oth “The Joint Statement from the American Society of Anesthesiologists [ASA], the Society for Pediatric Anesthesia [SPA], the American Society of Dentist Anesthesiologists [ASDA], and the Society for Pediatric Sedation [SPS] Regarding the Use of Deep Sedation/General Anesthesia for Pediatric Dental Procedures Using the Single-Provider/Operator Model
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” (Joint Statement) and the 2019 update of the American Academy of Pediatrics and American Academy of Pediatric Dentistry “Guidelines for Monitoring and Management of Pediatric Patients Before, During and After Sedation for Diagnostic and Therapeutic Procedures
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” (2019 AAP/AAPD Guidelines) were prepared without the input of the American Association of Oral and Maxillofacial Surgeons (AAOMS).
AAOMS and its members have been dedicated to providing safe, cost-effective, and accessible anesthesia services for adult and pediatric patients in the outpatient setting for more than 60 years with an unparalleled safety record. AAOMS and its Board of Trustees have long had a focus on patient safety as a core value that drives the Association's policies and functions, embracing a multifaceted approach to support the strong and long-held belief in a culture of safety and especially anesthesia patient safety.
In providing pediatric anesthesia, AAOMS agrees with the Joint Statement that, “One must always be prepared for unexpected adverse events. For children, this most commonly means compromised breathing (apnea, airway obstruction, laryngospasm).” Working directly in the airway, the oral and maxillofacial surgeon is well-trained to recognize and treat such adverse events. The Joint Statement does recognize the ability of the oral and maxillofacial surgeon to provide pediatric anesthesia and deep sedation along with resuscitative measures, and explicitly states, the ASA, SPA, ASDA and SPS “…in the interest of safe oral surgery/dental care for all children, endorse the highest standards for procedural monitoring, administration of sedating drugs, and resuscitation by trained professionals independent of the operating surgeon/dentist, as clearly stated in the revised AAP guidelines.
The use of a second oral surgeon to manage sedation, monitoring and rescue would be entirely consistent with this standard.”
The concern expressed in the Joint Statement about the oral and maxillofacial surgery pediatric anesthesia model is not the education, training and anesthesia/resuscitative capabilities of the oral and maxillofacial surgeon, but, rather, the Joint Statement concern focuses on “…an appropriately qualified, dedicated monitor who is prepared to meaningfully help in the event of a patient emergency” for patients undergoing deep sedation/general anesthesia.
The Joint Statement and the 2019 AAP/AAPD Guidelines advocate for “…the provision of a second well-trained professional capable of monitoring the patient, managing the airway, establishing venous access for the administration of rescue medications, and resuscitation,” and terms this approach as “…the multi-provider team-based
safe practice model,” during the delivery of deep sedation/general anesthesia with the requirement that “…the surgeon or proceduralist and the professional responsible for the monitoring and sedation of the patient are two distinct individuals with separate patient-specific tasks.”
The Joint Statement contends that a separate medical anesthesiologist, dental anesthesiologist or CRNA (anesthetist) providing anesthesia for a pediatric patient with an operating general or pediatric dentist and dental assistant constitutes a “multi-provider team-based
safe practice model.” AAOMS disputes this claim of safety because the general dentist and general dental assistant providing deep sedation/general anesthesia in their offices most likely do not have the capability to establish venous access, administer drugs and provide airway assistance. Unfortunately, such capability also is rarely possessed by the pediatric dentist (even those with PALS certification) or the pediatric dental assistant. The limited anesthesia education and training of the general and pediatric dentist–and the general and pediatric dental assistant–does not cover those specific patient safety skills; therefore, they would not be considered an “appropriately qualified” or “well-trained” professional.
AAOMS takes issue with the Joint Statement's claim that the OMS pediatric anesthesia team model “…does not ensure an appropriately qualified, dedicated monitor who is prepared to meaningfully help in the event of a patient emergency” during deep sedation/general anesthesia, and disagrees with the Joint Statement's conclusions regarding the dental anesthesia assistant and the Dental Anesthesia Assistant National Certification Examination (DAANCE). The statement that DAANCE was specifically designed to circumvent the recommendations of the AAP is erroneous. AAOMS developed the Dental Anesthesia Assistant National Certification Examination (DAANCE) to strengthen the anesthesia team model. Awarded national certification status in 2009, DAANCE is administered by a professional certification testing agency. Through the rigorous test development, calibration process and job-analysis assessment, the examination has proven to be psychometrically superior and validates the understanding and competency of those individuals performing a unique set of job skills for which they are being tested.
It is crucial to understand the significant differences in anesthesia training received by different types of dental providers. The anesthesia training for oral and maxillofacial surgeons begins with OMS residency education standards that require a comprehensive 32-week medical/anesthesia rotation with a minimum of 20 weeks rotation on the medical anesthesia service and four weeks dedicated to pediatric anesthesia. This education is then followed by an ongoing outpatient experience in all forms of anesthesia throughout the four to six years of OMS training. The mandated training in an oral and maxillofacial surgery program is significantly more comprehensive than that required in a pediatric or general dentistry residency.
Once in practice, AAOMS members–as a basic membership requirement–must participate in a mandatory Office Anesthesia Evaluation (OAE) program. This 25-year-old program is continually updated and improved as new and safer anesthesia practices and initiatives are developed and adopted. The OAE program requires completion of an on-site inspection of OMS facilities to validate that the highest level of safety is provided to patients. These inspections include ensuring proper emergency safeguards are in place and proper patient selection protocols are adhered to, as well as compliance with all state law and permitting requirements and appropriate training of all staff in the OMS office.
AAOMS also has developed state-of-the-art anesthesia emergency management simulation training modules, which help maintain the OMS team's critical skills in emergency airway management and office-based crisis management. These courses and more in development will continue to enhance and promote safety and excellence provided by the well-trained OMS anesthesia team.
Of note, AAOMS was the first dental specialty organization to embrace the mandatory requirement of end-tidal carbon dioxide monitoring in the delivery of outpatient office-based anesthesia. AAOMS actively supported revisions of the American Dental Association's Council on Dental Education and Licensure anesthesia guidelines requiring the use of end tidal CO2 monitoring for moderate and deep sedation in the dental setting. These revised guidelines reflect the accepted definitions of light, moderate, and deep sedation without distinctions based on route of administration.
Neither the Joint Statement nor the 2019 AAP/AAPD Guidelines actually define pediatric age. Numerous organizations and published papers have indicated that cardiopulmonary development of children 8 years and older allow for resuscitative techniques similar to that of small adults, while children 7 and under require different resuscitative techniques. Both the 2016 AAP/AAPD Guidelines
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and the 2019 update
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have recognized that anesthesia for young pediatric patients differ from older patients and state:Children younger than 6 years or those with developmental delay often require an increased depth of sedation to gain control of their behavior. Children younger than 6 years (particularly those younger than 6 months) may be at greatest risk of an adverse event. Children in this age group are particularly vulnerable to sedating medication's effects on respiratory drive, airway patency, and protective airway reflexes.
The American Heart Association has published recommendations for “what defines an infant, child, and adult” in “Part 10: Pediatric Advanced Life Support” of the Emergency Cardiovascular Care (ECC) Guidelines of the American Heart Association
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, which state:
For the purposes of these guidelines, the term “child” refers to the age group from 1 year to 8 years.
The establishment of a pediatric age of 7 and under is logical for the purposes of anesthesia regulation.
Oral and maxillofacial surgeons perform hundreds of thousands of office-based sedations and anesthetic procedures with an impeccable safety record throughout the United States every year. AAOMS observes with interest that both the Joint Statement and the 2019 AAP/AAPD Guidelines overlook important risk factors that can be present in the ever-increasing use of the itinerant practice of anesthesia in dental offices. The OMS anesthetic safety focus is on patient selection, a personalized anesthetic plan and crisis management. The concerns with the itinerant practice of anesthesia in a dental office are that, all too often, the support staff is inadequately trained and unfamiliar to the “mobile anesthesiologist,” and the facility may not be designed for anesthesia delivery. AAOMS believes it is unethical to perform anesthesia in an unsafe or unsuitably staffed facility. The provider of both the dental procedure and the anesthesia must comply with state laws pertaining to permitting and licensing of any office facility, including staffing requirements. Safety weaknesses in the itinerant model of dental office-based anesthesia delivery have resulted in cases of severe morbidity/mortality that have occurred utilizing the “multi-provider team-based
safe practice model.”
AAOMS also is concerned that expert opinion–recognized by medical researchers as the lowest level in the hierarchy of evidence-based practice in healthcare–was the chosen methodology on which the rationale of the 2019 AAP/AAPD Guidelines is based. No new data or evidence was introduced by the AAP/AAPD into the background information to support the changes. Specifically, no scientific evidence other than opinion was introduced or provided to support changes in dental personnel for pediatric deep sedation/general anesthesia.
It also is essential that AAOMS be an active participant in any conversations related to the delivery of anesthesia in dental offices. Any revisions related to the anesthetic care of the dental patient should be made only with the expertise and clinical knowledge base of the OMS community.
In a 2018 editorial published by the American Academy of Pediatric Dentistry
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, its chief policy officer along with others discussed the current state of safety measures in pediatric dentistry; “Our first revelation was that we do not really know how safe pediatric or any type of dental practice really is. No registry exists for morbidity and mortality, even for sedation.” They also stated that “Dentistry is devoid of any sort of coordinated system to identify safety-related events and address them as is common in medicine and hospital care.”
To the contrary, AAOMS has developed the OMS Quality Outcomes Registry (OMSQOR) that is now collecting data from community OMS practices to compile baseline data with which to scientifically evaluate and validate the observed safety record of the OMS anesthesia team model of office-based anesthesia delivery. Further, based on the successful ASA incident data collection program Anesthesia Incident Reporting System (AIRS), AAOMS has developed and launched the Dental Anesthesia Incident Reporting System (DAIRS). These anonymous, de-identified, self-reported registries collect data on incidents and near-miss incidents that are sedation- and anesthesia-related. These data will be used to drive continuous patient safety improvement initiatives and continuing education programs.
Despite the highest levels of quality care and a continuous focus on safety, a small number of adverse events occur regardless of the safeguards in place. These rare events create negative publicity, which has devastating consequences to all parties involved–including the entire dental and medical community. In the recent past, pediatric sedation and anesthesia became a particular focus of the news media. Adverse events in this age group are understandably disturbing. With the intense media focus, emotions instead of science and evidence-based medicine are being used to enact changes to anesthesia guidelines and rules both in the law, and within some professional society groups.
A review of recent data show that:
In California, a retrospective review
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of pediatric (21 & under) anesthesia deaths from 1/1/2010 – 12/31/2015, with no reliable estimate of the number of patients treated, showed nine documented deaths broken out as follows: three involved office sedation/anesthesia (one of these was in an OMS office [Caleb Sears]), three occurred in hospital, and three involved local anesthesia or local plus nitrous oxide/oxygen. Of the three cases that involved office sedation or anesthesia, two involved the use of oral conscious sedation and one involved the use of general anesthesia (Caleb Sears).
Data presented to the California state legislature in 2016 from the OMS National Insurance Company (OMSNIC), which provides malpractice coverage for about 300 (about 50%) of OMSs in California, has shown that there were no mortalities reported over an 11-year period (2005-2015) preceding the SB 501 deliberations.
In Texas
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, a recent review of “major events” (mortality or permanent morbidity) and “mishaps” (no permanent morbidity) in cases investigated by the state dental board between 2011 and 2016 found six cases (five deaths, one brain damage). These cases were broken out as: two adults (both medically compromised) and four children (three were healthy; one had cardiac disease). None of these were OMS cases, and four of them involved a “second” anesthesia provider (of which two were physician anesthesiologists and one was a dentist anesthesiologist).
The reports from Texas and California support that complications occur for all types of providers and staffing models. It is generally accepted that most complications during anesthesia are due to airway issues and failures of recognition and appropriate well-rehearsed response to emergencies. This is why AAOMS has stressed a team model, including DAANCE for assistants, emergency airway management simulation training for providers and office-based crisis management for the entire anesthesia team.
Repeatedly, retrospective and prospective studies, individual case studies, surveys and closed claims reports have shown very low morbidity and mortality rates for OMS anesthesia delivery. In a 2003 prospective cohort study of more than 34,000 patients, Perrott
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et al., reported an overall complication rate of 1.3% for office-based ambulatory anesthesia by the OMS anesthesia team model. Most complications were minor and self-limiting, and no complications resulted in long-term adverse sequelae. There were no deaths reported in this study of more than 34,000 patients.
These data are not surprising. The typical office-based anesthetic involves less depth of anesthetic; the surgeries tend to be more minor and shorter in length, and they are interruptible; and the patients are relatively healthy individuals. Multiple academic papers published in peer-reviewed scientific journals attest to this safety record.
A critical examination of the citations included in the Joint Statement reveal that seven of the 19 corresponding references refer to position papers. Two of the references are essentially opinion pieces. One reference is the AAOMS web page describing the DAANCE program and seven of the references are either case reports or articles from media sources describing unfortunate outcomes. Only two of the references present what could be considered analysis of some primary data. One of those references (Lee et al., 2013
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) looks at 42 pediatric deaths associated with patients undergoing sedation or general anesthesia for dental procedures. Of those 42 cases, the anesthesia provider was determined to be a general dentist or pediatric dentist in 25, an oral and maxillofacial surgeon in eight, and an anesthesiologist in seven (in two cases, the anesthesia provider could not be determined). Of note, the data presented show similar results whether an oral and maxillofacial surgeon or an anesthesiologist was the anesthesia provider. It is safe to assume the oral and maxillofacial surgeon was likely practicing using the OMS anesthesia team model and the anesthesiologist was likely an additional provider. In fact, the greatest number of mortalities was associated with general dentists and pediatric dentists, who receive less extensive training in medical assessment and emergency management than that of an oral and maxillofacial surgeon or anesthesiologist.
The authors of the 2019 AAP/AAPD Guidelines intend for the document to direct the use of pediatric procedural sedation in all settings; however, it is important to recognize that all specialty organizations in medicine and dentistry produce such guidelines for their own members. As per their own disclaimer, the report “does not indicate an exclusive course of treatment or serve as a standard of medical/dental care. Variations, taking into account individual circumstances, may be appropriate.” For example, the use of procedural sedation administered by the operating physician for painful procedures is common in Emergency Medicine as well as in Gastroenterology and Interventional Radiology. The American College of Emergency Physicians (ACEP) guidelines for the clinical practice of procedural sedation define an anesthesia team that differs significantly from the AAP/AAPD Guidelines and, in turn, differs from the
Parameters of Care: AAOMS Clinical Practice Guidelines for Oral and Maxillofacial Surgery. Each medical or surgical specialty should craft its own guidelines as it is ultimately the most knowledgeable of the unique resources and personnel required to provide effective and safe patient care.
AAOMS contends that any new overly restrictive guidelines based on hyperbole, opinion, fueled by emotion, and without scientific and statistically valid support will do significant harm by 1) reducing access to care, 2) by increasing costs, 3) by limiting care availability to at-risk populations and 4) by likely increasing the demand on already-overburdened hospital emergency room resources. Any changes should only be proposed when there is supporting scientific evidence and all of these intended or unintended consequences are considered.
AAOMS is dedicated to a culture of anesthesia safety and has had anesthesia safety as a core value through its entire existence. Dentistry as a whole is encouraged to recognize the expertise of oral and maxillofacial surgeons and join AAOMS in the pursuit of an ever-improving patient safety experience, working in unity to effect ongoing change to improve safety through quality initiatives based on measures that are evidence-based and validated. In addition, state dental boards and all stakeholders in the delivery of office-based anesthesia should be reminded of the OMS safety record, including that many thousands of moderate/deep sedations and general anesthetics are safely provided annually by this group.
The AAOMS Board of Trustees and all AAOMS members–today and always–remain committed to providing the highest levels of safe, quality and cost-effective patient care.
www.asahq.org
. Hopefully you never have to slash trach or crich somebody, but some OMFS (not all) are trained to be able to do that.
