in an asset register. For those items in an asset register, the following information should be captured and verified:

Equipment type (an international nomenclature system such as the Universal Medical Device Nomenclature System (UMDNS) should be used so that all institutions use a common name for the same type of device).
Make/manufacturer.
Model.
Serial number.
Date of acquisition.
Price paid (include any costly accessories).
Supplier details (name, address, contact person, contact details).
Location – department or ward where the unit is used.

The responsibilities, activities and role-players relating to equipment inventory are shown in Box 5.

Box 5: Inventory-related responsibilities, activities and actors

Body	Responsibility	Activity	People involved
HTM Service	Creates and updates the Equipment Inventory.	Organises the gathering of inventory data.	Either by: facility staff for their own facility; district staff for the facilities in their district; central staff for the health service as a whole; and using specialist help.
Inventory team		Visits each department in the health facility, and: looks in all rooms, cupboards, etc.; physically checks all equipment for the details required; and fills in the Equipment Inventory Record Sheets. If existing records are available: modifies or expands the information as necessary to cover new items; fills in any gaps; corrects entries; andupdates data in order to make the Equipment Inventory as accurate as possible.	Due to the workload and knowledge required, it is useful for the team to be made up of: two maintenance staff (from the relevant HTM team); a senior equipment user from the facility; and a member of staff from the department being assessed (who changes as team moves from department to department).
HTM teams	Compile the Equipment Inventory. Make hard copies.	Enter the data gathered, either onto an inventory card or a computer screen, for each individual device. Create summaries, prepare and print out hard copies. Provide a copy of the Equipment Inventory.to the Stores Controller for inclusion in the General Inventory held by stores.	Make use of trained technical staff and secretarial/computing support to assist with data entry.
Central-level HTM team	Develops the Equipment Inventory as an active (regularly updated) resource. Analyses the Equipment Inventory for planning purposes.	Uses computer-based tools required for this purpose (for example, word-processing spreadsheets or specific commercial inventory products which staff have been trained on.	Makes use of support from staff trained in keeping computerised records.

Asset management system

Proper asset management requires an appropriate information system which can be used to maintain data on those items that have been included in the asset register.

Equipment audits provide a snapshot of equipment status in a facility or groups of facilities, and can be aggregated to reveal the situation at national level. Audit data also serves to inform decision making related to needs assessment, asset management, maintenance strategies, replacement planning, and so on.

Also, once an inventory system is up and running, it will be necessary to periodically obtain estimates of total equipment stock values – this is used, for example, in benchmarking the total expenditure on maintenance. Flowchart 3 below shows the process for obtain such estimates.

Asset management software

It is essential to adopt and standardise on an appropriate asset management information system. There are a number of such systems available; serious consideration should be given to open-source solutions and/or or solutions which are cost-effective and sustainable, requiring minimal support.

Budgeting & financing

Estimates of budget lines for equipment expenditure

It is essential to have budget lines for health technologies/medical equipment in national, province, district and facility budgets. A process for developing budget lines is shown in Box 6.

Box 6: Process for developing budget lines for equipment expenditure

People responsible	Action
Finance officers, at all levels of the health service (central, province, district, facility)	Establish different budget lines (sub-divisions) as itemised below: a. capital funds to cover equipment replacement (depreciation); b. capital funds to cover additional new equipment requirements; c. capital funds to cover support activities which ensure equipment purchases can be used (installation, commissioning, and initial training); d. capital funds to cover pre-installation work for equipment purchases; e. capital funds to cover major rehabilitation projects; f. recurrent funds to cover equipment maintenance costs, including spare parts, service contracts, and minor works; g. recurrent funds to cover equipment operational costs, including consumable items and worn out accessories; h. recurrent funds to cover equipment-related administration, including energy requirements; and i. recurrent funds to cover ongoing training requirements.
HTM working groups	Start using these budget lines to analyse how money is allocated and spent for equipment purposes.
Health service providers	Ensure that budgets are presented by cost centre so that it is clear what allocations are made between national, provincial, district and facility levels. In this way, it can be seen what money is spent on equipment activities at each level of the health service. Lobby other bodies involved (such as Ministries of Finance, Public Works) to also show equipment expenditures to establish what is allocated by other agencies for equipment activities in the health service.

The high-level budgets thus obtained can then be “unpacked” into more detailed line expenditures, such as shown in Table 1 below, with projections covering 3-5-year budget cycles.

Estimates of maintenance costs for forward planning

An important – and often neglected – expenditure category is that of maintenance, be it for medical equipment or healthcare technologies and infrastructure in general. Box 7 unpacks the maintenance line item to indicate the various categories of maintenance-related expenditure for medical equipment, while Flowchart 4 suggests a process for estimating maintenance costs as part of planning.

Table 1: Example of a core equipment expenditure plan

Capital expenditure	Short term		Medium term
Capital expenditure	2012	2013	2014	2015
Replacement	Use calculations for rough estimations (see Note below)
New equipment
Support activities linked to purchases
Pre-installation
Rehabilitation
Sub-total
Recurrent expenditure
Equipment maintenance	Use calculations for rough estimations (see Note below)
Consumables
Administration
On-going training
Sub-total
Total expenditure

Note: Initially, rough estimates are used for the short- and long-term overview when preparing this Core Equipment Expenditure Plan. During annual planning the estimates are revised, using calculations for specific requirements, to obtain the Annual Equipment Budget. The experience gained from that annual revision process may mean that the long-term estimates in this Core Equipment Expenditure Plan may have to be altered, so that they are more realistic.

Box 7: Elements of annual maintenance budgets

I. Planned budgets: These allocate funds for anticipated maintenance costs, which can be derived from the following main areas of expenditure: a) spare parts – which are required regularly, determined from previous experience and any planned remedial work; b) spare parts – which are required according to planned preventive maintenance (PPM) schedules and timetables; c) maintenance materials – which are required regularly, determined by previous experience and any planned remedial work; d) maintenance materials – which are required according to PPM schedules and timetables; e) service contracts – required for any planned remedial work; f) service contracts – for breakdowns which are likely to be required, determined from previous experience; g) service contracts – required for PPM of complex equipment; h) calibration of workshop test equipment; i) replacement of tools at the end of their life; j) office material; and k) any increased maintenance requirements brought about by planned new equipment purchases under the capital expenditure budget. Note: there will be other elements which may fall under other budgets. These could include: other administrative costs which are included in budgets held by other departments; major repair works – in some cases the planned rehabilitation of equipment which rquires major work with the purchase of substantial amounts of materials or contracts (the large sums of money required for such projects may have to fall under the capital budget); and pre-installation work (such as site-preparation); this often falls under capital funds as it is linked to specific purchases.
II. Contingency budgets: In addition to planned budgets, contingency budgets also exist. These allocate funds for unplanned maintenance work, such as emergencies, or sudden breakdowns which could not be predicted.

[See Section 10.2 for further discussion on maintenance-related issues].

Estimates of consumable operating costs for forward planning

In Section A2 (Needs assessment) the importance of consumables for proper functioning and utilisation was highlighted. Since medical devices cover such a wide spectrum, the related consumables require insight and good management. A number of alternative approaches are suggested:

i. Consumption depends on the type of equipment used, the service provided, and how many patients are seen. Therefore, a rough estimation of consumable operating costs can be obtained by evaluating past usage rates/expenditures, and comparing these with expected patient loads and specific equipment usage rates per intervention.

ii. If the equipment is part of a “closed” purchasing system, the consumables are only made by one manufacturer and one is limited to a single supplier; this monopoly often increases the consumable costs. If the equipment is part of an “open” purchasing system, anyone can supply the consumables and different manufacturers’ consumables could be used; this competition brings down costs of consumable. Costs can also be kept down by using items which can be sterilised/re-used.

iii. Consumable operating costs vary according to equipment type, and can be expressed as a percentage of purchase cost or stock value, as shown by the examples below. But as the majority of equipment is likely to be technology that has low to medium consumable costs, one could use averages of 3% of the stock value for equipment with low consumable usage rates, and for others as shown in Table 2.

Table 2: Rough estimates of consumables’ operating costs for forward planning

Description	Consumable cost per year (relative to original purchase cost)
Equipment with high consumable operating costs, such as: Haemodialysis machine Automatic biochemical analyser Automatic haematology analyser Electrolyte analyser Blood gas analyser	70-120%
Equipment with medium consumable operating costs, such as: Conventional x-ray machine Anaesthesia machine	30% 20%
ECG recorder, three-channel Ultrasound, medical/obstetric Ventilator, ICU Physiological monitor EEG machine	15-25%
Autoclave, steam Incubator, baby, ICU	10-15% 5-15%
Equipment with low consumable operating costs, such as: Centrifuge, electrical Suction pump	5% 2-5%
Delivery bed Operating theatre lamp Slit lamp Operating microscope Water bath	1-2%

A different calculation is required when making specific or annual estimates. Annual operating budgets should be based on more exact estimates. These are not always easy to predict since epidemics, outbreaks, or surges in workload cannot, in most cases, be anticipated.

Generally with experience, and where standardisation of equipment is in place, the projection for equipment consumables and spare accessories becomes more predictable.

Specific or annual estimates of consumable operating costs

It is equally important to make provision for consumables on an annual basis. Flowchart 5 suggests how this could be done.

Estimates of equipment replacement costs

Equipment replacement needs to be provided for, especially in the case of complex and expensive equipment, to ensure that adequate resourcing is available at the appropriate time to ensure continuity – or at least minimal disruption – of service delivery. Flowchart 6 below suggests a process to establish estimates for replacement costs.

Rough estimates of equipment-related administrative costs for forward planning

The administrative costs associated with medical equipment are also seldom considered separately, since they are hidden within general overheads. Different countries suggest alternative approaches:

i. Administrative costs are a small percentage of any operating budget; for example:

the biggest percentage expense is for staff, taking 50-55%;
supplies/spares take 35-45%; and
administration takes only 10-20%.

Thus an equipment-user department could use an average of 15% of ~~their~~ its total operating budget for administrative costs.

ii. For HTM teams and clinical engineering service maintenance workshops, their administrative needs are not much higher than other administrative units in health facilities. Therefore, a reasonable estimate for the administrative costs[1] for HTM teams could be calculated by taking 10-20% of their total operating budget.

iii. A starting point is to use 5% of the equipment stock value to cover equipment-related administrative costs.

Requisitioning

The following checklists cover three commonly encountered scenarios:

Checklist 3: Request to purchase new equipment that is not yet in use at the institution

a. Why is it essential to have this equipment and how will it enhance the present patient care. How was this function performed before and up until this request?

b. Statistics of the patients who will be treated with this equipment.

c. Is this equipment in line with the norms of the service delivery – level of care –of the institution?

d. Accessibility to similar equipment or services in a close proximity to the Institution.

e. Is suitable accommodation available to install the equipment (building and facilities). Is the structure suitable to carry the additional mass? This to be confirmed by the Engineering Services Manager, in writing.

f. Are there engineering services available to operate the equipment and has the availability of the service been confirmed in writing by the Engineering Services Manager, for instance:

sufficient water pressure and flow (hot and cold);
sufficient water pressure and flow (hot and cold);
medical gas and compressed air (at the correct pressures and flow);
sufficient power at the correct voltage and current levels;
if required, a UPS system with a sufficient capacity;
a power line-conditioning unit for sensitive electronic equipment;
if required (for example autoclaves), is steam, condensate return and drainage available; and
if required, is the ventilation and air-conditioning sufficient.

g. Are proper specifications available from the HTM unit or is suitable equipment available from an approved period tender? State the tender and the item numbers.

h. Confirmation must be obtained from the Institution that they have a budget (sufficient funds) to pay for a service contract (where called for), as well as consumables and preventive and corrective maintenance of the new equipment.

i. Will not having the equipment in any way compromise patient care or safety?

Checklist 4: Request to replace existing equipment

a. Inventory of similar equipment available in the Institution.

b. Inventory of how many pieces of the type of equipment are functional.

c. Inventory of how many pieces of equipment are not functional and the reason thereof.

d. Is this equipment in line with the norms of service delivery – level of care – of the institution?

e. Reason for the condemning of the equipment, supported by a Condemning Certificate.

f. Where the replacement is a fixture for instance an x-ray machine or processor, what engineering or structural changes will be required?

g. Does the Institution have sufficient funds to purchase the equipment requested?

h. Does the Institution have a budget, sufficient funds to pay for a Comprehensive Service Contract for the equipment requested?

i. Is suitable accommodation available to install the equipment (building and facilities) and is the structure suitable to carry the additional mass? This to be confirmed by the Engineering Services Manager, in writing.

j. Are there engineering services available to operate the equipment and has the availability of the service been confirmed in writing by the Engineering Services Manager, for instance (as for above scenario – Checklist 5)?

k. Can this equipment be standardised for the reasons previously stated above?

l. Statistics of patients to be treated with the equipment requested.

m. Are there no other procedures available to treat the patients?

n. Will not having the equipment in any way compromise patient care or safety?

o. Are there proper specifications from the Health Technology Unit available, or is suitable equipment available from an approved period tender? State the tender and the item numbers.

Checklist 5: Request to purchase additional equipment similar to equipment already in use

a. Inventory of similar equipment available in the Institution.

b. Inventory of how many pieces of the type of equipment are functional.

c. Inventory of how many pieces of the type of equipment are not functional and the reason therefore.

d. Is this equipment in line with the norms of service delivery – level of care - of the institution?

e. Reason for requesting the additional equipment backed up with patient statistics. Has the function or status of the Institution changed?

f. Does the institution have sufficient funds to purchase the equipment?

g. Does the institution have a budget, sufficient funds to pay for a comprehensive service contract for the equipment requested?

h. Can this equipment be standardised for the reasons previously stated?

i. Are there no other procedures available to treat the patients?

j. Will not having the equipment in any way compromise patient care or safety? Are there proper specifications available from the Health Technology Unit or is suitable equipment available from an approved period tender. State the tender and item numbers?

Procurement

Introduction

Procurement, from a healthcare service perspective, is probably the most important activity within the medical equipment life-cycle. If the right (competent) people are driving a transparent, criteria-driven (not interest-driven) process, it is likely that the healthcare system will avail itself of the technology that is most appropriate to the intended application, while addressing issues around effectiveness, cost-of-ownership, institutional fit, technology maturity and compatibility, user competence, maintenance and so on. In many countries, procurement is being placed in the hands of generic supply-chain management personnel with little specialised knowledge of medical equipment specifically, and health technologies in general. It is therefore essential to ensure that a supporting environment is created to minimise the possibility of sub-optimal procurement outcomes.

Procurement (for capital equipment as opposed to consumables) should be seen as a process with two phases: one that commences with planning and needs assessment and ends with commissioning, and the other that extends over its operational lifetime and ensures that the equipment is provided with the necessary accessories, consumables, maintenance support, and so on.

There are four reasons for procuring equipment, each of which provides a different goal which will dictate when to acquire equipment. These can be placed in the following order of priority (see Box 8 below). Within each of the four categories shown, priorities will have to be set, and these can be based on appropriate indicators.

Box 8: Example of valid reasons and order of priority for purchasing of equipment

1. To cover depreciation of equipment.	Equipment is replaced as it reaches the end of its life and is taken out of service. This is necessary in order for the level of healthcare that is currently delivered to be sustained. [Note: This means that the size of the existing equipment stock remains the same, and does not imply an expansion of the health service.]
2. To obtain additional equipment items which are missing from the basic standard requirements.	Additional equipment may be required in order to provide a basic standard level of care. [Note: Missing items are identified by comparing the Equipment Inventory with the Standard Equipment List for the facility.]
3. To obtain additional equipment items beyond the basic standard.	This is done in order to upgrade the level of health service provided by the hospital. For example, new equipment may be needed to provide a new service, build a new special unit, or increase the level of care offered.
4. To obtain additional equipment items outside the facility’s own plans.	This will only be applicable if the additional items have been called for by directives from the national or provincial ministry, and cannot be stopped/refused for political reasons, such as “out of the ordinary”, high profile, or political projects.

Of course, procurement is not a self-contained, isolated process but links up with many other equipment-related processes; these are shown in Box 9 below.

Planning tools	How they help
When replacing items:
Replacement policy	Establishing and implementing this tool is much more likely to ensure that the necessary regular planned replacement of equipment takes place.
Equipment inventory and maintenance record system	These tools support identification of the need for replacement equipment at any time. For easy reference, estimated lifetimes for equipment could be entered into the inventory and could then prompt one when to purchase. The natural life of equipment is shortened by harsh environment, over-use, unskilled handling, neglect of maintenance and damage. Equipment malfunction and downtime also increase with the age of the equipment. Accordingly, cost-effectiveness decreases with age.
Replacement and condemnation criteria	These assist with judging when equipment has reached the end of its life, and therefore with identifying when equipment needs replacing.
Core equipment expenditure plan	Some of the equipment will have to be replaced every year, so it makes sense to spread budgeting for replacement over time. By allocating some money each year, one can avoid facing a large replacement bill later on. This tool should spread these costs over the long term. Equipment replacement needs can be estimated each year by assuming that each piece of equipment has an average lifetime of 10 years [1] - this means that on average 10% of equipment stock needs to be replaced each year.
Disposal policy and disposal procedures	When equipment is replaced, these tools will assist with the disposal of the old device or system. There may be government regulations regarding disposal that will provide additional information.
Stock- control system	Replacement equipment-related supplies should be purchased after an up-to-date stock take. Accurate stock control systems help with planning and ordering.
When buying additional new items:
Equipment development plan, and annual purchase plan	New equipment should be purchased according to an annual purchase plan (drawn each year from a long-term equipment development plan). This is based on an up-to-date inventory and Standard Equipment List. Accurate inventory record-keeping helps with planning and ordering.
Package of inputs	Planning in advance for what will be needed after the purchase is every bit as important as the purchase itself. Thus, one must ensure that the package of inputs required to keep equipment functioning through its life is procured.
Core equipment financing plan, and annual budget	Capital expenditure can only take place once sufficient funding sources have been identified. The long-term Core Equipment Financing Plan and Annual Budget should allocate known and possible sources of funds against elements of planned expenditure.

Additional items of equipment may need to be procured to accompany/complement the original item, if it is to function properly in certain environments. For example:

a voltage stabiliser (surge suppressor plus filter) - this offers protection against power supply fluctuations, but does not protect against power cuts. It monitors the power supply, removes surges and spikes, and maintains a continuously regulated alternating current output to the item;
an uninterruptible power supply - this offers protection against blackouts and power cuts of limited duration;
an air-conditioning unit; and
a water filter or treatment plant.

Preparation of specifications

Specifications have to be drawn up for every device that is planned to be purchased. Standardised specifications need to be drawn up for commonly used devices which can then be modified (where necessary) at institutional level.

General terms and conditions should also be part of specifications, including stipulations like the local availability of essential spare parts, and the presence of a registered sole agent for the specific brand.

Specifications should be functional specifications and drawn up based on features available in at least a few brands of the device commonly available in South Africa. Before making a selection the following may be considered:

demonstration of devices by supplier;
trial use of the device in a facility;
visit to a facility where the device is available;
verbal presentation on device made by a supplier of the device; and
communication with existing users of the device both locally and abroad.

A suggested format for specifications is as follows:

name of equipment;
Function;
essential features;
essential components;
additional components;
power supply;
additional requirements; and
training – user training, maintenance training.

In order to eliminate the possibility of outdated specifications being used, all specifications should have a validity date on the document. Specifications that are not valid or have expired should not be used. Copies of the latest specifications should be obtained from the appropriate HTM unit.

A sample specification (that for an infant incubator) is given in Annex I. For some equipment, such as sophisticated or imported items, or equipment which is new in the system, it may be necessary to specify the following item lines:

Site preparation details – supplier should provide technical instructions and details so that this work can be planned, either in-house or by contracting out.
Installation – assistance may be needed.
Commissioning – assistance may again be required.
Acceptance – the responsibilities of both the purchaser and supplier with respect to testing and/or acceptance of the goods must be clearly detailed.
Training of both users and technicians – help must be obtained if required.
Maintenance contract (an important part of after-sales support) – help must be requested if it is required. It will be necessary to agree and stipulate the duration, and whether it should extend beyond the warranty period, the cost and whether it includes the price of labour and spare parts, and the responsibilities of the owner and supplier.

There are a number of technical and environmental factors that need to be taken into account. For example:

If the area has an unstable power supply, is the supplier able to offer technical solutions (such as voltage stabilisers, an uninterruptible power supply)?
Will the geographical location (such as height above sea-level) affect the operation of equipment (such as motors, pressure vessels)? If so, can the manufacturer adjust the item’s specific needs?
Extremes of temperature, humidity, and dust may adversely affect equipment operation, and may require solutions such as air-conditioning, silica gel, polymerised coatings for printed circuit boards, and filters.

This information can be included within the generic equipment specifications. However, since much of the information is common to many pieces of equipment, some health service providers have found it simpler to develop a separate summary Technical and Environmental Data Sheet, which can be referred to in the purchase documents. This data sheet can be distributed to all suppliers, interested parties, trade delegations and other relevant bodies. Such a data sheet can be provided regardless of the length of specification or the procurement method used, ensuring that all parties are kept informed of prevailing national conditions which could affect the operation of equipment.

The following details should be included in a Technical and Environmental Data Sheet:

Electricity supply – mains or other supply, voltage and frequency values and fluctuations.
Water supply – mains or other supply, quality and pressure.
Environment: height above sea-level; mean temperature and fluctuations; humidity; dust level; vermin problems, etc.
Manufacturing quality – international or local standards required.
Language required – main and secondary.
Technology level required – manual, electro-mechanical or micro-processor controlled.

Evaluation and comparison process

The process of evaluation and comparison can often be time consuming. However, it is important to ensure that decisions for awarding contracts are not made simply on the basis of which items are the cheapest. During evaluation the items should be assessed against the requirements specified in the purchase document. The most common way to evaluate offers is to use an elimination process, where some offers are rejected at each stage. Offers should be judged against the following criteria:

Compliance with requirements in the purchase document.
Technical nature of the offer (part of the product selection criteria).
Financial nature of the offer (part of the product selection criteria).
Supplier qualification criteria.

By doing this, decisions are based on best value for money for the whole life-cycle cost, rather than simply being based on the item’s purchase price.

The process of evaluation and comparison must be fair and thorough. To achieve this, the process must follow a defined pattern to ensure all bids/quotes are dealt with in exactly the same way.

The evaluation process for tenders is similar to that for quotes, although the tender process is normally a far more comprehensive task and is also regulated by law. The tools for evaluation can be the same, but the amount of information required is usually much less with quotation methods. Obviously, if only three quotes are requested for a simple small order, the evaluation process should not take much time. The following evaluation steps are used, and some bids/quotes are rejected at the end of each step.

Step 1: Checking for compliance

The first step when evaluating offers is to determine which, if any, are not compliant with the technical, commercial, and other specifications in the purchase document. The procurement unit should be able to do this. It involves a more detailed examination of the offer to determine the compliance by the bidder with the requirements specified in the purchase document. This is known in tender processes as the substantial responsiveness of the bid. This process is more formal and comprehensive for tenders than for quotations.

A substantially responsive bid is one which:

conforms to all the terms and conditions; this means that the supplier has responded to all parts of the schedule of requirements, has filled in all the boxes, and is able to supply all the parts required; and
also establishes the bidder’s qualifications to supply and deliver the products within the delivery schedule; for example, the supplier:

- has enclosed signed audited accounts, signed company declarations on health, safety, and environmental activities, certificates of quality manufacturing, and a letter of authorisation from the manufacturer, and

- has nominated a representative in the country (if this was one of the compliance criteria).

All non-substantial bids will be rejected as non-responsive and should be excluded from further in-depth evaluation.

In practice it is found that most bids contain reservations from one or more of the detailed requirements. If these are just minor adjustments and do not represent a substantial deviation from expressed interests, one can still conclude that the bid is substantially responsive and therefore should be included. However, the reservations for closer clarification should be listed.

To assist in this examination one could ask for other clarifications from the bidder. One may also wish to inspect the quality methods and production methods stated in their documents. This request and response should be in writing. The bidders, however, are not allowed to make any changes to the substance or price of their offers. After evaluating the offers for compliance, some offers are discarded as the suppliers fail. The remaining offers can go forward to be compared in terms of technical performance (Step 3).

Step 2: Preparing the evaluation information

The procurement unit should collate and compile the information from all the responsive bids into evaluation information sheets. Box 10 gives an example of the sort of data that needs to be included.

Box 10: Evaluation information sheets

Evaluation Information Sheets present an easy way to compare different bids/quotes. For ease of comparison, it is best to allocate one page per subject matter (technical product details, price, etc.) and compare the offers side-by-side. Areas where each offer deviates from the equipment specification should be highlighted. Typical evaluation information sheets would include the following evaluation criteria: Technical product data: The international/regional standards that the equipment adheres to. Whether the operational method used is new, well tried, or old. The level of sophistication of the technology and the operating technique. Which functions and measurements do not meet the specifications in the purchase document. Whether any quality assurance certificates apply to the equipment. Accessories, consumables, spare parts: A list and the cost of accessories included in the offer. A list and the cost of consumables included in the offer. A list and the cost of spare parts included in the offer. The length of time spare parts will be available and their location. After-sales service: Cost of after-sales support. Guarantee/warranty periods. The details of the after-sales support that can be provided. Price information: The price. Delivery arrangements Costs to install, commission, and train. The life-cycle costs. Note: this is an example and not a comprehensive list. The information chosen to include will depend upon the complexity of the equipment purchased – less technical detail is needed for simple equipment or recurrent supplies.

Ideally the evaluation information sheets should allow side-by-side comparison of the offers. For tenders there are more responses and the orders tend to be more complex, so more paperwork is required to obtain a true comparison. Usually there is too much information to be compiled in a single sheet, so it may be better to use:

one sheet for collating purely technical information about the product;
one for information on accessories, consumables, and spare parts;
one for after-sales service; and
one for price information.

The procurement unit should present the evaluation information sheets to the procurement/tender committee (for tenders and high-value quotes) or the Procurement Manager (for low-value quotes). They should be accompanied by an explanation of the requirements, main objectives, and any binding constraints. Then the technical evaluation process (Step 3) can commence.

Step 3: Carrying out the technical evaluation

The procurement/tender committee should base its decision on advice from members of the group with professional knowledge relevant to the offer. If appropriate, it should also seek advice from representatives from the relevant user department and HTM team (for low-value quotes, the Procurement Manager should also seek advice from these end-users).

The committee should consider the product selection criteria, as set out in the purchase document. It is essential that the information provided by the supplier is related only to the equipment specification and the selection criteria listed in the purchase document – any additional information intended to sway the evaluation can be seen as corruption; hence the importance of detailing requirements adequately in the purchase document. The better the purchase document, the easier the evaluation process will be. Box 11 lists a few points to remember, relating to the technical aspects of the offer.

Box 11: Summary technical assessment

If a detailed specification was issued, then every detail of the offer must be closely checked to make sure it conforms to the original specification. If only a brief specification was issued, then the checks should be limited to ensuring the equipment or service offered meets the requirements. Any modifications or alternatives offered must be assessed individually, and decisions made whether any one is more cost-effective than another. The technical assessment includes suitability, safety, ability to commission and train, after-sales support, warranty arrangements and more – do not simply assess technical data concerning the equipment.

For both quotations and tenders it may be necessary to ask the supplier to clarify any ambiguities or uncertainties. Alternatively, a shortlist of suppliers can be drawn up and those included can be asked to demonstrate their equipment, as part of the technical evaluation (this is unlikely to be necessary for very simple equipment, and may be impossible for many overseas suppliers).

After the technical evaluation, some offers are discarded if they fail to meet the requirements. The remaining offers can go forward to be compared in terms of financial performance.

Issues to consider when choosing equipment

Choosing equipment is not easy, due to the wide range of products available. External influences also play a part. For instance, external support agencies may impose their own conditions regarding suppliers, which may result in inappropriate equipment being supplied or procured. The acquisition policy should clearly specify the “good selection criteria” to employ. All equipment should:

be appropriate to its intended target setting;
be of assured quality and safety;
be affordable and cost-effective;
be easily used and maintained; and
conform to the existing policies, plans and guidelines.

These criteria, unpacked in Checklist 6 below, should be used during the procurement process when evaluating and adjudicating between different offers from suppliers.

Checklist 6: Example of good selection criteria for equipment purchasing

Indicators of appropriateness	Criteria
Appropriate to setting	Equipment should be: suitable for the level of facility and service provided; acceptable to staff and patients; suitable for operator skills available; suitable for the local maintenance support capabilities; compatible with existing equipment and consumable supplies; compatible with existing utilities and energy supplies; suited to the local climate, geography and conditions; and able to be run economically with local resources.
Assured quality and safety	Equipment should be: of sufficient quality to meet institutional requirements and last a reasonable length of time; made of materials that are durable and hard-wearing; made from material that can be easily cleaned, disinfected, or sterilised without rusting; manufactured to meet internationally recognised safety and performance standards; suitably packaged and labelled so that it is not damaged in transit or during storage; and provided by reputable, reliable, licensed manufacturers, or registered suppliers.
Affordable and cost-effective	Equipment should be: available at a price that is cost-effective. Quality and cost often go together (for example, the cheaper option may be of poor quality and ultimately prove to be a false economy); affordable in terms of costs for freight, insurance, import tax, etc.; affordable in terms of installation, commissioning, and training of staff to use and maintain them; affordable to operate (for example, cover the costs of consumables, accessories, spare parts and fuel over its lifetime); affordable to maintain and service; affordable to dispose of safely; affordable in terms of the procurement process (for example the cost of a procurement agent or foreign exchange); and affordable in terms of staffing costs (for example, costs of any additional staff or specialisation training required).
Ease of use and maintenance	Equipment should be chosen for which the necessary skills in terms of operating, cleaning and maintenance are available; for which instructions and manuals are available in a suitable language; for which staff training is offered by the supplier; for which local after-sales support is available with real technical skills; which offers the possibility of additional technical assistance through service contracts; which comes with a warranty/guarantee, covering a reasonable length of time, for which the terms are understood ~~the terms~~ (for example, does it cover parts, labour, travel, refunds or replacements?); which offers a supply route for equipment-related supplies (for example, consumables, accessories, spare parts); and which offers assured availability of these supplies for a reasonable period (up to 10 years).
Conforms to existing policies, plans and guidelines	Equipment should be chosen: according to the purchasing and donations policy; according to the standardisation policy; according to the technology level described in the Standard Equipment Lists and Generic Equipment Specifications; which is deemed to be suitable, having studied available literature and compared products; and which is deemed to be suitable, having received feedback regarding previous purchases.

It may also be appropriate to have a set of criteria to evaluate equipment suppliers, both current and past, as per Checklist 7.

Checklist 7: Suggested criteria for evaluating current and past suppliers

Issue	Criteria
Participation record	Has the supplier accepted an award of bid/quotation and subsequently failed to deliver? Has the supplier attempted to alter or withdraw bids after submission? Has the supplier promised after-sales support, then failed to provide it?
Response to enquiry	Has the supplier adequately responded to all enquiries and within a reasonable period of time? Did the supplier provide regular updates on the status of outstanding orders?
Delivery time (for consumables)	What was the supplier’s average promised lead time? What was the actual lead time for the last round of procurement? What additional costs were incurred due to late shipments (if applicable)?
Adherence to delivery instructions	Did the shipments arrive under proper shipping conditions? Did the supplier send full shipments as requested, or were there partial shipments?
Provisions of documents	Were advance copies of documents provided according to contract terms? Did shipments arrive with all required documents correctly filled out and signed? Were adequate site preparation instructions provided? Were adequate training materials provided? If required documents were omitted, how did the supplier correct the problem?
Packing and labelling (mainly for consumables)	Was labelling complete and adequate for proper use? Was it in the correct language? Did the supplier ship the correct package size? Were the correct contents and quantities in each package? Did external packaging protect the product from damage during transport in country?
Product shelf life (for consumables)	Did the products comply with contractual terms for remaining shelf life? If not, how many were shipped with shelf life less than specified? Did the supplier replace items that did not have acceptable remaining shelf life or allow the return for credit or exchange of goods nearing their expiration date?
Compliance with contract financial terms	Did all invoices comply with contract pricing terms? Were all shipments correctly insured and shipped, according to financial terms in the contract? Were there any problems obtaining compensation or reimbursement for lost or damaged goods? Were there any problems obtaining compensation or reimbursement for poor services (such as commissioning and training)?
Quality of products and services	Have complaints been received concerning product quality for this supplier? Did the supplier cooperate in making samples available and paying for any quality-control tests performed by quality-assurance agencies? Have any complaints been received concerning the quality of services provided by this supplier (such as installation, commissioning, and initial training)? Have any complaints been received concerning the quality of after-sales support from this supplier?

Adapted from: Management Sciences for Health, 2002, “Managing drug supply”, MSH, Boston, USA.

6.5 Donations

Donations are a special case of procurement, and great care needs to be exercised in managing the procurement process associated with donated equipment. The World Health Organization (WHO)[1] and other bodies have drafted guidelines to facilitate this process.

Receipt, testing, installation & commissioning

Pre-installation work / site preparation

The site at which the device is to be installed has to be adequately prepared, more so in the case of large, sophisticated devices like x-rays, autoclaves. This has to be coordinated with logistics of the device supply so that the site is ready when the device is delivered at the institution. The associated utilities like appropriate power supply, water, compressed air and the like, as well as other appropriate requirements like radiation protection should also be taken into consideration. In situations where extensive site preparation is necessary, like in x-rays or CT scans, site works should be included as part of the acquisition process to ensure comprehensive and coordinated site preparation.

Pre-installation work involves:

preparing the site ready for equipment when it arrives;
organising any lifting equipment;
organising any warehouse (storage) space;
confirming installation and commissioning details; and
confirming training details.

In some cases, the pre-installation work required is minimal; in others it requires considerable labour and finance. As a general guide, site preparation is the work required to ensure that the room or space where the equipment will be installed is suitable. It often requires the provision of new service supply connections (for electricity, water, drainage, gas, waste) and may require some construction work. Site preparation tasks can include:

disposing of the existing obsolete item (disconnection, removal, cannibalising for parts, transport, decontamination and disposal);
extending pipelines and supply connections to the site, from the existing service installations;
upgrading the type of supply, such as increasing the voltage, or the pipeline diameter;
providing new surfaces, such as laying concrete, or providing new worktops; and
creating the correct installation site – for example, digging trenches, building a transformer house or a compressor housing.

In considering where to position equipment, the following types of questions should be asked:

Is there sufficient access to the room/space? (Door sizes and elevator capacity are very important for x-ray and other large machines.)
Is the room/space large enough?
Is the position and layout of the room/space suitable?
Are the required work surfaces and service supply points available?
Is the environment adequate for the purpose? (For example, is it air-conditioned? Dust-free? Away from running water?)

If new buildings or extensions are being constructed, different relevant departments and groups need to work closely together to design the rooms and plan the service supplies. Planners, users, architects, service engineers, and equipment engineers need to be consulted.

Site preparation can be carried out by:

in-house staff (for example, the facility HTM team or a central/regional HTM team);
maintenance staff from other national agencies (for example, electricians from the Ministry of Public Works);
a contractor who has been hired (for example, a private company or an NGO partner); and
the suppliers or their representative.

When planning and budgeting for the equipment, site-preparation costs should have been estimated for inclusion in the budget. However, as soon as the order is placed, the HTM working group / procurement unit should provide the supplier with details of the proposed equipment site and services, and officially request the necessary site preparation instructions.

Once these are received the HTM manager can plan the work, quantify the needs and costs for materials and contractors, and apply for a budget allocation. He or she should then oversee the work, and ensure it is undertaken before the equipment arrives.

Flowchart 8 below shows the common site preparation steps that may be required, depending on the type of equipment purchased. By the time the goods start to arrive, the site should be ready to receive them.

An overview of the acceptance process

Each health facility should have an official acceptance process for equipment that arrives on site (a simpler process is used when equipment-related supplies arrive on their own). During the acceptance process, the following should be established:

the complete order has arrived;

installation, commissioning, and initial training has taken place;
the equipment is mechanically and electrically safe for users and patients and is functioning properly; and
the equipment is entered into the health facility inventory.

A simple way to carry out these activities is to fill in a standard Acceptance Test Logsheet. This form is specially designed to make checking easier and to help to avoid mistakes. It is an important document since it is the first record to be placed in the equipment file and provides all relevant details of the start of the equipment’s life at the health facility, and commences the service history of the equipment. The Acceptance Test Logsheet has sections that cover all the components of the acceptance process, including:

delivery/receipt of the equipment on site;
unpacking and checking for damage and for the complete order;
assembly;
installation;
commissioning and safety testing;
official acceptance;
initial training;
registration – entering stocks into stores and onto records; and
handover.

Each of these sections in the logsheet needs to be completed and signed off to indicate that the activity has been successfully completed. Once the logsheet has been fully completed, it is signed off to certify that the equipment and services are satisfactory. Only then should payment be made.

If there are problems with goods or services, the Acceptance Test Logsheet should not be signed; instead ~~write~~ a fault report on the equipment’s shortcomings should be logged, outlining the problems encountered and advising that payment be withheld until the problems have been addressed.

The equipment is not normally put into routine use until the complaints have been resolved, the logsheet finally signed off, and the payments made. The acceptance process is straightforward for common low-complexity items of equipment that are simple to use. Installation, commissioning, and initial training are not major activities and can happen all at once – e.g. for a mobile examination lamp:

Installation involves using a test meter to check the electricity supply of the socket outlet, and then simply plugging in the lamp.
Commissioning involves using a test meter to check the electrical safety of the lamp so that it will not give the operator an electric shock.
Initial training involves ensuring the operator knows where the on/off switch is, how to handle the light bulb, and how to alter the angle of the head without pulling the lamp over.

Commissioning

Commissioning usually, but not always, takes place straight after installation. The technical and safety aspects of the equipment should already have been specified and considered during the selection process. However, it is also essential to carry out performance and safety tests on each piece of equipment. Such tests validate that each piece of equipment is safe and is capable of performing its intended function. Performance and safety tests should be carried out regardless of whether equipment is purchased, donated, leased or borrowed by the health facility. The commissioning team and any visiting installers are responsible for ensuring these tests take place. The steps in the commissioning process are shown in Flowchart 9.

Once the equipment has passed its safety, calibration, and function tests, the commissioning team is in a position to:

officially accept that the equipment has been received in a satisfactory condition, and
officially accept the equipment as the institution/department’s property.

This could trigger the payment for the goods only. Payment for services can only occur when the training is finished, if it was part of the purchase contract. If the equipment has not passed the tests, negotiations would be commenced with the supplier and complaints procedures initiated. The equipment should not be accepted or used until these issues have been resolved. Once the equipment is accepted, staff can be trained in its operation and maintenance.

Registration and handover

Once equipment and supplies have been officially accepted, they can be registered in various health facility records and systems, process them, and stored or used as appropriate. The commissioning team is responsible for ensuring that all these activities take place.

Entering new equipment orders into health facility records

All equipment and equipment-related supplies need to be entered into the health facility’s records and systems. The most common records and systems are the:

Equipment Inventory (manual or computerised). The HTM manager should enter new major pieces of equipment onto the Equipment Inventory. The type of information recorded should identify the particular piece of equipment, its manufacturer and location. The HTM manager can gather this information from the Acceptance Test Logsheet and the Register of New Stocks form. In addition, the HTM manager should allocate a unique inventory code number to each piece of equipment and ensure the equipment is labelled/marked with this code number.
Equipment File (manual or computerised). This acts as a service history for a particular piece of equipment. The HTM manager should open a new Equipment File for each piece of equipment, and label the file with the equipment’s inventory code number. The type of information recorded in this file at the acceptance stage should include details of the manufacturer/supplier and purchase contract terms. Much of this information will be contained in the completed Acceptance Test Logsheet, which should be the first document placed in this file with supplementary data as required. Subsequent records placed in the Equipment File are of any maintenance work carried out so that the file becomes the equipment’s service history.
Planned preventive maintenance (PPM) programme. The HTM manager should register equipment for any PPM carried out by maintenance staff (if it is taking place), and enter it onto their PPM timetable so that it gets attention at regular intervals. On handover of the equipment to the user, the HTM manager should liaise with the head of the user department about registering the equipment for any user PPM [BvR1] taking place, and entering it onto their user PPM timetable [see Section 10.2 for further discussion on maintenance].
Equipment card. This is a piece of card or laminated sheet that is permanently kept with the equipment. It can provide users with a summary of the equipment care instructions and a summary service history, such as dates when routine inspections, testing, and servicing took place.
Register of New Stocks form. This provides the Stores Controller with all the information required for entering each new piece of equipment and its supplies into the stores stock control system. The commissioning team should (partially) complete this form by gathering information from the available contract, packing lists, or invoice, according to a standard format. The type of information should identify the manufacturer/supplier’s order codes, description, and batch sizes of the equipment, consumables, accessories, and spare parts. The Stores Controller finishes completing the form by allocating and recording each item’s unique stores code. The Stores Controller provides copies of the finalised forms to the user departments and HTM team so they can order the correct replacement items in future. The HTM manager keeps this form in the relevant Equipment File.
Registering warranties. The guarantee or warranty of the equipment (if applicable) needs to be registered. The date of commencement and the period of the warranty which have been agreed with the supplier must be entered into all relevant procurement, finance, and maintenance records.
Note: Once the equipment has been checked and is confirmed as safe and ready for use, it is sensible to highlight this fact. Use a simple strip of tape placed across the main controls of the apparatus to clearly show that it has been tested. It is preferable to use printed warning notice tape, but other types could be used.

Storing manuals

Operator and service manuals should be supplied with the equipment, according to the purchase document. It is important to make sure that manuals are kept in a safe place, and are not lost by staff. It is also important to make them widely available for use among users and maintenance staff. This can be done by:

Storing the original copies in a safe place, such as the clinical engineering workshop library, the main stores office, or the HTM service library.
Making two photocopies of all operator manuals received, and giving one set to the head of the relevant user department, and the other to the HTM team or workshop responsible for the equipment’s maintenance.
Making one photocopy of the service manuals received, and giving it to the HTM team or workshop responsible for the equipment’s maintenance.
Asking for manuals or their content in other formats, such as CD-Rom, video, DVD.
Scanning the printed documents into a computer to convert them into electronic copies, and making them easily available to maintenance staff at many locations.
Recording in the Equipment File how the manuals were distributed. This helps with monitoring and updating the manuals in future.

Training

Introduction

After successful installation and commissioning, the users and maintainers need training on the type of equipment and the model purchased. This training can take place straight after commissioning, with the installation team acting as the trainers. However, the training team often involves different people, such as those with clinical or training skills. In this case, the training may take place sometime later when the training team has assembled.

Ideally, the initial training occurs straight after commissioning. After the training, the equipment can be handed over to the user department for regular use. However, if there is a delay before training can take place, one may have to consider whether to hand over the equipment before training staff. We recognise that there will be pressure to do this as all staff want to start using new equipment as soon as possible.

However, this should only be done if:

the equipment is a type that has been used before;
the staff are familiar with the equipment; and
experienced staff members are in charge of its use, until the remaining staff can be trained.

Note: Anyone using or working on equipment without proper training or authority whose actions result in an accident is likely to be found negligent.

Depending on the complexity of the equipment and the staff’s previous experience of it, initial training can include:

good practice when handling the equipment;
basic “dos and don’ts”;
how to operate the equipment (along with familiarisation with the symbols and markings on the machine);
the correct application of the equipment;
care, cleaning, and decontamination;
safety procedures;
planned preventive maintenance (PPM) for users; and
PPM and repair for maintainers.

The level and nature of training provided depends on whether the equipment is:

A standard make and model. If staff are familiar with the equipment, in-house staff could train new users and provide refresher training for other staff. The training sub-group should produce suitable and necessary training resources and handouts for the trainees, using the operator and service manuals, and any videos available.
A new make or model. If the equipment is unfamiliar, training should be carried out by the supplier or their representative, or by a central training team with knowledge of the equipment. The training sub-group should observe the training session, obtain copies of any overheads or handouts used, and compile its own training pack for future training.

Sometimes in-depth training is given only to very few staff members who, at a later stage, will train the rest of the users. In this case, a training timetable is needed to ensure the ongoing training occurs.

Note:

One should ensure that the chosen trainees turn up for the training sessions, and maintain records of the training that individual staff members have received.
A library of the training resources developed should be established.
The representatives of both the commissioning team and visiting training team should sign the Acceptance Test Logsheet, to avoid later disputes.

Correct application

Staff may feel confident about how to operate equipment, but it is imperative that they also know the correct “application” for the equipment. Staff need to be able to apply their taught (clinical) procedures correctly, and to employ the correct methods of application so that equipment is used to its fullest capacity.

Staff will need to be trained in order to fully appreciate when and how to use equipment. They will need to know:

when different features will be employed for different patients or uses the range of assistance a machine can offer them;
how to alter the relationship between the machine and the patient, or sample, for different purposes; and
the different procedures to pursue for different disorders or treatments.

They will also need to understand the safety precautions they must take. Traditionally, colleges offering basic training for health are responsible for teaching clinical procedures. Thus, they must have access to the necessary equipment for this purpose, both in their teaching rooms and at suitable clinical locations such as hospitals.

It is important to note that training is an ongoing endeavour. Staff come and go, and even staff who have received initial training on an item of equipment may need refresher training. It is therefore useful to have a mechanism that will trigger training interventions. Flowchart 10 suggests appropriate triggers.

Flowchart 10: Example of prompts showing that training is required

When the device is removed from service, professional users should know how to clean it and to organise decontamination.

Special case: for home-based care or patient-operated devices

Professional users, clinical supervisors and prescribers need to make sure that training for end-users enables them to use a medical device/equipment safely and effectively, and to perform routine maintenance as appropriate for the medical device/equipment. For example, end-users of ambulatory infusion pumps should be aware of how the medical device works, including special features such as bolus delivery, and the risks of siphoning if a syringe is removed from a driver. It is also essential that end-users are provided with information contained in manufacturer’s instructions and that it is explained and, where necessary, expanded upon. Where possible, user organisations should provide the same standards of equipment and training for end-users as they do for staff.

Operation

Introduction

“Operation” of equipment means using the correct physical methods to get the equipment to work. In order to do this successfully, the user needs to know:

the specific operating characteristics of the equipment;
the operational procedures that make the machine work;
how to use its various functions;
how to make it perform its customary cycles and routines; and
how to change the bulb, paper roll, batteries, etc.

The equipment manufacturer’s user manual is often the best source of this information. Other sources include:

written resources from staff training sessions;
experienced colleagues; and
a wide range of reference material.

Box 12 provides some examples of general strategies when operating equipment

Box 12. General strategies when operating equipment (for users)

Make sure you have the authority and knowledge to operate equipment before you start; Refer to the manufacturer’s operating manual for correct advice. Always follow the safety procedures specific to the machine. Only connect a machine to an electrical socket outlet which has been checked by the electrician for proper grounding, and only use the correct plug for the socket (for example, never put a two-pin plug into a three-pin socket). Do not start equipment that requires water for its operation without checking that the water supply is available. Use equipment/machinery only with the correct type and quantities of water, oil, fuel, etc. Always handle accessories carefully as these are the most easily damaged component of equipment. Always use the correct consumables without wasting them. Always respond to alarms, and check what is causing them. Ensure that the relevant waste pipeline is not blocked, before allowing equipment to discharge its contents into the waste water/sewage system or special container for hazardous material. If the electricity power supply is cut off, switch off all electrical equipment to protect it from electrical surges which may occur when the power is restored; once power is returned, ensure that vital equipment (such as refrigerators) is switched back on. Ensure that any mains-powered equipment which will be required to work off batteries during a power failure (defibrillator, vital signs monitor, ICU ventilator, etc.) is always plugged into a live socket and left switched on so that its batteries are continuously charged. When oxygen and other gases are no longer required, turn off the supply so that gas is not discharged into the atmosphere and wasted.

Each type of equipment has specific operating instructions. When operating equipment, it is also essential to follow good strategies for using consumable materials.

Equipment users should only operate equipment for which they are suitably qualified. Clinical meetings, committee meetings, departmental meetings, or specifically organised training sessions can all be used to provide application training (as appropriate).

For specialised devices e.g. autoclave, x-rays, the right type of personnel are required to operate these devices. Certification may be a requirement for some specialised devices. Regular monitoring has to be carried out for certain specialised devices (e.g. radiation safety monitoring for x-ray machines). User manuals should be provided for all devices to enable users to operate all devices safely and effectively, as well as for trouble-shooting for simple problems encountered with devices.

Care and cleaning

To maximise the life of equipment, it is necessary that equipment users and maintainers know how to look after the equipment and clean it. Users must care for and clean equipment regularly, to a given timetable. It is beneficial to do this because:

it is easier to see faults (such as damaged suction pump tubing) when the equipment is clean;
it prolongs the life of equipment (for example, protecting electronic parts from damage by dust, protecting metal from corrosion by liquids or chemicals, protecting rubber seals from degradation by greases);
it protects the operator and patient from infections (from microscope eyepieces, for example); and
it improves the performance of equipment (clean probes for ultrasound, clean seals on fridge doors, etc.).

The best information regarding the care and cleaning of equipment is usually contained in the manufacturer’s user manual and/or service manual. In addition, staff should have written resources from their training sessions and, in some cases, posters which provide the guidance and experience of their colleagues.

Equipment-related infection control

Internationally, the term “infection control” has come to mean control of a wide range of practices, processes and procedures in the clinical work of the health facility as a whole. Proper infection control (relating to equipment) can be achieved by making decisions about a number of different issues:

decontamination, through appropriate use of cleaning, disinfection, and sterilisation methods, as well as monitoring sterility;
linen handling; and
ensuring the workplace is clean.

Information and advice must be sought from the relevant national body that is responsible for infection control, since national policies should have been established to ensure that risks are reduced. It is suggested that the central HTM working group, or its smaller sub-group, the infection control committee, should be responsible for establishing policies and guidelines to prevent contamination through exposure to blood, body fluids, body parts, and infectious agents.

Staff accountability

Finally, the issue of staff accountability should be addressed. Checklist 8 includes checks for different role-players as part of a systemic approach.

Checklist 8: Strategies for making staff more accountable

Type of Staff	Strategies
Heads of section	- given overall responsibility for the equipment in their section, according to their inventory and undertake regular inventory checks to look for missing equipment and accessories; - made responsible for conforming to the local security regulations for the facility and its site; and - ensure their staff have sufficient skills to operate and care for equipment correctly and safely, and help them to access appropriate training or reference materials.
Operators-in-charge	- uring every shift, made responsible for undertaking functional checks on the equipment as part of user planned preventive maintenance (PPM) schedules.
Equipment users	- made responsible for the state of the equipment, accessories and consumables they handle and use; - take personal responsibility for ensuring they operate equipment correctly, and that they know the correct operating techniques and applications; - take personal responsibility for using the correct consumables in a non-wasteful way; - take personal responsibility for ensuring they operate equipment safely, and knowing the proper safety procedures; - made responsible for the daily care and cleaning of the equipment they use with the correct cleaning chemicals; - made responsible for monitoring that equipment is functioning properly and is providing the type of results expected, and reporting any faults immediately to the HTM team through their head of section; - ensure they have been specifically trained to undertake these tasks, and if they require further skill-development put in a request to their head of section; and - take responsibility for conforming to the local security regulations for the facility and its site.
purchasing and supplies officers	- made responsible for purchasing the correct consumables and cleaning chemicals.
Stores controllers	- made responsible for keeping track of stocks of consumables and materials in the various stores.
Health management teams	- develop a suitable working environment where managers are seen to be present, and performing well themselves; - consider positive strategies with bonuses and rewards for good behaviour with equipment, as incentives for making staff more responsible and accountable; and - consider disciplinary mechanisms so that staff are charged for intentional loss of, or damage to equipment and accessories, to make them more accountable for their actions.

Maintenance, risk-management and safety

Introduction

An effective medical equipment maintenance programme consists of adequate planning, management and implementation. Planning considers the financial, physical and human resources required to adequately implement the maintenance activities. Once the programme has been defined, financial, personnel and operational aspects are continually examined and managed to ensure the programme continues uninterrupted and improves as necessary. Ultimately, proper implementation of the programme is key to ensuring optimal equipment functionality. Box 13 lists the some of the responsibilities and tools typically associated with a medical equipment maintenance system.

Box 13: Summary of registers, ledgers and files used for maintenance and who keeps them

Equipment users and managers	- Work request/job forms used for recording the details of the request for maintenance support and also used by maintainers to record the work done. - User department maintenance files to keep track of the requests made and their progress. - User PPM schedules for each type of equipment, PPM timetables and wall calendars. - Equipment cards attached to/kept with all pieces of equipment, showing user PPM and care instructions and service due dates.
Maintainers	- Work request/job forms submitted by equipment users and used by the maintainers for recording the details of the work undertaken. - 'Personal record books[1]' to keep track of special problems and successes with work, which help to identify skill development needs. - PPM schedules for each type of equipment. - Equipment cards attached to/kept with all pieces of equipment used by the maintainers for recording dates when routine inspections, testing, and servicing took place, and are next due.
HTM manager (and possibly a clerk)	- Inventories of equipment, furniture, buildings, tools, etc. - PPM timetables and wall calendars showing when PPM was undertaken on different devices. - Job pending files and job completed files kept by the HTM team to keep track of the requests received and their progress. - A contractors’ record book/file to record which contractor undertook which job, and their performance. - Equipment files and section files which create service histories. - Statistics forms and statistics folders for keeping various statistical records for analysis and for compiling written reports for management.
HTM team’s stores-person	- A tools ledger in order to keep a record of: the tools owned, which staff members were allocated which tools, and the return of the tools at the end of the day. - Stock cards used by the HTM team’s stores-person to record and keep track of the different items stocked in the storeroom. - A stock control ledger kept by the HTM team in order to monitor the quantities of parts and materials used and kept in stock.

Simple repairs should be carried out by users. Other repairs should be carried out by clinical engineering personnel. Specialised or complex repairs should be carried out by suppliers.
Planned preventive maintenance should be carried out to minimise down-time of devices (e.g. to replace x-ray tube at time period recommended by manufacturer rather than when tube fails).
Calibration and testing should be carried out at regular intervals, as recommended by the manufacturer, by users or clinical engineering personnel – depending on the complexity of the device.
Records of maintenance and repairs of devices should be documented in a maintenance log, while a plant register is to be maintained for sophisticated or specialised devices.

A maintenance strategy includes procedures for inspection, as well as preventive and corrective maintenance. Performance inspections ensure that equipment is operating correctly, safety inspections ensure the equipment is safe for both patients and operators, and preventive maintenance (PM) aims to extend the life of the equipment and reduce failure rates. Additionally, some hidden problems may be discovered during a scheduled inspection. However, performing inspections of equipment only ensures that the device is in good operating condition at the time of inspection and cannot eliminate the possibility of failure during future use; the nature of most electrical and mechanical components is that they can potentially fail at any time. Corrective maintenance (CM) restores the function of a failed device and allows it to be put back into service.

Risk-based maintenance strategy

A risk-based maintenance strategy prioritises maintenance resources toward assets that carry the most risk if they were to fail. It is a methodology for determining the most economical use of maintenance resources. This is done so that the maintenance effort across a facility is optimised to minimise the total risk of failure.

A risk-based maintenance strategy is based on two main phases:

Risk assessment.
Maintenance planning based on the risk.

The maintenance frequency and type are prioritised based on the risk of failure. Assets that have a greater risk and consequence of failure are maintained and monitored more frequently. Assets that carry a lower risk are subjected to a less stringent maintenance programme. By this process, the total risk of failure is minimised across the facility in the most economical way.

Risk is adopted as an index for clarifying priority in risk maintenance[BvR1] technologies. That risk can be given as the product of the probability of failure occurring to the inspected area and the consequence of failure to the surroundings. In other words, risk is the expected value of the degree of impact. Figure 1 shows the concept of distribution of risk held by devices in a system.

Risk evaluation - factors impacting on risk

At the risk-evaluation stage, both the probability of the risk and the consequence of the risk are quantified in the context of the equipment group under consideration. For this specific model, more emphasis has been placed on risk factors impacting directly on the maintenance function.

Volume

Availability of alternative devices to perform the same required function

Score Intensity

5 - Very low volume (only one per hospital).

4 - Low volume.

3 - Medium (loan units available).

2 - Moderate (some duplication exist).

1 - High volume (high numbers per unit).

Function

Equipment function has a direct impact on the risk associated with the equipment:

Score Function

5 – Life-support.

4.5 - Surgical and intensive care.

4 - Physical therapy and treatment.

3.5 - Surgical and intensive care monitoring.

3 - Additional physiological monitoring and diagnostic.

2.5 - Analytical laboratory.

2 - Laboratory accessories.

1.5 - Computer and related.

1 - Patient Related Furniture and Other.

Physical risk

The risk associated with equipment failure and/or misuse measured by the impact on patient and/or staff injury

Score Risk

5 - Patient death.

4 - Patient or operator injury.

3 - Inappropriate therapy or misdiagnosis.

2 - Operational risk.

1 - No significant risk.

Maintenance intensity

Maintenance intensity in the operational environment also impacts on the risk model due to the specific requirements placed on scarce resources such as technical staff and financial constraints.

Score Intensity

5 - Extensive and costly with highly skilled technical staff involved.

4 - Moderate skilled technical resources required but still costly.

3 - Average skilled technical resources required with low cost associated.

2 - Low technical skill required with low cost.

1 - Minimal maintenance required.

Technology intensity

This is the risk associated with the requirements placed on the operator due to the nature and technology level of the equipment. Qualified operators and trained staff remain a scarce resource in the medical device industry.

Score Intensity

5 - Operator-certified and specialised training required.

4 - Specialist nursing training required.

3 - Average training required.

2 - Very low skill level required.

1 - No training required.

Risk ranking and risk classes

With the risk evaluation complete, the probability and consequence are combined to determine the total risk. This total risk is ranked against pre-determined levels of risk. As a result, the risk is either acceptable or unacceptable.

Equipment groups can therefore be divided into three major classes according to the risk evaluation outcome:

High-risk equipment – risk score of 75% and higher

Risk is not acceptable and preventive maintenance and condition monitoring is highly advised.
This category includes all life-support devices, key resuscitation devices, and other devices whose failure or misuse is reasonably likely to result in serious injury to patients or staff.
High impact on hospital operational activities.
Low volume of items increases risk.
Device history could increase or reduce risk.

Medium-risk equipment – risk score of 50% to 75%

Risk is not acceptable and preventive maintenance and/or condition monitoring advised.
This category includes devices whose misuse, failure, or absence would have significant impact on patient care, but would not likely cause immediate serious injury.
Medium impact on hospital operational activities.
Low volume of devices raises risk.
Device history could increase or reduce risk.

Low-risk equipment – risk score of 50% and lower

Risk is acceptable and very low level of preventive maintenance – if any maintenance is advised.
This category includes devices whose failure or misuse is unlikely to have serious consequences.
Very low impact on hospital operational activities.
High volume of devices reduces risk.

Inspection and preventive maintenance planning

Maintenance planning should always start with a basic approach ~~were~~ where only staff and maintenance material are required, and further evolve to a more advanced approach where the specific asset and method required for the asset are addressed. This also forms the basis for the maintenance excellence hierarchy. The preventative maintenance planning is based on the following diagram:

Equipment supported

The starting point for any advanced maintenance approach is to know exactly what is being maintained. The model therefore makes use of Standard Equipment List(s) obtained from NDoH. The Standard Equipment List (SEL) per level of care is a list of the medical equipment in the various nursing departments and provides detail per room level. The SELs for the various levels of care are combined in the model and standardised according to Universal Medical Device Nomenclature System™ (UMDNS). The combined equipment list is grouped according to the various equipment groups and the risk model applied.

Final quantities of equipment determined by number of facilities to achieve a theoretical equipment list per province/district. This theoretical HT Asset Register can now be further manipulated to accept changes made to quantities of specific unique items.

Method - maintenance procedures and intervals

Maintenance procedures and intervals are determined by the manufacturer and/or legal requirements. There are international minimum accepted norms available to determine not only the service/inspection interval (Table 4) but also the minimum procedure to be performed (NB with Table 4: All other types: once a year).

Table 4: Maintenance intervals for different equipment types

Equipment type	Interval p.a.	Equipment type	Interval p.a.
Anaesthesia Unit Vaporisers	2	Infusion Devices	1
Anaesthesia Unit Ventilators	2	Intra-Aortic Balloon Pumps	2
Anaesthesia Units	2	Isolated Power Systems	2
Apnoea Monitors	1	Laparoscopic Insufflators	1
Argon-Enhanced Coagulation Units	1	Mammography Units	2
Argon Surgical Lasers	2	Medical Gas/Vacuum Systems	1
Aspirators, Emergency and Tracheal	2	Mini C-arms	2
Automated External Defibrillators	2	Mobile C-arms	2
Autotransfusion Units	2	Mobile High-Efficiency-Filter Air Cleaners	4
Beds, Electric	1	Mobile x-ray Units	2
Blood Pressure Monitors, Electronic Indirect	1	Nd:YAG Surgical Lasers	2
Blood Pressure Monitors, Invasive	1	Oxygen-Air Proportioners	1
Blood/Solution Warmers	1	Oxygen Analysers	1
Capnometers and Multiple Medical Gas Monitors	1	Oxygen Concentrators	4
Carbon Dioxide Surgical Lasers	2	Pacemakers, External Invasive	1
Cardiac Resuscitators	2	Pacemakers, External Non-invasive	2
Centrifuges	1	Peritoneal Dialysis Units	2
Circulating-Fluid Pumps	1	Phototherapy Units	1
Circumcision Clamps	1	Physical Therapy Ultrasound Units	1
Conductive Furniture and Floors	12	Pneumatic Tourniquets	2
Critical Care Ventilators	2	Portable Ventilators	2
Cryosurgical Units	1	Pressure Transducers	2
Defibrillators	2	Pulmonary Resuscitators, Gas-Powered	1
ECG Monitors	1	Pulmonary Resuscitators, Manual	1
Electrical Receptacles	1	Pulse Oximeters	1
Electrocardiographs	1	Radiant Warmers	1
Electrosurgical Units	2	Radiographic Units, General Purpose	2
Fetal Monitors	1	Radiographic/Fluoroscopic Units, General-Purpose	2
Frequency-Doubled Nd:YAG Surgical Lasers	2	Smoke Evacuators	1
Heart-Lung Bypass Units	³4	Sphygmomanometers	1
Heated Humidifiers	1	Suction Regulators, Tracheal^*	2
Hemodialysis Units	4	Temperature Monitors	1
Ho:YAG Surgical Lasers	2	Traction Units	1
Hypo/Hyperthermia Units	1	Transcutaneous O₂/CO₂ Monitors	1
Infant Incubators	1	Ultrasound Scanners	1

Materials – service required items

Material required for preventive maintenance is very device- and manufacturer-specific and cannot be generalised or averaged to be used in the model. The majority of the maintenance and repair workload is simple tasks requiring common spare parts. Therefore, try to remember that more than 80% of all spare parts needed (in theory), represent less than 20% of the overall spare parts cost. In other words, only 20% of your maintenance and repair tasks can eat up 80% of your spare parts budget, because the equipment is complex and expensive.

Staff – human resource requirement

The maintenance and repair requirements of healthcare facilities are more demanding than those of most other facilities. The high intensity of use, long operating hours (24-hours per day for most primary care hospitals) and high-technology specialised equipment all lead to a relatively high maintenance workload usually fulfilled by a combination of internal staff and external service providers.

There are a number of statistical models to determine the ideal staff level but most fail owing to the complexity of the different variables:

Technology level of hospital.
Availability of internal maintenance specialisation.
Internal vs outsourced maintenance combination.
Cost constraints.
Etc.

To get a better estimation of staff levels as well as the impact of outsourced maintenance, this model takes a number of specific factors related to staff into consideration:

Maintenance intensity of specific equipment

The combined theoretical equipment list contains a total of 768 unique equipment descriptions. Each equipment type has been graded according to the service requirement assigned by the service procedure and interval, as follows:

Table 5: Grading of equipment service requirements

Level	Major Service	Minor Service	Verification	Predictive Inspection	Reactive Maintenance
1	XXX	XXX	XXX	XXX	XXX
2		XXX	XXX	XXX	XXX
3			XXX	XXX	XXX
4				XXX	XXX
5					XXX

Major service

A service that normally requires the replacement of parts as well as consumable service items.

Minor service

A service that normally only requires the replacement of consumable service items.

Verification

The verification of equipment performance to a standard in the form of a performance analyser and/or simulator.

Predictive inspection

The inspection of equipment to a set list. No tools and/or verification equipment required.

Reactive maintenance

Only reactive work performed on equipment breakdown and/or failure.

The specific level of maintenance is always determined by the highest service requirement and may not always include the lower service requirements. A device that requires a major service but no minor services or verification will therefore be graded as Level 1 maintenance intensity, although not all services are required.

Maintenance trade classification

The specific staff skill required as well as the skill level is assigned to the service requirement of every unique equipment description.

Electronic high

Electronically qualified person with specialisation on specific equipment.

Electronic medium

Electronically qualified person without specialisation on specific equipment.

Electronic low

Person with electronic background but no formal tertiary qualification.

Mechanical high

Mechanically qualified person with specialisation on specific equipment.

Mechanical medium

Mechanically qualified person without specialisation on specific equipment.

Mechanical low

Person with mechanical background but no formal tertiary qualification.

Maintenance labour time requirement

An average of labour time per unique equipment description is calculated based on equipment group risk (maintenance intensity) and assigns the following values per service type:

Table 6: Labour hours per service type

Labour hours	Maintenance intensity risk score
Service type	1	2	3	4	5
Major service	1	1.5	2.5	3.5	4.5
Minor service	0.5	0.75	1.25	1.75	2.25
Verification	0.5	0.5	0.5	0.5	0.5
Predictive maintenance	0.25	0.25	0.25	0.25	0.25

The only equipment group that does not form part of the above table is radiology equipment, where equipment verification has been extended to an average of two hours per verification.

Outsourcing of maintenance activities

Many equipment types require very specialised training and tools for preventative as well as reactive maintenance. This high specialisation requirement on the maintenance often leads to the outsourcing of maintenance. Outsourcing could occur per equipment group or per unique device (manufacturer specific).

This model incorporates three different categories that can be user selected per unique equipment type:

Outsourced

All maintenance activities related to the specific equipment are performed by outsourced service providers.

Combined

The major and minor services as well as reactive maintenance are performed by outsourced service providers and verification and predictive maintenance are performed by internal staff. As a norm, the ratio of outsourced labour to internal labour is set at 70% to 30%. The ratio can be changed to accommodate various scenarios.

Internal

All maintenance activities performed by internal staff with the exception of some reactive maintenance outsourced (unique cases).

The various types of outsourcing contracts include:

Full coverage contracts shall be considered contracts which include both unscheduled (emergency repair) and scheduled (preventive/interval) maintenance. This type of coverage will involve the least amount of work for the operator and the Health Technology/Clinical Engineering Department, as it will be up to the vendor to complete all maintenance of the equipment. The time invested in the management of the contract will involve the most effort by the Health Technology Department as the billing will have to be monitored and the contract will need to be overseen to ensure that all provisions of the contract(s) are being carried out in a timely manner.

Unscheduled maintenance only (emergency repair) contracts are desirable where the ability to perform the scheduled maintenance programme exists within the hospital. Each item of equipment should receive a minimum of one (1) preventive maintenance inspection per year by the internal staff.

Scheduled maintenance only (preventive/interval maintenance inspection) contracts shall be considered cost-effective where the need for expensive specialised test equipment is needed and is not owned by the hospital, and/or where the reliability of the equipment is such that the unscheduled downtime of the equipment does not warrant the need for full coverage. Cost-effectiveness shall be a major part in this decision.

Parts only contracts shall be considered where the expertise to perform the work required is contained within the facility but the cost of parts is expensive. The decision to acquire this type of contract shall be supported by documentation to the cost of parts and the capability of the Biomedical Engineering staff.
Variations of and combinations of the aforementioned are another possibility. Where documentation is present, it is possible to decide the most cost-effective method of coverage for each piece of equipment. The extent of coverage and any portion of the workload which can be performed by the in-house staff shall be prime consideration to the exact type of coverage required.

Implementation of preventative maintenance plan

There are various combinations of outsourced maintenance and the planner needs to be very aware of the different impact these combinations might have on internal staffing levels. A phased approach according to equipment risk level should form the baseline for implementation.

It would be impractical and not cost-effective to include all equipment in a preventive maintenance plan; if the risk is acceptable then the specific equipment should not form part of an IPM plan and only reactive maintenance should be performed. We can divide the equipment list into groups for specific action, as shown below (sub-types have been removed, e.g. Radiographic Units, Dental, Extraoral and Radiographic Units, Dental, Intraoral are covered by the term Radiographic Units, Dental[BvR1] ) for the sake of brevity; the full lists are available on request. For each equipment type, there are established procedures and protocols for what needs to be done – these are available from organisations such as ECRI.

A. High-risk with high maintenance intensity – typical outsourcing with comprehensive service contracts and short-term implementation:

o Anesthesia Units

o Angioplasty Systems

o Apheresis Units

o Autotransfusion Units

o Brachytherapy Systems

o Circulatory Assist Units, Cardiac, Intra-Aortic Balloon

o Collimators, Radiographic

o Densitometers, Bone[BvR2]

o Detectors, Fluid Level, Heart-Lung Bypass Unit

o Heart-Lung Bypass Units

o Heat Exchangers, Heart-Lung Bypass

o Hemodialysis Units

o Peritoneal Dialysis Units

o Positive Airway Pressure Units, Continuous

o Pulsatile Pressure Generators, Heart-Lung Bypass

o Radiographic Systems/Units

o Radiographic/Fluoroscopic Systems/Units

o Radiotherapy Beam Block Shaping Systems

o Radiotherapy Simulation Systems

o Radiotherapy Systems, Linear Accelerator

o Scanning Systems, Computed Tomography

o Scanning Systems, Gamma Camera

o Scanning Systems, Magnetic Resonance Imaging

o Stereotactic Systems

o Ventilators.

B. High-risk with medium maintenance intensity – typical outsourcing of major services, verification and inspections performed by internal staff and short-term implementation:

o Defibrillators

o Echocardiographs

o Incubators

o Inflators, Angioplasty Balloon

o Lasers

o Pacemakers, Cardiac, External, Invasive Electrodes

o Phototherapy Units

o Programmer/Testers, Implantable Cardiac Pacemaker

o Scanning Systems, Ultrasonic

o Phantoms, Computed Tomography

o Nerve Locators

o Stimulators, Electrical

o Valves, Positive End-Expiratory Pressure.

C. High, high risk with low maintenance intensity – typical reactive maintenance performed by internal staff with parts-only contracts as possibility and medium- to long-term implementation:

o Angioscopes

o Brachytherapy Applicators/Sources

o Extractors, Plasma

o Masks, Resuscitator

o Radioisotope Transfer Units

o Resuscitators, Pulmonary, Manual, Reusable

o Transducers, Ultrasonic.

D. Medium-risk with high maintenance intensity - typical outsourcing of major services, verification and inspections performed by internal staff and medium- to long-term implementation:

o Aerators, Ethylene Oxide

o Analysers, Laboratory

o Cabinets, Biological Safety

o Cameras, Identification

o Chromatography Systems

o Cleaners, Bedpan

o Compressors

o Computer Aided Detection Systems, Papanicolaou Smear

o Detectors, Air Bubble/Foam, Heart-Lung Bypass Unit

o Disinfecting Units, Liquid, Flexible Endoscope

o Injectors, Contrast Media

o Laminar Air Flow Units

o Lithotripters

o Microscopes, Light, Operating

o Microwave Therapy Systems, Tissue Ablation, Prostatic

o Pill Counters, Automatic

o Printers, Dry-Processing

o Radiofrequency Therapy Systems

o Sterilising Units

o Stools, Adjustable, Dentistry

o Tables, Imaging, Ultrasound

o Tables, Operating

o Telemanipulation Systems, Surgical

o Thrombometers

o Tissue Processors

o Urodynamic Measurement Systems.

E. Medium-risk with medium/low maintenance intensity - typical maintenance performed by internal staff and long-term implementation.

F. All low-risk equipment – reactive maintenance only.

[BvR1]Not clear – punctuation might solve it, or an “and”

[BvR2]Bone detectors (from next item)?

Healthcare Technology

Contents

Background

Health technology context

Application of the Guidelines

Associated process and related documents

Life cycle of Health Technology

Planning

Introduction

Service and related technology planning

Planning and budgeting when starting out

Needs assessment

Standard lists of equipment

Usefulness of the standard equipment lists

Equipment development plan

Prioritising and appraisal of options

Consumables

Asset management

Inventory

Asset management system

Asset management software

Budgeting & financing

Estimates of budget lines for equipment expenditure

Estimates of maintenance costs for forward planning

Estimates of consumable operating costs for forward planning

Specific or annual estimates of consumable operating costs

Estimates of equipment replacement costs

Rough estimates of equipment-related administrative costs for forward planning

Requisitioning

Procurement

Introduction

Preparation of specifications

Evaluation and comparison process

Issues to consider when choosing equipment

6.5 Donations

Receipt, testing, installation & commissioning

Pre-installation work / site preparation

An overview of the acceptance process

Commissioning

Registration and handover

Entering new equipment orders into health facility records

Storing manuals

Training

Introduction

Correct application

Special case: for home-based care or patient-operated devices

Operation

Introduction

Care and cleaning

Equipment-related infection control

Staff accountability

Maintenance, risk-management and safety

Introduction

Risk-based maintenance strategy

Risk evaluation - factors impacting on risk

Risk ranking and risk classes

Inspection and preventive maintenance planning

Equipment supported

Method - maintenance procedures and intervals

Materials – service required items

Staff – human resource requirement

Maintenance intensity of specific equipment

Maintenance trade classification

Maintenance labour time requirement

Outsourcing of maintenance activities

Implementation of preventative maintenance plan

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