Prostheses, orthoses and special devices The field of medical devices is now almost limitless. It comprises not only the classic medical and surgical instruments, but also infinitely delicate and complicated mechanisms, including computers, many of which are far beyond the understanding of most physicians. No matter how complicated the device, no matter how sophisticated the mechanism and its components, one must remember that the machine was invented, constructed and adapted to serve the most complex instrument ever created - the human body - which refuses to conform to a production-line philosophy. Equipment constructed by physicists and biomedical engineers is sometimes rejected outright by patients. The scientist then may experience frustration, whereas the physician, trained in a discipline characterized by unforeseeable outcomes of events, will accept defeat more readily. Moreover, the physician will always place a human being, especially a sick one, first and the machine second. Prostheses, orthoses and special devices are at an early stage of development but they clearly have a remarkable potential in medicine. As Philip Selby1 has stated: The medical equipment industry is still at an early stage of development in comparison with the pharmaceutical industry... bu.... the use of medical equipment is growing in the areas of diagnoses.., using a wide variety of prostheses that include artificial limbs, hearts and kidneys. Electronic devices will be used increasingly. Perhaps the most rapid development will be in equipment for carrying out manoeuvres that are at present beyond the scope of human dexterity, using miniaturized electronic equipment, for example, intra-corporeal television. I predict that, during the next decade, government will exercise ever stricter control over the medical equipment industry, as it is doing over the pharmaceutical industry. At the same time, government and industry will, I hope, agree to a constructive and willing partnership serving a common goal, thus ensuring the highest possible quality. This field is therefore one with which physicians must become familiar. One aspect of this topic is worth discussing in detail - the use of prostheses, orthoses and special appliances by disabled persons, for what applies to these devices often applies also to all medical gadgetry. Many points are of interest. Special equipment used by disabled persons can be described in terms of its purpose - to provide opti-
mal mobility, and to improve self-care and the capacity to perform the activities of daily life. There is a great variety of such equipment (e.g, wheelchairs, walkers, crutches, page turners, writing gadgets and commodes) and many so-called normal devices are modified for personal use by handicapped persons (e.g., electric typewriters, eating utensils, kitchenware, tools, household appliances and cars). The Canadian Medical Association has long been interested in the welfare of disabled Canadians. It took the association almost 10 years to persuade the federal government to remove the import duty from items not manufactured in Canada that are essential for the personal use of the disabled. In 1963 the General Council of the association requested "the setting up of a Canadian organization for the manufacture of prosthetic appliances, possibly using the skill of the Department of Veterans Affairs".2 In 1964 General Council stated through its committee on rehabilitation that at times the waiting period for an amputee to obtain an artificial limb was 8 months. General Council again asked the government "to give consideration to the expansion of D.V.A. Facilities".3 In 1966 the association made itself responsible for the creation of an interim board for the certification of prosthetists and orthotists. The board became permanent in 1967.. In 1965, when the prosthetic laboratories of the Department of Veterans Affairs, located in Sunnybrook Hospital, Toronto, became the responsibility of the Department of National Health and Welfare, some equipment was manufactured by the laboratories for Canadian research centres. But the laboratories never became, as was recommended, a crown corporation responsible for the manufacture of components for the whole of Canada. (Such a decision would have been directly related to a "make and buy" federal government policy.) Of course, market assessment would have been required to find out if such a corporation was financially viable. At present, components are being purchased mainly from the United States and Germany, and I am convinced that such parts should continue to be purchased abroad because their quality is excellent and because the number of persons with upper extremity amputation in this country does not appear sufficient to warrant the setting up of manufacturing facilities in Canada for this type of component.
234 CMA JOURNAL/FEBRUARY 5, 1977/VOL. 116
Many Canadians are permanently dependent on wheelchairs for mobility. At present some of these are manufactured by a small Canadian firm; others are assembled in Canada from components manufactured in the US. Wheelchairs are standard but, if needed, can be custom-made. However, when there is any deviation from a standard model the waiting period for delivery may be 4 to 6 months. Last year a quadriplegic patient had to be kept in hospital waiting for delivery of an electric wheelchair for 6 months - a waiting period that cost the taxpayer about $18 000. Since the introduction of electronic, carbon dioxide and hydraulic power to prosthetics and orthotics a few patients have been fitted with special powered appliances in this country. But the appliances must be finely honed in the research departments of rehabilitation centres that are struggling along from year to year, never certain that budgetary resources will be available. At the Rehabilitation Institute of Montreal, researchers have tried during the last few years to perfect a functional myoelectric orthosis permitting prehension for quadriplegic patients. The concept is good and a few patients have been fitted successfully. However, what has been created is still at the model-T stage. What is needed are expertise, consultants, equipment, parts and money. Of course there were consultants who offered their services gratis, but they came only once or twice - which leads me to paraphrase the Talmud: A consultant who charges nothing is worth nothing! What is the cost of prostheses, orthoses and wheelchairs? The cost of a conventional artificial arm ranges from $335 to $775 and a prosthetic appliance for a person with lower extremity amputation ranges from $380 to $940. The cost of a myoelectric upper extremity prosthesis is $1400. Orthotics - or braces - may cost from $85 for a simple drop-foot appliance to $570 for a full-length, double-bar brace with pelvic band and ischial support. A standard adult-model wheelchair will sell from $195 to $3 80. An electrically powered chair may be purchased for up to $1600. Who pays these costs? It is rarely the patient. Most frequently it is the government, benevolent organizations, benefactors or philanthropists. The situation, however, is changing. Effective July 1, 1975, Quebec provides under medicare, prostheses, orthoses and wheelchairs; the province also as-
sumes the cost of replacement, maintenance and repair. Coverage is most extensive in Saskatchewan; Manitoba and Alberta have partial coverage; but medicare schemes in Ontario and the maritime provinces do not cover the costs of appliances. There can be little doubt that soon all provinces will provide prostheses, orthoses and other equipment required by the disabled person under medicare. This important move from the provincial governments has and will generate a great demand from old and new consumers. Are we, as a country, ready to meet this expected demand in a reasonable period of time? At the Rehabilitation Institute of Montreal, hundreds of new and former patients have already been examined or reviewed for the purpose of being supplied with new appliances. With respect to wheelchairs it is estimated that 200 a month will be needed for at least 2 years. This is only regional. What happens if a projection is made for the whole of Canada? Regrettably, the Canadian federal and provincial governments have no idea of the number of disabled persons in Canada or in the various provinces. Nobody knows how many people with amputations or spinal cord injuries live in this country. The number of users of prostheses, orthoses and wheelchairs equally is unknown. However, Statistics Canada and Health and Welfare Canada are planning a joint survey to obtain this much-needed information (M. Wisenthal: personal communication, 1976). Some data have been provided by the British Ministry of Health Information. In 1971 the number of amputees in Britain was estimated at 68 000 (0.121%) of a total population of 55.5 million,5 which suggests that Canada has at least 20000 amputees. With respect to wheelchairs the British estimate is that 2100 persons per 1 million population use them. Translated into Canadian figures, it would mean approximately 50000 users. What would this mean in terms of cost? According to one source6 the cost of prostheses and orthoses in the US is $26 million for prostheses and $31 million for orthoses. In Canada this would represent $5.7 million. A further problem is patient acceptance of prostheses, orthoses and special devices. There is a common denominator in the manufacture of prosthetic and orthotic components. There is none, however, in the assembly and fitting of the finished product on patients. In each case one encounters not only technical problems but also psychologic reactions. For the disabled person the acquisition of a prosthesis or orthosis probably accounts for not more than 10% of the complex re. habilitation process. What really counts
is the acceptance of the device and, Research must be carried out in areas above all, competent training in its where there are physicians, physicists, use. Until a few years ago prostheses physical and occupational therapists, and orthoses were assembled and fitted prosthetists and orthotists. Research most often in small private shops. The must be conducted in areas where unipatient was measured, fitted and given versity facilities are readily accessible the appliance in the same manner as and patient requirements are varied. for a suit. The wearing of an artificial Last, but not least, industrial knowledge leg is quite a different story. Many and experience must be available persons with amputations, particularly even though commercial ventures rareof the arm, have been provided with iy produce useful research. prostheses but have never used them I conclude by enumerating some of because they have never been trained the guidelines that should be considered or been "sold" the idea of using an by government or industry or both. artificial limb. 1. Statistical data on the number of In 1952 at the Rehabilitation In- disabled people in Canada using prosstitute of Montreal we decided to theses, orthoses and special devices establish a prosthetics and orthotics should be made available. laboratory within the institute. The 2. The cost of prostheses, orthoses laboratory was opened on Apr. 1, 1957 and special devices to Canadian taxand from then on medical and psy- payers should be established. chologic assessment preceded most 3. Design of prostheses, orthoses prosthetic or orthotic fittings. Measure- and special devices should be standardment for and fitting of appliances, and ized and the metric system should be training in their use, have a rightful adopted. place in rehabilitation services that are 4. Production of prostheses, orthoses all conducted under one roof under and special equipment should be dethe overall supervision of physicians commercialized. trained in physical medicine and re5. If warranted, a crown corporation habilitation. Last year nearly 900 am- should be established to manufacture putees were thus team-treated and re- basic components. habilitated at the institute. It is en6. Research should be boosted and couraging that a number of institutions paid for by government and industry. in Canada and abroad have followed a 7. A permanent advisory committee, similar policy. to include government representatives, Because of our success, I recommend should be created; a group representing that the measurement for, and fitting industry, consumers and specialists of, prosthetic and orthotic devices be should be formed to study and lobby "decommercialized", and procedures implementation of the recommendainvolving the use of artificial limbs and tions of the permanent advisory comsupports become wholly the responsib- mittee. This recommendation should ility of specialized centres. This con- apply to all medical devices. 8. Strict controls over all medical cept is not unique: it has been recommended in a recent report of the Welsh devices should be established by govoffice of the Department of Health and ernment with the collaboration of inSocial Security.7 I also recommend that dustry and organized medicine. basic components be manufactured in G. GINGRAS, CC, MD, LL D, FRcP[C] Canada and distributed by a crown Executive director Rehabilitation Institute of Montreal corporation. The large facilities now Montreal, PQ under the jurisdiction of Health and Welfare Canada in Sunnybrook Hospital would be the logical place for such an undertaking. References An important and essential adjunct 1. SELBY P (ed): Health in 1980-1990 - A should be the standardization of comPredictive Study Based on an International ponents. It is unacceptable that a perInquiry. No. 6 Perspective in Medicine, Basel, Karger, 1974, p 78 son fitted in Halifax should not be able 2. Transactions of the Ninety-Sixth Annual to find spare parts for his appliance in Meeting of The Canadian Medical AssociaWinnipeg or Vancouver. The Canadian tion, Toronto, June 10-12, 1963, p 36 Standards Association and the govern3. Transactions of the Ninety-Seventh Annual Meeting of The Canadian Medical Associament should see that such a situation is tion, Vancouver, June 22-25, 1964, p 75 resolved. Furthermore, the metric sys4. Transactions of General Council at the One tem should be adopted immediately. It Hundredth Annual Meeting of The Canadian would greatly help standardization not Medical Association, Quebec, June 9 and 10, 1967, p 83 only in Canada but also internationally. 5. Report of the Committee on Prosthetics, The pattern of research in prosOrthotics and Special Equipment, Vancouver, thetics, orthotics and special devices is SPARC of BC, 1973, appendix II also important. It must be conducted 6. Ibid, appendix III and encouraged not only following wars 7. Report of a Sub-Committee of the Standing Medical Advisory Committee of the Central or tragedies such as deformity due to Health Services Council: Rehabilitation, Lonthalidomide, but on a continuin2 basis. don, HMSO. 1972 CMA JOURNAL/FEBRUARY 5, 1977/VOL. 116 235
mal mobility, and to improve self-care and the capacity to perform the activities of daily life. There is a great variety of such equipment (e.g, wheelchairs, walkers, crutches, page turners, writing gadgets and commodes) and many so-called normal devices are modified for personal use by handicapped persons (e.g., electric typewriters, eating utensils, kitchenware, tools, household appliances and cars). The Canadian Medical Association has long been interested in the welfare of disabled Canadians. It took the association almost 10 years to persuade the federal government to remove the import duty from items not manufactured in Canada that are essential for the personal use of the disabled. In 1963 the General Council of the association requested "the setting up of a Canadian organization for the manufacture of prosthetic appliances, possibly using the skill of the Department of Veterans Affairs".2 In 1964 General Council stated through its committee on rehabilitation that at times the waiting period for an amputee to obtain an artificial limb was 8 months. General Council again asked the government "to give consideration to the expansion of D.V.A. Facilities".3 In 1966 the association made itself responsible for the creation of an interim board for the certification of prosthetists and orthotists. The board became permanent in 1967.. In 1965, when the prosthetic laboratories of the Department of Veterans Affairs, located in Sunnybrook Hospital, Toronto, became the responsibility of the Department of National Health and Welfare, some equipment was manufactured by the laboratories for Canadian research centres. But the laboratories never became, as was recommended, a crown corporation responsible for the manufacture of components for the whole of Canada. (Such a decision would have been directly related to a "make and buy" federal government policy.) Of course, market assessment would have been required to find out if such a corporation was financially viable. At present, components are being purchased mainly from the United States and Germany, and I am convinced that such parts should continue to be purchased abroad because their quality is excellent and because the number of persons with upper extremity amputation in this country does not appear sufficient to warrant the setting up of manufacturing facilities in Canada for this type of component.
234 CMA JOURNAL/FEBRUARY 5, 1977/VOL. 116
Many Canadians are permanently dependent on wheelchairs for mobility. At present some of these are manufactured by a small Canadian firm; others are assembled in Canada from components manufactured in the US. Wheelchairs are standard but, if needed, can be custom-made. However, when there is any deviation from a standard model the waiting period for delivery may be 4 to 6 months. Last year a quadriplegic patient had to be kept in hospital waiting for delivery of an electric wheelchair for 6 months - a waiting period that cost the taxpayer about $18 000. Since the introduction of electronic, carbon dioxide and hydraulic power to prosthetics and orthotics a few patients have been fitted with special powered appliances in this country. But the appliances must be finely honed in the research departments of rehabilitation centres that are struggling along from year to year, never certain that budgetary resources will be available. At the Rehabilitation Institute of Montreal, researchers have tried during the last few years to perfect a functional myoelectric orthosis permitting prehension for quadriplegic patients. The concept is good and a few patients have been fitted successfully. However, what has been created is still at the model-T stage. What is needed are expertise, consultants, equipment, parts and money. Of course there were consultants who offered their services gratis, but they came only once or twice - which leads me to paraphrase the Talmud: A consultant who charges nothing is worth nothing! What is the cost of prostheses, orthoses and wheelchairs? The cost of a conventional artificial arm ranges from $335 to $775 and a prosthetic appliance for a person with lower extremity amputation ranges from $380 to $940. The cost of a myoelectric upper extremity prosthesis is $1400. Orthotics - or braces - may cost from $85 for a simple drop-foot appliance to $570 for a full-length, double-bar brace with pelvic band and ischial support. A standard adult-model wheelchair will sell from $195 to $3 80. An electrically powered chair may be purchased for up to $1600. Who pays these costs? It is rarely the patient. Most frequently it is the government, benevolent organizations, benefactors or philanthropists. The situation, however, is changing. Effective July 1, 1975, Quebec provides under medicare, prostheses, orthoses and wheelchairs; the province also as-
sumes the cost of replacement, maintenance and repair. Coverage is most extensive in Saskatchewan; Manitoba and Alberta have partial coverage; but medicare schemes in Ontario and the maritime provinces do not cover the costs of appliances. There can be little doubt that soon all provinces will provide prostheses, orthoses and other equipment required by the disabled person under medicare. This important move from the provincial governments has and will generate a great demand from old and new consumers. Are we, as a country, ready to meet this expected demand in a reasonable period of time? At the Rehabilitation Institute of Montreal, hundreds of new and former patients have already been examined or reviewed for the purpose of being supplied with new appliances. With respect to wheelchairs it is estimated that 200 a month will be needed for at least 2 years. This is only regional. What happens if a projection is made for the whole of Canada? Regrettably, the Canadian federal and provincial governments have no idea of the number of disabled persons in Canada or in the various provinces. Nobody knows how many people with amputations or spinal cord injuries live in this country. The number of users of prostheses, orthoses and wheelchairs equally is unknown. However, Statistics Canada and Health and Welfare Canada are planning a joint survey to obtain this much-needed information (M. Wisenthal: personal communication, 1976). Some data have been provided by the British Ministry of Health Information. In 1971 the number of amputees in Britain was estimated at 68 000 (0.121%) of a total population of 55.5 million,5 which suggests that Canada has at least 20000 amputees. With respect to wheelchairs the British estimate is that 2100 persons per 1 million population use them. Translated into Canadian figures, it would mean approximately 50000 users. What would this mean in terms of cost? According to one source6 the cost of prostheses and orthoses in the US is $26 million for prostheses and $31 million for orthoses. In Canada this would represent $5.7 million. A further problem is patient acceptance of prostheses, orthoses and special devices. There is a common denominator in the manufacture of prosthetic and orthotic components. There is none, however, in the assembly and fitting of the finished product on patients. In each case one encounters not only technical problems but also psychologic reactions. For the disabled person the acquisition of a prosthesis or orthosis probably accounts for not more than 10% of the complex re. habilitation process. What really counts
is the acceptance of the device and, Research must be carried out in areas above all, competent training in its where there are physicians, physicists, use. Until a few years ago prostheses physical and occupational therapists, and orthoses were assembled and fitted prosthetists and orthotists. Research most often in small private shops. The must be conducted in areas where unipatient was measured, fitted and given versity facilities are readily accessible the appliance in the same manner as and patient requirements are varied. for a suit. The wearing of an artificial Last, but not least, industrial knowledge leg is quite a different story. Many and experience must be available persons with amputations, particularly even though commercial ventures rareof the arm, have been provided with iy produce useful research. prostheses but have never used them I conclude by enumerating some of because they have never been trained the guidelines that should be considered or been "sold" the idea of using an by government or industry or both. artificial limb. 1. Statistical data on the number of In 1952 at the Rehabilitation In- disabled people in Canada using prosstitute of Montreal we decided to theses, orthoses and special devices establish a prosthetics and orthotics should be made available. laboratory within the institute. The 2. The cost of prostheses, orthoses laboratory was opened on Apr. 1, 1957 and special devices to Canadian taxand from then on medical and psy- payers should be established. chologic assessment preceded most 3. Design of prostheses, orthoses prosthetic or orthotic fittings. Measure- and special devices should be standardment for and fitting of appliances, and ized and the metric system should be training in their use, have a rightful adopted. place in rehabilitation services that are 4. Production of prostheses, orthoses all conducted under one roof under and special equipment should be dethe overall supervision of physicians commercialized. trained in physical medicine and re5. If warranted, a crown corporation habilitation. Last year nearly 900 am- should be established to manufacture putees were thus team-treated and re- basic components. habilitated at the institute. It is en6. Research should be boosted and couraging that a number of institutions paid for by government and industry. in Canada and abroad have followed a 7. A permanent advisory committee, similar policy. to include government representatives, Because of our success, I recommend should be created; a group representing that the measurement for, and fitting industry, consumers and specialists of, prosthetic and orthotic devices be should be formed to study and lobby "decommercialized", and procedures implementation of the recommendainvolving the use of artificial limbs and tions of the permanent advisory comsupports become wholly the responsib- mittee. This recommendation should ility of specialized centres. This con- apply to all medical devices. 8. Strict controls over all medical cept is not unique: it has been recommended in a recent report of the Welsh devices should be established by govoffice of the Department of Health and ernment with the collaboration of inSocial Security.7 I also recommend that dustry and organized medicine. basic components be manufactured in G. GINGRAS, CC, MD, LL D, FRcP[C] Canada and distributed by a crown Executive director Rehabilitation Institute of Montreal corporation. The large facilities now Montreal, PQ under the jurisdiction of Health and Welfare Canada in Sunnybrook Hospital would be the logical place for such an undertaking. References An important and essential adjunct 1. SELBY P (ed): Health in 1980-1990 - A should be the standardization of comPredictive Study Based on an International ponents. It is unacceptable that a perInquiry. No. 6 Perspective in Medicine, Basel, Karger, 1974, p 78 son fitted in Halifax should not be able 2. Transactions of the Ninety-Sixth Annual to find spare parts for his appliance in Meeting of The Canadian Medical AssociaWinnipeg or Vancouver. The Canadian tion, Toronto, June 10-12, 1963, p 36 Standards Association and the govern3. Transactions of the Ninety-Seventh Annual Meeting of The Canadian Medical Associament should see that such a situation is tion, Vancouver, June 22-25, 1964, p 75 resolved. Furthermore, the metric sys4. Transactions of General Council at the One tem should be adopted immediately. It Hundredth Annual Meeting of The Canadian would greatly help standardization not Medical Association, Quebec, June 9 and 10, 1967, p 83 only in Canada but also internationally. 5. Report of the Committee on Prosthetics, The pattern of research in prosOrthotics and Special Equipment, Vancouver, thetics, orthotics and special devices is SPARC of BC, 1973, appendix II also important. It must be conducted 6. Ibid, appendix III and encouraged not only following wars 7. Report of a Sub-Committee of the Standing Medical Advisory Committee of the Central or tragedies such as deformity due to Health Services Council: Rehabilitation, Lonthalidomide, but on a continuin2 basis. don, HMSO. 1972 CMA JOURNAL/FEBRUARY 5, 1977/VOL. 116 235
