Criteria for Use of Blue ``Star of Life'' for Emergency Medical Services |
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Topics: National Highway Traffic Safety Administration
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Michael Brownlee
Federal Register
August 11, 1994
[Federal Register: August 11, 1994] ----------------------------------------------------------------------- DEPARTMENT OF TRANSPORTATION National Highway Traffic Safety Administration [Docket No. 93-51, Notice No. 2] Criteria for Use of Blue ``Star of Life'' for Emergency Medical Services AGENCY: National Highway Traffic Safety Administration (NHTSA), DOT. ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: This notice amends NHTSA's guidelines for the authorized use of the blue ``Star of Life'' symbol for emergency medical services. Comments received in response to an earlier notice suggested uses for this symbol that were not considered when these guidelines were first developed. These amendments are intended to provide additional flexibility to the States within the purposes for which the blue Star of Life was originally registered as a certification mark. EFFECTIVE DATE: September 12, 1994. FOR FURTHER INFORMATION CONTACT: Susan D. Ryan, Chief, Emergency Medical Service Division, National Highway Traffic Safety Administration, 400 Seventh Street, SW., Washington, DC 20590; phone (202) 366-5440. SUPPLEMENTARY INFORMATION: NHTSA's Authority The Secretary of Transportation approved the use of the blue ``Star of Life'' as a symbol for the Department's Emergency Medical Services program in a memorandum dated November 18, 1976. On February 1, 1977, the Commissioner of Patents and Trademarks issued to NHTSA a certificate of registration for the blue ``Star of Life'' symbol as a certification mark. This registration gives NHTSA exclusive legal authority to control the use of the mark throughout the United States, and remains in effect for 20 years. It may be renewed for an additional 10 years in accordance with 15 U.S.C. section 1059. Current Guidelines In accordance with its registration as a certification mark, the blue ``Star of Life'' may be used on emergency medical care vehicles to certify that they meet DOT standards, by emergency medical care personnel to certify that they are trained to meet DOT standards, and on road maps and highway signs to indicate the location of or access to qualified emergency medical care services. In a memorandum dated September 14, 1977, NHTSA authorized States and Federal agencies that are involved with emergency medical services to permit use of the blue ``Star of Life'' certification mark in accordance with criteria and specifications outlined in the memorandum. Request for Modification of Guidelines In July 1992, a State requested an advisory opinion from NHTSA on the use of the blue ``Star of Life'' symbol in the State's Emergency Medical Services-Do Not Resuscitate (EMS-DNR) program. The State proposed to use the mark to alert State certified prehospital emergency medical care providers that a person wearing a bracelet which displays the ``Star of Life'' and the letters ``EMS-DNR'' does not wish to be resuscitated. NHTSA determined that this use does not meet the criteria outlined in the memorandum dated September 14, 1977. Accordingly, NHTSA denied the State's request to use the ``Star of Life'' in connection with the EMS-DNR program. In response to NHTSA's decision to deny the State's request, the National Association of EMS Physicians (NAEMSP), the National Association of State Emergency Medical Services Directors (NASEMSD), and the American College of Emergency Physicians (ACEP) contacted NHTSA to express their support for use of the blue ``Star of Life'' by the State's EMS-DNR program. These organizations made four primary arguments in support of the proposed use of the ``Star of Life'' for EMS-DNR purposes. First, they contended that the proposed use would provide EMS personnel with a consistent location where they could look for EMS orders on terminally ill persons who desire not to undergo resuscitation. The organizations indicated that they consider the proposed use appropriate because the DNR bracelet would alert EMS personnel of a medical condition or appropriate medical treatment. Second, the organizations asserted that the ``Star of Life'' is a unique symbol widely recognized by EMS personnel, which has come to symbolize the entire EMS system rather than the limited criteria in the September 1977 NHTSA memorandum. Third, the organizations contended that since NHTSA has ``historically'' granted State EMS offices some discretionary authority regarding use of the ``Star of Life,'' NHTSA should allow State EMS offices to determine the use of the ``Star of Life'' on EMS-DNR bracelets within their respective States. Finally, at the time the guidelines were developed, the possibilities for the use of the ``Star of Life'' on a DNR bracelet were not considered. The organizations urged NHTSA to reexamine the appropriate use of the symbol and either rescind or reissue the guidelines to permit such use. Federal Register Notice Requesting Comments NHTSA continued to have concerns about expanding the authorized uses of the blue ``Star of Life.'' However, it also recognized that the current guidelines for the authorized use of the blue ``Star of Life'' certification mark had not been revised since their publication in September 1977. Accordingly, the agency decided that it was appropriate to reevaluate the guidelines in view of the current trends and possible uses for the symbol and to examinate the symbol's purpose and whether it should be expanded at this time. On August 3, 1993, NHTSA published a notice in the Federal Register (58 FR 41316) announcing that it was considering whether to expand the purposes for which the blue ``Star of Life'' could be used and whether other changes to the guidelines for the authorized use of the symbol would be appropriate. The notice requested comments from the public on whether the agency should authorize the use of the ``Star of Life'' symbol in EMS-DNR programs, including its use on personal items, such as bracelets or necklaces, to identify individuals who are DNR candidates. The notice also requested comments on whether the agency should make other revisions to its guidelines for the authorized use of the blue ``Star of Life.'' Comments Received Eighteen comments were received by the agency in response to the August 3 notice. Commenters included one Federal agency (the U.S. Fire Administration), two national organizations (the American College of Emergency Physicians and the National Association of State EMS Directors), one medical school, eight State EMS Directors, four regional or local EMS officials and an interested individual. Each of the comments addressed the central issue concerning whether to permit the use of the ``Star of Life'' symbol for DNR purposes. In addition, some comments made suggestions regarding other aspects of the criteria and specifications that were outlined in 1977. Use of ``Star of Life'' for Do Not Resuscitate Programs Of the eighteen comments received, only two States, two regional or local EMS officials and an interested individual opposed the use of the ``Star of Life'' symbol for a DNR program. The Federal agency, the medical school, both national organizations, six States and two regional or local EMS officials either supported or stated that they did not oppose the use of the ``Star of Life'' symbol for DNR purposes. Many of these comments expressed strong support for the symbol's use for these purposes. To assist the agency in deciding whether to permit the use of the ``Star of Life'' for this purpose, NHTSA requested in its August 3, 1993 notice comments addressing a number of specific questions. These questions, and the comments we received responding to them, are discussed below. 1. State EMS-DNR Programs NHTSA requested that comments provide examples of State EMS programs that have developed or are developing EMS-DNR identification programs and the identification symbols used in those programs. The comments reported that the States of California and Virginia have developed statewide DNR programs. Genesee County, MI also reported that it has a DNR program. Virginia employs the ``Star of Life'' symbol; California employs the Medic-Alert symbol; Genesee County uses a purple wrist identification bracelet. The States of Washington, Maine and Maryland are all in the process of developing DNR programs. Each of these States indicated that it is interested in or would strongly consider using the ``Star of Life'' for its DNR program. 2. Confuse the Public NHTSA sought comments on whether the proposed use of the ``Star of Life'' symbol would confuse the general public. In particular, the agency asked whether the use would likely confuse the public as to the identification and location of qualified EMS personnel and equipment. Comments from California, San Diego, the Northern Mariana Islands and the Genesee County Medical Control authority in Genesee County, MI predicted that use of the ``Star of Life'' for DNR purposes would confuse the public. More specifically, California stated, ``use of the `Star of Life' on DNR bracelets would likely confuse individuals as to the identification of qualified EMS personnel.'' However, no evidence was cited for this prediction. Virginia (which uses the ``Star of Life'' symbol for its DNR program) reported that there have been no instances of confusion. In addition, the State asserted its belief that it ``would be very unlikely that anyone would mistake the patient with such a bracelet * * * for a qualified EMT,'' since patients who are eligible to wear such bracelets have been diagnosed with a terminally ill condition. The U.S. Fire Administration, the National Association of State EMS Directors and the State of New Jersey agreed with Virginia that use of the ``Star of Life'' symbol for DNR programs is extremely unlikely to confuse the public. 3. Difficulty with Identification. NHTSA requested that States with established EMS-DNR programs explain the difficulties, if any, that EMS personnel are encountering with the identification symbols used for EMS-DNR candidates. Virginia (which uses the ``Star of Life'' symbol) and California and San Diego (which use the Medic-Alert symbol) all reported that they were aware of no problems of identification or verification with the system they use. 4. Benefits and Disadvantages NHTSA requested that comments discuss the benefits and disadvantages that are likely to result from using the ``Star of Life'' to identify persons requesting a particular treatment or withholding of treatment by qualified EMS personnel. California and San Diego commented that they saw no benefit to expanding the use of the ``Star of Life'' symbol regarding the identification of patients who elect to execute DNR directives. In fact, California saw it simply as a training issue. The State said EMTs could as easily be trained to identify DNR candidates using other symbols. California also asserted that use of the ``Star of Life'' for DNR services would be contrary to NHTSA training programs, which focus on the search for a Medic Alert bracelet to determine vital patient information. Comments from Virginia, on the other hand, point out that the DOT National Standard Curricula provide for EMTs and others ``to check a patient's `Medic Alert' bracelet as part of the patient assessment after initial resuscitative measures have been carried out.'' California is correct that the DOT National Standard Curricula advise EMTs and others to seek patient information from medical identification items, such as ``Medic Alert'' bracelets. However, NHTSA disagrees that use of the ``Star of Life'' for DNR purposes is contrary to this training. As explained in Virginia's comments, EMTs and others are trained to seek patient information (as part of patient assessment) only after advanced directives (such as initial resuscitative measures and other treatment and transportation protocols) are followed. The 1994 edition of the DOT National Standard Curriculum for EMT-Basic makes clear the distinction between patient identification information and advanced directives. The Curriculum also indicates that the use of advanced directives (such as DNR) is a State issue and informs instructors to modify the curriculum to accommodate those advanced directives used in the State where the instruction is taking place. A few commenters expressed the concern that use of the symbol for a DNR program would either dilute or be entirely incompatible with the original meaning of the ``Star of Life.'' Leo R. Schwartz, who was Chief of NHTSA's Emergency Medical Services Division at the time the symbol was developed and registered as a certification mark with the Commissioner of Patents and Trademarks, argued that the mark was envisioned as and should remain ``a symbol of life,'' not a ``barrier'' to care. He strongly objected to the use of the ``Star of Life'' with an ``act of omission, with death as an end result.'' Others disagreed with these comments, and strongly supported expansion of the use of the symbol. A number of comments, for example, recognized that the role of EMS has expanded since 1977, when the ``Star of Life'' was first registered as a certification mark, and asserted that the proposed expanded use of the symbol is not incompatible (indeed it is appropriate) with current broader EMS missions. Other comments went further. The Department of Fire/Rescue Services, Frederick County, MD stated: The current request for an EMS-DNR program use is consistent with the direction of modern, managed health care, where the patient may give advance directives for their level of treatment. This is going to be more apparent in the health care reform recommendations that will be published in the near future. Similar sentiments were expressed in comments from Dr. Nicholas Benson, East Carolina University School of Medicine: As our nation becomes more involved with health care reform, one of the key issues to be resolved is which patients with sudden cardiac death should be resuscitated and which should not * * * Physicians, including myself, do not wish to make this determination alone; this is a decision that must include the express wishes of the patient, or his/her legal guardian. The Prehospital Do Not Resuscitate programs across the nation seek to respond to this need by predetermining which patients wish to be resuscitated and under what conditions. NHTSA's cornerstone contribution to this should be the use of the Star of Life, because of its long-standing use as a symbol denoting professionalism and compassion in prehospital care. As the profession of EMS has grown in the past 20 years, the implications of the use of the Star of Life have grown, as well. It has become a universally recognized symbol of professionalism and expertise in emergency medical care. The use of the Star of Life in Prehospital Do Not Resuscitate programs is 100% consistent with this growth. The benefit most often cited in support of using the ``Star of Life'' symbol for DNR purposes is the level of recognition enjoyed by the symbol. The comments were uniform in their acknowledgement of how highly visible and widely recognized the symbol has become. The U.S. Fire Administration commented that, ``EMS personnel are already trained to look for these bracelets, and as such save valuable time in situations where time is a critical factor.'' Maine EMS stated, ``The decision to begin resuscitation must be rapidly made by EMS personnel if it is to [be] implemented successfully * * * The Star of Life, alone or as part of a logo, is instantly recognized by EMS personnel * * * The availability of this universal symbol will greatly assist in this purpose.'' The States of Washington and New Jersey could think of no disadvantages to using the ``Star of Life'' for a DNR program. 5. Competitive Effect NHTSA requested comments on the competitive effect of the proposed ``EMS-DNR'' bracelet/``Star of Life'' symbol on private organizations that offer services which alert EMS personnel to a patient's condition. We received no comments alleging any adverse competitive effects. One State commented that, if there are any such adverse effects, they will have to yield to the more important public interest in the use of symbols that are universally recognized. 6. Use of Symbol for Other Medical Conditions Comments were sought regarding whether the agency should authorize the use of the ``Star of Life'' symbol for services or programs that would alert EMS personnel to other medical conditions of a patient, i.e., diabetes, heart disease, high blood pressure. Comments on this issue generally tracked the commenter's position on the use of the ``Star of Life'' for DNR. Commenters (such as Maryland) that favored use of the ``Star of Life'' for DNR purposes, supported the symbol's use for diabetes, heart disease, high blood pressure or other medical conditions. Commenters (such as San Diego) that did not favor use of the ``Star of Life'' for DNR purposes, opposed the symbol's use for these other purposes. The State of California, however, expressed a different view. While it opposed use of the ``Star of Life'' for DNR purposes, it stated that if the symbol is approved for use in DNR programs, its use should also be approved for services and programs that will alert EMS personnel to other medical conditions of the patient. Change to Specifications for Use of Symbol Based on the weight of the comments received, NHTSA has decided to amend the specifications. As amended, States and Federal agencies with emergency medical services involvement are authorized to permit use of the ``Star of Life'' symbol to alert emergency care providers to medical conditions or to identify appropriate treatment. The States and Federal agencies then will have the authority to determine within their respective jurisdictions the medical conditions (i.e., diabetes, heart disease, high blood pressure) and the treatments (i.e., DNR) they wish to include. The ``Star of Life'' would be used for these purposes, in accordance with programs established by the State or Federal agency. This decision is consistent with many of the comments that favored giving States some discretionary authority to determine the appropriate uses for the ``Star of Life'' within their borders. Other Issues Raised Many of the comments pointed out that the ``Star of Life'' is currently being used in ways that are not restricted to ``certified'' vehicles and personnel. For example, they stated that the symbol is being used on patient care products, on personal items used by EMS personnel, and in logos of national, state and local EMS organizations. In addition, they alleged that many of the logos use formats that do not comply with the 1977 specifications. Some of the comments went so far as to question whether, as a result of such varied uses and formats, the ``Star of Life'' has become generic and lost its validity as a certification mark. The commenters who noted that the ``Star of Life'' symbol is being used in ways, other than on ``certified'' vehicles and personnel, are correct. These uses are appropriate, provided they fall within the scope of the Criteria for the Use of the ``Star of Life'' Symbol. The criteria that were established in 1977 provided for the symbol to be used not only on ambulances and to indicate the location of EMS personnel, but also ``to identify medical equipment and supplies for installation and use in . . . ambulances;'' ``on EMS personal items such as badges, lapel pins, plaques, buckles, names plates, etc.;'' ``on printed material having direct EMS application such as books, pamphlets, letterheads . . .'' and ``[by] entrepreneurs engaged in the production of goods or publication of printed material [having direct EMS application].'' As explained below, NHTSA has made some changes to these criteria in today's notice, but in general continues to support these related uses of the ``Star of Life.'' There have been attempts to use the symbol for purposes that are not EMS-related (such as in connection with furniture or automobile repair businesses). When these inappropriate and unauthorized uses have come to NHTSA's attention, we have taken immediate steps to ensure that they do not continue. We strongly disagree that the symbol has become generic or lost its validity. The agency recognizes that the ``Star of Life'' is currently being used or has been incorporated into the logos of some EMS organizations using formats that do not comply strictly with the 1977 specifications. We have decided some additional flexibility in this area is warranted and have, therefore, changed this aspect of the 1977 specifications, as explained below. Some comments suggested that NHTSA, as well as State EMS Directors, should support additional programs aimed at educating the public about the meaning of the ``Star of Life'' symbol and when and how the symbol is to be used. The comments recommended also that efforts to supervise its proper use should be increased. NHTSA will continue to take steps against the inappropriate and unauthorized use of the ``Star of Life'' symbol of which it becomes aware. We encourage State EMS Directors, or others in the EMS field, to bring such uses to the agency's attention. We also encourage State EMS Directors to educate EMS personnel on the proper use of the symbol, and to educate the public in their respective States on matters such as how to recognize and when to look for the ``Star of Life.'' One commenter seemed to believe that, since NHTSA owns the certification mark to the ``Star of Life,'' the symbol may be used by NHTSA alone. We believe this comment reflects a misunderstanding of the nature of certification marks. Unlike a trade or service mark, which creates for the owner exclusive rights to use the registered symbol, a certification mark is owned by one person and used by others. Such a mark is to be used, for example, to certify quality or other origin. The ``Star of Life'' symbol was registered and is owned by NHTSA. NHTSA has authorized its use to certify compliance with certain standards (such as compliance by an ambulance with Federal Specifications or completion by EMS personnel of appropriate training courses). NHTSA has also authorized its use on goods employed or in connection with services performed as part of EMS systems, at the national, State or local level. Other Changes to Criteria and Specifications NHTSA requested comments on whether the agency should make other revisions to the criteria and specifications that were established on September 14, 1977. We received extensive and thoughtful comments from the National Association of State EMS Directors (NASEMSD). We have adopted some of the changes recommended by NASEMSD, as well as some additional changes based on our own review. Many of the criteria have been amended to make them less restrictive. Some of the criteria, particularly those sections that attempted to detail the appearance of the ``Star of Life'' for various uses, have been deleted entirely and replaced instead with more general instructions and restrictions. As amended, the criteria provide that the ``Star of Life'' may be used on emergency care vehicles that either meet Federal specifications or are authorized to be used for emergency responses by a State or Federal agency. They continue to provide that the symbol may be used to indicate the location of and access to qualified emergency medical care. The criteria clarify that the ``Star of Life'' may be worn or used on patches, badges, lapel pins and other similar items by persons who have completed training and are authorized by a State or Federal agency to provide EMS care and by persons who by title and function are involved in the administration or supervision of or otherwise participate in an EMS system. As explained above, the criteria have been amended to provide that the ``Star of Life'' may be used to inform providers of medical conditions (such as diabetes) or to identify appropriate treatment (such as DNR), in accordance with programs established by the State or Federal agency. The criteria continue to provide that the symbol may be used on EMS training materials, other materials (such as letterheads and publications) having direct EMS application, medical equipment and supplies intended for use by EMS providers and by entrepreneurs engaged in the production or publication of these items. With regard to the appearance of the ``Star of Life,'' the specifications continue to include a sample of the registered blue ``Star of Life'' symbol and to identify the color of the symbol and its dimensions. The criteria, as amended, indicate that deviations in size may be made, provided they are proportionate, and that other deviations may be made, provided they create the same commercial impression created by the registered mark. Deviations which change the basic, overall commercial impression created on the public are not permitted. The criteria continue to provide instructions for including the symbol to show that the ``Star of Life'' is a registered certification mark. They have been amended to provide that some manner of demarcation should be used on patches, lapel pins and other similar items to distinguish whether the person wearing such item is an EMS provider or an individual involved in the administration or supervision of an EMS system. Provisions that attempted to detail the appearance of the ``Star of Life'' for these and other uses have been deleted. Appendix A to this notice contains the revised criteria and specifications for the Use of the ``Star of Life'' Symbol. Issued on: August 5, 1994. Michael Brownlee, Associate Administrator for Traffic Safety Programs. Appendix A Criteria and Specifications for the Use of the ``Star of Life'' Symbol The ``Star of Life'' is a certification mark that was issued on February 1, 1977 (Certificate of Registration No. 1,058,022), by the Commissioner of Patents and Trademarks to the National Highway Traffic Safety Administration (NHTSA). The certification mark is to be used on emergency medical care vehicles to certify that they meet Federal standards; by emergency medical care personnel to certify, based on their training and affiliation with a qualified emergency medical care system, that they are authorized to provide emergency medical care; on road maps and highway signs to indicate the location of or access to qualified emergency medical care services; and such other EMS-related uses that the Administrator of the National Highway Traffic Safety Administration (NHTSA) may authorize. Any other use is prohibited. Unauthorized use shall be reported to the NHTSA Administrator for investigation and legal action as may be required. NHTSA authorizes the States (as defined in 23 U.S.C. Sec. 401) and Federal agencies with EMS involvement to permit use of the ``Star of Life'' symbol for the following purposes: 1. To identify emergency medical care vehicles that meet the Federal Specifications for Ambulances--Emergency Care Vehicles (KKK-C- 1822 GSA-FSS) or are authorized by a State or Federal agency involved in the provision of emergency medical care to respond to scenes requiring the provision of emergency medical care. 2. To indicate the location of and access to qualified emergency medical care services. 3. On patches or other apparel or personal items (such as badges, lapel pins, buckles, name plates, plaques, etc.) worn or used by an individual: a. who: i. has satisfactorily completed any training course that meets or exceeds the U.S. Department of Transportation National Standard Curricula or has been approved by a State or Federal agency involved in the provision of emergency medical care; and ii. is authorized by a State or Federal agency involved in the provision of emergency medical care to participate in a qualified emergency medical care system; or b. who by title and function is authorized by a State or Federal agency involved in the provision of emergency medical care to administer, directly supervise, or otherwise participate in all or a specific part of a qualified emergency medical care system. 4. On bracelets or other items of apparel worn by a patient to inform authorized emergency medical care providers to medical conditions or to identify appropriate treatment with regard to that patient, in accordance with programs established by a State or Federal agency involved in the provision of emergency medical care. 5. On training materials that meet or exceed the U.S. Department of Transportation National Standard Curricula or have been approved by a State or Federal agency involved in the provision of emergency medical care. 6. On materials such as books, pamphlets, letterheads, plans, manuals, reports, and publications that either have direct EMS application or were generated by an EMS organization. An EMS organization is an organization that either is involved in the provision of emergency medical care or represents persons or organizations who are so involved. 7. To identify medical equipment and supplies intended for use by authorized emergency medical care providers in the provision of emergency medical care. 8. By entrepreneurs engaged in the production of medical equipment and supplies or the publication of materials described above. The following restrictions apply to the use of the ``Star of Life'': 1. As a registered certification mark, the ``Star of Life'' must always be accompanied by the symbol consisting of a capital letter R surrounded by a circle, i.e.. This marking shall appear immediately adjacent to the ``Star of Life'' on all decals, uniform patches, printed material, plaques, pins, buckles, name plates, etc. Where the item consists solely of the ``Star of Life'' and does not have an adjacent surface of surrounding area (e.g., a lapel pin), the shall appear on the reverse side of the item. 2. The Specifications below include a sample of the registered blue ``Star of Life'' symbol, and identify the color of the symbol and its dimensions (for three sizes). Deviations in size may be made, provided they are proportionate. Other deviations may be made, provided they create the same commercial impression created by the registered mark. 3. Some manner of demarcation (such as function-identifying words or letters printed on bars and attached across the bottom separately, and edging of different colors) should be used on patches or other apparel or personal items (such as badges, lapel pins, buckles, name plates, plaques, etc.) worn or used by an individual, to distinguish those worn or used by an individual: a. who: i. has satisfactorily completed any training course that meets or exceeds the U.S. Department of Transportation National Standard Curricula or has been approved by a State or Federal agency involved in the provision of emergency medical care; and ii. is authorized by a State or Federal agency involved in the provision of emergency medical care to participate in a qualified emergency medical care system; from those worn or used by an individual: b. who by title and function is authorized by a State or Federal agency involved in the provision of emergency medical care to administer, directly supervise, or otherwise participate in all or a specific part of a qualified emergency medical care system. Specifications BILLING CODE 4910-59-P ![]()
TN11AU94.004 [FR Doc. 94-19562 Filed 8-10-94; 8:45 am] BILLING CODE 4910-59-C