By Anne Blythe
More than two years have passed since Hemant “Henry” Patel, a beloved and respected cardiologist, died in a New Hanover County hospital after a dental implant procedure spiraled out of his oral surgeon’s control.
During what was pitched as a routine procedure which should have taken no more than 30 minutes, Patel’s heart rate and oxygen saturation levels dropped to dangerously low levels while he was sedated.
Mark Austin, the former oral surgeon who put Patel under anesthesia before and during the implant procedure on July 30, 2020, has since consented to permanently surrender his dental license and agreed to participate in a program for health care workers with substance use problems.
There has been a call for new sedation and anesthesia rules in North Carolina’s dentistry profession since Patel’s premature death at age 53 on Aug. 3, 2020. Shital Patel, who describes herself as “a victim” and “a widow” on a mission, never thought she would lose the husband she expected to grow old with when she was only 47.
“My husband did not die of a disease, an illness, an accident,” Patel told the eight-member North Carolina State Board of Dental Examiners on Nov. 17. “He died at a dental office.”
Patel has advocated for all N.C. dentists who administer deep sedation and anesthesia to be required to have an anesthesiologist or certified registered nurse anesthetist, or CRNA, at their side when performing procedures on patients in a subconscious state.
That crusade has resulted in proposed changes to North Carolina’s dental anesthesia rules that seek to thread the needle between being stricter about how sedation is applied and not restricting access to care.
Michael Lee, a Republican state senator from Wilmington, set the potential for change in motion in May 2021 after approaching the dental board with Patel’s story and a strong recommendation.
Lee encouraged the board to change sedation and anesthesia policies and regulations through the state’s complicated and cumbersome rule-making process with the understanding that inaction could lead to his introduction of a Senate bill to amend the law.
Since then, the board has held public hearings and heard a hue and cry from oral surgeons, opposing any new regulation requiring a separate anesthesiologist or CRNA as an overreaction to an isolated and unfortunate event caused by an outlier in the profession.
A heavily attended public hearing in February brought a record number of responses for the board. Some supported the proposed changes. Others staunchly opposed them.
Oral surgeons argued that there is no science to support that requiring the presence of an anesthesiologist or CRNA would enhance patient safety or decrease the number of adverse events.
From the widespread opposition, a new rule change proposal was born.
On Sept. 9, the board considered a revised proposal developed by a task force and several committees. They considered comments from the state Department of Health and Human Services and the deans of North Carolina’s dental schools at East Carolina University and UNC-Chapel Hill.
Though many acknowledged the devastating loss of Patel, a revered member of the Wilmington community and cardiologists and health care providers nationally, they lamented that adding anesthesiologists and CRNAs into the mix could make emergency dental care cost-prohibitive and inaccessible for some.
Now a revised proposal is under consideration. The public has until Friday, Dec. 2 to submit comments to the board.
The North Carolina State Board of Dental Examiners is considering making changes to its sedation rules. To comment on the recommended revisions, email Bobby D. White, chief executive officer at [email protected].
The revised proposal includes some new requirements, according to a dental board statement, including:
- The use of capnography — the monitoring of carbon dioxide in the respiratory gasses during sedation;
- The timely delivery of other critical information such as the patient’s breathing, level of sedation and airway management during a procedure;
- Limits on the maximum dosage of medications that sedation providers can administer;
- The addition of dental board staff to resume routine, post-COVID-19 inspection of dental offices where anesthesia and sedation services are offered; and
- An enhancement of reporting requirements for adverse procedures.
“Notably absent from these proposed rules, however, is the requirement for a separate anesthesia provider to administer and deliver general anesthesia and sedation drugs when the treating dentist is performing certain dental procedures,” the board statement continues.
The board also plans to work with the state’s dental schools, community colleges and continuing education providers to develop a required course designed specifically for North Carolina permit holders and staff to address medical emergencies, including airway management. They also would explore the development of a similar program for dental assistants who could be dedicated to monitoring patients and providing support when a patient is sedated.
There was a point when the dental board considered moving ahead with what they described as “the medical model,” which would have required the presence of more staff in such situations.
DHHS opposed such a requirement, saying it would result in significant access barriers for NC Medicaid beneficiaries and the state’s children enrolled in the North Carolina Health Choice program for low-income families.
DHHS officials told the dental board the number of medical anesthesiologists and CRNAs who choose voluntarily to participate in the publicly funded insurance programs is very limited. The demand for dental services is high, according to DHHS.
Last year, 36,000 adults and 21,000 pediatric Medicaid and NCHC beneficiaries received anesthesia or sedation services under the current dental model, DHHS reported to the board.
A new requirement, DHHS and dental board members contended, might not only result in “serious harm or even death” from emergency dental infections, it could mean emergency departments across the state are inundated with patients seeking such oral health care.
“NC Medicaid’s chief concern is that NC Medicaid and NCHC patients will experience a delay in their treatment due to the higher priority assigned to the care of patients with commercial insurance,” Mark W. Casey, dental officer in the DHHS Division of Health Benefits, said in a four-page letter dated March 3, 2022, to the dental board. “We believe that the rule change’s impact has the potential to make a divide in the timeliness of care between private pay and publicly insured patients even wider than it is present.”
The deans of the UNC Adams School of Dentistry in Chapel Hill and the ECU School of Dental Medicine in Greenville issued a joint statement on Jan. 31, 2022, to the dental board. In their 19-page letter to Bobby White, the board’s executive director, Edward J. Swift, interim UNC dental school dean, and D. Gregory Chadwick, ECU dean, said that demanding a separate anesthesia provider is counter to standards of the Commission on Dental Accreditation through which all dental schools attain and maintain their accreditation.
Several advanced dental education programs require sedation training as an integral part of the training, the deans stated, Since no such program is available to dental students and recent graduates in North Carolina, the deans posited, dental residents would not be eligible to provide deep sedation, moderate sedation or pediatric moderate sedation, as the commission requires.
The proposed rule for a separate anesthetist or CRNA “specifies four types of practitioners who qualify as ‘dedicated anesthesia providers,’ however, none of those categories include a ‘resident in training’ or similar designation,” Swift and Chadwick wrote. “As such, UNC and ECU residents would not be eligible to provide deep sedation, moderate sedation or pediatric moderate sedation as required by CODA for accreditation, which could be a fatal blow to our programs.”
To require such measures, the board concluded, would have “far-reaching adverse consequences to numerous citizens in our state.”
All won’t be happy
Nonetheless, the board acknowledged the gulf between those advocating for restraint and those pushing for North Carolina to lead the way on a requirement that no other state has adopted.
“The board realizes that proposing rules that do not require the medical model will come as a disappointment to many,” the statement continues. “We do not wish this decision to be viewed as a callous disregard of those who have died due to anesthesia mishaps in dental offices.
“We know that each person who passed away was valued, loved and important to their families, friends and the communities in which they lived, worked and worshipped. This is especially true of Dr. Henry Patel about whom the board received hundreds of comments highlighting his outstanding character and the breadth of his love as a caring husband, father, friend and physician. We extend our deepest sympathy to his and to each family.”
At the Nov. 17 hearing, Patel’s widow took a moment to personalize the five other North Carolina cases since 2014 with outcomes similar to her husband’s in an emotional plea to the board.
“We are not here to ask for radical changes,” Patel said. “We are here to ask for appropriate changes. We are here to ask for saving the next family from what my children and I go through every single day.
“If it was not for my husband’s reputation, legacy, his case would not be discussed at the national-level medical meetings as well as dental meetings in the state that was discussed in North Carolina,” Patel added.
“I know this is not an easy decision in any way, but please do consider, every family matters. There is no threshold that needs to be reached for us to say, ‘Oh, you know what? We’ve lost too many. Let’s start looking for a change.’”
Too much weight in studies?
At the Nov. 17 hearing, several speakers questioned the studies submitted to the board by oral surgeons at a February public hearing, as well as in comments to the board since then. The research included studies showing there are about 34 deaths nationwide from dental anesthesia, with another 281 deaths where dental sedation was a contributing factor. Another study submitted argued that moving from the “dental model” to a “medical model” would not increase safety.
“Rather, requiring the medical model in dentistry could provide the public with the false sense that the medical model eliminates the risk of morbidity and mortality when this assumption is not supported by peer-reviewed studies,” the study argued.
Mary Ellen Bonczek, a chief nurse executive at New Hanover Regional Medical Center where Henry Patel worked and died, spoke at length at the Nov. 17 hearing. She questioned the board’s reliance on older studies.
“Requiring the shift to the ‘medical model’ will not eliminate the provision of office-based emergency services requiring dental anesthesia,” Bonczek said. “But it will require an interdisciplinary team approach and preplanning to ensure the appropriate team is assembled for the individualized safe plan for the patient.”
Similar to Patel, Bonczek urged the board to go beyond its recommended changes and do more to ensure “the dental profession merits and receives the confidence of the public.”
“No one is expecting that all risks are eliminated,” Bonczek told the dental board. “As the regulatory body, and oversight agency, the board has an ethical duty to keep patient safety in the forefront of decisions and ethically mitigate and reduce the risk of injuries and death.”
Joseph Hendrick, a Shelby dentist recently elected president of the North Carolina Dental Society, an advocacy organization for oral health care providers, said he supports the board’s most recent sedation rule proposal.
“Those changes do not require two sedation practitioners in the treatment area simultaneously, but those standards when properly followed, can and will have allowed for safe, efficient and effective treatment of our dental public,” Hendrick told the board on Nov. 17.
The board did not respond to speakers at its Nov. 17 meeting. In September, though, it tried to reassure the public that it holds safety in high regard.
Do your own checks
In its Sept. 9 statement, the board said “its duty is to remind the public that each death occurred not because current rules were weak or unenforced, or the current model ineffective. Rather, these deaths occurred primarily because individual practitioners made extremely poor choices and were negligent in the practice of dentistry and emergency preparedness.”
The board further stated that each oral health provider involved in an incident where a death occurred because of proven negligence by the provider “received appropriate discipline,” including permanent loss of their permits and licenses.
That did not stop the board, though, from encouraging North Carolinians and anybody else making a trip to the dentist from doing a bit of research on their own, especially when anesthesia and sedation services are recommended.
“Check the board’s website under the ‘license verification’ tab to determine if your dentist has been the subject of any disciplinary action,” its Sept. 9 statement urges.
The statement also encouraged consumers to ask about the cost and availability of having an anesthesia provider on hand, “if you believe it is to be in your best interest and choose another dentist if your request is denied.”