Steven L. Essig, DDS
Chair, NYSDA Council on Dental Practice

Portable, hand-held X-ray devices are revolutionizing dentistry’s ability to improve access by enabling dentists to provide care to a greater variety of patients in settings outside the traditional dental office or hospital clinic. Once restricted by large, stationary X-ray machines, dentists now can practice in settings previously inaccessible. The hand-held X-ray device aids treatment in mobile clinics in remote areas and settings without dental operatories, e.g., nursing homes. These units facilitate treatment for young children and patients with physical disabilities. They are used in dental schools and for veterinary and forensic examinations as well.

Based on the recommendation by the NYSDA Council on Dental Practice, the NYSDA Board of Governors adopted resolution 11-N-08 at its November meeting:

Resolved: That NYSDA seek changes to the New York State Department of Health regulations to allow certification of portable, handheld X-ray machines that demonstrate acceptable safety standards.

The council made its recommendation after hearing a presentation from a company manufacturing a hand-held X-ray system.  While the specific device presented demonstrates adequate safety protection for both patients and operators, not all hand-held units marketed meets the same standards.

The New York State Health Department’s current regulations preclude the certification of this type of device. The use of such devices does not comply with two sections of the regulations found in Part 16 of the State Sanitary Code:

• Section 16.53(a)(7) – requires the operator to stand at least six feet from the patient and the X-ray tube or behind a protective barrier during an exposure
• Section 16.53(b)(3) – prohibits the holding of the X-ray tube during exposures.

Nonetheless, the Bureau of Environmental Radiation Protection has been granting variances certifying some units for individual applicants. These include private dental offices, dental schools and the New York State Forensic Investigation Center. After requests from NYSDA to update its regulations, the Bureau of Environmental Radiation Protection revised its application form to facilitate certification of hand-held units for dentists with appropriate training in using the device. The Bureau has updated its variance application, eliminating requirements that the machines be utilized only in specific “special” settings. The new form requires only a signature confirming that the dentist will adhere to certain requirements:

1. The unit is operated by authorized personnel who have been trained in the operation of the device.
2. Any person operating the hand-held unit must have his or her exposure to radiation monitored.  
3. The hand held-unit is operated only with the scatter shield in place.  
4. When not in use, the hand-held unit is secured to prevent inadvertent exposures or use by unauthorized personnel.

Dentists now wishing to utilize a hand-held unit will submit the signed variance form to the state when they register a machine. According to Gene Miskin, director of the New York City Department of Health’s Bureau of Radiological Health, the bureau will be developing its own variance form for applicants wishing to register hand-held X-ray devices.