President’s message
Misunderstanding of AORN standards causes. reactions AORN has long been recognized as the resource for answers to problems dealing with aseptic practice and nursing practice in the operating room. It has been presenting workshops and seminars and publishingarticles on these subjects for 25 years. The views presented were those of the presenters and authors, however, and did not have the official endorsement of the Association. Because of the differing ideas, confusion resulted leading members to request that AORN establish guidelines or standards they could apply in their practice settings. Consequently, the first AORN Technical Standards Committee was appointed in 1974 by President Patricia Rogers. The committee was composed of OR nurses, a bacteriologist, and a surgeon. The committee’s task, as outlined by the Board of Directors, was to research topics and present written standards for the Board’s review and approval. After much discussion, the Board further directed the committee to develop optimum standards rather than minimum standards. The Board believed that many regulatory agencies were already developing minimum standards and that as an educational organizationwe should present standards that challengedour members to seek improvement in their practice. We were not expecting immediate compliance by all OR nurses but were attempting to provide them with a goal to reach in the future. Since 1974, AORN has developed standards for OR sanitation; OR wearing apparel,
s
draping and gowning materials; sponge, needle, and instrument procedures; preoperative skin preparation for patients; surgical hand scrubs; inhospital packaging material; administrative nursing practice; and in collaboration with the American Nurses’ Association Standards for Nursing Practice: Operating Room. From the outset of publication of AORN standards, objections have been raised by members, industry, hospitals, and physicians who interpret them as mandatory. Even though AORN’s interpretation of the word “standard” has been communicated numerous times, confusion still exists. In her November 1976 “President’s message,” President Barba Edwards again clarified AORN’s position when she wrote, “First, let‘s describe the term ‘standard’as it is being used. I believe much of the confusion and discussion centers around the multiple definitions and, therefore, uses of the term standard. People think of a standard as a unit of measurement, or a regulation, or a rule of law. Roget‘s Thesaurus lists about a dozen ways in which it can be used and one denotes ‘duty, moral duty or obligation, what ought to be done, onus, responsibility’. The technical standards are written in the context of ‘what ought to be done’. We can describe them as something that should be done or ought to be done to maximize the technical aspects of OR nursing. . . . Think of these standards as goals to be reached. . . . This is somewhat the idea of the committee in writing these standards. It realizedthat to be effectivethe standards must reach for the ultimate.” Because of the controversy surrounding our standards, the Board on several occasions has discussedusing an alternate word such as “guidelines” but has retained the word stan-
AORN Jburnal, December 1977, Val 26, No 6
1009
Voluntary consensus and regulatory standards
The purpose of this letter is to point out some of the differences between voluntary consensus and regulatory standards and how these differences should be considered during the voluntary standards development process. The Medical Devices Standards Management Board has requested this letter in an effort to further effective voluntary efforts that serve governmental needs. The Medical Device Amendments of 1976 (PL 94-295) draw a clear distinction between voluntary consensus standards and mandatory standards adopted by the Food and Drug Administration (FDA). The distinction between these two types of standards will affect the process by which standards are developed. Because of the significant differences between voluntary consensus and mandatory standards, many voluntary consensus standards will not be acceptable for regulatory purposes or will have to be significantlyrevised to be used as regulatory standards. Consequently, voluntary consensus standards organizations should clearly understand the differences in purpose and effect of voluntary and regulatory standards. Many voluntary consensus standards
express, in general terms, desirable technical concepts that establish a frame of reference for safety and effectiveness. While establishingthis generalframe of reference for voluntary purposes may be desirable, attempts to enforce strict compliance with such standards under regulation could impose severe or impossible conditions of compliance on both users and manufacturers. For example, some voluntary standards may include requirements not within the present state of the art or requirements so expensive that implementation would be impractical. Voluntary consensus standards, by definition, do not require absolute conformance on the part of the manufacturer or user. Voluntary consensus standards that are later put through proper FDA procedures and become regulatory standards require strict compliance by the manufacturer or user in order to avoid criminal and civil liabilities. Section 514 of the medical device law authorizes the FDA to promulgate regulatory standards only on attributes of devices that (a) should be subject to regulatory standards and (b) will help assure the safety and effectiveness of devices. Unless there is an identified or potential safety or effectiveness problem with one or more device characteristics,Section 514 would not permit a regulatory standard to be set. Many voluntary consensus standards deal with attributes of devices that may not, in a regulatory sense, help assure the safety and effectiveness of devices. Consequently, their use for regulatory purposes, in terms of
dard. We believe this is appropriate, but once again we reiterate that these are optimum voluntary standards and should not be construed as potential regulatory documents. The most recent misunderstanding resulted from publicationof the “Standards for cleaning and processing anesthesia equipment” (AORN Journal, June 1977, 1268-1274). It was not AORN’s intent to dictate policy to anesthesiologists and anesthetists through publication of these standards. The development of these standards was the result of the
expressed need of AORN members who are responsible for this function in their ORs. These standards were presented as the ultimate or optimum voluntary standard and should not be misinterpreted as a regulatory standard. In developing these standards, the Technical Standards Committee integrated information currently available in the anesthesia literature. The Board of Directors approved the standards as written, fully realizing that it may be a few years before hospitals could imple-
Edifor’s note: The following letter was written by Michael J Miller, chairman, Standards Activities Committee, Medical Devices Standards Management Board of the American National Standards Institute, and sent to voluntary standards organizations. It is reprinted with permission of the author.
1010
AORN Journal, December 1977,Vol26, No 6
purpose and effect, would be inappropriate. The word “standard’ should be considered in its broadest context to include guidelines, protocols, practices and procedures, specifications, performance and design standards, test methods, and any other voluntary consensus documents that directly or indirectly could be used to impose safety and effectiveness requirements on manufacturers and users. It is unclear at the present time exactly what use the FDA will make of voluntary standards. It is clear from a reading of Section 514 that a voluntary consensus standard could be used as the starting pointtoward the development of a regulatory standard. For this reason, voluntary standards organizationsmay wish to determine at an early stage whether standards development efforts are intended to result in documents that should or should not be used in a regulatory context. The purpose of this letter is to point out that since voluntary consensus standards may become the basis for regulatory standards, voluntary consensus efforts should clearly document voluntary consensus standards with clear statements of rationale and scope so the documents intended only for voluntary purposes (where regulatory consideration of safety and effectiveness are not involved) will not be construed as potential regulatory documents. For example, purchase specifications standards agreed on by manufacturers and users should not generally be regarded as regulatory standards. To explain further, a specification standard reflects an understanding between a manufacturer and a
user for certain products primarily for communication and convenience and not primarily for regulation of safety and effectiveness, except in a secondary sense. The purpose of this letter is not to discourage voluntary consensus efforts. The purpose is to begin to draw a clear line between voluntary consensus documents and potential regulatory documents and to provide guidance and assistance to the FDA as they consider voluntary consensus documents which may or may not be used for regulatory purposes. While the FDA must strictly adhere to the legislative authority outlined in the medical device law in reviewing, revising, and adopting voluntary consensus standards as regulatory standards, a clear understanding of the differences between the two documents and the reflection of this difference in the developmental process, clear statements of scope and rationale, and good communications will help avoid the adoption of voluntary consensus standards that were not intendedto be used as regulatory documents. I hope this letter makes it clear that responsible standards writing and approval can only be undertaken with a clear and full understanding of the Medical Device Amendments of 1976 (particularly Section 514) and its potential relationshipsto voluntary standards. There are many summaries of this law available and copies are available from Michael J Miller, Chairman of the Standards Activities Committee of the Medical Devices Standards Management Board, American National Standards Institute, Inc, 1430 Broadway, New York, NY 10018.
ment them in entirety due to the design and cost of anesthesia equipment. We believethis is in keeping with our approach to developing standards-an ultimate goal to be reached. Because AORN failed to preamble this publication with our philosophy of standards, reactions to the “Standards for cleaning and processing anesthesia equipment” have been received by AORN from the anesthesia organizations. These organizations saw them as regulatorystandards and an attempt to dictate anesthesia policy.
AORN has corresponded and met with the American Society of Anesthesiologists (ASA) and the American Association of Nurse Anesthetists (AANA) in an attempt to clarify AORN’s position and resolve our differences. As a result of these meetings, AORN will develop a written philosophy of our standards activities that will be attached to all AORN standards. Further meetings with ASA and AANA are being planned to discuss the “Standards for cleaning and processing anesthesia equipment” and possible revisions. If an impasse
AORN Journal,December 1977,Vol26, No 6
1011
between organizational philosophies occurs, the parties involved may request that the 279 Committee of the American National Standards Institute (ANSI) develop a voluntary consensus standard for the cleaning and processing of anesthesia equipment. The American National Standards Institute is a voluntary standard-writing organization. The 279 Committee is responsiblefor anesthesia standards as well as other areas and is composed of representatives of interested professionals. ANSI standards have the overwhelming support of interested professionals, industry, and government. ANSI standards tend to reflect the current state of the art; whereas, AORN “Standards for cleaning and processing anesthesia equipment” are perhaps more far reaching. AORN standards, which are voluntary, represent the position of the Association, not a consensus. In light of reactions to our “Standards for cleaning and processing anesthesia equipment,” I must point out that, in the introduction, it states the standards “have been reviewed by a panel of anesthesiologists.” The anesthesiologists were independent practitioners and not representativesof ASA. Theirtask was to critique the first draft, and they did not necessarily agree with its entire contents. AORN’s original intent in developing standards remains the same-to improve patient care by meeting the expressed needs of our membership through the provision of optimum standards that require consistent upgrading of our practice. We believe this is an appropriate activity of our Association, but because of the misunderstandings,we will continueto explore the ramifications of labeling these documents as standards. The 1978 AORN House of Delegates will address the issue of standards and so I suggest that you read the accompanying “Voluntary consensus and regulatory standards,” which explains the difference between voluntary consensus standards and regulatory standards. The AORN Board of Directors is responsible for the development of all AORN technical standards and would appreciateyour views on the direction it has taken. We are your representatives,and we hope we are working in your best interest. I have a plaque on my desk at work that sums it up for me. “A man could do nothing if
1012
he waited until he could do it so well that no one would find fault with what he had done.”
Nancy L Ertl, RN President
Teaching incidental appendectomies A recent survey shows that a majority of directors of approved residencies in general surgery and in obstetrics and gynecology in the US teach their students to perform incidental appendectomies in abdominal surgery. The study was reported by Robert J Hays, MD, Amarillo, Tex, in the Journal of the American Medical Association. Of the 467 directors of surgical residencies, 77% responded: of the 396 directors of obstetrics-gynecology residencies, 76% responded.The directors of surgical programs were asked: “Do you recommend incidental appendectomy in uncomplicated (1) intra-abdominal operations in which the gastrointestinal tract is not opened, (2) gastrointestinal operations in which the colon is opened, or (3) abdominal hysterectomies?” Directors of obstetrics-gynecology residency programs were asked: “Do you recommend incidental appendectomy at the time of uncomplicated abdominal hysterectomy?” The obstetrical-gynecology directors were 66% in favor of the operation, 27% against. Surgery directors were 69% in favor of the operation with abdominal hysterectomy (21% against); 55% in favor with abdominal operation, colon opened (38% against); and 66% in favor with abdominal operation, colon not opened (27% against). The discrepancy was accounted for by respondents not answering with an unqualified yes or no. An indication of the emotional response both in favor of and against incidental appendectomywas that more than 50% of the respondents sent in “strongly worded, hand-written comments” with their questionnaires. In all situations questioned, however, the majority of directors continue to recommend incidental appendectomy.
AORN Journal, December 1977, Vol26, No 6
Misunderstanding of AORN standards causes. reactions AORN has long been recognized as the resource for answers to problems dealing with aseptic practice and nursing practice in the operating room. It has been presenting workshops and seminars and publishingarticles on these subjects for 25 years. The views presented were those of the presenters and authors, however, and did not have the official endorsement of the Association. Because of the differing ideas, confusion resulted leading members to request that AORN establish guidelines or standards they could apply in their practice settings. Consequently, the first AORN Technical Standards Committee was appointed in 1974 by President Patricia Rogers. The committee was composed of OR nurses, a bacteriologist, and a surgeon. The committee’s task, as outlined by the Board of Directors, was to research topics and present written standards for the Board’s review and approval. After much discussion, the Board further directed the committee to develop optimum standards rather than minimum standards. The Board believed that many regulatory agencies were already developing minimum standards and that as an educational organizationwe should present standards that challengedour members to seek improvement in their practice. We were not expecting immediate compliance by all OR nurses but were attempting to provide them with a goal to reach in the future. Since 1974, AORN has developed standards for OR sanitation; OR wearing apparel,
s
draping and gowning materials; sponge, needle, and instrument procedures; preoperative skin preparation for patients; surgical hand scrubs; inhospital packaging material; administrative nursing practice; and in collaboration with the American Nurses’ Association Standards for Nursing Practice: Operating Room. From the outset of publication of AORN standards, objections have been raised by members, industry, hospitals, and physicians who interpret them as mandatory. Even though AORN’s interpretation of the word “standard” has been communicated numerous times, confusion still exists. In her November 1976 “President’s message,” President Barba Edwards again clarified AORN’s position when she wrote, “First, let‘s describe the term ‘standard’as it is being used. I believe much of the confusion and discussion centers around the multiple definitions and, therefore, uses of the term standard. People think of a standard as a unit of measurement, or a regulation, or a rule of law. Roget‘s Thesaurus lists about a dozen ways in which it can be used and one denotes ‘duty, moral duty or obligation, what ought to be done, onus, responsibility’. The technical standards are written in the context of ‘what ought to be done’. We can describe them as something that should be done or ought to be done to maximize the technical aspects of OR nursing. . . . Think of these standards as goals to be reached. . . . This is somewhat the idea of the committee in writing these standards. It realizedthat to be effectivethe standards must reach for the ultimate.” Because of the controversy surrounding our standards, the Board on several occasions has discussedusing an alternate word such as “guidelines” but has retained the word stan-
AORN Jburnal, December 1977, Val 26, No 6
1009
Voluntary consensus and regulatory standards
The purpose of this letter is to point out some of the differences between voluntary consensus and regulatory standards and how these differences should be considered during the voluntary standards development process. The Medical Devices Standards Management Board has requested this letter in an effort to further effective voluntary efforts that serve governmental needs. The Medical Device Amendments of 1976 (PL 94-295) draw a clear distinction between voluntary consensus standards and mandatory standards adopted by the Food and Drug Administration (FDA). The distinction between these two types of standards will affect the process by which standards are developed. Because of the significant differences between voluntary consensus and mandatory standards, many voluntary consensus standards will not be acceptable for regulatory purposes or will have to be significantlyrevised to be used as regulatory standards. Consequently, voluntary consensus standards organizations should clearly understand the differences in purpose and effect of voluntary and regulatory standards. Many voluntary consensus standards
express, in general terms, desirable technical concepts that establish a frame of reference for safety and effectiveness. While establishingthis generalframe of reference for voluntary purposes may be desirable, attempts to enforce strict compliance with such standards under regulation could impose severe or impossible conditions of compliance on both users and manufacturers. For example, some voluntary standards may include requirements not within the present state of the art or requirements so expensive that implementation would be impractical. Voluntary consensus standards, by definition, do not require absolute conformance on the part of the manufacturer or user. Voluntary consensus standards that are later put through proper FDA procedures and become regulatory standards require strict compliance by the manufacturer or user in order to avoid criminal and civil liabilities. Section 514 of the medical device law authorizes the FDA to promulgate regulatory standards only on attributes of devices that (a) should be subject to regulatory standards and (b) will help assure the safety and effectiveness of devices. Unless there is an identified or potential safety or effectiveness problem with one or more device characteristics,Section 514 would not permit a regulatory standard to be set. Many voluntary consensus standards deal with attributes of devices that may not, in a regulatory sense, help assure the safety and effectiveness of devices. Consequently, their use for regulatory purposes, in terms of
dard. We believe this is appropriate, but once again we reiterate that these are optimum voluntary standards and should not be construed as potential regulatory documents. The most recent misunderstanding resulted from publicationof the “Standards for cleaning and processing anesthesia equipment” (AORN Journal, June 1977, 1268-1274). It was not AORN’s intent to dictate policy to anesthesiologists and anesthetists through publication of these standards. The development of these standards was the result of the
expressed need of AORN members who are responsible for this function in their ORs. These standards were presented as the ultimate or optimum voluntary standard and should not be misinterpreted as a regulatory standard. In developing these standards, the Technical Standards Committee integrated information currently available in the anesthesia literature. The Board of Directors approved the standards as written, fully realizing that it may be a few years before hospitals could imple-
Edifor’s note: The following letter was written by Michael J Miller, chairman, Standards Activities Committee, Medical Devices Standards Management Board of the American National Standards Institute, and sent to voluntary standards organizations. It is reprinted with permission of the author.
1010
AORN Journal, December 1977,Vol26, No 6
purpose and effect, would be inappropriate. The word “standard’ should be considered in its broadest context to include guidelines, protocols, practices and procedures, specifications, performance and design standards, test methods, and any other voluntary consensus documents that directly or indirectly could be used to impose safety and effectiveness requirements on manufacturers and users. It is unclear at the present time exactly what use the FDA will make of voluntary standards. It is clear from a reading of Section 514 that a voluntary consensus standard could be used as the starting pointtoward the development of a regulatory standard. For this reason, voluntary standards organizationsmay wish to determine at an early stage whether standards development efforts are intended to result in documents that should or should not be used in a regulatory context. The purpose of this letter is to point out that since voluntary consensus standards may become the basis for regulatory standards, voluntary consensus efforts should clearly document voluntary consensus standards with clear statements of rationale and scope so the documents intended only for voluntary purposes (where regulatory consideration of safety and effectiveness are not involved) will not be construed as potential regulatory documents. For example, purchase specifications standards agreed on by manufacturers and users should not generally be regarded as regulatory standards. To explain further, a specification standard reflects an understanding between a manufacturer and a
user for certain products primarily for communication and convenience and not primarily for regulation of safety and effectiveness, except in a secondary sense. The purpose of this letter is not to discourage voluntary consensus efforts. The purpose is to begin to draw a clear line between voluntary consensus documents and potential regulatory documents and to provide guidance and assistance to the FDA as they consider voluntary consensus documents which may or may not be used for regulatory purposes. While the FDA must strictly adhere to the legislative authority outlined in the medical device law in reviewing, revising, and adopting voluntary consensus standards as regulatory standards, a clear understanding of the differences between the two documents and the reflection of this difference in the developmental process, clear statements of scope and rationale, and good communications will help avoid the adoption of voluntary consensus standards that were not intendedto be used as regulatory documents. I hope this letter makes it clear that responsible standards writing and approval can only be undertaken with a clear and full understanding of the Medical Device Amendments of 1976 (particularly Section 514) and its potential relationshipsto voluntary standards. There are many summaries of this law available and copies are available from Michael J Miller, Chairman of the Standards Activities Committee of the Medical Devices Standards Management Board, American National Standards Institute, Inc, 1430 Broadway, New York, NY 10018.
ment them in entirety due to the design and cost of anesthesia equipment. We believethis is in keeping with our approach to developing standards-an ultimate goal to be reached. Because AORN failed to preamble this publication with our philosophy of standards, reactions to the “Standards for cleaning and processing anesthesia equipment” have been received by AORN from the anesthesia organizations. These organizations saw them as regulatorystandards and an attempt to dictate anesthesia policy.
AORN has corresponded and met with the American Society of Anesthesiologists (ASA) and the American Association of Nurse Anesthetists (AANA) in an attempt to clarify AORN’s position and resolve our differences. As a result of these meetings, AORN will develop a written philosophy of our standards activities that will be attached to all AORN standards. Further meetings with ASA and AANA are being planned to discuss the “Standards for cleaning and processing anesthesia equipment” and possible revisions. If an impasse
AORN Journal,December 1977,Vol26, No 6
1011
between organizational philosophies occurs, the parties involved may request that the 279 Committee of the American National Standards Institute (ANSI) develop a voluntary consensus standard for the cleaning and processing of anesthesia equipment. The American National Standards Institute is a voluntary standard-writing organization. The 279 Committee is responsiblefor anesthesia standards as well as other areas and is composed of representatives of interested professionals. ANSI standards have the overwhelming support of interested professionals, industry, and government. ANSI standards tend to reflect the current state of the art; whereas, AORN “Standards for cleaning and processing anesthesia equipment” are perhaps more far reaching. AORN standards, which are voluntary, represent the position of the Association, not a consensus. In light of reactions to our “Standards for cleaning and processing anesthesia equipment,” I must point out that, in the introduction, it states the standards “have been reviewed by a panel of anesthesiologists.” The anesthesiologists were independent practitioners and not representativesof ASA. Theirtask was to critique the first draft, and they did not necessarily agree with its entire contents. AORN’s original intent in developing standards remains the same-to improve patient care by meeting the expressed needs of our membership through the provision of optimum standards that require consistent upgrading of our practice. We believe this is an appropriate activity of our Association, but because of the misunderstandings,we will continueto explore the ramifications of labeling these documents as standards. The 1978 AORN House of Delegates will address the issue of standards and so I suggest that you read the accompanying “Voluntary consensus and regulatory standards,” which explains the difference between voluntary consensus standards and regulatory standards. The AORN Board of Directors is responsible for the development of all AORN technical standards and would appreciateyour views on the direction it has taken. We are your representatives,and we hope we are working in your best interest. I have a plaque on my desk at work that sums it up for me. “A man could do nothing if
1012
he waited until he could do it so well that no one would find fault with what he had done.”
Nancy L Ertl, RN President
Teaching incidental appendectomies A recent survey shows that a majority of directors of approved residencies in general surgery and in obstetrics and gynecology in the US teach their students to perform incidental appendectomies in abdominal surgery. The study was reported by Robert J Hays, MD, Amarillo, Tex, in the Journal of the American Medical Association. Of the 467 directors of surgical residencies, 77% responded: of the 396 directors of obstetrics-gynecology residencies, 76% responded.The directors of surgical programs were asked: “Do you recommend incidental appendectomy in uncomplicated (1) intra-abdominal operations in which the gastrointestinal tract is not opened, (2) gastrointestinal operations in which the colon is opened, or (3) abdominal hysterectomies?” Directors of obstetrics-gynecology residency programs were asked: “Do you recommend incidental appendectomy at the time of uncomplicated abdominal hysterectomy?” The obstetrical-gynecology directors were 66% in favor of the operation, 27% against. Surgery directors were 69% in favor of the operation with abdominal hysterectomy (21% against); 55% in favor with abdominal operation, colon opened (38% against); and 66% in favor with abdominal operation, colon not opened (27% against). The discrepancy was accounted for by respondents not answering with an unqualified yes or no. An indication of the emotional response both in favor of and against incidental appendectomywas that more than 50% of the respondents sent in “strongly worded, hand-written comments” with their questionnaires. In all situations questioned, however, the majority of directors continue to recommend incidental appendectomy.
AORN Journal, December 1977, Vol26, No 6
