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While the discipline of clinical engineering has long been limited to the area of medical equipment management, few areas in hospital engineering practice so closely meet the literal definition of "clinical" engineering as the care of the immunocompromised patient. Although ventilation has been the domain of the plant maintenance department, the increasing numbers of clinical engineers being given responsibility for plant functions, as well as the critical nature of the topic, make the care of the bone marrow transplant (BMT) patient an appropriate area of clinical engineering practice. Further, as clinical engineering branches out of the equipment management area, the clinical engineer can be truly termed the "hospital engineer".

Clinical engineering programs typically establish the content and frequency of a device's inspection and preventive maintenance procedures at the time of implementation. In some programs, these are not altered throughout the device's useful life. In others, history data and traditional statistical methods are used to adapt procedures to change in risk measures. Such methods are essentially reactive in that they are based upon past trends and do not readily consider potentialities for future change in the performance and utilization environments. Chaos theoretical concepts and related measures, when implemented in artificial intelligence programs such as neural networks and genetic algorithms, and used as an adjunct with computerized technology management programs, can assist in asking and answering the more dynamic, proactive questions necessary for effective inspection and preventive maintenance optimization. Today's healthcare environment is ideal for exploring their utilization.

The project described in this paper concerns the assurance of quality in biomedical equipment management. The project commenced in 1988 with the establishment of the Clinical Engineering Department at the General Hospital of Bolzano, which was entrusted with the task of managing all biomedical equipment installed within its health institutions. To ensure the systematic and organic management of biomedical technology, new technical and administrative procedures were introduced. The results achieved have been validated both through a detailed analysis of staff replies to a specific questionnaire and on the basis of several objective indicators, such as maintenance costs and equipment breakdown times.

In surveys during the past decade, CEs and BMETs have reported an increasing frequency of respiratory illnesses they believed to be acquired as a result of their occupation. These illnesses varied from mild to severe in terms of long-term prognosis. With the increasing numbers of cases of drug-resistant organisms, respiratory infections are a growing concern for healthcare workers, employers, and government officials. Armed with a better knowledge base about symptoms, transmission and prevention, CEs and BMETs will be more aware of potential biohazardous situations and the necessary personal protective measures to be employed. Both the Occupational Safety and Health Administration (OSHA) and the Centers for Disease Control and Prevention (CDCP) have issued guidelines for preventing airborne transmission of infectious diseases. This paper addresses the respiratory illnesses reported by CEs and BMETs as occupational concerns, as well as briefly discussing potential epidemic pulmonary conditions.

Nongovernmental organizations (NGOs) have played a major role in the diffusion of biomedical engineering training to developing nations. This paper reviews the roles and unique attributes of NGOs in biomedical engineering training programs. The activities of one leading NGO in this field, Project HOPE, are discussed with examples drawn from around the world. Future challenges to biomedical engineering in the developing world, and the potential of NGOs to provide a response to these needs, are considered.

Reports bear witness that a significant proportion of all healthcare equipment in developing countries is not in use. There are many and varied reasons this, including inappropriateness or a lack of basic maintenance. This report addresses these issues, including guidelines for procurement staff and end-users and a bibliography. Examples of the considerations involved are given in the specialties of therapy oxygenation, laboratory tests and solar-powered equipment.

This feature article presents an overview of how the biomedical equipment technology field developed. It begins with some of the early medical equipment breakthroughs, such as the discovery of X rays. The article then traces the key role of the military in electronic technology design, leading to the concept of specially trained individuals to maintain medical equipment. The Technical Education Research Center is discussed, along with the evolution of BMET schools. Formal BMET education had a strong advocate in Ralph Nader, whose concerns about electrical safety in hospitals supported the need for trained technicians to test medical equipment. BMET certification, BMET careers, and Clinical Engineering are discussed. The article concludes with some speculation on healthcare reform and its possible effect on the biomedical equipment profession.

Hepatitis is the primary occupational hazard for healthcare workers. Not until the 1970s were hepatitis viruses isolated and identified as types A and B. In the late 1970s, hepatitis D was discovered as a major cause of fulminant hepatitis. Soon, it was evident that another type was also at work. Because testing was only available for types A and B, the new category was referred to as non-A, non-B. In the 1980s, scientists identified two more viruses from this non-A, non-B group, namely hepatitis E and hepatitis C. These five types of hepatitis have different modes of transmission. The fecal-to-oral route is the mode of transmission for hepatitis types A and E. But, types B and D are bloodborne pathogens. With the advent of a safe vaccine for hepatitis B, this category is declining. To date, hepatitis C appears to have multiple routes of transmission, with half the cases being posttransfusion. In the United States, 85,000 people per year develop chronic hepatitis C, which ultimately leads to severe liver damage. This paper addresses each of the five viruses that have been grouped by routes of transmission, prevention techniques for BMETs and CEs, and statistics of reported cases to the Centers for Disease Control and Prevention (CDCP) over the last 20 years.

In late 1993, a survey was sent to the subscribers of the Journal of Clinical Engineering to determine: (1) if employers were responding to the biohazards protection needs of BMETs and CEs; (2) if personal protective equipment was being utilized; (3) if occupational exposure perceptions and concerns had changed since a previous survey four years ago; and (4) if educational efforts targeting BMETs and CEs were still needed. The 267 respondents were divided into four groups according to certification status and job title. Results showed that employers were doing an excellent job of providing personal protective equipment, but 50% of the BMETs and CEs chose not to use it. Even though though the occupational exposure illness and disability rate increased to 21% from the 1989 survey rate of 18%, BMETs and CEs still feel confident in their abilities to recognize potential biohazard problems based on visual clues, which can be an error in judgement that can lead to serious adverse effects including illness, disability, or death.

The frequency of inspection of the authors' scheduled maintenance program was reviewed and modified, using the work of Fennigkoh (1989). This work extended to 2,700 devices located at four hospital sites supported by a regional service. These devices included all clinical equipment, including diagnostic imaging and renal dialysis. Review of the inspection frequencies was necessary as part of the quality assurance program and to ensure consistency between similar devices. Equipment was first evaluated according to four criteria to determine if it should be on the scheduled performance assurance program. These criteria included: equipment function, physical risk to patients, maintenance requirements, and incident or related history. The frequency of inspection of included devices was then assessed according to an algorithm that looked at device maintenance requirements and manufacturers' recommendations. Devices were scheduled for inspection once, twice or, in rare cases, four times per year. The quality of the inspection program was enhanced by a systematic review. As an added bonus, the required staffing resources to comply with the scheduled performance assurance declined by 29%.

Performance improvements in healthcare and, specifically, in clinical engineering are required by the Joint Commission on the Accreditation of Healthcare Organizations' Plant Technology and Safety Management (PTSM) documents. The goals of healthcare service quality assurance are to establish performance requirements and improve patient outcomes. It is important that these goals be kept in the forefront of the design of clinical engineering quality assurance planning. Indicator/threshold pairs must be carefully chosen on the basis of some logical relation to the desired goals of the overall program.

The purpose of this study was to identify empirically the roles of assistive technology service providers in the United States. Via factor analysis, the following six job roles were identified: (a) Device Selection and Maintenance Activities, (b) Environmental Modification Activities, (c) Dissemination of Information on Assistive Technology Activities, (d) Evaluation of Suitability of Assistive Device Activities, (e) Administration Activities, and (f) Product Development Activities. The identified roles can provide a potential guide for the development of education or training curricula for assistive technology service providers. Those job role categories can be considered to be required areas of knowledge in a curriculum for assistive technology specialists. The identified roles can also be utilized to help define the profession of assistive technology. That definition could help guide the development of eligibility criterion and examination content for a credentialing programme for qualified assistive technology service providers in the future. A clear description of the job of assistive technology service providers can help administrators create needed positions within service delivery organizations such as state department of rehabilitation services and a rehabilitation hospital. The results could be valuable to the administrators responsible for setting job role criteria for assistive technology service providers. Such criteria are necessary for making effective hiring and employee evaluation decisions. In addition, the results can provide other professionals who utilize assistive technology services with an accurate picture of the services available from assistive technology service providers. When professionals on a rehabilitation team know what to expect of each other, clients are better served. Thus a better understanding of the roles of assistive technology service providers can contribute to better utilization of their services by a multidisciplinary team. This would in turn increase the chances of assistive technology services being offered to clients. Replication of the present study is encouraged to verify the obtained results. A future study should also focus on examining the roles of assistive technology service providers by directly observing their daily work activities. The task inventory used in the present study (ATTI) might be utilized to help guide such observations.

Three Careers "Fact Sheets" include information on CE and BMET job titles, job descriptions, and certification. These materials are intended to aid in furthering professional recognition for Clinical Engineers and BMETs, and may be useful in communicating with Administration or Human Resources departments.

Technology, as applied in healthcare, is an encompassing term for products, equipment, procedures and services allied in some way with healthcare. This paper discusses technology as the word applies to healthcare. Areas of activity under the umbrella of technology--technology transfer, technology assessment and technology management--will be defined and discussed from the standpoint of their interaction with clinical engineering. The clinical engineering profession has approached participation in each of these activities in a nonsystematic manner, resulting in limited impact and a limited role. To go beyond its present role, the profession must study the processes of technology assessment, transfer, and management to understand their components, critical paths, strengths and weaknesses. This research should be undertaken by a joint group of clinical engineers representing practitioners and academia. Existing key players or professions should be identified, the role clinical engineers wish to pursue as a professional group and the skills required to assure competency should be declared, and appropriate resources for acquiring knowledge and experience identified.

Modern healthcare managers are looking for better ways to motivate their employees as well as document and evaluate employee performance. The term productivity is familiar to most healthcare managers. The term efficiency is less familiar. These terms are defined and their significance for use as unique and valuable indicators of effective employee performance is discussed. Similar criteria were applied to make a general comparison between biomedical technician performance in two different hospitals in Tegucigalpa, Honduras, in Central America. A performance-based incentive program using an Incentive Pay Index chart is proposed as a tool through which hospital or company managers can provide technicians or technologists with ongoing motivation to improve both their productivity and efficiency on the job.

This paper presents definitions of the terms bioengineering, biomedical engineering and clinical engineering. These definitions lead to the conclusion that clinical engineers must be individuals with at least a four-year bachelor's degree in an engineering specialty who are also well versed in the design, modification and testing of medical instrumentation. Educational programs for clinical engineers in the 1990s must be based upon clear definitions of these professionals' roles. Clinical engineering education should include direct professional experience obtained through internship programs similar to the program described here.

Northern California Kaiser Foundation Hospitals' Biomedical Engineering developed a regional rental medical equipment management program in response to the revised 1989 Joint Commission's Health Care Organization Accreditation Standards. The program shifts the operational and safety responsibility for the equipment from the hospitals to the rental vendor. Rental vendors who agreed to Biomedical Engineering's performance standards became preferred vendors from which Kaiser Foundation Hospitals rented their equipment. This program has become a standard adopted by other hospitals that are members of BAMMI (Bay Area Managers of Medical Instrumentation).

Planning a profession's future is a formidable task that must be based on both what the members want to become and what is natural to the marketplace. The hospital industry, however, will not wait for clinical engineering to establish its profession. Competition will arise and push aside the unprepared. Clinical engineering's leadership has not created a clear vision of their profession's role in improving healthcare, nor have they helped others to internalize a sincere professional purpose and to share the responsibility for change. This paper examines the profession and articulates action that only clinical engineers can take to increase their value in the hospital industry.

The medical field is faced with the increasing sophistication of software-controlled medical equipment. Clinical engineers must understand and become familiar with these sophisticated software-driven medical devices and stand-alone medical software programs in order to evaluate their suitability for the desired purpose. They must be able to assess the nature of the software, its potential and its risks. Numerous aspects of software development and safety must be considered when developing and/or evaluating such software devices and programs.

This paper reviews the sociology of professions, examines the background and historical development of professions, and then reviews the present status of the profession of clinical engineering. The historical components of the professionalization process are investigated along with the societal perceptions, the role of education, and the functions of professional societies. The progress of an occupation toward professionalization involves: the appearance of training schools; establishment of university educational programs; licensure or certification; a formal code of ethics; and establishment of one or more national professional associations. A rationale is presented here for the formation of a clearly identified professional society for clinical engineers based on: (1) The need to identify the territory of the clinical engineer by defining the body of knowledge on which clinical engineering is based; (2) The need to structure the educational system of clinical engineering; (3) The need to represent the clinical engineer in the healthcare system; and (4) The need to gain status as a profession.

The Veterans Administration has developed a program to evaluate the level of competency of its medical equipment repairmen and to recognize those who surpass an established level of competency. This evaluation is carried out by means of testing. A passing score of 70% on all sections of the exam results in certification while failure results in enrollment in correspondence or short courses. Periodic evaluations of the exam are carried out to determine questions to be added or deleted and those which should be reworded. Since time limits are set for completing the exam, those time limits are also evaluated.

A previously published survey indicated that clinical engineers and BMETs may not be aware of the scope of biological hazards they may encounter in their work (Baker, 1989). In this third article of a four-part series, various pathogens affecting the respiratory and gastrointestinal systems are discussed. Infection hazards and methods of transmission are examined, and recommendations are provided to help ensure the safety of CEs, BMETs, and patients. The recommendations presented include suggested disinfection procedures for contaminated equipment. Persons interested in further information are advised to contact the infection control officer at their facility, or the Centers for Disease Control.

There are various methods of computing productivity in Clinical Engineering. A simple algorithm based on time standards is presented in this paper. Duties required to support the inspection and repair functions and the time needed to perform them, as well as other functions provided by the Clinical Engineering Department, are discussed. The final "standards" presented in this paper may be applied to other facilities and other situations only with great caution. This study was performed on a certain complement of equipment and with a certain depth of testing. This paper should be read in its entirety to place the results reported in proper context. This is preliminary information, and an expanded data base of studies would be required before a universal standard, if indeed possible, could be adopted. This paper does, however, provide results comparable to other studies performed in recent years, and some consensus on typical inspection and repair time is emerging. Radiographic units, laboratory equipment, and various specialty items are not included.

In the continuing development of clinical engineering, new problem areas are beginning to emerge. Issues related to career development are gaining prominence, and job satisfaction, career advancement, and "burnout" are becoming increasingly important. To address these issues, clinical engineers must assume personal responsibility for their own careers. They must broaden their perception of clinical engineering to include a managerial perspective. The extent to which they assume managerial responsibilities is a function of their personal interests and talents. This involvement can range from a consultative role in decisions involving high technology to a position in the institution's top management staff. This broader definition will significantly benefit not only the field of clinical engineering but individual practitioners as well.

Successful hospital CEOs, administrators and department heads skilled at their professions, face a major challenge from the onslaught of rapidly developing medical instrumentation technology. To meet this rapidly growing challenge, they must identify their needs, survey their resources, and take positive action now to develop the necessary clinical engineering and equipment control programs to cope cost effectively with the future. This article provides an overview of the fundamental problem for the hospital administrator, suggests a direction toward solution, and provides a primer on the resources available to effectively deal with, if not solve, the enormous problem posed by the ever increasing technology dependence of health care.

In response to the growing concern over the management of medical technology in hospitals, and in view of recent changes pertaining to medical technology that have been made by the Joint Commission on Accreditation of Hospitals in the United States, the Canadian Council on Hospital Accreditation recently asked the Canadian Medical & Biological Engineering Society (CMBES) to prepare a brief on the proper role of clinical engineering in Canadian hospitals. The brief prepared by the CMBES outlines seven basic principles associated with clinical engineering, hospital accreditation, and the proper management of medical technology in hospitals. It appears that these principles may form the initial basis for changes to the Canadian Hospital Accreditation Guide and Questionnaires. A comparative assessment of the Canadian and American approaches by clinical engineers may help to advance the cause of better health care in both countries.

Acceptance of the BMET into the patient care picture, and recognition of the BMET as an equal contributor to quality patient care are central to the advancement of this relatively new career field. One factor in gaining this acceptance is the overall image presented by those who call themselves BMET's. An understanding of emerging professions and the effect of dress on image enhancement can provide useful insight into the phenomena of professional recognition. A second aspect of development important to any professional is continuing educational growth. A performance-evaluation scheme, stressing and promoting continuing education, is described in this paper.

The ability to modify or replace organs or functions and to intervene in the transmission of hereditary characteristics is a fundamental turning point in the development of living organisms and of bioengineering. The history of bioengineering leading to this stage is briefly reviewed and reinterpreted. The view is proposed that bioengineering is the instrument by which metabiology - the continuance of biology with other means - is brought about. Metabiology deals with the study of living organisms as they can be modified by outside interventions on their functions, organs or sub-organs. Some of the fundamental questions raised by interventions from the outside on the organism - such as the loss of validity of the concept of homeostasis and the destruction of any vestige of orthogenesis - are briefly explored. Part II of this paper will appear in the next issue of this Journal.

A medical equipment preventive maintenance system using a Radio Shack microcomputer is described. The system generates a schedule of equipment to be inspected each week. The software is written in BASIC for easy modification or transfer to other commercially available microcomputers. The system has been in use for nine months with good results.

An open forum was held on May 16, 1989 on the topic, A New Clinical Engineering Society? Representatives of the AAMI, IEEE/EMBS, ASHE and the SBET presented descriptions of the roles and services of their societies in support of Clinical Engineers and BMETs. Independent Clinical Engineers described their concerns regarding the development of the field; a proposal was made for the establishment of a new CE society. About 50 professionals, representing a broad cross section of clinical engineering, participated in a debate that touched on educational requirements certification, ethics, independence of action, "marketing" of the roles of CEs and BMETs, and the possible need for a new CE society. A vote was taken to represent the opinion of those present. The idea of immediately forming a new society was voted down and an ad hoc Task Force on Clinical Engineering was formed under the chairmanship of Yadin David, Ph.D. The participants called upon the AAMI, IEEE/EMBS, and the ASHE to appoint representatives to the Task Force. The new Task Force could: (1) recommend the formation of a new society; (2) call for increased cooperation between existing societies and propose long-range plans; or (3) recommend the formation of a College of Clinical Engineering or an umbrella organization to bring existing societies together.

The New England Medical Center can be traced back to 1796 when the Boston Dispensary opened the first HMO. Now, the center complex covers four city blocks, offers 47 medical residency programs, has over $20 million in funded research, and includes a medical school, dental school, and the Human Nutrition Research Center. The Medical Engineering Department began in 1971 as a joint venture between the center and Tufts University. Operated on a "fee-for-service" basis, the department consists of nine people in medical engineering and an additional four in radiology engineering. The department performs quality assurance and preventive maintenance work, along with as-needed repairs, throughout the center on an equipment roster that includes over 1,200 computer terminals and printers, 58 intensive care beds, and 200+ I.V. pumps. Specialized equipment allows the department to perform audiology repairs. Future goals include integrating the radiology repair staff into the medical engineering group, improving the group's productivity, and eliminating some of the existing service contracts.

A multi-disciplinary task force convened to examine present and future program needs of the Medical Engineering Department at the North Carolina Memorial Hospital, University of North Carolina School of Medicine. The committee recommended changes that would reduce technician turnover, improve continuing education, increase salaries, improve services for patient care and allow the hospital to comply with the requirements of the Joint Commission on the Accreditation of Hospitals. An important by-product of this study approach led to improved communications and work relations with all departments that receive services from the Medical Engineering Department.

This paper describes a computerized Hospital Information System (HIS) installed in Mount Zion Hospital and Medical Center along with the Clinical Engineering Department's involvement in the minor and major maintenance of the 48 data stations consisting of terminals and printers. This paper also includes a summary of maintenance man-hour distribution, data station repair problems and the type of repair equipment and personnel needed to maintain hospital computer systems.

Because of the growth of medical technology, Clinical Engineers have increased responsibilities in respect to this new technology and so to modern medicine itself. This results in a need to ensure that an ethical consciousness of responsibilities to patients, physicians, and institutions grows within Clinical Engineers as they move into evermore important roles within the health care system. Clinical Engineers must have clearly defined roles, as well as authority acknowledged and supported by other health care professionals. Most importantly, Clinical Engineers themselves must recognize the seriousness of their professional responsibilities as they contribute to the maintenance of equipment, use and design instrumentation, and fulfill roles in administration, management, and research. As members of the health care team, Clinical Engineers must be prepared to face ethical issues arising from defective or inadequate equipment, hazards and incidents, scarcity and resources, conflict of interest, confidentiality, clinical research, "truth-telling," and care of the terminally ill.

Inter-institutional comparisons of productivity and cost-effectiveness can be a valuable source of feedback to the in-house biomedical or clinical engineering services manager. But for such comparisons to be valid, all institutions must use the same criteria. As yet, there are no standard definitions for such criteria and, in most cases, the necessary data are not kept. Therefore, reliable comparisons are not possible. It is possible, however, to keep data on the variety of tasks common to all clinical engineering departments that can then be compared inter-institutionally. As task comparisons become more common, "norms" will evolve that can become standards for the profession. From there, it is a realizable step to standards that permit comparison of productivity and cost-effectiveness. A national organization, like the American Hospital Association could help by including clinical engineering data as part of their annual hospitals survey.

This paper explores the pursuit of quality in the area of clinical/biomedical engineering from the perspective of one who looks at the methods for measuring quality from the outside. The health care world is running in many different directions to identify methods for defining and measuring quality. Yet, quality assurance is not a magical process to eliminate all ills from health care. It is a cyclical management process that may make the difference between the long-term growth and development of clinical engineering and the alternative elimination of that function.

This paper constitutes a review of the certification process for Clinical Engineers, and specifically the nature and activities of the National Certification Commission. It describes written and oral certification examinations, and the working relationship between the Board of Examiners and the National Board of the Commission. This paper discusses BMET Certification and its relationship to the central role of Clinical Engineers. The need for Certification is stressed and its effect on the quality of health care is discussed.

The problems of cost, personnel qualifications, task assignment, and productivity involved in establishing a clinical engineering department are addressed in this paper. A basic department consisting of a Clinical Engineer, a Biomedical Equipment Technician, a Testing Technician and a Clerical Assistant can provide a full range of clinical engineering services to a hospital with 225 instruments. The annual cost of such a department, including materials, would be approximately $90,000. The average capital investment in a selection of 225 instruments would be on the order of $860,000. This paper discusses levels of skills within a clinical engineering department, and the services that a hospital could expect from a four-man department.

A fully developed in-house clinical engineering program has much to offer to a large community hospital. In the southeast U.S., many community hospitals-600 beds or fewer-have implemented partial programs and, as a result, have received only a partial return on their investment. A comprehensive program extends maintenance support to all patient-care devices, is intimately involved in the new device specification, evaluation, and selection process with the medical staff-standardizing whenever appropriate- and significantly involved in the continuing education program for in-house users of devices.

The purchaser of telemetry monitoring systems for operating and recovery rooms has little information available on the practical aspects of ownership and usage. To explore this problem, we recorded 76 telemetry failures (both operator and machine failure) occurring over six months among 18 telemetry channels located in operating and recovery rooms. We experienced approximately one telemetry failure every three days or every 60 surgical procedures. Factory repairs were required on 29 transmitters and 19 receivers during a two-year period. We observed that 28% of the failures were attributable to lead and electrode problems, 25% to battery depletion, 22% to mechanical or electronic component failures, 12% to inappropriate control settings and frequency mismatching, and 13% to miscellaneous difficulties. The following problems were observed. Transmitters were dropped frequently and occasionally immersed in liquids. Thus, waterproofing is recommended for OR use, and lead-failure warning circuitry is mandatory. Inappropriate control settings and frequency mismatching led to a previously unrecognized hazard: that is, it is possible to receive and display ECG data from the wrong patient located in a distant room. (Stethoscopic monitoring can be used to confirm that the data being displayed are from the correct patient.) Battery failure can occur at inopportune times, e.g., during cardiac arrest. Transmitters are frequently "lost" because of their small size and high mobility. This study indicated to us that, in the operating room, telemetry is not desirable because of its high cost compared to hard wired systems, poor reliability, and the possible hazard of displaying data from the wrong patient if improperly used.

This paper describes, in chronological order, the steps taken to install productivity measurements and controls within the Clinical Engineering Department of a large teaching hospital. Motivation for this project involved both preparation for going "for profit" and the need to resolve an over-budget condition of labor cost. The project steps included current hospital management reports, database adequacy, supervisors' time logs, computerized budget spread sheets, testing changes on a financial simulation model, developing labor task standards, and departmental labor performance reporting. The project yielded significant positive results for the department's performance versus budget and also led to growth in supervisory and management skills.