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WHO IS ALLOWED TO PERFORM USER CERTIFICATIONS FOR LAUGH GAS SEDUCTION? AN OVERVIEW OF THE APPLICABLE DIRECTIVES
Nitrous oxide sedation has been established in Germany since 2010 as a standard method for minimal sedation of patients in dentistry. Responsible for this are a safe technique, clearly defined standards in the application and a high level of training through various training institutions.
The scientific consensus is clear: with a high level of training and certification of users and a standardized quality of application, nitrous oxide sedation is an integral, safe component of today’s dentistry.
WHAT ARE THE STANDARDS FOR “APPROPRIATE” EDUCATION FOR DENTISTS?
We would like to summarize here the most important statements of the relevant professional associations:
BZÄK POSITION PAPER OF 2018:
“The safe mastery of sedation procedures, including potential emergencies, requires in-depth training. The training is to be done by self-study using teaching materials and a 14-hour attendance course for minimal sedation with nitrous oxide as a mono-substance, …. The face-to-face course must include practical exercises.”[i]
“Training to perform sedation is provided by qualified dentists and/or physicians. “
To the position paper of the BZÄK
TRAINING STANDARDS OF THE GERMAN SOCIETY FOR DENTAL SEDATION E.V. FROM 2012
“ Training is provided by an anesthesiologist with theoretical expertise and extensive practical experience. He or she should have at least three years of post licensure professional experience in anxiolysis and analgesia techniques. The course consists of a minimum of 14 hours of instruction, including a clinical-practicum component in which the technique of nitrous oxide sedation is taught hands-on on a machine.”[ii]
To the training standards of the DGFDS
DGKIZ AND BDAI: SCIENTIFIC COMMUNICATION ON THE USE OF NITROUS OXIDE FOR MINIMAL SEDATION OF CHILDREN IN DENTISTRY 2013
“Sedation of children for dental procedures in office settings requires A training of all personnel involved in the process; The ability to apply requires a specific training (education and periodic training) required by, for example, the European Academy of Dentists(1997), the Council of European Dentists(CED) 2011 and the NICE Guidelines (2010).” [iv]
To the statement DGKIZ/BDA
CED RESOLUTION ON THE USE OF INHALED NITROUS OXIDE SEDATION IN DENTISTRY 2012
“Mandatory content of a 2-day theory course (10-14 hours): Anxiety and behavior management strategies, technical aspects of various sedation devices, chemical, physiological, and biological aspects of nitrous oxide, emergencies, and immediate life-saving measures. It is strongly recommended that anesthesiologists or “sedationists” be involved in teaching.”[iii]
About the CED guidelineFACIT
The broad consensus of all scientific institutions regarding the requirement for adequate training of responsible dentists for the independent use of nitrous oxide sedation is:
- the applying and responsible dentist should attend at least 2-day course
- Course instructors and speakers should be trained anesthesiologists or sedationists , also experienced in the use and training dentists are often described as adequate instructors, at least for parts of the curriculum
There is no scientific opinion that describescertification of users by medical device consultants as sufficient or permissible in the context of a device delivery in one day.
What about team training?
The medical-technical training of teams and assistants with regard to the handling, care and maintenance of a medical device is a completely different matter and lies in the area of the specifications of the MPG and the MPBetreibV. Such instruction and training must be carried out on a device-specific basis and can be performed by the manufacturers or their authorized specialists.
This does not constitute a certification for independent use on patients.
