Introduction to medical technology management practices

Chapter 28

Introduction to medical technology management practices Yadin Davida, Thomas M. Juddb, Raymond Peter Zambutoc a

Center for TeleHealth and Biomedical Engineering Department, Texas Children’s Hospital, Houston, TX, United States, bQuality Assessment, Improvement and Reporting, Kaiser Permanente Georgia Region, Atlanta, GA, United States, cCEO Technology in Medicine, Inc., Holliston, MA, United States

The quest of every society is to continuously improve the quality of its members’ lives, through promotion of health, prevention of disease, and access to an efficient healthcare delivery system. Many different methods and strategies for pursuing efficient delivery systems have been tried, and others will be experimented with in the future, but it is evident that we have not yet found the optimal approach. Health care ranges from the fight against diseases to the maintenance of physical and mental functioning, and its delivery largely depends on technology, especially medical technology. Therefore, medical technology management is one of the most important segments of the healthcare system, and it is the segment that carries the best potential for clinical engineers (CEs) to demonstrate their unique expertise and leadership excellence. Medical technology contributes to the advancement of health care in many ways. It contributes to screening of abnormalities and their risks. It contributes to the diagnosis of clinical signs that identify the nature or the cause or the extent of the pathology. It contributes to treatment in the restoration, improvement, and replacement of bodily function as well as preventing further deterioration or pain sensation. It contributes to rehabilitation by restoring, replacing, improving, or maintaining physical or mental function impairment. Technology is expected to reduce the risk of a disease, shorten illness duration, improve the quality and accuracy of care, increase access to care, and replace or limit the decay of a person’s functions so and return that person to a state of quality life. In addition, technology is expected to contain cost, to enhance healthy behavior, and to reduce intervention risks. In summary, acquisition of medical technology is accomplished primarily for the following five reasons: 166

1. To improve diagnostic, therapeutic, or rehabilitation efficiency 2. To increase the health system’s cost effectiveness or reimbursement 3. To reduce risk exposure and eliminate errors 4. To attract high-quality professionals 5. To expand the service area or to better serve the beneficiary base Healthcare delivery systems around the world are going through major transformations. While knowledge is continuously being created and disseminated at an accelerating rate, the allocation of resources for implementation of preferred solutions is lagging behind, creating a gap that could overwhelm the system if left unchecked. This chapter addresses technology management practices that close this gap by achieving an efficient and effective methodology for the assessment and deployment of medical technology. Technologies in general and medical technology in particular play a significant role in the healthcare transformation. To ensure that technology is safe and effective, there is a need to understand adequately the potential of technology and the importance of its associated management methodology and tools. Without such management methodology and tools, technology function and patient outcomes will be impaired. Forward-looking managers recognize that properly constructed medical technology management methodologies and tools provide objectives and guideline protocols for efficient practice and decision-making processes in the following stages in the technology life cycle: ● ● ●

Strategic technology planning Technology assessment Technology acquisition and implementation Clinical Engineering Handbook. https://doi.org/10.1016/B978-0-12-813467-2.00028-6 Copyright © 2020 Elsevier Inc. All rights reserved.

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Technology risk management and quality improvement (QI) Technology utilization and servicing Technology value or cost/benefit ratio analysis

The management of assessment and deployment of safe and effective medical technology lags behind both the knowledge and practice patterns of management in general. In the highly complex environment of the healthcare delivery system, the challenge to invest in management methods and practices has diminished such that the consequences of medical technology decisions are inadequately factored into the larger strategy. While this varies from one patient population to another and from one hospital type to another, these management tools, where they are used, have a direct impact on patient care outcomes, hospital operations, and financial efficiency. Only by applying these tools and methodologies can the system optimize the development of medical technology and the facilities that house it. There are three types of managers: those who make things happen, those who watch things happen, and those who wonder what happened. This chapter describes the managerial tools that can facilitate the transformation of a “watcher” into a “maker.”

Strategic medical technology planning The healthcare delivery system is going through a transition that is driven by four major forces: budget, structure, technology, and social expectations. The impact of any one or combination of these forces may change from time to time, as does their relative significance, creating a result that is the subject of public debate. It is clear, however, that health care is being subjected to mounting pressure by the needs to (1) identify its goals; (2) select and define priorities; (3) allocate resources more effectively; and (4) achieve system-wide integration. The healthcare delivery system presents a complex environment wherein policies, facilities, technologies, drugs, information, and a full range of human interventions interact. It is in this clinical environment that patients in various conditions, skilled staff, contract labor, and a wide variety of technologies converge. The dynamics of this swirling environment, as they relate to medical technology management, include leadership, resources, competencies, risk exposure, regulations, rate of change, and the ability to demonstrate impact on outcomes. Care providers are faced with the ubiquitous presence of medical technology at the vortex of changing provider and patient roles compounded by system accessibility and integration challenges. Society demands, in addition to user competency, improved quality of care, reduction in error rates, and containment of expenditures. Without a systematic approach, this scenario often leaves hospitals without a clear direction for meeting these expectations. Short-term cost pressures can drive hospital decisions that conflict with the other factors.

One apparent solution that would bring a sense of order and reason to this volatile environment is to seek ways for hospitals to more effectively manage their available technology resources and to do more with less available capital by only selecting “appropriate” technologies that have longer and more reliable life cycles. Proven technologies that fit well into their budgets and operations can be supported and relied upon to provide safe and effective care. Healthcare delivery organizations have begun to combine strategic technology planning with other technology management activities in programs that effectively integrate decisions about adoption of newer technologies with the hospital’s existing technology base—a process that has resulted in better care outcomes at higher efficiencies. Well-integrated medical technology programs will steer hospitals through these transition times by improving performance, eliminating preventable errors, and reducing operational costs.

The scope of technology to be managed Technology, as defined by David and Judd (1993), means merely the use of “tools,” that is, the involvement of any agent that assists in the performance of a task. In this context, the technology that has been developed for, and deployed in, the healthcare delivery system ranges from the “smart” facilities within which care is being provided to the products that are used in and around the provision of healthcare services. Technology “tools” have been introduced at an increasing rate during the past 100 years and include the use of techniques, instruments, materials, systems, facilities, and information. Of all the factors and resources that will shape the future of the health of humankind, the one that most often stretches the imagination is medical technology. However, medical technology is often blamed for contributing to the escalation of healthcare costs without receiving recognition for improving access to the system and the quality and efficiency of the system. The past decade has shown a trend toward increased legislation in support of more regulations in health care. These and other pressures will require technology managers to be familiar with the regulations and to be able to manage a program that demonstrates compliance with these requirements throughout the life cycle of the technology. If you subscribe to the saying, “You cannot manage what you do not measure, and you cannot measure what you do not define,” then the need for the development of a systematic and comprehensive planning process for technology adoption is obvious. In terms of defining the scope of technology to be managed, the healthcare organization must develop a rationale for adoption. Without this most basic tool, the process becomes increasingly randomized overtime until no consistent system of management can survive. One example of a ranking of rationale for technology adoption is the following list:

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Contribute to meeting/exceeding standard of care Positively impact care quality or level Impact life quality Improve intervention’s accuracy, specificity, reliability, and/or safety Reduce disease longevity/length of stay

their interaction with budgeting processes require a unique set of skills and technical management expertise that is consistent with the characteristics of a mature clinical engineering professional. This expertise facilitates the integration of clinical objectives with management and technical threads that permeate the organization. This aspect of the planning process must include the following elements: ●

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More effective care/protocol/decision-making Impact operational efficiency and effectiveness Impact development or current service offering Impact liability exposure, contribute to reduction in errors Increase compliance with regulations Reduce dependence on user skill level Impact supporting departments Increase utilization rate and reduce maintenance load

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Impact access to care Increase customers’ convenience and/or satisfaction Impact organization or service image Improve return on investment (ROI) or revenue stream Lower the cost of adoption and ownership Impact market share

In order for the planning process to maximize the value it adds, it must include standard elements of analysis and must be somewhat predictive in several areas where trends may change over the course of implementation of the plan. The planning process must include the following elements: ●

Strategic planning process The strategic planning process is the road map for the introduction and development of technology and services, and their related policies into the core business of the hospital to maximize the value outputs of the program. The outputs of this process are measured as changes in cost, quality, performance efficiency, or quality of life. The road map is an important guideline because it identifies a common vision for timely response to fundamental needs. The following key components must be present in the plan to ensure the optimal allocation of funds needed: ●

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Regional planning, coordination, and technology assessment Strategic technology planning and priority setting Budget development and approval processes Technology management and service planning Technology acquisition Technology audit and risk management

A technology strategic plan is derived from, and supports, well-defined clinical objectives. The ability to contribute to this process and the development of these components and

Creation of a plan to support the facility’s vision and communicate its process to staff Periodic review of the alignment between the vision and strategy Identification of areas/topics where changes are needed Determination of priorities and creation of a plan to meet the objectives Inclusion in the plan of the details of specific expectations from information technology, medical technology, and building spaces—transforming experts’ knowledge into service strategy Delineation of clinical goals for road map planning, interaction with operations and capital budgeting processes, acquisition and deployment timing, equipment asset management, and monitoring and evaluation

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Assess changing clinical goals. The clinical goals are updated annually. For a given year, key hospital participants, through the strategic planning process, determine the clinical services that the hospital should be offering in its referral area. These must be projected with accuracy at the outset. Take into account healthcare trends, demographic and market-share data, and space and facilities plans. Analyze the facility’s strengths and weaknesses, goals and objectives, and opportunities and threats. Conduct an audit of the existing technology base, including its condition, life expectancy, and utilization rate. Audit and project the costs of healthcare providers using the existing technology, considering turnover of personnel as well as technology. Integrate assessment and prioritization of new and emerging technologies. Ensure strong compliance with and support of anticipated technological and utilization standards. Review technological trends and their operations impact.

If all of these areas are considered, the outcome of this process will be the following: ●

A coherent plan that supports the objectives outlined in the organization’s vision for the coming year

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A predictable level of technology that is capable of meeting requirements for a standard level of operation in the referral area Offerings of better and more efficacious and consistent healthcare services Effective use of limited resources and provision for growth of the organization’s intellectual property A strategic technology plan that helps technology managers to match available technical abilities (both existing and new) with clinical requirements and financial capability A definition for the level of service expected Priorities in budgeting for technological adoption and acquisitions

To accomplish this goal, CEs and technology managers must understand why their institutions’ values and mission are as they are; must pursue knowledge and collect information that supports their institutions’ strategic plans; and must be able to translate their operations according to the strategic planning process utilizing the often limited resources allocated to them. Although a technology manager might not be assigned to develop an institution’s overall strategic plan, he or she must understand and be ready to offer logical and informative input to the hospital management. The CE will be prepared to provide this input in the following ways: ●

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By committing to a professional involvement with, and understanding of, all the hospital services By understanding technology assessment methodology and equipment life-cycle functions By determining the ways in which the hospital’s technological deployment is best evaluated By articulating justifications and provisions for adoption of new technologies or enhancement of existing ones By assisting in providing a review of emerging technological innovations and in determining the impact that they can have in the hospital. (A good rapport with the research and development industry facilitates this.) By visiting the sites of technology development—research or manufacturing—as well as the exhibit areas at major scientific and medical meetings, because tomorrow’s clinical devices are in the research laboratories today By being familiar with the institution and its equipment users’ ability to assimilate new technology

The past decade has seen a trend toward increased customer expectations, legislation, and regulation in health care. These developments and financial pressures require that additional or replacement medical technology be well anticipated and justified. Proper planning will provide the rationale for sound technology adoption. Today’s

­ arketplace demands cost effectiveness, competitiveness, m and flexibility from every hospital if it is to survive and grow. Such demands require that the effective CE be able to articulate the differences among factors such as clinical necessity, code compliance, management support, market preference, and arbitrary decision.

Technology assessment As medical technology continues to evolve, so does its impact on patient outcomes, hospital operations, and financial resources. The ability to manage this continual evolution and its subsequent implications has become a major challenge in all healthcare organizations. To be successful, it must be an integral part of hospital operations that address the needs of the patient, and it must smoothly mesh people and technology. The manager who commands knowledge about the organization’s culture, the equipment users’ needs, the existing environment within which equipment will be applied, equipment engineering, and emerging technological capabilities will be successful at implementing and managing technological changes. In the technology assessment phase, the clinical engineering professional needs to wear two hats in order to lead the team and to contribute to the decision-making process. The team should incorporate representatives of equipment users, equipment maintainers, physicians, purchasing or reimbursement managers, administration, and other members from the institution, as applicable.

Technology audit With a coherent clinical strategic plan in place, the hospital can conduct a credible audit. Each major clinical service or product line must be analyzed to determine how well the existing technology base supports it and supports the conditions of that technology. A Medical Technology Advisory Committee (MTAC), consisting of hospital management, physicians from major specialties, nurses, program managers, and CEs should be appointed to conduct this analysis. The key steps that should be taken during the audit are as follows: 1. Develop a hospital-wide complete inventory (i.e., quantity and quality of equipment included), and compare the existing technology base against known and evolving standard-of-care information, patient-outcome data, and known equipment problems 2. Collect and review information on technology utilization and assess appropriate use, opportunities for improvement, and reduction of risk level 3. Review technology users’ (physicians, nurses, technologists, and support staff) educational needs as they relate to the application and servicing of medical equipment

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4. Determine appropriate credentialing of users for competence in the application of new technologies, assess needs, determine whether requirements are being met, and assess risks involved (credentialing committees will be the primary group to match clinician skills with evolving clinical treatment procedures or protocols) 5. Keep current with published clinical protocols and practice guidelines using available healthcare standards directories 6. Utilize clinical outcomes data for quality assurance and risk management program feedback The audit will allow the gathering of information about the existing technology base and will enhance the capability of the MTAC to assess the need for new and emerging technologies as well as the impact of these technologies on their major clinical services. In this assessment, the following issues should be considered: ● ● ● ● ● ● ● ● ● ●

Needs Value of the technology Technical validity Ability to assimilate the technology Ability to integrate with existing technological platforms Medical staff satisfaction Impact on staffing and delivery of care Impact on facilities Impact on standards of care and quality Economic considerations (e.g., reimbursement, l­ ife-cycle costs)

The committee will then set priorities for equipment replacement and implementation of new and emerging technologies, which, over a period of several years, will guide the acquisitions that provide the desired service developments or enhancements. Priorities will be set based on the need, risk, cost (acquisition, operational, and maintenance), utilization, and fit with the clinical strategic plan.

Budget strategies All of the information collected above will bear on the developing of budget strategies. Strategic technology planning requires a 3–5-year long-range capital spending plan. The MTAC, as appropriate, will provide key information regarding capital budget requests and make recommendations to the capital budget committee (CBC) each year. There is a threefold purpose for the capital budgeting process: 1. To develop procedures to solicit and review technology requests 2. To coordinate capital expenditures with available resources 3. To determine optimal financing methods for acquisition

The MTAC should review the final capital budget listing in order to recommend when the items should be purchased during the next year and, if possible, to determine if there should be centralized, coordinated acquisition processes planned for similar items from different departments. Long-term capital equipment budgets are derived from the analysis of replacement life cycles, organization financial conditions, annual operations support costs (including service, upgrades, and repairs), and true needs justification coupled with a 3-year budget cycle. Each item of equipment listed on the budget is highlighted as either a replacement or a new requirement for an existing or new program. The replacement life cycle is modified from standard tables by factors such as average duty cycles and utilization and escalating repair and service history. Economic justifications for clinical services revolve around a “make or buy” decision—whether the service should be performed by the clinical services in-house or should just be purchased from the commercial market. The needs justification usually centers on the capabilities of the clinical staff.

Prerequisites for medical technology assessment Medical technology has a major strategic factor in positioning the hospital and its perception in the competitive environment of healthcare providers. Numerous dazzling new biomedical devices and systems are continuously being introduced. They are being introduced at a time when the pressure on hospitals to contain expenditures is mounting. Therefore, forecasting the deployment of medical technology and the capacity to continuously evaluate its impact on the hospital require that the hospital be willing to make the commitment and to provide the support such a program. An in-house “champion” is needed in order to provide the leadership that continuously and objectively plans. This figure might use additional in-house or independent expertise as needed. To focus the function of this program in large, academically affiliated, and government hospitals, the position of a chief technology officer (CTO) is becoming justifiable. While executives have traditionally relied on members of their staffs to produce objective analyses of the hospital’s technological needs, they nevertheless are too often subjected to the biases of various interest groups, including marketing and vendor appeals. More than one executive has made a purchasing decision for biomedical technology only to discover later that some needed or expected features were not included with the installation or that those features were not yet approved for delivery. These features have come to be known as “futureware” or “vaporware.” Or, alternatively, it may be discovered that the installation has not been adequately planned, ending therefore as a disturbing, unscheduled, expensive, and long undertaking.

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Most hospitals that will be providers of quality care will be conducting technology assessment activities in order to be able to project needs for new assets and to efficiently manage existing assets within the limits of the available resources. In order to be effective, an interdisciplinary approach and a cooperative attitude are required because the task is complex. The ability to integrate information from disciplines such as clinical, technical, financial, administrative, and facilities in a timely and objective manner is critical to the success of the assessment. Medical technology includes medical and surgical procedures, drugs, equipment and facilities, and the organizational and supportive systems within which care is provided. This definition focuses on equipment, systems, facilities, and procedures (but not drugs). There are considered to be two tiers of investigation in medical technology assessment, given that it is the evaluation of the effectiveness of equipment, systems, and procedures in treating or preventing disease or injury: 1. Primary: clinical safety and effectiveness in terms of physical indicators of patient care outcome. 2. Secondary: synthesizing the results of clinical impact to project financial outcome and reimbursement decisions for payers. This chapter also emphasizes medical equipment management as an essential element of medical technology management, including the notion of the skills to forecast medical equipment changes and the impact of those changes on the hospital market position. While most consideration is usually given to capital asset management (see Chapter 35) when it comes to medical equipment, one should not exclude the accessories, supplies, and disposables from the medical equipment management program. Another often-overlooked factor in medical equipment management is the impact of the maturity of the technology on education and training as well as on servicing. Equipment that is highly innovative, in development or in clinical trials, will have a far different learning curve for users as well as maintainers than equipment based on more mature technologies.

As mentioned earlier, technology assessment is a function of technology planning that begins with the assessment of the hospital’s existing technology base. Technology assessment is, rather than an equipment comparison, a major, new function of a clinical engineering department. It is important that CEs be well prepared for the challenge. They must have a full understanding of the missions of their particular hospitals, a familiarity with the healthcare delivery system, and the cooperation of the hospital administration and the medical staff. To maximize their effectiveness, CEs need access to database services and libraries; the ability to visit scientific and clinical exhibits; the capability to establish an industrial network; and a relationship with peers throughout the country. The need for clinical engineering involvement in such a program is evident when one considers the problems typically encountered: ●

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A deeper look at these symptoms using a proper technology assessment analysis likely would reveal the following: ●

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Technology assessment program Increasingly more hospitals are faced with capital or equipment requests that are much larger than the capital budget. The most difficult decision, then, is the one that matches clinical needs with financial capability. In that process, the following questions are often asked: How can a hospital avoid costly technology mistakes? How can a hospital wisely target capital dollars for technology? How can a hospital avoid medical staff conflicts as they relate to technology? How can a hospital control equipment-related risks? How can a hospital maximize the useful life of the equipment or systems while minimizing the cost of ownership?

Recently purchased equipment, or its functions, is underused. Users experience problems with equipment. Maintenance costs are excessive. The facility is unable to comply with the standards or guidelines (e.g., JCAHO requirements) for equipment management. A high percent of equipment awaits repair. Training is inefficient because of a shortage of allied health professionals.

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The lack of a central clearinghouse to collect, index, and monitor all technology-related information for future planning purposes The absence of procedures for identifying emerging technologies for potential acquisition The lack of a systematic plan for conducting technology assessment, and thus an inability to maximize the benefits from deployment of available technology The inability to benefit from the organization’s own previous experience with a particular type of technology The random replacement of medical technologies, rather than a systematic plan based on a set of well-developed criteria The failure to integrate technology acquisition into the strategic and capital planning of the hospital

The following scenario suggests one way to address these problems and symptoms. To address these issues, efforts to develop a technology assessment plan are initiated with the following objectives: 1. To accumulate information on medical equipment 2. To facilitate systematic planning 3. To create an administrative structure supporting the assessment program and its methodology

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4. To monitor the replacement of outdated technology 5. To improve the capital budget process by focusing on long-term needs relative to the acquisition of medical equipment This program, and specifically the collection of up to date, pertinent information, requires the expenditures of certain resources and active participation in a network of colleagues who practice in this field. Membership in organizations and societies that provide such information should be considered, as should subscriptions to computerized databases and printed sources. The Director of Clinical Engineering (DCE) chairs the MTAC, while another CE from the same department serves as the committee’s designated technical coordinator for a specific task force. Once the committee accepts a request from an individual user, it identifies other users who might have an interest in that equipment or system, and it authorizes the technical coordinator to assemble a task force consisting of users who the committee has identified. This task force then serves as an ad hoc committee that is responsible for the establishment of performance criteria that will be used during the assessment of the equipment described on a request for review (RR) form. During any specific period, there might be multiple task forces, each focusing on a specific equipment protocol. The task force coordinator cooperates with the material management department in conducting a market survey, in obtaining the specified equipment for evaluation purposes, and in scheduling vendor-provided in-service training. The scheduling of the in-service training for the users can be highly frustrating at times, as the shortage of allied health professionals reduces availability for training while increasing the need for training due to higher staff turnover rate. It is highly recommended, therefore, that this activity be well coordinated with the users’ group training coordinator. After establishment of a task force, the committee’s technical coordinator analyzes the evaluation objectives and devises appropriate technical tests, in accordance with recommendations from the taskforce. Only equipment that has successfully passed technical tests will proceed to a clinical trial. During the clinical trials, the clinical coordinator collects and then reports to the task force the summary of experiences gained. The technical coordinator then combines the results from the technical tests and the clinical trials into a summary report and prepares the task force’s recommendations for MTAC approval. In these roles, the CE serves as the technical coordinator and as the clinical coordinator bridging the gap between the clinical and the technical needs of the hospital. The technology assessment process begins with a department or individual filling out two forms: (1) an RR form (Fig. 1) and (2) a capital asset request (CAR) form. These forms are submitted to the hospital’s product standards

committee, which determines whether an assessment process is to be initiated, and the priority for its completion. It also determines whether a previously established standard for this equipment already exists. In the RR form, the originator delineates the rationale for acquiring the medical device. For example, the way the item will improve patient care; generate cost savings, support the quality of service; and provide ease of use, as well as who the primary user will be. In the CAR form, the originator describes the item, estimates its cost, and offers some justification for its purchase. The CAR is then routed to the capital budget office for review. During this process, the optimal financing method for acquisition is determined. If funding is secured, the CAR is routed to the materials management department where, together with the RR, it will be processed. The rationale for having the RR accompany the CAR is to ensure that pricing information is included as part of the assessment process. The CAR is the device by which the purchasing department sends product requests for bid. Any RR that is received without a CAR, or any CAR involving medical equipment that is received without a RR is returned to the originator without action. Both forms are then sent to the clinical engineering department, where a full-time employee designated as a coordinator reviews and prioritizes various requests for the committee to review. Both forms must be sent to the MTAC if the item requested is not currently used by the hospital or if it does not conform to previously adopted hospital standards. The committee has the authority to recommend either acceptance or rejection of any request, based on a consensus of its members. If the request is approved by the MTAC, then the requested technology or equipment will be evaluated using technical and performance standards. Upon completion of the review, a recommendation is returned to the hospital’s product standards committee, which reviews the results of the technology assessment, determines whether the particular product is suitable as a hospital standard, and decides whether it should be purchased. If approved, the request to purchase will be reviewed by the CBC to determine whether the required expenditure fits within the available financial resources of the institution, and whether or when it might be feasible to make the purchase. To ensure coordination of the technology assessment program, the chairman of the MTAC also serves as a permanent member of the hospital’s CBC. Accordingly, there is a planned integration between technology assessment and budget decisions. As a footnote to this example, it is important that those involved in the process understand fully the way that standards are developed, the way they are used and modified, and, most significantly, the effect of these activities on the entire spectrum of health-related matters. Some standards address, for example, protection of the power distribution

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FIG. 1  Request for review (RR) form.

system in the healthcare facility; protection of individuals from radiation sources, such as lasers and X-rays; and protection of the environment from hazardous substances (see Chapter 116). The practicing professional should fully appreciate the intent of standards in general and should participate in their development and use.

Technology assessment and clinical engineering Clinical engineering departments are at the threshold of a revolution toward the comprehensive management of all ­healthcare technology. Increasing pressures for greater

a­ ttention to the quality, fiscal containment, and risk mitigation and error reduction should be matched with skillful and competent management focusing on the characteristics of healthcare technology. A well-organized program will have a significant impact on the hospital’s bottom line, which is a highly desirable outcome in today’s financial climate. Hospitals and vendors that operate with organized asset management programs are already benefiting from the involvement of clinical engineering professionals. The role of CEs is threaded throughout the program as it relates to medical equipment and systems. CEs contribute to, and participate in, every phase of the equipment life cycle, from the capital budget planning, the equipment evaluation, and the performance

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validation, to the acceptance testing, user training, inventory control, repair and maintenance services, and incident investigation. Their involvement improves the planning for the new (and the management of the existing) equipment inventory, thus impacting integration, quality, finance, and risk.

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Device evaluation One of the best methods of ensuring that the contribution a technology makes is valuable to the hospital is to analyze carefully each medical device in preparation for its assimilation into the hospital operations. This process of equipment evaluation provides information that can be used to screen unacceptable performance, by either the vendor or the equipment, before it becomes a problem for the hospital (see Chapter 33). The evaluation process consists of technical, clinical, financial, and operational aspects. These aspects were evaluated earlier, as described in the MTAC function; however, the emphasis here is on the CE’s responsibility. It is assumed that in order to fulfill these duties, the CE is familiar with the emerging and evolving technologies and can translate the clinical needs of the users into an effective and comprehensive bid specification document. The document should be clear, facilitating a competitive bidding environment and comparison of vendors and their wares. This document sets the whole equipment evaluation and selection into motion. Validation criteria for key elements, such as system configuration, extent of facility preparation and operation disturbance, performance requirements, users and maintainers training, warranty, documentation, delivery schedule, and implementation plan, should be spelled out. Cost of service support and price for future upgrades need to be locked. After the vendor has responded to the informal request or the request for proposal (RFP) information, the clinical engineering department will be responsible for evaluating the technical responses, while the materials management department evaluates the financial responses. In translating clinical needs into a specification list, key features or “must have” attributes of the desired device are identified. In practice, clinical engineering and materials management develop a “must have” list and an “extras” list. The “extras” list contains features that could tip the decision in favor of one vendor, all other factors being equal. These specification lists are sent to the vendor and are effective in a self-elimination process that results in a time savings for the hospital. Once the “must have” attributes have been satisfied, the remaining “candidate” devices are evaluated technically and the “extras” are considered. This is accomplished by assigning a weighing factor, for example, 0–5, to denote the relative importance of each of the desired attributes. The relative ability of each device to meet the defined requirements is then rated. Consider the following examples of attributes:

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Accuracy and repeatability Ease of use Reliability Expected user’s skill level Serviceability and warranty Performance Compatibility and interchangeability Ability to be upgraded Safety Cost

Each of these attributes is important, but some are more important than others. In assigning the weighing factors, the CE must take into account the relative importance of each of these attributes. He or she should create a bidding environment that will enable a direct comparison of vendors. Therefore, the RFP should provide details of delivery training and installation, a detailed description of the “must haves” and the “extras,” and the cost of service and upgrades, as well as identifying recourse for vendor deficiencies. The performance of the acceptance testing accomplishes the following: ●

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Verifies by incoming inspection that each medical device received is capable of performing its designed function Obtains baseline measures that can be used later to resolve specified problems Assures compliance with the equipment management program, the relevant factors of which include: Verification that the chosen vendor has delivered a complete system with all of the accessories and other needed supplies Documentation of full compliance with terms that were prescribed in the conditions of sale and agreed upon when the bid was awarded Initiation of an asset control record by the clinical engineering department

This last item is the point where the equipment enters into the equipment maintenance program, the warranty period is initiated (if applicable), and testing criteria are documented. The review of each of the vendors’ responses, the performance of comparative tests and value analysis, and the performance of acceptance testing are the steps that will reduce procurement costs and problems. They will prevent problems such as dissatisfaction, cost overrun, postimplementation surprises, unplanned service costs, slow resolution or delayed response, prolonged startup, performance gaps, overcharges, and unauthorized promises. Existing inventory utilization should be monitored periodically. The utilization level can be measured and compared with the budgeted level. The utilization rate of existing inventory is a good indicator in justifying additional capital requests.

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Risk reduction Significant progress in controlling risk has been achieved with the early implementation of an equipment management program. With the development of the dynamic equipment risk factors and associated failure analysis techniques, proactive techniques to contain risk can now be implemented (see Chapter 55). These techniques should be used for assessing new equipment as well as for the management of existing inventory. Error avoidance and lessons learned from analysis of near-miss events are useful tools for further reduction of potential risk (see Chapter 54). An organization may have a variety of objectives, such as profit, growth, and the performance of a public service. However, a fundamental management commitment to minimizing the adverse effect of accidental loss to an organization is the founding principle of a risk management program. Risk management is the process of making and carrying out decisions that will minimize adverse incidents. Such a program requires development of criteria, identification of problems, and action to reduce those problems. The medical technology management program participates in the organization effort early on and throughout the equipment life cycle by assessing equipment performance. Impact of risk and quality is monitored prior to purchase decision; during installation, maintenance, and repair; and as indicators for disposition or replacement. Faulty design, poor manufacturing, lack of compatibility with existing technology, and mismatch with users’ skills or needs can be corrected during the equipment selection and incoming inspection. On the other hand, incorrect operating procedures, the lack of a (or an inadequate) maintenance program, or faulty repair work can be corrected by failure analysis and corrective action based on the information collection and an evaluation system that has been described in the JCAHO Plant, Technology, and Safety Management publication. The collection of equipment failure analysis information over several years indicates that equipment risk factor is dynamic. The dynamic equipment risk factor is a modification of a static factor that is assigned to a medical device when it first enters the equipment management program. This static factor is being modified, continuously, over its life cycle by risk factors that derive from information collected about the equipment performance experiences. Periodically, a summary report of significant equipmentrelated performance is prepared. The report’s data comprise elements that show 1. The ratio of completed to scheduled inspections. 2. The number and percentage of devices that fail to pass the prescribed inspection. 3. The number and percentage of devices for which a user’s complaint was registered, even if no problem was found.

4. The number and percentage of devices that show physical damage. 5. Devices that were involved in an unusual event, that is, an accident. Each element is counted as an event, and thresholds above which unsafe conditions may exist can be determined. Each individual device has its own history and thus its own risk level. The failure elements report allows the structured progression from considering an isolated device performance to clustering equipment users’ behavior and their interaction with the devices. In essence, this change is a translation of an equipment repair service into a technology management function that aids the hospital in selecting better equipment, establishing more effective users training that is proportional to measured risk, scheduling maintenance more efficiently, and prioritizing capital replacement. The trending of this information overtime will guide the annual review of the effectiveness of the clinical engineering program. The program should be complemented with a professional communication between the CE and the various manufacturers. It will result in the availability of better and safer products, less complex operation and maintenance instructions, more effective in-service training, and rapid resolution when action is needed. A well-managed equipment program provides a systematic approach to controlling technology-related risks in all of its phases, from the needs analysis to equipment disposition. Equipment-related data elements provide qualitative criteria for evaluating equipment and users performance in relation to equipment use. Through the development of a failure analysis program, continuous improvement in equipment performance and simultaneous reduction of risk potential in the clinical environment is achievable.

Technical asset management An accountable, systematic approach will assure that costeffective, efficacious, safe, and appropriate equipment is available to meet the demands of quality patient care. Such an approach requires that resources committed to the acquisition and the management of medical equipment will be monitored. It is assumed that the financial group manages cost accounting. The medical equipment management program’s purpose is to ensure that a process is dedicated to the management of technology. The MTAC provides a comprehensive and integrated approach to the analysis, implementation, and management of new or additional medical technology. It will turn a fragmented and unpredictable decision-making process into a new technique that is well conceived and that supports the hospital’s mission. Bold action is required in order to achieve this, including gathering knowledge regarding the trends in

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medical technology; the development of decision criteria and analytical techniques; the interaction with budget strategies and financial alternatives; the implementation of the capital assets management program; the determination of facility design and long-range services impacts; and the coordination of technology and assets information into hospital operations. This technique will fill many gaps in database reports that are critical to effective operation and hospital performance. Once it becomes integrated, this process may impact a broad range of parameters, including monthly profit and loss, employee productivity, cost accounting, departmental utilization, the effect of physicians’ practice patterns on resources, use of hospital resources in relation to patient outcome, analysis of charges, comparative data from other hospitals, profitability forecasts, and procedures pricing.

Asset management The attributes of ideal asset management are demonstrated through the continuous availability of robust and reliable equipment and systems at the lowest possible life-cycle cost, whenever and wherever needed (see Chapter 35). Asset management attributes are outlined below. 1. Acquisition and equipment life cycle (a) Involvement in the process of determining the need for equipment (both short- and long-term needs) (b) Preparation of bid specifications and supporting negotiation (c) Careful and detailed prepurchase evaluation and selection (d) Development and performance of acceptance testing (e) Technical support over the equipment’s life cycle (f) Recommendations for, and assistance in, its disposition by replacement, refurbishment, upgrade, or declared obsolescence 2. Technical support (a) Establishment of complete equipment inventory with control records, files containing operating and service manuals, and testing and quality-assurance indicators (b) Incoming equipment acceptance testing and application of a control-number tag (c) Hazard and recall notification and incidents handling system (d) Periodic, as well as preventive, maintenance of all equipment, performed by either hospital personnel or outside vendors (e) Equipment repair, including management and integration of service vendor activities (f) Day-to-day assistance to equipment users promoting improvement in clinical use of equipment (e.g., periodic “equipment rounds” in the diagnostic-imaging department)

3. Information and Training (a) Dissemination of users of manuals and other labels (b) Processing and tracking hazard and recall data (c) Initial and ongoing training of all clinical personnel in the safe and effective use of patient care equipment on at least an annual basis (d) Investigation of incidents, prompt reporting as appropriate, equipment-related incidents, hazards, and problems. Methods to avoid learned errors should be discussed during staff training 4. Monitoring and evaluation (a) Development of, implementation of, and participation in quality assurance and risk management activities (b) Periodic assessment of the equipment management program’s effectiveness with the combination of objective and subjective data (c) Ensuring of effective communication and feedback between relevant personnel in the hospital (e.g., clinical staff, purchasing, clinical engineering, hospital administration, and equipment vendors). It is important to focus all service-related communication between hospital departments and vendors in the clinical engineering department 5. Documentation of program activities described above to meet regulatory, accreditation, and problem solving requirements and to minimize liability A clinical engineering program, through outstanding performance in equipment management, will win the support of the hospital and will be asked to be involved in the full range of technology management activities, including: ●

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An equipment control program that encompasses routine performance testing, inspection, periodic and preventive maintenance, on-demand repair services, incidents investigation, and actions on recalls and hazards Multidisciplinary involvement in equipment acquisition and replacement decisions; development of new services; and planning of new construction and major renovations, including intensive participation by clinical engineering, materials management, and finance departments Training programs for all users of patient care equipment QI, as it relates to technology use Technology-related risk management

Clinical engineering needs Because medical assets, the technology, the information, and their interaction with users are mission critical, professional management review is expected to guide this process. Clinical engineering professionals have the skills and the

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competency to provide this service. However, an effective program requires that administrative and clinical personnel have a clear vision of the program deliverables and ROI. The deliverables must be well documented and periodically reported, highlighting changes in medical assets characteristics and performance, clinical engineering personnel development and turnover rate, risk mitigation results, cost containment achieved, customer satisfaction, and participation in scientific publications. To deliver all of these items, a clinical engineering program requires strong and capable leadership, commitment of budget for personnel, test equipment, and appropriate space. Clinical engineering leadership must be able to identify the needs for a quality program and to determine the impact if the expected level of fiscal support is not obtained. To accomplish this, workload and budget allocations per unit of service must be developed and established for the organization and for clinical engineering functions. Because medical assets management consists of a variety of tasks, individual impact and alternatives should be studied and presented to management. A successful clinical engineering program is largely dependent on adequate budgetary support for training, administrative overhead, subscription to technical services, and access to supplies. Strong relationships with peers in other organizations, including professional societies and vendors,

should be encouraged, and information technologies such as computer hardware and software programs are necessary. Within the organization, there should be a demonstration of strong support for the clinical engineering program through clear and immediate communications and involvement of members of the program in space and equipment planning, purchasing decisions, and service contract review. Organizations that have adopted this approach have harvested the benefits of planting and nourishing the seeds of optimal medical technology management.

Reference David, Y., Judd, T.M., 1993. Medical Technology Management. Biophysical Measurement Series. SpaceLabs Medical, Redmond, WA.

Further Information Andrade, J.D., 1994. Medical and Biological Engineering in the Future of Health Care. University of Utah Press, Salt Lake City, UT. Bronzino, J.D., 1992. Management of Medical Technology: A Primer for Clinical Engineers. Butterworth-Heineman, Boston, MA. Bronzino, J.D., Smith, V.H., Wade, M.L., 1991. Medical Technology and Society: An Interdisciplinary Perspective. MIT Press, Cambridge, MA. Reisner, S.J., 1978. Medicine and the Reign of Technology. Cambridge University Press, New York.