Industry’s viewpoint
Meetin the needs or health care: 1975
B
As we approach the Bicentennial year, we are looking at the basic purposes of our nation, drawing a balance between past accomplishment and future hopes. For all of us in the health care profession, this reassessment should give us both confidence and courage. It gives us confidence because the achievements in all parts of the health care system, including medical research, design and production of medical products, and delivery of health care by trained professionals have led to the most rapid advances ever seen in the technology of health care and to the lengthening of life expectations. But, there is also a need for courage because we still face problems and challenges throughout the health care system. There are imperfections in our system, many of which OR nurses see on a daily basis. These include maldistribution of health care services in different parts of our country and even in different parts of the same city rising costs of health care, due to the increasing sophistication, complexity, and success of modern medicine, the higher level of services provided by our hospitals, and inflation in the costs we
560
all pay for services and materials the trend toward increased government scrutiny of many aspects of health care, including health insurance, peer review, and virtually all areas of the design and delivery of medical care Some of these problems are, in a sense, “good” problems in that they are the direct result of progress-f life-saving advances in medical care. But, they still present issues and challenges with which we must be concerned. It is the professionals in the health care industry who should take leadership in developing solutions to the issues. It is up to us, the manufacturers as well as physicians and nurses, to assure that new programs and government regulations, intended to improve patient care, are shaped and implemented so as to move effectively toward intended goals. One example is the regulation of medical devices, called for by legislation now pending in Congress and which will almost certainly become law before the end of 1975. The medical device industry supports, with amendments, the House version of this legislation introduced by Congressman Paul Rogers (D-Fla), and has worked closely with the Food and Drug Administration (FDA) and the relevant Congressional subcommittees in developing many of its provisions. Passage of the bill is only the beginning; following this will be a long and complex period of developing the regulations, already underway at the FDA in consultation with industry and advisory committees.
AORN Journal, October 1975,Val 22, N o 4
The legislation requires FDA to classify all medical devices and diagnostics within three areas: 1. those devices which are safe when used as directed and which, therefore, should be subject only to general controls 2. those devices for which performance standards should be set 3. those devices used in life-sustaining situations, where premarket scientific review will be required (the most restrictive level). The first step will be classifying these devices. After that, standards will be developed for thousands of products, and procedures for premarket review will be established. Expectations are that over 60% of all medical devices and diagnostics now on the market will fall in the area of standards. From our point of view, and we believe, from the standpoint of professional users and patients, it is essential that these standards be, as intended by Congress, performance standards. This sounds simple and obvious, but some standards already in draft form indicate that care will be required to avoid letting “standards” become “product specifications” that would limit or prohibit changes in design, materials, or manufacturing practices, thereby inhibiting the continuing process of product development essential to both better products and reduced costs. Development of these standards will be contracted by FDA to standards-making groups with significant opportunities for users, such as OR nurses, to suggest the form specific standards should take. Our organization strongly backs the concept that nurses and other professional groups should be involved in the development of sound and reasonable standards, and our Washington staff will cooperate with the Association of Operating Room Nurses in seeing that the role of OR nurses is recognized and their skills drawn upon by government. OR nurses are also invited to participate in a program begun this year by the Health Industry Manufacturers Association (HIMA) to develop and share new ideas on ways to control or reduce the costs of health care. We are soliciting submissions from professionals in all areas of health care and from anyone else who may have a new concept or a new technique that will improve
562
efficiency and effectiveness in providing health care. For example, ideas might deal with management or use of operating room supplies or in scheduling and administration of operating, recovery, or intensive care rooms. Entries in the form of short papers, a 100-word summary with up to 500 words of explanation and additional data if necessary, should reach the Health Industry Manufacturers Association, 1030 15th St NW, Washington, DC 20005, by Nov 1, 1975. We have set aside $10,000 for these awards, which will be made at the next HlMA convention in February 1976. Jerry Peers, RN, executive director of AORN, is a member of the panel of judges. As a new group created through the merger of the Health Industries Association and the Medical-Surgical Manufacturers Association, HlMA now represents the manufacturers of medical devices and diagnostics in dealing with government, the general public, and other groups concerned with health care. We will continue the programs developed in previous years by the Health Industries Association to assist members in their exhibition activities at major national conventions including AORN’s. We expect that OR nurses and the manufacturers of medical devices and diagnostics will continue to work together on many other programs in the years ahead. Above all, we intend to keep the lines of communication open between us. In succeeding articles for this series, I will discuss such topics as “What makes a sterile product”; “The good shelf life: Maintaining sterility of packaged hospital items”; “The reuse of disposable products”; and “Electrostatic spark hazard.” We welcome suggestions from AORN members on other subjects they would like us to discuss from the basis of the special experience and expertise of the firms that develop and manufacture medical devices and diagnostics. As a new association, we are glad to join with OR nurses and other health care professionals in working toward the continued improvement of health services.
Harold 0 Buzzell, President Health Industry Manufacturers Association
AORN Journal, October 1975, Vol22. No 4
Meetin the needs or health care: 1975
B
As we approach the Bicentennial year, we are looking at the basic purposes of our nation, drawing a balance between past accomplishment and future hopes. For all of us in the health care profession, this reassessment should give us both confidence and courage. It gives us confidence because the achievements in all parts of the health care system, including medical research, design and production of medical products, and delivery of health care by trained professionals have led to the most rapid advances ever seen in the technology of health care and to the lengthening of life expectations. But, there is also a need for courage because we still face problems and challenges throughout the health care system. There are imperfections in our system, many of which OR nurses see on a daily basis. These include maldistribution of health care services in different parts of our country and even in different parts of the same city rising costs of health care, due to the increasing sophistication, complexity, and success of modern medicine, the higher level of services provided by our hospitals, and inflation in the costs we
560
all pay for services and materials the trend toward increased government scrutiny of many aspects of health care, including health insurance, peer review, and virtually all areas of the design and delivery of medical care Some of these problems are, in a sense, “good” problems in that they are the direct result of progress-f life-saving advances in medical care. But, they still present issues and challenges with which we must be concerned. It is the professionals in the health care industry who should take leadership in developing solutions to the issues. It is up to us, the manufacturers as well as physicians and nurses, to assure that new programs and government regulations, intended to improve patient care, are shaped and implemented so as to move effectively toward intended goals. One example is the regulation of medical devices, called for by legislation now pending in Congress and which will almost certainly become law before the end of 1975. The medical device industry supports, with amendments, the House version of this legislation introduced by Congressman Paul Rogers (D-Fla), and has worked closely with the Food and Drug Administration (FDA) and the relevant Congressional subcommittees in developing many of its provisions. Passage of the bill is only the beginning; following this will be a long and complex period of developing the regulations, already underway at the FDA in consultation with industry and advisory committees.
AORN Journal, October 1975,Val 22, N o 4
The legislation requires FDA to classify all medical devices and diagnostics within three areas: 1. those devices which are safe when used as directed and which, therefore, should be subject only to general controls 2. those devices for which performance standards should be set 3. those devices used in life-sustaining situations, where premarket scientific review will be required (the most restrictive level). The first step will be classifying these devices. After that, standards will be developed for thousands of products, and procedures for premarket review will be established. Expectations are that over 60% of all medical devices and diagnostics now on the market will fall in the area of standards. From our point of view, and we believe, from the standpoint of professional users and patients, it is essential that these standards be, as intended by Congress, performance standards. This sounds simple and obvious, but some standards already in draft form indicate that care will be required to avoid letting “standards” become “product specifications” that would limit or prohibit changes in design, materials, or manufacturing practices, thereby inhibiting the continuing process of product development essential to both better products and reduced costs. Development of these standards will be contracted by FDA to standards-making groups with significant opportunities for users, such as OR nurses, to suggest the form specific standards should take. Our organization strongly backs the concept that nurses and other professional groups should be involved in the development of sound and reasonable standards, and our Washington staff will cooperate with the Association of Operating Room Nurses in seeing that the role of OR nurses is recognized and their skills drawn upon by government. OR nurses are also invited to participate in a program begun this year by the Health Industry Manufacturers Association (HIMA) to develop and share new ideas on ways to control or reduce the costs of health care. We are soliciting submissions from professionals in all areas of health care and from anyone else who may have a new concept or a new technique that will improve
562
efficiency and effectiveness in providing health care. For example, ideas might deal with management or use of operating room supplies or in scheduling and administration of operating, recovery, or intensive care rooms. Entries in the form of short papers, a 100-word summary with up to 500 words of explanation and additional data if necessary, should reach the Health Industry Manufacturers Association, 1030 15th St NW, Washington, DC 20005, by Nov 1, 1975. We have set aside $10,000 for these awards, which will be made at the next HlMA convention in February 1976. Jerry Peers, RN, executive director of AORN, is a member of the panel of judges. As a new group created through the merger of the Health Industries Association and the Medical-Surgical Manufacturers Association, HlMA now represents the manufacturers of medical devices and diagnostics in dealing with government, the general public, and other groups concerned with health care. We will continue the programs developed in previous years by the Health Industries Association to assist members in their exhibition activities at major national conventions including AORN’s. We expect that OR nurses and the manufacturers of medical devices and diagnostics will continue to work together on many other programs in the years ahead. Above all, we intend to keep the lines of communication open between us. In succeeding articles for this series, I will discuss such topics as “What makes a sterile product”; “The good shelf life: Maintaining sterility of packaged hospital items”; “The reuse of disposable products”; and “Electrostatic spark hazard.” We welcome suggestions from AORN members on other subjects they would like us to discuss from the basis of the special experience and expertise of the firms that develop and manufacture medical devices and diagnostics. As a new association, we are glad to join with OR nurses and other health care professionals in working toward the continued improvement of health services.
Harold 0 Buzzell, President Health Industry Manufacturers Association
AORN Journal, October 1975, Vol22. No 4
