Technology in health care

Chapter 65

Technology in health care Jonathan A. Gaev International Programs, ECRI, Plymouth Meeting, PA, United States

Medical technology encompasses a wide range of medical devices. Practicing clinical engineers often focus on a few areas of medical device technology, such as defibrillators, electrosurgical units, and physiological monitors. This chapter addresses the entire spectrum of medical devices with which the clinical engineer should be concerned, the medical devices that are required for almost all diagnostic and therapeutic medical interventions. These devices have different lifetimes because they may be disposable, reusable, or implantable. They are made of a range of materials, such as plastics, ceramics, metals, wood, and biologic products, and they rely upon all types of physical principles for their functioning (e.g., electronic, hydraulic, mechanical, chemical, optical, and radiation). People use them to improve patient health. Medical devices, as distinguished from drugs, achieve their action without directly entering metabolic pathways. Like the systems of the body, devices are specialized to perform specific tasks. Over 5000 different types of devices are in the market today, and the clinical engineer must be comfortable working with this great variety of devices. The main features to consider when working with a medical device in a healthcare setting are the clinical condition to be addressed, the user of the device, and the requirements for use, including power, training, storage, maintenance, and cost. Reusable devices, disposable devices, accessories, and consumables must be considered in the effective management of medical device technology. Devices are usually part of a chain of equipment. For example, an X-ray unit might require film and film processors in order to produce an image for a radiologist to read. It is almost impossible to find a medical intervention that does not involve medical technology. Simple devices, such as a scale, stethoscope, thermometer, latex gloves, and sphygmomanometers, are part of almost all medical examinations. Complex devices include imaging equipment, clinical laboratory equipment, and implants. Some devices are used just once, and some are used for 20 years or more. The tremendous range of application, sophistication, cost, life span, and functionality of medical devices and their in-

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timate relationship with people set them apart from many other technologies. Training, maintenance, selection, and use must be considered to ensure that the device will do its job of helping people to stay well. This chapter discusses the role of medical device technology in health care.

The healthcare market Epidemiology The goal of the healthcare provider is to solve clinical problems (not to buy, use, or maintain medical devices). One must understand the relationship between the clinical problem and the devices used. For example, coagulation of blood can be achieved by using a bandage costing 10 cents, an electrosurgical unit costing $3000, or a laser costing $120,000. The causes of morbidity and mortality will vary. In wealthier populations and countries, people tend to live longer and tend to have more chronic diseases, including coronary artery disease, cancer, stroke, and chronic obstructive pulmonary disease. Poorer populations suffer more from infectious diseases, including diarrhea and malaria (Coe and Banta, 1992). The world’s 10 leading killer diseases in 2016 (WHO Global Health Observatory Data, n.d.) are listed below: ● ● ● ● ● ● ● ● ● ●

Ischemic heart disease: 9.433 millions Stroke: 5.7814 millions Chronic obstructive pulmonary disease: 3.041 millions Lower respiratory infections: 2.957 millions Alzheimer's disease and other dementias: 1.993 millions Trachea, bronchus, and lung cancers: 1.708 millions Diabetes mellitus: 1.599 millions Road injury: 1.402 millions Diarrheal diseases: 1.383 millions Tuberculosis: 1.293 millions

https://www.who.int/gho/mortality_burden_disease/ causes_death/top_10/en/

Clinical Engineering Handbook. https://doi.org/10.1016/B978-0-12-813467-2.00066-3 Copyright © 2020 Elsevier Inc. All rights reserved.

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Healthcare spending and health Most of the world delivers the majority of health services through the public sector. The United States is an exception, delivering almost all services through the private sector. In 2011, in the developed world, US$1008 was spent per person each year (WHO Global Health Expenditure Atlas, 2014). For comparison, Table  1 shows a sample of countries with the highest per capita expenditures in their respective regions of the world. Although the United States spends more on health care than any other country in the world, its population does not enjoy the longest lifespan. Therefore, one must ask, “What does money buy in terms of health?” In wealthier countries, demand for drugs and devices is strong. Long-term care for the aged represents a large and growing expenditure. In less-wealthy countries, spending is focused on drugs, which generally are quite cost effective to treat diseases. Less funding is available for medical devices and for device maintenance (Table 2). In many

d­ eveloping countries, the majority of medical devices do no function, because of lack of maintenance, training, disposables, power, or other requirements. Devices represent only 4.4% of the total spent on health care. Because of the size of the market, this money is spent differently in each part of the world. In the larger markets of the developed world, purchasers have direct relationships with device manufacturers. In the smaller markets of the developing world, manufacturers work through local distributors. Information such as hazard warnings and recalls can be lost because of these intermediaries, and spare parts and repairs tend to take much longer when working through distributors. Devices are a relatively small part of worldwide health expenditures (Table 3). Much more is spent on drugs than is spent on medical devices. About one-half of the drug expenditures are for the treatment of cardiovascular, respiratory, and central nervous system problems and infectious diseases.

Medical device sales TABLE 1  Healthcare expenditures and life expectancy.

Area

Healthcare spending % GDP ($USA)

Healthcare spending per capita ($USA)

Life expectancy

United States

8

$49,668

779

Switzerland

7

$79,501

782

Israel

5

$30,494

782

Argentina

6

$11,717

775

South Africa

4

$7336

454

From WHO Global Health Expenditure Atlas, September 2014; ISBN 978 92 4 150444 7.

TABLE 2  Estimated healthcare expenditures in 2012.

In the United States, imaging equipment and other “big ticket” items represent a smaller portion of the medical device market than do disposable devices (Table 4). In 1996, of the medical devices sold, X-ray equipment comprised 7%; general electromedical equipment, 14%; for surgical appliances and supplies, 30%; surgical and medical instruments, 30%; diagnostic products (mostly in the clinical laboratory), 15%; and dental equipment and supplies, 4%. Clearly, most of the money spent on medical devices does not go toward “big ticket” items. In hospitals, labor is the largest expense, averaging 53.8% in 1998 in the United States (Health Forum, LLC, 2000). Capital medical equipment is a small part of the budget of a typical hospital. Disposables are also a significant expense for most hospitals and may exceed the cost of capital medical equipment (Table 4). One sees a similar pattern when analyzing individual procedures. For example, in one institution’s costs for a thoracotomy for lung cancer, salaries accounted for 54%,

Developed world

Developing world

Total ($ billion)

$2374

$552

Hospital care

37%

42%

TABLE 3  Medical device expenditures 1996.

Physician services

19%

22%

Worldwide ($ billions)

$129

Drugs and medical

12%

19%

United States

42%

European Union

27%

Nondurables Long-term care

6%

3%

Japan

15%

Other

26%

14%

Rest of the world

16%

From Medical Health care and Marketplace Guide, 1998b. Dorland’s Biomedical, Philadelphia, PA, pp. I–28.

From Medical Health care and Marketplace Guide, 1998c. 14th ed., Dorland’s Biomedical, Philadelphia, PA, pp. I–495.

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TABLE 4  Medical device sales 1999. Product

1999 Revenue ($million)

Incontinence supplies

$2010

Home blood glucose monitoring products

$1710

Wound-closure products

$1500

Implantable defibrillators

$1334

Soft contact lenses

$1159

X-ray equipment

$1140

Orthopedic fixation devices

$1122

Pacemakers

$1112

Examination gloves

$1088

Coronary stents

$1086

Ultrasound equipment

$1070

Arthroscopic accessory instruments

$919

Magnetic resonance

$890

Computed tomography

$790

From Medical Device and Diagnostic Industry (MDDI), October 2000. Industry Snapshot 12:47–56; Medical Health Care and Marketplace Guide (MHMG), 16th ed., Vol. 1 2000–2001. Dorland Health care Information, Philadelphia, PA, pp. I–1010.

supplies and medication 27%, and capital equipment only about 7% (Marrin et al., 1997).

Definitions Although medical devices do not represent society’s largest healthcare expense, they remain crucial to the delivery of health care. In all societies, government often is involved in use and sale. The US Food and Drug Association defines in section  201(h) of the Federal Food Drug & Cosmetic (FD&C) Act a medical device as: “an instrument, apparatus, implement, machine, contrivance, implant in vitro reagent, or other similar or related article, including a component part, or accessory, which is: 1. Recognized in the official National Formulary, or in the United States Pharmacopeia, or any supplement to them; 2. Intended for use in the diagnosis of disease or other conditions, or the cure, mitigation, treatment, or prevention of disease, in man or other animals; or 3. Intended to affect the structure or any function of man or other animals, and which does not achieve its primary intended purpose through chemical action within or on the body of man or other animals and which is

not ­dependent upon being metabolized for the achievement of any of its intended principle purposes. The term ‘device’ does not include software functions excluded pursuant to section 520(o).” Devices that meet this definition include disposables (some are reused for a single patient, and some are thrown away after a single use), reusables, and implants. Medical devices are part of the elements of health care that include medical procedures, surgical procedures, and drugs. The medical device technology area of medical ­information-based devices, including information systems, diagnostic tools, picture archiving and retrieval systems (PACS), and electronic patient records is new. The trend certainly is to include more information-processing capability in all medical devices (Sloane, 2004; Rosow and Adam, 2004; Witters and Campbell, 2004).

Attitudes The intimate relationships among the technology, the practitioner, and the patient are critical distinctions in the medical field. Devices are used to affect the health of the patient. The practitioner feels responsible for achieving the best possible result, so he must feel comfortable using the devices. Practitioners need to have experience using the devices and must believe that the devices work properly. Familiarity with devices and the results that can be obtained with them are important to the healthcare professional. Clinical effectiveness is hard to prove, and practitioners can be skeptical about acceptable results being obtainable via a new technology. This need for reliability and consistency and the need for training in the use of technology lead many medical professionals to resist changes in technology unless a clear benefit can be demonstrated in clinical practice. If the current device is adequate for a practitioner’s art, the practitioner will resist acceptance of new technology, especially if it will require more training, or if it will change the way the clinician works. For the clinical engineer to perform effectively, the attitudes and the environment of the user must be understanding. Healthcare professionals are trained in the use of devices, but not necessarily in the general principles of engineering, mathematics, or physics relating to the devices. Many healthcare professionals see devices as tools; they prefer not to spend too much time on the tool, so that they can focus on the clinical needs of their patients. Time is usually at a premium in healthcare settings, so the healthcare professional does not always have the necessary amount of time to learn how to use a new device. Clinicians might be unaware of alternatives to the devices they are using. Clinical engineers can bridge the gap between technical knowledge and clinical needs and thus can help the clinician to deliver the best possible patient care.

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Nomenclature and codification Nomenclature systems are essential to managing the great variety of medical devices. A unique reference for each device enables one to organize information related to that device, such as work orders, service history, service contract information, hazards, recalls, in-service training, and other device-related expenditures. The problem is similar to that facing a library. Having millions of books is a useless resource if they cannot be located. Just as a library uses a classification system to organize its books, the clinical engineer needs to have a nomenclature system to uniquely identify medical devices. Maintaining the nomenclature system is quite time consuming, so most institutions use a standard system, such as the Universal Medical Device Nomenclature System (UMDNS) which is available without charge from ECRI (www.ecri.org), Global Medical Device Nomenclature (GMDN) available at www.gmdnagency.org, and now the new Unique Device Identification System UDI (https://www.fda.gov/medical-devices/ device-advice-comprehensive-regulatory-assistance/ unique-device-identification-system-udi-system). It is no surprise that there are standards, rules, and regulations for the use of technologies that impact health. In ECRI’s directory of national and international standards, there are over 43,000 medical equipment standards, prepared by over 1400 agencies throughout the world. Clinical societies also publish guidelines for their members regarding medical technology. The National Guidelines Clearinghouse (http://www.guideline.gov) is a good source. Some hospitals require the practitioner to complete a training program before using certain technologies, such as surgical lasers or endoscopes.

a drug, device, and medical facility. One must understand this context to ensure that devices contribute appropriately to clinical outcomes. More specifically, one must take a systems approach (see Sheperd, 2004) and must consider the four following interfaces (Fig. 1) (see Bruley, 1994): ● ● ● ●

Device-user Device-patient Device-environment/facility (hospital, home, or other) Device-accessories/disposables/consumables

Device-user Although one thinks of the doctor as the user of the device, most of the time a nurse or technician is the actual user. One must be aware of the differences in perspective, training, and education between the person who specifies the device and the person who uses it. Users must be trained to operate the device and to interpret the results. Most of the medical device problems in the hospital are related to user error. Frequently, the clinical engineering department can help to reduce errors by training users (see Wear, 2004).

Device-patient Almost all devices touch patients or draw samples from the patients’ bodies. The wide variation in the patient population must be understood for an adequate understanding of ways in which the device will accommodate that variation. It is crucial to understand exactly how a device interfaces with a patient and how it can accommodate a range of patients. Certain groups of patients, such as newborns, children, very large or small adults, and elderly patients, might have special needs. Some devices require special accessories so that they can accommodate groups of patients.

Safety Safety is also related to standards, guidelines, and, mostly, common sense. Maintenance and device selection are important, but the majority of the problems come from the way the equipment is used and the relationships between the device and other systems (see Miodownik, 2004). Energy-producing devices, such as lasers and radiological equipment, have special engineering-safety requirements. Device classification systems depend on perspective. If one were classifying devices for safety, one might use high risk for life support devices; medium risk for devices whose failure would affect patients, but not cause serious harm; and low risk for devices whose failure would not be likely to harm patients.

The environment of a device Devices do not help people all by themselves. They help only when they are part of a medical intervention. An intervention requires a patient, a practitioner, and it might require

FIG. 1  Device interfaces.

432  SECTION | 7  Medical devices: Design, manufacturing, evaluation, and control

Device-facility All devices have conditions and requirements for their storage and use, including temperature, humidity, electrical power, water, pH, shielding from electromagnetic fields, and connection to specialized gases. Be especially careful when devices are designed to be used in one environment, such as a major hospital, but are used in another environment, such as a home (Dyro, 1998). Similarly, caution must be taken when devices designed for adults are used with children. Even simple devices, such as sharps containers, have contextual implications. In a children’s hospital, they must be out of the reach of the child because the child might consider the device to be a toy and thus might want to put his hand inside to play with it.

Accessories, disposables, and drugs Device-accessories/disposables/consumables Most devices have reusable and disposable components. An infusion pump has a disposable infusion set; a defibrillator may have disposable electrodes; and an X-ray unit typically has a film cartridge. The entire group has to function correctly. The manufacturer of the device might not produce or sell the disposables or consumables. Conversely, the manufacturer of the disposable or consumable might not sell or produce the medical device. Sometimes, only one manufacturer makes the disposable or consumable. The relationship between the disposables and the consumables affects the use and cost of the device. The profit from consumables is so high for some clinical lab equipment that the manufacturer will offer the device for free if the hospital commits to purchasing the consumables from the manufacturer.

Disposable devices Disposable devices are designed to be discarded after one use, or after multiple uses on the same patient. Some of these devices are quite expensive (catheters used in catheterizations can cost $400 or more), so there are powerful financial incentives to reuse devices, even though the devices were designed for a single use. Some institutions reuse single-use devices. There is a great controversy about the risks to the patient when single-use devices are reused. In many cases, there are alternatives to a reusable and disposable device. Some associate the following characteristics with reusable devices: strength, difficulty to clean, and low cost (i.e., if labor costs to reprocess the device are low). Disposable devices are thought to be cleaner, easier to keep sterile, less robust, and, ultimately, more expensive. When making a choice, it is important that one be certain as to the reason for deciding on a reusable or disposable device, and to review assumptions as time goes on. The cost of reprocessing can change as labor costs change and as new technologies

to help in reprocessing and sterilization become available. Both types of devices, reusable and disposable, still need to be inspected before use.

Differences between devices and drugs Drugs and devices sometimes come together directly, as in an intravenous (IV) pump, and indirectly, as in the case of clinical lab analyzers, often determine what drugs are prescribed by the clinician. Devices such as stents are now impregnated with drugs during manufacture. The line between drug and device is changing, so it is important to appreciate the differences between them. Devices and drugs are used to help patients, require a trained person. Drugs, however, do not require periodic maintenance, do not break, and do not require as many people to keeping them working. Drugs do not have a “work history,” nor do they require service contracts and the same type of record keeping. Teaching a doctor how to prescribe a drug is quite different from teaching a doctor, nurse, or technician how to use a medical device.

Example: Treating patients with diabetes The following discussion details the requirements for treating diabetes, one of the world’s most common diseases. Diabetes is expected to affect over 200 million people worldwide by 2005. In the United States, about 10 million people have been diagnosed, and another 7 million have the disease and do not know it. Annually, over 600,000 new cases are diagnosed in the United States, where the disease afflicts men and women in equal proportion. Diabetes is the seventh leading cause of death in the United States (NDIC, 2001). Diabetes and its associated complications are among the most prevalent, costly diseases in the world. The worldwide market for glucose-monitoring products exceeds $4.7 billion. In the United States, direct costs of diabetes care are estimated at about $50 billion, almost 6% of the total personal healthcare expenditures, while the complications of uncontrolled diabetes result in nearly $100 billion in annual medical costs. Diabetes is a chronic disorder of blood glucose regulation that commonly results in the development of cardiovascular, ophthalmic, neuropathic, and nephropathic complications. It is classified by two major types: type 1 (lack of insulin production and release) and type 2 (resistance to insulin’s actions). In type 1 diabetes, islet cells have been destroyed by an autoimmune response, and insulin production is reduced to insufficient levels for maintenance of blood glucose regulation; thus, insulin deficiency is the main cause. In type 2 diabetes, the body cannot properly respond to the insulin produced by the pancreas. Glucose remains in the blood instead of supplying the body with the fuel it needs.

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In the Unites States, about 500,000 people have type 1 diabetes, which typically begins in childhood. The rest have type 2 diabetes, which usually develops after age 40. Type 2 diabetes is often found in elderly people and is also associated with obesity. Several recent studies have shown that keeping glucose levels close to normal was associated with a major reduction in the secondary long-term complications of diabetes. For a patient with type 1 diabetes, this management requires blood glucose testing several times per day, three to four daily insulin shots, and lifestyle changes. Tight control is recommended as an important way to delay the onset and to dramatically slow the progression of long-term complications from diabetes, such as retinopathy, neuropathy, nephropathy, and cardiovascular disease. About 40% of the patients who are diagnosed with type 2 diabetes will require insulin therapy and will benefit from tight control of their blood glucose levels. The disease must be managed during the life of the patient because there is no cure. The diagnosis and treatment of an adult patient with type 2 diabetes is discussed below. The equipment used, the location of the equipment used, and the practitioners involved in treating the patient are described. The equipment ranges from simple to complex devices and includes disposables, reusables, and home care equipment (i.e., a wide range of technology involved in treating a patient). The relevant equipment, assuming that the disease progresses significantly, is described. Fortunately, not all patients will suffer all symptoms of the disease.

Diagnosis During a routine physical examination, the patient might report symptoms such as excessive eating, thirst, frequent urination, or weight loss. Blood tests confirm the diagnosis. Because many patients have no symptoms, screening is performed by measuring the glucose level as part of general blood tests performed on patients over age 45. Urine tests for glucose are no longer used to diagnose diabetes in the United States. Blood is drawn in a physician’s office and is contained in either a sealed test tube that has a preservative to inhibit glycolysis, or in a special tube with a barrier to keep the serum/plasma separate from the red blood cells. To prepare the sample so that it can be read on the clinical chemistry analyzer, it must be spun on a tabletop centrifuge (acquisition cost: $2000) at 3200–3500 rpm to separate the serum/ plasma from the rest of the sample. (Most clinical laboratory equipment does not accept whole blood—only serum/ plasma.) The sample should be stored cold and should be sent to the clinical laboratory within a few hours of being drawn. Once received by the clinical laboratory, the blood sample is tested on a clinical chemistry analyzer (acquisition cost: $100,000) by a laboratory technician. Glucose levels

outside of predetermined values indicate that the patient has diabetes. The tests should be repeated on another day, to confirm the diagnosis.

Diet and exercise Many patients with type 2 diabetes can be treated with diet and exercise. Counseling is important. Ideally, the patient meets with a dietician or a nurse educator to obtain advice regarding changes in diet and activity. The patient’s weight is monitored at home and during office visits, using a patient scale. If diet and exercise do not control the levels of blood glucose, the patient will be prescribed oral medications, or, in some cases, insulin. He or she will need to monitor blood glucose levels at home, using a blood glucose monitor.

Blood glucose monitors Blood glucose monitors are portable, battery-powered devices (ECRI, 2000a). The patient places a drop of blood from the finger onto a paper test strip, which is impregnated with a glucose-specific enzyme that reacts with the glucose in the blood. The strip is inserted into the blood glucose meter and is read using either reflectance photometry or electrochemical technology to determine the glucose level in the blood. These monitors are also used to monitor blood glucose levels in clinical settings. The average cost for home blood glucose monitors cost is $55. They last about 3 years. (Hospital units, which have additional capabilities to store and transfer information, cost about $,000.) The strips cost about $0.35 apiece, for home use ($0.70 for hospital use). Assuming two readings per day, the test strips cost about $260 per year. The worldwide market for glucose meters and strips is about $3 billion dollars per year and is expected to double by 2008. Persons with diabetes need to have their blood glucose levels measured by a clinical laboratory two to four times per year, depending on the severity of their disease. A hemoglobin A1c test is performed in the clinical laboratory using manual or automated equipment at least twice per year. Other tests, including kidney-function and urine-­ microalbumin tests, can be performed as needed. Patients can be prescribed medications to help the body to use the insulin that it produces more efficiently. Most of these patients monitor their blood sugar at home by using a blood glucose monitor.

Insulin injections Some type 2 diabetes patients will require insulin injections in order to maintain appropriate blood glucose levels and thus to decrease their risk of complications, which can include blindness, kidney damage, nerve damage, and ­circulatory

434  SECTION | 7  Medical devices: Design, manufacturing, evaluation, and control

problems. Home monitoring using a blood glucose monitor is a critical part of the treatment. These patients must inject themselves two or more times per day with insulin, using an insulin syringe. Insulin must be stored in a refrigerator and must be protected at all times from temperatures greater than 86°F (30°C) or less than 36°F (2°C). Injections are given at room temperature to facilitate absorption, so the patient may keep a personal supply at room temperature. Insulin is stable for 1 month at room temperature. The patient always needs to have an extra vial of insulin on hand in case of emergency. The syringes cost about $28 per box of 100. They are sold as single-use devices, although some patients choose to reuse them. The annual cost for two syringes per day is about $200 per year.

Blood testing Patients with type 2 diabetes normally will have a blood glucose test performed every 3 months, and a hemoglobin A1c test performed every 6 months. Glucose monitoring represents 19% of all in vitro diagnostic tests performed annually in the United States. Because the patient uses a blood glucose monitor at home to check their glucose levels and to adjust their insulin dosage, it is important to compare the results using home machines to those obtained by the clinical chemistry analyzer. Agreement should be within 15%. Because diabetics are at greater risk of heart disease, cholesterol testing (or, more precisely, testing for lipids and triglycerides) is performed one or more times per year. Some diabetics will develop kidney disease, which may progress to the point where they require dialysis.

Dialysis Dialysis is the removal of toxins from blood by a machine (ECRI, 2000b). Some patients can treat themselves at home by flushing their abdominal cavity (peritoneal dialysis— typically performed daily). More often, hemodialysis is required. It takes place during three sessions of 5 h, using a dialysis machine in a hospital, nursing home, or other facility. The equipment required includes a water-­purification system, dialysis machine (acquisition cost: $25,000), dialyzer, and disposables. The patient is connected to the machine by a dialysis technician. The machine filters the patient’s blood, toxins are removed, and the blood is returned to the patient. A medical specialist supervises the operation of the facility.

Eye examination To prevent blindness, an ophthalmologist performs detailed eye exams several times per year. Retinal surgery is often

required and is performed using an ophthalmic laser (ECRI, 2000c) (acquisition cost: About $55,000).

Heart Because diabetes can lead to coronary artery disease, the cardiovascular condition of the patients is carefully monitored using EKG and stress tests. Prevention includes control of weight, exercise level, and diet. If coronary artery disease develops, bypass surgery, stents, angioplasty, and laser treatments may be performed. Circulatory complications can lead to the need for amputation of the feet and legs. More than half of the amputations that take place in the Unites States are performed on diabetics. Wounds do not heal well for diabetics, and wound healing on extremities is difficult.

Summary of devices used in diabetes Diabetes is one of the most costly diseases in the world. The direct cost of diabetes in the United States represents about 6% of the total personal healthcare expenditures. Treating the complications of this terrible disease costs nearly $100 billion each year. The devices that are used to manage diabetes are found in home, doctor’s offices, hospitals, and specialized centers. Patients, caregivers, doctors, nurses, laboratory technicians, and medical specialists use the equipment. The equipment chain includes syringes ($0.28) scales, sphygmomanometers, stethoscopes, fundoscopes, blood glucose monitors, refrigerators, and clinical chemistry analyzers ($100,000). The annual cost for syringes and test strips for home glucose measurements is $460. More sophisticated equipment is required when complications occur. All of the equipment in this chain is required in order for the patient to receive proper treatment.

References Bruley, M., 1994. Accident and forensic investigation. In: Van Gruting, C.W.D. (Ed.), Medical Devices, International Perspectives on Health and Safety. Elsevier Science, Amsterdam. Coe, G.A., Banta, D., 1992. Health care technology transfer in Latin America and the Caribbean. Int. J. Technol. Assess. Health Care 8 (2), 255–267. Dyro, J.F., 1998. Methods for analyzing home care medical device accidents. J. Clin. Eng. 23 (5), 359–368. ECRI, 2000a. Portable blood glucose monitors (update evaluation). Health Devices 29 (6), 200–237. ECRI, 2000b. Hemodialysis Units. Health care Product Comparison System. ECRI, 2000c. Ophthalmic Lasers. Health care Product Comparison System. Health Forum, LLC, 2000. Table  8, 1988 Utilization, personnel and finances. Hosp. Stat. 164–165.

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Marrin, C.A.S., Johnson, L.C., Beggs, V.L., Batelden, P.B., 1997. Clinical process cost analysis. Ann. Thorac. Surg. 64, 690–694. Miodownik, S., 2004. Interaction Between Medical Devices. Clinical Engineering Handbook, 249. Elsevier, Academic Press. National Diabetes Information Clearinghouse (NDIC). Diabetes Statistics. http://www.niddk.nih.gov/health/diabetes/pubs/dmstats/dmstats.com, February 2, 2001. Rosow, E., Adam, J., 2004. Real-Time Executive Dashboards and Virtual Instrumentation: Solution for Health care Systems. Clinical Engineering Handbook, 476. Elsevier, Academic Press. Sheperd, M., 2004. Systems Approach to Medical Device Safety. Clinical Engineering Handbook, 246. Elsevier, Academic Press. Sloane, E.B., 2004. Information System Management, Clinical Engineering Handbook, 451. Elsevier, Academic Press. Wear, J.O., 2004. In-Service Education. Clinical Engineering Handbook, 317. Elsevier, Academic Press. WHO Global Health Observatory Data – n.d. https://www.who.int/gho/ mortality_burden_disease/causes_death/top_10/en. WHO Global Health Expenditure Atlas, September 2014. ISBN 978 92 4 150444 7. Witters, D., Campbell, C.A., 2004. Wireless Medical Telemetry. Clinical Engineering Handbook, 492. Elsevier, Academic Press.

Further information Association for the Advancement of Medical Instrumentation 1110 North Glebe Road, Suite 220 Arlington VA 22201-4795 Tel: 703 525 4890 Fax: 703 276 0793 http://www.aami.org American Hospital Association One North Franklin Chicago Illinois 60606-3421 Tel: 312 422 0300 http://www.aha.org ECRI 5200 Butler Pike Plymouth Meeting, PA 19462 Tel: + 1 610 826 6000 Fax: + 1 610 834 1275 http://www.ecri.org

Journal of Clinical Engineering Aspen Publishers, Inc. 7201 McKinney Circle Frederick, MD 21704 Tel: 800 638 8437 Canon Communications LLC 11444 W. Olympic Blvd. Los Angeles, CA 90064 Tel: 310 445 4200 Fax: 310 445 4299 http://www.devicelink.com/mddi National Guidelines Clearinghouse, http://www.guideline.gov. Serpa-Flórez, F., 1993. Technology transfer to developing countries: lessons from Colombia. Int. J. Technol. Assess. Health Care 9, 233–237.

Further reading Briggs, J., 2001. Diagnostics Industry Overview. Clinical Laboratory Products Magazine. http://www.clpmag.com. Medical Device and Diagnostic Industry (MDDI), 2000. Industry Snapshot 12, 47–56. Medical Health Care and Marketplace Guide (MHMG), October 2000. 16th ed., Vol. 1 2000–2001. Dorland Health care Information, Philadelphia, PA. pp. I–1010. Medical Health care and Marketplace Guide, 1998a. 14th ed. 1998. Dorland’s Biomedical, Philadelphia, PAI–21. Medical Health care and Marketplace Guide, 1998b. 1998. Dorland’s Biomedical, Philadelphia, PAI–28. Medical Health care and Marketplace Guide, 1998c. 14th ed. Dorland’s Biomedical, Philadelphia, PAI–495. Subramanian, S., 2004. Physiological Monitoring and Clinical Information Systems. Clinical Engineering Handbook, 451. Elsevier, Academic Press. World Health Organization, 2000. The World Health Report 2000 Health Systems: Improving Performance. World Health Organization, Geneva. World Health Organization, 1997. The World Health Report 1997 Health Systems: Improving Performance. World Health Organization, Geneva.