1 I n t r o d u c t i o n HEALTHCARE SYSTEMS in most of the developed countries of the world, including Canada, can be characterised by a number of statements. Healthcare expenditures have been increasing as a fraction of the Gross National Product (GNP) (SCHIEBER and POULLIER, 1990). In Canada, more than $2500 was the projected spending on healthcare for every man, woman and child in 1992. More than 1 per cent of G N P is spent on caring for patients in the last year of their life (FUCHS, 1984). We really do not know how much of what we do to patients is beneficial; in fact, it has been estimated that at least 40 per cent of the health ser- vices provided to people is inappropriate, inefficient, inef- fective or even dangerous (BARKIN, 1991). Basically, there are two concerns: quality of care and costs of care. Are we collectively managing to deliver care of quality while con- trolling costs of care? Healthcare delivery systems are cur- rently under a microscope.

Technology has been blamed as one major cause of healthcare expenditure. Some have attributed 15-20 per cent of the increases in hospital costs in recent years to technology (BANTA, 1990). In Canada, it has been esti- mated that on average it is responsible for about a 3 per cent increase in overall healthcare costs each year (FINEBERG, 1991). Although pharmaceuticals comprise the fastest growing component, with annual cost increases between 10 and 20 per cent, device-driven costs are not far behind. In 1988, expenditures on medical devices in Canada were estimated to be about $2 billion; this does not include any associated clinical or operational costs. The projection for the turn of the century is $6 billion (Industry, Science & Technology Canada, 1991).

First received 15th May and in final form 20th June 1992

�9 IFMBE: 1993

Trends such as these have influenced, and will continue to influence, the development and diffusion of technologies in healthcare. This is the rapidly moving environment to which all sorts of professionals in healthcare, including biomedical and clinical engineers, have to respond.

2 Healthcare t e c h n o l o g y The term 'healthcare technology' has come to be inter-

preted very broadly, especially over the past 20 to 30 years. At one extreme, it is taken to mean any kind of knowledge, and at the other, it could be a piece of machinery. However, for practical purposes, various ways of clas- sifying technologies have been defined. By type, healthcare technologies comprise drugs, devices, procedures and support systems. By application, there are preventive, diag- nostic, therapeutic, rehabilitative or palliative technologies. In a third classification, technologies are referred to as being 'embodied' or 'disembodied'. A technology is said to be disembodied if it is an idea or a procedure that can be used without requiring a new piece of equipment or a new drug in which the new technology is contained or embodied (FEENY, 1986). Thus, a magnetic resonance imaging unit is embodied, a pre-admission clinic is not.

From the perspective of the biomedical or clinical engi- neer, the most important class of technologies are the embodied technologies. These include diagnostic pro- cedures (e.g. single photon emission computed tomography), therapeutic procedures (e.g. laser surgery) and support systems (e.g. expert decision support systems), as well as devices and instruments such as infusion pumps and electronic thermometers.

Healthcare technologies can be thought of as having a 'life cycle', from innovation to obsolescence (in some cases). It is useful to understand the various stages of this cycle, so that the roles of various healthcare professionals and

M BEC Healthcare technology assessment special feature January 1993 HTA33

their information needs may be better understood. In reality, research, development and diffusion take place interactively, in a nonlinear sense (GELIJNS, 1990). How- ever, a more simplistic and linear model has been advo- cated by some (FEENY, 1986). In this model, the stages of technological development are: innovation, development, diffusion and evaluation.

Innovation is the first stage of the invention of healthcare technologies, and is the result mainly of work by researchers (clinical, scientific and technical) in universities, hospitals and industry. Development is an iterative process with innovation, by means of which testing and improve- ments take place. In the case of medical devices, there is more involvement of healthcare facilities at this stage. In practice, diffusion begins when there are promising reports of a new technology. Many factors drive diffusion, includ- ing the presence of influential advocates of the technology, who may be clinicians, engineers or scientists. Unfor- tunately, in most cases, evaluation follows the start of diffu- sion. Whereas, in the past, evaluation was limited to safety and efficacy aspects, it has now reached the much broader proportions of technology assessment. However, com- prehensive evaluations of this type are the exception rather than the rule.

3 T e c h n o l o g y a s s e s s m e n t in heal thcare Medical practitioners have evaluated the effects of what

they do for a long time. In fact, it was in 1747 that the first controlled trial was reported, in which the effectiveness of citrus fruit in treating scurvy in sailors was studied (LIND, 1988). In the early part of this century, Ernest Codman developed systematic procedures to evaluate medical care, despite some considerable lack of support from colleagues (NEUHAUSER, 1990).

The early work on evaluation was limited to safety and eff• considerations. Did it work? Was it toxic? The main objective was to assist practitioners in making treat- ment decisions, or in determining policies on treatment. In recent years, however, due mainly to the set of circum- stances described in the introduction, the scope of evalu- ation has broadened. The purpose of technology assessment is now to assist decisionmakers (in government institutions and professions) establish policies on develop- ment, acquisition and utilisation of healthcare technologies, by analysing the consequences for society of using such technologies.

Technology assessment now encompasses many more dimensions than safety and efficacy; its perspective is much broader (MENoN, 1991). The range of impacts of healthcare technologies is so much broader that it requires the involvement of different kinds of researchers, using data of new and different types, and developing and applying new methodologies. Despite the concern that physicians have that assessment may infringe on their practices, and of others, such as technology developers that it will slow down the introduction of new and useful devices, it is clear that technology assessment is here to stay (FuCHS and GARBER, 1990). It is therefore important for healthcare professionals, in particular biomedical and clinical engi- neers, to understand the many aspects of this topic so that they can contribute meaningfully to decisionmaking (BLACK, 1991). In hospitals, for example, clinical engineers should be playing more active roles in technology plan- ning, acquisition and management, thereby improving the relatively ad hoc way this is usually performed.

Technology assessment is of interest to various sectors of the healthcare industry. For the purposes of this paper,

HTA34

five sectors can be identified: governments/payers for healthcare services, hospitals, technology manufacturers, professional groups and university researchers. The inter- est is based on a need for information. Governments (who are the principal payers for healthcare in Canada) need information on the impact of new technologies on costs of care, human resource requirements, on other services, and on non-healthcare sectors of society (RuTTEN and HAAN, 1990).

Hospitals have a somewhat narrower focus, and admin- istrators of hospitals need information to decide whether to purchase a new device, or introduce a new technology. The questions they face include: Are there renovation costs ? What about maintenance and operating costs ? Will this replace an existing service? Are there training implica- tions, both clinical and technical ? What will the impact on hospitalisation patterns be? What about staff scheduling? (DEBER and THOMPSON, 1992).

Manufacturers of devices, especially in this day and age, have to know how effective the device is, whether it will replace existing technology, what costs of supplies might be, and to recognise that early assessment can increase the 'hit rate' in picking winning technologies (TYsoN, 1989). Practitioners, with primary responsibility for delivering healthcare, have to recognise that patient preferences have to be taken into account, and that safe, effective and appropriate care needs to be carefully determined (American Medical Association, 1992). Finally, university researchers are the ones primarily responsible for developing biomedical technology and methodologies for technology assessment, as well as undertaking assessment studies (JENNETT, 1988).

4 Biomedical/clinical engineering and technology assessment 'Biomedical engineering' has been defined as 'the appli-

cation of engineering science and technology to biology and medicine' (GESELOWITZ, 1989). In North America, and particularly in the USA, a distinction has emerged between 'biomedical engineering' and 'clinical engineering'. Those whose primary interest and responsibility are in tech- nology research and development are referred to as bio- medical engineers, whereas clinical engineers are, generally speaking, technology managers in healthcare facilities. Clinical engineering is viewed by some as 'an important subspecialty of biomedical engineering that deals specifi- cally with the clinical aspects of health care delivery' (BRONZINO, 1990).

The roles of biomedical and clinical engineers have been discussed at length in the literature (BRoNZINO, 1986; HEN- DERSON, 1989; GOODMAN, 1991; GORDON, 1990). As far as technology assessment is concerned, these roles may be grouped into two: technology development and tech- nology management. In each of these roles, it is important for the biomedical/clinical engineer to be aware of the con- siderations that go into allocation of resources for the delivery of healthcare. More narrowly stated, it is impor- tant to know the implications of decisions made regarding development, acquisition and use of technologies on healthcare.

The ultimate outcome of the use of any technology is the state of health and wellbeing of the patient; all health- care professionals need to be mindful of this fact. Ethical considerations are important, too (SAHA et al. 1985). Infor- mation as to what the development and availability of a new device would result in and how the acquisition and utilisation of this device would affect a hospital needs to be

MBEC Healthcare technology assessment special feature January 1993

generated and used in making decisions. And because these impacts depend very much on technical and scientific principles and considerations, biomedical and clinical engi- neers must be involved in the process. Although in some hospitals they have this involvement, it is not true in most hospitals.

5 T e c h n o l o g y a s s e s s m e n t e d u c a t i o n

The need to prepare healthcare professionals academi- cally so that they can create and use technology assess- m e n t data to improve the quality and efficiency of healthcare delivery has never been more strongly advo- cated. Progress on a formal basis has been slow, however. One major reason for this is the integrative nature of the field of healthcare technology assessment. It cuts across the traditional disciplines such as clinical epidemiology, eco- nomics, social sciences and the basic and applied sciences.

Despite this, there has been progress in Canada and elsewhere on a number of fronts. In clinical medicine, for example, clinical epidemiology training is beginning to (though slowly) incorporate aspects of technology assess- ment. For example, McGill University in Montreal offers a course in Health Care Technology Assessment, lasting 13 weeks. Topics include assessment methods, diffusion of technology, quality assurance and policy issues. A course is also offered in Preventive Medicine (Assessment of Medical Technologies) at the University of Wisconsin- Madison. This is directed primarily to students with an interest in healthcare management, health systems engin- eering and evaluation. Students are introduced to basic ideas and tools of cost-effectiveness analysis in this course.

There are also specific workshops in which technology assessment concepts are taught. Some of these are sched- uled regularly by organisations such as McMaster Uni- versity and the Universit6 de Montreal, in Canada, the International Society for Technology Assessment in Health Care, and the COMETT-ASSESS Project of the European Community (University/Industry Partnership in the Train- ing of Health Care Technology Assessment).

It has also been recognised that skills of health services administrators need to be enhanced in the design and use of technology assessment. Consequently, the Association of University Programs in Health Administration (AUPHA) has undertaken a project in part to improve health admin- istration programmes by providing guidance to uni- versities in designing curricula for technology assessment.

Most universities in North America that have bio- medical/clinical engineering programmes offer courses on anatomy and physiology bioinstrumentation, data acquisi- tion, signal processing biomechanics, computer applica- tions, control systems etc. Many of these are considered 'core' topics (BRONZINO, 1990). Clinical engineering pro- grammes have, in addition, internships or practica during which students learn practical technology management skills (LASZLO, 1991). In some schools, there are courses with titles such as 'Special topics in biomedical engineer- ing', in which more 'non-traditional' or global issues are discussed. If technology assessment is taught at all, it is generally through this forum.

It is essential that biomedical engineers be taught aspects of healthcare technology assessment. This is partic- ularly important for engineers whose role is that of tech- nology management in a hospital. Such education would allow practising engineers not only to conduct and manage technology assessment projects, but also to appraise results of other studies for decisionmaking in hos- pitals.

Biomedical/clinical engineers should be acquainted with

topics such as: diffusion of technologies in healthcare, and determinants of diffusion; dimensions of assessment (safety, efficacy, effectiveness, legal consequences etc.); assessment methodologies (clinical trials, databases, over- views etc.); principles of economic evaluation (cost-effec- tiveness, cost-utility etc.); sources of assessment data and limitations of technology assessment. There is a body of literature which has developed over the past decade and a half, principally by national technology assessment agencies, from which such case studies could be developed.

The case study approach is one that allows many aspects of healthcare technology assessment to be demon- strated and discussed. The breadth of the field, the kinds of data available, the importance of who is doing the assess- ment will all be made apparent in such an approach. Tech- niques of pooling of individual trials can be understood, as well as their limitations. Most importantly, biomedical engineers will then be able to use assessment reports gener- ated by organisations such as CCOHTA or ECRI in deter- mining the impact of specific technologies on their institutions.

This proposed training could be integrated into a bio- medical or clinical engineering curriculum as a course in its own right. However, it may be more reasonable to begin by introducing the concepts of technology assess- ment through seminar series, or by organising regional two-to-three day workshops. Because, at the present time, there is not a large number of people who could conduct full university courses on this topic, and because the entire curriculum would have to be reviewed before doing this, shorter and more intensive courses or workshops may be more easily held. There are some centres, mainly involved in economic evaluations, that do offer workshops that may meet the need until formal and specific courses become practical.

6 Conclus ions Healthcare technology assessment, as it has come to be

known, is a relatively young field. A good body of know- ledge is still being developed, but there is no 'professional' discipline of technology assessment as yet. Experts are scarce and training materials and programmes are in their infancy. However, there is a clear need for assessment information to assist in healthcare decisionmaking.

Healthcare professionals are not yet familiar with this field. However, to quote an Institute of Medicine pub- lication, ' . . . biomedical personnel need training in the main ideas of technology assessment even if they are not carrying out the assessment themselves, because they must be able to appraise the strengths and merits of studies' (Institute of Medicine, 1985). This applies to biomedical engineers as well. They have to take a broader view on technology and how it impacts on healthcare systems. It is only by formal education, beginning perhaps with work- shops or symposia but finally being part of university cur- ricula, that this can be achieved.

References American Medical Association (1992) Technology assessment in

medicine. Joint report of the Council on Scientific Affairs and the Council on Medical Service. Arch. Int. Med., 152, 46-50.

BANTA, H. O. (1990) Future health care technology and the hos- pital. Health Policy, 14, 61-73.

BARKIN, M. (1991) Canadian health faces the future. Ann. Royal Coll. of Physicians & Surgeons of Canada, 24, 457-458.

BLACK, M. (1991) Technology assessment in health care. Rev. Europ. de Technol. Biomed., 13, 34-35.

BRONZINO, J. D. 0986) Biomedical enyineering and instrumen-

MBEC Healthcare technology assessment special feature January 1993 HTA35

ration: Basic concepts and application. PWS Pubt. Co., Boston. BRONZINO, J. O. (1990) Education of clinical engineering in the

1990s. J. Clin. Eng., 15, 185-189. DEBER, R. and THOMPSON, G. G. (1992) Purchasing hospital

capital equipment. What role for technology assessment? In Restructuring Canada's health services system. How do we get there from here? DEBER, R. and THOMPSON, G. G. (Eds.), Uni- versity of Toronto Press, Toronto, 213-222.

FEENY, D. (1986) New health technologies: their effect on health and the cost of health care. In Health care technology: effec- tiveness, efficiency and public policy. FEENY, D., GUYATT, G. and TUGWELL, P. (Eds.), Institute for Research on Public Policy, Montreal, 5-24.

FINEBERG, H. V. (1991) Technology assessment and policy making. In Proc. Symp. on Health Care Technol. Assess., 1989, Government of Quebec, Quebec City, 13-18.

Fucns, V. R. (1984) Though much is taken: reflections on aging, health and medical care. Milbank Memorial Fund Quarterly, 62, Spring, 143-165.

FUCHS, V. R. and GARBER, A. M. (1990) The new technology assessment. The New Engl. J. Med., 323, 673-677.

GELIJNS, A. C. (1990) Comparing the development of drugs, devices and clinical procedures. In Modern methods of clinical investigation. GELIJNS, A. C. (Ed.), National Academy Press, Washington, 147-201.

GESELOWITZ, D. B. (1989) On the theory of the electrocardio- gram. Proc. IEEE, 77, 857-876.

GOODMAN, G. R. (1991) Technology assessment transfer, and management: The implications to the professional develop- ment of clinical engineering. J. Clin. Eng., 16, 117-122.

GORDON, G. J. (1990) Hospital technology management: the TaD of clinical engineering. Ibid., 15, 111-117.

HENDERSON, J. D. (1989) Biomedical/clinical engineering. Austral- asian Phys. Eng. Sci. in Med., 12, 228-232.

Industry, Science & Technology Canada (1991) Medical devices sector initiative: strategic analysis and options for the medical devices industry. Government of Canada, Ottawa.

Institute of Medicine (1985) Assessing medical technologies. National Academy Press, Washington, 160.

JENNETT, B. (1988) The role of universities in assessing technology and disseminating information. Int. J. Technol. Assess. in Health Care, 4, 47-50.

LASZLO, C. (1991) The clinical engineering program at the Uni- versity of British Columbia (abstract). Med. & Biol. Eng. &

Comput., 29, 16th Int. Conf. on Med. and Biol. Eng./9th Int. Conf. on Med. Physics, Kyoto, Japan, 7th-12th July 1991, Suppl., 503.

LIND, J. (1988) An inquiry into the nature, causes, and cure of the scurvy. Excerpted in The challenge of epidemiology. Issues and selected readings. Buck<, C., LLOPIS, A., NAJERA, E. and TERRIS, M. (Eds.), Pan American Health Organization, Washington, 20-23.

MENON, D. (1991) Technology assessment. In Feeling the squeeze. The practice of middle management in Canadian health care

facilities. ZIEBARTH, S. (Ed.), Canadian Hospital Association, Ottawa, 361-368.

NEUHAUSER, D. (1990) Ernest Amory Codman, M.D., and end results of medical care. Int. J. Technol. Assess. in Health Care, 6, 307-325.

RUTXEN, F. and HAAN, G. (1990) Cost-effective use of medical technology: regulatory instruments and economic incentives. In Policy making in health care, changing goals and new tools. Jt3NSSON, B., RUTTEN, F. and VANG, J. (Eds.), Health Services Studies, Link6ping Collaborating Centre, Link6ping, 30-40.

SAHA, S., MISRA, S. and SAHA, P. (1985) Bioengineers, health-care technology and bioethics. J. Med. Eng. & Technol., 9, 55-60.

SCHIEBER, G. J. and POULLIER, J. P. (1990) Overview of interna- tional comparisons of health care expenditures. In Health care systems in transition. The search for efficiency. Organisation for Economic Co-operation & Development, Paris, 9 16.

TYSON, T. (1989) Technology assessment: the new competitive edge. Med. Dev. Diag. Industry, 11,(11), 10-12.

Author 's b iography Dr D. Menon holds a B.Sc. (Hons) degree in Physics (University of Singapore), a Ph.D. in Physics and a Master's in Health Services Administration (University of Alberta, Canada). He has conducted biomedical research at the University of Alberta and the Montreal Neurological Institute. He has also been in hospital management, most recently being Director of Research & Technology,

University of Alberta Hospitals, with responsibility for clinical engineering services. He is currently Executive Director, Cana- dian Coordinating Office for Health Technology Assessment, Ottawa.

HTA36 MBEC Healthcare technology assessment special feature January 1993