Physicans and medical electronic equipment: A critical review of our modus operandi

Annotations

Of one doctor

The trends toward specialization and over-specialization make it difficult or even impossible for a patient to identify or even have a responsible private doctor. Many patients now go to buildings, institutions, clinics or groups, but not to a doctor. The history and physical examination are too frequently obtained by a doctor in training, out of the medical school only a year or two or even not yet graduated. Consultants are engaged freely, each without a sense or feeling of full responsibility for the patient. The patient belongs to the building, institution, or group. One doctor may be head of a “committee” of doctors in his section, but on weekends, holidays, or vacations even the “chairman” of the committee is off duty. Thus, during these periods and at night the patient becomes the patient of another doctor who is not fully acquainted with his illness, data, and therapy and who displays little sense of responsiblity for the total care of the patient. Nevertheless, being on “duty” at the time, this doctor makes diagnostic and therapeutic decisions of importance, often drastic. The intentions are good, but the personal responsibility for proper motivation in management is lacking. In short, too many patients are treated by committee.

Furthermore, referrals to specialists must be kept among the members of the “closed” group or committee regardless of ability. However, the private physician can send his patient with impunity to the best consultant available and from anywhere in the world. Patients and their families need one private doctor, not a committee. This doctor assumes full responsibility for all medical decisions and the consequences. The patient then knows to whom to go for advice and the solution of medical problems. The maturity and ability of the physician are known A close doctor-patient relationship develops, and the patient knows who his doctor is and also understands the role and responsibility of any consultants employed. Every person or family needs one doctor, not an institution or building, for the ‘best and most satisfying medical care. George E. Burch, M.D. !l’ut!an~ University School of Medicine 1430 Tulane Ave. New Orleans. La 70112

Physicians and medical electronic equipment: A critical review of our modus operandi

Modem technology has profoundly affected the practice of medicine. It has enhanced the quality of medical care, but against this its implementation has brought about new complexities in procurement, management, and operation. These complexities have been created primarily by the growth of the medical industry and the expansion of the consumer market that now ranges from large medical centers and community hospitals to practitioners’ offices. At this juncture the physician has been called to assume new responsibilities, to manage and operate complex hardware, to understand the intricacy of the electronics and, based upon medical and managerial judgement, decide on the purchase of equipment, define specifications, system operations, etc. It is pertinent, therefore, to ask if the current generation of cardiologists and physicians at large are qualified to undertake this responsibility and if current trainees are being prepared to do so in the future. In a time of spiraling cost of health care delivery, when federal support to sponsored programs is being curtailed and

American Heart Journal

when the consumer, the federal government and insurance carriers are in search of ways to decelerate this inflationary process it is pertinent for our profession to assess our role in the control of this growing technology, our efficiency in exerting this control, and then search for methods to transform the system into a more efficient operation. Some of the questions we should ask ourselves in this regard are: 1. Where did we gain the expertise to evoke complex technical decisions? 2. Do we have the knowledge required to evaluate in a critical manner the systems we purchase? 3. If problems exist, what actions are we taking to remedy them? Let us analyze each of these questions separately. In the majority of cases physicians’ “expertise” in these technical matters is the product of growth through trial and error and in only few instances does it result from a formal education in electronics or engineering directly applicable to the problems they need to solve. Although this method has appeared

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Annotations successful it is not possible to determine if a different approach, encompassing for instance a team of physiciansengineers would have provided more efficacious results. Concerning our knowledge to evaluate the systems we purchase, this assessment should start before the purchase order and involve primarily: need, cost effectiveness, equip ment efficiency, backup procedures, safety, and maintenance. On the subjects of need and cost effectiveness, we must consider the economics of the application and if we are putting our own funds where they can do the most good. Thus the question of whether the method of payment is to be derived from patient service or as a direct overhead item increasing total operational cost is an important one. In certain areas such as direct lifesaving equipment, expense is less important and the cost can be accepted as a real fact of improving the quality of medical care. However, in many other areas serious doubt can be raised about a real need. Thus the justification for purchasing catheterization laboratory equipment that will be used once or twice a week and where the patient will have to bear directly or indirectly the cost is a moot point. In these areas a cost analysis should definitely be performed to ascertain that this new ap preach will not unnecessarily increase the cost while only marginally improving care, or just compete with a neighboring institution. Through a regional utilization of resources the unnecessary overlap of expensive items can be avoided, decreasing operational cost. It is pertinent to ask whether, when we purchase equipment, its efficiency has been evaluated carefully. After requirements and specifications are well delineated, selection of a specific vendor should be made after factual information concerning past performance, equipment design, engineering, and quality workmanship has been duly investigated. Regarding the matter of backup procedures, presumably we should at least have a system analysis done to determine the backup procedures necessary to allow some continuance of service in the event of a breakdown. This is of the utmost importance in areas of critical care where the primary justification for the equipment is its permanent availability with 24-hour service provided. Standby equipment should be available in the areas of patient monitoring to avoid singlepoint failure leading to total system blackout. On the subject of safety, it is necessary to analyze that neither the equipment nor the system in which the equipment operates can generate hazardous currents in the event of a malfunction. Means for verifying equipment performance should be provided considering that an incorrect readout due to misalignment can itself establish a critical situation jeopardizing patient safety. Regarding maintenance, the equipment should be analyzed to see that the quality of workmanship and layout are such as to provide a high mean time between failures and when failures do occur, that the technicians can get inside to determine the cause of the failure. Vendors frequently rely on independent service organizations and one important consideration is their ability to provide service under contract in a predetermined period of time. Failure to do so results in prolonged down-time that is extremely costly by virtue of idle personnel and hardware. Although awareness of these subjects has increased and tk Intersociety Committee on Heart

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Disease Resources has described these problems and proposed some solutions, they have not been fully and widely implemented. If we all perform an inner search and self-critique, in most cases we may have to admit that we do not always consider these points, we do not have analyses conducted before the equipment is purchased, and we frequently have to live with our errors. Furthermore, we may ask ourselves: Are we train ing the new generation of specialists to be qualified to assume this role? It is probably fair to say that in the majority of training centers, this subject is not touched on in any formal manner. What corrective steps could be taken to improve our current modus operandi? Two clearly definable solutions that can provide the physician with sound guidance from a medical, engineering, and managerial point of view are: (1) education of medical groups, and (2) development of clinical engineering teams. Regarding the education of medical groups, numerous postgraduate courses are currently offered. The various professional organizations, however, have placed a negligible effort in the formal education of physicians, in the technical and economical problems associated with purchase, operation, and maintenance of equipment. It would be useful for the various associations to sponsor postgraduate courses in these areas. The faculty, composed of medical experts, biomedical engineers, and electronic engineers could provide an in depth discussion of various areas of equipment utilized. These organizations should also encourage the development of “users groups” which should meet at regular intervals, probably during national conventions. These groups of individuals, sharing common interests and problems, would discuss various operational techniques, suggestions for improvement in design, etc., together with members of duly organized committees and manufacturing representatives. Concerning the development of clinical-engineering teams, the concept of clinical engineering has been advocated for some time, but recent surveys indicate that only 300 are currently employed in U. S. hospitals. Perhaps this small representation is due to the supposition that engineers cannot appreciate medical problems, and hence physicians with some engineering training can make better clinical engineers than engineers with some medical training. Perhaps we are reluctant to go outside our profession to seek advice in engineering-type areas directly related to the way we are going to practice medicine. However, we must face facts. Our modus operandi is such that neither do we have the time nor the inclination for long term planning, analyses, and studies on equipment operation. On the other hand, the clinical engineer’s approach is to anticipate and avoid crises. He will most probably have received his training in the industrial environment where errors in design can affect whole product lines; consequently his work is largely oriented around preventing problems. Thus a mutually beneficial, valuable interface exists. The question, therefore, is to find a means for it to be utilized, to find a way where each side of the team can, without conflicting responsibilities, exercise their expertise. The physician members of the team should be responsibile for specifying the operational requirements, what the equipment should do, and how the people will be operating it. The engineering members should specify the hardware and, if computers are

March, 1974, Vol. 87, No. 3

Annotations

involved, the software configurations to meet these requirements. The engineering members may also be able to help in establishing our operational requirements if they know what hardware and software are available and what these components can do. University centers that have consistently provided leadership in the development of new medical practices should be the first to implement this approach in an organized, coordinated fashion making the services of this team available to

Clinical problems associated with biologic availability of digoxin

Heart Journal

to prevent discussed.

repeated

occurrences

of the prob-

Jorge C. Rios, M.D. Associate Professor of Medicine Director, ECG Laboratory Michael Shaffer, B.S.E. E. Assistant Research Professor of Anesthesiology George Washington University Medical Center Washington, D. C.

the variable

Treatment with any of the cardiac glycosides requires care and caution. The response of individual patients is not predictable and since the time of Withering physicians have been taught to titrate the daily dosage to each patient’s needs. The ratio between toxic and effective doses is often low. In these circumstances it is highly desirable that preparations of the glycosides should be consistent in potency. In the last two years it has become clear that tablets of digoxin used in many countries of the world are far from equivalent in their potency.les It was the introduction of sensitive and accurate methods for assay of plasma digoxin concentrations which brought this problem to light, but it has almost certainly existed for many years. The clinical problem lies with the fact that a digoxin tablet may contain the correct dose of the drug, but provide only a portion of this dose for absorption by the patient, i.e., there is a low biologic availability of the digoxin dose. When digoxin is administered orally as a solution absorption is nearly complete.’ Incomplete absorption occurs if a digoxin tablet dissolves very slowly in the gastrointestinal fluids. It appears that the capacity to absorb digoxin is then limited by the gastrointestinal transit time. The dissolution rate of digoxin tablets marketed in the United States and Britain varies considerably from brand to brand and some brands vary widely from batch to batch. 6,s This variation in dissolution rate leads to marked differences in the plasma digoxin levels and clinical response achieved during maintenance digoxin therapy.“fg*” Table I shows the mean digoxin levels recorded in 19 patients. Each had used four different brands of digoxin at the same daily dosage. Levels with brand A are 35 per cent higher than those obtained with brand D. Some patients are markedly sensitive to differences in the dissolution rate of the tablets and with them the changes in dioxin level are even more startling (Fig. 11. Until recently, over half the British patients using digoxin received Lanoxin (Burroughs Wellcome). Even with this, the longest established brand, there have been formulation difficulties. Fig. 2 shows the changes in the plasma digoxin levels achieved with Lanoxin during recent years.11*12 These differences have resulted from modifications, at first thought unimportant,

American

the community lems we have

I D

Fig. 1. Plasma use of brands day.

C BRAND6

1

I A

digoxinlevels recorded in patient M. W. during A, B, C, and D. Digoxin dose was 0.5 mg. per

made in the manufacturing process at the end of 1969 and in May, 1972. The basis of the differences in the dissolution rate and efficacy of the tablets appears to be the size of the digoxin particles. In the United Kingdom powders of pure digoxin used for tablet manufacture have a geometric mean particle diameter of over 20 microns. Digoxin powders of this large size dissolve slowly and are very poorly absorbed.i3 Tablets of high bioavailability are obtained from such powders only when the manufacturing method produces a reduction in digoxin particle size. The variation in the bioavailability of digoxin results in two types of clinical problem. Standard dosages of slowly dissolving tablets may fail to produce a clinical response since ineffective digoxin levels are achieved If continued on such tablets the patient remains underdigitalized. If the dosage is increased until a satisfactory response is obtained then dosages of 2.5 mg. per day or more may be required; in this

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