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The Press for Internationalization
Viewpoint
The Press for Internationalization The Ophthalmic Roles of The American National Standards Institute and The International Standards Organization ARTHUR H. KEENEY, MD, DSC As the automobile industry is engulfed in debate on the "world car," the high precision German and Japanese ophthalmic industries are capturing world markets in photography and optically assisted diagnostic and surgical equipment. Since 1979, these nations have also been positioning their leadership to dominate most optical product categories such as corrective lenses, contact lenses, spectacle frames, sunglasses, etc. Surgical implants follow only a few steps removed and surgical instruments just one or two more. At this writing FOR SALE signs are posted on American Optical Corp. (except for its Instrument Division) and Bausch and Lomb (except for its Contact Lens Division). In all technically advanced countries, national standards for products and, in turn, international standards hammered out from them, play vital roles as to what and whose products will be available. Standards also influence final cost to physicians and patients by volume factors of national vs international markets. Ophthalmic Standards in the US have been developed primarily through the American National Standards Institute (ANSI) (beginning under the name of American Standards Association in 1918). A few ophthalmologists, usually representing the American Academy, have exercised key roles in this work since the late 1940s. The first standards covered safety lenses and then ophthalmic lenses. The early lens standards were more dreamlike goals than the working documents of the 1970s. Many of the latter have been adopted by OSHA, incorporated into state regulations, or gained legal impact by citation in trial procedures. Subsequent ANSI standards have been published on glass and plastic lenses (Z80.l), contact lenses (Z80.2), From the Department of Ophthalmology, University of Louisville, Louisville, Kentucky. Requests for reprints to Arthur H. Keeney, MD, Department of Ophthalmology, University of Louisville, School of Medicine, 301 E. Muhammad Ali Boulevard, Louisville, KY 40202. OI61-6420/82/0IOO/039AJ$OO.60
accessory solutions (Z80.4), sunglasses (Z80.3), ophthalmic frames (Z80.5), and the most recent (June 1981), submitted for endorsement is the intraocular lens standard (Z80.7). A few others are in draft and cycles of revision. Germany through its Deutsches Institute fur Normung (DIN) has over 90 published ophthalmic standards (more than ten times our number) and over 30 in draft. Although this may seem to us like compulsive overkill, it clearly represents the meticulous attention to detail of the German optical industry. The German standards would even cover techniques of measuring acuity, which the International Ophthalmological Council has been unable to agree upon for more than a half century. Once extended from a German (DIN) internal document to formal adoption as an International Standards Organization (ISO) standard, it then falls under the authority of treaty binding within the US and 84 signatory nations to the General Agreement on Tariffs and Treaties (GATT). In 1979, the US Congress amended certain international commitments under GAIT to observe international standards, generally wherever they are applicable. The second round of international deliberations on ISO Ophthalmic Optics was hosted in London by the British Standards Institute June 14-17, 1981. Although official US delegates increased from five in 1980 to seven this year, the German delegation increased from 13 to IS, including three ophthalmologists (Claass of Munester, Eisenfeld of Munchen, and von Haugwitz of Hamburg). Montague Ruben, senior surgeon at Moorfields Eye Hospital, again headed the British delegation of 12 and chaired Working Group 1 on contact lenses. M. Galceran of Essilor International in Paris presided over the plenary sessions and the group on ophthalmic lenses. The flTm commitment of the German optical industry to very tight standards was clearly voiced by Mr. Kratzer of Carl Zeiss. He is not only chief of the German delegation but also chairman of subcommittee 7 on Other
© American Academy of Ophthalmology
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OPHTHALMOLOGY • JANUARY 1982 • VOLUME 89 • NUMBER 1
Optical Instruments. Frequently, the US and the UK, as well as the Japanese delegations, were in agreement but needed broader support. They would have benefitted by active input from colleague nations such as Australia and Canada who have been observers rather than participants. The independence of American ophthalmic practitioners to choose equipment, order specific lenses or products, and possibly even to defend their procedures in court may be greatly altered by international standards. Such parameters, however, can be markedly influenced by full American participation in each relevant ANSI committee and, in turn, with the US Technical Advisory Groups to ISO. Subcommittees of the ISO/Technical Committee met in Germany and in Massachusetts this fall. Under ANSI sanction, this country will host the third round of major meetings in
40A
1982. With ophthalmic industries in this nation in a survival challenge, an understanding union of ophthalmology and its related industries is essential. ANSI is the official and only route from this nation to ISO. In order to have logical, physiologic standards, medical and surgical judgment must be part of their development. Standards must also be within the capability of sound and economic production techniques. Just as we need not measure the width of streets in millimeters, we need not measure an ophthalmic lens in hundredths of a diopter. The American Academy of Ophthalmology has made major program and financial commitments to the development of standards. It is essential for all ophthalmic organizations to provide official representation and solicit friendly allied nations in the maintenance of logical ophthalmic practices.
The Press for Internationalization The Ophthalmic Roles of The American National Standards Institute and The International Standards Organization ARTHUR H. KEENEY, MD, DSC As the automobile industry is engulfed in debate on the "world car," the high precision German and Japanese ophthalmic industries are capturing world markets in photography and optically assisted diagnostic and surgical equipment. Since 1979, these nations have also been positioning their leadership to dominate most optical product categories such as corrective lenses, contact lenses, spectacle frames, sunglasses, etc. Surgical implants follow only a few steps removed and surgical instruments just one or two more. At this writing FOR SALE signs are posted on American Optical Corp. (except for its Instrument Division) and Bausch and Lomb (except for its Contact Lens Division). In all technically advanced countries, national standards for products and, in turn, international standards hammered out from them, play vital roles as to what and whose products will be available. Standards also influence final cost to physicians and patients by volume factors of national vs international markets. Ophthalmic Standards in the US have been developed primarily through the American National Standards Institute (ANSI) (beginning under the name of American Standards Association in 1918). A few ophthalmologists, usually representing the American Academy, have exercised key roles in this work since the late 1940s. The first standards covered safety lenses and then ophthalmic lenses. The early lens standards were more dreamlike goals than the working documents of the 1970s. Many of the latter have been adopted by OSHA, incorporated into state regulations, or gained legal impact by citation in trial procedures. Subsequent ANSI standards have been published on glass and plastic lenses (Z80.l), contact lenses (Z80.2), From the Department of Ophthalmology, University of Louisville, Louisville, Kentucky. Requests for reprints to Arthur H. Keeney, MD, Department of Ophthalmology, University of Louisville, School of Medicine, 301 E. Muhammad Ali Boulevard, Louisville, KY 40202. OI61-6420/82/0IOO/039AJ$OO.60
accessory solutions (Z80.4), sunglasses (Z80.3), ophthalmic frames (Z80.5), and the most recent (June 1981), submitted for endorsement is the intraocular lens standard (Z80.7). A few others are in draft and cycles of revision. Germany through its Deutsches Institute fur Normung (DIN) has over 90 published ophthalmic standards (more than ten times our number) and over 30 in draft. Although this may seem to us like compulsive overkill, it clearly represents the meticulous attention to detail of the German optical industry. The German standards would even cover techniques of measuring acuity, which the International Ophthalmological Council has been unable to agree upon for more than a half century. Once extended from a German (DIN) internal document to formal adoption as an International Standards Organization (ISO) standard, it then falls under the authority of treaty binding within the US and 84 signatory nations to the General Agreement on Tariffs and Treaties (GATT). In 1979, the US Congress amended certain international commitments under GAIT to observe international standards, generally wherever they are applicable. The second round of international deliberations on ISO Ophthalmic Optics was hosted in London by the British Standards Institute June 14-17, 1981. Although official US delegates increased from five in 1980 to seven this year, the German delegation increased from 13 to IS, including three ophthalmologists (Claass of Munester, Eisenfeld of Munchen, and von Haugwitz of Hamburg). Montague Ruben, senior surgeon at Moorfields Eye Hospital, again headed the British delegation of 12 and chaired Working Group 1 on contact lenses. M. Galceran of Essilor International in Paris presided over the plenary sessions and the group on ophthalmic lenses. The flTm commitment of the German optical industry to very tight standards was clearly voiced by Mr. Kratzer of Carl Zeiss. He is not only chief of the German delegation but also chairman of subcommittee 7 on Other
© American Academy of Ophthalmology
39A
OPHTHALMOLOGY • JANUARY 1982 • VOLUME 89 • NUMBER 1
Optical Instruments. Frequently, the US and the UK, as well as the Japanese delegations, were in agreement but needed broader support. They would have benefitted by active input from colleague nations such as Australia and Canada who have been observers rather than participants. The independence of American ophthalmic practitioners to choose equipment, order specific lenses or products, and possibly even to defend their procedures in court may be greatly altered by international standards. Such parameters, however, can be markedly influenced by full American participation in each relevant ANSI committee and, in turn, with the US Technical Advisory Groups to ISO. Subcommittees of the ISO/Technical Committee met in Germany and in Massachusetts this fall. Under ANSI sanction, this country will host the third round of major meetings in
40A
1982. With ophthalmic industries in this nation in a survival challenge, an understanding union of ophthalmology and its related industries is essential. ANSI is the official and only route from this nation to ISO. In order to have logical, physiologic standards, medical and surgical judgment must be part of their development. Standards must also be within the capability of sound and economic production techniques. Just as we need not measure the width of streets in millimeters, we need not measure an ophthalmic lens in hundredths of a diopter. The American Academy of Ophthalmology has made major program and financial commitments to the development of standards. It is essential for all ophthalmic organizations to provide official representation and solicit friendly allied nations in the maintenance of logical ophthalmic practices.