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Dr. KW asks:
I am having difficulty finding out the state regulations for a cone beam ct machine. Does anyone know what is involved in getting a CBCT and what is required for the state regulations or approvals needed to use it (I am in CT, by the way)? I have not been able to find a set of laws or guidelines anywhere. I have been told that it cannot be used in a dental office and requires a radiologist to read every scan. Is any of that true? Do different states have different regulations? I would appreciate any help.
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3 Responses to “ State Regulations for CBCT Machines? ”
Cone beam CT machines are dental devices approved by the FDA. As such dentists can own them and install them in their offices. On a state level, some states mandate a certificate of need to purchase and install these machines in dental offices. Up until recently, both Michigan and Connecticut required this, but I am certain efforts are being made to change this. With respect to requiring a radiology report, that’s a two-edged problem. OMSNIC, the oral surgeon’s malpractice carrier, just published recommendations in their quarterly newsletter stating that they felt radiology reports should accompany all 3D cone beam scans. So it may turn out that insurance carriers ask this of us going forward, in order to have our malpractice insurance cover us in case something is missed. Remember, dentists, by virtue of their licenses, are de facto radiologists. But can most of us interpret the expanded field of view on 3D images with a high degree of accuracy? That’s why teleradiology companies, like i-dontics, offers a radiology report by a board-certified oral & maxillofacial radiologist to all dentists. The other problem is that if you buy a CT machine and take scans for another dentist, your malpractice carrier will NOT cover you in case of a third party lawsuit. You need error & omission insurance for that. While it appears intriguing to get a CT machine and turn it into a business besides using it for your patients, there is lots to consider.
Contact the State Board, they would inform you about the requirements.
Additionally, you cannot “disclaimer” your way (ask for indemdification) out of your responsibility to diagnose what appears on the images. I see some companies issue a disclaimer for patients to sign indicating it is only for dental structures and the dentist is not responsible for anything else. This will not withstand legal scrutiny and the center and/or the dentist will be responsible for any failure to diagnose. I have a colleague examining two cases where masses were not identified on conebeam images by the dentists. Both dentists obtained “waivers of responsibility”, however motions for summary judgment based on those disclaimers were denied and the cases are moving forward. As such, if you’re considering conebeams, either have the cases read by a radiological specialist or refer the patient with the scan if anything is abnormal. The question you must ask yourself if you choose the latter, can you catch everything that is abnormal ?
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