Six-year-old Caleb Sears died after receiving anesthesia for a dental procedure. The oral surgeon was busy operating when Caleb stopped breathing. He was unable to place a breathing tube so that Caleb’s brain could get the oxygen it needed.
After Caleb’s death, his family determined that no other family should have to experience such a devastating loss, worked with the California Legislature to create Caleb’s Law. The original version of the bill would have required:
“all oral surgeons and dentists performing deep sedation or general anesthesia on minors in California have a licensed anesthesiologist or certified registered nurse anesthetist present during the procedure, whose sole role is to monitor the patient.”
As often happens, the law was weakened during the legislative process, but a modified version was signed into law and became effective in California as of Jan 1, 2017. It updated the adverse event data collection, instituted a disclosure that anesthesia in dentistry is practiced differently than in medicine, and asked that the California dental board do a study on the safety for children undergoing anesthesia in dentistry and make recommendations to improve safety.
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What has happened since then?
The complete Dental Board met last December and discussed the study and proposed recommendations. One of the recommendations they voted to approve required, for children under age seven undergoing deep sedation or general anesthesia, that there always be a dedicated qualified anesthesia provider who is tasked with the administration and monitoring of the patient through the recovery period.
This anesthesia provider could be another qualified anesthesia-trained dentist, a physician anesthesiologist, or a certified nurse anesthetist. Other recommendations were a requirement that capnography be used to continually monitor the level of CO2 in the child’s blood, a sensitive indicator of whether there is adequate ventilation of the body. The Board also recommended that dentists who want to maintain a permit to sedate children to the deepest levels of sedation should perform a certain number of sedations on young children each year to remain active.
A bill to codify these Dental Board recommendations was introduced by Assembly Member Thurmond this year for legislative session 2017. This bill was sponsored by the American Academy of Pediatrics, CA (AAP-CA) and supported by the California Society of Anesthesiologists and the American Society of Dentist Anesthesiologists.
Simultaneously, the dental lobby, led by the California Association of Oral and Maxillofacial Surgeons, introduced a competing bill that they claimed codified “some” of the recommendations. Notably, the dental lobby’s bill did not require a separate trained anesthesia provider to monitor children, even for the highest risk and youngest patients, ages 0 to 6-years old. Their bill and current practice would continue to allow for an unlicensed dental assistant to monitor patients of all ages.
The dental assistant has many important jobs in the dental office but is not qualified to monitor patients undergoing deep sedation and general anesthesia. A dental assistant likely does not have any formal physiology education and sometimes their formal education stops at high school. They cannot interpret an EKG, recognize when there is an issue arising, or even help to rescue a patient from a pending disaster.
Anesthesia providers know that things can and do happen when people are given anesthesia drugs. Many studies have continued to show that the ability to recognize and to respond to an emerging disaster is the crucial skill needed to avoid adverse outcomes. This is why anesthesia experts throughout the country are pushing so hard to have anesthesia-trained individuals monitoring children undergoing deep sedation and general anesthesia in dental offices.
Although the AAP-CA sponsored bill codified what the Dental Board of California recommended, the dental lobby successfully prevented the bill from passing this legislative session. It will be up for reconsideration again next year. The dentists’ resistance to the bill stems completely from the requirement for a separate anesthesia-trained provider to be required for patients of any age. They claim that having this dedicated trained monitor would not prevent bad outcomes. But, anesthesia experts disagree.
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The American Society of Anesthesiologists (ASA) which establishes the standards of the medical practice of anesthesiology says in its Standards for Basic Anesthetic Monitoring that:
“Qualified anesthesia personnel shall be present in the room throughout the conduct of all general anesthetics, regional anesthetics, and monitored anesthesia care.”
The “Catch 22”
The dentists’ claims rest on the lack of data to support making the change. However, and this is the Catch 22, they are not collecting and tracking the needed data. Further, this claim is bogus because there really are no differences in the drugs that are used in dentistry for anesthesia and the drugs that used in medical settings. The idea that dental anesthesia is somehow different than anesthesia for any other type of surgery—or that dentists know more about anesthesiology than anesthesiologists—baffles most people involved in this legislative battle: The drugs used are the same, they are given to humans. There simply is no difference.
The problem legislatively is that medicine takes a lot of these safety measures for granted. In medicine, we are not doing studies on young children to see whether there are better outcomes when someone trained in anesthesia is dedicated to monitoring them versus the surgeon tasked with performing the procedure and the anesthesia simultaneously.
We decided years ago that it was safer to have a dedicated trained monitor who has the necessary skills to handle recognition of an emerging adverse event and rescue the patient. This is echoed in current practice throughout specialties, like the ASA’s and national policy guidelines published by the American Academy of Pediatric Dentistry (AAPD) and the American Academy of Pediatrics (AAP).
Dental organizations opposing this requirement simply do not have an incentive to do these studies because they do not want to see any change to this aspect of the anesthesia practice. Frankly, they see it as too costly.
Looking back, to ensure passage of the stronger legislation, it probably would have been better to start with clear and precise language contained in national policy guidelines and include references to published studies to support the changes we were trying to make. For example, the language in the AAPD guidelines on personnel required for deep sedation and general anesthesia has been recently been updated to include this language:
“Deep sedation/general anesthesia techniques in the dental office require at least three individuals:
- independently practicing and currently licensed anesthesia provider
- operating dentist
- support personnel.”
As we move forward, in the next year’s legislative session, we hope that this crafted language is clear enough so that our legislators will pass this critically important patient safety bill.
Annie Kaplan, MD, Michael Wong, JD, and Patricia Salber, MD, MBA
Annie Kaplan, MD (L) is Caleb Sears' aunt and a physician. She has been advocating on behalf of her family to make pediatric dental anesthesia safer both through change in practice and through public education. She has been instrumental in the crafting of Caleb's Law.
Michael Wong, JD (M) is the driving force behind the Physician-Patient Alliance for Health & Safety (PPAHS), an advocacy group of physicians, patient advocates, and healthcare organizations.
Patricia Salber, MD, MBA (R) is an internist, emergency physician, and Editor-in-Chief of The Doctor Weighs In. She is also a media advisor to PPAHS.
The death of Caleb Sears was very preventable. It started with the poor training that the OMFSs receive in pediatrics. Under the CODA guidelines oral surgery considers pediatrics 18 years and under. Under these guidelines, an oral surgeon may attempt placing a 6 year old to sleep when the only ‘pediatric’ experience they have is with teenagers.
The prevention continues with an OS who is ill prepared to manage emergencies, pediatric or otherwise. Not having all necessary medications in the operating room and dispensed for a patient of this size. It was practicing below the standard of care regardless of being an operator anesthetist or a mobile anesthesia provider. This line of thinking may have come from poor training in pediatrics. The OS knew that he had a problem but was ill prepared to manage it. It had nothing to do with him performing the surgery.
Accidents and deaths in dental anesthesia come in all forms, including the solo MD anesthesia provider. In the study completed by the Texas Dental Board, there were more deaths due to mobile practitioners in that five year period and none reported as caused by oral surgery offices. I read an article by Dr. Charles Cote in which he describes what he thinks is the accident of the operator/anesthetist. But, what he was actually describing was the practice of the mobile anesthesia provider who may have no more help than a dental office that is only trained in BLS. Eventually, the dental office may have some exposure in managing airways but this comes with time and repetition. How many mobile anesthesia providers only visit an office once a month or less? Essentially, these mobile anesthesia providers must manage complications solo in many circumstances.
Dental assistants can become very good airway managers. Essentially, a Certified Dental Assistant and RN have the same amount of training in airway management coming out of school. Virtually NONE. It is the day in and day out exposure to anesthesia and airway management that makes the assistant proficient.
In summary, all anesthesia providers need to improve their practice in dental offices. Dental boards need to examine the actually training of the anesthesia providers in pediatrics and how many cases they perform per year to maintain it. Mobile anesthesia providers need to consider having a trained assistant, CDA or RN. There are also cases of M&M where the mobile anesthesia provider does not have all the needed equipment. Office inspections with equipment in place should be considered.
These are not popular options.
Caleb’s Law should be focused on the level of training of the anesthesia provider and not the mode of practice.
Ensuring all healthcare clinicians are properly trained for their role is a core purpose of Osler. Healthcare in general needs to take certification for practice far more seriously : https://www.osler.community/osler-blog/2017/10/16/certification-in-health-time-to-get-serious
Osler is dedicated to providing clinicians with all the information they need, including collecting data that allows us to enhance standards of practice. To see how this can work, see here : httpss://learning.oslertechnology.com/demo/product_demo/story.html
The American Dental Association Council on Dental Education and Licensure endorses the monitoring of dental patients undergoing sedation and, in particular, the use of capnography to monitoring these patients – httpss://bit.ly/2lkXxUT:
“believes the use of capnography in all office-based procedures requiring moderate, deep or general anesthesia aids the provider and offers an important measure of safety for the patient. The use of such capnography monitoring equipment for office-based anesthesia-related procedures has been shown to provide real benefits for the provider and a safer experience for patients. Capnography, long the standard of care in the hospital OR, has been greatly improved and is quickly becoming an important asset in the ambulatory surgical setting as well.”
The Oral Surgeon lobby is very powerful and succeeded in preventing the passage of a law codifying the recommendations of the dental board. It is all about money. The oral surgeons don’t want the money they get from providing anesthesia to go to someone else, i.e. a separate anesthesia provider. It is shameful.
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