Assessment of Medical Equipment Maintenance Management

Abstract

Today's modern hospital is highly dependent on different types of medical equipment to help diagnose, monitor, and treat patients. Medical equipment maintenance is important to reduce costs, reduce patient dissatisfaction, treat the patient in a timely manner, and reduce mortality and risks during patient care. Good maintenance management is important to have well-planned and implemented programs through which hospitals can minimize medical device failures or other problems with the operation of medical equipment. Medical equipment plays an important role in the hospital system; therefore, the acquisition, maintenance, and replacement of medical equipment are key factors in hospitals for the implementation of the health service. Thus, in order to ensure the quality of medical devices for the provision of medical care, it is imperative to evaluate the safety of using hospital maintenance management. In order to achieve these goals, hospitals must develop checklists that identify the state of performance of medical equipment maintenance. It is essential for clinical managers and engineers not only to increase the capacity of the hospital but also to predict the risks of sudden failure. Given the lack of unique and comprehensive maintenance management checklists, the current goal is to design and develop medical equipment maintenance management checklists.

1. Introduction

Medical equipment is a product that can directly affect human lives. They have been and are considerable investments and in many cases have high maintenance costs. That is why it is important to have a well-planned, managed maintenance program that can keep medical equipment in a reliable, safe, and available medical service. In addition, such a management program extends the life of the equipment and minimizes the cost of its maintenance [1].

A modern medical equipment maintenance strategy includes periodic inspection procedures to which preventive maintenance (PM) and corrective maintenance (CM) are added when necessary. Performance inspections ensure that the equipment operates correctly within the limits set by the manufacturer or according to the standards in force for that type of equipment. Safety inspections ensure that the equipment is safe to use for both patients and operators. Preventive maintenance (PM) aims to extend the life of the equipment and reduce the downtime of medical equipment [2].

In addition, there may be some hidden issues that can be easily detected during a scheduled inspection. The technical inspection procedure of medical equipment only ensures that the device is in good working order at the time of inspection and cannot eliminate the possibility of a malfunction during future use. It must be borne in mind that by their nature, electrical and mechanical components can be damaged at any time. Corrective maintenance (CM) restores the operation of a defective device and allows it to be put back into operation in optimal parameters.

2. Maintenance program planning (inventory and resources)

Planning a maintenance program requires more effort to establish a comprehensive medical equipment management program. There are a number of critical factors to consider:

1. Inventory – types and models of medical equipment to be followed by technical staff and the steps by which they are specifically included in specific maintenance programs;

2. Methodology – identify the method by which maintenance will be provided to the medical equipment included in the program;

3. Resources – the financial, technical, and human resources included in the program.

In the process of planning a maintenance program, it is essential to determine the types of medical equipment they need to be included in a maintenance management program. This fact will depend on the types of medical services to be provided covered by the program, ranging from primary care clinics to hospitals as well as the range of equipment in them. The clinical engineering department of the hospital is the one that has to identify and select the medical equipment to be included in the inventory and to include it in the maintenance program [3].

A maintenance program can be implemented in several ways, the variety of methodologies available at a given time must be taken into account. For example, the healthcare provider may enter into service contracts with device manufacturers, independent service organizations, or a combination of both, in addition to the assistance that their own technical staff can provide.

As for the resources needed for maintenance, they are difficult to predict. This requires a well-maintained maintenance history, personnel requirement calculations, test equipment as well as their technical knowledge to repair defective equipment. Outside suppliers are required for the maintenance of complex equipment. Maintenance often requires access to equipment that can be difficult to obtain due to budget constraints and purchasing difficulties, especially when buying from abroad (Table 1). In order to meet such challenges, it is important to consider the financial advance, technical, and human resources required to properly carrying out the planned activities [4].

	Initial cost	Operating cost
Technical resources	Space, tools, test equipment, and computer resources	Utilities, operation, maintenance, and calibration
Human resources	Recruiting and initial training	Salaries and continuing education
Maintenance	Not applicable	Service contract, spare parts, and materials

Table 1.

Financial resources required for a maintenance program.

A maintenance schedule is also based on a defined number of physical resources. This category includes workspace, tools and test equipment, consumables, spare parts, and maintenance and service manuals required to perform maintenance. Various testing tools and equipment are required to perform PM and/or CM procedures, depending on the type of medical equipment. It is possible to perform many PM and CM with a basic set of electronic service instruments and test equipment (e.g. temperature meter, voltmeter, power indicator, oscilloscope, and electrical safety meter) (Table 2). However, all these involve additional costs that must be provided in the financial and technological management.

Medical device	Test equipment required
All electrical equipment	Electrical safety analyzer
ICU monitors and ECG machines	Simulators/arrhythmia simulators
Defibrillators	Defibrillator analyzer
Electrosurgical units	Frequency electrosurgical analyzer
Ventilators, heart-lung machine, and anesthesia machine	Pneumatic tester and pneumatic flow meter
Noninvasive blood pressure monitors	Noninvasive blood pressure simulator
Anesthesia machines and ventilators,	Gas flow meters

Table 2.

Test equipment for some medical device category.

3. Operational management (developing or changing inspection and preventive maintenance procedures)

Fortunately, in hospitals, we see more and more technology. And this can only make us happy, proving to us that medicine is advancing, so the diagnosis is made earlier and more precisely, the treatment is more personalized and more effective. Overall, technology allows us to better care for the patient for his/her benefit, but also for the doctor, who has powerful tools to practice his/her profession. At the same time, the presence of these increasingly sophisticated medical equipment comes with the need for medical engineers in hospitals who know how to use this equipment, to identify when they are not used correctly or when they no longer work at optimal parameters.

For a patient, the staff of a hospital means doctors, nurses, and sisters, and it is normal to be like that, because only with them they interact but, a hospital in order to operate continuously, 24/7, in safe conditions, there is a whole team of technicians behind it, which makes this possible. Someone has to make sure that the medical equipment, the ventilation systems, the medical gas systems, and the electrical network are working properly, and these are the bioengineers, the clinical engineers, and the medical engineers.

Operational management involves making very diverse decisions, which can be classified into two broad categories: strategic and tactical. Strategic decisions have a longer time horizon and are less structured than tactical ones. They focus on the entire organization, drawing certain lines and directions, while tactical decisions are more focused on departments, teams, and issues. Device management takes place within a generalized business model, so clinical engineers work in collaboration with the financial and procurement departments of the institution to ensure efficient management of technical equipment, but also assistance policies are properly implemented through the efficient use of financial resources [5]. Consequently, the role of clinical engineering includes the development of equipment support strategies, the management and periodic review of these strategies, as well as the management of both fiscal resources and specialized personnel. Various problems may occur with medical devices resulting from device malfunctions, equipment operation problems, or malfunctioning devices [6, 7].

The first maintenance policies developed consisted of interventions on the devices that worked until their accidental shutdown (breakdown) due to wear and tear or due to the occurrence of malfunctions. The intervention is considered satisfactory as long as the device/system is operating at a minimum acceptable level (reactive maintenance) [8].

The development and increase in the complexity of medical equipment have led to the modernization and updating of maintenance techniques and policies. The preventive and predictive activity makes it possible to plan the shutdown, prepare the intervention team, ensure the necessary spare parts, and respectively, reduce to a minimum the parking time for repair [9]. Predictive maintenance is a qualitative leap forward in a modern maintenance system, regardless of the scope or specifics of production, as it provides all the information needed to:

• early detection of defects;

• their location;

• fault diagnosis; and

• calculation of the safe operating time of the machine.

Many healthcare providers have now implemented continuous quality improvement programs based on innovation in the way care is provided in order to improve safety, control costs, and make these services more accessible and effective for patients. Staff involved in operational management also use risk management methodologies to optimize hospital resources to provide a healthcare technology management program that focuses on ensuring that the hospital’s clinical work can be performed safely and cost-effectively.

The lack of specialized technical staff, including medical bioengineers and clinical engineers in hospitals, as well as an inefficient maintenance system are the major causes that determine incidents of all kinds. This has been highlighted more than ever, during the pandemic, when hospitals and all their medical equipment were and still are overburdened. During this time, more than ever, we have realized that the rules and standards of hospital care (including the care of medical equipment, medical gas networks, ventilation, electrical networks, etc.) need to be improved, and maintenance policies need to be optimized as quickly as possible.

4. Risk-based biomedical equipment management program

Healthcare is one of the largest industries in the world, with a high degree of diversity in terms of therapeutic activities and how they are performed. There is compelling evidence that while healthcare brings enormous benefits to all people, the frequency of errors and unwanted events is increasing, directly related to the development of innovation in biomedical technologies. Understanding and ensuring the safety of medical care is an extreme challenge in health system management [10].

For departments and organizations that target medical devices, whether they are manufactured or used, one of the key goals should be patient safety and risk management. Risk management is a complex process of identifying, analyzing, and responding to potential risks, through a documented approach, which uses material, financial, and human resources to achieve objectives, aiming to reduce their exposure to losses [11]. Thus, internal control is directly associated with risk management, because, through the measures taken, a functional framework is reasonably ensured that allows that entity to achieve its objectives [12].

The risk appetite of the organization must be clearly articulated in the policy, and this can be informed through legal and financial issues. Policy should also clearly define roles and responsibilities in risk management. There must also be a periodic review process in which each risk is reviewed to ensure that control measures are effective and that the residual risk is properly classified. The policy should set out the process, methods, and tools used to manage the risks within the organization.

Risk management is a cyclical process, which takes place throughout the course of an activity and involves several stages of work as shown in Figure 1.

Figure 1.

Risk management cycle.

4.1 Risk identification

The first step in the risk management process involves focusing efforts on identifying all possible sources of risk that could affect in any way the development of the project or activity analyzed. Effective risk management assumes that risk identification is an ongoing process that allows the entity to connect to the process of change and adaptation. An efficient risk management process at the level of the entity must also take into account the priorities of the institutions under coordination/subordination or under authority, which contribute to the achievement of the objectives of the respective entity [13].

The sources of risk come from both inside and outside an organization that provides healthcare services. External sources are those sources of risk that are the result of events outside the organization under analysis. The main factors that can influence the external risk environment and that need to be taken into account are as follows:

• regulations and/or legislation – each healthcare provider must identify those laws and regulations under which they operate and which define the limits of action of this entity;

• modifying/updating the objectives – in some situations, the treatment of some risks by the managers of the organization is influenced by the external decisions that influence the own activities;

• sometimes, budget cuts can affect the achievement/limitation or stoppage of some professional activities or the number of employees.

Due to the fact that in the case of external risk no preventive measures can be taken, the only way to act is by insurance. Internal sources are the result of events within the organization. These sources of risk can be controlled. In this category, we can distinguish the risks of using technology equipment, the risks of specialized labor, or the risks associated with organizational management. These risks can be prevented by simply eliminating the sources that produce them, which is possible due to the fact that they are generated by the activity of the organization, so they come from within it.

4.2 Risk assessment (impact/probability)

There are two main categories in the risk analysis process:

• qualitative risk analysis;

• quantitative risk analysis.

The results of the qualitative risk analysis are less accurate, as they are more indicative than precise. In the qualitative analysis, the Probability Impact Matrix technique can be used, a technique that combines the two components of risk, thus presenting an overview of it [10]. This method can be applied at several levels, with varying degrees of difficulty. Most healthcare organizations use a 535 risk matrix based on Australian standards AS/4360: 2004, where the two axes correspond to the scales for consequences, sometimes called severity and probability as illustrated in Figure 2 [14].

Figure 2.

Probability impact matrix examples.

If these results are not satisfactory, the risk management also provides the quantitative analysis which presents results in numerical form as a result of the calculations made. If the risk analyst cannot give an accurate probability of such an event occurring, he/she can instead calculate the size of the losses or depreciations generated.

In this sense, risk management has developed a series of calculation methods and techniques such as [15]:

• SWOT analysis (Strengths, Weaknesses, Opportunities and Threats): in practice, a few risk analyses have been shown to be effective when using this simple and well-known method.

• Concatenation principle: by concatenating the risks, a chain of risky events is identified, and these will be analyzed together.

• Script technique: this technique involves describing one or more possible ways of conducting an event from a concrete situation.

• Expected value analysis.

• Decision-based tree analysis.

• Monte Carlo simulation method.

4.3 Reaction to risk/attitude toward risk

Measures should be taken to reduce the probability (possibility) of occurrence of the risk and/or to reduce the consequences (impact) on the results (objectives), if the risk is materialized. Risk response is a reduction in risk exposure if it is a threat.

If disposal is not feasible, control measures should be put in place:

• Elimination or avoidance

• Replacement

• Control of risks at source

• Separation and isolation

• Safe working procedures

• Training, instruction, and supervision

• Personal protection

• Other considerations: social assistance facilities, first aid, and emergency procedures

Lack of control can compromise the entire risk management process.

4.4 Risk monitoring, review, and reporting

In general, the risk management framework should not be seen as a single task but should be continually reviewed to ensure that it remains fit for purpose. There are a variety of technical standards for medical devices designed to ensure the consistency of a device’s safety throughout its life [16, 17]. These should be seen as a starting point in the risk profile and are the basis of the medical device directives: directive on implantable active medical devices (90/385/EEC), Medical Devices Directive (93/42/EEC), and directive on in vitro diagnostic medical devices (98/79/EEC). Another useful standard is BS ISO 31100 which sets a framework for incorporating risk management into any organization [18].

5. Work order system for corrective maintenance

A very important component in the management of medical technologies is represented by the realization of a maintenance program in which to take into account the characteristics and failures of medical equipment. At the moment of including such a maintenance strategy, a distinction will have to be made between older medical devices and high-tech devices, as they cannot be effectively managed if the same maintenance strategies are used [19]. The World Health Organization has issued guidelines for the application of corrective maintenance at the hospital level. Corrective maintenance is actually a whole process from identifying the defect to repairing the device and putting it back into operation.

5.1 Troubleshooting and repair

The first step in the corrective maintenance process is to report a fault/incident to a user. Also, a malfunction can be found when a medical technician/bioengineer from the Department of Clinical Engineering performs the periodic technical inspection. In order to make the maintenance process more efficient, the first step is the realization of the finding and then the corrective maintenance is initiated. A reduction in the failure time of the defective medical device can be achieved when the medical technician/bioengineer performs some corrective maintenance steps himself/herself and uses internal expertise or external service providers. This corrective maintenance may be accomplished at various levels:

• component level: old generation equipment requires isolation of the fault by troubleshooting and repairing the level of components. In the case of new generation medical equipment, electronic devices, repairing the level of components can be time-consuming and difficult. In addition, this type of maintenance is not feasible, so the repair of the board level or even the system level is applied.

• board level: in the case of modern electronic equipment, the faults of a certain circuit board are isolated, and the entire board is replaced.

• device or system level: in the case of modern equipment, troubleshooting and repairing at the plate level are sometimes difficult and time-consuming. Therefore, if the cost of a repair exceeds 60% of the value of the purchase of new equipment, it is more profitable to replace the entire device or subsystem.

The type of corrective maintenance applied at the hospital level is dependent on a number of cumulative factors including the availability of financial, physical, and human resources, as well as the urgency of a particular request for repair. One strategy that can be considered is the application of repairs at the device level, in emergency situations and when more time is available, the repair can be used at the plate level or at the component level. If it is proposed to repair the component level, parts may need to be replaced.

Replacement can be done with specialized parts from the manufacturer or with spare parts recovered from malfunctioning or obsolete equipment (only after the announced risk assessment).

5.2 Factors affecting equipment failures

In the event of an unforeseen fault, environmental factors must also be considered, such as stabilizing the power supply sources by using voltage regulators, installing uninterruptible power supplies (UPS), using surge protection devices and avoiding connection. Another important environmental aspect is the interaction of medical devices with other utility systems (e.g. medical gas and vacuum systems, temperature and ventilation control systems, water supply, and information technology).

There must be a permanent collaboration with the other categories of engineers in the organization in order to optimize the capacity of the utility systems so that the medical equipment works in optimal parameters. The environment in which medical equipment is used should be controlled in terms of temperature and humidity. There are situations in which some medical equipment is designed to be used in accordance with the specific climate of a country/region. In this case, the maintenance procedures in a particular country or region are adjusted according to these local factors. Other important environmental factors are the age and condition of medical equipment or old facilities built to old standards that are not applicable.

5.3 Inspection and return to service

The actions required after the repair is completed include recalibration processes and a performance and safety inspection. These activities are essential for measuring device performance. Once these activities are completed, the medical equipment will be returned for use to the patient care.

5.4 Reporting

In the case of corrective maintenance, a decisive role is played by the periodic technical verification, part of the preventive maintenance process. The technical file of the medical device in which any intervention made on the medical device is recorded is a reference document in corrective maintenance that helps to make decisions. Existing data in the worksheet includes the actions performed, the parts replaced, and their cost helps to identify if or when the parts need to be replaced again and helps to explain the condition of the parts during the current inspection.

5.5 Safety

An important aspect in the corrective maintenance process is the consideration of safety aspects. In this case, procedures must be included regarding the safety of the technical staff during maintenance, the safety of the user after maintenance, and the general control of infections. In order to increase the safety of service personnel, it is necessary to train and use personal protective equipment and knowledge of techniques that will allow technical personnel to work safely in dangerous conditions.

Following maintenance, in particular following procedures which could have affected the safety features of a medical device, the technical staff must check that the device is safe to use, mechanically and electrically. Particular attention shall be paid to the electrical safety of medical devices so that they are earth-proof and leakage current is measured to ensure that they are within the applicable limits. (In the absence of electrical safety test equipment, technical personnel must rely on careful repair techniques and simple electrical tests to verify the integrity of the device). Physicians should be advised to check the settings of the device and perform basic operational checks before using the device with patients [20].

An important conclusion we can draw is that the best maintenance strategy is to apply the mixed maintenance strategy. This process is due to the fact that we are talking about a very large number of medical equipment and complex technologies. The maintenance process must be divided between the parts: internal maintenance is adopted for surgical lamps, sciatic lamps, and telemetry devices. In the case of critical devices, maintenance is covered by full-risk agreements with authorized manufacturers or service centers.

External maintenance is adopted for anesthesia machines, mechanical ventilators, electrocardiographs, patient monitors, and surgical tables [21].

6. Managing a maintenance program in a hospital

Good management of medical technologies at the hospital level can minimize malfunctions in medical devices. If we refer to developing countries, here the problem is the limited financial resources. In this case, a proper management of medical technologies, based on increasing reliability and reducing failures, could lead to the provision of good health services in limited economic conditions. Assessing the effectiveness of any maintenance program is critical to optimizing the use of available resources within the hospital. The emphasis cannot be placed solely on scheduled maintenance [22].

Patients’ access to an accurate diagnosis, effective treatment, or rehabilitation process with appropriate medical devices is related to the efficient management of the maintenance of medical devices. This process can increase the efficiency and productivity of medical technology resources, which is especially important when resources are limited (Figure 3) [23].

Figure 3.

A summary of basics for evaluating and identifying the mode of operation within the clinical engineering department of any hospital.

A possible approach to medical technology management involves the inclusion of a priority analysis step. The division into three levels of emergency (high, medium, and low) can be proposed based on the operation and implementation of subsequent actions in appropriate stages, appropriate to urgency, criticality, and seriousness. This analysis of priorities can be done both in terms of preventive maintenance, corrective maintenance, and in the case of a replacement program. In this case, the management priority can be recognized by the maintenance [24].

Another operational diagram that can be applied to evaluate the management process of medical technologies is the Ishikawa diagram or the fish bone diagram. This diagram is a verbal tool that has the relationship between an effect (a problem) and all possible causes that influence the effect (Figure 4).

Figure 4.

Ishikawa diagram or the fish bone diagram applied to the management process of medical technologies.

The optimization of the functions of the maintenance department can be obtained by implementing a procedure that includes three important aspects: the task of the annual maintenance plan, the time available for the technical department, and the amount of equipment to be maintained. Taking into account these parameters, it is possible to estimate the personnel necessary to perform the maintenance function, responding to the most critical component of the management act – human resources [25]. Another approach involves designing a set of key performance indicators (KPIs) useful for assessing the performance of medical equipment maintenance in the management process (Figure 5).

Figure 5.

Block diagram of the process required to calculate the set proposed by the KPI, starting from technological, organizational, and financial data.

A proper evaluation of the medical equipment maintenance process should include the development of a checklist for evaluating medical technology management. Implementing a list can be helpful in ensuring the profitability of health facilities and the reliability of medical equipment. In addition, she/he is involved in decision-making in support of the selection, measurement, repair, and maintenance of medical equipment, in particular for capital equipment managers and hospital medical engineers, and also for the evaluation of this process.

An example of a maintenance management evaluation checklist proposes the inclusion of 15 indicators: type of medical equipment, quality control tests, application of training processes, correct storage of medical equipment and spare parts, existence of maintenance contracts, supervision of the process of operation, the existence of the decommissioning procedure, the existence of the reintegration system in use/system and the reporting of adverse events, ensuring the supply of electricity in optimal conditions, implementation of a process of continuous development of maintenance, general administration, management, and allocation of a separate budget for medical equipment maintenance services [23].

Another approach to evaluating the management process was implemented by Herrera-Galán and included evaluating the performance of the maintenance function by implementing management audits. Assessments include equipment availability, response to a service request, monitoring and control of biomedical equipment, staff training, quality of work performed by maintenance technicians, workload of maintenance technicians, control of work performed by maintenance technicians, effectiveness of annual planning, and maintenance and performance of the department. The results of this research show that the audit technique is a valuable checklist in evaluating the performance of a hospital. And in this case, it was highlighted that the most critical component of the results of a management audit is human resources [26].

Amerion et al. managed to identify the effective factors that influence the management of medical technologies at the level of a military hospital. Following the study, 26 components with an important influence on the management process were extracted. These are user training, human resources, user engagement and experience, the foreign exchange market, regular checks, and trade name. Attention to the evaluation of these components could reduce maintenance costs and increase the lifespan of medical equipment. The process of training users that must be continuous and the quality of human resources are the two main aspects [27].

A general conclusion regarding the implementation of management strategies in the maintenance of medical equipment shows us that the necessary adequate resources underlying are human resources, material, financial, and documentation resources [28].

7. Conclusion

The maintenance of medical equipment becomes more expensive every year, and to optimize maintenance programs and reduce total cost of ownership, hospital management structures are constantly looking for solutions to extend the time of operation of equipment, in the required safety and technical performance and through the efficient use of available resources. The analysis and substantiation of capital expenditures in medical organizations must be based on quantifiable factors, with a direct impact on the full associated costs. In order to optimize operating and support costs, medical technology management structures develop medical equipment maintenance programs, based on assessments and prioritization, based on risks and costs. The development of alternative plans for medical equipment must take into account the complexity and large number of existing equipment, the skills of its own specialists and their number, the technical means of calibration and control, and the budgetary resources available.

In this regard, healthcare facilities need to implement evidence-based maintenance strategies, through the development of prioritization procedures aimed at a balanced assessment of relevant factors in the life of medical equipment, through an integrated approach to the elements of reliability-based maintenance, on risk-based conditions and maintenance.

Conflict of interest

The authors declare no conflict of interest.