tabletMedical devices Management (MDM) involves the organisation and coordination of all of the following activities, which ensure the successful management of physical pieces of hardware:

Gathering reliable information about your equipment; Planning your technology needs and allocating sufficient funds for them; Purchasing suitable models and installing them effectively; Providing sufficient resources for their use; Operating them effectively and safely; Maintaining and repairing the equipment; Decommissioning, disposing, and replacing unsafe and obsolete items; and ensuring staff have the right skills to get the best use out of your equipment.

This will require you to have broad skills in the management of a number of areas, including: technical problems; finances; purchasing procedures; stores supply and control; workshops; staff development.

However, you also need skills to manage the place of Medical devices in the health system. Therefore, MDM means managing how Medical devices should interact and balance with your:

medical and surgical procedures; support services; consumable supplies, and facilities so that the complex whole enables you to provide the health services required.

Technology is the platform on which the delivery of healthcare rests, and the basis for provision of all health interventions. Technology generation, acquisition and utilisation require massive investment, and related decisions must be made carefully to ensure the best match between the supply of technology and health system needs, the appropriate balance between capital and recurrent costs, and the capacity to manage technology throughout its life. Health facilities are still burdened with many problems, including non-functioning medical equipment as a result of factors such as inadequate planning, inappropriate procurement, poorly organised and managed healthcare technical services, and a shortage of skilled personnel. The (mis-)management of physical assets impacts on the quality, efficiency and sustainability of health services at all levels, be it in a hospital setting with sophisticated life-support equipment, or at the primary healthcare level where simple equipment is needed for effective diagnosis and safe treatment of patients.

Clear policy, technical guidance, and practical tools are needed for effective and efficient management of Medical devices for it to impact on priority health problems and the health system's capacity to adequately respond to health needs and expectations. What is vital - at all levels and at all times - is a critical mass of affordable, appropriate, and properly functioning equipment used and applied correctly by competent personnel, with minimal risk to their patients and to themselves. Medical devices managers should aim to promote better management of medical devices and to provide practical advice on all aspects of its acquisition and utilisation, as well as on the organisation and financing of healthcare technical services that can deliver effective MDM. MDM capacity-building initiatives should be developed, and implemented by the designated manager, and will therefore contribute to MDM best practice. The World Health Organization (WHO) uses the broader term 'health technology', which it defines as including: 'devices, drugs, medical and surgical procedures - and the knowledge associated with these - used in the prevention, diagnosis and treatment of disease as well as in rehabilitation, and the organisational and supportive systems within which care is provided'. MDM activities require a multi-disciplinary approach, therefore it is important to form mixed teams which include representatives from the planning, financial, clinical, technical, and logistical areas. Allocation of responsibilities will depend upon a number of factors, including: the health service provider; the size of the organisation; the number of decentralised levels of authority; the size of the health facility; the level of autonomy.

At every level, there should also be a committee which regularly considers all equipment-related matters, and ensures decisions are made that are appropriate to the health system as a whole. The term MDM Working Group, (MDM WG) is used for this committee, which will advise the Health Management Teams on all equipment issues.

Due to its role, the MDM WG must be multi-disciplinary. Depending on the operational level of the MDM WG, its members could include the following: Head of medical/clinical services; Head of support services; Purchasing and supplies officer; Finance officer; Representatives from both medical equipment and plant maintenance; Representatives of equipment users from a variety of areas (medical/clinical, nursing, paramedical, support services, etc); Co-opted members (if specific equipment areas are discussed).

The MDM Working Group prepares the annual plans for equipment purchases, rehabilitation, and funding, and prioritises expenditure across the facility/district as a whole. It may have various sub-groups to help consider specific aspects of equipment management, such as pricing, commissioning, safety, etc. It is the goal of Medical Devices Management (MDM) to ensure that all the equipment belonging to health service providers is properly managed, utilised, maintained, and safeguarded. Financial investment in equipment also has to be protected, in order to avoid a situation where income is lost because equipment cannot be used. Joint ventures with commercial companies for equipment management can become profit centres for device management delivering: Hospital procurement solutions; Telehealth software and technology solutions; Wellbeing software and technology solutions; 24/7 Call centres.

MDM Managers (at all levels of the MDMS) are key to a successful financial management system for the MDM Service developing annual action plans for the financial management cycle of the MDM Service. This includes planning what maintenance, repair, training, and range of consultancy services can be supplied to customers, according to the skills available; planning the adequate supply and stock levels of spare parts and maintenance materials (and possibly equipment accessories and consumables); undertaking financial monitoring of the MDM Teams; monitoring progress against targets for performance and making sound financial decisions.

MDM Teams set their own operational targets and make operational plans and develop their own operational and capital budgets to undertake maintenance, repair, training, and consultancy work for customers, formally account for their use of resources, keep a comprehensive equipment and maintenance record system and produce financial reports.

Health Service Providers decide whether the MDM Service will run as a profit or cost centre and what degree of cost recovery will be required thereby ensuring that financial management is an integral part of Medical devices management and providing sufficient resources for the operations of the MDM Service, and for all MDM activities decide on corrective action in response to financial reporting.

Health Management Teams (at all levels), and their MDMWG liaise with and oversee the MDM Service allowing MDM Teams to service clients at other sites and set goals for health facilities which will provide a guide for the target-setting of the MDM Teams. This provides suitable space for workshop facilities, agreement on: the budget format for the MDM Team, the accounting system for the MDM Team, and the outcome from financial reporting.

Finance Officers understand the financial management requirements for MDM Teams providing MDM Teams with advice on the financial procedures, transactions, and paperwork used by the health service provider, helping with the budgeting process and establishing the accounting system.

Accountants are consulted and offer advice on setting up a suitable accounting system for the MDM Service and are consulted and offer advice on the outcome of financial reports.

Customers (such as health facilities) settle bills and pay for MDM services promptly.

Government Bodies provide the legal and policy framework for Medical devices management and the legal and policy framework for financial management.

Framework Requirements

In order to deliver quality health services, it is essential to undertake effective Medical devices management (MDM). There are various framework requirements to help you do this. These include legislation, CQC regulations, NHSLA standards, and Trust policies. These framework requirements create the boundary conditions within which you undertake Medical devices management. They include central or national guiding principles, policy issues, and high-level assumptions that can impede or assist you in your work. It is very difficult to function effectively if these framework requirements do not exist, and you should lobby your client organisation to develop them. Depending on how autonomous their health facilities are, you may be able to develop these framework requirements at client facilities.

Consider four issues that provide key background conditions:

      1. 1. a vision for health services equipment provision
        1. 1.1. Standardisation
      2. 2. User Training
      3. 3. provision of maintenance
      4. 4. Finances



It is unhelpful if lots of individuals pull in different directions, with no coordinated plan for MDM as a whole. Standardisation - (also known as rationalisation, normalisation, and harmonisation) - the process of reducing the range of makes and models of equipment available in your stock, by purchasing particular named makes and models. It is easier to achieve standardisation if equipment is planned and ordered on an organisation-wide or health service provider basis. It is therefore important to combine forces with other facilities or health service providers, and it may be wise to follow standardisation strategies of DB2006 (05) - Managing Medical Devices. It is important that these standardisation efforts do not just apply to products purchased by health facilities, but also to donations. By concentrating on a smaller range for each equipment type, your technical, procedural, and training skills will increase and your costs and logistical requirements will decrease bring about such changes, you will require skills in: managing change, staff motivation, effective communication, encouragement, supportive training with demonstrations.

Financial Management Cycle

MDM Teams need to set operational targets for their work, and decide what budgets are required to achieve these. They need to account for the use of the money, monitor whether the money was well spent, and be able to report on their financial situation. The MDM Team needs to review how well it is carrying out all these tasks, and to evaluate whether the targets of the MDM Service have been fulfilled or whether changes are required. This process of financial decision-making consists of a logical sequence of activities.

Step 1: Setting Operational Targets and Preparing an Operational
The MDM Team begins by setting targets for its operations for the coming year. These are determined, to a large extent, by the goals of the health facility and MDM Working Group. The MDM Team prepares an operational plan, which will then be integrated into the overall plan for the Medical devices Management Service

Step 2: Budgeting
The budget translates the operational plan into monetary terms. The MDM Team considers the financial resources required to implement the operational plan. They consider the costs of their planned equipment management activities and decide what financial resources are required. The budget is the key financial planning tool of the MDM Team.

Step 3: Accounting
Accounting provides managers, decision-makers, donors, and creditors with financial statements that reflect the financial results of the MDM Team's work. The team can then use this information to gauge whether their resources have been administered efficiently and productively. It is therefore a very important management tool. One key aim of every accounting system is to provide financial data for planning and decision-making. Another is to provide a record of expenditure, in order to ensure propriety.

Step 4: Financial Monitoring
By monitoring progress, MDM Managers at all levels of the MDMS, can make constructive adjustments for the future. The accounting system, together with the operational budget, enables them to monitor and control the work of their team and to decide whether their financial resources are being well spent.

Step 5: Financial Reporting
Financial reports provide an invaluable insight into the operational performance of MDM Teams.

Step 6: Decision-making and Taking Action
MDM Teams may prepare sensible operational plans and budgets, keep detailed accounts, and carry out monitoring and reporting. However, none of these activities will be effective unless the teams have the power and ability to make decisions and take action. The planning process should involve representatives of all different types of staff in the: MDM Team, MDM Working Group, Finance Office, and Health Management Team.

At the end of the year, it is essential to review and carefully analyze the results achieved on all goals, before starting to develop action plans for the following year. This step is the most important: to review results on a regular basis with the people who are doing the work. Important elements of quality management are: a management team approach, supervision and evaluation, participative leadership, methods for encouraging staff,

individual responsibility and initiative, control measures such as performance measurements and impact analysis, and community participation.

Medical devices technology and management is important activity for the benefit of the patient, and the benefit of the organisation in terms of both cost and safety.

John Sandham
Nov 2013