Healthcare Technology Management (sometimes referred to as clinical engineering, clinical engineering management, clinical technology management, healthcare technology management, medical equipment management, biomedical maintenance, biomedical equipment management, and biomedical engineering) is a term for the professionals who manage operations, analyze and improve utilization and safety, and support servicing healthcare technology. These healthcare technology managers are, much like other healthcare professionals referred to by various specialty or organizational hierarchy names.
Some of the titles of healthcare technology management professionals are biomed, biomedical equipment technician, biomedical engineering technician, biomedical engineer, BMET, biomedical equipment management, biomedical equipment services, imaging service engineer, imaging specialist, clinical engineer technician, clinical engineering equipment technician, field service engineer, field clinical engineer, clinical engineer, and medical equipment repair person. Regardless of the various titles, these professionals offer services within and outside of healthcare settings to enhance the safety, utilization, and performance on medical devices, applications, and systems.
A medical device is any device intended to be used for medical purposes. Thus what differentiates a medical device from an everyday device is its intended use. Medical devices benefit patients by helping health care providers diagnose and treat patients and helping patients overcome sickness or disease, improving their quality of life. Significant potential for hazards are inherent when using a device for medical purposes and thus medical devices must be proved safe and effective with reasonable assurance before regulating governments allow marketing of the device in their country. As a general rule, as the associated risk of the device increases the amount of testing required to establish safety and efficacy also increases. Further, as associated risk increases the potential benefit to the patient must also increase.
They are a fundamental part of managing, maintaining, and/or designing medical devices, applications, and systems for use in various healthcare settings, from the home and the field to the doctor's office and the hospital.
HTM includes the business processes used in interaction and oversight of the technology involved in the diagnosis, treatment, and monitoring of patients. The related policies and procedures govern activities such as the selection, planning, and acquisition of medical devices, and the inspection, acceptance, maintenance, and eventual retirement and disposal of medical equipment.
A business process or business method is a collection of related, structured activities or tasks by people or equipment which in a specific sequence produce a service or product for a particular customer or customers. Business processes occur at all organizational levels and may or may not be visible to the customers. A business process may often be visualized (modeled) as a flowchart of a sequence of activities with interleaving decision points or as a process matrix of a sequence of activities with relevance rules based on data in the process. The benefits of using business processes include improved customer satisfaction and improved agility for reacting to rapid market change. Process-oriented organizations break down the barriers of structural departments and try to avoid functional silos.
Responsibilities of the Healthcare Technology Management Professional
The healthcare technology management professional's purpose is to ensure that equipment and systems used in patient care are operational, safe, and properly configured to meet the mission of the healthcare; that the equipment is used in an effective way consistent with the highest standards of care by educating the healthcare provider, equipment user, and patient; that the equipment is designed to limit the potential for loss, harm, or damage to the patient, provider, visitor, and facilities through various means of analysis prior to and during acquisition, monitoring and foreseeing problems during the lifecycle of the equipment, and collaborating with the parties who manufacture, design, regulate, or recommend safe medical devices and systems.
Some but not all of the healthcare technology management professional's functions are:
Asset management refers to systematic approach to the governance and realization of value from the things that a group or entity is responsible for, over their whole life cycles. It may apply both to tangible assets and to intangible assets. Asset management is a systematic process of developing, operating, maintaining, upgrading, and disposing of assets in the most cost-effective manner.
A work order is usually a task or a job for a customer, that can be scheduled or assigned to someone. Such an order may be from a customer request or created internally within the organization. Work orders may also be created as follow ups to Inspections or Audits. A work order may be for products or services.
Data quality refers to the state of qualitative or quantitative pieces of information. There are many definitions of data quality but data is generally considered high quality if it is "fit for [its] intended uses in operations, decision making and planning". Moreover, data is deemed of high quality if it correctly represents the real-world construct to which it refers. Furthermore, apart from these definitions, as the number of data sources increases, the question of internal data consistency becomes significant, regardless of fitness for use for any particular external purpose. People's views on data quality can often be in disagreement, even when discussing the same set of data used for the same purpose. When this is the case, Data Governance is used to form agreed upon definitions and standards for data quality. In such cases, data cleansing, including standardization, may be required in order to ensure data quality.
Equipment Control & Asset Management
Every medical treatment facility should have policies and processes on equipment control and asset management. Equipment control and asset management involves the management of medical devices within a facility and may be supported by automated information systems (e.g., enterprise resource planning (ERP) systems are often found in U.S. hospitals, and the U.S. military health system uses an advanced automated system known as the Defense Medical Logistics Standard Support (DMLSS) suite of applications) or may use a dedicated equipment management and maintenance software (e.g., BME Assistor). Equipment control begins with the receipt of a newly acquired equipment item and continues through the item's entire lifecycle. Newly acquired devices should be inspected by in-house or contracted biomedical equipment technicians (BMETs), who will receive an established equipment control/asset number from the facilities equipment/property manager. This control number is used to track and record maintenance actions in their database. This is similar to creating a new chart for a new patient who will be seen at the medical facility. Once an equipment control number is established, the device is safety inspected and readied for delivery to clinical and treatment areas in the facility.
A health facility is, in general, any location where healthcare is provided. Health facilities range from small clinics and doctor's offices to urgent care centers and large hospitals with elaborate emergency rooms and trauma centers. The number and quality of health facilities in a country or region is one common measure of that area's prosperity and quality of life. In many countries, health facilities are regulated to some extent by law; licensing by a regulatory agency is often required before a facility may open for business. Health facilities may be owned and operated by for-profit businesses, non-profit organizations, governments, and in some cases by individuals, with proportions varying by country. See also the recent review paper, which provides a comprehensive classification of health facilities from the location analysis perspective.
Enterprise resource planning (ERP) is the integrated management of main business processes, often in real-time and mediated by software and technology.
Facilities or healthcare delivery networks may rely on a combination of equipment service providers such as manufacturers, third-party services, in-house technicians, and remote support. Equipment managers are responsible for continuous oversight and responsibility for ensuring safe and effective equipment performance through full-service maintenance. Medical equipment managers are also responsible for technology assessment, planning and management in all areas within a medical treatment facility (e.g. developing policies and procedures for the medical equipment management plan, identifying trends and the need for staff education, resolution of defective biomedical equipment issues).
This industry is new, and there is not a clear line between IT and Bio-Med.
Work Order Management
Work order management involves systematic, measurable, and traceable methods to all acceptance/initial inspections, preventive maintenance, and calibrations, or repairs by generating scheduled and unscheduled work orders. Work order management may be paper-based or computer-base and includes the maintenance of active (open or uncompleted) and completed work orders which provide a comprehensive maintenance history of all medical equipment devices used in the diagnosis, treatment, and management of patients. Work order management includes all safety, preventive, calibration, test, and repair services performed on all such medical devices. A comprehensive work order management system can also be used as a resource and workload management tool by managers responsible for personnel time, total number of hour’s technician spent working on equipment, maximum repair dollar for one time repair, or total dollar allowed to spend repairing equipment versus replacement.
Post-work order quality checks involve one of two methods: 100% audit of all work orders or statistical sampling of randomly selected work orders. Randomly selected work orders should place more stringent statistical controls based on the clinical criticality of the device involved. For example, 100% of items critical to patient treatment but only 50% of ancillary items may be selected for sampling. In an ideal setting, all work orders are checked, but available resources may dictate a less comprehensive approach. Work orders must be tracked regularly and all discrepancies must be corrected. Managers are responsible to identify equipment location
Data Quality Management
Accurate, comprehensive data are needed in any automated medical equipment management system. Data quality initiatives can help to insure the accuracy of clinical/biomedical engineering data. The data needed to establish basic, accurate, maintainable automated records for medical equipment management includes: nomenclature, manufacturer, nameplate model, serial number, acquisition cost, condition code, and maintenance assessment. Other useful data could include: warranty, location, other contractor agencies, scheduled maintenance due dates, and intervals. These fields are vital to ensure appropriate maintenance is performed, equipment is accounted for, and devices are safe for use in patient care.
Nomenclature: It defines what the device is, how, and the type of maintenance is to be performed. Common nomenclature systems are taken directly from the ECRI Institute Universal Medical Device Nomenclature System.
Manufacturer: This is the name of the company that received approval from the FDA to sell the device, also known as the Original Equipment Manufacturer (OEM).
Nameplate model: The model number is typically located on the front/behind of the equipment or on the cover of the service manual and is provided by the OEM. E.g. Medtronic PhysioControl’s Lifepak 10 Defibrillator can actually be any one of the following correct model numbers listed: 10-41, 10-43, 10 -47, 10-51, and 10-57.
Serial number: This is usually found on the data plate as well, is a serialized number (could contain alpha characters) provided by the manufacturer. This number is crucial to device alerts and recalls.
Acquisition cost: The total purchased price for an individual item or system. This cost should include installation, shipping, and other associated costs. These numbers are crucial for budgeting, maintenance expenditures, and depreciation reporting.
Condition code: This code is mainly used when an item is turned in and should be changed when there are major changes to the device that could affect whether or not an item should be salvaged, destroyed, or used by another Medical Treatment Facility.
Maintenance assessment: This assessment must be validated every time a BMET performs any kind of maintenance on a device.
Several other management tools, such as equipment replacement planning and budgeting, depreciation calculations, and at the local level literature, repair parts, and supplies are directly related to one or more of these fundamental basics. Data Quality must be tracked monthly and all discrepancies must be corrected.
Quality Assurance
Quality Assurance is a way of identifying an item of supply or equipment as being defective. A good quality control/engineering program improves quality of work and lessens the risk of staff/patient injuries/death.
Patient Safety
Safety of our patients/staff is paramount to the success of our organizations mission. The Joint Commission publishes annual lists detailing “National Patient Safety Goals” to be implemented by healthcare organizations. Goals are developed by experts in patient safety nurses, physicians, pharmacists, risk managers, and other professionals with patient-safety experience in a variety of settings. Patient safety is among the most important goals of every healthcare provider, and participation in a variety of committees and processes concerned with patient safety provides a way for biomedical managers and clinical engineering departments to gain visibility and positively affect their workplace.
Risk management
This program helps the medical treatment facility avoid the likelihood of equipment-related risks, minimize liability of mishaps and incidents, and stay compliant with regulatory reporting requirements. The best practice is to use a rating system for every equipment type. For example, a risk-rating system might rate defibrillators as considered high risk, general-purpose infusion pumps as medium risk, electronic thermometers as low risk, and otoscopes as no significant risk. This system could be set up using Microsoft Excel or Access program for a manager's or technician's quick reference.
In addition, user error, equipment abuse, no problem/fault found occurrences must be tracked to assist risk management personnel in determining whether additional clinical staff training must be performed.
Risk management for IT networks incorporating medical devices will be covered by the standard ISO/IEC 80001. Its purpose is: "Recognizing that MEDICAL DEVICES are incorporated into IT-NETWORKS to achieve desirable benefits (for example, INTEROPERABILITY), this international standard defines the roles, responsibilities and activities that are necessary for RISK MANAGEMENT of IT-NETWORKS incorporating MEDICAL DEVICES to address the KEY PROPERTIES". It resorts some basic ideas of ISO 20000 in the context of medical applications, e.g. configuration, incident, problem, change and release management, and risk analysis, control and evaluation according to ISO 14971. IEC 80001 "applies to RESPONSIBLE ORGANIZATIONS, MEDICAL DEVICE manufacturers and other providers of information technologies for the purpose of comprehensive RISK MANAGEMENT".
Hospital Safety Programs
The Joint Commission stipulates seven management plans for hospital accreditation. One of the seven is safety. Safety includes a range of hazards including mishaps, injuries on the job, and patient care hazards. The most common safety mishaps are "needle-sticks" (staff accidentally stick themselves with a needle) or patient injury during care. As a manager, ensure all staff and patients are safe within the facility. Note: it’s everyone’s responsibility!
There are several meetings that medical equipment managers are required to attend as the organizations technical representative:
Patient Safety
Environment of Care
Space Utilization Committee
Equipment Review Board
Infection Control (optional)
Educational Requirements For Bio-Medical Engineer: Students should take the most challenging science, math, and English courses available in high school. All biomedical engineers have at least a bachelor's degree in engineering. Many have advanced graduate degrees as well. Courses of study include a sound background in mechanical, chemical, or industrial engineering, and specialized biomedical training. Most programs last from four to six years, and all states require biomedical engineers to pass examinations and be licensed.
Duties & Responsibilities For Bio-Medical Engineer: Description: Biomedical Engineers use engineering principles to solve health related and medical problems. They do a lot of research in conjunction with life scientists, chemists, and medical professionals to design medical devices like artificial hearts, pacemakers, dialysis machines, and surgical lasers. Some conduct research on biological and other life systems or investigate ways to modernize laboratory and clinical procedures. Frequently, biomedical engineers supervise biomedical equipment maintenance technicians, investigate medical equipment failure, and advise hospitals about purchasing and installing new equipment. Biomedical engineers work in hospitals, universities, industry, and research laboratories.
Working Conditions: Biomedical engineers work in offices, laboratories, workshops, manufacturing plants, clinics and hospitals. Some local travel may be required if medical equipment is located in various clinics or hospitals. Most biomedical engineers work standard weekday hours. Longer hours may be required to meet research deadlines, work with patients at times convenient to them, or work on medical equipment that is in use during daytime hours.
Duties: Biomedical engineers work closely with life scientists, chemists and medical professionals (physicians, nurses, therapists and technicians) on the engineering aspects of biological systems. Duties and responsibilities vary from one position to another but, in general, biomedical engineers:
• design and develop medical devices such as artificial hearts and kidneys, pacemakers, artificial hips, surgical lasers, automated patient monitors and blood chemistry sensors.
• design and develop engineered therapies (for example, neural-integrative prostheses).
• adapt computer hardware or software for medical science or health care applications (for example, develop expert systems that assist in diagnosing diseases, medical imaging systems, models of different aspects of human physiology or medical data management).
• conduct research to test and modify known theories and develop new theories.
• ensure the safety of equipment used for diagnosis, treatment and monitoring.
• investigate medical equipment failures and provide advice about the purchase and installation of new equipment.
• develop and evaluate quantitative models of biological processes and systems.
• apply engineering methods to answer basic questions about how the body works.
• contribute to patient assessments.
• prepare and present reports for health professionals and the public.
• supervise and train technologists and technicians.
Biomedical engineers may work primarily in one or a combination of the following fields:
• bioinformatics – developing and using computer tools to collect and analyze data.
• bioinstrumentation – applying electronic and measurement techniques.
• biomaterials – developing durable materials that are compatible with a biological environment.
• biomechanics - applying knowledge of mechanics to biological or medical problems.
• bio-nano-engineering – developing novel structures of nanometer dimensions for application to biology, drug delivery, molecular diagnostics, microsystems and nanosystems.
• biophotonics – applying and manipulating light, usually laser light, for sensing or imaging properties of biological tissue.
• cellular and tissue engineering – studying the anatomy, biochemistry and mechanics of cellular and sub-cellular structures, developing technology to repair, replace or regenerate living tissues and developing methods for controlling cell and tissue growth in the laboratory.
• clinical engineering – applying the latest technology to health care and health care systems in hospitals.
• genomics and genetic engineering – mapping, sequencing and analyzing genomes (DNA), and applying molecular biology methods to manipulate the genetic material of cells, viruses and organisms.
• medical or biological imaging – combining knowledge of a physical phenomenon (for example, sound, radiation or magnetism) with electronic processing, analysis and display.
• molecular bioengineering – designing molecules for biomedical purposes and applying computational methods for simulating biomolecular interactions.
• systems physiology - studying how systems function in living organisms.
• therapeutic engineering – developing and discovering drugs and advanced materials and techniques for delivering drugs to local tissues with minimized side effects.
Related Research Articles
Biomedical engineering (BME) or medical engineering is the application of engineering principles and design concepts to medicine and biology for healthcare purposes. This field seeks to close the gap between engineering and medicine, combining the design and problem solving skills of engineering with medical biological sciences to advance health care treatment, including diagnosis, monitoring, and therapy. Also included under the scope of a biomedical engineer is the management of current medical equipment within hospitals while adhering to relevant industry standards. This involves equipment recommendations, procurement, routine testing and preventative maintenance, through to decommissioning and disposal. This role is also known as a Biomedical Equipment Technician (BMET) or clinical engineering.
Medical physics is, in general, the application of physics concepts, theories, and methods to medicine or healthcare. Medical physics departments may be found in hospitals or universities.
A bloodborne disease is a disease that can be spread through contamination by blood and other body fluids. Bloodborne pathogens are microorganisms such as viruses or bacteria. The most common examples are HIV, hepatitis B (HVB), hepatitis C (HVC) and viral hemorrhagic fevers.
Health informatics is information engineering applied to the field of health care, essentially the management and use of patient healthcare information. It is a multidisciplinary field that uses health information technology (HIT) to improve health care via any combination of higher quality, higher efficiency, and new opportunities. The disciplines involved include information science, computer science, social science, behavioral science, management science, and others. The NLM defines health informatics as "the interdisciplinary study of the design, development, adoption and application of IT-based innovations in healthcare services delivery, management and planning". It deals with the resources, devices, and methods required to optimize the acquisition, storage, retrieval, and use of information in health and bio-medicine. Health informatics tools include computers, clinical guidelines, formal medical terminologies, and information and communication systems, among others. It is applied to the areas of nursing, clinical medicine, dentistry, pharmacy, public health, occupational therapy, physical therapy, biomedical research, and alternative medicine, all of which are designed to improve the overall of effectiveness of patient care delivery by ensuring that the data generated is of a high quality.
Health technology is defined by the World Health Organization as the "application of organized knowledge and skills in the form of devices, medicines, vaccines, procedures and systems developed to solve a health problem and improve quality of lives". This includes pharmaceuticals, devices, procedures, and organizational systems used in the healthcare industry, as well as computer-supported information systems. In the United States, these technologies involve standardized physical objects, as well as traditional and designed social means and methods to treat or care for patients.
A medical laboratory scientist (MLS), also traditionally referred to as a clinical laboratory scientist (CLS), or medical technologist (MT), is a healthcare professional who performs chemical, hematological, immunologic, histopathological, cytopathological, microscopic, and bacteriological diagnostic analyses on body fluids such as blood, urine, sputum, stool, cerebrospinal fluid (CSF), peritoneal fluid, pericardial fluid, and synovial fluid, as well as other specimens. Medical laboratory scientists work in clinical laboratories at hospitals, reference labs, biotechnology labs and non-clinical industrial labs.
A biomedical engineering/equipment technician/technologist or biomedical engineering/equipment specialist is typically an electro-mechanical technician or technologist who ensures that medical equipment is well-maintained, properly configured, and safely functional. In healthcare environments, BMETs often work with or officiate as a biomedical and/or clinical engineer, since the career field has no legal distinction between engineers and engineering technicians/technologists.
Clinical engineering is a speciality within HTM biomedical engineering responsible primarily for applying and implementing medical technology to optimize healthcare delivery. Roles of clinical engineers include training and supervising biomedical equipment technicians (BMETs), working with governmental regulators on hospital inspections/audits, and serving as technological consultants for other hospital staff. Clinical engineers also advise medical device producers regarding prospective design improvements based on clinical experiences, as well as monitor the progression of the state-of-the-art in order to redirect hospital procurement patterns accordingly.
Health information management (HIM) is information management applied to health and health care. It is the practice of acquiring, analyzing and protecting digital and traditional medical information vital to providing quality patient care. With the widespread computerization of health records, traditional (paper-based) records are being replaced with electronic health records (EHRs). The tools of health informatics and health information technology are continually improving to bring greater efficiency to information management in the health care sector. Both hospital information systems and Human Resource for Health Information System (HRHIS) are common implementations of HIM.
The Association for the Advancement of Medical Instrumentation (AAMI) is an organization for advancing the development, and safe and effective use of medical technology founded in 1965 by Robert D. Hall, Jr. and Robert J. Allen, President and Vice President respectively of Tech/Reps, Inc.. AAMI was created by the Tech/Reps' team as both a vehicle to help their clients introduce innovative medical devices into common medical practice and to set safety standards in both their design and usage. Dr. John Merrill of Peter Bent Brigham Hospital, and John Abele, Sales Manager of Advanced Instruments, Inc. joined with Hall and Allen to establish AAMI. Among the first members were Doctors Paul Dudley White, Michael Debakey, Adrian Kantrowitz, and the US Surgeon General. AAMI members now include decision makers in the medical technology profession—clinical engineers, biomedical equipment technicians, manufacturers, sterile processing professionals, researchers, quality assurance and regulatory affairs experts, and other healthcare technology management professionals. In 1966, AAMI was introduced to the public at large through MEDAC 66 held in Boston at which Drs. Debakey and Kantrowitz introduced the world's first artificial hearts and debated the merits of each.
Maintenance Engineering is the discipline and profession of applying engineering concepts for the optimization of equipment, procedures, and departmental budgets to achieve better maintainability, reliability, and availability of equipment.
ECRI Institute is an independent nonprofit organization authority on the medical practices and products that provide the safest, most cost-effective care.
ISO 14971 is an ISO standard for the application of risk management to medical devices. The ISO Technical Committee responsible for the maintenance of this standard is ISO TC 210 working with IEC/SC62A through Joint Working Group one (JWG1). This standard is the culmination of the work starting in ISO/IEC Guide 51, and ISO/IEC Guide 63. The latest significant revision was published in 2007 with a minor update published in 2009. In 2013, a technical report ISO/TR 24971 was published by ISO TC 210 to provide expert guidance on the application of this standard.
Engineering World Health (EWH) is a non-profit organization that works with hospitals and clinics that serve resource-poor communities of the developing world. EWH's focus is on the repair and maintenance of medical equipment - rather than donation - and on building local capacity to manage and maintain the equipment without international aid.
Biomedical sciences are a set of sciences applying portions of natural science or formal science, or both, to knowledge, interventions, or technology that are of use in healthcare or public health. Such disciplines as medical microbiology, clinical virology, clinical epidemiology, genetic epidemiology, and biomedical engineering are medical sciences. In explaining physiological mechanisms operating in pathological processes, however, pathophysiology can be regarded as basic science.
Medical device connectivity is the establishment and maintenance of a connection through which data is transferred between a medical device, such as a patient monitor, and an information system. The term is used interchangeably with biomedical device connectivity or biomedical device integration. By eliminating the need for manual data entry, potential benefits include faster and more frequent data updates, diminished human error, and improved workflow efficiency.
Joseph Antony Cafazzo is a Canadian biomedical engineer, educator, and researcher.
In its succinct definition, “Healthcare Engineering is engineering involved in all aspects of healthcare”. The term “engineering” in this definition covers all engineering disciplines such as Biomedical, Chemical, Civil, Computer, Electrical, Environmental, Industrial, Information, Materials, Mechanical, Software, and Systems Engineering. Based on the definition of "healthcare", a more elaborated definition of Healthcare Engineering is the following:“Healthcare Engineering is engineering involved in all aspects of the prevention, diagnosis, treatment, and management of illness, as well as the preservation and improvement of physical and mental health and well-being, through the services offered to humans by the medical and allied health professions”.
References
Bowles, Roger "Techcareers: Biomedical Equipment Technicians" TSTC Publishing
Khandpur, R. S. "Biomedical Instrumentation: Technology and Applications". McGraw Hills
Northrop, Robert B., "Noninvasive Instrumentation and Measurement in Medical Diagnosis (Biomedical Engineering)".
Webb, Andrew G., "Introduction to Biomedical Imaging (IEEE Press Series on Biomedical Engineering)".
Yadin David, Wolf W. von Maltzahn, Michael R. Neuman, and Joseph D. Bronzino,. Clinical Engineering (Principles and Applications in Engineering).
Villafañe, Carlos CBET: "Biomed: From the Student's Perspective" ( ISBN978-1-61539-663-4). www.Biomedtechnicians.com.
Willson K., Ison K., Tabakov S., "Medical Equipment Management", CRC Press
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