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The regulation of medical devices
PREVENTIVE
MEDICINE
19, 693-699 (1990)
The Regulation of Medical Devices’ H. DAVID
BANTA,
M.D.
MTDITNO, P.O. Box 188, 2300 AD Leiden, The Netherlands
INTRODUCTION
Medical devices have become a visible and dramatic part of modern medical care. The period following World War II has seen the development of a tremendous range of devices that have revolutionized medical practice and improved or prolonged millions of lives. At the same time, devices are not automatically beneficial, and they (like all technology) are associated with risk. Recent examples include ultrasound equipment that often does not comply with electrical safety guidelines, leakage of insulin pumps, defective artificial cardiac valves, and reactions of the body to materials used in implants. Issues of balancing risk and benefit are familiar in the field of drugs. Drugs are regulated for efficacy and safety in most countries, and many countries make concerted attempts to influence the prescribing of drugs. International organizations such as Health Action International continually monitor the situation with regard to drugs. Devices, however, get much less attention, It seems peculiar that they are almost ignored despite their similarities to drugs: they are pervasive in medical care, they are products made and marketed by a profit-making industry, they are often taken into the body, and they are associated with demonstrable problems of efficacy and safety. In addition, they are associated with important economic effects in terms of health care expenditures and the strength of national industrial efforts. Medical devices span a vast array of supplies and equipment, from common items of low unit costs, such as bandages and syringes, to infrequently purchased items with high unit costs, such as imaging equipment and open heart machines. A medical device is any instrument, apparatus, or similar or related article that is intended to prevent, diagnose, mitigate, or treat disease or to affect the structure or function of the body (1). The purpose of this article is to highlight this important area. Obviously, the use of devices in health care practice is an important issue in itself. However, this article will deal only with the technical evaluation and regulation of devices. Regulation of radiologic and imaging equipment will not be described. I propose that the subject of regulation of medical devices needs much more attention from national and international policy-making groups.
’ Presented at the International
Conference on Health Policy, Jerusalem, Israel,
June
7-19,
1987.
693 0091-7435/90 $3.00 Copyright 0 1990 by Academic Press, Inc. All rights of reproduction in any form reserved.
694
H. DAVID
THE MEDICAL
BANTA
DEVICES INDUSTRY
World commerce is now dominated by multinational firms. This is wellrecognized in the case of the pharmaceutical industry, but the medical devices or equipment industry has not received the same degree of attention. Nonetheless, devices are often made by pharmaceutical companies, and some of the following generalizations concerning the drug industry probably also apply to the devices industry. Seventy percent of the world’s production of pharmaceuticals, valued at U.S. $84 billion in 1980, is produced in the industrialized countries that are concentrated in Western Europe and North America. The three largest drug manufacturing countries-the United States, Japan, and West Germany-together represent half of the output of pharmaceutical products (2). In total, in 1980 the industrialized countries exported U.S. $13.2 billion and imported U.S. $9.5 billion in drugs. The top 50 drug companies supply nearly two-thirds of all the pharmaceutical products shipped for human use, while the top 25 companies supply about onehalf (3). In 1980, the top 13 companies in the world were U.S., German, or Swiss. All of the 50 largest firms are transnational corporations that sell in foreign markets and usually engage in manufacturing and research and development activities abroad as well. The European firms are the most internationalized in terms of drug sales. Almost all of the main European firms have more than 50% of their sales outside their home country. Little is known about the international medical device and equipment industry except that it has grown dramatically and that in many cases, pharmaceutical companies have diversified into devices because of potential profits. It is also known from U.S. information that, in that country at least, the average device manufacturer is much smaller than the average drug company, with an average of only 70 employees. In the United States, sales of medical devices grew from less than U.S. $1 billion in 1958 to more than U.S. $17 billion in 1983, an annual increase of more than 12% (1, p. 17). [In 1981, sales of pharmaceuticals in the United States were about U.S. $16 billion (4, p. 2)]. It is known that the devices industry realizes generous profits. These profits are related not only to the technical advances, but also and especially to the climate of medical care, the extent of prepayment for medical services, and the general lack of scrutiny of devices for benefits and risks until fairly recently (1). There were at least 3,000 firms selling medical devices in the United States in 1983, and this figure too has dramatically increased (1). Employment in the industry grew from 129,000 to 200,000 during the period 1958-1983 (l).* Medical devices make an important contribution to the U.S. economy in terms of exports (5-7). During the 1980s the United States has exported more than U.S. $2 billion a year and imported around U.S. $1.5 billion, with an average surplus of close to U.S. $1 billion a year (1, p. 36). ’ Figures given here are taken from Department of Commerce surveys of U.S. industry. They are not complete because of certain exclusions, including multiproduct companies.
PROCEEDINGS-CONFERENCE
ON
HEALTH
POLICY
695
THE CASE OF THE DALKON SHIELD
While one case cannot exemplify all of the issues concerning medical devices, one important case illustrates the problems that can arise when there is no systematic approach to protecting health care consumers from risky devices. The Dalkon Shield is an intrauterine birth control device that was marketed, beginning in 1970, by A. H. Robins, a major U.S. pharmaceutical corporation (8). Approximately 2.3 million devices were sold in the United States from 1970 to 1974, and about 2 million were sold in about 79 other countries (9). The U.S. Agency for International Development (AID) alone bought about 700,000 Shields for use in less developed countries (9). The Dalkon Shield was not rigorously tested for its efficacy and safety, and was considerably less effective than promotional literature claimed (8). At that time, devices were not generally regulated in the United States, so the Food and Drug Administration (FDA) did not rigorously evaluate the device. By 1972, it was becoming apparent that pregnancy rate among women using the device was considerably higher than claimed, and that side effects were also common, and sales began to slump. A public relations firm was hired to promote sales, despite the accumulating evidence (8). A number of deaths from septic abortion were reported, and many other cases of infection, pelvic inflammatory disease, and uterine perforations were reported. A study by the Center for Disease Control in 1973 found 3,502 women who were hospitalized with disease and injury related to the Shield during the first 6 months of 1973. Robins continued to try to promote the device and attempted to cover up the mounting evidence of complications. In 1974, under pressure from the FDA, Robins withdrew the Dalkon Shield from the U.S. market. However, Robins continued to sell the Shield abroad for at least 9 months longer (9) and did not actually withdraw the device from the market until 1980 (10). In 1984, Robins launched a major national public information effort in the United States, recommending that the Dalkon Shield be removed from all wearers. Robins also wrote a letter to embassies of 79 countries where the Shield was known to be sold, but did not develop any further publicity addressed to non-U.S. citizens. U.S. court investigators later found that Robins had “engaged in an ongoing fraud by knowingly misrepresenting the nature, quality, safety, and efficacy of the Dalkon Shield. The ongoing fraud has also involved the destruction and withholding of relevant evidence” (9). Robins paid millions of dollars in law suits. The Dalkon Shield is an example of what can happen without regulation of medical devices. With regulation, the Food and Drug Administration would have required Robins to monitor 1,500 to 2,000 users for 2 years or more and submit the results to the FDA. Without regulation, Robins could market the Shield without prior testing for safety in either animals or humans (9). It will never be known how many problems arise or could arise with medical devices. In addition, no one can say how often industry engages in false advertising and fraudulent practices. The fact is, there are problems, and industry does not always behave well. Which is more reasonable-to let the problems develop to see how serious and frequent they can be, or to develop programs aimed at preventing such problems?
696
H.
REGULATION
OF MEDICAL
DAVID
BANTA
DEVICES IN THE UNITED STATES
Regulation of medical devices is intended to protect consumers’ health and safety by attempting to ensure that marketed products are effective and safe. Prior to 1976, the U.S. FDA had limited authority over medical devices under the Food, Drug, and Cosmetic Act of 1938 (1). Beginning in 1968, the U.S. Congress established a radiation control program to authorize the establishment of standards for electronic products, including medical and dental radiology equipment. From the early 1960s to 1975, concern over devices increased, and six U.S. Presidential messages were given to encourage medical device legislation. In 1969, the Department of Health, Education, and Welfare appointed a special committee (the Cooper Committee) to review the scientific literature associated with medical devices. The Committee estimated that over a lo-year period, 10,000 injuries were associated with medical devices, of which 731 resulted in death. The majority of problems were associated with three device types: artificial heart valves (512 deaths and 300 injuries); cardiac pacemakers (89 deaths and 186 injuries); and intrauterine contraceptive devices (100 deaths and 8,000 injuries) (5). These activities culminated in passage of the Medical Device Amendments of 1976. The Amendments provided for regulation according to the degree of potential risk posed by a device. Devices that had been marketed before 1976 were to be assigned to three classes: Class I, encompassing devices in which general controls such as good manufacturing practices were deemed adequate to ensure safety and efficacy; Class II, an intermediate category, for devices for which general controls were deemed insufficient to ensure safety and efficacy and for which performance standards could be developed; and Class III, for devices that support life, prevent health impairment, or present an unreasonable risk of illness or injury and require FDA approval before marketing (1). In Class III, the manufacturer is required to submit evidence of efficacy and safety from well-designed studies. By early 1984, FDA had classified the majority of devices on the market. Twenty-seven percent of device types were in Class I, 64% were in Class II, and 8% were in Class III. Devices marketed after 1976 are subject to full regulation unless they are found substantially equivalent to a device already on the market in 1976. By the end of 1981, only about 300 of the 17,000 products submitted for clearance to FDA after 1976 had been found not substantially equivalent (1, p. 9). The effect of the amendments is difficult to assess. Substantial damage to industry has not been documented, although some small manufacturers, especially those making contact lenses, have had serious difficulties with the amendments. Since no systematic information is available on the extent to which problems of efficacy and safety occur with devices, the effect of the amendments in terms of public protection cannot be assessed. Voluntary reports and recalls for high risks have mostly involved implantable devices, often with electrical problems, and cardiovascular devices (1, p. 10). The Amendments have had the great benefit of producing information. Prior to passage of the Amendments, no one knew how many companies were manufacturing and marketing medical devices in the United States. No one knew how many or what type of devices were on the market. It was then impossible to say where information-for example, from evaluations-would be
PROCEEDINGS-CONFERENCE
ON
HEALTH
POLICY
697
most useful. Much more is now known about the industry in the United States, but, as indicated above, less is known about the international industry. DEVICE REGULATION
IN OTHER COUNTRIES
No country regulates medical devices as consistently and thoroughly as the United States. However, there is a trend toward regulation in other industrialized countries, especially in Europe (11, 12). France requires registration and evaluation of medical devices for public hospitals. Germany passed a law about 3 years ago that requires the registration of all medical devices linked to approval by defined testing organizations. England’s Department of Health and Social Security is active in evaluating selected devices. And Italy also has a law, passed in 1986, that requires registration of all medical devices marketed in the country. INTERNATIONAL
ACTIVITIES
CONCERNING
DEVICE REGULATION
In Europe, an important international organization working in the area of devices is the European Commission (EC). The EC has directives dealing with medical equipment. For example, under EC directives, all governments are required to develop standards for x-ray machines and x-ray therapy. Under another EC directive, issued by the International Electrotechnical Committee, requires member states to set standards for electrical safety. An EC working group on biomedical engineering (COMAC-BME) focuses on the safety of medical equipment. At present, the group is examining such technologies as perinatal monitoring, chromosome analysis, technology for sensory impairment, aids to the disabled, replacement of body function, quantitative electrocardiography, imaging (especially NMR), blood flow measurement by ultrasound, medical telemetry, and accelerated fracture healing. The World Health Organization, especially the European office in Copenhagen (EURO), has become increasingly involved in medical devices, especially promoting the idea of international exchange of information. International cooperation and communication could make much more information on medical equiment available and save evaluation resources of all countries. DISCUSSION
Medical devices are an important part of health care. That fact is evident to all health care workers. They have undoubtedly benefited millions of people. They are also associated with health risks and financial costs. Their importance in the economy does not seem so visible. With health care expenditures approaching or exceeding 10% of the gross national product in a number of developed countries, the medical device industry has been growing rapidly. At the same time, several governments promote the industry as a way of reducing unemployment and increasing exports. The medical devices industry differs from the drug industry in some important respects. In particular, it is made up of many smaller firms rather than multinational giants. This makes it more difficult to track devices. In addition, small companies may not have the resources to carefully evaluate their products. An important part of the development and diffusion process is technical eval-
698
H.
DAVID
BANTA
uation of devices to assure that they are safe and do what they are claimed to do. Programs for this purpose exist in some countries and are being considered in others. It seems clear that governments have the responsibility to protect their citizens against unsafe or inefftcacious devices. The problem, however, is that few countries have the resources to deal with the vast array of devices made all over the world. Even a rich country like The Netherlands has this problem. Less developed countries have even fewer resources (13). Industry is not automatically opposed to regulation. Some industry spokesman have promoted regulation by requirements for good manufacturing practices. However, it is probably true that industry as a whole would be opposed to programs to regulate individual devices. At the same time, manufacturers recognize the advantage of regulation by FDA in the international marketplace. Because there is no other long-standing program of the size of FDA, approval by FDA for marketing in the United States is often taken by buyers to mean that the device is safe and efftcacious. There is no clear answer to the problem highlighted in this article. However, some steps could greatly improve the present situation: (a) Require that all manufacturers register the devices sold in a particular country. This would at least let policy-makers know what was being sold within their borders. If companies were also required to indicate how many of each device were sold in the country, priorities for information collection could be developed. (b) Participate in developing networks for the exchange of information. The Food and Drug Administration is eager to participate in such networks, as are other national institutes, such as TN0 in The Netherlands. (c) Develop the resources to evaluate high prority devices that might not be evaluated elsewhere. This would not only make information available for national decisions, but it would also make it possible to furnish information to those in other countries, stimulating them to release their own data. High priority devices are generally those necessary to life or functioning. Device regulation is only one tool. Generally, the success of regulatory efforts in health care is questionable, especially when dealing with individual behavior, such as that of physicians. However, regulation seems more successful when it deals with products, especially when used to ensure minimum standards of safety and efficacy. CONCLUSION
Such regulation is increasing worldwide, presumably because of growing concerns among the public and policy-makers. Pressures are building up to force the development of such regulation, meaning that the present offers particular opportunities for shaping policies toward medical devices in the future. REFERENCES 1. Office of Technology Assessment. Federal Policies and the Medical Devices Industry. Washington, DC: U.S. Government Printing Offke, 1984. 2. United Nations Industrial Development Organization (UNIDO). Global study of the pharmaceutical industry. Vienna, 1980 (Report No. (ID/WG.331/6).
PROCEEDINGS-CONFERENCE
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HEALTH
POLICY
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3. Gerefti G. The Pharmaceutical Industry and Dependency in the Third World. Princeton, NJ: Princeton Univ. Press, 1983. 4. IMS Pharmaceutical Marketletter, London, 11 January 1982. 5. U.S. Congress, House Committee on Interstate and Foreign Commerce. Medical Devices, Hearings before the Subcommittee on Public Health and the Environment, October 23-24, 19731, Serial No. 93-61. Washington, DC: U.S. Government Printing OffIce, 1973. 6. U.S. Department of Commerce. Data Furnished to the Pan American Health Organization, 1983. 7. U.S. Department of Commerce, Bureau of the Census. Highlights of the U.S. Export and Import Trade. Washington, DC, December, 1982. Table E-5, p. 36. 8. The National Women’s Health Network. The Dalkon Shield. Washington, DC, 1985. 9. Mintz M. A crime against women, A. H. Robbins and the Dalkon Shield. Multinarional Monitor 1986; 7:1-7. 10. Beardshaw V. Dalkon Shield. Memorandum Written for the Paris Meeting of Health Action International (HAI), 21-22 September 1985. 11. Beneken JEW, Brown BH, Skupinski, W. Biomedical engineering programme of the European community. J Med Eng Tech 1985; 9:61. 12. European Commission. A General Approach to the Field of Certification and Judgment. Official Publication of the European Commission. No. C 267/3. 19-10-89. 13. Groot LMJ. Medical technology in the health care system of the Netherlands. In: Banta D, Kemp K, Eds. The Management of Health Care Technology in Nine Countries. New York: Springer, 1982: 150-166. 14. FINEP. Politica de Saude, Producao e Mercado de Equipamentos Medicos. Rio de Janeiro, Brazil, July 1983. 15. Hosto. Kansen en bedreigingen van de Nederlandse industrie op het gebied van de medische technologie/instrumentatie. Onderzoek uitgevoerd door Hosto Consult in opdracht van het Ministerie van Economische Zaken. 1984.
MEDICINE
19, 693-699 (1990)
The Regulation of Medical Devices’ H. DAVID
BANTA,
M.D.
MTDITNO, P.O. Box 188, 2300 AD Leiden, The Netherlands
INTRODUCTION
Medical devices have become a visible and dramatic part of modern medical care. The period following World War II has seen the development of a tremendous range of devices that have revolutionized medical practice and improved or prolonged millions of lives. At the same time, devices are not automatically beneficial, and they (like all technology) are associated with risk. Recent examples include ultrasound equipment that often does not comply with electrical safety guidelines, leakage of insulin pumps, defective artificial cardiac valves, and reactions of the body to materials used in implants. Issues of balancing risk and benefit are familiar in the field of drugs. Drugs are regulated for efficacy and safety in most countries, and many countries make concerted attempts to influence the prescribing of drugs. International organizations such as Health Action International continually monitor the situation with regard to drugs. Devices, however, get much less attention, It seems peculiar that they are almost ignored despite their similarities to drugs: they are pervasive in medical care, they are products made and marketed by a profit-making industry, they are often taken into the body, and they are associated with demonstrable problems of efficacy and safety. In addition, they are associated with important economic effects in terms of health care expenditures and the strength of national industrial efforts. Medical devices span a vast array of supplies and equipment, from common items of low unit costs, such as bandages and syringes, to infrequently purchased items with high unit costs, such as imaging equipment and open heart machines. A medical device is any instrument, apparatus, or similar or related article that is intended to prevent, diagnose, mitigate, or treat disease or to affect the structure or function of the body (1). The purpose of this article is to highlight this important area. Obviously, the use of devices in health care practice is an important issue in itself. However, this article will deal only with the technical evaluation and regulation of devices. Regulation of radiologic and imaging equipment will not be described. I propose that the subject of regulation of medical devices needs much more attention from national and international policy-making groups.
’ Presented at the International
Conference on Health Policy, Jerusalem, Israel,
June
7-19,
1987.
693 0091-7435/90 $3.00 Copyright 0 1990 by Academic Press, Inc. All rights of reproduction in any form reserved.
694
H. DAVID
THE MEDICAL
BANTA
DEVICES INDUSTRY
World commerce is now dominated by multinational firms. This is wellrecognized in the case of the pharmaceutical industry, but the medical devices or equipment industry has not received the same degree of attention. Nonetheless, devices are often made by pharmaceutical companies, and some of the following generalizations concerning the drug industry probably also apply to the devices industry. Seventy percent of the world’s production of pharmaceuticals, valued at U.S. $84 billion in 1980, is produced in the industrialized countries that are concentrated in Western Europe and North America. The three largest drug manufacturing countries-the United States, Japan, and West Germany-together represent half of the output of pharmaceutical products (2). In total, in 1980 the industrialized countries exported U.S. $13.2 billion and imported U.S. $9.5 billion in drugs. The top 50 drug companies supply nearly two-thirds of all the pharmaceutical products shipped for human use, while the top 25 companies supply about onehalf (3). In 1980, the top 13 companies in the world were U.S., German, or Swiss. All of the 50 largest firms are transnational corporations that sell in foreign markets and usually engage in manufacturing and research and development activities abroad as well. The European firms are the most internationalized in terms of drug sales. Almost all of the main European firms have more than 50% of their sales outside their home country. Little is known about the international medical device and equipment industry except that it has grown dramatically and that in many cases, pharmaceutical companies have diversified into devices because of potential profits. It is also known from U.S. information that, in that country at least, the average device manufacturer is much smaller than the average drug company, with an average of only 70 employees. In the United States, sales of medical devices grew from less than U.S. $1 billion in 1958 to more than U.S. $17 billion in 1983, an annual increase of more than 12% (1, p. 17). [In 1981, sales of pharmaceuticals in the United States were about U.S. $16 billion (4, p. 2)]. It is known that the devices industry realizes generous profits. These profits are related not only to the technical advances, but also and especially to the climate of medical care, the extent of prepayment for medical services, and the general lack of scrutiny of devices for benefits and risks until fairly recently (1). There were at least 3,000 firms selling medical devices in the United States in 1983, and this figure too has dramatically increased (1). Employment in the industry grew from 129,000 to 200,000 during the period 1958-1983 (l).* Medical devices make an important contribution to the U.S. economy in terms of exports (5-7). During the 1980s the United States has exported more than U.S. $2 billion a year and imported around U.S. $1.5 billion, with an average surplus of close to U.S. $1 billion a year (1, p. 36). ’ Figures given here are taken from Department of Commerce surveys of U.S. industry. They are not complete because of certain exclusions, including multiproduct companies.
PROCEEDINGS-CONFERENCE
ON
HEALTH
POLICY
695
THE CASE OF THE DALKON SHIELD
While one case cannot exemplify all of the issues concerning medical devices, one important case illustrates the problems that can arise when there is no systematic approach to protecting health care consumers from risky devices. The Dalkon Shield is an intrauterine birth control device that was marketed, beginning in 1970, by A. H. Robins, a major U.S. pharmaceutical corporation (8). Approximately 2.3 million devices were sold in the United States from 1970 to 1974, and about 2 million were sold in about 79 other countries (9). The U.S. Agency for International Development (AID) alone bought about 700,000 Shields for use in less developed countries (9). The Dalkon Shield was not rigorously tested for its efficacy and safety, and was considerably less effective than promotional literature claimed (8). At that time, devices were not generally regulated in the United States, so the Food and Drug Administration (FDA) did not rigorously evaluate the device. By 1972, it was becoming apparent that pregnancy rate among women using the device was considerably higher than claimed, and that side effects were also common, and sales began to slump. A public relations firm was hired to promote sales, despite the accumulating evidence (8). A number of deaths from septic abortion were reported, and many other cases of infection, pelvic inflammatory disease, and uterine perforations were reported. A study by the Center for Disease Control in 1973 found 3,502 women who were hospitalized with disease and injury related to the Shield during the first 6 months of 1973. Robins continued to try to promote the device and attempted to cover up the mounting evidence of complications. In 1974, under pressure from the FDA, Robins withdrew the Dalkon Shield from the U.S. market. However, Robins continued to sell the Shield abroad for at least 9 months longer (9) and did not actually withdraw the device from the market until 1980 (10). In 1984, Robins launched a major national public information effort in the United States, recommending that the Dalkon Shield be removed from all wearers. Robins also wrote a letter to embassies of 79 countries where the Shield was known to be sold, but did not develop any further publicity addressed to non-U.S. citizens. U.S. court investigators later found that Robins had “engaged in an ongoing fraud by knowingly misrepresenting the nature, quality, safety, and efficacy of the Dalkon Shield. The ongoing fraud has also involved the destruction and withholding of relevant evidence” (9). Robins paid millions of dollars in law suits. The Dalkon Shield is an example of what can happen without regulation of medical devices. With regulation, the Food and Drug Administration would have required Robins to monitor 1,500 to 2,000 users for 2 years or more and submit the results to the FDA. Without regulation, Robins could market the Shield without prior testing for safety in either animals or humans (9). It will never be known how many problems arise or could arise with medical devices. In addition, no one can say how often industry engages in false advertising and fraudulent practices. The fact is, there are problems, and industry does not always behave well. Which is more reasonable-to let the problems develop to see how serious and frequent they can be, or to develop programs aimed at preventing such problems?
696
H.
REGULATION
OF MEDICAL
DAVID
BANTA
DEVICES IN THE UNITED STATES
Regulation of medical devices is intended to protect consumers’ health and safety by attempting to ensure that marketed products are effective and safe. Prior to 1976, the U.S. FDA had limited authority over medical devices under the Food, Drug, and Cosmetic Act of 1938 (1). Beginning in 1968, the U.S. Congress established a radiation control program to authorize the establishment of standards for electronic products, including medical and dental radiology equipment. From the early 1960s to 1975, concern over devices increased, and six U.S. Presidential messages were given to encourage medical device legislation. In 1969, the Department of Health, Education, and Welfare appointed a special committee (the Cooper Committee) to review the scientific literature associated with medical devices. The Committee estimated that over a lo-year period, 10,000 injuries were associated with medical devices, of which 731 resulted in death. The majority of problems were associated with three device types: artificial heart valves (512 deaths and 300 injuries); cardiac pacemakers (89 deaths and 186 injuries); and intrauterine contraceptive devices (100 deaths and 8,000 injuries) (5). These activities culminated in passage of the Medical Device Amendments of 1976. The Amendments provided for regulation according to the degree of potential risk posed by a device. Devices that had been marketed before 1976 were to be assigned to three classes: Class I, encompassing devices in which general controls such as good manufacturing practices were deemed adequate to ensure safety and efficacy; Class II, an intermediate category, for devices for which general controls were deemed insufficient to ensure safety and efficacy and for which performance standards could be developed; and Class III, for devices that support life, prevent health impairment, or present an unreasonable risk of illness or injury and require FDA approval before marketing (1). In Class III, the manufacturer is required to submit evidence of efficacy and safety from well-designed studies. By early 1984, FDA had classified the majority of devices on the market. Twenty-seven percent of device types were in Class I, 64% were in Class II, and 8% were in Class III. Devices marketed after 1976 are subject to full regulation unless they are found substantially equivalent to a device already on the market in 1976. By the end of 1981, only about 300 of the 17,000 products submitted for clearance to FDA after 1976 had been found not substantially equivalent (1, p. 9). The effect of the amendments is difficult to assess. Substantial damage to industry has not been documented, although some small manufacturers, especially those making contact lenses, have had serious difficulties with the amendments. Since no systematic information is available on the extent to which problems of efficacy and safety occur with devices, the effect of the amendments in terms of public protection cannot be assessed. Voluntary reports and recalls for high risks have mostly involved implantable devices, often with electrical problems, and cardiovascular devices (1, p. 10). The Amendments have had the great benefit of producing information. Prior to passage of the Amendments, no one knew how many companies were manufacturing and marketing medical devices in the United States. No one knew how many or what type of devices were on the market. It was then impossible to say where information-for example, from evaluations-would be
PROCEEDINGS-CONFERENCE
ON
HEALTH
POLICY
697
most useful. Much more is now known about the industry in the United States, but, as indicated above, less is known about the international industry. DEVICE REGULATION
IN OTHER COUNTRIES
No country regulates medical devices as consistently and thoroughly as the United States. However, there is a trend toward regulation in other industrialized countries, especially in Europe (11, 12). France requires registration and evaluation of medical devices for public hospitals. Germany passed a law about 3 years ago that requires the registration of all medical devices linked to approval by defined testing organizations. England’s Department of Health and Social Security is active in evaluating selected devices. And Italy also has a law, passed in 1986, that requires registration of all medical devices marketed in the country. INTERNATIONAL
ACTIVITIES
CONCERNING
DEVICE REGULATION
In Europe, an important international organization working in the area of devices is the European Commission (EC). The EC has directives dealing with medical equipment. For example, under EC directives, all governments are required to develop standards for x-ray machines and x-ray therapy. Under another EC directive, issued by the International Electrotechnical Committee, requires member states to set standards for electrical safety. An EC working group on biomedical engineering (COMAC-BME) focuses on the safety of medical equipment. At present, the group is examining such technologies as perinatal monitoring, chromosome analysis, technology for sensory impairment, aids to the disabled, replacement of body function, quantitative electrocardiography, imaging (especially NMR), blood flow measurement by ultrasound, medical telemetry, and accelerated fracture healing. The World Health Organization, especially the European office in Copenhagen (EURO), has become increasingly involved in medical devices, especially promoting the idea of international exchange of information. International cooperation and communication could make much more information on medical equiment available and save evaluation resources of all countries. DISCUSSION
Medical devices are an important part of health care. That fact is evident to all health care workers. They have undoubtedly benefited millions of people. They are also associated with health risks and financial costs. Their importance in the economy does not seem so visible. With health care expenditures approaching or exceeding 10% of the gross national product in a number of developed countries, the medical device industry has been growing rapidly. At the same time, several governments promote the industry as a way of reducing unemployment and increasing exports. The medical devices industry differs from the drug industry in some important respects. In particular, it is made up of many smaller firms rather than multinational giants. This makes it more difficult to track devices. In addition, small companies may not have the resources to carefully evaluate their products. An important part of the development and diffusion process is technical eval-
698
H.
DAVID
BANTA
uation of devices to assure that they are safe and do what they are claimed to do. Programs for this purpose exist in some countries and are being considered in others. It seems clear that governments have the responsibility to protect their citizens against unsafe or inefftcacious devices. The problem, however, is that few countries have the resources to deal with the vast array of devices made all over the world. Even a rich country like The Netherlands has this problem. Less developed countries have even fewer resources (13). Industry is not automatically opposed to regulation. Some industry spokesman have promoted regulation by requirements for good manufacturing practices. However, it is probably true that industry as a whole would be opposed to programs to regulate individual devices. At the same time, manufacturers recognize the advantage of regulation by FDA in the international marketplace. Because there is no other long-standing program of the size of FDA, approval by FDA for marketing in the United States is often taken by buyers to mean that the device is safe and efftcacious. There is no clear answer to the problem highlighted in this article. However, some steps could greatly improve the present situation: (a) Require that all manufacturers register the devices sold in a particular country. This would at least let policy-makers know what was being sold within their borders. If companies were also required to indicate how many of each device were sold in the country, priorities for information collection could be developed. (b) Participate in developing networks for the exchange of information. The Food and Drug Administration is eager to participate in such networks, as are other national institutes, such as TN0 in The Netherlands. (c) Develop the resources to evaluate high prority devices that might not be evaluated elsewhere. This would not only make information available for national decisions, but it would also make it possible to furnish information to those in other countries, stimulating them to release their own data. High priority devices are generally those necessary to life or functioning. Device regulation is only one tool. Generally, the success of regulatory efforts in health care is questionable, especially when dealing with individual behavior, such as that of physicians. However, regulation seems more successful when it deals with products, especially when used to ensure minimum standards of safety and efficacy. CONCLUSION
Such regulation is increasing worldwide, presumably because of growing concerns among the public and policy-makers. Pressures are building up to force the development of such regulation, meaning that the present offers particular opportunities for shaping policies toward medical devices in the future. REFERENCES 1. Office of Technology Assessment. Federal Policies and the Medical Devices Industry. Washington, DC: U.S. Government Printing Offke, 1984. 2. United Nations Industrial Development Organization (UNIDO). Global study of the pharmaceutical industry. Vienna, 1980 (Report No. (ID/WG.331/6).
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3. Gerefti G. The Pharmaceutical Industry and Dependency in the Third World. Princeton, NJ: Princeton Univ. Press, 1983. 4. IMS Pharmaceutical Marketletter, London, 11 January 1982. 5. U.S. Congress, House Committee on Interstate and Foreign Commerce. Medical Devices, Hearings before the Subcommittee on Public Health and the Environment, October 23-24, 19731, Serial No. 93-61. Washington, DC: U.S. Government Printing OffIce, 1973. 6. U.S. Department of Commerce. Data Furnished to the Pan American Health Organization, 1983. 7. U.S. Department of Commerce, Bureau of the Census. Highlights of the U.S. Export and Import Trade. Washington, DC, December, 1982. Table E-5, p. 36. 8. The National Women’s Health Network. The Dalkon Shield. Washington, DC, 1985. 9. Mintz M. A crime against women, A. H. Robbins and the Dalkon Shield. Multinarional Monitor 1986; 7:1-7. 10. Beardshaw V. Dalkon Shield. Memorandum Written for the Paris Meeting of Health Action International (HAI), 21-22 September 1985. 11. Beneken JEW, Brown BH, Skupinski, W. Biomedical engineering programme of the European community. J Med Eng Tech 1985; 9:61. 12. European Commission. A General Approach to the Field of Certification and Judgment. Official Publication of the European Commission. No. C 267/3. 19-10-89. 13. Groot LMJ. Medical technology in the health care system of the Netherlands. In: Banta D, Kemp K, Eds. The Management of Health Care Technology in Nine Countries. New York: Springer, 1982: 150-166. 14. FINEP. Politica de Saude, Producao e Mercado de Equipamentos Medicos. Rio de Janeiro, Brazil, July 1983. 15. Hosto. Kansen en bedreigingen van de Nederlandse industrie op het gebied van de medische technologie/instrumentatie. Onderzoek uitgevoerd door Hosto Consult in opdracht van het Ministerie van Economische Zaken. 1984.